City of Lorain v. Purdue Pharma L.P. et al

Filing 1

Notice of Removal from Lorain County Court of Common Pleas, case number 17 CV 192705 with jury demand, Filing fee paid $ 400, receipt number 0647-8271689.. Filed by Endo Health Solutions Inc. (Attachments: #1 Civil Cover Sheet, #2 Exhibit 1 State Court Documents, #3 Exhibit 2 Miscellaneous Case Documents, #4 Exhibit 3 Case Law, #5 Exhibit 4 Case Law) (Coleman, Tera) Modified text on 8/4/2017 (P,WL).

EXHIBIT 1

Service of Process
Transmittal
07/10/2017
CT Log Number 531543403

TO:

Carol Purcell
Endo Pharmaceuticals Inc.
1400 Atwater Dr
Malvern, PA 19355-8701

RE:

Process Served in Delaware

FOR:

Endo Pharmaceuticals Inc.  (Domestic State: DE)

ENCLOSED ARE COPIES OF LEGAL PROCESS RECEIVED BY THE STATUTORY AGENT OF THE ABOVE COMPANY AS FOLLOWS:
TITLE OF ACTION:

THE CITY OF LORAIN, Pltf. vs. PURDUE PHARMA L.P., et al., Dfts. // To: Endo
Pharmaceuticals Inc.

DOCUMENT(S) SERVED:

Summons, Complaint

COURT/AGENCY:

Lorain County Common PLeas Court, OH
Case # 17CV192705

NATURE OF ACTION:

Product Liability Litigation - Drug Litigation - Opioid

ON WHOM PROCESS WAS SERVED:

The Corporation Trust Company, Wilmington, DE

DATE AND HOUR OF SERVICE:

By Certified Mail on 07/10/2017 postmarked: "Not Post Marked"

JURISDICTION SERVED :

Delaware

APPEARANCE OR ANSWER DUE:

Within 28 days after service, exclusive of the day of service (Document(s) may
contain additional answer dates)

ATTORNEY(S) / SENDER(S):

John R. Clirnaco
CLIMACO, WILCOX, PECA, & GAROFOLI, C.O., L.P.A
55 Public Square, Suite 1950
Cleveland, OH 44113

ACTION ITEMS:

CT has retained the current log, Retain Date: 07/10/2017, Expected Purge Date:
07/15/2017
Image SOP
Email Notification,  Jobina Jones-McDonnell  [e-mail]
Email Notification,  Helen Howlett  [e-mail]
Email Notification,  Marian Gustafson  [e-mail]
Email Notification,  Carolyn Hazard  [e-mail]
Email Notification,  Par Notice Dept  [e-mail]
Email Notification,  Carol Purcell  [e-mail]

SIGNED:
ADDRESS:

The Corporation Trust Company
1209 N Orange St

Page 1 of  2 / HN
Information displayed on this transmittal is for CT
Corporation's record keeping purposes only and is provided to
the recipient for quick reference. This information does not
constitute a legal opinion as to the nature of action, the
amount of damages, the answer date, or any information
contained in the documents themselves. Recipient is
responsible for interpreting said documents and for taking
appropriate action. Signatures on certified mail receipts
confirm receipt of package only, not contents.

Service of Process
Transmittal
07/10/2017
CT Log Number 531543403

TO:

Carol Purcell
Endo Pharmaceuticals Inc.
1400 Atwater Dr
Malvern, PA 19355-8701

RE:

Process Served in Delaware

FOR:

Endo Pharmaceuticals Inc.  (Domestic State: DE)

TELEPHONE:

Wilmington, DE 19801-1120
302-658-7581

Page 2 of  2 / HN
Information displayed on this transmittal is for CT
Corporation's record keeping purposes only and is provided to
the recipient for quick reference. This information does not
constitute a legal opinion as to the nature of action, the
amount of damages, the answer date, or any information
contained in the documents themselves. Recipient is
responsible for interpreting said documents and for taking
appropriate action. Signatures on certified mail receipts
confirm receipt of package only, not contents.

TOM ORLANDO
Lorain County Clerk of Courts
225 Court St. First Floor
Elyria, OH 44035-5512

LI 1 1 1 1111

9414 7266 9904 2088 2314 56

7)FlI

-Co

05. posTAGE

C

$

U040143'200 JUL 03

17CV192705
ENDO PHARMACEUTICALS INC
C/O THE CORPORATION TRUST CO
1209 ORANGE ST
WILMINGTON DE 19801

LORAIN COUNTY COURT OF.n-OMMON PLEAS
LORAIN COUNTY JUSTICE CENTER
225 COURT STREET
ELYRIA, OHIO 44035
CASE NO. 17CV192705

LORAIN OHIO (CITY OF)
200 WEST ERIE AVE
LORAIN, OH 44052
VS.
TO: ENDO PHARMACEUTICALS INC
C/O THE CORPORATION TRUST CO
1209 ORANGE ST
WILMINGTON, DE 19801

SUMMONS ON COMPLAINT
You have been named defendant in a complaint filed in Lorain County Court of Common Pleas by
plaintiff(s):
LORAIN OHIO (CITY OF)
200 WEST ERIE AVE
LORAIN, OH 44052
A copy of the complaint is attached hereto. The name and address of the plaintiff's attorney is:

tr

DAVID M CUPPAGE
CLIMACO WILCOX PECA & GAROFOLI CO LPA
55 PUBLIC SQUARE SUITE 1950
CLEVELAND, OH 44113
You are hereby summoned and required to serve a copy of your answer to the complaint upon the
plaintiff's attorney, or upon the plaintiff, if he has no attorney of record, within TWENTY-EIGHT (28) DAYS
after service of this summons on you, exclusive of the day you receive it. Your answer must ALSO be
filed with this Court within three (3) days after you serve, (delivered or by mail), a copy of your answer on
the plaintiff's attorney.
If you fail to appear and defend, judgment by default will be rendered against you for the relief demanded
in the complaint.
TOM ORLANDO
CLERK OF COURTS OF COMMON PLEAS
LORAIN COUNTY, OHIO
6/30/2017
BY: _
Deputy Clerk

e/2 d

*17CV192705*

FILED
LORAIN COUNTY
;2011 JUN 29 A 8:33
COURT OF COt;MON PLEAS
TOM ORLANDO

IN THE COURT OF COMMON PLEAS

THE CITY OF LORAIN,
200 West Erie Avenue

Lorain, Ohio 44052

wRAIN

IrcICV 192705
JUDGE:JUDGE RAYMOND J. EWERS

Plaintiff,
V.
PURDUE PHARMA L.P.
do The Prentice Hall Corporation
2711 Centerville Road
Wilmington, DE 19808
and
PURDUE PHARMA INC.
do The Prentice Hall Corporation
2711 Centerville Road
Wilmington, DE 19808
and
THE PURDUE FREDERICK COMPANY, INC.
do The Prentice Hall Corporation
2711 Centerville Road
Wilmington, DE 19808
and
TEVA PHARMACEUTICALS USA, INC.
do Corporate Creations Network Inc.
3411 Silverside Road
Wilmington, DE 19810
and

COMPLAINT FOR DAMAGES
(JURY DEMAND HEREON)

CEPHALON, INC.
do Corporate Creations Network Inc.
3411 Silverside Road
Wilmington, DE 19810
and
JOHNSON & JOHNSON
One Johnson & Johnson Plaza
New Brunswick, NJ 08933
and
JANSSEN PHARMACEUTICALS, INC.
116 Pine Street, Suite 320
Harrisburg, PA 17101
and
ORTHO-MCNEIL-JANSSEN
PHARMACEUTICALS, INC. N/K/A JANSSEN
PHARMACEUTICALS, INC.
116 Pine Street, Suite 320
Harrisburg, PA 17101
and
. JANSSEN PHARMACEUTICA, INC. N/K/A
'JANSSEN PHARMACEUTICALS, INC.
116 Pine Street, Suite 320
Harrisburg, PA 17101
and
ENDO PHARMACEUTICALS, INC.
do The Corporation Trust Co.
1209 Orange Street

Wilmington, DE 19801
and
ALLERGAN PLC F/K/A ACTAVIS PLC
CT Corporation System
4400 Easton Commons Way, Suite 125
Columbus, Ohio 43215

and
ACTAVIS, INC. F/K/A WATSON
PHARMACEUTICALS, INC.
Corporate Creations Network, Inc.
119 E. Court Street
Cincinnati, Ohio 45202
and
WATSON LABORATORIES, INC.
Corporate Creations Network Inc.
119 E. Court Street
Cincinnati, OH 45202
and
ACTAVIS LLC
Corporate Creations Network Inc.
119 E. Court Street
Cincinnati, OH 45202
and
ACTAVIS PHARMA, INC. F/K/A WATSON
PHARMA,
Corporate Creations Network Inc.
119 E. Court Street
Cincinnati, OH 45202
and
ENDO HEALTH SOLUTIONS INC.
do The Corporation Trust Co.
1209 Orange Street
Wilmington, DE 19801
and
MCKESSON CORPORATION
50 West Broad Street, Suite 1330
Columbus, Ohio 43215
and

CARDINAL HEALTH, INC.
7000 Cardinal Place
Dublin, Ohio 43017
and
AMERISOURCEBERGEN CORPORATION
1300 East Ninth Street
Cleveland, Ohio 44114
and
RUSSELL PORTENOY
39 Broadway, 1St Floor
New York, NY 10006
and
PERRY FINE
615 Arapeen Way, Suite 155
Salt Lake City, UT 84132
and
SCOTT FISHMAN
2221 Stockton Blvd.
Sacramento, CA 95817
and
LYNN WEBSTER
PRA Health Sciences
3838 S 700 E #202
Salt Lake City, UT 84106
Defendants.

>

INTRODUCTION
PARTIES
Plaintiff.
Defendants.
FACTS RELEVANT TO ALL CAUSES OF ACTION

1
13
13
13
28

A. Background on Pain Medicine
28
Safe and Effective Treatment of Chronic Pain Centers on Informed Risk Management

28
Opioid Use Is Associated with Known and Substantial Risks.
29
Long-Term Opioid Use Benefits Are Unproven and Contradicted.
35
Defendants' Impact on the Perception and Prescribing of Opioids.
38
B. Defendants Promoted Their Branded Products Through Direct Marketing to Prescribers
and Consumers.
40
1. Defendants Relied Upon Branded Advertisements.
40
2. Defendants Relied Upon Their Sales Forces and Recruited Physician Speakers. 41
3. Defendants Directed These Promotional Efforts Through Detailed Marketing Plans. 45
Targeting categories of prescribers
45
Increasing "direct to consumer" marketing
46
Differentiating each brand
46
Moving beyond office visits
47
4. Defendants Marketed Opioids in Lorain Using the Same Strategies and Messages They
Employed Nationwide.
48
C. Defendants Used "Unbranded" Marketing to Evade Regulations and Consumer
Protection Laws.
49
Regulations Governing Branded Promotion Require that it Be Truthful, Balanced, and
Supported by Substantial Evidence.
49
Defendants Deployed Front Groups and Doctors to Disseminate Unbranded
Information on Their Behalf.
51
a. Defendants' Use of KOLs
54
Defendant Russell Portenoy.
56
Defendant Lynn Webster
58
b. "Research" That Lacked Supporting Evidence
59
c. Treatment Guidelines
62
i. FSMB
62
AAPM/APS guidelines
64
American Geriatrics Society
65
Guidelines That Did Not Receive Defendants' Support
66
d. Continuing Medical Education
68
Unbranded Patient Education
70
Defendants' Use of Front Groups
70
American Pain Foundation
71
The American Academy of Pain Medicine
73

Defendants Acted in Concert with KOLs and Front Groups in the Creation, Promotion,
and Control of Unbranded Marketing
74
Defendants Targeted Vulnerable and Lucrative Populations.
76
The Elderly
76
Veterans
77
D. Why Defendants' Marketing Messages Are Misleading and Unfair
79
Defendants and Their Third-Party Allies Misrepresented that Opioids Improve
80
Function
Defendants and Their Third-Party Allies Concealed the Truth About the Risk of
Addiction from Long-Term Opioid Use
85
Defendants and Their Third-Party Allies Misrepresented that Addiction Risk Can Be
Avoided or Managed
95
Defendants and Their Third-Party Allies Created Confusion By Promoting the
97
Misleading Term "Pseudoaddiction "
Defendants and Their Third-Party Allies Claimed Withdrawal is Simply Managed 99
Defendants and Their Third-Party Allies Misrepresented that Increased Doses Pose No
101
Significant Additional Risks
Defendants and Their Third-Party Allies Deceptively Omitted or Minimized Adverse
Effects of Opioids and Overstated the Risks of Alternative Forms of Pain Treatment. 104
Purdue Misleadingly Promoted OxyContin as Providing 12 Hours of Relief 107
E. Each Defendant Engaged in Deceptive Marketing, Both Branded and Unbranded, that
111
Targeted and Reached City Prescribers.
112
1. Acatvis
Actavis' Deceptive Direct Marketing
112
i. Actavis' Deceptive Sales Training
114
117
Actavis' Deceptive Speaking Training
Actavis's Deceptive Statements to City of Lorain Prescribers and Patients 120
120
2. Cephalon
121
a. Cephalon's Deceptive Direct Marketing
i. Cephalon's Fraudulent Off-Label Marketing of Actiq and Fentora 121
Cephalon launched its fraudulent marketing scheme for Actiq 122
October 1, 2006 — Cephalon fraudulently marked Actiq's successor drug,
123
Fentora
September 2007 — Reports of death and serious side effects led the FDA to
issue a public health warning for Fentora
126
d) May 6, 2008 — The-FDA- rejected-Cephalon's request for expanded-approval of
Fentora
127
March 26, 2009 —the FDA's Division of Drug Marketing, Advertising and
Communications ("DDMAC") warned Cephalon about its misleading advertising of
128
Fentora
Cephalon continues to knowingly, deceptively, and illegally promote Fenotra
129
for off-label uses
Cephalon's Misrepresentation of the Risks Associated with the Use of Opioids for
130
the Long-Term Treatment of Chronic Pain
132
b. Cephalon's Deceptive Third-Party Statements

132
i. FSMB — Responsible Opioid Prescribing
APF — Treatment Options: A Guide for People Living with Pain 133
136
Key Opinion Leaders and Misleading Science
137
Misleading Continuing Medical Education
140
c. Cephalon's Deceptive Third-Party Statements to City Prescribers and Patients
140
3. Endo
141
a. Endo's Deceptive Direct Marketing
141
i. Endo's Sales Force and Deceptive Sales Training
Endo's Sales Force Deceptively Minimized the Risks of Addiction Associated
144
with Chronic Opioid Therapy.
Endo's Sales Force Deceptively Implied that Chronic Opioid Therapy Would
146
Improve Patients' Ability to Function.
Endo's Sales Force Deceptively presented the Risks and Benefits of Opioids to
148
Make Them Appear Safer Than Other Analgesics
Endo's Speakers Bureau Programs Deceptively Minimized the Risks of Addiction
148
Associated with Chronic Opioid Therapy
150
Endo's Misleading Journal Supplement
150
Endo's Deceptive Unbranded Advertising
151
b. Endo's Deceptive Third-Party Statements
152
i. APF
155
a) Misleading Medical Education
157
b) Pain Knowledge
158
c) Exit Wounds
159
Front Groups: FSMB, AAPM, and AGS
ii. Other
161
iii. Key Opinion Leaders and Misleading Science
165
c. Endo's Deceptive Statements to City Prescribers and Patients
166
4. Janssen
167
a. Janssen's Deceptive Direct Marketing
167
i. Janssen's Deceptive Sales Training
169
ii. Janssen's Deceptive Speakers Bureau Programs
170

iii. Janssen's Deceptive Unbranded Advertising
171
b. Janssen's Deceptive Third-Party Statements
i. AAPM and AGS — Finding Relief: Pain Management for Older Adults 171
174
AGS — Misleading Medical Education
175
APF
175
Let's Talk Pain
179
Exit Wounds
c. Janssen's Deceptive Statements to Lorain Prescribers and Patients 179
179
i. Janssen's Deceptive Medical Education Programs in Lorain
179

ii. Janssen's Deceptive Detailing Practices in Lorain
180
5. Purdue
180
a. Purdue's Deceptive Direct Marketing
185
b. Purdue's Deceptive Third-Party Statements
185
i. APF
185
Purdue's Control of APF
190
A Policymaker's Guide
111

192
c) Treatment Options: A Guide for People Living with Pain
Work with Other Third Party Front Groups and KOLs 193
ii. Purdue's
193
FSMB — Responsible Opioid Prescribing
AGS — Pharmacological Management of Persistent Pain in Older Persons 194
Chronic Pain Management and Opioid Use: Easing Fears, Managing Risks, and
195
Improving Outcomes
Managing Patient's Opioid Use: Balancing the Need and Risk 195
Path of the Patient, Managing Chronic Pain in Younger Adults at Risk for
195
Abuse
196
0 Overview of Management Options
197
iii. Purdue's Misleading Science
a) Purdue's Deceptive Statements to Lorain Prescribers and Patients 197
199
F. The Result of Defendants' Fraudulent Scheme
1. Defendants' Fraudulent and Deceptive Marketing of Opioids Directly Caused Harm to
199
Lorain.
200
a. Increase in Opioid Prescribing Nationally
207
a. The City's Increased Spending on Opioids
207

Defendants' Misrepresentations Were Material
The City's Increased Costs Correlate with Defendants' Promotion 209
2. Defendants' Fraudulent and Deceptive Marketing of Opioids Directly Caused Harm to
209
Lorain Consumers.
Increased Opioid Use Has Led to an Increase in Opioid Abuse, Addiction, and
209
Death
Increased Opioid Use Has Increased Costs Related to Addiction Treatment 210
Increased Opioid Use Has Fueled An Illegal Secondary Market for Narcotics and the
211
Criminals Who Support It
212
3. Defendants' Fraudulent Marketing Has Led to Record Profits
213
Fraudulently Concealed Their Misrepresentations
4. Defendants

iv

Plaintiff, the City of Lorain, Ohio ("Plaintiff," "City," or "City of Lorain"), by and through its
undersigned attorneys, for its Complaint against Defendants Purdue Pharma L.P.; Purdue Pharma Inc.;
the Purdue Frederick Company, Inc.; Teva Pharmaceuticals USA, Inc.; Cephalon, Inc.; Johnson &
Johnson; Janssen Pharmaceuticals, Inc.; Janssen Pharmaceutica, Inc. n/k/a Janssen Pharmaceuticals,
Inc.; Ortho-McNeil-Janssen Pharmaceuticals, Inc. n/k/a Janssen Pharmaceuticals, Inc.; Endo Health
S.olutions Inc.; Endo Pharmaceuticals, Inc.; Allergan plc f/k/a Actavis plc; Actavis, Inc. f/k/a Watson
Pharmaceuticals, Inc.; Watson Laboratories, Inc.; Actavis LLC; and Actavis Pharma, Inc. f/k/a
Watson Pharma, Inc. (collectively, "Manufacturers" or "Defendants"); McKesson Corporation,
Cardinal Health Inc., Amerisource Drug Corporation (Collectively, "Distributor Defendants" or
"Defendants") Russell Portenoy; Perry Fine; Scott Fishman; and Lynn Webster; (collectively,
"Physicians" or "Defendants") alleges as follows:
INTRODUCTION
This case is about one thing: corporate greed. Defendants put their desire for profits
above the health and well-being of the City of Lorain consumers at the cost of Plaintiff.
The City of Lorain provides a wide range of services to its residents, including law
enforcement, fire, emergency medical services, and general services for families and children, and
public assistance.
In recent years, the City of Lorain has been forced to expend exorbitant amounts of
money, described further below, due to what is commonly referred to as the "opioid epidemic" and as
a direct result of the actions of Defendants.
Plaintiff is one of the largest employers in Lorain County, Ohio, employing around 455
people. Plaintiff is also responsible for partially funding a medical insurance plan for its employees.
Defendants knew that opioids were effective treatments for short-term post-surgical
and trauma-related pain, and for palliative (end-of-life) care. Yet they also knew—and had known for
1

years—that opioids were addictive and subject to abuse, particularly when used long-term for chronic
non-cancer pain (pain lasting three months or longer, hereinafter referred to as "chronic pain"), and
should not be used except as a last-resort.
Defendants further knew—and had known for years—that with prolonged use, the
effectiveness of opioids wanes, requiring increases in doses and markedly increasing the risk of
significant side effects and addiction.L 2
Defendants also knew that controlled studies of the safety and efficacy of opioids were
limited to short-term use (not longer than 90 days), and in managed settings (e.g., hospitals), where the
risk of addiction and other adverse outcomes was much less significant.
Indeed, the U.S. Food and Drug Administration ("FDA") has expressly recognized that
there have been no long-term studies demonstrating the safety and efficacy of opioids for long-term
use.3
Prescription opioids, which include well-known brand-name drugs like OxyContin and
Percocet, and generics like oxycodone and hydrocodone, are narcotics. They are derived from or
possess properties similar to opium and heroin, which is why they are regulated as controlled
substances.4 Like heroin, prescription opioids work by binding to receptors on the spinal cord and in

I See, e.g., Russell K. Portenoy, Opioid Therapy for Chronic Nonmalignant Pain: Current Status, 1 Progress in
Pain Res. & Mgmt. 247 (1994).
2 The authoritative Diagnostic and Statistical Manual of Mental Disorders, (5th ed. 2013) ("DSM-V")
classifies addiction as a spectrum of "substance use disorders" that ranges from misuse and abuse of
drugs to addiction. Patients suffer negative consequences wherever they fall on the substance use
disorder continuum. Throughout this Complaint, "addiction" refers to this range of substance use
disorders.
3 Letter from Janet Woodcock, M.D., Dir., Ca. for Drug Eval. & Res., to Andrew Kolodny, M.D.,
Pres. Physicians for Responsible Opioid Prescribing, Re Docket No. FDA-2012-P-0818 (Sept. 10,
2013).
4 Since passage of the Controlled Substances Act ("GSA") in 1970, opioids have been regulated as
controlled substances. Controlled substances are categorized in five schedules, ranked in order of their
potential for abuse, with Schedule I being the highest. The GSA imposes a hierarchy of restrictions on
prescribing and dispensing drugs based on their medicinal value, likelihood of addiction or abuse, and
2

the brain, dampening the perception of pain. Opioids also can create a euphoric high, which can make
them addictive. At certain doses, opioids can slow the user's breathing, causing respiratory depression
and, ultimately, death.
In order to expand the market for opioids and realize blockbuster profits, Defendants
needed to create a sea change in the medical and public perception that would permit the use of
opioids not just for acute and palliative care, but also for long periods of time to treat more common
aches and pains, like lower back pain, arthritis, and headaches.
Defendants, through a sophisticated and highly deceptive and unfair marketing
campaign that began in the late 1990s, deepened around 2006, and continues to the present, Set out to,
and did, reverse the popular and medical understanding of opioids. Chronic opioid therapy—the
prescribing of opioids to treat chronic pain long-term—is now commonplace.
To accomplish this. reversal, Defendants spent hundreds of significant of dollars: (a)
developing and disseminating seemingly truthful scientific and educational materials and advertising
that misrepresented the risks, benefits, and superiority of opioids used long-term to treat chronic pain
(b) deploying sales representatives who visited doctors and other prescribers and delivered misleading

safety. Opioids generally had been categorized as Schedule II or Schedule III drugs. Schedule 11 drugs
have a high potential for abuse, have a currently accepted medical use, and may lead to severe
psychological or physical dependence. 21 U.S.C. 5 812. Schedule II drugs may not be dispensed
without an original copy of a manually signed prescription from a doctor, which may not be refilled,
and filled by a pharmacist who both must be licensed by their state and registered with the DEA. 21
U.S.C. 5 829. Opioids that have been categorized as Schedule II drugs include morphine (Avinza,
Embeda, Kadian, MS Contin), fentanyl (Duragesic, Actiq, Fentora), methadone, oxycodone
(OxyContin, Percocet, Percodan, Tylox), oxymorphone (Opana), and hydromorphone (Dilaudid,
Palladone). Schedule III drugs are deemed to have a lower potential for abuse, but their abuse still may
lead to moderate or low physical dependence or high psychological dependence. 21 U.S.C. 5 812.
Schedule III drugs may not be dispensed without a written or oral prescription, which may not be
filled or refilled more than six months after the date of the prescription or be refilled more than five
times. 21 U.S.C. § 829. Some opioids had been categorized as Schedule III drugs, including forms of
hydrocodone and codeine combined with other drugs, like acetaminophen. However, in October 2013,
the FDA, following the recommendation of its advisory panel, reclassified all medications that contain
hydrocodone from Schedule III to Schedule II. See 21 C.F.R. § 1308.
3

messages about the use of opioids (c) recruiting prescribing physicians as paid speakers as a means of
both securing those physicians' future "brand loyalty" and extending their reach to the physicians'
peers; (d) funding, assisting, encouraging, and directing certain doctors, known as "key opinion
leaders" ("KOLs"), not only to deliver scripted talks, but also to draft misleading studies, present
continuing medical education programs ("CMEs") that were deceptive and lacked balance, and serve
on the boards and committees of professional societies and patient advocacy groups that delivered
messages and developed guidelines supporting chronic opioid therapy; and (e) funding, assisting,
directing, and encouraging seemingly neutral and credible professional societies and patient advocacy
groups (referred to hereinafter as "Front Groups") that developed educational materials and treatment
guidelines that were then distributed by Defendants, which urged doctors to prescribe, and patients to
use, opioids long-term to treat chronic pain.
13. These efforts, executed, developed, supported, and directed by Defendants, were
designed not to present a fair view of how and when opioids could be safely and effectively used, but
rather to convince doctors and patients that the benefits of using opioids to treat chronic pain
outweighed the risks and that opioids could be used safely by most patients. Defendants and the third
parties whom they recruited and supported, all profited handsomely through their dissemination of
these deceptions. KOLs and Front Groups saw their stature in the medical community elevated
dramatically due to Defendants' funding, and Defendants saw an equally dramatic rise in their
revenues.
14. Working individually, with, and through these Front Groups and KOLs, Defendants
pioneered a new and far broader market for their potent and highly addictive drugs— the chronic pain
market. Defendants persuaded doctors and patients that what they had long understood—that opioids
are addictive drugs and unsafe in most circumstances for long-term use— was untrue, and to the
contrary, that the compassionate treatment of pain required opioids. Ignoring the limitations and
4

cautions in their own drugs' labels, Defendants: (a) overstated the benefits of chronic opioid therapy,
promised improvement in patients' function and quality of life, and failed to disclose the lack of
evidence supporting long-term use; (b) trivialized or obscured their serious risks and adverse
outcomes, including the risk of addiction, overdose, and death; (c) overstated their superiority
compared with other treatments, such as other non-opioid analgesics, physical therapy, and other
alternatives; and (d) mischaracterized the difficulty of withdrawal from opioids and the prevalence of
withdrawal symptoms. There was, and is, no reliable scientific evidence to support Defendants'
marketing claims, and there was, and is, a wealth of scientific evidence that these claims are false.
Defendants also deceptively and unfairly marketed the drugs for indications and benefits that were
outside of the drugs' labels and not supported by substantial evidence.
Even Defendants' KOLs initially were very cautious about whether opioids were
appropriate to treat chronic pain. Some of these same KOLs have since recanted their pro-opioid
marketing messages and acknowledged that Defendants' marketing went too far. Yet despite the voices
of renowned pain specialists, researchers, and physicians who have sounded the alarm on the
overprescribing of opioids to treat chronic pain, Defendants continue to disseminate their misleading
and unfair marketing claims to this day.
Defendants' efforts were wildly successful. The United States is now awash in opioids.
In 2012, health care providers wrote 259 million prescriptions for opioid painkillers— enough to
medicate every adult in America around the clock for a month. Twenty percent of all doctors' visits in
2010 resulted in the prescription of an opioid, nearly double the rate in 2000. Opioids—once a niche
drug—are now the most prescribed classof drugs—more than blood pressure, cholesterol, or anxiety
drugs. While Americans represent only 4.6% of the world's population, they consume 80% of the
opioids supplied around thc world and 99% of thc global hydrocodone supply. Together, opioids
generated $8 billion in revenue for drug companies in 2012.
5

It was Defendants' marketing—and not any medical breakthrough—that rationalized
prescribing opioids for chronic pain and opened the floodgates of opioid use and abuse. The result has
been catastrophic.
According to the U.S. Centers for Disease Control and Prevention ("CDC"), the nation
has been swept up in an opioid-induced "public health epidemic." 5 According to the CDC,
prescription opioid use contributed to 16,651 overdose deaths nationally in 2010; 16,917 in 2011; and
16,007 in 2012. One Defendant's own 2010 internal data shows that it knew that the use of
prescription opioids gave rise to 40% of drug-related emergency department visits in 2010 and 40% of
drug poisoning deaths in 2008, and that the trend of opioid poisonings was increasing from 1999-2008.
For every death, more than 30 individuals are treated in emergency rooms.
According to the Ohio Department of Health, in 2007 unintentional drug poisoning
became the leading cause of injury death in Ohio, surpassing motor vehicle accidents for the first time
in history.6 From 2000 to 2015, Ohio's death rate due to unintentional drug poisonings increased 642
percent, which was "drive largely by opioid related overdoses"'
In 2014, more people died of opioid overdoses in Ohio than any other state in the
Country.
In 2000, there were 411 unintentional drug overdose deaths in Ohio. l3y 2015, this
number grew to 3,050.9
The City of Lorain is located within Lorain County, Ohio. Lorain County has seen a
significant spike in overdose deaths due to opioids. In 2012, there were a total of 127 accidental

5 CDC, Examining the Growing Problems of Prescription Drug and Heroin Abuse (Apr. 29, 2014), accessed at
http://www.cdc.gov/washington/testimony/2014/00140429.htm.
6 https://www.odh.ohio.gov/health/vipp/drug/dpoison.aspx (accessed on May 30,h, 2017)
7 Id
Id.
9 Id

6

overdose deaths in Lorain County, with 83% associated with opiate use.1° In 2013, that number
jumped over 11%. The majority of these deaths were residents of the City of Lorain":
Opiate Related Deaths Reported to Lorain County
Coroner, 2012-2013: City/Township of Residence
Out of County = 9
Sheffield township

shettieids!..ake

Avon Lake
1

lyric township

Brownhetm
2
New Russia
Henrietta 0 Carlisle
0 01>er II rLJ

Caindien

0

Columbia
1

1

Grafton village
Pittsfield LaGrange
0

Brighton Wellington
1 2

Rochester

Penfield
1
Total Deaths
BM 10+
al (-3- 0
0 1-5 (14)
0
0 (9)

Huntington

0

1

0

Data Source: Lorain County Coroner

23. The last week of January, 2016, was the only week of the year which a person didn't
overdose and die in Lorain County.12

24 .According_to__Lorain_County_Coroner_Dr.._Stephan Evans,_from_2000 to 2009 there
were about 12 1/2 overdose deaths per year on average in Lorain County. In 2016, there were about
132, or ten times more. In 2017, Lorain County is on track for over 200 overdose deaths."
m "Lorain County Opiate Related Deaths 2012-2013", accessed at http://www.publicsafety.ohio.gov/links/OCJS-LorainCounty-Opiate-Related-Deaths.pdf
m
12 "OPIOD OVERLOAD: County Struggles as epidemic widens", The Chronicle, accessed at
http://www.chroniclet.com/Local-News/201 7/06/11 /OPIOID-OVERLOAD-County-struggles-as-epidemicwidens.html

7

The use of opioid pain medication has directly correlated and caused the increase in
drugs such as heroin and fentanyl being used within Lorain County. According to the National
Institute on Drug Abuse, based on data collected from a 2013 study, 80% of heroin users reported
using prescription opioids prior to heroin."
A steep drop in employment and manufacturing in Ohio, including the City of Lorain,
has been attributed to the opioid epidernic.15
The City of Lorain has made significant attempts to fight the epidemic of prescription
opioid medications, heroin, and other opioids which have taken over its community. This includes
increased law enforcement, educational and community programs, drug support programs, providing
Naloxone to its law enforcement and emergency medical providers, as well as others.
The City of Lorain has taken steps and will foreseeably continue to take steps in efforts
to combat the opioid epidemic which has been caused by the actions of the Defendants. These
government efforts create an increased cost and spending.
But even these alarming statistics do not fully communicate the toll of prescription
opioid abuse on patients and their families.
The dramatic increase in opioid prescriptions to treat common chronic pain conditions
has resulted in a population of addicts who seek drugs from doctors. When turned down by one
physician, many of these addicts deploy increasingly desperate tactics—including doctor-shopping, use
of aliases, and criminal means—to satisfy their' cravings.
Efforts by doctors to reverse course for a chronic pain patient already on opioids longterm include managing the physical suffering and psychological distress a patient endures while
13
14 h ttps:/ /www.drugabuse.gov/publications/research-reports/relationship-between-prescription-drug-heroinabuse/prescription-opioid-us e-ris k-factor-heroin-use
15 haps://www.forbes.com/sites/adammillsap/2016/10/18/rust-belt-cities-and-moving-to-opportunity-itstime-to-get-back-on-the-hillbilly-highway/#2881ebce7d82

8

withdrawing from the drugs. This process is often thwarted by a secondary criminal market wellstocked by a pipeline of drugs that is diverted to supply them. Even though they never would have
prescribed opioids in the first place, many doctors feel compelled to continue prescribing opioids to
patients who have become dependent on them.
According to the CDC, more than 12 million Americans age 12 or older have used
prescription painkillers without a prescription in 2010 16 , and adolescents are abusing opioids in
alarming numbers.
Opioid abuse has not displaced heroin, but rather triggered a resurgence in its use,
imposing additional burdens on the City and local agencies that address heroin use and addiction.
According to the CDC, the percentage of heroin users who also use opioid pain relievers rose from
20.7% in 2002-2004 to 45.2% in 2011-2013. Heroin produces a very similar high to prescription
opioids, but is often cheaper. While a single opioid pill may cost $10-$15 on the street, users can obtain
a bag of heroin, with multiple highs, for the same price. It is hard to imagine the powerful pull that
would cause a law-abiding, middle-aged person who started on prescription opioids for a back injury to
turn to buying, snorting, or injecting heroin, but that is the dark side of opioid abuse and addiction.
Dr. Robert DuPont, former director of the National Institute on Drug Abuse, opines
that opioids are more destructive than crack cocaine:
[Opioid abuse] is building more slowly, but it's much larger. And the potential]] for
death, in particular, [is] way beyond anything we saw then. . . . [F]or pain medicine, a
one-day dose can be sold on the black market for $100. And a single dose can [be]
lethal to a non-patient. There is no other medicine that has those
characteristics. And if you think about that combination and the significant of people

IS CDC, Presxciiption Painkiller Overdoses in the US (Nov. 2011),
https://www.cdc.gov/vitalsigns/painkilleroverdoses/.

9

who are using these medicines, you get some idea of the exposure of the society to the
prescription drug problem.17
Countless City residents suffer from chronic pain, which takes an enormous toll on
their health, their lives, and their families. These residents deserve both appropriate care and the ability
to make decisions based on accurate and complete information about treatment risks and benefits. But
Defendants' deceptive and unfair marketing campaign deprived City residents and their doctors of the
ability to make informed medical decisions and, instead, caused important, sometimes life-or-death
decisions to be made based not on science, but on hype. Defendants deprived patients, their doctors,
and health care payors of the chance to exercise informed judgment and subjected them to enormous
costs and suffering.
Defendants' actions are not permitted or excused by the fact that their labels (with the
exception of Cephalon's labels for Fentora and Acdq) may have allowed, or did not exclude, the use of
opioids for chronic non-cancer pain. The FDA's approval did not give Defendants license to
misrepresent the risks, benefits, or superiority of opioids. Indeed, what makes Defendants' efforts
particularly nefarious—and dangerous—is that, unlike other prescription drugs marketed unlawfully in
the past, opioids are highly addictive controlled substances. Defendants deceptively and unfairly
engaged a patient base that—physically and psychologically—could not turn away from their drugs,
many of whom were not helped by the drugs or were profoundly damaged by them.
Nor is Defendants' causal role broken by the involvement of doctors. Defendants'
marketing efforts were both ubiquitous and highly persuasive; their deceptive messages tainted
virtually every source doctors could rely on for information and prevented them from making
informed treatment decisions. Defendants targeted not only pain specialists, but also primary care

17 Transcript, Use and Abuse of Prescription Painkillers, The Diane Rehm Show (Apr. 21, 2011),
http://thedianerehmshow.org/shows/2011-04-21/use-and-abuse-prescription-painkillers/transcript.

10

physicians (PCPs), nurse practitioners, physician assistants, and other non-path specialists who were
even less likely to be able to assess the companies' misleading statements. Defendants were also able to
callously manipulate what doctors wanted to believe—namely, that opioids represented a means of
relieving their patients' suffering and of practicing medicine more compassionately.
By 2014, nearly two million Americans were either abusing opioid medications or were
dependent on opioids." According to the CDC, opioids have created a "public health epidemic" as of
2016.'9
Defendants' marketing campaign has been extremely harmful and has cost American
lives — including lives of residents of the City of Lorain. Deaths from prescription opioids have
quadrupled since 1999. From 2000 to 2014 nearly 500,000 people died from such overdoses; seventyeight Americans die everyday from opioid overdoses.29
It is estimated that, in 2012, 2.1 million people in the United States suffered from
substances use disorders related to prescription opioid pain relievers.21
The National Institutes of Health ("NIH") not only recognizes the opioid abuse
problem, but also identifies Defendants' "aggressive marketing" as a major cause: "Several factors are
likely to have contributed to the severity of the current prescription drug abuse problem. They include
drastic increases in the number of prescriptions written and dispensed, greater social acceptability

18 CDC, Injury Prevention & Control: Opioid Overdose, Prescription Opioids, Addiction and
Overdose. Available at http://www.cdc.gov/drugoverdose/opioids/prescribed.html (accessed May
17, 2017).
19 CDC, Examining the Growing Problems of .Prescription Drug and Heroin Abuse, (Apr. 29, 2014),
http://www.cdc.gov/washington/testimony/2014/ts0140429.htm (accessed May 17, 2017).
29 CDC, Injury Prevention & Control: Opioid Overdose, Understanding the Epidemic.
21 Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on
Drug Use and Health: Summag of National Findings, NSDUH Series H- 46, HHS Publication No. (SMA)
13-4795. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013.

11

for using medications for different purposes, and aggressive marketing by pharmaceutical companies.»22 As
shown below, the "drastic increases in the number of prescriptions written and dispensed" and the
"greater social acceptability for using medications for different purposes " are not really independent
causative factors but are in fact the direct result of "the aggressive marketing by pharmaceutical
companies."
The rising numbers of persons addicted to opioids have led not only to an increase in
health care costs to the City, and specifically the Plaintiff; but also a major increase in issues such as
drug abuse, diversion,23 and crimes related to obtaining opioid medications. The City of Lorain has
been severely and negatively impacted due to the fraudulent misrepresentations and omissions by
Defendants regarding the use and risk related to opioids. In fact, Defendants have been and continue
to be aware of the high levels of diversion of their product.
- Due to the conduct of the Defendants, the commission of criminal acts has been
undertaken not only by individuals seeking to obtain opioids, but by physicians themselves. The
actions of Defendants have created an environment where select physicians have sought to profit at
the expense of their patients who become addicted to opioid pain medications, often accepting cash
payments and ordering unnecessaiy medical tests, again at the expense of the City of Lorain.
As a direct and foreseeable consequence of Defendants' wrongful conduct, Plaintiff
has been required to spend significant of dollars each year in its efforts to combat the public nuisance
created by Defendants' deceptive marketing campaign. Plaintiff has incurred and continues to incur
costs related to opioid addiction and abuse, including, but not limited to, health care costs, criminal
justice and victimization costs, social costs, and lost productivity costs. Defendants' misrepresentations
America's Addiction to Opioids: Heroin and Prescription Drug Abuse. Available at
http:/ /www.drugabuse.gov/about-nida/legislative-activities /testimony-to- congress/201 5 /americasaddiction-to-opioids-heroin-prescription-drug-abuse#_ftn2 (accessed Maybe17, 2017) (emphasis
added).
23
The CDC defines using or obtaining opioids illegally as "diversion."
22

12

regarding the safety and efficacy of long-term opioid use proximately caused injury to Plaintiff and its
residents.
JURISDICTION AND VENUE
This Court has jurisdiction over this action pursuant to 1345.04 (as to the Ohio
Consumer Sales Practices Act claim), 4165.01 (as to the Ohio Deceptive Trade Practices Act claim),
R.C. 2307.382 (as to the Ohio Products Liability Act claim); and 2305.01 (as to the common law public
nuisance, common law fraud, unjust enrichment and negligence claims).
Venue is proper in Lorain County pursuant to Ohio Civ. R. 3(B)(3), (6) and (7).
This action is non-removable because there is incomplete diversity of residents and no
substantial federal question is presented.
PARTIES
A. Plaintiff.
The City of Lorain is the tenth largest City in the State of Ohio and is located within
Lorain County. Per the 2010 census, its population was 64,000. Plaintiff provides services on behalf
of its residents, public health, public assistance, law enforcement, and emergency care. As mentioned
above, Plaintiff also partially funds the insurance plan for its employees.
Plaintiff brings this action on its own behalf and also as subrogee of its employees and
residents and, as such, Plaintiff stands in the shoes of its subrogors, and is entitled to all the rights of
its subrogors. In making payments on behalf of its employees and residents, Plaintiff did not act as a
volunteer but rather acted under compulsion, for the protection of its interests, or as parens patriae.
B. Defendants.
50. Purdue Pharma L.P. is a limited partnership organized under the laws of Delaware.
Purdue Pharma Inc. is a Delaware corporation with its principal place of business in Stamford,

13

Connecticut, and The Purdue Frederick Company, Inc. is a Delaware corporation with its principal
place of business in Stamford, Connecticut (collectively, "Purdue").
51. Purdue is primarily engaged in the manufacture, promotion, and distribution of opioids
nationally and in the City of Lorain, including the following:
OxyContin (oxycodone hydrochloride extended release) is a Schedule II opioid
agonist24 tablet first approved in 1995 and indicated for the "management of
pain severe enough to require daily, around-the-clock, long-term opioid
treatment arid for which alternative treatment options are inadequate." Prior to
April 2014,25 OxyContin was indicated for the "management of moderate to
severe pain when a continuous, around-the-clock opioid analgesic is needed for
an extended period of time."
MS Contin (morphine sulfate extended release) is a Schedule II opioid agonist
tablet first approved in 1987 and indicated for the "management of pain severe
enough to require daily, around-the-clock, long-term opioid treatment and for
which alternative treatment options are inadequate." Prior to April 2014, MS
Contin was indicated for the "management of moderate to severe pain when a

24

An opioid agonist is a drug that activates certain opioid receptors in the brain. An antagonist, by
contrast, blocks the receptor and can also be used in pain relief or to counter the effect of an opioid
overdose.
25 The labels for OxyContin and other long-acting opioids were amended in response to a 2012
citizens' petition by doctors. The changes were intended to clarify the existing obligation to "make an
individualized assessment of patient needs." The petitioners also successfully urged that the revised
labels heighten the requirements for boxed label warnings related to addiction, abuse, and misuse by
changing "Monitor for signs of misuse, abuse, and addiction" to "[Drug name] exposes users to risks
of addiction, abuse, and misuse, which can lead to overdose and death." Letter from Bob Rappaport,
Dir. Ctr. for Drug Evaluations & Res., Labeling Supplement and PMR IPost-MarketingResearchl Required
(Sept. 10, 2013), •
http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM367697.pdf.
14

continuous, around-the-clock opioid analgesic is needed for an extended period
of time."
Dilaudid (hydromorphone hydrochloride) is a Schedule II opioid agonist first
approved in 1984 (injection) and 1992 (oral solution and tablet) and indicated
for the "management of pain in patients where an opioid analgesic is
appropriate."
Dilaudid-HP (hydromorphone hydrochloride) is a Schedule II opioid agonist
injection first approved in 1984 and indicated for the "relief of moderate-tosevere pain in opioid-tolerant patients who require larger than usual doses of
opioids to provide adequate pain relief."
Butrans (buprenoiphine) is a Schedule III opioid partial agonist transdermal
patch first approved in 2010 and indicated for the "management of pain severe
enough to require daily, around-the-clock, long-term opioid treitment and for
which alternative treatment options are inadequate." Prior to April 2014,
Butrans was indicated for the "management of moderate to severe pain when a
continuous, around-the-clock opioid analgesic is needed for an extended period
of time."
Hysingla ER (hydrocodone bitrate) is a Schedule II opioid agonist tablet first
approved in 2014 and indicated for the management of pain severe enough to
require daily, around-the-clock, long-term opioid treatment and for which
alternative treatment options are inadequate.
g. Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride) is a
Schedule II combination product of oxycodonc, an opioid agonist, and
naloxone, an opioid antagonist, first approved in 2014 and indicated for the
15

management of pain severe enough to require daily, around-the-clock, longterm opioid treatment and for which alternative treatment options are
inadequate.
OxyContin is Purdue's largest-selling opioid. Since 2009, Purdue's national annual sales
of OxyContin have fluctuated between $2.47 billion and $2.99 billion, up four-fold from 2006 sales of
$800 million. OxyContin constitutes roughly 30% of the entire market for analgesic drugs (i.e.,
painkillers).
In 2007, Purdue settled criminal and civil charges against it for misbranding OxyContin
and agreed to pay the United States $635 million—at the time one of the largest settlements with a
drug company for marketing misconduct.26 Pursuant to its settlement, Purdue operated under a
Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health
and Human Services, which required the company, inter alia, to ensure that its marketing was fair and
accurate, and to monitor and report on its compliance with the Agreement.
Defendant Teva Pharmaceuticals USA, Inc. ("Teva USA") is a Delaware
corporation with its principal place of business in North Whales, Pennsylvania. Teva USA is a wholly
owned subsidiary of Teva Pharmaceutical Industries, Ltd. ("Teva Ltd."), an Israeli corporation.
Defendant Cephalon, Inc. is a Delaware corporation with its principal place of business
in Frazer, Pennsylvania. In 2011, Teva Ltd. acquired Cephalon, Inc.
Teva USA and Cephalon, Inc. work together closely to market and sell Cephalon
products in the United States. Teva USA conducts Teva Ltd.'s sales and marketing activities for
Cephalon in the United States and has done so since Teva Ltd.'s October 2011 acquisition of
Cephalon. Teva USA holds out Actiq and Fentora as Teva products to the public. Teva USA sells all
former Cephalon branded products through its "specialty medicines" division. The FDA approved
26

https://oighhs.gov/publications/docs/press/2007/SemiannualRelfal12007E.pdf
16

prescribing information and medication guide, which is distributed with Cephalon opioids marketed
and sold in Lorain, discloses that the guide was submitted by Teva USA, and directs physicians to
contact Teva USA to report adverse events. (Teva USA and Cephalon, Inc. collectively are referred to
herein as "Cephalon.")
57. Cephalon has been in the business of manufacturing, selling, and distributing the
following opioids, nationally and in Lorain:
Actiq (fentanyl citrate) is a Schedule II opioid agonist lozenge (lollipop) first
approved in 1998 and indicated for the "management of breakthrough cancer
pain in patients 16 years of age and older who are already receiving and who are
tolerant to opioid therapy for their underlying persistent cancer pain."
Fentora (fentanyl citrate) is a Schedule II opioid agonist buccal tablet (similar to
plugs of smokeless tobacco) first approved in 2006 and indicated for the
"management of breakthrough pain in cancer patients 18 years of age and older
who are already receiving and who are tolerant to around-the-clock opioid
therapy for their underlying persistent cancer pain."
58. In November 1998, the FDA granted restricted marketing approval for Actiq, limiting
its lawful promotion to cancer patients experiencing pain. The FDA specified that Actiq should not be
marketed for off-label uses, stating that the drug must be prescribed solely to cancer patients. In 2008,
Cephalon pleaded guilty to a criminal violation of the Federal Food, Drug and Cosmetic Act for its
misleading promotion of Actiq and two other drugs, and agreed to pay $425 million in fines, damages,
and penalties.
59. Teva USA was in the business of selling generic opioids, including a generic form of
OxyContin from 2005 through 2009 nationally and within the City of Lorain.

17

On September 29, 2008, Cephalon entered into a five-year Corporate Integrity
Agreement with the Office of Inspector General of the U.S. Department of Health and Human
Scrvices.27 The agreement, inter alia, required Cephalon to send doctors a letter advising them of the
settlement terms and gave them a means to report questionable conduct of its sales representatives;
disclose payments to doctors on its web site; and regularly certify that the company has an effective
compliance program.
Janssen Pharmaceuticals, Inc. is a Pennsylvania corporation with its principal place of
business in Titusville, New Jersey, and is a wholly owned subsidiary of Johnson & Johnson, a New
Jersey corporation with its principal place of business in New Brunswick, New Jersey. Janssen
Pharmaceuticals, Inc. was formerly known as Ortho-McNeil- Janssen Pharmaceuticals, Inc., which in
turn was formerly known as Janssen Pharmaceutica Inc. Defendant Ortho-McNeil-Janssen
Pharmaceuticals, Inc., now known as Janssen Pharmaceuticals, Inc., is a Pennsylvania corporation with
its principal place of business in Titusville, New Jersey. Janssen Pharmaceutica, Inc., now known as
Janssen Pharmaceuticals, Inc., is a Pennsylvania corporation with its principal place of business in
Titusville, New Jersey. Johnson & Johnson is the only company that owns more than 100/n of Janssen
Pharmaceuticals, Inc.'s stock, and it corresponds with the FDA regarding Janssen's products. Upon
information and belief, Johnson & Johnson controls the sale and development of Janssen
Pharmaceutical's drugs, and Janssen Pharmaceuticals, Inc.'s profits inure to Johnson & Johnson's
benefit. (Janssen Pharmaceuticals, Inc., Ortho-McNeil-Janssen Pharmaceuticals, Inc., Janssen
Pharmaceutica, Inc., and Johnson & Johnson collectively are referred to herein as "Janssen.")
62. Janssen manufactures, sells, and distributes a range of medical devices and
pharmaceutical drugs in Lorain and the rest of the nation, including Duragesic (fentanyl), which is a
Schedule II opioid agonist iransdermal patch first approved in 1990 and indicated for the
27

https://www.justice.gov/archive/opa/pr/2008/September/08-civ-860.html (accessed May 30, 2017)

18

"management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock,
long-term opioid treatment and for which alternative treatment options are inadequate."
63. Until January 2015, Janssen also developed, marketed, and sold Nucynta and Nucynta
ER:
Nucynta ER (tapentadol extended release) is a Schedule II opioid agonist tablet
first approved in 2011 and indicated for the "management of pain severe
enough to require daily, around-the-clock, long-term opioid treatment and for
which alternative treatment options are inadequate." Prior to April 2014,
Nucynta ER was indicated for the "management of moderate to severe chronic
pain in adults [and] neuropathic pain associated with diabetic peripheral
neuropathy (DPN) in adults." The DPN indication was added in August 2012.
Nucynta (tapentadol) is a Schedule II opioid agonist tablet and oral solution
first approved in 2008 and indicated for the "relief of moderate to severe acute
pain in patients 18 years of age or older."
64. Together, Nucynta and Nucynta ER accounted for $172 million in sales in 2014.n
Prior to 2009, Duragesic accounted for at least $1 billion in annual sales.
65. Endo Health Solutions Inc. is a Delaware corporation with its principal place of
business in Malvern, Pennsylvania. Endo Pharmaceuticals, Inc. is a wholly-owned subsidiary of Endo
Health Solutions Inc. and is a Delaware corporation with its principal place of business in Malvern,
_ _
Pennsylvania. (Endo Health Solutions Inc. and Endo Pharmaceuticals, Inc. collectively are referred to
herein as "Endo.")

28

http://www.prnewswire.com/news-releases/depomed-announces-closing-of-acquisition-of-us-riRhts-to-nucyntatapentadol-nucynta-er-tapentadol-extended-release-tablets-and-nucynta-tapentadol-oral-solution-from-ianssenpharmaceuticals-inc-for-105-billion-300060453.html (accessed May 30, 2017)
19

66. Endo develops, markets, and sells prescription drugs, including the following opioids,
in the City of Lorain and nationally:
Opana ER (oxymorphone hydrochloride extended release) is a Schedule II
opioid agonist tablet first approved in 2006 and indicated for the "management
of pain severe enough to require daily, around-the-clock, long-term opioid
treatment and for which alternative treatment options are inadequate." Prior to
April 2014, Opana ER was indicated for the "relief of moderate to severe pain
in patients requiring continuous, around-the-clock opioid treatment for an
extended period of time."
On June 8th , 2017, the U.S. Food and Drug Administration requested that
Endo remove Opana ER from the market based on concern that "the benefits
of the drug may no longer outweigh its risks."29 This is the first time the FDA
has ever taken steps to remove a currently marketed opioid pain medication
from sale due to public health concerns.
Opana (oxymorphone hydrochloride) is a Schedule II opioid agonist tablet first
approved in 2006 and indicated for the "relief of moderate to severe acute pain
where the use of an opioid is appropriate."
Percodan (oxycodone hydrochloride and aspirin) is a Schedule II opioid agonist
tablet .first approved in 1950 and first marketed by Endo in 2004 and indicated
for the "management of moderate to moderately severe pain."

29 https://vv-ww.fda.nov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm

20

(accessed June 12th, 2017)

e. Percocet (oxycodone hydrochloride and acetaminophen) is a Schedule II opioid
agonist tablet first approved in 1999 and first marketed by Endo in 2006 and
indicated for the "relief of moderate to moderately severe pain."30
Opioids made up roughly $403 million of Endo's overall revenues of $3 billion in 2012.
Opana ER yielded revenue of $1.15 billion from 2010 to 2013, and alone accounted for 10% of
Endo's total revenue in 2012. Endo also manufactures and sells generic opioids nationally and in the
City of Lorain, both itself and through its subsidiary, Qualitest Pharmaceuticals, Inc., including generic
oxycodone, oxymorphone, hydromorphone, and hydrocodone products.
Allergan PLC is a public limited company incorporated in Ireland with its principal
place of business in Dublin, Ireland. Actavis PLC acquired Allergan PLC in March 2015, and the
combined company changed its name to Allergan PLC in March 2015. Prior to that, Watson
Pharmaceuticals, Inc. acquired Actavis, Inc. in October 2012; the combined company changed its
name to Actavis, Inc. in January 2013 and then to Actavis plc in October 2013. Watson Laboratories,
Inc. is a Nevada corporation with its principal place of business in Corona, California, and is a wholly
owned subsidiary of Allergan PLC (f/k/a Actavis, Inc., f/k/a Watson Pharmaceuticals, Inc.). Actavis
Pharma, Inc. (f/k/a Actavis, Inc.) is a Delaware corporation with its principal place of business in New
Jersey, and was formerly known as Watson Pharma, Inc. Actavis LLC is a Delaware limited liability
company with its principal place of business in Parsippany, New Jersey. Each of these defendants is
owned by Allergan plc, which uses them to market and sell its drugs in the United States. Upon
information and belief, Allergan plc exercises control over these marketing and sales efforts, and
profits from the sale of Allergan/Actavis products ultimately inure to its benefit. (Allergan plc, Actavis

30 In addition, Endo marketed Zydone (hydrocodone bitartrate and acetaminophen), a Schedule III
opioid agonist tablet indicated for the "relief of moderate to moderately severe pain," from 1998
through 2013. 'the FDA's website indicates this product is currently discontinued, but it appears on
Endo's own website.
21

plc, Actavis, Inc., Actavis LLC, Actavis Pharma, Inc., Watson Pharmaceuticals, Inc., Watson Pharma,
Inc., and Watson Laboratories, Inc. hereinafter collectively are referred to as "Actavis.")
Actavis engages in the business of marketing and selling opioids in Lorain and across
the country, including the branded drugs Kadian and Norco, a generic version of Kadian, and generic
versions of Duragesic and Opana. Kadian (morphine sulfate extended release) is a Schedule II opioid
agonist capsule first approved in 1996 and indicated for the "management of pain severe enough to
require daily, around-the-clock, long-term opioid treatment and for which alternative treatment
options are inadequate." Prior to April 2014, Kadian was indicated for the "management of moderate
to severe pain when a continuous, around-the-clock opioid analgesic is heeded for an extended period
of time." Actavis acquired the rights to Kadian from King Pharmaceuticals, Inc., on December 30,
2008 and began marketing Kadian in 2009.
Defendant McKesson Corporation ("McKesson") is a Delaware corporation with its
principal place of business in San Francisco, California.
Defendant McKesson had a net income in excess of $1.5 Billion in 2015.
Defendant McKesson distributes pharmaceuticals to retail pharmacies and institutional
providers to customers in all 50 states, including the State of Ohio and the City of Lorain.
Upon information and belief, defendant McKesson is a pharmaceutical distributor
licensed to do business in Ohio.
Defendant McKesson is the largest pharmaceutical distributor in North America.
Upon information and belief, McKesson delivers one-third of all pharmaceuticals used
in North America.
Defendant McKesson does substantial business in the State of Ohio and the City of
Lorain.

22

Defendant Cardinal Health Inc. ("Cardinal") is an Ohio Corporation with its principal
place of business in Dublin, Ohio.
Defendant Cardinal distributes pharmaceuticals to retail pharmacies and institutional
providers to customers in all 50 states, including Ohio and the City of Lorain.
Upon information and belief, defendant Cardinal is a pharmaceutical distributor
licensed to do business in Ohio.
Defendant Cardinal does substantial business in the State of Ohio and the City of
Lorain.
Upon information and belief, defendant Cardinal is one of the largest distributors of
opioid pain medications in the Country, including the State of Ohio.
Upon information and belief, Defendant A meris ourceB ergen Corporation
("Amerisource") is a Delaware Corporation with its principal place of business in Chesterbrook,
Pennsylvania.
Defendant Amerisource does substantial business in the State of Ohio and the City of
Lorain.
Upon information and belief, Defendant Amerisource is a pharmaceutical distributor
licensed to do business in the State of Ohio.
Defendant Amerisource distributes pharmaceuticals to retail pharmacies and

institutional providers_to customers in_a1L50_states, including Ohio and _the City_of_Lorain
Upon information and belief, defendant Amerisource is one of the largest distributors
of opioid pain medications in the Country, including the State of Ohio and the City of Lorain.
The three pharmaceutical distributor defendants (hereinafter "Distributor
Defendants") are three of the largest opioid distributors in the Country, the State of Ohio, and within
the City of Lorain.
23

88. The Distributor Defendants purchased opioids from manufacturers, such as the named
defendants herein, and sold them to pharmacies throughout Lorain.
The Distributor Defendants played an integral role in the chain of opioids being
distributed throughout thc City of Lorain.
Pursuant to Section 4729-9 of the Ohio Administrative Code, entitled "Dangerous
Drugs", distributors/wholesalers such as the defendants are required to create record keeping,
including establishing and maintaining inventories and records of all transactions of dangerous drugs
such as opioid pain medications. Pursuant to section (i) "[T]he wholesaler shall inform the state
board of pharmacy of suspicious orders for drugs when discovered. Suspicious orders are those which,
in relation to the wholesaler's records as a whole, are of unusual size, unusual frequency, or deviate
substantially from established buying patterns.
The Distributor Defendants were each on notice that the controlled substances they
distributed or prescribed were the kinds that were susceptible to diversion for illegal purposes, abused,
overused, and otherwise sought for illegal, unhealthy and problematic purposes.
The Distributor Defendants were each on notice that there was an alarming and
suspicious rise in distributing opioids to retailers within the State of Ohio, the County of Lorain, and
the City of Lorain.
As entities involved in the distribution of opioid medications, Distributor Defendants

were engaged in abnormally and/or inherently dangerous activity and had a duty of care under Ohio
law.
The Distributor Defendants had a duty to notice suspicious or alarming orders of
opioid pharmaceuticals and to report suspicious orders to the proper authorities and governing bodies
including the DEA and the Ohio State Board of Pharmacy.

24

The Distributor Defendants knew or should have known that they were supplying vast
amounts of dangerous drugs to the City of Lorain that were already facing abuse, diversion, misuse,
and other problems associated with the opioid epidemic.
According to the Ohio Department of Health, "from 1999 to 2007 in Ohio, there were
increases of 304 percent and 325 percent respectively in the unintentional drug poisoning death rate
and total grams of prescription opioids distributed per 100,000 population." 31
Comparing 1997 to 2011 creates even more startling results. In 1997, distribution of
OxyCodone to retain pharmacies in Ohio was under 4,000 grams per 100,000. By 2011, thus number
jumped to nearly 28,000 grams per 100,000.3'
The Distributor Defendants failed in their duty to take any action to prevent or reduce
the distribution of these drugs from at least 2007 through the present time.
The Distributor Defendants were in a unique position and had a duty to inspect,
report, or otherwise limit the flow of these drugs in the City of Lorain.
The Distributor Defendants, in the interest of their own massive profits, intentionally
failed in this duty.
The Distributor Defendants have displayed a continuing pattern of failing to submit
suspicious order reports.
In 2008, McKesson paid a $13.2 million fine to settle similar claims regarding

suspicious orders from internet-pharmacies 33
Despite these prior penalties, McKesson's pattern of failing to report suspicious orders
continued for many years.

http://www.healthy.ohio.gov/en/vipp/data/—/media/B36238133B2C746308AA51232575613DD.ashx
http://opiatecollaborative.cuyahogacounty.us/pdf OpiateCollaborative/en-US/OpioidEpidemic.pdf
33 http://www. wvgazettemail.com/news-health/20161218/suspicious-drug-order-rules-never-enforced-by-state
(accessed May 30, 2017)
31

32

25

According to the DEA, McKesson "supplied various U.S. pharmacies an increasing
amount of oxycodone and hydrocodone pills" during the time in question, and "frequently misused
products that are part of the current opioid epidemic."34
On January 17, 2017, the DEA announced that McKesson had agreed to pay a record
$150 million fine and suspend the sale of controlled substances from distribution centers in several
states.35
In 2008, defendant Cardinal paid a $34 million penalty to resolve allegations that it
failed to report suspicious opioid orders.36
Despite this past penalty, in 2017, it was announced that Defendant Cardinal agreed to
a $44 million fine to "resolve allegations that it failed to alert the Drug Enforcement Agency to
suspicious orders of powerful narcotics by pharmacies in Florida, Maryland, and New York.37
108.. Defendant Amerisource faced a criminal inquiry "into its oversight of painkiller sales"
in 2012.38 They have paid out fines for similar claims to the State of West Virginia.
Despite the charges, fines, and penalties brought against the Distributor Defendants in
the past, they continued to fail to report suspicious orders or prevent the flow of prescription opioids,
including into the City of Lorain.
The Distributor Defendants are also members of the Healthcare Distribution
Management Association ("FIDMA"). The HDMA created "Industry Compliance Guidelines" which
A

34 haps: /www.justice.gov/ opa/pamckesson-agrees-pay-record-150-million-settlement-failurereport-suspicious-orders (accessed May 30, 2017)

35 Id

36 https://www.justice.gov/usao-wdwa/plunited-states-reaches-34-million-settlement-cardinal-health-civil-penaltiesunder-0 (access May 30, 2017)
https://www.washingtonpost.com/national/health-science/cardinal-health-fined-44-million-foropioid-reporting-violations /2017/01 /11 /4f217c44-d82c-11 e6-9a361d296534b31e_story.html?utm_term=.7049c4431465 (accessed on May 17, 2017).
38
http://www.nytirnes.com/2013/06/12/business/walgreen-to-pay-80-million-settlement-overpainkiller-sales.html (accessed on May 17, 2017).

26

stressed the critical role of each member of the supply chain in distributing controlled substances.
The HDMA guidelines provided that "[alt the center of a sophisticated supply chain, Distributors are
uniquely situated to perform due diligence in order to help support the security of controlled
substances they deliver to their customers."
Between the years in question, including 2007 through 2016, the Distributor
Defendants shipped significant of doses of highly addictive controlled opioid pain killers into the City
of Lorain.
Many of these orders should have been stopped, or at the very least, investigated as
potential suspicious orders.
The sheer volume of the increase in opioid pain medications, including OxyCodone,
being distributed to retailers, should have put the Distributor Defendants on notice to investigate and
report such orders.
The Distributor Defendants delivered an excessive and unreasonable amount of opioid
pain medications to retailers in the City of Lorain.
Upon information and belief, the Distributor Defendants did not refuse to ship or
supply any opioid medications to any pharmacy within the City of Lorain from 2007 to the present.
The Defendant Distributors knew or should have known that they were distributing
levels of opioid medications that far exceeded the legitimate needs of the City of Lorain.

117 The Defendant_Distributors_also_paid their sales force bonuses and commissions on
the sale of most or all of the highly addictive opioid pain medications within the City of Lorain.
The Distributor Defendants made substantial profits from the opioids sold in the City
of Lorain.
The Distributor Defendants violated Ohio State Board of Pharmacy rules, codes and
regulations for distributors by failing to properly report suspicious orders.
27

By the actions and inactions described above, the Distributor Defendants showed a
reckless disregard for the safety of the residents of the City of Lorain.
By the actions and inactions described above, the Distributor Defendants caused great
harm to the City of Lorain.
Russell Portenoy, M.D., is an individual residing in New York. Defendant Dr. Portenoy
is a physician licensed to practice medicine in the state of New York. Dr. Portenoy was instrumental in
promoting opioids for sale and distribution nationally and in the City of Lorain.
Perry Fine, M.D., is an individual residing in Utah. Dr. Fine was instrumental in
promoting opioids for sale and distribution nationally and in the City of Lorain.
Scott Fishman, M.D., is an individual residing in California. Dr. Fishman was
instrumental in promoting opioids for sale and distribution nationally and in the City of Lorain.
Lynn Webster, M.D., is an individual residing in Utah. Dr. Webster was instrumental
in promoting opioids for sale and distribution nationally and in the City of Lorain.
FACTS RELEVANT TO ALL CAUSES OF ACTION
A. Background on Pain Medicine.
1. Safe and Effective Treatment of Chronic Pain Centers on Informed Risk
Management.
The practice of medicine centers on informed risk management. Prescribers must
weigh the potential risks and benefits of each treatment option, as well as the risk of non-treatment.
127. Accordingly, the safe and effective treatment of chronic pain requires that a physician
be able to weigh the relative risks of prescribing opioids against both (a) the relative benefits that may
be expected during the course of opioid treatment and (b) the risks and benefits of alternatives.

28

This bedrock principle of full disclosure is particularly important in the context of
chronic opioid therapy because of the risk that patients will become physically and psychologically
dependent on the drugs, finding it difficult to manage or terminate their use.
The FDA-approved drug labels on each of Defendants' opioids do not attempt to
advise physicians how to maximize the benefits and minimize the risks for patients on long-term
chronic opioid therapy. The labels contain no dosing cap above which it would be unsafe for any
doctor to prescribe to any patient. Nor do any of the labels provide a duration limit, after which the
risks to a patient might increase. Thus, doctors and patients rely more heavily on educational materials
such as treatment guidelines, CMEs, and scientific and patient education articles and websites to
inform their treatment decisions.
2. Opioid Use Is Associated with Known and Substantial Risks.
Opium has been recognized as a tool to relieve pain for millennia; so has the
magnitude of its potential for abuse, addiction and its dangers. Opioids are related to illegal drugs like
opium and heroin. In fact, types of fentanyl, a widely-distributed opioid in the United States, have now
been made illegal in China.
During the Civil War, opioids, then known as "tinctures of laudanum," gained
popularity among doctors and pharmacists for their ability to reduce anxiety and relieve pain —
particularly on the battlefield — and they were popularly used in a wide variety of commercial products
ranging from pain elixirs to cough suppressants and beverages. By 1900, an estimated 300,000 people
were addicted to opioids in the United States." Many doctors prescribed opioids solely to avoid

" Substance Abuse and Mental Health Services Administration, Medication-Assisted Treatment
for Opioid Addiction in Opioid Treatment Programs, Treatment Improvement Protocol (TIP
Services), No. 43 (2005).
29

patients' withdrawal. Both the numbers of opioid addicts and the difficulty in weaning patients from
opioids made clear their highly addictive nature.
Due to concerns about their addictive properties, opioids have been regulated at the
federal level as controlled substances by the U.S. Drug Enforcement Administration ("DEA") since
1970. The labels for scheduled opioid drugs carry black box warnings of potential addiction and
Isjerious, life-threatening, or fatal respiratory depression," as the result of an excessive dose.
Studies and articles from the 1970s and 1980s also made the reasons to avoid opioids
clear. Scientists observed negative outcomes from long-term opioid therapy in pain management
programs; opioids' mixed record in reducing pain long-term and failure to improve patients' function;
greater pain complaints as most patients developed tolerance to opioids; opioid patients' diminished
ability to perform basic tasks; their inability to make use of complementary treatments like physical
therapy due to the side effects of opioids; and addiction. Leading authorities discouraged, and even
prohibited, the use of opioid therapy for chronic pain.
Discontinuing opioids after more than just a few weeks of. therapy will cause most
patients to experience withdrawal symptoms. These withdrawal symptoms include: severe anxiety,
nausea, vomiting, headaches, agitation, insomnia, tremors, hallucinations, delirium, pain, and other
serious symptoms, which may persist for months after a complete withdrawal from opioids,
depending on how long the patient had been using opioids.
When under the continuous influence of opioids over time, patients grow tolerant to
their analgesic effects. As tolerance increases, a patient typically requires progressively higher doses to
obtain the same levels of pain reduction to which he or she has become accustomed — up to and
including doses that are "frighteningly high."4° At higher doses, the effects of withdrawal are more

4° M.

Katz, Long-term Opioid Treatment of Nonmalignant Pain: A Believer Loses His
Faith, 170(16) Archives of Internal Med. 1422 (2010).
30

substantial, thus leaving a patient at a much higher risk of addiction. A patient can take the opioids at
the continuously escalating dosages to match pain tolerance and still overdose at recommended levels.
Dr. Andrew Kolodny, Chief Medical Officer for Phoenix House, a national addiction
treatment program, has explained the effect of opioids as akin to "hijack[ing] the brain's reward
system," which in turn convinces a user that "the drug is needed to stay alive."4' A patient's fear of the
unpleasant effects of discontinuing opioids combined with the negative reinforcement during a period
of actual withdrawal can drive a patient to seek further opioid treatment—even where ineffective or
detrimental to quality of life—simply to avoid the deeply unpleasant effects of withdrawal.
Patients that receive high doses of opioids as part of long-term opioid therapy are three
to nine times more likely to suffer an overdose from opioid-related causes than those on low doses. As
compared to available alternative pain remedies, scholars have suggested that tolerance to the
respiratory depressive effects of opioids develops at a slower rate than tolerance to analgesic effects.
Accordingly, the practice of continuously escalating doses to match pain tolerance can, in fact, lead to
an overdose even when opioids are taken as recommended.
Further, "a potential side effect from chronic use [of opioids] can be abuse and
addiction . . . . [i]n fact, correct use and abuse of these agents are not polar opposites—they arc
complex, inter-related phenomena." 42 It is very difficult to tell whether a patient is physically
dependent, psychologically dependent, or addicted. Drug-seeking behaviors, which are signs of
addiction, will exist and emerge when opioids are suddenly not available, the dose is no longer
effective, or tapering of a dose is undertaken too quickly.

41 David Montero, Actor's Death Sows Doubt Among 0.C.'s Recovering Opioid Addicts, The Orange Cnty.
Reg. (Feb. 3, 2014), http://www.oeregister.com/articles/heroin-600148-shaffer-hoffman.html.
42 Wilson M. Compton & Nora D. Volkow, Major Increases in Opioid Analgesic Abuse in the United States:
Concerns and Strategies, 81(2) Drug & Alcohol Dependence 103, 106 (2006).

31

Studies have shown that between 30% and 40% of long-term users of opioids
experience problems with opioid use disorders.43
Each of these risks and adverse effects—dependence, tolerance, and addiction—is fully
disclosed in the labels for each of Defendants' opioids (though, as described below, not in Defendants'
marketing). " Prior to Defendants' deceptive marketing scheme, each of these risks was wellrecognized by doctors and seen as a reason to use opioids to treat chronic pain sparingly and only after
other treatments had failed.
Opioids vary by duration. Long-acting opioids, such as Purdue's OxyContin and MS
Contin, Janssen's Nucynta ER and Duragesic, Endo's Opana ER, and Actavis's Kadian, are designed
to be taken once or twice daily and are purported to provide continuous opioid therapy for, in
general, 12 hours. Short-acting opioids, such as Cephalon's Actiq and Fentora, are designed to be
taken in addition to long-acting opioids to address "episodic pain" and provide fast-acting,
.supplemental opioid therapy lasting approximately 4 to 6 hours.
Defendants promoted the idea that pain should be treated by taking long-acting
opioids continuously and supplementing them with short-acting, rapid- onset opioids for episodic pain.
Defendant Purdue was aware that its drug OxyContin did not provide pain relief for up
to 12 hours. Purdue was also aware of the risk that patients would then take additional pain
medications, beyond what was prescribed, to make of up for that gap in time. Despite this knowledge,
Purdue continued to market OxyContin as lasting for 12 hours.

:Joseph A. Boscarino et al., Risk factors for drug dependence among out-patients on opioid therapy in a large US
health-care gstem, 105(10) Addiction 1776 ( 2010); Joseph A. Boscarino et al., Prevalence of Prescription
Use
Opioid-U Disorder Amon,g Chronic Pain Patients: Comparison of the DSM-5 vs. DSM-4 Diagnostic Criteria,
30(3) Journal of Addictive Diseases 185 (2011).
" For example, Purdue's OxyContin label (October 5, 2011) states: "Physical dependence and
tolerance are not unusual during chronic opioid therapy."
43

32

While it was once thought that long-acting opioids would not be as susceptible to
abuse and addiction as short-acting ones, this view has been discredited. OxyContin's label now states,
as do all labels of Schedule II long-acting opioids, that the drug "exposes users to risks of addiction,
abuse, and misuse, which can lead to overdose and death." The FDA has required extended release
and long-acting opioids to adopt "Risk Evaluation Mitigation Strateg[ies]" on the basis that they
present "a serious public health crisis of addiction, overdose, and death."45
In 2013, in response to a petition to restrict the labels of long-acting opioid products,
the FDA noted the "grave risks" of opioids, "the most well-known of which include addiction,
overdose, and even death."46 The FDA further warned that "[Oren proper use of opioids under
medical supervision can result in life-threatening respiratory depression, coma, and death."47 The
FDA required that—going forward—opioid makers of long-acting formulations clearly communicate
these risks in their labels. Thus, the FDA confirmed what had previously been accepted practice in the
treatment of pain— that the adverse outcomes from opioid use include "addiction, unintentional
overdose, and death" and that long-acting or extended release opioids "should be used only when
alternative treatments are inadequate!" 48
Notably, in reaching its conclusion, the FDA did not rely On new or otherwise
previously unavailable scientific studies regarding the properties or effects of opioids.
The FDA-approved labels on each of Defendant's opioids do not attempt to advise
physicians on how to maximize the benefits and minimize the risks for patients on long term opioid

FDA, Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting
0 pioi ds (last updated Oct. 9, 2014),
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.
46 Letter from Janet Woodcock, M.D., Dir., Ctr. for Drug Eval. & Res., to Andrew Kolodny, M.D.,
Pres. Physicians for Responsible Opioid Prescribing, Re Docket No. FDA-2012-P-0818 (Sept. 10,
2013).
45

47 m.
48

Id. at 7 (emphasis in original).
33

therapy. The labels contain no dosage cap above which it would be unsafe to prescribe to any patient.
Nor do they provide a duration limit. Doctors and patients rely heavily on education materials, such as
treatment guidelines, CMEs, and scientific and patient education articles and websites, to inform their
treatment decisions.
On July 25, 2012, the Physicians for Responsible Opioid Prescribing ("PROP"), a nonprofit organization made up of doctors and other health care professionals, petitioned the FDA to
change the labeling of opioid medications. The petition was signed by thirty-seven physicians located
nationwide. In its letter to the FDA, the group stated that "an increasing body of medical literature
suggests that long term-use of opioids may be neither safe nor effective for many patients, especially
when prescribed in high doses."49
In its petition, PROP also stated that "many clinicians are under the false impression
that chronic opioid therapy ("COT") is an evidence-based treatment for chronic non-cancer pain" and
that "these misconceptions lead to overprescribing and high dose prescribing." It was also their
opinion that "the current label on opioid analgesics does not comply with [FDA law]".
As the basis for its petition, PROP provided "Statements of Scientific Basis for
Petition" which provided a list of detailed reports and studies proving the risks of opioid medications,
the high risk of addiction, the exaggerated and false benefits, and further medically backed reasons to
change the labelling of opioid medications to reduce prescribing.
In 2013, in response to a petition to require manufacturers to strengthen warnings
on the labels of long-acting opioid products, the FDA warned of the "grave risks" of opioids,
including "addiction, overdose, and even death." The FDA further warned, "[e]ven proper use of
opioids under medical supervision can result in life- threatening respiratory depression, coma, and

49 July 25, 2012 letter from PROP to FDA, accessed at http://www.citizen.org/documents/2048.pdf
on May 17, 2017.

34

death." Because of those grave risks, the FDA said that long-acting or extended release opioids
"should be used only when alternative treatments are inadequate."50 The FDA required that — going
forward — opioid makers of long-acting formulations clearly communicate these risks on their labels.
In 2016, the FDA expanded its warnings for immediate-release opioid pain
medications, requiring similar changes to the labeling of immediate-release opioid pain medications as
it had for extended release opioids in 2013. The FDA also required several additional safety-labeling
changes across all prescription opioid products to include additional information on the risk of these
medications.5'
The facts on which the FDA relied in 2013 and 2016 were well known to
Defendants in the many years since they began marketing these drugs.
3. Long-Term Opioid Use Benefits Are Unproven and Contradicted.
Despite the fact that opioids are now routinely prescribed, there has never been
evidence of their safety and efficacy for long-term use.
Defendants have always been aware of these gaps in knowledge. While promoting
opioids to treat chronic pain, Defendants have failed to disclose the lack of evidence to support their
long-term use and have failed to disclose the contradictory evidence that chronic opioid therapy
actually makes patients sicker.
There are no controlled studies of the use of opioids beyond 16 weeks, and no
evidence that opioids improve patients' pain and function long-term. The first random, placebo-

Letter from Janet Woodcock, M.D., Dir., Ctr. For Drug Eval. & Res., to Andrew Kolodny,
M.D., Pres. Physicians for Reiponsible Opioid Prescribing, Re Docket No. FDA-2012-P-0818 (Sept. 10,
2013) (emphasis in original).
51 FDA announces enhanced warnings for immediate-release opioid pain medications related to risks
of misuse, abuse, addiction, overdose and death. Available at
http: / /www. fda.gov/newsevents /newsroom /pres sannouncements /ucm491739.htrn (accessed May
17, 2017).
5°

35

controlled studies appeared in the 1990s, and revealed evidence only for short-term efficacy and only
in a minority of patients.52
A 2004 report reviewed 213 randomized, controlled trials of treatments for cancer pain
and showed that, while opioids had short-term efficacy, the data was insufficient to establish long-term
effectiveness. Subsequent reviews of the use of opioids for cancer and non-cancer pain consistently
note the lack of data to assess long-term outcomes. For example, a 2007 systematic review of opioids
for back pain concluded that opioids have limited, if any, efficacy for back pain and that evidence did
not allow judgments regarding long-term use. Similarly, a 2011 systematic review of studies for noncancer pain found that evidence of long-term efficacy is poor.00ne year later, a similar review reported
- poor evidence of long-term efficacy for morphine, tramadol, and oxycodone, and fair evidence for
transdermal fentanyl (approved only for use for cancer pain).
On the contrary, evidence exists to show that opioid drugs are not effective to treat
chronic pain, and may worsen patients' health. A 2006 study-of-studies found that opioids as a class
did not demonstrate improvement in functional outcomes over other non-addicting treatments. Most
notably, it stated: "For functional outcomes, the other analgesics were significantly more effective than
were opioids."" Another review of evidence relating to the use of opioids for chronic pain found that
up to 22.9% of patients in opioid trials dropped out before the study began because of the intolerable
effects of opioids, and that the evidence of pain relief over time was weak.
52 Nathaniel Katz, Opioids:-After-Thousands-of—
of—S-till-Getting-to -Know You, 23(4) Clin J. Pain 303
(2007); Roger Chou et al., Research Gaps on Use of Opioids for Chronic Noncancer Pain, 10(2) J. Pain 147
(2009).
53 Andrea D. Furlan et al., Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects:,
174(11) Can. Med. Ass'n J. 1589 (2006). This same study revealed that efficacy studies do not typically
include data on opioid addiction. In many cases, patients who may be more prone to addiction are prescreened out of the study pool. This does not reflect how doctors actually prescribe the drugs, because
even patients who have past or active substance use disorders tend to receive higher doses of opioids.
Karen H. Seal, Association of Mental Health Disorders With Prescqption Opioids and High-Risk Opioids in US
Veterans of Iraq and Afghanistan, 307(9) J. Am. Med. Ass'n 940 (2012).

36

Endo's own research shows that patients taking opioids, as opposed to other
prescription pain medicines, report higher rates of obesity (30% to 39%); insomnia (9% to 22%); and
self-described fair or poor health (24% to 34%).
Increasing duration of opioid use is strongly associated with an increasing prevalence of
mental health conditions (depression, anxiety, post-traumatic stress disorder, or substance abuse),
increased psychological distress, and greater health care utilization.
As a pain specialist noted in an article titled Are We Making Pain Patients Worse?,
"[O]pioids may work acceptably well for a while, but over the long term, function generally declines, as
does general health, mental health, and social functioning. Over time, even high doses of potent
opioids often fail to control pain, and these patients are unable to function normally.,,54
This is true both generally and for specific pain-related conditions. Studies of the use of
opioids long-term for chronic lower back pain have been unable to demonstrate an improvement in
patients' function. Conversely, research consistently shows that long-term opioid therapy for patients
who have lower back injuries does not help patients return to work or to physical activity. This is due
partly to addiction and other side effects.
As many as 30% of patients who suffer from migraines have been prescribed opioids
to treat their headaches. Users of opioids had the highest increase in the number of headache days per
month, scored significantly higher on the Migraine Disability Assessment (MIDAS), and had higher
rates of depression, compared to non-opioid users. A survey by the National Headache Foundation
found that migraine patients who used opioids were more likely to experience sleepiness, confusion,
and rebound headaches, and reported a lower quality of life than patients taking other medications.
The lack of evidence for the efficacy of opioid use long-term has been welldocumented nationally in the context of workers' compensation claims, where some of the most
54

Andrea Rubenstein, Are we making pain patients worse?, Sonoma Medicine (Fall 2009).
37

detailed data exists. Claims involving workers who take opioids are almost four times as likely to reach
costs of over $100,000 than claims treated without opioids, as these patients suffer greater side effects
and are slower to return to work. Even adjusting for injury severity and self-reported pain score, taking
an opioid for more than seven days and receiving more than one opioid prescription increased the risk
that the patient would be on work disability one year later. A prescription for opioids, as the first
treatment for a workplace injury, doubled the average length of the claim.
4. Defendants' Impact on the Perception and Prescribing of Opioids.
Before Defendants began the marketing campaign complained of herein, generally
accepted standards of medical practice dictated that opioids should only be used short-term, for
instance, for acute pain, pain relating to recovery from surgery, or for cancer or palliative care. In
those instances, the risks of addiction are low or of little significance.
In 1986, the World Health Organization ("WHO") published an "analgesic ladder" for
the treatment of cancer pain.55 The WHO recommended treatment with over-the- counter or
prescription acetaminophen or non-steroidal anti-inflammatory drugs ("NSAIDs") first, and then the
use of unscheduled or combination opioids, and then stronger (Schedule II or III) opioids if pain
persisted. The WHO ladder pertained only to the treatment of cancer pain, and did not contemplate
the use of narcotic opioids for chronic pain—because the use of opioids for chronic pain was not
considered appropriate medical practice at the time.
Studies and articles from the 1970s and 1980s made the reasons to avoid opioids clear.
Scientists observed negative outcomes from long-term opioid therapy in pain management programs:
opioids' mixed record in reducing pain long-term and failure to improve patients' function; greater
pain complaints as most patients developed tolerance to opioids; opioid patients' diminished ability to
perform basic tasks; their inability to make use of complementary treatments like physical therapy due
55

http://apps.whointhrisibitstream/10665/43944/1/9241561009 eng.pdf (accessed May 30, 2017)

38

to the side effects of opioids; and addiction. Leading authorities discouraged, or even prohibited, the
use of opioid therapy for chronic pain.
In 1986, Defendant Dr. Russell Portenoy, who later became Chairman of the
Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York, while at
the same time serving as a top spokesperson for drug companies, published an article reporting that
"[flew substantial gains in employment or social function could be attributed to the institution of
opioid therapy.,>56
Writing in 1994, Dr. Portenoy described the prevailing attitudes regarding the dangers
of long-term use of opioids:
The traditional approach to chronic nonmalignant pain does not accept the
long-term administration of opioid drugs. This perspective has been justified by
the perceived likelihood of tolerance, which would attenuate any beneficial
effects over time, and the potential for side effects, worsening disability, and
addiction. According to conventional thinking, the initial response to an opioid
drug may appear favorable, with partial analgesia and salutary mood changes,
but adverse effects inevitably occur thereafter. It is assumed that the motivation
to improve function will cease as mental clouding occurs and the belief takes
hold that the drug can, by itself, return the patient to a normal life. Serious
management problems are anticipated, including dfficuly in discontinuing a problematic
therapy and the development of drug seeking behavior induced by the desire to maintain
analgesic effects, avoid withdrawal, and pelpetuate reinforcing psychic effects. There is an
implicit assumption that little separates these outcomes from the highly aberrant behaviors
associated with addiaion.57 (Emphasis provided)

According to Portenoy, these problems could constitute "compelling reasons to reject long term
opioid administration as a therapeutic strategy in all but the most desperate cases of chronic
nonmalignant pain."58

56 Russell K. Portenoy & Kathleen M. Foley, Chronic Use of Opioid Analgesics in Non-Malignant
Pain: Report of 38 cases, 25(2) Pain 171 (1986).
57 Russell K. Portenoy, Opioid Therapy for Chronic Nonmalignant Pain: Current Status, 1 Progress in

Res. & Mgmt. 247 (1994) (emphasis added).
58

Id.

39

Pain

For the reasons outlined by Dr. Portenoy, and in the words of one researcher from the
Harvard Medical School, "it did not enter [doctors] minds that there could be a significant number of
chronic pain patients who were successfully managed with opioids."59 Defendants changed that
perception.
B. Defendants Promoted Their Branded Products Through Direct Marketing to
Prescribers and Consumers.
Defendants' direct marketing proceeded on two tracks, serving two related purposes.
First, Defendants worked through branded and unbranded marketing to build confidence in long-term
opioid use by overstating its benefits and downplaying its risks, thereby expanding the chronic pain
market. In addition, Defendants worked through their own staffs of sales representatives, physician
speakers whom those representatives recruited, and advertising in medical journals to claim their share
of that broader market. Defendants directed all of this activity through carefully designed marketing
plans that were based on extensive research into prescriber habits and the efficacy of particular sales
approaches and messages.
1. Defendants Relied Upon Branded Advertisements.
Defendants engaged in widespread advertising campaigns touting the benefits of their
branded drugs. Defendants published print advertisements in a broad array of medical journals,
ranging from those aimed at specialists, such as the Journal of Pain and Clinical Journal of Pain, to journals
- with wider medical audiences, such as - the -journal of The American -Medical Association. Defendants'
advertising budgets peaked in 2011, when they collectively spent more than $14 million on the medical

59 Igor Kissin, Long-term opioid treatment of chronic nonmalignant pain: unproven efficag and neglected safety?, 6 J.
Pain Research 513, 514 (2013) (quoting Loeser JD, Five crises in pain management, 20(1) Pain Clinical
Updates 1-4 (2012).

40

journal advertising of opioids, nearly triple what they spent in 2001. The 2011 total includes $8.3
million by Purdue, $4.9 million by Janssen, and $1.1 million by Endo.°
A number of these branded advertisements deceptively portrayed the benefits of opioid
therapy for chronic pain. As just one example, a 2005 Purdue advertisement for OxyContin that ran in
the Journal of Pain touted the drug as an "around-the-clock analgesic . . . for an extended period of
time." The advertisement featured a man and boy fishing and proclaimed that "There Can Be Life
With Relief." This depiction falsely implied that OxyContin provides both effective long-term pain
relief and functional improvement, claims that, as described below, are unsubstantiated and
contradicted in medical literature.
2. Defendants Relied Upon Their Sales Forces and Recruited Physician Speakers.
Each Defendant promoted the use of opioids for chronic pain through "detailers"—
sales representatives who visited individual physicians and their staff in their offices—and small group
speaker programs. By establishing close relationships with doctors, Defendants' sales representatives
were able to disseminate their misrepresentations in targeted, one-on-one settings that allowed them to
differentiate their opioids and to address individual prescribers' concerns about prescribing opioids for
chronic pain. Representatives were trained on techniques to build these relationships, with Actavis
even rolling out an "Own the Nurse" kit as a "door opener" to time with doctors.
Defendants developed sophisticated plans to select prescribers for sales visits based on
their specialties and prescribing habits. In accordance with common industry practice, Defendants
purchase and closely analyze prescription sales data from IMS Health. This data allows them to

60 In 2011, Actavis spent less than $100,000 on such advertising, and Cephalon spent nothing. These
companies' medical journal advertising peaked earlier, with Actavis spending $11.7 million in 2005, and
Cephalon spending about $2 million in each of 2007 and 2008.
41

precisely track the rates of initial prescribing and renewal by individual doctors, which in turn allows
them to target, tailor, and monitor the impact of their appeals.
Defendants, in particular, relied upon "influence mapping," i.e.., using decile rankings
or similar breakdowns to identify the high-volume prescribers on whom detailing would have the
greatest sales impact. Endo, for example, identified prescribers representing 30% of its nationwide
sales volume and planned to visit these physicians three times per month. Defendants also closely
monitored doctors' prescribing after a sales representative's visit to allow them to refine their planning
and messaging and to evaluate and compensate their detailers.
Defendants' sales representatives have visited hundreds of thousands of doctors,
including thousands of visits to City prescribers, and as described herein, spread misinformation
regarding the risks, benefits, and superiority of opioids for the treatment of chronic pain. This
misinformation includes deceptive and unfair claims regarding the risks of opioids for chronic pain,
particularly the risks of addiction, withdrawal, and high doses, as well as the benefits.
Each Defendant carefully trained its sales representatives to deliver company-approved
messages designed to generate prescriptions of that company's drugs specifically, and opioids in
general. Pharmaceutical companies exactingly direct and monitor their sales representatives—through
detailed action plans, trainings, tests, scripts, role-plays, supervisor tag-alongs, and other means—to
ensure that individual detailers actually deliver the desired messages and do not veer off-script.
Pharmaceutical companies likewise require their detailers to deploy sales aids reviewed, approved, and
supplied by the company and forbid them to use, in industry parlance, "homemade bread"—i.e.,
promotional materials not approved by the company's marketing and compliance departments. Sales
representatives' adherence to their corporate training is typically included in their work agreements.
Departing from their company's approved messaging can, and does, lead to severe consequences
including termination of employment.
42

Besides carefully training their sales representatives, Defendants used surveys of
physicians—conducted by third-party research firms—to assess how well their core messages came
across to prescribers.
In addition to making sales calls, Defendants' detailers also identified doctors to serve,
for payment, on Defendants' speakers' bureaus and to attend programs with speakers and meals paid
for by Defendants. Defendants almost always selected physicians who were "product loyalists," as they
were sure to be asked whether they prescribe the drug themselves. Endo, for instance, sought to use
specialists in pain medicine—including high prescribers of its drugs—as local "thought leaders" to
market Opana ER to primary care doctors. Such invitations are lucrative to the physicians selected for
these bureaus; honorarium rates range from $800 to $2,000 per program, depending on the type of
event, speaker training is typically compensated at $500 per hour.
These speaker programs and associated speaker trainings serve three purposes: they
provide an incentive to doctors to prescribe, or increase their prescriptions of, a particular drug; a
forum in which to further market to the speaker him or herself; and an opportunity to market to the
speaker's peers. Defendants grade their speakers and future opportunities are based on speaking
performance, post-program sales, and product usage. Defendants also track the prescribing of event
attendees, with Endo noting that "physicians who came into our speaker programs wrote more
prescriptions for Opana ER after attending than before." It would make little sense for Defendants to
devote significant resources to programs that did not increase their sales.
182. Like the sales representatives who select them, speakers are expected to stay "on
message"—indeed, they agree in writing to follow the slide decks provided to them. Endo's speaker
rules, for example, provide that "all slides must be presented in their entirety and without alterations. .
. and in sequence." This is important because the FDA regards promotional talks as part of product
labeling, and requires their submission for review. Speakers thus give the appearance of providing
43

independent, unbiased presentations on opioids, when in fact they are presenting a script prepared by
Defendants' marketing departments. Although these meal-based speaker events are more expensive to
host, and typically have lower attendance than CMEs, they are subject to less professional scrutiny and
thus afford Defendants greater freedom in the messages they present.
Defendants devoted massive resources to these direct sales contacts with prescribers.
In 2014, Defendants collectively spent $168 million on detailing branded opioids to physicians
nationwide. This figure includes $108 million spent by Purdue, $34 million by Janssen, $13 million by
Cephalon, $10 million by Endo, and $2 million by Actavis. The total figure is more than double
Defendants' collective spending on detailing in 2000. Detailers' role in Defendants' overall
promotional efforts was also carefully calibrated; Endo, for example, found that devoting 61% of its
marketing budget to sales representatives reflected an lajppropriate combination of personal . . . and
non-personal. . . selling initiatives."
Defendants have spent hundreds of significant of dollars promoting their opioids
through their respective sales forces because they understand that detailers' sales pitches are effective.
Numerous studies indicate that marketing can and does impact doctors' prescribing habits,61 and faceto-face detailing has the highest influence on intent to prescribe. Defendants could see this
phenomenon at work not only in the aggregate, as their sales climbed with their promotional spending,
but also at the level of individual prescribers whom they targeted for detailing, and who responded by
prescribing more of Defendants' drugs.
See, e.g., Puneet Manchanda & Pradeep K. Chintagunta, Responsiveness of Physician Prescription Behavior to
S alegtbrce Effort: An Individual Level Analysis, 15 (2-3) Mktg. Letters 129 (2004) (detailing has a positive
impact on prescriptions written); Ian Larkin, Restrictions on Pharmaceutical Detailing Reduced Off-Label
Prescribing of Antidepressants and Antipgchotics in Children, 33(6) Health Affairs 1014 ( 2014) (finding
academic medical centers that restricted direct promotion by pharmaceutical sales representatives
resulted in a 34% decline in on-label use of promoted drugs); see also Art Van Zee, The Promotion and
Marketing of OxyContin: Commercial Triumph, Public Health Tragedy, 99(2) Am J. Pub. Health 221 (2009)
(correlating an increase of OxyContin prescriptions from 670,000 annually in 1997 to 6.2 million in
2002 to a doubling of Purdue's sales force and trebling of annual sales calls).
61

44

3. Defendants Directed These Promotional Efforts Through Detailed Marketing
Plans.
Defendants guided their efforts to expand opioid prescribing through comprehensive
marketing and business plans for each drug. These documents, based on the companies' extensive
market research, laid out ambitious plans to bring in new prescribers and increase overall prescribing
of Defendants' opioids.
a. Targeting categories of prescribers
Defendants targeted, by zip codes and other local boundaries, individual health care
providers for detailing. Defendants chose their targets based on the potential for persuading a provider
to prescribe, ease of in-person access, and the likelihood of higher numbers of prescriptions at higher
doses, with no correlation to demonstrated need or demand for opioid therapy, or to risk of abuse.
Collectively, Defendants' marketing plans evince dual strategies, which often operated
parallel to one another. Defendants' sales representatives continued to focus their detailing efforts on
pain specialists and anesthesiologists, the highest-volume prescribers of opioids and, as a group, more
educated than other practitioners about opioids' risks and benefits. Seeking to develop market share
and expand sales, however, Defendants also targeted increasing numbers and types of prescribers for
marketing.
This expanded market of prescribers was, as a group, less informed about opioids and,
as market research concluded, more susceptible to Defendants' marketing messages. These prescribers
included nurse practitioners and physician assistants who, a 2012 Endo business plan noted, were
"share acquisition" opportunities because they were "3x times more responsive than MDs to details"
and wrote "96% of [their] prescriptions . . . without physician consult."

45

The expanded market also included internists and general practitioners who were lowto mid-volume prescribers. Actavis, for example, rolled out a plan in 2008 to move beyond "Kadian
loyalists" to an "expanded audience" of "low morphine writers."
b. Increasing "direct to consumer" marketing
Defendants knew that physicians were more likely to prescribe their branded
medications when patients asked for those medications. Endo's research, for example, found that such
communications resulted in greater patient "brand loyalty," with longer durations of Opana ER
therapy and fewer discontinuations. Defendants thus increasingly took their opioid sales campaigns
directly to consumers, including through patient-focused "education and support" materials. These
took the form of pamphlets, videos, or other publications that patients could view in their physician's
office, as well as employer and workers' compensation plan initiatives to, as Endo put it, "[dirive
demand for access through the employer audience by highlighting cost of disease and productivity
loss."
Defendants also knew that one of the largest obstacles to patients starting and
remaining on their branded opioids—including by switching from a competitor's drug—was out- ofpocket cost. They recognized they could overcome this obstacle by providing patients financial
assistance with their insurance co-payments, and each of the Defendants did so through vouchers and
coupons distributed during detailing visits with prescribers. A 2008 Actavis business review, for
example, highlighted co-pay assistance, good for up to $600 per patient per year, as a way to drive
conversions to Kadian from competitor drugs like Avinza and MS Contin. In 2012, Janssen planned to
distribute 1.5 million savings cards worth $25 each.
c. Differentiating each brand
192. Purdue's OxyContin was the clear market leader in prescription opioid therapy, with
30% of the market for analgesic drugs in 2012. However, by 2010, Defendants had begun facing
46

increasing pushback from the medical community and regulators based on the growing problems of
opioid addiction and abuse. Both market conditions prompted Defendants to pursue product
differentiation strategies—particularly an emphasis on their products being less subject to diversion,
abuse, and addiction—as a means of grabbing market share from Purdue and other competitors.
Endo, for example, tracked in detail prescriber "switching" from OxyContin to Opana
ER. Actavis and Janssen did the same for switches to Kadian and Nucynta ER, respectively. Pressure
to stand out among other drugs resulted in Defendants identifying marketing themes that thereafter
were reflected in Defendants' deceptive and harmful messages to physicians and consumers. A 2008
Janssen plan emphasized "value" messaging in support of Nucynta ER, including claims of less dose
escalation, lower toxicity, fewer withdrawal symptoms, and less dependence, and a 2009 Opana ER
market research report focused on greater potency and lower abuse potential of Opana ER vis-à-vis
OxyContin.
d. Moving beyond office visits
Defendants sought to reach additional prescribers by expanding beyond traditional
sales calls and speaker events to new channels for their messages. For their sales forces, these included
marketing to prescribers through voice mail, postcards, and email—so- called "e-detailing."
Defendants also created new platforms for their speakers by implementing "peer to peer" programs
such as teleconferences and webinars that were available to prescribers nationally. These programs
allowed Defendants to use this more seemingly credible vehicle to market to, among other hard-toreach audiences, prescribers at hospitals, academic centers, and other locations that limit or prohibit inperson detailing. Employing these new approaches, each Defendant relied heavily on speakers to
promote its drugs.

47

4. Defendants Marketed Opioids in Lorain Using the Same Strategies and Messages
They Employed Nationwide.
Defendants employed the same marketing plans and strategies and deployed the same
messages in Lorain as they did nationwide.
Across the pharmaceutical industry, "core message" development is funded and
overseen on a national basis by corporate headquarters. This comprehensive approach ensures that
Defendants' messages are accurately and consistently delivered across marketing channels—including
detailing visits, speaker events, and advertising—and in each sales territory. Defendants consider this
high level of coordination and uniformity crucial to successfully marketing their drugs.
Defendants ensure marketing consistency nationwide through national and regional
sales representative training; national training of local medical liaisons, the company employees who
respond to physician inquiries; centralized speaker training; single sets of visual aids, speaker slide
decks, and sales training materials; and nationally coordinated advertising. Defendants' sales
representatives and physician speakers were required to stick to prescribed talking points, sales
messages, and slide desks, and supervisors traveled with them periodically to check on both their
performance and compliance.
As they did nationwide, Defendants extensively tracked the prescribing behavior of
City-area health care providers and used that data to target their detailing and speaker- recruiting
efforts.- Top prescribers were profiled at the city, region, zip code, and sometimes facility levels, with
information about their specialty, prescribing patterns (including product and dose), product loyalty
and refill history. Providers' prescribing volume was ranked and sorted into deciles.
199. As described herein, misrepresentations and deceptions regarding the risks, benefits,
and superiority of opioid use to treat chronic pain were part and parcel of Defendants' marketing
campaigns in Lorain.

48

C. Defendants Used "Unbranded" Marketing to Evade Regulations and Consumer
Protection Laws.
In addition to their direct marketing efforts, Defendants used unbranded, third- party
marketing, which they deployed as part of their national marketing strategies for their branded drugs.
Each Defendant executed these strategies through a network of third-party KOLs and Front Groups,
with which it acted in concert by funding, assisting, encouraging, and directing their efforts. At the
same time, Defendants exercised substantial control over the content of the messages third parties
generated and disseminated, and distributed certain of those materials themselves. As with their other
marketing strategies, Defendants' unbranded marketing created, and relied upon, an appearance of
independence and credibility that was undeserved but central to its effectiveness. Unlike their direct
promotional activities, Defendants' unbranded marketing allowed them to evade the oversight of
federal regulators and gave them greater freedom to expand their deceptive messages.
1. Regulations Governing Branded Promotion Require that it Be Truthful, Balanced,
and Supported by Substantial Evidence.
Drug companies that make, market, and distribute opioids are subject to generally
applicable rules requiring truthful marketing of prescription drugs. A drug company's branded
marketing, which identifies and promotes a specific drug, must: (a) be consistent with its label and
supported by substantial scientific evidence; (b) not include false or misleading statements or material
'
omissions; and (c) fairly bala.nce the drug's benefits and risks.62 The regulatory framework governing
the marketing of specific drugs reflects a public policy designed to ensure that drug companies, which
are best suited to understand the properties and effects of their drugs, are responsible for providing
prescribers with the information they need to accurately assess the risks and benefits of drugs for their
patients.

62

21 U.S.C. 5 352(a); 21 C.F.R. 55 1.21(a), 202.1(e)(3), 202.1(e)(6).
49

Further, the Federal Food, Drug, and Cosmetic Act ("FDCA") prohibits the sale in
interstate commerce of drugs that are "misbranded." A drug is "misbranded" if it lacks "adequate
directions for use" or if the label is false or misleading "in any particular."° "Adequate directions for
use" are directions "under which. the layman can use a drug safely and for the purposes for which it is
intended!"64 "Labeling" includes more than the drug's physical label; it also includes "all . . . other
written, printed, or graphic matter . . . accompanying" the drug, including promotional material.°
"The term "accompanying" is interpreted broadly to include promotional materials—posters, websites,
brochures, books, and the like—disseminated by or on behalf of the manufacturer of the drug.°
Thus, Defendants' promotional materials are part of their drugs' labels and are required to be accurate,
balanced, and not misleading.
Labeling is misleading if it is not based on substantial evidence, if it materially
misrepresents the benefits of the drug, or if it omits material information about or minimizes the
frequency or severity of a product's risks. "The most serious risks set forth in a product's labeling are
generally material to any presentation of efficacy." The FDA notes that "Rdecause people expect to
see risk information, there is no reason for them to imagine that the product has important risks that
have been omitted . . . especially if some risks are included."67 Promotion that fails to present the most
important risks of the drug as prominently as its benefits lacks fair balance and is therefore deceptive.
It is also illegal for drug companies to distribute materials that exclude contrary
evidence or information about the drug's safety or efficacy or present conclusions that "clearly cannot

63

21 U.S.C. 55 352.
21 C.F.R. 5 201.5.
65
21 U.S.C. 5 321(m).
66
See id.
67
FDA, Draft Guidance for Indust, Presenting Risk Information in Prescription Drus and Medical Device
Promotion, May 2009, at 14.
64

50

be supported by the results of the study."68 Further, drug companies must not make comparisons
between their drugs and other drugs that represent or suggest that "a drug is safer or more effective
than another drug in some particular when it has not been demonstrated to be safer or more effective
in such particular by substantial evidence or substantial clinical experience."69
While the FDA must approve a drug's label, it is the drug company's responsibility to.
ensure that the material in its label is accurate and complete and is updated to reflect any new
information.79 Promotional materials also must be submitted to the FDA when they are first used or
disseminated. The FDA does not have to approve these materials in advance; if, upon review, the
FDA determines that materials marketing a drug are misleading, it can issue an untitled letter or
warning letter. The FDA uses untitled letters for violations such as overstating the effectiveness of the
drug or making claims without context or balanced information. Warning letters address promotions
involving safety or health risks and indicate the FDA may take further enforcement action.
2. Defendants Deployed Front Groups and Doctors to Disseminate Unbranded
Information on Their Behalf.
Drug companies market both directly and indirectly, using third party validators (such
as scientists, physicians, or patient or professional organizations) that appear to be independent and
therefore more credible. The FDA has made clear that its promotional requirements apply to both
forms of marketing:
FDA's regulation of prescription drug product promotion extends both to promotional
activities that are carried out by the firm itself, and to promotion conducted on the
firm's behalf.

68

21 C.F.R. 99.101(a)(4).
21 C F . R. § 202.1 (e) (6) (i_i).
70
See 21 C.F.R. § 201.56 (providing general requirements for prescription drug labeling); see also Wyeth
v. Levine, 555 U.S. 555 (2009) (holding that a drug company bears responsibility for the content of its
drug labels at all times); 21 C.F.R. 5 314.70(c)(6) (iii)(A-C) (allowing manufacturers to make changes
that "strengthen .. . a warning, precaution, or adverse reaction" or "strengthen a statement about drug
abuse, dependence, psychological effect, or overdosage").
69

51

Therefore, a firm is responsible for the content generated by its employees or any
agents acting on behalf of the firm who promote the firm's product. For example, if an
employee or agent of a firm, such as a medical science liaison or paid speaker (e.g., a
key opinion leader) acting on the firm's behalf, comments on a third- party site about
the firm's product, the firm is responsible for the content its employee or agent
provides. A firm is also responsible for the content on a blogger's site if the blogger is
acting on behalf of the firm?'
In addition to being carried out directly or through third parties, drug companies'
promotional activity can be branded or unbranded; unbranded marketing refers not to a specific drug,
but more generally to a disease state or treatment. By using unbranded communications, drug
companies can sidestep the extensive regulatory framework governing branded communications.
Defendants disseminated many of their false, misleading, imbalanced, and unsupported
statements indirectly, through KOLs and Front Groups, and in unbranded marketing materials. These
KOLs and Front Groups were important elements of Defendants' marketing plans, which specifically
contemplated their use, because they seemed independent and therefore outside FDA oversight.
Through unbranded materials, Defendants, with their own knowledge of the risks, benefits and
advantages of opioids, presented information and instructions concerning opioids generally that were
contrary to, or at best, inconsistent with information and instructions listed on Defendants' branded
marketing materials and drug labels. Defendants did so knowing that unbranded materials typically are
not submitted to or reviewed by the FDA.
Even where such unbranded messages were channeled through third-party vehicles,
Defendants adopted these messages as their own when they cited to, edited, approved, and distributed
such materials knowing they were false, misleading, unsubstantiated, unbalanced, and incomplete.

FDA, Draft Guidance for Industpl on Fulfilling Re,gulatoy Requirements for Postmarketing Submissions of
Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, January 2014, at 1, 4,
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm38
1352.pdf.
71

52

Unbranded brochures and other materials that are "disseminated by or on behalf of [the]
manufacturer" constitute drug "labeling" that may not be false or misleading in any particular. See 21.
C.F.R. 202.1(e)(7)(1)(2).72 Defendants' sales representatives distributed third-party marketing material
that was deceptive to Defendants' target audiences. Defendants are responsible for these materials.
Moreover, Defendants took an active role in guiding, reviewing, and approving many
of the misleading statements issued by these third parties, ensuring that Defendants were consistently
aware of their content. By funding, directing, editing, and distributing these materials, Defendants
exercised control over their deceptive messages and acted in concert73 with these third parties to
fraudulently promote the use of opioids for the treatment of chronic pain.
For example, drug companies have been admonished for making functional claims in
FDA-reviewed branded materials because there is no evidence for such claims. Thus, drug companies
were put on notice that the FDA would not allow such claims in branded materials. Defendants
instead created and disseminated these same unsupported claims—that opioids allow patients to sleep,
return to work, or walk more easily—through unbranded marketing materials.
The third-party publications Defendants assisted in creating and distributing did not
include the warnings and instructions mandated by their FDA-required drug labels and consistent with
the risks and benefits known to Defendants. For example, these publications either did not disclose

- 22- This regulation-provides:- "Brochures, booklets, mailing pieces, detailing pieces, file cards; bulletins;
calendars, price lists, catalogs, house organs, letters, motion picture films, film strips, lantern slides,
sound recordings, exhibits, literature, and reprints and similar pieces of printed, audio, or visual matter
descriptive of a drug and the references published . . . containing drug information supplied by the
manufacturer, packer, or distributor of the drug and which are disseminated by or on behalf of its
manufacturer, packer, or distributor are hereby determined to be labeling, as defined in section 201(m)
of the act." As labeling, such third party-created content distributed by a drug company may not be
misleading and must meet the accuracy, substantiation, and fair balance requirements in the FDCA.
73 As used in this Complaint, the allegation that Defendants "acted in concert" with third parties is
intended to mean both that they conspired with these third parties to achieve some end and that they
aided and abetted these third parties in the commission of acts necessary to achieve it.
53

the risks of addiction, abuse, misuse, and overdose, or affirmatively denied that patients faced a serious
risk of addiction.
By acting through third parties, Defendants were able to both avoid FDA scrutiny and
give the false appearance that the messages reflected the views of independent third parties. Later,
Defendants would cite to these sources as "independent" corroboration of their own statements. As
one physician adviser to Defendants noted, third-party documents not only had greater credibility, but
broader distribution as doctors did not "push back" at having materials from, for example, the nonprofit American Pain Foundation ("APF") on display in their offices, as they might with first party,
drug company pieces. Nevertheless, the independence of these materials was a ruse—Defendants were
in close contact with these third parties, paid for and were aware of the misleading information they
were disseminating about the use of opioids to treat chronic pain, and regularly helped them to tailor
and distribute their misleading, pro-opioid messaging.
As part of a strategic marketing scheme, Defendants spread and validated their
deceptive messages through the following vehicles: (a) KOLs, who could be counted upon to write
favorable journal articles and deliver supportive CMEs; (b) a body of biased and unsupported scientific
literature; (c) treatment guidelines; (d) CMEs; (e) unbranded patient education materials; and (f) Front
Group patient-advocacy and professional organizations, which exercised their influence both directly
and through Defendant-controlled KOLs who served in leadership roles in those organizations.
a. Defendants' Use of KOLs
Defendants cultivated a small circle of doctors who, upon information and belief, were
selected and sponsored by Defendants solely because they favored the aggressive treatment of chronic
pain with opioids. Defendants' support helped these doctors become respected industry experts. In
return, these doctors repaid Defendants by touting the benefits of opioids to treat chronic pain.

54

Pro-opioid doctors have been at the hub of Defendants' promotional efforts,
presenting the appearance of unbiased and reliable medical research supporting the broad use of
opioid therapy for chronic pain. KOLs have written, consulted on, edited, and lent their names to
books and articles, and given speeches and CMEs supportive of chronic opioid therapy. They have
served on committees that developed treatment guidelines that strongly encourage the use of opioids
to treat chronic pain (even While acknowledging the lack of evidence in support of that position) and
on the boards of pro-opioid advocacy groups and professional societies that develop, select, and
present CMEs. Defendants were able to exert control of each of these modalities through their KOLs.
In return, the KOLs' association with Defendants provided not only money, but
prestige, recognition, research funding, and avenues to publish. This positioned them to exert even
more influence in the medical community.
Although some KOLs initially may have advocated for more permissive opioid
prescribing with honest intentions, Defendants cultivated and promoted only those KOLs who could
be relied on to help broaden the chronic opioid therapy market. Defendants selected, funded, and
elevated those doctors whose public positions were unequivocal and supportive of using opioids to
treat chronic pain.74 These doctors' professional reputations were then dependent on continuing to
promote a pro-opioid message, even in activities that were not directly funded by the drug companies.
Defendants cited and promoted favorable studies or articles by these KOLs. By
contrast, Defendants did not support, acknowledge, or disseminate the publications of doctors critical
of the use of chronic opioid therapy. Indeed, one prominent KOL sponsored by Defendants, Russell

74 Opioid-makers were not the first to mask their deceptive marketing efforts in purported science.
The tobacco industry also used KOLs in its effort to persuade the public and regulators that tobacco
was not addictive or dangerous. For example, the tobacco companies funded a research program at
Harvard and chose as its chief researcher a doctor who had expressed views in line with industry's
views. He was dropped when he criticized low-tar cigarettes as potentially more dangerous, and later
described himself as a pawn in the industry's campaign.

55

Portenoy, stated that he was told by a drug company that research critical of opioids (and the doctors
who published that research) would never obtain funding. Some KOLs have even gone on to become
direct employees and executives of Defendants, like Dr. David Haddox, Purdue's Vice President of
Risk Management, or Dr. Bradley Galer, Endo's former Chief Medical Officer.
Defendants provided substantial opportunities for KOLs to participate in research
studies on topics Defendants suggested or chose, with the predictable effect of ensuring that many
favorable studies appeared in the academic literature. As described by Dr. Portenoy, drug companies
would approach him with a study that was well underway and ask if he would serve as the study's
author. Dr. Portenoy regularly agreed.
Defendants also paid KOLs to serve as consultants or on their advisory boards and
give talks or present CMEs, typically over meals or at conferences. Since 2000, Cephalon, for instance,
has paid doctors more than $4.5 million for programs relating to its opioids.
These KOLs were carefully vetted to ensure that they were likely to remain on-message
and supportive of a pharmaceutical industry agenda. One measure was a doctor's prior work for
trusted Front Groups.
Defendants kept close tabs on the content of the misleading materials published by
these KOLs. In many instances they also scripted what these KOLs said—as they did with all their
recruited speakers. The KOLs knew, or deliberately ignored, the misleading way in which they
portrayed the use of opioids to treat chronic pain to patients and prescribers, but they continued to
publish those misstatements to benefit themselves and Defendants, all the while causing harm to City
prescribers and patients.
i. Defendant Russell Portenoy
224. Defendant Dr. Russell Portenoy, former Chairman of the Department of Pain
Medicine and Palliative Care at Beth Israel Medical Center in New York, is one example of a KOL
56

whom Defendants identified and promoted to further their marketing campaign. Dr. Portenoy
received research support, consulting fees, and honoraria from Cephalon, Endo, Janssen, and Purdue
(among others), and was a paid consultant to Cephalon and Purdue.
Defendant Dr. Portenoy was instrumental in opening the door for the regular use of
opioids to treat chronic pain. He served on the American Pain Society ("APS") / American Academy
of Pain Medicine ("AAPM") Guidelines Committees, which endorsed the use of opioids to treat
chronic pain, first in 1997 and again in 2009. He was also a member of the board of APF, an advocacy
organization almost entirely funded by Defendants.
Defendant Dr. Portenoy also made frequent media appearances promoting opioids and
spreading misrepresentations. He appeared on Good Morning America in 2010 to discuss the use of
opioids long-term to treat chronic pain. On this widely watched program, broadcast in Lorain and
across the country, Dr. Portenoy claimed: "Addiction, when treating pain, is distinctly uncommon. If a
person does not have a history, a personal history, of substance abuse, and does not have a history in
the family of substance abuse, and does not have a very major psychiatric disorder, most doctors can
feel very assured that that person is not going to become addicted."Th
Defendant Dr. Portenoy has recently admitted that he "gave innumerable lectures in
the late 1980s and '90s about addiction that weren't true." These lectures falsely claimed that fewer
than 1% of patients would become addicted to opioids. According to Dr. Portenoy, because the
primary goal was to "destigmatize" opioids, he and other doctors promoting them overstated their
benefits and glossed over their risks. Dr. Portenoy also conceded that "[d]ata about the effectiveness

's Good Morning America television broadcast, ABC News (Aug. 30, 2010).
57

of opioids does not exist." 76 Portenoy candidly stated: "Did I teach about pain management,
specifically about opioid therapy, in a way that reflects misinformation? Well, . I guess I did."77
Defendant Lynn Webster
Another KOL, Defendant Dr. Lynn Webster, was the co-founder and Chief Medical
Director of Lifetree Clinical Research, an otherwise unknown pain clinic in Salt Lake City, Utah. Dr.
Webster was President in 2013 and is a current board member of AAPM, a front group that ardently
supports chronic opioid therapy.78 He is a Senior Editor of Pain Medicine, the same journal that
published Endo special advertising supplements touting Opana ER. Dr. Webster was the author of
numerous CMEs sponsored by Cephalon, Endo, and Purdue. At the same time, Dr. Webster was
receiving significant funding from Defendants (including nearly $2 million from Cephalon).
Dr. Webster had been under investigation for overprescribing by the DEA, which
raided his clinic in 2010. More than 20 of Dr. Webster's former patients at the Lifetree Clinic have died
of opioid overdoses. Ironically, Dr. Webster created and promoted the Opioid Risk Tool, a five
question, one-minute screening tool relying on patient self-reports that purportedly allows doctors to
manage the risk that their patients will become addicted to or abuse opioids. The claimed ability to presort patients likely to become addicted is an important tool in giving doctors confidence to prescribe
opioids long-term, and for this reason, references to screening appear in various industry-supported
guidelines. Versions of Dr. Webster's Opioid Risk Tool appear on, or are linked to, websites run by
Endo, Janssen, and Purdue. In 2011, Dr. Webster presented, via webinar, a program sponsored by
Purdue titled, Managing Patient's Opioid Use. Balancing the Need and the Rick. Dr. Webster recommended

hThomas Catan & Evan Perez, A Pain-Drug Champion Has Second Thoughts, Wall St. J., Dec. 17, 2012.
Id.
78 Journal supplements are paid for by drug manufacturers and, although they may be designed to
blend into the rest of the journal, are not peer-reviewed and constitute drug company advertising.
76
77

58

use of risk screening tools, urine testing, and patient agreements to prevent "overuse of prescriptions"
and "overdose deaths." This webinar was available to and was intended to reach City doctors.
Dr. Webster also was a leading proponent of the concept of "pseudoaddiction," the
notion that addictive behaviors should be seen not as warnings, but as indications of undertreated pain.
In Dr. Webster's description, the only way to differentiate the two was to increase a patient's dose of
opioids. As he and his co-author wrote in a book entided Avoiding Opioid Abuse While Managing Pain
(2007), when faced with signs of aberrant behavior, increasing the dose "in most cases . . . should be
the clinician's first response." Endo distributed this book to doctors. Years later, Dr. Webster reversed
himself, acknowledging that Ipseudoaddiction] obviously became too much of an excuse to give
patients more medication."79
b. "Research" That Lacked Supporting Evidence
Rather than find a way to actually test the safety and efficacy of opioids for long- term
use, Defendants led people to believe that they already had. Defendants created a body of false,
misleading, and unsupported medical and popular literature about opioids that (a) understated the risks
and overstated the benefits of long-term use; (b) appeared to be the result of independent, objective
research; and (c) was thus more likely to shape the perceptions of prescribers, patients and payors. This
literature was, in fact, marketing material focused on persuading doctors and consumers that the
benefits of long-term opioid use outweighed the risks.
To accomplish this, Defendants—sometimes through third-patty consultants and/or
advocacy organizations—commissioned, edited, and arranged for the placement of favorable articles in
academic journals. Defendants' internal documents reveal plans to submit research papers and

79 John Fauber & Ellen Gabler, NetivorkinsFuels Painkiller Boom, Milwaukee Wisc. J. Sentinel (Feb.
19, 2012).

59

A

"studies" to long lists of journals, including back-up options and last resort, "fast-track" application
journals, that they could use if the pending paper was rejected everywhere else.
Defendants coordinated the timing and publication of manuscripts, abstracts,
posters/oral presentations, and educational materials in peer-reviewed journals and other publications
to support the launch and sales of their drugs. The plans for these materials did not originate in the
departments within the Defendant organizations that were responsible for research, development or
any other area that would have specialized knowledge about the drugs and their effects on patients, but
in Defendants' marketing departments and with Defendants' marketing and public relations
consultants. Defendants often relied on "data on file" or presented posters, neither of which are
subject to peer review. They also published their articles not through a competitive process, but in paid
journal supplements, which allowed Defendants to publish, in nationally circulated journals, studies
supportive of their drugs.
Defendants also made sure that favorable articles were disseminated and cited widely in
the medical literature, even where references distorted the significance or meaning of the underlying
study. Most notably, Purdue promoted a 1980 reference in the well-respected New England Journal of
Medicine: J. Porter & H. Jick, Addiction Rare in Patients Treated with Narcotics, 302(2) New Eng. J. Med. 123
(1980) ("Porter-Jick Letter"). It is cited 856 times in Google Scholar, and 86 times since 2010. It also
appears as a reference in two CME programs in 2012 sponsored by Purdue and Endo.8° Defendants
and those acting on their behalf fail to reveal that this "article" is actually a letter-to-the-editor, not a
peer-reviewed study (or any kind of study at all). The Porter-Jick Letter, reproduced in full below,
describes a review of the charts of hospitalized patients who had received opioids. (Because it was a

AAPM, Safe Opioid Prescribing Course, February 25-26, 2012, sponsored by Purdue and Endo;
"Chronic Pain Management and Opioid Use," October 11, 2012, sponsored by Purdue. Each CME is
available for online credit, including to prescribers in Lorain County.
80

60

A

1980 study, standards of care almost certainly would have limited opioids to acute or end-of-life
situations, not chronic pain.)
ADDICTION RARE IN PATIENT'S TREATED
W I TI-1 NA R COT I CS

To the Editor: Recently, we examined our current files to determine the incidence of narcotic addiction in 39,946 hospitalized
medical patients' who were monitored consecutively. Although
there were 11,882 patients who received at least one narcotic preparation, there were only four cases of reasonably well documented
addiction in patients who had no history of addiction. The addiction was considered major in only one instance. The drugs implicated were meperidine in two patients,2 Percodan in one, and
hydromorphone in one. We conclude that despite widespread use of
narcotic drugs in hospitals, the development of addiction is rare in
medical patients with no history of addiction.
JANE Pot:et-Ex
Hensi-TEL jtcx,
Boston Collaborative Drug
Surveillance Program
Boston University Medical Center

Waltham, MA 02154

Jick H, Miettinen OS, Shapiro S. L.ewis GP, Siskind Y. Slone D.
Comprehensive drug surveillance. JA.MA. 1970; 213:1455-60.
Miller RR, Jick H. Clinical effects of mepericline in hospitalized medical
patients. J Clin Pharmaccol. 1978; 18:180-8.

The Porter-Jick Letter notes that, when these patients' records were reviewed, it found
almost no references to signs of addiction, though there is no indication that caregivers were instructed
to assess or document signs of addiction. None of these serious limitations is disclosed when
Defendants, or those acting on their behalf, cite the Porter-Jick Letter, typically as the sole scientific
support for the proposition that opioids are rarely addictive, even when taken long-term. In fact, Dr.
Jick later complained that his letter had been distorted and misused.
Defendants worked not only to create or elevate favorable studies in the literature, but
to discredit or bury negative information. Defendants' studies and articles often targeted articles that
contradicted Defendants' claims or raised concerns about chronic opioid therapy. In order to do so,
Defendants—often with the help of third-party consultants—targeted a broad range of media to get
their message out, including negative review articles, letters to the editor, commentaries, case-study
reports, and newsletters.

61

A

Defendants' strategies—first, to plant and promote supportive literature and then, to
cite the pro-opioid evidence in their promotional materials, while failing to disclose evidence that
contradicts those claims—are flatly inconsistent with their legal obligations. The strategies were
intended to, and did, knowingly and intentionally distort the truth regarding the risks, benefits and
superiority of opioids for chronic pain relief resulting in distorted prescribing patterns.
c. Treatment Guidelines
Treatment guidelines have been particularly important in securing acceptance for
chronic opioid therapy. They are relied upon by doctors, especially the general practitioners and family
doctors targeted by Defendants, who are otherwise not experts, nor trained, in the treatment of
chronic pain. Treatment guidelines not only directly inform doctors' prescribing practices, but are cited
throughout the scientific literature and referenced by third-party payors in determining whether they
should cover treatments for specific indications. Furthermore, Endo's internal documents indicate that
pharmaceutical sales representatives employed by Endo, Actavis, and Purdue discussed treatment
guidelines with doctors during individual sales visits.
i. FSMB
The Federation of State Medical Boards ("FSMB") is a trade organization representing
the various state medical boards in the United States. The state boards that comprise the FSMB
membership have the power to license doctors, investigate complaints, and discipline physicians. The
FSMB finances opioid- and pain-specific programs through grants from Defendants.
240. In 1998, the FSMB developed Model Guidelines for the Use of Controlled Substances for the
Treatment of Pain ("FSMB Guidelines"), which FSMB admitted was produced "in collaboration with
pharmaceutical companies."81 The FSMB Guidelines taught not that opioids could be appropriate in
limited cases or after other treatments had failed, but that opioids were "essential" for treatment of

62

chronic pain, including as a first prescription option. The FSMB Guidelines failed to mention risks
relating to respiratory depression and overdose, and they discussed addiction only in the sense that
"inadequate understandings" of addiction can lead to "inadequate pain control."
A 2004 iteration of the FSMB Guidelines and the 2007 book adapted from the 2004
guidelines, Responsible Opioid Prescribing, also make these same claims. These guidelines were posted
online and were available to and intended to reach City physicians.
The publication of Responsible Opioid Prescribing was backed largely by drug
manufacturers, including Cephalon, Endo, and Purdue. The FSMB financed the distribution of
Responsible Opioid Prescribing by its member boards by contracting with drug companies, including Endo
and Cephalon, for bulk sales and distribution to sales representatives (for distribution to prescribing
doctors).
In all, 163,131 copies of Responsible Opioid Prescribing were distributed to state medical
boards (and through the boards, to practicing doctors), and the FSMB benefitted by earning
approximately $250,000 in revenue and commissions from their sale. The FSMB website describes the
book as the "leading continuing medication education (CME) activity for prescribers of opioid
medications."
Drug companies relied on FSMB guidelines to convey the message that "undertreatment of pain" would result in official discipline, but no discipline would result if opioids were
prescribed as part of an ongoing patient relationship and prescription decisions were documented.
FSMB turned doctors' fear of discipline on its head—doctors, who used to believe that they would be
disciplined if their patients became addicted to opioids, were taught that they would be punished
instead if they failed to prescribe opioids to their patients with pain.
245. FSMB, more recently, has moderated its stance. Although the 2012 revision of Responsible Opioid Prescribing continued to teach that "pseudoaddiction" is real and that opioid addiction
63

•

risk can be managed through risk screening, it no longer recommended chronic opioid therapy as a
first choice after the failure of over-the-counter medication and has heightened its addiction and risk
warnings.
AAPM/APS Guidelines
AAPM and the APS are professional medical societies, each of which received
substantial funding from Defendants from 2009 to 2013 (with AAPM receiving over $2 million).
They issued a consensus statement in 1997, The Use of Opioids for the Treatment of Chronic
Pain, which endorsed opioids to treat chronic pain and claimed that the risk that patients would
become addicted to opioids was low." The co-author of the statement, Dr. Haddox, was, at the time, a
paid speaker for Purdue. Dr. Portenoy was the sole consultant. The consensus statement, which also
formed the foundation of the FSMB Guidelines, remained on AAPM's website until 2011. The
statement was taken down from AAPM's website only after a doctor complained, though it lingers on
the internet elsewhere."
AAPM and APS issued their own guidelines in 2009 ("AAPM/APS Guidelines") and
continued to recommend the use of opioids to treat chronic pain." Fourteen of the 21 panel members
who drafted the AAPM/APS Guidelines, including KOLs Dr. Portenoy and Dr. Perry Fine of the
University of Utah, received support from Janssen, Cephalon, Endo, and Purdue.
The 2009 Guidelines promote opioids as "safe and effective" for treating chronic pain,
despite acknowledging limited evidence, and conclude that the risk of addiction is manageable for
patients regardless of past abuse histories. One panel member, Dr. Joel Saper, Clinical Professor of

Consensus statement, The Use of Opioids for the Treatment of Chronic Pain, APS & AAPM (1997),
available at http://opiareastematicas.comigeneralidades/OPIOIDES.DOLORCRONICO.pdf.
82

83 Id

84 Roger Chou et al., Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Path,
The Journal of Pain: Official Journal of the American Pain Society 113-130 (2009)

64

lop

Neurology at Michigan State University and founder of the Michigan Headache & Neurological
Institute, resigned from the panel because of his concerns that the 2009 Guidelines were influenced by
contributions that drug companies, including Defendants, made to the sponsoring organizations and
committee members. These AAPM/APS Guidelines have been a particularly effective channel of
deception and have influenced not only treating physicians, but also the body of scientific evidence on
opioids; the Guidelines have been cited 732 times in academic literature, were disseminated in Lorain
during the relevant time period, are still available online, and were reprinted in the Journal of Pain.
Defendants widely referenced and promoted the 2009 Guidelines without disclosing
the acknowledged lack of evidence to support them.
American Geriatrics Society
The American Geriatrics Society ("AGS"), a nonprofit organization serving health care
professionals who work with the elderly, disseminated guidelines regarding the use of opioids for
chronic pain in 2002 (The Management of Persistent Pain in Older Persons, hereinafter "2002 AGS
Guidelines") and 2009 (Pharmacological Management of Persistent Pain in Older Persons, hereinafter "2009
AGS Guidelines"). The 2009 AGS Guidelines included the following recommendations: "All patients
with moderate to severe pain . . . should be considered for opioid therapy (low quality of evidence,
strong recommendation)," and "the risks [of addiction] are exceedingly low in older patients with no
current or past history of substance abuse."85 These recommendations, which continue to appear on
AGS's website, are not supported by any study or other reliable scientific evidence. Nevertheless, they
have been cited 278 times in Google Scholar since their 2009 publication.
252. AGS contracted with Defendants Endo, Purdue, and Janssen to disseminate the 2009
Guidelines, and to sponsor CMEs based on them. These Defendants were aware of the content of the
Pharmacological Management of Persistent Pain in Older Persons, 57J. Am. Geriatrics Soc'y 1331,
1339, 1342 (2009), available at http://onlinelibrary.wiley.com/doi/10.1111415264637.2009.00699.x/full.
85

65

•

2009 Guidelines when they agreed to provide funding for these projects. The 2009 Guidelines were
first published online on July 2, 2009. AGS submitted grant requests to Defendants including Endo
and Purdue beginning July 15, 2009. Internal AGS discussions in August 2009 reveal that it did not
want to receive up-front funding from drug companies, which would suggest drug company influence,
but would instead accept commercial support to disseminate the publication. However, by drafting the
guidelines knowing that pharmaceutical company funding would be needed, and allowing these
companies to determine whether to provide support only after they had approved the message, AGS
ceded significant control to these companies. Endo, Janssen, and Purdue all agreed to provide support
to distribute thc guidelines.
According to one news report, AGS has received $344,000 in funding from opioid
makers since 2009." Five of 10 of the experts on the guidelines panel disclosed financial ties to
Defendants, including serving as paid speakers and consultants, presenting CMEs sponsored by
Defendants, receiving grants from Defendants, and investing in Defendants' stock. The Institute of
Medicine recommends that, to ensure an unbiased result, fewer than 50% of the members of a
guidelines committee should have financial relationships with drug companies.
iv. Guidelines That Did Not Receive Defendants' Support
The extent of Defendants' influence on treatment guidelines is demonstrated by the
fact that independent guidelines—the authors of which did not accept drug company funding—
reached very different conclusions. The 2012 Guidelines for Rey)onsible Opioid Prescribing in Chronic NonCancer Pain, issued by the American Society of Interventional Pain Physicians ("ASIPP"), warned that
"[t]he recent revelation that the pharmaceutical industry was involved in the development 6f opioid
guidelines as well as the bias observed in the development of many of these guidelines illustrate that

John Fauber & Ellen Gables, Narcotic Painkiller Use Booming Among Elderly, Milwaukee J. Sentinel,
May 30, 2012.

86

66

the model guidelines are not a model for curtailing controlled substance abuse and may, in fact, be
facilitating it." ASIPP's Guidelines further advise that "therapeutic opioid use, specifically in high
doses over long periods of time in chronic non-cancer pain starting with acute pain, not only lacks
scientific evidence, but is in fact associated with serious health risks including multiple fatalities, and is
based on emotional and political propaganda under the guise of improving the treatment of chronic
pain." ASIPP recommends long-acting opioids in high doses only "in specific circumstances with
severe intractable pain" and only when coupled with "continuous adherence monitoring, in wellselected populations, in conjunction with or after failure of other modalities of treatments with
improvement in physical and functional status and minimal adverse effects!"87
Similarly, the 2011 Guidelines for the Chronic Use of Opioids, issued by the American
College of Occupational and Environmental Medicine, recommend against the "routine use of opioids
in the management of patients with chronic pain," finding "at least moderate evidence that harms and
costs exceed benefits based on limited evidence," while conceding there may be patients for whom
opioid therapy is appropriate.88
The Clinical Guidelines on Management of Opioid Therapy for Chronic Pain, issued by the U.S.
Department of Veterans Affairs ("VA") and Department of Defense ("DOD") in 2010, notes that
their review:
revealed the lack of solid evidence based research on the efficacy of long-term opioid
therapy. Almost all of the randomized trials of opioids for chronic non-cancer pain
were short-term efficacy studies. Critical research gaps . . . include: lack of effectiveness
studies on long-term benefits and harms of opioids . . .; insufficient evidence to draw
strong conclusions about optimal approaches to risk stratification. . .; lack of evidence

87 Laxmaiah Manchikanti, et al., American Society of Interventional Pain Physicians (ASIPP) Guidelines
for Responsible Opthid Prescribing in Chronic Non-Cancer Pain: Part 1, Evidence Assessment, 15 Pain Physician
(Special Issue) S1-S66; Part 2 — Guidance, 15 Pain Physician (Special Issue) S67-S116 (2012).
88 American College of Occupational and Environmental Medicine's Guidelines for the Chronic Use of Opioids,
(2011), available at. https: / /www.nhms .org/ sites /de fault/ files /Pdfs /AC OEM%202011Chronic%20Pain%200pioid%20.pdf

67

,

on the utility of informed consent and opioid management plans . . .; and treatment of
patients with chronic non-cancer pain at higher risk for drug abuse or misuse."
d. Continuing Medical Education
CMEs are ongoing professional education programs provided to doctors. Doctors are
required to attend a certain number and, often, type of CME programs each year as a condition of
their licensure. These programs are delivered in person, often in connection with professional
organizations' conferences, online, or through written publications. Doctors rely on CMEs not only to
satisfy licensing requirements, but to get information on new developments in medicine or to deepen
their knowledge in specific areas of practice. Because CMEs are typically delivered by KOLs.who are
highly respected in their fields, and are thought to reflect these physicians' medical expertise, they can
be especially influential to doctors.
The countless doctors and other health care professionals who participate in accredited
CMEs constitute an enormously important audience for opioid reeducation. As one target, Defendants
aimed to reach general practitioners, whose broad area of focus and lack of specialized training in pain
management made them particularly dependent upon CMEs and, as a result, especially susceptible to
Defendants' deceptions.
In all, Defendants sponsored CMEs that were delivered thousands of times, promoting
chronic opioid therapy and supporting and disseminating the deceptive and biased messages described
in this Complaint. These CMEs, while often generically titled to relate to the treatment of chronic pain,
focused on opioids to the exclusion of alternative treatments, inflated the benefits of opioids, and
frequently omitted or downplayed their risks and adverse effects.

" Management of Opioid Therapy for Chronic Pain Working Group, VA/DoD Clinical Practice
Guideline for Management of Opioid Therapy for Chronic Pain (May 2010), available at
hap: / /www.healthquality.va.gov/guidelines /Pain/cot/COT_312_Full-er.pdf.
68

The American Medical Association ("AMA") has recognized that support from drug
companies with a financial interest in the content being promoted "creates conditions in which
external interests could influence the availability and/or content" of the programs and urges that
"[w]hen possible, CME[s] should be provided without such support or the participation of individuals
who have financial interests in the educational subject matter."9°
Dozens of CMEs that were available to and attended or reviewed by City doctors
during the relevant time period did not live up to the AMA's standards.
The influence of Defendants' funding on the content of these CMEs is clear. One
study by a Georgetown University Medical Center professor compared the messages retained by
medical students who reviewed an industry-funded CME article on opioids versus another group who
reviewed a non-industry-funded CME article. The industry-funded CME did not mention opioidrelated death once; the non-industry-funded CME mentioned opioid-related death 26 times. Students
who read the industry-funded article more frequently noted the impression that opioids were
underused in treating chronic pain. The "take-aways" of those reading the non- industry-funded CME
mentioned the risks of death and addiction much more frequently than the other group. Neither group
could accurately identify whether the article they read was industry-funded, making cleat the difficulty
health care providers have in screening and accounting for source bias.9'
263 By sponsoring CME programs presented by Front Groups like APF, .AAPM, and
others, Defendants could expect messages to be favorable to them, as these organizations_were
otherwise dependent on Defendants for other projects. The sponsoring organizations honored this
principle by hiring pro-opioid KOLs to give talks that supported chronic opioid therapy. Defendant-

Opinion 9.0115, Financial Relationships with Industry in CME, Am. Med. Ass'n (Nov. 2011), available at
http:/ /eo2.commpartners.com/users/ama/downloads/120328_0pinion_E-9_0115.pdf.
91 Adriane Fugh-Berman, Marketing Messages in Industg-Funded CME, PharmedOut (June 25, 2010),
available at pharmedout.galacticrealms.com/Fugh-BermanPrescriptionforConflict6-25-10.pdf.
69

driven content in these CMEs had a direct and immediate effect on prescribers' views on opioids.
Producers of CMEs and Defendants measured the effects of CMEs on prescribers' views on opioids
and their absorption of specific messages, confirming the strategic marketing purpose in supporting
them.
e. Unbranded Patient Education
Pharmaceutical industry marketing experts see patient-focused advertising, including
direct-to-consumer marketing, as particularly valuable in "increas[ing] market share . . . by bringing
awareness to a particular disease that the drug treats."92 Evidence also demonstrates that physicians are
willing to acquiesce to patient demands for a particular drug— even for opioids and for conditions for
which they are not generally recommended.93 An Actavis marketing plan, for example, noted that
Idlirect-to-consumer marketing affects prescribing decisions." Recognizing this fact, Defendants put
their relationships with Front Groups to work to engage in largely unbranded patient education about
opioid treatment for chronic pain.
The drug companies expect that they will recoup their investment in direct-toconsumer advertisements by capturing at least some of any additional prescriptions that result from
patients "asking their doctor" about drugs that can treat their pain. Doctors also may review direct-toconsumer materials sales representatives give them to distribute to patients.
f. Defendants' Use of Front Groups
266. As noted above, Defendants Cephalon, Endo, Janssen, and Purdue entered into
arrangements with numerous organizations to promote opioids. These organizations depend upon

92 Kanika J ohar, An Insider's Peripective: Defense of the Pharmaceutical Industry's Marketing Practices, 76 Albany
L. Rev. 299, 308 (2013).
93 Prescribers often accede to patient requests. According to one study, nearly 20% of sciatica patients
requesting oxycodone would receive a prescription for it, compared with 1% making no request. More
than half of patients requesting a strong opioid received one. J.B. McKinlay et al., Effects of Patient
Medication Requests on Physician Prescribing Behavior, 52(2) Med. Care 294 (2014).

70

Defendants for significant funding and, in some cases, for their survival. They were involved not only
in generating materials and programs for doctors and patients that supported chronic opioid therapy,
but also in assisting Defendants' marketing in other ways—for example, responding to negative articles
and advocating against regulatory changes that would constrain opioid prescribing. They developed
and disseminated pro-opioid treatment guidelines; conducted outreach to groups targeted by
Defendants, such as veterans and the elderly; and developed and sponsored CMEs that focused
exclusively on use of opioids to treat chronic pain. Defendants funded these Front Groups in order to
ensure supportive messages from these seemingly neutral and credible third parties, and their funding
did, in fact, ensure such supportive messages.
i. American Pain Foundation
The most prominent of Defendants' Front Groups was APF, which received more
than $10 million in funding from opioid manufacturers from 2007 until it closed its doors in May
2012. Endo alone provided more than half of that funding; Purdue was next, at $1.7 million.
APF issued education guides for patients, reporters, and policymakers that touted the
benefits of opioids for chronic pain and trivialized their risks, particularly the risk of addiction. APF
also launched a campaign to promote opioids for returning veterans, which has contributed to high
rates of addiction and other adverse outcomes—including death—among returning soldiers. APF also
engaged in a significant multimedia campaign—through radio, television and the internet—to educate
patients about their "right" to pain treatment, namely opioids. All of the programs and materials were
available nationally and were intended to reach City residents.
269. In addition to Perry Fine, Russell Portenoy, and Scott Fishman, who served on APF's
Board and reviewed its publications, another board member, Lisa Weiss, was an employee of a public
relations firm that worked for both Purdue and APF.

71

In 2009 and 2010, more than 80% of APF's operating budget came from
pharmaceutical industry sources. Including industry grants for specific projects, APF received about
$2.3 million from industry sources out of total income of about $2.85 million in 2009; its budget for
2010 projected receipts of roughly $2.9 million from drug companies out of total income of about $3.5
million. By 2011, APF was entirely dependent on incoming grants from defendants Purdue, Cephalon,
Endo, and others to avoid using its line of credit. As one of its board members, Russell Portenoy,
explained, the lack of funding diversity was one of the biggest problems at APF.
APF held itself out as an independent patient advocacy organization. It often engaged
in grassroots lobbying against various legislative initiatives that might limit opioid prescribing, and thus
the profitability of its sponsors. It was often called upon to provide "patient representatives" for
Defendants' promotional activities, including for Purdue's Partners Against Pain and Janssen's Let's Talk
Pain. As laid out below, APF functioned largely as an advocate for the interests of Defendants, not
patients. Indeed, as early as 2001, Purdue told APF that the basis of a grant was Purdue's desire to
"strategically align its investments in nonprofit organizations that share [its] business interests."
In practice, APF operated in close collaboration with opioid makers. On several
occasions, representatives of the drug companies, often at informal meetings at Front Group
conferences, suggested activities and publications APF could pursue. APF then submitted grant
proposals seeking to fund these activities and publications, knowing that drug companies would
support projects conceived as a result of these communications.
273. APF assisted in other marketing projects for drug companies. One project funded by
another drug company—APF Reporter's Guide: Coveting Pain and Its Management (2008)94—recycled text
that was originally created as part of the company's training document.

94

haps://assets.documentcloud.org/documents/277606/aDf-reporters- guide.pdf (accessed May 30, 2017)

72

The same drug company made general grants, but even then, it directed how APF used
them. In response to an APF request for funding to address a potentially damaging state Medicaid
decision related to pain medications generally, the company representative responded, "I provided an
advocacy grant to APF this year—this would be a very good issue on which to use some of that. How
does that work?"
The close relationship between APF and the drug company was not unique, but in fact
mirrors the relationships between APF and Defendants. APF's clear lack of independence—in its
finances, management, and mission—and its willingness to allow Defendants to control its activities
and messages, support an inference that each Defendant that worked with APF was able to exercise
editorial control over its publications.
Indeed, the U.S. Senate Finance Committee began looking into APF in May 2012 to
determine the links, financial and otherwise, between the organization and the manufacturers of opioid
painkillers. The investigation caused considerable damage to APF's credibility as an objective and
neutral third party and Defendants stopped funding it. Within days of being targeted by Senate
investigation, APF's board voted to dissolve the organization "due to irreparable economic
circumstances." APF "cease[d] to exist, effective immediately."95
The AmenCan Academy of Pain Medicine
The American Academy of Pain Medicine, with the assistance, prompting,

involvement, and funding of Defendants, issued treatment guidelines and sponsored and hosted
medical education programs essential to Defendants' deceptive marketing of chronic opioid therapy.
AAPM has received over $2.2 million in funding since 2009 from opioid
manufacturers. AAPM maintains a corporate relations council, whose members pay $25,000 per year
(on top of other funding) to participate. The benefits include allowing members to present educational
http://www.painfoundation.org (last visited May 17, 2017).
73

programs at off-site dinner symposia in connection with AAPM's marquee event—its annual meeting
held in Palm Springs, California, or other resort locations. AAPM describes the annual event as an
"exclusive venue" for offering education programs to doctors.
Membership in the corporate relations council also allows drug company executives
and marketing staff to meet with AAPM executive committee members in small settings. Defendants
Endo, Purdue, Cephalon and Actavis were members of the council and presented deceptive programs
to doctors who attended this annual event.
AAPM is viewed internally by Endo as "industry friendly," with Endo advisors and
speakers among its active members. Endo attended AAPM conferences, funded its CMEs, and
distributed its publications. The conferences sponsored by AAPM heavily emphasized sessions on
opioids-37 out of roughly 40 at one conference alone. AAPM's presidents have included top
industry-supported KOLs Perry Fine, Russell Portenoy, and Lynn Webster. Dr. Webster was even
elected president of AAPM while under a DEA investigation. Another past AAPM president, Dr.
Scott Fishman, stated that he would place the organization "at the forefront" of teaching that "the
risks of addiction are . . . small and can be managed."96
AAPM's staff understood that they and their industry funders were engaged in a
common practice. Defendants were able to influence AAPM through both their significant and regular
funding, and the leadership of pro-opioid KOLs within the organization.
3. Defendants Acted in Concert with KOLs and Front Groups in the Creation,
Promotion, and Control of Unbranded Marketing.
282. Like cigarette manufacturers, which engaged in an industry-wide effort to misrepresent
the safety and risks of smoking, Defendants worked with each other and with the Front Groups and

96 Interview by Paula Moyer with Scott M. Fishman, M.D., Professor of Anesthesiology and Pain
Medicine, Chief of the Division of Pain Medicine, Univ. of Cal., Davis (2005),
http://www.medscape.org/viewarticle/500829.

74

KOLs they funded and directed to carry out a common scheme to deceptively present the risks,
benefits, and superiority of opioids to treat chronic pain.
Defendants acted through and with the same network of Front Groups, funded the
same KOLs, and often used the very same language and format to disseminate the same deceptive
messages. These KOLs have worked reciprocally with Defendants to promote misleading messaging
regarding the appropriate use of opioids to treat chronic pain. Although participants knew this
information was false and misleading, these misstatements were nevertheless disseminated to Lorain
prescribers and patients.
One vehicle for their collective collaboration was Pain Care Forum ("PCF"). PCF
began in 2004 as an APF project with the stated goals of offering "a setting where multiple
organizations can share information" and to "promote and support taking collaborative action
regarding federal pain policy issues." APF President Will Rowe described the Forum as "a deliberate
effort to positively merge the capacities of industry, professional associations, and patient
organizations."
PCF is comprised of representatives from opioid manufacturers and distributors
(including Cephalon, Endo, Janssen, and Purdue); doctors and nurses in the field of pain care;
professional organizations (e.g., American Academy of Pain Management, APS, and American Society
of Pain Educators); patient advocacy groups (e.g., APF and ACPA); and other like-minded
organizations (e.g., FSMB and Wisconsin Pain & Policy Studies Group), almost all of which received
substantial funding from Defendants.
PCF, for example, developed and disseminated "consensus recommendations" for a
Risk Evaluation and Mitigation Strategy ("REMS") for long-acting opioids that the FDA mandated in

75

2009 to communicate the risks of opioids to prescribers and patients.97 This was critical as a REMS
that went too far in narrowing the uses or benefits, or highlighting the risks of chronic opioid therapy,
would deflate Defendants' marketing efforts. The recommendations—drafted by Will Rowe of APF—
claimed that opioids were "essential" to the management of pain, and that the REMS "should
acknowledge the importance of opioids in the management of pain and should not introduce new
barriers."" Defendants worked with PCF members to limit the reach and manage the message of the
REMS, which enabled them to maintain, and not undermine, their deceptive marketing of opioids for
chronic pain.
4. Defendants Targeted Vulnerable and Lucrative Populations.
a. The Elderly
Elderly patients taking opioids have been found to be exposed to elevated fracture
risks, a greater risk for hospitalizations, and increased vulnerability to adverse drug effects and
interactions, such as respiratory depression, which, as Defendants acknowledge in their labels (but not
in their marketing), occurs more frequently in elderly patients. A 2010 paper in the Archives of Internal
Medicine reported that elderly patients who used opioids had a significantly higher rate of death, heart
attacks, and strokes than users of NSAIDs. Defendants' targeted marketing to the elderly and the
absence of cautionary language in their promotional materials flies in the face of scientific evidence and
their own labels, and creates a heightened risk of serious injury to elderly patients.
Defendants also promoted the notion—also without adequate scientific foundation—
that the elderly are particularly unlikely to become addicted to opioids. AGS's 2009 Guidelines, for
example, which Purdue, Endo, and Janssen publicized, described the risk of addiction as "exceedingly

The FDA can require a drug maker to develop a REMS—which could entail (as in this case) an
education requirement or distribution limitation—to manage serious risks associated with a drug.
98 Defendants also agreed that short-acting opioids should also be included in REMS as not to
disadvantage the long-acting, branded drugs.
97

76

low in older patients with no current or past history of substance abuse." Yet, a 2010 study examining
overdoses among long-term opioid users found that patients 65 or older were among those with the
largest number of serious overdoses.
Defendants' efforts have paid off. Since 2007, prescriptions for the elderly have grown
at twice the rate of prescriptions for adults between the ages of 40 and 59.
b. Veterans
Veterans, too, are suffering greatly from the effects of Defendants' targeted marketing.
A 2008 survey showed that prescription drug abuse among military personnel had doubled from 2002
to 2005, and then nearly tripled again over the next three years. In 2009, military doctors wrote 3.8
million prescriptions for narcotic pain pills—four times as many as they had in 2001. Further, onethird of veterans prescribed opioids as of 2012 remained on take-home opioids for more than 90 days.
Although many of these veterans are returning from service with traumatic injuries, the increase in
opioid prescribing is disproportionate to the population and, in far too many cases, unsuited for their
treatment. Among former service members receiving VA services nationally in a single year (2005),
1,013 had died of an accidental drug overdose—double the rate of the civilian population.
The City has a substantial population of veterans who must cope with the
consequences of oveiprescribing opioids.
Opioids are particularly dangerous to veterans. According to a study published in the
2013 Journal of American Medicine, veterans returning from Iraq and Afghanistan who were
prescribed opioids have a higher incidence of adverse clinical outcomes, such as overdoses and selfinflicted and accidental injuries; 40% of veterans with post-traumatic stress disorder received opioids
and benzodiazepines (anti-anxiety drugs) that, when mixed with alcohol, can cause respiratory
depression and death. According to a VA Office of Inspector General Report, despite the risks, 92.6%

77

of veterans who were prescribed opioid drugs were also prescribed benzodiazepines.99 Again, as with
elderly patients, Defendants both purposefully sought to increase opioid prescribing to this vulnerable
group and omitted from their promotional materials the known, serious risks opioids pose to them.
Exit Wounds, a 2009 publication sponsored by Purdue, distributed by APP with grants
from Janssen and Endo, and written as a personal narrative of one veteran, describes opioids as
"underused" and the "gold standard of pain medications" and fails to disclose the risk of addiction,
overdose, or injury. It notes that opioid medications "increase a person's level of functioning" and that
"Mong experience with opioids shows that people who are not predisposed to addiction are unlikely to
become addicted to opioid pain medications." The book also asserts that "[d]enying a person opioid
pain medication because he or she has a history of substance abuse or addiction is contrary to the
model guidelines for prescribing opioids, published by the U.S. Federation of State Medical Boards."
As laid out above, the FSMB itself received support from Defendants during the time it created and
published its guidelines.
Exit Wounds minimizes the risks of chronic opioid therapy and does not disclose the
risk that opioids may have fatal interactions with benzodiazepines, which were taken by a significant
number of veterans.199 It is not the unbiased narrative of a returning war veteran. It is pure marketing,
sponsored by Purdue, Endo, and Janssen. Janssen, for example, supported the marketing effort, and its
insufficient disclosures, despite acknowledging on the label for its opioid Duragesic that its use with
benzodiazepines "may cause respiratory depression, hypotension, and profound sedation or potentially
result in coma." A similar warning is found on the labels of other Defendants' opioids.

(accessed May 30, 2017)
loo FDA guidance states that materials designed to target a particular audience should disclose risks

99 https://www.va.gov/oig/pubs/VAOIG-14-00895-163.pdf

particular to that audience. See FDA Notice, Guidance for Industry, "Brief Summary and Adequate
Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and
Promotional Labeling for Prescription Drugs," August 6, 2015.
78

The deceptive nature of Exit Wounds is obvious in comparing it to guidance on opioids
published by the VA and DOD in 2010 and 2011. The VA's Taking Opioids Reiponsib# describes
opioids as "dangerous." It cautions against taking extra doses and mentions the risk of overdose and
the dangers of interactions with alcohol. The list of side effects from opioids includes decreased
hormones, sleep apnea, hyperalgesia, addiction, immune system changes, birth defects and death—
none of which is disclosed in Exit Wounds.
D. Why Defendants' Marketing Messages Are Misleading and Unfair
Defendants' marketing of opioids for long-term use to treat chronic pain, both directly
and with and through third parties, included information that was false, misleading, contrary to
credible scientific evidence and their own labels, and lacked balance and substantiation. Their
marketing materials omitted material information about the risks of opioids, and overstated their
benefits. Moreover, Defendants inaccurately suggested that chronic opioid therapy was supported by
evidence, and failed to disclose the lack of evidence in support of treating chronic pain with opioids.
There are seven primary misleading and unfounded representations. Defendants and
the third parties with which they teamed:
misrepresented that opioids improve function;
concealed the link between long-term use of opioids and addiction;
misrepresented that addiction risk can be managed;
• masked the signs of addiction-by- calling-them-clpseudoaddiction";
falsely claimed withdrawal is easily managed;
misrepresented or omitted the greater dangers from higher doses of opioids; and
deceptively minimized the adverse effects of opioids and overstated the risks of
NSAIDs.

79

In addition to these misstatements, Purdue purveyed an eighth deception that
OxyContin provides a full 12 hours of pain relief.
Exacerbating each of these misrepresentations and deceptions was the collective effort
of Defendants and third parties to hide from the medical community the fact that the FDA "is not
aware of adequate and well-controlled studies of opioid use longer than 12 weeks."101
1. Defendants and Their Third-Party Allies Misrepresented that Opioids Improve
Function
Each of the following materials was created with the expectation that, by instructing
patients and prescribers that opioids would improve patients' function and quality of life, patients
would demand opioids and doctors would prescribe them. These claims also encouraged doctors to
continue opioid therapy in the belief that failure to improve pain, function, or quality of life, could be
overcome by increasing doses or prescribing supplemental short-acting opioids on an as-needed basis
for breakthrough pain.
However, not only is there no evidence of improvement in long-term functioning, but
a 2006 study-of-studies found that "[for functional outcomes . . . other analgesics were significantly
more effective than were opioids."102 Studies of the use of opioids in chronic conditions for which
they are commonly prescribed, such as low back pain, corroborate this conclusion and have failed to
demonstrate an improvement in patients' function. Research consistently shows that long-term opioid
therapy for patients who have lower back injuries does not cause patients to return to work or physical

Letter from Janet Woodcock, M.D., Dir., Ctr. for Drug Eval. & Res., to Andrew Kolodny, M.D.,
Pres. Physicians for Responsible Opioid Prescribing, Re Docket No. FDA-2012-P-0818 (Sept. 10,
2013).
102
Andrea D. FurIan et al., Opioidsfor chronic noncancer pain: a meta-analysis of effectiveness and side effects,
174(11) Can. Med. Ass'n J. 1589-1594 (2006). This study revealed that efficacy studies do not typically
include data on opioid addiction, such that, if anything, the data overstate effectiveness.
101

80

activity. 103 Indeed, one Defendant's own internal marketing plans characterized functional
improvement claims as "aspirational." Another acknowledged in 2012 that "[s]ignificant investment in
clinical data [was] needed" to establish opioids' effect on mitigating quality of life issues, like social
isolation.
The long-term use of opioids carries a host of serious side effects, including addiction,
mental clouding and confusion, sleepiness, hyperalgesia, and immune-system and hormonal
dysfunction that degrade, rather than improve, patients' ability to function. Defendants often omitted
these adverse effects as well as certain risks of drug interactions from their publications.
Yet each of the following statements by Defendants, suggests that the long-term use of
opioids improve patients' function and quality of life, and that scientific evidence supports this claim.

Actavis

Documents from a 2010 sales training indicate that Actavis trained its sales
force to instruct prescribers that "most chronic benign pain patients do have
markedly improved ability to function when maintained on chronic opioid
therapy." (Emphasis added.)
Documents from a 2010 sales training indicate that Actavis trained its sales force
that increasing and restoring function is an expected outcome of chronic
Kadian therapy, including physical, social, vocational, and recreational function.
Actavis distributed a product advertisement that claimed that use of Kadian to
treat chronic pain would allow patients to return to work, relieve "stress on your
body and your mental health," and cause patients to enjoy their lives. The
FDA warned Actavis that such claims were misleading, writing: "We are not.
_ aware of-substantial-evidence or substantial clinical experience- demonstrating
that the magnitude of the effect of the drug has in alleviating pain, taken
together with any drug-related side effects patients may experience . . .

103 Moreover, users of opioids had the highest increase in the number of headache days per month,
scored significantly higher on the Migraine Disability Assessment (MIDAS), and had higher rates of
depression, compared to non-opioid users. They also were more likely to experience sleepiness,
confusion, and rebound headaches, and reported a lower quality of life than patients taking other
medications.

81

results in any overall positive impact on a patient's work, physical and mental
functioning, daily activities, or enjoyment of life."104
d. Actavis sales representatives told Lorain prescribers that prescribing Actavis's
opioids would improve their patients' ability to function and improve their
quality of life.

Cephalon

Cephalon sponsored the FSMB's Responsible Opioid Prescribing (2007),
which taught that relief of pain itself improved patients' function. Responsible
Opioid Prescribing explicitly describes functional improvement as the goal of a
"long-term therapeutic treatment course." Cephalon also spent $150,000 to
purchase copies of the book in bulk and distributed the book through its pain
. sales force to 10,000 prescribers and 5,000 pharmacists.
Cephalon sponsored the American Pain Foundation's Treatment Options: A
Guide for People Living with Pain (2007), which taught patients that opioids, when
used properly "give [pain patients] a quality of life we deserve." The Treatment
Options guide notes that non-steroidal anti-inflammatory drugs have greater risks
associated with prolonged duration of use, but there was no similar warning for
opioids. APF distributed 17,200 copies in one year alone, according to its 2007
annual report. The publication is also currently available online.
Cephalon sponsored a CME written by key opinion leader Dr. Lynn Webster,
titled Optimking Opioid Treatment for Breakthrough Pain, which was offered online
by Medscape, LLC from September 28, 2007, to December 15, 2008. The CME
taught that Cephalon's Actiq and Fentora improve patients' quality of life and
allow for more activities when taken in conjunction with long- acting opioids.
Cephalon sales representatives told Lorain prescribers that opioids
would increase patients' ability to function and improve their quality of life.

Endo

Endo sponsored a website, painlcnowledge.com, through APF and NIPC,
which, in 2009, claimed that with opioids, "your level of function should improve;
you may find you are now able to participate in activities of daily living, such as
work and hobbies, that you were not able to enjoy when your pain was worse."
Endo continued to provide funding for this website through 2012, and closely
tracked unique visitors to it.
A CME sponsored by Endo, titled Persistent Pain in the Older Patient, taught that
chronic opioid therapy has been "shown to reduce pain and improve

104

Warning Letter from Thomas Abrams, Dir., FDA Div. of Mktg., Adver., & Comrnc'ns, to Doug
Boothe, CEO, Actavis Elizabeth LLC (Feb. 18. 2010), available at
http://www.fda.gov/Drugs / Guidanc e C omp lian ceRegula toryInforma tio n /En forcementA c tivitiesbyF
DA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm259240.htm.
82

depressive symptoms and cognitive functioning."
k. Endo distributed handouts to prescribers that claimed that use of Opana ER to
treat chronic pain would allow patients to perform work as a chef. This flyer
also emphasized Opana ER's indication without including equally prominent
disclosure of the "moderate to severe pain" qualification.105
1. Endo's sales force distributed FSMB's Reiponsible Opioid Prescribing (2007) which
taught that relief of pain itself improved patients' function. Relionsible Opioid
Prescribing explicitly describes functional improvement as the goal of a "long-term
therapeutic treatment course."
Endo provided grants to APF to distribute Exit Wounds to veterans, which taught
that opioid medications "increase your level of functioning" (emphasis in the
original). Exit 1Vounds also omits warnings of the risk of interactions between
opioids and benzodiazepines, which would increase fatality risk.
Benzodiazepines are frequently prescribed to veterans diagnosed with posttraumatic stress disorder.
Endo sales representatives told Lorain prescribers that opioids would
increase patients' ability to function and improve their quality of life by helping
them become more physically active and return to work.

Janssen

Janssen sponsored a patient education guide titled Finding Relic[ Pain
Management for Older Adults (2009), which its personnel reviewed and approved,
and its sales force distributed. This guide features a man playing golf on the
cover and lists examples of expected functional improvement from opioids, like
sleeping through the night, returning to work, recreation, sex, walking, and
climbing stairs. The guide states as a "fact" that "opioids may make it easier for
people to live normally" (emphasis in the original). The myth/fact structure
implies authoritative backing for the claims that does not exist. 'The targeting of
older adults also ignored heightened opioid risks in this population
Janssen sponsored, developed, and approved content of a website, Let's Talk
Pain in 2009, acting in conjunction with the APF, AAPM, and ASPMN, whose
participation in Let's Talk Pain Janssen financed and orchestrated. This website
featured an interview, which was edited by Janssen personnel, claiming that
opioids were what allowed a patient to "continue to function," inaccurately
implying her experience would be representative. This video is still available
today on youtube.com.

105 FDA regulations require that warnings or limitations be given equal prominence in disclosure, and
failure to do so constitutes "misbranding" of the product. 21 C.F.R. 5 202.1(e)(3); see also 21 U.S.C.
5331 (a).

83

Janssen. provided grants to APF to distribute Exit Wounds to veterans, which
taught that opioid medications "increase your level of functioning" (emphasis in
the original). Exit Wounds also omits warnings of the risk of interactions between
opioids and benzodiazepines, which would increase fatality risk. Benzodiazepines
are frequently prescribed to veterans diagnosed with post-traumatic stress
disorder.
Janssen sales representatives told Lorain prescribers that opioids would
increase patients' ability to function and improve their quality of life by helping
them become more physically active and return to work.
Purdue

Purdue ran a series of advertisements for OxyContin in 2012 in medical journals
titled "Pain vignettes," which were case studies featuring patients, each with
pain conditions persisting over several months, recommending OxyContin for
each. One such patient, "Paul," is described as a "54-year- old writer with
osteoarthritis of the hands," and the vignettes imply that an OxyContin
prescription will help him work more effectively.
Purdue sponsored APF's A Poligmaker's Guide to Understanding Pain & Its
Management, which inaccurately claimed that "multiple clinical studies" had
shown that opioids are effective in improving daily function, psychological
health, and health-related quality of life for chronic pain patients." The sole
reference for the functional improvement claim noted the absence of long-term
studies and actually stated: "For functional outcomes, the other analgesics were
significantly more effective than were opioids." The Poligmaker's Guide is still
available online.
Purdue sponsored APF's Treatment Options: A Guide for People Living with Pain
(2007), which counseled patients that opioids, when used properly, "give [pain
patients] a quality of life we deserve." APF distributed 17,200 copies in one year
alone, according to its 2007 annual report. The guide is currently available
online.
Purdue sponsored APF's Exit Wounds (2009), which taught veterans that opioid
medications "increase your level of functioning." Exit Wounds also omits
warnings of the risk of interactions between opioids and benzodiazepines, which
would increase fatality risk. Benzodiazepines are frequently prescribed to •
veterans diagnosed with post-traumatic stress disorder.
Purdue sponsored the FSMB's Reiponsible Opioid Prescribing (2007), which taught
that relief of pain itself improved patients' function. Reiponsible Opioid
Prescribing explicitly describes functional improvement as the goal of a "longterm therapeutic treatment course." Purdue also spent over $100,000 to
support distribution of the book.
Purdue sales representatives told Lorain prescribers that opioids
84

would increase patients' ability to function and improve their quality of life.
2. Defendants and Their Third-Party Allies Concealed the Truth About the Risk of
Addiction from Long-Term Opioid Use
The fraudulent representation that opioids are rarely addictive is central to Defendants'
scheme. To reach chronic pain patients Defendants, and the Front Groups and KOLs that they
directed, assisted, and collaborated with, had to overcome doctors' legitimate fears that opioids would
addict their patients. The risk of addiction is an extremely weighty risk—condemning patients to,
among other things, dependence, compulsive use, haziness, a lifetime of battling relapse, and a
dramatically heightened risk of serious injury or death. But for Defendants' campaign to convince
doctors otherwise, finding benefits from opioid use for common chronic pain conditions sufficient to
justify that risk would have, and previously had, posed a nearly insurmountable challenge.
Through their well-funded, comprehensive marketing efforts, Defendants and their
KOLs and Front Groups were able to change prescriber perceptions despite the well-settled historical
understanding and clear evidence that opioids taken long-term are often addictive. Defendants and
their third-party partners: (a) brazenly maintained that the risk of addiction for patients who take
opioids long-term was low; and (b) omitted the risk of addiction and abuse from the list of adverse
outcomes associated with chronic opioid use, even though the frequency and magnitude of the risk—
and Defendants' own labels—compelled disclosure.
Further, in addition to falsely claiming opioids had low addiction risk or omitting
disclosure of the risk of addiction altogether, Defendants employed language that conveyed to
prescribers that the drugs had lower potential for abuse and addiction. Further, in addition to making
outright misrepresentations about the risk of addiction, or failing to disclose that serious risk at all,
Defendants used code words that conveyed to prescribers that their opioid was less prone to abuse
and addiction. For instance, sales representatives for Actavis, Endo, Janssen, and Purdue promoted

85

their drugs as having "steady-state" properties with the intent and expectation that prescribers would
understand this to mean that their drugs caused less of a rush or a feeling of euphoria, which can
trigger abuse and addiction. Further, Endo actively promoted its reformulated Opana ER on the basis
that it was "designed to be crush-resistant," suggesting both (a) that Endo had succeeded in making
the drug harder to adulterate, and (b) that it was less addictive, in consequence. In fact, however, Endo
knew that "the clinical significance of INTAC Technology or its impact on abuse/misuse has not been
established for Opana ER" and that Opana ER could still be ground and cut into small pieces by those
looking to abuse the drug. In the same vein, Janssen denied that Nucynta ER was an opioid and
claimed that it was not addictive, and Purdue claimed that its opioids were not favored by addicts and
did not produce a buzz, all of which falsely suggested that its opioids were less likely to be abused or
addictive.
Each of the following was created with the expectation that, by instructing patients and
prescribers that addiction rates are low and that addiction is unlikely when opioids are prescribed for
pain, doctors would prescribe opioids to more patients. For example, one publication sponsored
exclusively by Purdue—APF's 2011 A Poligimaker's Guide to Understanding Pain & Its Management—
claimed that opioids are not prescribed often enough because of "misconceptions about opioid
addiction."106
Acting directly or with and through third parties, each of the Defendants claimed that
the potential for addiction from its drugs was relatively small, or non-existent, even though there was
no scientific evidence to support those claims, and the available research contradicted them. A recent
literature survey found that while ranges of "problematic use" of opioids ranged from <1% to 81%,107

106

http://s3.documentcloud.ora/documents/277603/apf-policymakers-guide.pdf (accessed May 30, 2017)

Cited for the low end of that range was the 1980 Porter-Jick letter in the New England Journal of
Medicine.
107

86

108 These estimates are
abuse averaged between 21% and 29% and addiction between 8% and 12%.
well in line with Purdue's own studies, showing that between 8% and 13% of OxyContin patients
became addicted, but on which Purdue chose not to rely, instead citing the Porter-Jick letter.
The FDA has found that 20% of opioid patients use two or more pharmacies, 26%
obtain opioids from two or more prescribers, and 16.5% seek early refills—all potential "red flags" for
abuse or addiction. 109 The FDA in fact has ordered manufacturers of long-acting opioids to
"[c]onduct one or more studies to provide quantitative estimates of the serious risks of misuse, abuse,
addiction, overdose and death associated with long-term use of opioid analgesics for management of
chronic pain," in recognition of the fact that it found "high rates of addiction" in the medical
literature.11°
Of course, the significant (and growing) incidence of abuse, misuse, and addiction to
opioids is also powerful evidence that Defendants' statements regarding the low risk of addiction were,
and are, untrue. This was well-known to Defendants who had access to sales data and reports, adverse
event reports, federal abuse and addiction-related surveillance data, and other sources that
demonstrated the widening epidemic of opioid abuse and addiction.
Acting directly or through and with third parties, each of the Defendants claimed that
the potential for addiction even from long-term use of its drugs was relatively small, or non- existent,

108

Kevin Vowels et al, Ratesofopioid-misuse,-abuse, and addiction in chronic pain: a gstemati
review and data :synthesis, 156 PAIN 569-76 (April 2015).
109 Len Paulozzi, M.D., "Abuse of Marketed Analgesics and Its Contribution to the National Problem
of Drug Abuse," available at http://www.fda.gov/downloads/AdvisoryCommittees/
CommitteesMeetingMaterials /Drugs /Anes the ticAndLifeSupportDrugsAdvisoryCommittee/UCM233
244. pdf
110 September 10, 2013 letter from Bob Rappaport, M.D., to NDA applicants of ER/LA opioid
analgesics, available at http: / /www. fda.gov/downloads /Drugs/DrugSafety/InformationbyDnigClass/
UCM367697.pdf ; Letter from Janet Woodcock, M.D., Dir., Ctr. for Drug Eval. & Res., to Andrew
Kolodny, M.D., Pres. Physicians for Responsible Opioid Prescribing, Re Docket No. FDA-2012-P0818 (Sept. 10, 2013).
87

despite the fact that the contention was false and there was no scientific evidence to support it.
Examples of these misrepresentations are laid out below:
Actavis

Documents from a 2010 sales training indicate that Actavis trained its sales
force that long-acting opioids were less likely to produce addiction than shortacting opioids, although there is no evidence that either form of opioid is
less addictive or that any opioids can be taken long-term without the risk of
addiction.
Actavis had a patient education brochure distributed in 2007 that claimed
addiction is possible, but it is "less likely if you have never had an
addiction problem." Although the term "less likely" is not defined, the
overall presentation suggests the risk is so low as not to be a worry.
Kadian sales representatives told Lorain prescribers that Kadian was
"steady state" and had extended release mechanisms, the implication of
which was that it did not produce a rush or euphoric effect, and therefore was
less addictive and less likely to be abused.
Kadian sales representatives told Lorain prescribers that the contents
of Kadian could not be dissolved in water if the capsule was opened, implying
that Kadian was less likely to be abused—and thereby less addictive—than
other opioids.
Kadian sales representatives omitted any discussion of addiction risks related to
Actavis's drugs to City prescribers.

Cephalon

Cephalon sponsored and facilitated the development of a guidebook, Opioid
Medications and REMS: A Patient's Guide, which claims, among other things,
that "patients without a history of abuse or a family history of abuse do not
commonly become addicted to opioids."
Cephalon sponsored APF's Treatment Options: A Guide for People Living with Pain
(2007), which taught that addiction is rare and limited to extreme
cases of unauthorized dose escalations, obtaining opioids from multiple
sources, or theft.
—

Endo

Cephalon sales representatives omitted any discussion of addiction risks related
to Cephalon's drugs to City prescribers.
Endo trained its sales force in 2012 that use of long-acting opioids resulted
in increased patient compliance, without any supporting evidence.
Endo's advertisements for the 2012 reformulation of Opana ER claimed it
was designed to be crush resistant, in a way that conveyed that it was less likely to
be abused. This claim was false; the FDA warned in a May 10, 2013 letter
88

that there was no evidence Endo's design "would provide a reduction in
oral, intranasal or intravenous abuse" and Endo's "post-"post-marketing date
submitted are insufficient to support any conclusion about the overall or
route-specific rates of abuse." Further, Endo instructed its sales
representatives to repeat this claim about "design," with the intention of
conveying Opana ER was less subject to abuse.
k. Endo sponsored a website, painknowledge.com, through APF and NIPC,
which, in 2009, claimed that: "[p]eople who take opioids as prescribed usually
do not become addicted." Although the term "usually" is not defined, the
overall presentation suggests the risk is so low as not to be a concern. The
language also implies that, as long as a prescription is given, opioid use will
not become problematic. Endo continued to provide funding for this website
through 2012, and closely tracked unique visitors to it.
1. Endo sponsored a website, PainAction.com, which stated "Did you know?
Most chronic pain patients do not become addicted to the opioid medications
that are prescribed for them."
Endo sponsored CMEs published by APF's NIPC, of which Endo was the
sole funder, titled Persistent Pain in the Older Adult and Persistent Pain in the Older
Patient. These CMEs claimed that opioids used by elderly patients present
"possibly less potential for abuse than in younger patients[,]" which lacks
evidentiary support and deceptively minimizes the risk of addiction for
elderly patients.
Endo distributed an education pamphlet with the Endo logo titled Living with
Someone with Chronic Pain, which inaccurately minimized the risk of addiction:
"Most health care providers who treat people with pain agree that most
people do not develop an addiction problem."
Endo distributed a patient education pamphlet edited by key opinion leader
Dr. Russell Portenoy titled Understanding Your Pain: Taking Oral Opioid
Analgesics. It claimed that "[a]ddicts take opioids for other reasons [than pain
relief], such as unbearable emotional problems." This implies that pain
patients prescribed opioids will not become addicted, which is unsupported
and untrue.
Endo contracted with AGS to produce a CME promoting the 2009 guidelines
P.
for the Pharmacological Management of Persistent Pain in Older Persons. These
guidelines falsely claim that "the risks [of addiction] are exceedingly low in
older patients with no current or past history of substance abuse." None of
the references in the guidelines corroborates the claim that elderly patients
are less likely to become addicted to opioids, and there is no such evidence.
Endo was aware of the AGS guidelines' content when it agreed to provide
this funding, and AGS drafted the guidelines with the expectation it would
seek drug company funding to promote them after their completion.
89

Endo sales representatives told Lorain prescribers that its drugs were "steady
state," the implications of which was that they did not produce a rush or
euphoric effect, and therefore were less addictive and less likely to be abused.
Endo provided grants to APF to distribute Exit Wounds (2009) to veterans,
which taught that "[l]ong experience with opioids shows that people who are
not predisposed to addiction are very unlikely to become addicted to opioid
pain medications." Although the term "very unlikely" is not defined, the
overall presentation suggests that the risk is so low as not to be a concern.
Endo sales representatives omitted discussion of addiction risks related to
Endo's drugs.

Janssen

Janssen sponsored a patient education guide titled Finding Relief: Pain
Management for Older Adults (2009), which its personnel reviewed and
approved and which its sales force distributed. This guide described a
"myth" that opioids are addictive, and asserts as fact that "[m]any studies
show that opioids are rare/y addictive when used properly for the
management of chronic pain." Although the term "rarely" is not defined, the
overall presentation suggests the risk is so low as not to be a concern. The
language also implies that as long as a prescription is given, opioid use is not
a problem.
Janssen contracted with AGS to produce a CME promoting the 2009
guidelines for the Pharmacological Management of Persistent Pain in Older Persons.
These guidelines falsely claim that "the risks [of addiction] are exceedingly
low in older patients with no current or past history of substance abuse."
The study supporting this assertion does not analyze addiction rates by age
and, as already noted, addiction remains a significant risk for elderly patients.
Janssen was aware of the AGS guidelines' content when it agreed to provide
this funding, and AGS drafted the guidelines with the expectation it would
seek drug company funding to promote them after their completion.
Janssen provided grants to APF to distribute Exit Wounds (2009) to veterans,
which taught that [l]ong experience with opioids shows that people who are
not predisposed to addiction are very unlikely to become addicted to opiold
pain medications." Although the term "very unlikely" is not defined, the
overall presentation suggests the risk is so low as not to be a worry.
Janssen currently runs a website, Prescribere.iponsibly.com (last modified July 2,
2015), which claims that concerns about opioid addiction are "overstated."
A June 2009 Nucynta Training module warns Janssen's sales force that
physicians are reluctant to prescribe controlled substances like Nucynta, but
this reluctance is unfounded because "the risks . . . are much smaller than
90

commonly believed."
Janssen sales representatives told Lorain prescribers that its drugs were
"steady state," the implication of which was that they did not produce a rush
or euphoric effect, and therefore were less addictive and less likely to be
abused.
Janssen sales representatives told Lorain prescribers that Nucynta and
Nucynta ER were "not opioids," implying that the risks of addiction and
other adverse outcomes associated with opioids were not applicable to
Janssen's drugs. In truth, however, as set out in Nucynta's FDA-mandated
label, Nucynta "contains tapentadol, an opioid agonist and Schedule II
substance with abuse liability similar to other opioid agonists, legal or illicit."
aa. Janssen's sales representatives told Lorain prescribers that Nucynta's unique
properties eliminated the risk of addiction associated with the drug.
bb. Janssen sales representatives omitted discussion of addiction risks related to
Janssen's drugs.

91

Purdue published a prescriber and law enforcement education pamphlet in
2011 entitled Providing Reli ff, Preventing Abuse, which under the heading,
"Indications of Possible Drug Abuse," shows pictures of the stigmata
of injecting or snorting opioids—skin popping, track marks, and perforated
nasal septa. In fact, opioid addicts who resort to these extremes are
uncommon; the far more typical reality is patients who become dependent
and addicted through oral use.'" Thus, these misrepresentations wrongly
reassure doctors that, as long as they do not observe those signs, they need
not be concerned that their patients are abusing or addicted to opioids.
Purdue sponsored APF's A Poligmaker's Guide to Understanding Pain & Its
Management, which inaccurately claimed that less than 1% of children
prescribed opioids will become addicted. This publication is still available
online. This publication also asserted that pain is undertreated due to
"misconceptions about opioid addiction."

ff.

Purdue sponsored APF's Treatment Options: A Guide for People Living with Pain
(2007), which asserted that addiction is rare and limited to extreme cases of
unauthorized dose escalations, obtaining opioids from multiple sources, or
theft.

gg.

A Purdue-funded study with a Purdue co-author claimed that "evidence that
the risk of psychological dependence or addiction is low in the absence of a
history of substance abuse."112 The study relied only on the Porter-Jick letter
to the editor concerning a chart review of hospitalized patients, not patients
taking Purdue's long-acting, take-home opioid. Although the term "low" is
not defined, the overall presentation suggests the risk is so low as not to be a
worry.

hh.

_

dd.

cc.

Purdue

Purdue contracted with AGS to produce a CME promoting the 2009
guidelines for the Phamacological Management of Persistent Pain in Older Persons.
These guidelines falsely claim that "the risks [of addiction] are exceedingly
low in older patients with no current or past history of substance abuse."
None of the references in the guidelines corroborates the claim that elderly
patients are less likely to become addicted to opioids and the claim is, in fact,
untrue. Purdue was aware of the AGS guidelines' content when it agreed to
provide this funding, and AGS drafted—the guidelines with the expectation ff—
would seek drug company funding to promote them after their completion.

Purdue itself submitted briefing materials in October 2010 to a meeting of the FDA's Joint Meeting
of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk
Management Advisory Committee in which it stated that OxyContin was used non-medically by
injection 4-17% of the time.
112 C.
Peter N. Watson et al., Controlled-release oxycodone relieves neuropathic pain: a randomked controlled trial I
painful diabetic neuropathy, 105 Pain 71 (2003).
92

Purdue sponsored APF's Exit Wounds (2009), which counseled veterans that
"Piong experience with opioids shows that people who are not
predisposed to addiction are very unlikely to become addicted to opioid
pain medications." Although the term "very unlikely" is not defined, the
overall presentation suggests it is so low as not to be a worry.
Purdue sales representatives told Lorain prescribers that its drugs were
"steady state," the implication of which was that they did not produce a rush
or euphoric effect, and therefore were less addictive and less likely to be
abused.
kk. Purdue sales representatives told Lorain prescribers that Butrans has a lower
abuse potential than other drugs because it was essentially tamper- proof and,
after a certain point, patients no longer experience a "buzz" from increased
dosage.
H. Advertisements that Purdue sent to Lorain prescribers stated that OxyContin
ER was less likely to be favored by addicts, and, therefore, less likely to be
abused or diverted, or result in addiction.
mm. Purdue sales representatives omitted discussion of addiction risks related to
Purdue's drugs.
312. In addition to denying or minimizing the risk of addiction and abuse generally,
Defendants also falsely claimed that their particular drugs were safer, less addictive, and less likely to be
abused or diverted than their competitors' or predecessor drugs. In making these claims, Defendants
said or implied that because their drug had a "steady-state" and did not produce peaks and valleys,
which cause drug-seeking behavior—either to obtain the high or avoid the low—it was less likely to be
abused or addicting. Endo also asserted in particular that, because a reformulation of Opana ER was
(or was designed to be) abuse-deterrent or tamper-resistant, patients were less likely to become

addicted to it. Defendants had no evidence to support any of these claims, which, by FDA regulation,
must be based on head-to-head trials; 113 the claims also were false and misleading in that they
misrepresented the risks of both the particular drug and opioids as a class.

See Guidance for Indus/DI, "Abuse-Deterrent Opioids—Evaluation and Labeling," April 2015
(describing requirements for premarket and postmarket studies).
113

93

Further, rather than honestly disclose the risk of addiction, Defendants, and the third
parties they directed and assisted and whose materials they distributed, attempted to portray those who
were concerned about addiction as unfairly denying treatment to needy patients. To increase pressure
on doctors to prescribe chronic opioid therapy, Defendants turned the tables; it was doctors who fail
to treat their patients' chronic pains with opioids—not doctors who cause their patients to become
addicted to opioids—who are failing their patients (and subject to discipline). Defendants and their
third-party allies claimed that purportedly overblown worries about addiction cause pain to be undertreated and opioids to be over-regulated and under-prescribed. This mantra of under-treated pain and
under-used drugs reinforced Defendants' messages that the risks of addiction and abuse were not
significant and were overblown.
For example, Janssen's website, Let's Talk Pain, warns in a video posted online that
"strict regulatory control has made many physicians reluctant to prescribe opioids. The unfortunate
casualty in all of this is the patient, who is often undertreated and forced to suffer in silence." The
program goes on to say: "Because of the potential for abusive and/or addictive behavior, many
healthcare professionals have been reluctant to prescribe opioids for their patients . . . . This
prescribing environment is one of many barriers that may contribute to the undertreatment of pain, a
serious problem in the United States."
In the same vein, a Purdue website called In the Face of Pain complains, under the
heading of "Protecting Access," that, through at least mid-2013, policy governing the prescribing of
opioids was "at odds with" best medical practices by "unduly restricting the amounts that can be
prescribed and dispensed"; "restricting access to patients with pain who also have a history of
substance abuse"; and "requiring special government-issued prescription forms only for the
medications that are capable of relieving pain that is severe." This unsupported and untrue rhetoric

94

aims to portray doctors who do not prescribe opioids as uncaring, converting their desire to relieve
patients' suffering into a mandate to prescribe opioids.
3. Defendants and Their Third-Party Allies Misrepresented that Addiction Risk Can
Be Avoided or Managed
To this day, defendants each continue to maintain that most patients can safely take
opioids long-term for chronic pain without becoming addicted. Presumably only to explain why
doctors encounter so many patients addicted to opioids, Defendants and their third-party allies have
come to admit that some patients could become addicted, but that doctors can avoid or manage that
risk by using screening tools or questionnaires. These tools, they say, identify those with higher
addiction risks (stemming from personal or family histories of substance abuse, mental illness, or
abuse) so that doctors can more closely monitor patients at greater risk of addiction.
There are three fundamental flaws in these assurances that doctors can identify and
manage the risk of addiction. First, there is no reliable scientific evidence that screening works to
accurately predict risk or reduce rates of addiction. Second, there is no reliable scientific evidence that
high-risk or addicted patients can take opioids long-term without triggering addiction, even with
enhanced monitoring and precautions. Third, there is no reliable scientific evidence that patients
without these red flags are necessarily free of addiction risk.
Addiction is difficult to predict on a patient-by-patient basis, and there are no reliable,
validated tools to do so. A recent Evidence Report by the Agency for Healthcare Research and Quality
("AHRQ"), which "systematically review[ed] the current evidence on long-term opioid therapy for
chronic pain" identified Irdo study" that had "evaluated the effectiveness of risk mitigation strategies,
such as use of risk assessment instruments, opioid management plans, patient education, urine drug
screening, prescription drug monitoring program data, monitoring instruments, more frequent
monitoring intervals, pill counts, or abuse- deterrent formulations on outcomes related to overdose,

95

addiction, abuse or misuse."14 Furthermore, attempts to treat high-risk patients, such as those who
have a documented predisposition to substance abuse, by resorting to patient contracts, more frequent
refills, or urine drug screening are not proven to work in the real world, if busy doctors even in fact
attempt them.
Most disturbingly, despite the widespread use of screening tools, patients with past
substance use disorders—which every tool rates as a risk factor—receive, on average, higher doses of
opioids.
Each Defendant claimed that the risk of addiction could be avoided or managed,
claims that are deceptive and without scientific support:
Actavis

Documents from a 2010 sales training indicate that Actavis trained its
sales force that prescribers can use risk screening tools to limit the
development of addiction.

Cephalon

Cephalon sponsored APF's Treatment Options: A Guide for People Living
with Pain (2007), which taught patients that "opioid agreements" between
doctors and patients can "ensure that you take the opioid as prescribed."

Endo

Endo paid for a 2007 supplement"' available for continuing education
credit in the Journal of Family Practice. This publication, titled Pain
Management Dilemmas in Primary Care: Use of Opioids, recommended
screening patients using tools like the Opioid Risk Tool or the Screener
and Opioid Assessment for Patients with Pain, and advised that patients
at high risk of addiction could safely (e.g., without becoming addicted)
receive chronic opioid therapy using a "maximally structured approach"
involving toxicology screens and pill counts.

Purdue

Purdue's unbranded website, In the Face of Pain (inthefaceofpain.com)
"restrictu
states that policies that access to patients_with_pain_who-also
have a history of substance abuse" and "requiring special government-

The Effectiveness and Risks of Long-term Opioid Treatment of Chronic Pain, Agency for Healthcare Res, &
)
Quality (September 19, 2014.
115 The Medical journal, The Lancet found that all of the supplement papers it received failed peerreview. Editorial, "The Perils of Journal and Supplement Publishing," 375 The Lancet 9712 (347) 2010.
"4

96

issued prescription forms for the only medications that are capable of
relieving pain that is severe" are "at odds with" best medical practices.116
Purdue sponsored a 2012 CME program taught by a KOL titled Chronic
Pain Management and Opioid Use: Easing Fears, Managing Risks, and
Improving Outcomes. This presentation recommended that use of
screening tools, more frequent refills, and switching opioids could treat a
high-risk patient showing signs of potentially addictive behavior.
Purdue 'sponsored a 2011 webinar taught by Dr. Lynn Webster, titled
Managing Patient's Opioid Use: Balancing the Need and Risk. This
publication taught prescribers that screening tools, urine tests, and
patient agreements have the effect of preventing "overuse of
prescriptions" and "overdose deaths."
Purdue sales representatives told Lorain prescribers that screening tools
can be used to select patients appropriate for opioid therapy and to
manage the risks of addiction.
4. Defendants and Their Third-Party Allies Created Confusion By Promoting the
Misleading Term "Pseudoaddiction."
321. Defendants and their third-party allies developed and disseminated each of the
following misrepresentations with the intent and expectation that, by instructing patients and
prescribers that signs of addiction are actually the product of untreated pain, doctors would prescribe
opioids to more patients and continue to prescribing them, and patients would continue to use opioids
despite signs that the patient was addicted. The concept of "pseudoaddiction" was coined by Dr.
David Haddox, who went to work for Purdue, and popularized by Dr. Russell Portenoy, who
consulted for Cephalon, Endo, Janssen, and Purdue. Much of the same language appears in other
Defendants' treatment of this issue, highlighting the contrast between "undertreated pain" and "true
addiction," as if patients could not experience both. As KOL Dr. Lynn Webster wrote:

See In the Face of Pain Fact Sheet: Protecting Access to Pain Treatment, Purdue Pharma L.P. (Resources
verified Mar. 2012),
www.inthefaceofpain.com/content/uploads/2011/12/factsheet_ProtectingAccess.pdf.
116

97

"[Pseudoaddiction] obviously became too much of an excuse to give patients more medication.. . . It
led us down a path that caused harm. It is already something we are debunking as a concept."17
322. Each of the publications and statements below falsely states or suggests that the
concept of "pseudoaddiction" is substantiated by scientific evidence and accurately describes the
condition of patients who only need, and should be treated with, more opioids:
Actavis

Documents from a 2010 sales training indicate that Actavis trained its sales
force to instruct physicians that aberrant behaviors like self-escalation of
doses constituted "pseudoaddiction."

Cephalon

Cephalon sponsored FSMB's Responsible Opioid Prescribing (2007), which
taught that behaviors such as "requesting drugs by name," "demanding or
manipulative behavior," seeing more than one doctor to obtain opioids, and
hoarding are all signs of "pseudoaddiction." Cephalon also spent $150,000 to
purchase copies of the book in bulk and distributed it through its pain sales
force to 10,000 prescribers and 5,000 pharmacists.

Endo

Endo distributed copies of a book by KOL Dr. Lynn Webster entitled
Avoiding Opioid Abuse While Managing Pain (2007). Endo's internal planning
documents describe the purpose of distributing this book as to "Nncrease the
breadth and depth of the Opana ER prescriber base." The book claims that
when faced with signs of aberrant behavior, the doctor should regard it as
"pseudoaddiction" and thus, increasing the dose in most cases . . . should be
the clinician's first response." (emphasis added).
Endo spent $246,620 to buy copies of FSMB's Responsible Opioid Prescribing
(2007), which was distributed by Endo's sales force. This book asserted that
behaviors such as "requesting drugs by name," "demanding or manipulative
behavior," seeing more than one doctor to obtain opioids, and hoarding, are all
signs of "pseudoaddiction."

Janssen

From 2009 to 2011 Janssen's website, Let's Talk Pain, stated that
"pseudoaddiction___refers....to_patient_b.ehaviors_that_may_o_ccur_when pain is
under-treated" and that "[p]seudoaddiction is different from true addiction
because such behaviors can be resolved with effective pain
management."(emphasis added).

" John Fauber & Ellen Gabler, NehvorkingFuels Painkiller Boom, Milwaukee Wisc. J. Sentinel (Feb.19,
2012).
1

98

Purdue

Purdue published a prescriber and law enforcement education pamphlet in
2011 entitled Providing Relief, Preventing Abuse, which described
"pseudoaddiction" as a concept that "emerged in the literature to describe the
inaccurate interpretation of [drug-seeking behaviors] in patients who have pain
that has not been effectively treated."
Purdue distributed to physicians, at least as of November 2006, and posted on
its unbranded website, Partners Against Pain, a pamphlet copyrighted 2005 and
titled Clinical Issues in Opioid Prescribing. This pamphlet included a list of conduct,
including "illicit drug use and deception" it defined as indicative of
"pseudoaddiction" or untreated pain. It also states: "Pseudoaddiction is a
term which has been used to describe patient behaviors that may occur when
pain is undertreated. . . . Even such behaviors as illicit drug use and
deception can occur in the patient's efforts to obtain relief. Pseudoaddiction
can be distinguished from true addiction in that the behaviors resolve when the pain
is effectively treated." (Emphasis added.)
Purdue sponsored FSMB's Responsible Opioid Prescribing (2007), which taught
that behaviors such as "requesting drugs by name, "demanding or manipulative
behavior," seeing more than one doctor to obtain opioids, and hoarding, are all
signs of "pseudoaddiction." Purdue also spent over $100,000 to support
distribution of the book.
Purdue sponsored APF's A Policymaker's Guide to Understanding Pain & Its
Management, which states: "Pseudo-addiction describes patient behaviors that
may occur when pain is undertreated. . . . Pseudo-addiction can be
distinguished from true addiction in that this behavior ceases when pain is
effectively treated." (Emphasis added.)

5. Defendants and Their Third-Party Allies Claimed Withdrawal is Simply Managed
Defendants and their third-party allies promoted the false and misleading messages
below with the intent and expectation that, by misrepresenting the difficulty of withdrawing from
opioids, prescribers and patients would be more likely to start chronic opioid therapy and would fail to
recognize the actual risk of addiction.
In an effort to underplay the risk and impact of addiction, Defendants and their thirdparty allies frequently claim that, while patients become "physically" dependent on opioids, physical
dependence can be addressed by gradually tapering patients' doses to avoid the adverse effects of
withdrawal. They fail to disclose the extremely difficult and painful effects that patients can experience
99

when they are removed from opioids—effects that also make it less likely that patients will be able to
stop using the drugs.
In reality, withdrawal is prevalent in patients after more than a few weeks of therapy.
Common symptoms of withdrawal include: severe anxiety, nausea, vomiting, headaches, agitation,
insomnia, tremors, hallucinations, delirium, and pain. Some symptoms may persist for months, or even
years, after a complete withdrawal from opioids, depending on how long the patient had been using
opioids. Withdrawal symptoms trigger a feedback loop that drives patients to seek opioids,
contributing to addiction.
Each of the publications and statements below falsely states or suggests that
withdrawal from opioids was not a problem and they should not be hesitant about prescribing or using
opioids:
Actavis

‘
Endo
Janssen

Documents from a 2010 sales training indicate that Actavis trained its
sales force that discontinuing opioid therapy can be handled "simply"
and that it can be done at home. Actavis's sales representative training
claimed opioid withdrawal would take only a week, even in addicted
patients.
A CME sponsored by Endo, titled Persistent Pain in the 0 'der Adzilt, taught
that withdrawal symptoms can be avoided entirely by tapering the dose by
10-20% per day for ten days.
A Janssen PowerPoint presentation used for training its sales
representatives titled "Selling Nucynta ER" indicates that the "low
incidence of withdrawal symptoms" is a "core message" for its sales
force. This message is repeated in numerous janssen training materials
between 2009 and 2011. The studies supporting this claim did not
describe withdrawal symptoms M patients taking Nucynta ER beyond
90 days or at high doses and would therefore not be representative of
withdrawal symptoms in the chronic pain population. Patients on
opioid therapy long-term and at high doses will have a harder time
discontinuing the drugs and are more likely to experience withdrawal
symptoms. In addition, in claiming a low rate of withdrawal symptoms,
Janssen relied upon a study that only began tracking withdrawal
symptoms in patients two to four days after discontinuing opioid use;
Janssen knew or should have known that these symptoms peak earlier
than that for most patients. Relying on data after that initial window
painted a misleading picture of the likelihood and severity of
withdrawal associated with chronic opioid therapy. Janssen also knew
100

or should have known that the patients involved in the study were not
on the drug long enough to develop rates of withdrawal symptoms
comparable to rates of withdrawal suffered by patients who use
use for which Janssen promoted
for
opioids chronic pain—the
Nucynta ER.

Purdue

Janssen sales representatives told Lorain prescribers that patients on
Janssen's drugs were less susceptible to withdrawal than those on other
opioids.
Purdue sponsored APF's A Policymaker's Guide to Understanding Pain &
Its Management, which taught that "Symptoms of physical dependence can
often be ameliorated by gradually decreasing the dose of medication
during discontinuation," but did not disclose the significant hardships that
often accompany cessation of use.
Purdue sales representatives told Lorain prescribers that the effects
of withdrawal from opioid use can be successfully managed.
Purdue sales representatives told Lorain prescribers that the
potential for withdrawal on Butrans was low due to Butrans's low potency
and its extended release mechanism.

6. Defendants and Their Third-Party Allies Misrepresented that Increased Doses Pose
No Significant Additional Risks
Each of the following misrepresentations was created with the intent and expectation
that, by misrepresenting and failing to disclose the known risks of high dose opioids, prescribers and
patients would be more likely to continue to prescribe and use opioids, even when they were not
effective in reducing patients' pain, and not to discontinue opioids even when tolerance required them
to reach even higher doses.
Defendants and their third-party allies claimed that patients and prescribers could
increase doses of opioids indefinitely without added risk, even when pain was not decreasing or when
doses had reached levels that were "frighteningly high," suggesting that patients would eventually reach
a stable, effective dose. Each of Defendants' claims also omitted warnings of increased adverse effects
that occur at higher doses, and misleadingly suggested that there was no greater risk to higher dose
opioid therapy.
101

These claims are false. Patients receiving high doses of opioids as part of long-term
opioid therapy are three to nine times more likely to suffer an overdose from opioid-related causes
than those on low doses. As compared to available alternative pain remedies, scholars have suggested
that tolerance to the respiratory depressive effects of opioids develops at a slower rate than tolerance
to analgesic effects. Accordingly, the practice of continuously escalating doses to match pain tolerance
can, in fact, lead to overdose even where opioids are taken as recommended. The FDA has itself
acknowledged that available data suggest a relationship between increased doses and the risk of
adverse effects. Moreover, it is harder for patients .to terminate use of higher-dose opioids without
severe withdrawal effects, which contributes to a cycle of continued use, even when the drugs provide
no pain relief and are causing harm—the signs of addiction.
Each of the following claims suggests that high-dose opioid therapy is safe:
Actavis

Cephalon

a.

Documents from a 2010 sales training indicate that Actavis trained its sales
force that "individualization" of opioid therapy depended on increasing
doses "until patient reports adequate analgesia" and to "set dose levels on
[the] basis of patient need, not on [a] predetermined maximal dose." Actavis
further counseled its sales representatives that the reasons some physicians
had for not increasing doses indefinitely were simply a matter of physician
"comfort level," which could be overcome or used as a tool to induce them
to switch to Actavis's opioid, Kadian.
Cephalon sponsored APF's Treatment Options: A Guide for People Living with Pain
(2007), which claimed that some patients "need" a larger dose of their opioid,
regardless of the dose currently prescribed.
Cephalon sponsored a CME written by KOL Dr. Lynn Webster, Optimizing
Opioid Treatment for Breakthrough Pain, which was offered online by
Medscape, LLC from September 28, 2007 through December 15, 2008. The
CME taught that non-opioid analgesics and combination opioids that include
aspirin and acetaminophen arc less effective to treat breakthrough pain
because of dose limitations.
Cephalon sales representatives assured Lorain prescribers that opioids were
safe, even at high doses.

102

Endo sponsored a website, painknowledge.com, through APP and NIPC,
which, in 2009, claimed that opioids may be increased until "you are on the
right dose of medication for your pain," and once that occurred, further dose
increases would not occur. Endo funded the site, which was a part of Endo's
marketing plan, and tracked visitors to it.

Endo

Endo distributed a patient education pamphlet edited by KOL Dr. Russell
Portenoy tided Understanding Your Pain: Taking Oral Opioid Analgesics. In
Q&A format, it asked: "If I take the opioid now, will it work later when I
really need it?" The response was: "The dose can be increased . . . . You
won't 'run out' of pain relief."
Janssen sponsored a patient education guide entitled Finding Relief: Pain
Management for Older Adults (2009), which its personnel reviewed and
approved and its sales force distributed. This guide listed dose limitations as
"disadvantages" of other pain medicines and omitted any discussion of risks
of increased doses of opioids. The publication also falsely claimed that it is a
"myth" that "opioid doses have to be bigger over time."

Janssen

Purdue's In the Face of Pain website, along with initiatives of APF, promoted
the notion that if a patient's doctor does not prescribe them what—in their
view—is a sufficient dose of opioids, they should find another doctor who
will. In so doing, Purdue exerted undue, unfair, and improper influence over
prescribers who face pressure to accede to the resulting demands.

Purdue

Purdue sponsored APF's A . Poligmaker's Guide to Understanding Pain & Its
Management, which taught that dose escalations are "sometimes necessary,"
even indefinitely high ones. This suggested that high dose opioids are safe
and appropriate and did not disclose the risks from high dose opioids. This
publication is still available online.
J.

Purdue sponsored APF's Treatment Options: A Guide for People Living with Pain
(2007), which taught patients that opioids have "no ceiling dose" and are
therefore the most appropriate treatment for severe pain. The guide also
claimed that some patients "need" a larger dose of the drug, regardless of the
dose currently prescribed. This language fails to disclose heightened risks at
elevated doses.

k.

Association-in
American-MedicalPurdue sponsored a CME issued-by-the2003, 2007, 2010, and 2013. The CME., Overview of Management Options, was
edited by KOL Dr. Russell Portenoy, among others, and taught that other
drugs, but not opioids, are unsafe at high doses. The 2013 version is still
available for CMK credit.

1.

Purdue sales representatives told Lorain prescribers that opioids were just as
effe.crive for treating patients long-term and omitted any discussion that
increased tolerance would require increasing, and increasingly dangerous,
doses.
103

7. Defendants and Their Third-Party Allies Deceptively Omitted or Minimized
Adverse Effects of Opioids and Overstated the Risks of Alternative Forms of Pain
Treatment.
Each of the following misrepresentations was created with the intent and expectation
that, by omitting the known, serious risks of chronic opioid therapy, including the risks of addiction,
abuse, overdose, and death, and emphasizing or exaggerating risks of competing products, prescribers
and patients would be more likely to choose opioids. Defendants and their third-party allies routinely
ignored the risks of chronic opioid therapy. These include (beyond the risks associated with misuse,
abuse, and addiction): hyperalgesia, a "known serious risk associated with chronic opioid analgesic
therapy in which the patient becomes more sensitive to certain painful stimuli over time;"1" hormonal
dysfunction; decline in immune function; mental clouding, confusion, and dizziness; increased falls and
fractures in the elderly; neonatal abstinence syndrome (when an infant exposed to opioids prenatally
withdraws from the drugs after birth); and potentially fatal interactions with alcohol or
benzodiazepines, which are used to treat post-traumatic stress disorder and anxiety (disorders
frequently coexisting with chronic pain conditions).119
Despite these serious risks, Defendants asserted, or implied, that opioids were
appropriate first-line treatments and safer than alternative treatments, including NSAIDs such as
ibuprofen (Advil, Motrin) or naproxen (Aleve). While NSAIDs can pose significant gastrointestinal,
renal, and cardiac risks, particularly for elderly patients, Defendants' exaggerated descriptions of those

Letter from Janet Woodcock, M.D., Dir., Ctr. for Drug Eval. & Res., to Andrew Kolodny, M.D.,
Pres. Physicians for Responsible Opioid Prescribing, Re Docket No. FDA-2012-P-0818 (Sept. 10,
2013).
'19 Several of these risks do appear in the FDA-mandated warnings. See, e.g., the August 13, 2015
OxyContin Label, Section 6.2, identifying adverse reactions including: "abuse, addiction ... death, ...
hyperalgesia, hypogonadism . . . mood altered . . . overdose, palpitations (in the context of withdrawal),
seizures, suicidal attempt, suicidal ideation, syndrome of inappropriate antidiuretic hormone secretion,
and urticaria [hives]."
118

104

risks were deceptive in themselves, and made their omissions regarding the risks of opioids all the
more striking and misleading. Defendants and their third-party allies described over-the-counter
NSAIDs as life-threatening and falsely asserted that they were responsible for 10,000-20,000 deaths
annually (more than opioids), when in reality the number is closer to 3,200. This description of
NSAIDs starkly contrasted with their representation of opioids, for which the listed risks were nausea,
constipation, and sleepiness (but not addiction, overdose, or death). Compared with NSAIDs, opioids
are responsible for roughly four times as many fatalities annually.
As with the preceding misrepresentations, Defendants' false and misleading claims
regarding the comparative risks of NSAIDs and opioids had the effect of shifting the balance of
opioids' risks and purported benefits. While opioid prescriptions have exploded over the past two
decades, the use of NSAIDs has declined during that same time.
Each of the following reflects Defendants' deceptive claims and omissions about the
risks of opioids, including in comparison to NSAIDs:
Documents from a 2010 sales training indicate that Actavis trained its sales
force that the ability to escalate doses during long-term opioid therapy,
without hitting a dose ceiling, made opioid use safer than other forms of
therapy that had defined maximum doses, such as acetaminophen or
NSAIDs.

Actavis

Actavis also trained physician-speakers that "maintenance therapy with opioids
can be safer than long-term use of other analgesics," including NSAIDs, for
older persons.
c
Cephalon

Kadian sales representatives told Lorain prescribers that NSAIDs were more
toxic than opioids.
Cephalon sponsored APF's Treatment Options: A Guide for People Living
with Pain (2007), which taught patients that opioids differ from NSAIDs in
that they have "no ceiling dose" and are therefore the most appropriate
treatment for severe pain. The publication attributed 10,000 to 20,000 deaths
annually to NSAID overdose. Treatment Options also warned that risks of
NSAIDs increase if "taken for more than a period of months," with no
corresponding warning about opioids.
Cephalon sales representatives told City prescribers that NSAIDs were
105

more toxic than Cephalon's opioids
Endo distributed a "case study" to prescribers tided Case Challenges in Pain
Management: Opioid Therapy for Chronic Pain. The study cites an example,
meant to be representative, of a patient "with a massive upper
gastrointestinal bleed believed to be related to his protracted use of
NSAIDs" (over eight years), and recommends treating with opioids instead.

Endo

Endo sponsored a website, painknowledge.com, through APF and NIPC,
which contained a flyer called "Pain: Opioid Therapy." This publication
included a list of adverse effects from opioids that omitted significant
adverse effects like hyperalgesia, immune and hormone dysfunction,
cognitive impairment, tolerance, dependence, addiction, and death. Endo
continued to provide funding for this website through 2012, and closely
tracked unique visliors to it.
Endo provided grants to APF to distribute Exit Wounds (2009), which
omitted warnings of the risk of interactions between opioids and
benzodiazepines, which would increase fatality risk. Exit Wounds also
contained a lengthy discussion of the dangers of using alcohol to treat
chronic pain but did not disclose dangers of mixing alcohol and opioids.

Janssen

l•

Endo sales representatives told Lorain prescribers that NSAIDs were more
toxic than opioids.
Janssen sponsored a patient education guide tided Finding Relief: Pain
Management for Older Adults (2009), which its personnel reviewed and
approved and its sales force distributed. This publication described the
advantages and disadvantages of NSAIDs on one page, and the
"myths/facts" of opioids on the facing page. The disadvantages of NSAIDs
are described as involving "stomach upset or bleeding," "kidney or liver
damage if taken at high doses or for a long time," "adverse reactions in
people with asthma," "increase [in] the risk of heart attack and stroke." The
only adverse effects of opioids listed are "upset stomach or sleepiness,"
which the brochure claims will go away, and constipation.

k.

Janssen sponsored APF's Exit Wounds (2009), which omits warnings of the
risk of interactions between opioids and benzodiazepines. Janssen's label for
Duragesic, however, states that use with benzodiazepines "may cause
respiratory depression, [low blood pressure], and profound sedation or
potentially result in coma. Exit Wounds also contained a lengthy discussion of
the dangers of using alcohol to treat chronic pain but did not disclose
dangers of mixing alcohol and opioids.

1.

Janssen sales representatives told Lorain prescribers that Nucynta was not an
opioid, making it a good choice for chronic pain patients who previously
were unable to continue opioid therapy due to excessive side effects. This
statement was misleading because Nucynta is, in fact, an opioid and has the
same effects as other opioids.
106

Purdue m. Purdue sponsored APF's Exit Wounds (2009), which omits warnings of the
risk of interactions between opioids and benzodiazepines, which would
increase fatality risk. Exit Wounds also contained a lengthy discussion of the
dangers of using alcohol to treat chronic pain but did not disclose dangers of
mixing alcohol and opioids.
Purdue sponsored APF's Treatment Options: A Guide for People Living with Pain
(2007), which advised patients that opioids differ from NSAIDs in that they
have "no ceiling dose" and are therefore the most appropriate treatment for
severe pain. The publication attributes 10,000 to 20,000 deaths annually to
NSAID overdose. Treatment Options also warned that risks of NSAIDs
increase if "taken for more than a period of months," with no corresponding
warning about opioids.
Purdue sponsored a CME issued by the American Medical Association in
2003, 2007, 2010, and 2013; The 2013 version is still available for CME
credit. The CME, Overview of Management Options, was edited by KOL Dr.
Russell Portenoy, among others, and taught that NSAIDs and other drugs,
but not opioids, are unsafe at high doses.
Purdue sales representatives told Lorain prescribers that NSAIDs were more
P.
toxic than opioids.

8. Purdue Misleadingly Promoted OxyContin as Providing 12 Hours of Relief
In addition to making the deceptive statements above, Purdue also dangerously misled
doctors and patients about OxyContin's duration and onset of action.
Purdue promotes OxyContin as an extended-release opioid, but the oxycodone does
not enter the body on a linear rate. OxyContin works by releasing a greater proportion of oxycodone
into the body upon administration, and the release gradually tapers, as illustrated in the following chart,
which was, upon information and belief, adapted from Purdue's own sales materials:12°

120

Jim Edwards, 'Wow Purdue Used Misleading Charts to Hide OxyContin's Addictive Power," CBSNeivs.com,
Sept. 28, 2011, http://www.cbsnews.com/news/how-purdue-used-misleading-charts-to- hideoxycontins-addictive-power/. The 160 mg dose is no longer marketed. Purdue's promotional materials
in the past displayed a logarithmic scale, which gave the misleading impression the concentration
remained constant.
107

OxyContin P1 Figure, Linear y-axis

BD
40
20

7
2 3 4 5 6
Hours From Dosing

8

1-40 mg -0-80 mg
-•,-10 mg 141.20 mg -4

9

10

11

12

-0-1 60 Mg -4E-10 mg 4112h Steady-State

I

Figure 1
The reduced release of the drug over time means that the oxycodone no longer provides the same level
of pain relief; as a result, in many patients, OxyContin does not last for the 12 hours for which Purdue
promotes it—a fact that Purdue has known at all times relevant to this action.
337. OxyContin tablets provide an initial absorption of approximately 40% of the active
medicine. This has a two-fold effect. First, the initial rush of nearly half of the powerful opioid—
OxyContin is roughly twice as powerful as morphine—triggers a powerful psychological response.
OxyContin- thushehavesrnore- Ii ke an immediate -release- opioidT which -Purdue itself once • clairned -was
more addicting in its original 1995 FDA-approved drug label. Second, the initial burst of oxycodone
means that there is less of the drug at the end of the dosing period, which results in the drug not
lasting for a full 12 hours and precipitates withdrawal symptoms in patients, a phenomenon known as
"end of dose" failure. (The FDA found in 2008 that a "substantial number" of chronic pain patients

108

will experience "end-of-dose failure" with OxyContin.) The combination of fast onset and end-of-dose
failure makes OxyContin particularly addictive, even compared with other opioids.
338. Purdue nevertheless has falsely promoted OxyContin as if it were effective for a full 12
hours. Its advertising in 2000 included claims that OxyContin provides "Consistent Plasma Levels
Over 12 Hours." That claim was accompanied by a chart depicting plasma levels on a logarithmic
scale. The chart minimized the rate of end-of-dose failure by depicting 10 mg in a way that it
appeared to be half of 100 mg in the table's y-axis. That chart, shown below, depicts the same
information as the chart above, but does so in a way that makes the absorption rate appear more
consistent:
for moderato to severe pain when a continuous, around4he-clock
analgesic is needed for an extended period of time

Consistent Plasma Levels Over 12 Hours
Plasma concentrafions (ng/mt.) over time of various dosage strengths

OxyContin• 80 end
160 mg Tablets FOR
USE ONLY IN OPIOIDTOLERANT PATIENTS
requiring minimum daily
oxycoclone equivalent
dosages of 160 rag and
320 mg, respectively.
These tablet strengths
may cause fatal 'mire.
tory depression when
administered to patients
not previously exposed
to Voids

Steady state achieved within 24 to $6 hours

339. More recently, other Purdue advertisements also emphasized "Q12h" (meaning twicedaily) dosing. These include an advertisement in the February 2005 Journal of Pain and 2006 Clinical
Journal of Pain featuring an OxyContin logo with two pill cups, reinforcing the twice-a-day message.
Other advertisements that ran in the 2005 and 2006 issues of the journal of Pain depict a sample
prescription for OxyContin, with "Q12h" handwritten for emphasis.

109

The information that OxyContin did not provide pain relief for a full 12 hours was
known to Purdue, and Purdue's competitors, but was not disclosed to general practitioners. Purdue's
knowledge of some pain specialists' tendency to prescribe OxyContin three times per day instead of
two (which would have compensated for end-of-dose failure) was set out in Purdue's internal
documents as early as 1999 and is apparent from MEDWATCH Adverse Event reports for
OxyContin.121 Even Purdue's competitor, Endo, was aware of the problem; Endo attempted to
position its Opana ER drug as offering "durable" pain relief, which Endo understood to suggest a
contrast to OxyContin. Opana ER advisory board meetings featured pain specialists citing lack of 12hour dosing as a disadvantage of OxyContin. Endo even ran advertisements for Opana ER referring
to "real" 12-hour dosing.
Purdue's failure to disclose the prevalence of end-of-dose failure meant that prescribers
in Lorain were not informed of risks relating to addiction, and that they received the misleading
message that OxyContin would be effective for treating chronic pain for the advertised duration.
Furthermore, doctors would compensate by increasing the dose or prescribing "rescue" opioids, which
had the same effect as increasing the amount of opioids prescribed to a patient.122' '23

MEDWATCH refers to the FDA's voluntary adverse event reporting system.
122 Purdue's Clinical Issues in Opioid Prescribing, put out in 2005 under Purdue's unbranded Partners
Against Pain banner,-states- that "it is recommended-that a-supplementary-immediate-release.medication
be provided to treat exacerbations of pain that may occur with stable dosing." References to "rescue"
medication appear in publications Purdue sponsored such as APF's A Poligmaker's Guide (2011) and
the 2013 CME Overview of Pain Management Options.
123 The Connecticut Attorney General's office filed a citizens' petition with the FDA on January 27,
2004, requesting that the OxyContin label be amended with a warning not to prescribe the drug more
than twice daily as a means of compensating for end-of-dose failure. The FDA denied this request on
September 11, 2008. The FDA found that the state had failed to present sufficient evidence that more
frequent dosing caused adverse outcomes, but the FDA did not challenge the Connecticut finding that
end-of-dose failure of OxyContin was prevalent. Indeed, the FDA found that end-of-dose failure
affected a "substantial" number of chronic pain patients prescribed OxyContin.
121

110

E. Each Defendant Engaged in Deceptive Marketing, Both Branded and Unbranded, that
Targeted and Reached City Prescribers.
342. Defendants—and the Front Groups and KOLs who depended on and worked
alongside them—were able to affect a sea change in medical opinion in favor of accepting opioids as a
medically necessary long-term treatment for chronic pain. As set forth below, each Defendant
contributed to that result through a combination of both direct marketing efforts and third-party
marketing efforts over which that Defendant exercised editorial control. These deceptive and
misleading statements were directed to, and reached, City prescribers and patients, with the intent of
distorting their views on the risks, benefits, and superiority of opioids for treatment of chronic pain.
343 Defendants engaged in their deceptive marketing campaign, both nationwide and in
Lorain, using a number of strategies. Defendants trained their sales forces and recruited physician
speakers to deliver these deceptive messages and omissions, and they in turn conveyed them to
prescribers. Defendants also broadly disseminated promotional messages and materials, both by
delivering them personally to doctors during detailing visits and by mailing deceptive advertisements
directly to prescribers. Because they are disseminated by Defendant drug manufacturers and relate to
Defendants' drugs, these materials are considered "labeling" within the meaning of 21 C.F.R. 5 1.3(a),
which means Defendants are liable for their content.
344. As described below, the City has located a number of City-area prescribers who
received Defendants' misrepresentations. 1..;a.ch of the misrepresentations received by these doctors
constitutes an integral piece of a centrally directed marketing strategy to change medical perceptions
regarding the use of opioids to treat chronic pain. Defendants were aware of each of these
misrepresentations, and Defendants approved of them and oversaw their dissemination at the national,
corporate level.

111

1. Acatvis
As described below, Actavis promoted its branded opioid, Kadian, through a highly
deceptive marketing campaign, carried out principally through its sales force and recruited physician
speakers. As internal documents indicate, this campaign rested on a series of misrepresentations and
omissions regarding the risks, benefits, and superiority of opioids, and indeed incorporated each of the
types of deceptive messages. Based on the highly coordinated and uniform nature of Actavis's
marketing, Actavis conveyed these deceptive messages to City prescribers. Actavis did so with the
intent that City prescribers and/or consumers would rely on the messages in choosing to use opioids
to treat chronic pain.124
a. Actavis' Deceptive Direct Marketing
To help devise its marketing strategy for Kadian, Actavis commissioned a report from
one of its consultants in January 2005 about barriers to market entry. The report concluded that two
major challenges facing opioid manufacturers in 2005 were (i) overcoming "concerns regarding the
safety and tolerability" of opioids, and (ii) the fact that "physicians have been trained to evaluate the
supporting data before changing their respective practice behavior." To address these challenges, the
report advocated a "[p]ublication strategy based on placing in the literature key data that influence
members of the target audience" with an "emphasis . . . on ensuring that the message is believable and
relevant to the needs of the target audience." This would entail the creation of "effective copy points .
. . backed by published references" and "developing and placing publications that demonstrate [the]
efficacy [of opioids] and [their] safety/positive side. effect profile." According to the report, this would
allow physicians to "reach(' a mental agreement" and change their "practice behavior" without having
first evaluated supporting data—of which Actavis (and other Defendants) had none.
124 Actavis also sold various generic opioids, including Norco, which were widely prescribed in Lorain
and benefited from Actavis's overall promotion of opioids, but were not directly marketed by sales
representatives.

112

The consulting firm predicted that this manufactured body of literature "w[ould], in
turn, provide greater support for the promotional message and add credibility to the brand's
advocates" based on "either actual or perceived 'scientific exchange" in relevant medical literature.
(emphasis added). To this end, it planned for three manuscripts to be written during the first quarter of
2005. Of these, "[t]he neuropathic pain manuscript will provide evidence demonstrating KADIAN is
as effective in patients with presumptive neuropathic pain as it is in those with other pain types"; "[t]he
elderly subanalysis . . . will provide clinicians with evidence that KADIAN is efficacious and well
tolerated in appropriately selected elderly patients" and will "be targeted to readers in the geriatrics
specialty"; and "[t]he QDF/BID manuscript will . . . .call attention to the fact that KADIAN is the
only sustained-release opioid to be labeled for [once or twice daily] use." In short, Actavis knew exactly
what each study would show—and how that study would fit into its marketing plan—before it was
published. Articles matching Actavis's descriptions later appeared in the Journal of Pain and the Journal of
the American Geriatrics Society.
To ensure that messages based on this science reached individual physicians, Actavis
deployed sales representatives, or detailers, to visit prescrs in Lorain and across the country. At the
peak of Actavis's promotional efforts in 2011, the company spent $6.7 million on detailing.
To track its detailers' progress, Actavis's sales and marketing department actively
monitored the prescribing behavior of physicians. It tracked the Kadian prescribing activity of
individual physicians, and assessed the success of its marketing efforts by tabulating how many Kadian
prescriptions a prescriber wrote after he or she had been detailed. As described below, Kadian
monitored numerous City physicians.
Actavis also planned to promote Kadian by giving presentations at conferences of
organizations where it believed it could reach a high concentration of pain specialists. Its choice of
conferences was also influenced by the host's past support of opioids. For example, Actavis
113

documents show that Actavis presented papers concerning Kadian at an annual meeting of AGS
because AGS's guidelines "support the use of opioids."
Actavis targeted prescribers using both its sales force and recruited physician speakers,
as described below.
1. Actavis' Deceptive Sales Training
Actavis's sales representatives targeted physicians to deliver sales messages that were
developed centrally and deployed uniformly across the country. These sales representatives were
critical in delivering Actavis's marketing strategies and talking points to individual prescribers.
Actavis's strategy and pattern of deceptive marketing is evident in its internal training
materials. A sales education module titled "Kadian Learning System" trained Actavis's sales
representatives on the marketing messages—including deceptive claims about improved function, the
risk of addiction, the false scientific concept of "pseudoaddiction," and opioid withdrawal—that sales
representatives were directed and required, in turn, to pass on to prescribers, nationally and in Lorain.
The sales training module, dated July 1, 2010, includes the misrepresentations
documented in this Complaint, starting with its promise of improved function. The sales training
instructed Actavis sales representatives that "most chronic benign pain patients do have markedly
improved ability to function when maintained on chronic opioid therapy," when, in reality, available
data demonstrate that patients .on chronic opioid therapy are less likely to participate in daily activities
like work. The sales training also misleadingly implied that the dose of prescription opioids could be
escalated without consequence and omitted important facts about the increased risks of high dose
opioids. First, Actavis taught its sales representatives, who would pass the message on to doctors, that
pain patients would not develop tolerance to opioids, which would have required them to receive
increasing doses: "Although tolerance and dependence do occur with long-term use of opioids, many
studies have shown that tolerance is limited in most patients with [Chronic pain]." Second, Actavis
114

instructed its sales personnel that opioid "[d]oses are titrated to pain relief, and so no ceiling dose can
be given as to the recommended maximal dose." Actavis failed to explain to its sales representatives
and, through them, to doctors, the greater risks associated with opioids at high doses.
355, Further, the 2010 sales training module highlighted the risks of alternate pain
medications without providing a comparable discussion of the risks of opioids, painting the erroneous
and misleading impression that opioids are safer. Specifically, the document claimed that "NSAIDs
prolong the bleeding time by inhibiting blood platelets, which can contribute to bleeding
complications" and "can have toxic effects on the kidney." Accordingly, Actavis coached its sales
representatives that "[t]he potential toxicity of NSAIDs limits their dose and, to some extent, the
duration of therapy" since "Whey should only be taken short term." By contrast, the corresponding
section related to opioids neglects to include a sin,gle side effect or risk associated with the use of
opioids, including from long-term use.
This sales training module also severely downplayed the main risk associated with
Kadian and other opioids—addiction. It represented that "there is no evidence that simply taking
opioids for a period of time will cause substance abuse or addiction" and, instead, "[i]t appears likely
that most substance-abusing patients in pain management practices had an abuse problem before
entering the practice." This falsely suggests that few patients would become addicted, that only those
with a prior history of abuse are at risk of opioid addiction, and that doctors could screen for those
patients and safely prescribe to others. To the contrary, opioid addiction affects a significant
population of patients; while patients with a history of abuse may be more prone to addiction, all
patients are at risk, and doctors may not be able to identify, or safely prescribe to, patients at greater
risk.
The sales training also noted that there were various "signs associated with substance
abuse," including past history or family history of substance or alcohol abuse, frequent requests to
115

change medication because of side effects or lack of efficacy, and a "social history of dysfunctional or
high-risk behaviors including multiple arrests, multiple marriages, abusive relationships, etc." This is
misleading, as noted above, because it implies that only patients with these kinds of behaviors and
history become addicted to opioids.
Further, the sales training neglected to disclose that no risk-screening tools related to
opioids have ever been scientifically validated. The AHRQ recently issued an Evidence Report that
could identify Irdo study" that had evaluated the effectiveness of various risk mitigation strategies—
including the types of patient screening implied in Actavis's sales training—on outcomes related to
overdose, addiction, abuse or misuse.
The sales training module also directed representatives to counsel doctors to be on the
lookout for the signs of "[Aseudoaddiction," which were defined as "[b]ehaviors (that mimic addictive
behaviors) exhibited by patients with inadequately treated pain." However, the concept of
"pseudoaddiction" is unsubstantiated and meant to mislead doctors and patients about the risks and
signs of addiction.
Finally, the 2010 national training materials trivialized the harms associated with opioid
withdrawal by explaining that "[p]hysical dependence simply requires a tapered withdrawal should the
opioid medication no longer be needed." This, however, overlooks the fact that the side effects
associated with opiate withdrawal are severe and a serious concern for any person who wishes to
discontinue long-term opioid therapy.
The Kadian Learning System module dates from July 2010, but Actavis sales
representatives were passing deceptive messages on to prescribers even before then. A July 2010 "Dear
Doctor" letter issued by the FDA indicated that "Netween June 2009 and February 2010, Actavis
sales representatives distributed . . . promotional materials that .. . omitted and minimized serious risks
associated with [Kadian]." Certain risks that were misrepresented included the risk of "[m]isuse,
116

[a]buse, and [d]iversion of [o]pioids" and, specifically, the risk that "[o]pioid agonists have the potential
for being abused and are sought by drug abusers and people with addiction disorders and are subject
to criminal diversion." The FDA also took issue with an advertisement for misrepresenting Kadian's
ability to help patients "live with less pain and get adequate rest with less medication," when the
supporting study did not represent "substantial evidence or substantial clinical experience."
Actavis's documents also indicate that the company continued to deceptively market its
drugs after 2010. Specifically, a September 2012 Kadian Marketing Update, and the "HCP Detail" aid
contained therein, noted that Kadian's "steady state plasma levels" ensured that Kadian "produced
higher trough concentrations and a smaller degree of peak-to-trough fluctuations" than other opioids.
Actavis also commissioned- surveys of prescribers to ensure Kadian sales
representatives were promoting the "steady-state" message. That same survey—paid for and reviewed
by Actavis—found repeated instances of prescribers being told by sales representatives that Kadian
had low potential of abuse or addiction. This survey also found that prescribers were influenced by
Actavis's messaging. A number of Kadian prescribers stated that they prescribed Kadian because it was
"without the addictive potential" and wouldn't "be posing high risk for addiction." As a result,
Actavis's marketing documents celebrated a "perception" among doctors that Kadian had "low abuse
potential".
Finally, the internal documents of another Defendant, Endo, indicate that
pharmaceutical sales representatives employed by Endo, Actavis, and Purdue discussed the
AAPM/APS Guidelines with doctors during detailing visits. These guidelines deceptively concluded
that the risk of addiction is manageable for patients regardless of past abuse histories.
Actavis' Deceptive Speaking Training
Actavis also increasingly relied on speakers—physicians whom Actavis recruited to
market opioids to their peers—to convey similar marketing messages. Actavis set a goal to train 100
117

new Kadian speakers in 2008 alone, with a plan to set up "power lunch teleconferences" connecting
speakers to up to 500 participating sites nationwide. Actavis sales representatives, who were required
to make a certain number of sales visits each day and week, saw the definition of sales call expanded to
accommodate these changes; such calls now included physicians' "breakfast & lunch meetings with
Kadian advocate/speaker."
A training program for Actavis speakers included training on many of the same
messages found in the Kadian Learning System, as described below. The deceptive messages in
Actavis's speakers' training are concerning for two reasons: (a) the doctors who participated in the
training were, themselves, prescribing doctors, and the training was meant to increase their
prescriptions of Kadian; and (b) these doctors were trained, paid, and directed to deliver these
messages to other doctors who would write prescriptions of Kadian.
Consistent with the training for sales representatives, Actavis's speakers' training falsely
minimized the risk of addiction posed by long-term opioid use. Actavis claimed, without scientific
foundation, that "[o]pioids can be used with minimal risk in chronic pain patients without a history of
abuse or addiction." The training also deceptively touted the effectiveness of "Risk Tools," such as the
Opioid Risk Tool, in determining the "risk for developing aberrant behaviors" in patients being
considered for chronic opioid therapy. In recommending the use of these screening tools, the speakers'
training neglected to disclose that none of them had been scientifically validated.
The speakers' training also made reference to "pseudoaddiction" as a "[c]ondition
characterized by behaviors, such as drug hoarding, that outwardly mimic addiction but are in fact
driven by a desire for pain relief and usually signal undertreated pain." It then purported to assist
doctors in identifying those behaviors that actual!), indicated a risk of addiction from those that did not.
Behaviors it identified as "[m]ore suggestive of addiction" included "[p]rescription forgery,"
lijnjecting oral formulations," and "[m]ultiple dose escalations or other nonadherence with therapy
118

despite warnings." Identified as "Mess suggestive of addiction" were "[a]ggressive complaining about
the need for more drugs," "Mequesting specific drugs," "[d]rug hoarding during periods of reduced
symptoms," and "[u]napproved use of the drug to treat another symptom." By portraying the risks in
this manner, the speakers' training presentation deceptively gave doctors a false sense of security
regarding the types of patients who can become addicted to opioids and the types of behaviors these
patients exhibit.
The speakers' training downplayed the risks of opioids, while focusing on the risks of
competing analgesics like NSAIDs. For example, it asserted that "Acetaminophen toxicity is a major
health concern." The slide further warned that "Acetaminophen poisoning is the most common cause
of acute liver failure in an evaluation of 662 US Subjects with acute liver failure between 1998-2003,"
and was titled "Opioids can be a safer option than other analgesics." However, in presenting the risks
associated with opioids, the speakers' training focused on nausea, constipation, and sleepiness, and
ignored the serious risks of hyperalgesia, hormonal dysfunction, decline in immune function, mental
clouding, confusion, and di7ziness; increased falls and fractures in the elderly, neonatal abstinence
syndrome, and potentially fatal interactions with alcohol or benzodiazepines. As a result, the training
exaggerated the risks of NSAIDs, both absolutely and relative to opioids, to make opioids appear to be
a more attractive first-line treatment for chronic pain.
The speakers' training also misrepresented the risks associated with increased doses of
opioids. For example, speakers were instructed to "[s]tart low and titrate until patient reports adequate
analgesia" and to "[s]et dose levels on [the] basis of patient need, not on predetermined maximal
dose." However, the speakers' training neglected to warn speakers (and speakers bureau attendees) that
patients on high doses of opioids are more likely to suffer adverse events.

119

b. Actavis's Deceptive Statements to City of Lorain Prescribers and Patients
The misleading messages and training materials Actavis provided to its sales force and
speakers were part of a broader strategy to convince prescribers to use opioids to treat their patients'
pain, without complete and accurate information about the risks, benefits, and alternatives. This
deception was national in scope and included Lorain. Actavis's nationwide messages reached Lorain
prescribers in a number of ways. For example, they were carried into Lorain by Actavis's sales
representatives during detailing visits as well as made available to City patients and prescribers through
websites and ads, including ads in prominent medical journals. They have also been delivered to City
prescribers by Actavis's paid speakers, who were required by Actavis policy and by FDA regulations to
stay true to Actavis's nationwide messaging.
Once trained, Actavis's sales representatives and speakers were directed to, and did,
visit potential prescribers in Lorain as elsewhere, to deliver their deceptive messages. These contacts
are demonstrated by Actavis's substantial effort in tracking the habits of individual City physicians
prescribing Kadian, and by the direct evidence of Actavis detailing City prescribers.
Actavis tracked, in substantial detail, the prescribing behavior of Lorain area physicians.
2. Cephalon
At the heart of Cephalon's deceptive promotional efforts was a concerted and
sustained effort to expand the market for its branded opioids, Actiq and Fentora, far beyond their
— — _FDA-approved _use_in opioid,tolerant_cancer patients. Trading on their rapid-onset formulation,
Cephalon touted its opioids as the answer to "breakthrough pain"—a tcrm its own KOL allies planted
in the medical literature—whether cancer pain or not. Cephalon promoted this message through its
sales force, paid physician speakers, advertisements, and CMEs, even after the FDA issued the
company warnings and rejected an expanded drug indication.

120

Even as it promoted Actiq and Fentora off-label, Cephalon also purveyed many of the
deceptive messages described above. It did so both directly—through detailing visits and speaker
programs—and through the publications and CMEs of its third-party partners. These messages
included misleading claims about functional improvement, addiction risk, pseudoaddiction, and the
safety of alternatives to opioids.
Based on the highly coordinated and uniform nature of Cephalon's marketing,
Cephalon conveyed these deceptive messages to Lorain prescribers. The materials that Cephalon
generated in collaboration with third-parties were also distributed or made available in Lorain.
Cephalon distributed these messages, or facilitated their distribution, in Lorain with the intent that
Lorain prescribers and/or consumers would rely on them in choosing to use opioids to treat chronic
pain.
a. Cephalon's Deceptive Direct Marketing
Like the other Defendants, Cephalon directly engaged in misleading and deceptive
marketing of its opioids through its sales force and branded advertisements. These messages were
centrally formulated and intended to reach prescribers nationwide, including those practicing in the
Lorain area. Cephalon also spent the money necessary to aggressively promote its opioid drugs, setting
aside $20 million to market Fentora in 2009 alone.
i. Cephalon's Fraudulent OffLabel Marketing of Actig and Fentora •
Chief among Cephalon's direct marketing efforts was its campaign to deceptively
promote its opioids for off-label uses. Cephalon reaps significant revenue from selling its opioids for
treatment of chronic non-cancer pain. However, neither of its two opioid drugs— Actiq or Fentora—
is approved for this purpose. Instead, both have indications that are very clearly and narrowly defined
to limit their use to a particular form of cancer pain. Despite this restriction, and in order to claim its
piece of the broader chronic non-cancer pain market, Cephalon deceptively and unlawfully marketed
121

Actiq and then Fentora for patients and uses for which they were not safe, effective, or allowed. This
resulted in prescriptions written and paid and, grievously, caused patients to be injured and die.
Cephalon's efforts to expand the market for its drugs beyond cancer pain extended to Lorain
prescribers.
a) Cephalon launched its fraudulent marketing scheme for Actiq
Cephalon's Actiq is a powerful opioid narcotic that is delivered to the bloodstream by a
lollipop lozenge that dissolves slowly in the mouth. As described by one patient, Actiq "tastes like the
most delicious candy you ever ate."125
Actiq is appropriately used only to treat "breakthrough" cancer pain that cannot be
controlled by other medications. Breakthrough pain is a short-term flare of moderate-to- severe pain in
patients with otherwise stable persistent pain. Actiq is a rapid-onset drug that takes effect within 10-15
minutes but lasts only a short time. It is also an extremely strong drug, considered to be at least 80
times more powerful than morphine. Fentanyl, a key ingredient in Actiq, has been linked to fatal
•
respiratory complications in patients. Actiq is not safe in any dose for patients who are not opioid
tolerant, meaning patients who have taken specific doses of opioids for a week or longer and whose
systems have acclimated to the drugs.
In 1998, the FDA approved Actiq "ONLY for the management of breakthrough
cancer pain in patients with malignancies who are already receiving and who arc tolerant to opioid
therapy for their underlying persistent cancer pain."126 (emphasis in FDA document). Because of
Actiq's dangers, wider, off-label uses—as the FDA label makes clear—are not permitted:
This product must not be used in opioid non-tolerant patients because life-threatening
respiratory depression and death could occur at any dose in patients not on a chronic

See John Carreyrou, Narcotic Lollipop' Becomes Big Seller Despite FDA Curbs, Wall St. J., Nov. 3, 2006.
FDA Approval Letter for NDA 20-747 (Nov. 4, 1998) at 5,.
http: //www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/207471tr.pdf.
125
126

122

regimen of opioids. For this reason, ACTIQ is contraindicated in the management of
acute or postoperative pain.127
Actiq and Fentora are thus intended to be used only in the care of cancer patients and
only by oncologists and pain specialists who are knowledgeable of, and skilled in, the use of Schedule
II opioids to treat cancer pain. Unlike other drugs, of which off-label uses are permitted but cannot be
promoted by the drug maker, Actiq and Fentora are so potent that off- label use for opioid naive
patients is barred by the FDA, as their labels make clear.
Notwithstanding the drug's extreme potency and related dangers, and the FDA's
explicit limitations, Cephalon actively promoted Actiq for chronic non-cancer pain—an unapproved,
off-label use. Cephalon marketed Actiq as appropriate for the treatment of various conditions
including back pain, headaches, pain associated with sports-related injuries, and other conditions not
associated with cancer and for which it was not approved, appropriate, or safe.
Actiq's initial sales counted in the tens of significant of dollars, corresponding to its
limited patient population. But by 2005, Actiq sales reached $412 million, making it Cephalon's
second-highest selling drug. As a result of Cephalon's deceptive, unlawful marketing, sales exceeded
$500 million by 2006.
b) October 1, 2006 — Cephalon fraudulently marked Actiq's successor
drug, Fentora
Actiq was set to lose its patent protection in September 2006. To replace the revenue
stream that would be lost once generic competitors came to market, Cephalon purchased a new opioid
drug, Fentora, from Cima Labs and, in August 2005, submitted a New Drug Application ("NDA") to
the FDA for approval. Like Actiq, Fentora is an extremely powerful and rapid-onset opioid. It is

Actiq Drug Label, July 2011. The 1998 version does not substantively differ: "Because lifethreatening hypoventilation could occur at any dose in patients not taking chronic opiates, Actiq is
contra- indicated in the management of acute or postoperative pain. This product must not be used in
opioid non-tolerant patients." (emphasis in original).
12.7

123

administered by placing a tablet in the mouth until it disintegrates and is absorbed by the mucous
membrane that lines the inside of the mouth.
On September 25, 2006, the FDA approved Fentora, like Actiq, only for the treatment
of breakthrough cancer pain in cancer patients who were already tolerant to around- the-clock opioid
therapy for their underlying persistent cancer pain. Fentora's unusually strong and detailed black box
warning label—the most serious medication warning required by the FDA—makes clear that, among
other things:
Fatal respiratory depression has occurred in patients treated with FENTORA, including
following use in opioid non-tolerant patients and improper dosing. The substitution of
FENTORA for any other fentanyl product may result in fatal overdose.
Due to the risk of respiratory depression, FENTORA is contraindicated in the
management of acute or postoperative pain including headache/migraine and in opioid
non-tolerant patients.128
When Cephalon launched Fentora on October 1, 2006, it picked up the playbook it had
developed for Actiq and simply substituted in Fentora. Cephalon immediately shifted 100 general pain
sales representatives from selling Actiq to selling Fentora to the very same physicians for uses that
would necessarily and predictably be off-label. Cephalon's marketing of Actiq therefore "primed the
market" for Fentora. Cephalon had trained numerous KOLs to lead promotional programs for
Fentora, typically including off-label uses for the drug. Cephalon billed Fentora as a major advance that
offered a significant upgrade in the treatment of breakthrough pain generally—not breakthrough
cancer pain in particular—from Actiq. Cephalon also developed a plan in 2007 to target elderly
chronic pain patients via a multi-city tour with stops at AARP events, YMCAs, and senior living

Fentora Drug Label, February 2013, http://www.accessdata.fda.gov/drugsatfda_docs/label/
2013/021947s0081bl.pdf

128

124

On February 12, 2007, only four months after the launch, Cephalon CEO Frank
Baldino told investors:
Re've been extremely pleased to retain a substantial portion, roughly 75% of the
rapid onset opioid market. We executed our transition strategy and the results in
our pain franchise have been better than we expected. With the successful launch of
FENTORA and the progress in label expansion program, we are well positioned
to grow our pain franchise for many years to come.129
On May 1, 2007, just seven months after Fentora's launch, Cephalon's then-Executive
Vice President for Worldwide Operations, Bob Roche, bragged to financial analysts that Fentora's
reach would exceed even Actiq's. He described the company's successful and "aggressive" launch of
Fentora that was persuading physicians to prescribe Fentora for ever broader uses. He identified two
"major opportunities"—treating breakthrough cancer pain and:
The other opportunity of course is the prospect for FENTORA
outside of cancer pain, in indications such as breakthrough lower
back pain and breakthrough neuropathic pain. . . .
We believe that a huge opportunity still exists as physicians and
patients recognize FENTORA as their first choice rapid onset
opioid medication. . . . [opioids are] widely used in the treatment
of. . . non-cancer patients . . . .
Of all the patients taking chronic opioids, 32% of them take that
medication to treat back pain, and 30% of them are taking their
opioids to treat neuropathic pain. In contrast only 12% are taking
them to treat cancer pain, 12%.
We know from our own studies that breakthrough pain episodes
experienced by these non-cancer sufferers respond very well to
FENTORA. And for all these reasons, we are tremendously
excited about the significant impact FENTORA can have on
patient health and wellbeing and the exciting growth potential
that it has for Cephalon.
In summary, we have had a strong launch of FENTORA and
129 See Cephalon 04 2006 Earnings Call Transcript, Seeking Alpha (February 12, 2007, 8:48 PM EST)
at 5, http://seekingalpha.com/article/26813-cephalon-q4-2006-earnings-call-transcript.

125

continue to grow the product aggressively. Today, that growth is
coming from the physicians and patient types that we have
identified through our efforts in the field over the last seven years.
In the future, with new and broader indications and a much
bigger field force presence, the opportunity that FENTORA
represents is enormous.'"
c) September 2007 — Reports of death and serious side effects led the
FDA to issue a public health warning for Fentora
On September 10, 2007, Cephalon sent letters to doctors warning of deaths and other
"serious adverse events" connected with the use of Fentora, indicating that "Nhese deaths occurred as
a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing,
and/or improper product substitution."131 The warning did not mention Cephalon's deliberate role in
the "improper patient selection."
Two weeks later, the FDA issued its own Public Health Advisory. The FDA
emphasized, once again, that Fentora should be prescribed only for approved conditions and that dose
guidelines should be carefully followed. The FDA Advisory made clear that several Fentora-related
deaths had occurred in patients who were prescribed the drug for off-label uses. The FDA Advisory
warned that Fentora should not be used for any off-label conditions, including migraines, postoperative pain, or pain due to injury, and that it should be given only to patients who have developed
opioid tolerance. The Advisory reiterated that, because Fentora contains a much greater amount of
fentanyl than other opiate painkillers, it is not a suitable substitute for other painkillers.132

See Cephalon c,Q1 2007 Earnings Call Transcript, Seeking Alpha (May 1, 2007, 8:48 PM EST) at 23,
http:/ /seekingalpha.com/article/34163-cephalon-q1-2007-earnings-call-transcript?page=1.
131 Letter from Jeffrey M. Dayno, M.D., Vice President, Medical Services, Cephalon, Inc. to
Healthcare Providers (Sept. 10, 2007),
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMed icalProducts/UCM154439.pdf.
132 FDA Public Health Advisory, Important Information . for the Safe Use of Fentora ffentanyl buccal tablets)
(Sept. 26, 2007),
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/
ucm051273.htm.
130

126

Notwithstanding the regulatory scrutiny, Cephalon's off-label marketing continued.
Cephalon's 2008 internal audit of its Sales & Marketing Compliance Programs concluded that
marketing and tactical documents, as written, may be construed to promote off-label uses. The same
report acknowledged that Cephalon lacked a process to confirm that speakers' program participants
were following Cephalon's written, formal policies prohibiting off-label promotion, and that "noncompliant [Cephalon Speaker Programs] may be taking place." Moreover, the report acknowledged
that Cephalon's "call universe" may include "inappropriate prescribers"— prescribers who had
nothing to do with cancer pain.
d) May 6, 2008 — The FDA rejected Cephalon's request for expanded
approval of Fentora
Cephalon filed a supplemental new drug application, ("sNDA"), asking the FDA to
approve Fentora for the treatment of non-cancer breakthrough pain. Cephalon admitted that Fentora
already had been heavily prescribed for non-cancer pain, but argued that such widespread use
demonstrated why Fentora should be approved for these wider uses.133 Cephalon's application also
conceded that "[t]o date, no medication has been systematically evaluated in clinical studies or
approved by the FDA for the management of [breakthrough pain] in patients with chronic persistent
non-cancer-related pain." Id.
In response to Cephalon's application, the FDA presented data showing that 95% of
all Fentora use was for treatment of lion-cancer pain.134 By a vote of 17-3, the relevant Advisory
Committee—a panel of outside experts—voted against recommending approval of Cephalon's sNDA
133 See Fentora CII: AdvzIrog Committee Briefing Document, U.S. FDA Anesthetic & Life Support
Drugs Advisory Comm. & Drug Safety & Risk Mgint. Advisory Comm. (May 6, 2008),
http: / /www.fda.gov/ohrms /dockets / ac/08 /briefing/ 2008-4356b2-02-Cephalon.pdf.
134 See Yoo Jung Chang & Lauren Lee, Review of Fentora and Actig Adverse Events from the Adverse Event
Reporting System ("AERS') Database, U.S. FDA Anesthetic 8c Life Support Drugs Advisory Comm. &
Drug Safety 8c Risk Mgmt. Advisory Comm. (May 6, 2008),
hap: / /www.fda.gov/ ohrms/ dockets /ac/08 / slides /2008-4356s2-02-FDAcorepresentations .ppt#289,1
(last visited May 17, 2017).

127

for Fentora, citing the potential harm from broader use. On September 15, 2008, the FDA denied
Cephalon's application and requested, in light of Fentora's already off- label use, that Cephalon
implement and demonstrate the effectiveness of proposed enhancements to Fentora's Risk
Management Program. In December 2008, the FDA followed that request with a formal request
directing Cephalon to submit a Risk Evaluation and Mitigation Strategy for Fentora.
e) March 26, 2009 — the FDA's Division of Drug Marketing,
Advertising and Communications ("DDMAC") warned Cephalon
about its misleading advertising of Fentora
395 Undeterred by the rejection of its sNDA, Cephalon continued to use its general pain
sales force to promote Fentora off-label to pain specialists as an upgrade of Actiq for the treatment of
non-cancer breakthrough pain. Deceptively and especially dangerously, Cephalon also continued to
promote Fentora for use by all cancer patients suffering breakthrough cancer pain, and not only those
who were opioid tolerant.
*
396. On March 26, 2009, DDMAC issued a Warning Letter to Cephalon, telling Cephalon
that its promotional materials for Fentora amounted to deceptive, off-label promotion of the drug.'35
Specifically, the Warning Letter asserted that a sponsored link on Google and other search engines for
Fentora, which said "{l}earn about treating breakthrough pain in patients with cancer,"136 was improper
because it "misleadingly broaden[ed] the indication for Fentora by implying that any patient with

135 Letter from Michael Sauers, Regulatory Review Officer, Division of Drug Marketing, Advertising
and Communications, to Carole S. Marchione, Senior Director and Group Leader, Regulatory Affairs
(March 26, 2009),
http: //www. fda .gov/downloads / Drugs / GuidanceComplianceRegula tory In formation /
En forcementAc tivitiesb yFDA /WarningLettersandN o ticeo fViola tionLet ters to PharmaceuticalC oinp ani
es /UCM166238.pdf.
136 Screen shots of the sponsored link are available here: http://wwwida.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA /WarningLettersan dN o tic
cofViolationLetterstoPharmaceuticalCompanies/UCM166240.pdf.

128

cancer who requires treatment for breakthrough pain is a candidate for Fentora therapy . . . when this
is not the case."
DDMAC emphasized that Fentora's label was limited to cancer patients with
breakthrough pain "who are already receiving and who are tolerant to around-the-clock opioid
therapy for their underlying persistent cancer pain." (emphasis in original). DDMAC explained
that the advertisement was "especially concerning given that Fentora must not be used in opioid nontolerant patients because life-threatening hypoventilation and death could occur at any dose in patients
not on a chronic regimen of opioids." (Emphasis in DDMAC also warned Cephalon that,
based on a review of Cephalon-sponsored links for Fentora on internet search engines, the company's
advertisements were "misleading because they make representations and/or suggestions about the
efficacy of Fentora, but fail to communicate any risk information associated with the use" of the drug.
(emphasis in original).
f) Cephalon continues to knowingly, deceptively, and illegally promote
Fenotra for off-label uses
Cephalon's own market research studies confirm that its Fentora promotions were not
focused on physicians who treat breakthrough cancer pain. Cephalon commissioned several market
research studies to determine whether oncologists provided an "adequate" market potential for
Fentora. These studies' central goal was to determine whether oncologists treat breakthrough cancer
pain themselves, or -whethe.r they refer such patients to general pain specialists. The first study,
completed in 2007, reported that 90% of oncologists diagnose and treat breakthrough cancer pain
themselves, and do not refer their breakthrough cancer pain patients to pain specialists. The second
study, completed in 2009, confirmed the results of the 2007 study, this time reporting that 88% of
oncologists diagnose and treat breakthrough cancer pain themselves and rarely, if ever, refer those
patients to general pain specialists. (One reason that general pain specialists typically do not treat

129

oncological pain is that the presence of pain can, in itself, be an indicator of a change in the patient's
underlying condition that should be monitored by the treating oncologist.)
Cephalon was well aware that physicians were prescribing Fentora for off-label uses.
Cephalon was also aware that its detailing had an impact on prescription rates.
In 2011, Cephalon wrote and copyrighted an article titled "2011 Special Report: An
Integrated Risk Evaluation and Risk Mitigation Strategy for Fentanyl Buccal Tablet (FENTORAe)
and Oral Transmucosal Fentanyl Citrate (ACTIQ0)" that was published in Pain Medicine News.137 The
article promoted Cephalon's drugs for off-label uses by stating that the "judicious use of opioids can
facilitate effective and safe management of chronic pain" and noted that Fentora "has been shown to
be effective in treatment of [break through pain] associated with multiple causes of pain," not just
cancer.138
Cephalon's Misrepresentation of the Risks Associated with the Use of Opioids for the
Long-Term Treatment of Chronic Pain
Cephalon's conduct in marketing Actiq and Fentora for chronic non-cancer pain,
despite their clear (and deadly) risks and unproved benefits, was an extension, and reaped the benefits,
of Cephalon's generally deceptive promotion of opioids for chronic pain.
There is no scientific evidence corroborating a link between chronic opioid therapy and
increased functionality. Any suggestion of such a link is, in fact, false.
Along with deploying its sales representatives, Cephalon used speakers bureaus to help
reach prescribers. The company viewed each treating physician as a vehicle to generate prescriptions
— whether written by that physician directly or caused indirectly by his or her influence over other
physicians.

137
138

http://www.pharmacytimes.com/pub1ications/issue/2012/ianuary2012/r514-jan-12-rems (accessed May 30, 2017)

Id.
130

Having determined that speakers were an effective way to reach prescribers, Cephalon
set to work ensuring that its speakers would disseminate its misleading messages. Cephalon did not
disclose to speakers that, even when these tools are applied, they are unable to control for the risk of
addiction.
As with the other Defendants, Cephalon deployed the made-up concept of
"pseudoaddiction" to encourage prescribers to address addictive behavior in the worst way possible—
with more opioids.
Working with FSMB, Cephalon also trained its speakers to turn doctors' fear of
discipline on its head—doctors, who believed that they would be disciplined if their patients became
addicted to opioids, were taught instead that they would be punished if they failed to prescribe opioids
to their patients with pain. Through this messaging, Cephalon aimed to normalize the prescribing of
opioids for chronic pain and failed to acknowledge the serious risks of long-term opioid use and its
inappropriateness as a front-line treatment for pain.
Finally, Cephalon also developed a guidebook called Opioid Medications and REMS: A
Patient's Guide, which deceptively minimized the risks of addiction from the long- term use of opioids.
Specifically, the guidebook claimed that "patients without a history of abuse or a family history of
abuse do not commonly, become addicted to opioids," which is dangerously false. Cephalon
distributed the guidebook broadly, and it was available to, and intended to reach, prescribers in Lorain.
The misleading messages and materials Cephalon provided to its sales force and its
speakers were part of a broader strategy to convince prescribers to use opioids to treat their patients'
pain, without complete and accurate information about the risks, benefits, and alternatives. This
deception was national in scope and included Lorain. Cephalon's nationwide messages have reached
Lorain prescribers in a number of ways; they were delivered by Cephalon's sales representatives in
detailing visits and made available to City patients and prescribers through websites and ads, including
131

ads in prominent medical journals. They have also been delivered to City prescribers by Cephalon's
paid speakers, who were required by Cephalon policy to stay true to the company's nationwide
messaging.
b. Cephalon's Deceptive Third-Party Statements
Like the other Defendants, Cephalon also relied on third parties to disseminate its
messages through deceptive publications and presentations. By funding, developing and reviewing the
content, and distributing and facilitating the distribution of these messages, Cephalon exercised
editorial control over them. Cephalon, in some instances, used its sales force to directly distribute
certain publications by these Front Groups and KOLs, rendering those publications "labeling" within
the meaning of § 21 C.F.R. 1.3(a) and making Cephalon responsible for their contents. Cephalon also
deployed its KOLs as speakers for talks and CMEs to selected groups of prescribers.
Cephalon's relationships with several such Front Groups and KOLs—and the
misleading and deceptive publications and presentations those relationships generated—are described
below.
i. FSMB — Reiponsible Opioid Prescribing
In 2007, for example, Cephalon sponsored and distributed through its sales
representatives FSMB's Reiponsible Opioid Prescribing, which was drafted by Dr. Fishman. Dr. Fishman
was frequently hired by a consulting Firm, Conrad & Associates LLC, to write pro-opioid marketing
pieces disguised as science. Dr. Fishman's work was reviewed and approved by drug company
representatives, and he felt compelled to draft pieces that he admits distorted the risks and benefits of
chronic opioid therapy in order to meet the demands of his drug company sponsors.
Responsible Opioid Prescribing was a signature piece of Dr. Fishman's work and contained
a number of deceptive statements. This publication claimed that, because pain had a negative impact
on a patient's ability to function, relieving pain—alone—would "reverse that effect and improve
132

function." However, the truth is far more complicated; functional improvements made from increased
pain relief can be offset by a number of problems, including addiction.
414.

Re.sponsible Opioid Prescribing also misrepresented the likelihood of addiction by

mischaracterizing drug-seeking behavior as "pseudoaddiction." It explained that "requesting drugs by
name," engaging in "demanding or manipulative behavior," seeing more than one doctor to obtain
opioids, and hoarding were all signs of "pseudoaddiction" and likely the effects of undertreated pain,
rather than true addiction. There is no scientific evidence to support the concept of
"pseudoaddiction," and any suggestion that addictive behavior masquerades as "pseudoaddiction" is
false.
41.5. Cephalon spent $150,000 to purchase copies of Roponsible Opioid Prescribing in bulk. It
then used its sales force to distribute these copies to 10,000 prescribers and 5,000 pharmacists
nationwide. These were available to, and intended to, reach prescribers and pharmacists in Lorain.
APF — Treatment Options: A Guide for People Living with Pain
Cephalon also exercised considerable control over the Front Group APF, which
published and disseminated many of the most egregious falsehoods regarding chronic opioid therapy.
Their relationship, and several of the APF publications, are described in detail below.
Documents indicate that Cephalon provided APF with substantial assistance in
publishing deceptive information regarding the risks associated with the use of opioids for chronic
pain. An April 3, 2008 Fentora Assessment Strategy Tactics Team Meeting presentation outlines
Cephalon's strategy to prepare for a meeting at which the FDA Advisory Committee would consider
expanding the indication of Fe.ntora to include chronic, non-cancer pain. Cephalon prepared by
"reaching out to third-party organizations, KOLs, and patients to provide context and, where
appropriate, encourage related activity." First among the Front Groups listed was APF.

133

Cephalon was among the drug companies that worked with APF to "educate" the
Institute of Medicine of the National Academies (TOM) on issues related to chronic opioid therapy.
APF President Will Rowe circulated a document to Cephalon and other drug company personnel that
contained key message points and suggested that they "[c]onsider using this document in your
communications with the members of the IOM Committee." According to Rowe, recipients should
"consider this a working document which you can add to or subtract from." Rowe also advised that, if
recipients "have an ally on that Committee," they should "consider sharing this document with that
person."
Cephalon personnel responded enthusiastically, with Cephalon's Associate Director for
Affiance Development stating her belief that "the document does a good job of bringing together
many important ideas." Cephalon reviewed and directed changes to this document, with the Cephalon
Associate Director thanking Rowe "for incorporating the points we had raised." The close
collaboration between Cephalon and APF on this project demonstrates their agreement to work
collaboratively to promote the use of opioids as an appropriate treatment for chronic pain.
Cephalon's influence over APF's activities was so pervasive that APF's President, Will
Rowe, even reached out to Defendants—including Cephalon—rather than his own staff, to identify
potential authors to answer a 2011 article critical of opioids that had been published in the Archives of
Internal Medicine.
421 Starting_in_2007,_Cephalon sponsored APF's Treatment Options: A Guide . for People Living

with Pain.'" It is rife with misrepresentations regarding the risks, benefits, and superiority of opioids.
422. For example, Treatment Options deceptively asserts that the long-term use of opioids to
treat chronic pain could help patients function in their daily lives by stating that, when used properly,
opioids "give [pain patients] a quality of life [they] deserve." There is no scientific evidence
139

https://assets.documentcloud.org/documents/277605/apf-treatmentoptions.pdf (accessed May 30, 2017)
134

corroborating that statement, and such statements are, in fact, false. Available data demonstrate that
patients on chronic opioid therapy are actually less likely to participate in life activities like work.
Treatment Options also claims that addiction is rare and is evident from patients' conduct
in self-escalating their doses, seeking opioids from multiple doctors, or stealing the drugs. Treatment
Options further minimizes the risk of addiction by claiming that it can be avoided through the use of
screening tools, like "opioid agreements," which can "ensure [that patients] take the opioid as
prescribed." Nowhere does Treatment Options explain to patients and prescribers that neither "opioid
agreements" nor any other screening tools have been scientifically validated to decrease the risks of
addiction, and the publication's assurances to the contrary are false and deceptive.
Treatment Options also promotes the use of opioids to treat chronic pain by painting a
misleading picture of the risks of alternate treatments, most particularly NSAIDs. Treatment Options
notes that NSAIDs can be dangerous at high doses, and attributes 10,000 to 20,000 deaths a year
annually to NSAID overdose. According to Treatment Options, NSAIDs are different from opioids
because opioids have "no ceiling dose," which is beneficial since some patients "need" larger doses of
painkillers than they are currently prescribed. These claims misleadingly suggest that opioids are safe
even at high doses and omit important information regarding the risks of high-dose opioids.
Additionally, Treatment Options warns that the risks associated with NSAID use increase
if NSAIDs are "taken for more than a period of months," but deceptively omits any similar warning
about_the_risks associated with the long-term use of opioids. This presentation paints a misleading
picture of the risks and benefits of opioid compared with alternate treatments.
426. APF distributed 17,200 copies of Treatment Options in 2007 alone. It is currently
available online and was intended to reach Lorain prescribers and pharmacists.

135

. Key Opinion Leaders and Misleading Science
Cephalon also knew that its misleading messages would be more likely to be believed
by prescribers if they were corroborated by seemingly neutral scientific support.
Employing these tactics, Cephalon caused the term "breakthrough pain"—a term it
seeded in the medical literature—to be used in articles published by practitioners and clinicians it
supported. With funding from Cephalon, for example, Lir. Portenoy wrote an article that purported to
expand the definition of breakthrough cancer pain to non-cancer indications, vastly expanding the
marketing potential of Cephalon's Fentora. The article was published in the nationally circulated Journal
of Pain in 2006 and helped drive a surge in Fentora prescriptions.
The concept of "breakthrough pain" ultimately formed the sole basis for the central
theme of promotional messages Cephalon cited to support the approval and marketing of Actiq and
Fentora, rapid-acting opioids which begin to work very quickly but last only briefly. Neither of these
drugs had a natural place in the treatment of chronic pain before Cephalon's marketing campaign
changed medical practice. A recent literature survey of articles describing non-cancer breakthrough
pain calls into question the validity of the concept, suggesting it is not a distinct pain condition but a
hypothesis to justify greater dosing of opioids. In other words, Cephalon conjured the science of
breakthrough pain in order to sell its drugs.
As one scholar has pointed out, references to breakthrough pain in articles published
on the MEDLINE bibliographic database spiked in 1998 and again in 2006. H° These spikes coincide
with FDA's approval of Actiq and Fentora.

140 Adriane Fugh-Berman, Marketing Messages in Industg-Funded CME, PharmedOut , Georgetown U.
Med. Ctr. (June 25, 2010), available at pharmedout.galacticrealms.com/Fugh
BermanPrescriptionforConflict6-25-10.pdf. (accessed date)
136

iv. Misleading Confirming Medical Education
Cephalon developed sophisticated plans for the deployment of its KOLs, broken down
by sub-type and specialty, to reach targeted groups of prescribers through CMEs. Cephalon used the
CME programs it sponsored to deceptively portray the risks related to the use of opioids to treat
chronic non-cancer pain and promote the off-label use of Actiq and Fentora.
In 2007 and 2008, Cephalon sponsored three CMEs that each positioned Actiq and
Fentora as the only "rapid onset opioids" that would provide effective analgesia within the time period
during which "breakthrough pain" was at its peak intensity. Although the CMEs used only the generic
names of the drugs, the description of the active ingredient and means of administration means that a
physician attending the CME knew it referred only to Actiq or Fentora.
The CMEs each taught attendees that there was no sound basis for the distinction
between cancer and non-cancer "breakthrough pain," and one instructed patients that Actiq and
Fentora were commonly used in non-cancer patients, thus effectively endorsing this use. Optimizing
Opioid Treatment for Breakthrough Pain, offered online by Medscape, LLC from September 28, 2007,
through December 15, 2008, was prepared by KOL Dr. Webster and M. Beth Dove. It recommends
prescribing a "short-acting opioid" (e.g., morphine, hydromorphone, oxycodone) "when pain can be
anticipated," or a rapid-onset opioid when it cannot. The only examples of rapid-onset opioids then on
the market were oral transmucosal fentanyl citrate (i.e., Actiq) or fentanyl effervescent buccal tablet
(i.e., Fentora): "Both are indicated for treatment of [breakthrough pain] in opioid-tolerant cancer
patients and are frequently prescribed to treat [breakthrough pain] in noncancer patients as well."
Optimizing Opioid Treatment for Breakthrough Pain not only deceptively promoted
Cephalon's drugs for off-label use, but also misleadingly portrayed the risks, benefits, and superiority
of opioids for the treatment of chronic pain. For example, the CME misrepresented that Actiq and
Fentora would help patients regain functionality by advising that they improve patients' quality of life
137

and allow for more activities when taken in conjunction with long-acting opioids. The CME also
minimized the risks associated with increased opioid doses by explaining that NSAIDs were less
effective than opioids for the treatment of breakthrough pain because of their dose limitations, without
disclosing the heightened risk of adverse events on high-dose opioids.
Around the same time, Dr. Webster was receiving nearly $2 million in funding from
Cephalon.
Optimizing Opioid Treatment for Breakthrough Pain was available online and was
intended to reach City prescribers.
Cephalon similarly used an educational grant to sponsor the CME Breakthrough Pain:
Improving Recognition and Management, which was offered online between March 31, 2008, and March 31,
2009, by Medscape, LLC. The direct result of Cephalon's funding was a purportedly educational
document that echoed Cephalon's marketing messages. The CME deceptively omitted Actiq's and
Fentora's tolerance limitations, cited examples of patients who experienced pain from accidents, not
from cancer, and, like Cephalon's OptimkingOpioid Treatment CME, taught that Actiq and Fentora were
the only products on the market that would take effect before the breakthrough pain episode subsided.
This CME was available online and was intended to reach City prescribers.
Lastly, KOL Dr. Fine authored a CME, sponsored by Cephalon, titled Opioid-Based
Management of Persistent and Breakthrough Pain, with KOLs Dr. Christine A. Miaskowski and Michael J.
Brennan, M.D. Cephalon paid to have this CME published in a supplement of Pain Medicine News in
2009.141 It instructed prescribers that "clinically, broad classification of pain syndromes as either
cancer- or noncancer-related has limited utility," and recommended dispensing "rapid onset opioids"
for "episodes that occur spontaneously" or unpredictably, including "oral transmucosal fentanyl," i.e.,

https://www.yumpu.com/en/document/view/11409251/opioid-based-management-of-persistent-and-breakthroughpain (accessed May 30, 2017)
141

138

Actiq, and "fentanyl buccal tablet," i.e., Fentora, including in patients with chronic non-cancer pain. Dr.
Miaskowski disclosed in 2009, in connection with the APS/AAPM Opioid Treatment Guidelines, that
she served on Cephalon's speakers bureau:42 Dr. Fine also received funding from Cephalon for
consulting services.
Opioid-Based Management of Persistent and Breakthrough Pain was available to and was
intended to reach City prescribers.
Cephalon's control over the content of these CMEs is apparent based on its advance
knowledge of their content. A December 2005 Cephalon launch plan set forth key "supporting
messages" to position Fentora for its product launch. Among them was the proposition that "15minute onset of action addresses the unpredictable urgency of [breakthrough pain]." Years later, the
same marketing messages reappeared in the Cephalon-sponsored CMEs described above. Echoing the
Cephalon launch plan, Optimizing Opioid Treatment for Breakthrough Pain stated that "[t]he
unpredictability of [breakthrough pain] will strongly influence the choice of treatment" and that
Fentora "delivers an onset of analgesia that is similar to [Actiq] at 15 minutes." Similarly, OpioidBased Management of Persistent and Breakthrough Pain defined "breakthrough pain" as
"unpredictable," over a table describing both cancer and non-cancer "breakthrough pain."
Cephalon tracked the effectiveness of its deceptive marketing through third parties,
demonstrating that Cephalon not only planned for, but depended upon, their activities as a key
element of its marketing strategy. These programs were available to prescribers in Lorain and, based on
the uniform and nationwide character, of Cephalon's marketing featured the same deceptive messages
described above.

14214 of 21 panel members who drafted the AAPM/APS Guidelines received support from
Janssen, Cephalon, Endo, and Purdue.

139

c. Cephalon's Deceptive Third-Party Statements to City Prescribers and Patients
Cephalon used various measures to disseminate its deceptive statements regarding the
risks of off-label use of Actiq and Fentora and the risks, benefits, and superiority of opioids to City
patients and prescribers.
Cephalon's speakers regularly held talks for City prescribers. These talks followed the
same deceptive talking points covered in Cephalon's speakers' training.
Cephalon also targeted City prescribers through the use of its sales force.
Given that Cephalon's own studies demonstrated that the overwhelming majority of
oncologists diagnose and treat breakthrough cancer pain themselves, Cephalon knew the only purpose
of representatives meeting with these prescribers was to promote off-label use. Based on the uniform
and nationwide character of Cephalon's marketing, Cephalon's deceptive messages would have been
disseminated to City prescribers by Cephalon's sales representatives during these events.
Sales representatives, and the misrepresentations on which they were trained, drove
significant Fentora sales.
3. Endo
Endo promoted its opioids through the full array of marketing channels. The company
deployed its sales representatives, paid physician speakers, journal supplements, and advertising in
support of its branded opioids, principally Opana and Opana ER. Misleading claims about the
purportedly-lower-abuse -potential_of_Opana_ER_featured_prominently in this campaign. Endo also
made many other, deceptive statements and omissions. These included deceptive messages about functional improvement, addiction risk, "pseudoaddiction," addiction screening tools, and the safety of
alternatives to opioids.
At the same time, Endo also relied on third-party partners to promote the safety,
efficacy, and superiority of opioids generally, through a combination of CMEs, websites, patient
140

education pamphlets, and other publications. These materials echoed the misrepresentations described
above, and also made deceptive statements about withdrawal symptoms and the safety of opioids at
higher doses.
Through the highly coordinated and uniform nature of Endo's marketing, Endo
conveyed these deceptive messages to City prescribers. The materials that Endo generated in
collaboration with third-parties also were distributed or made available in Lorain. Endo distributed
these messages, or facilitated their distribution, in Lorain with the intent that City prescribers and/or
consumers would rely on them in choosing to use opioids to treat chronic pain.
a. Endo's Deceptive Direct Marketing
Like the other Defendants, Endo used deceptive direct marketing to increase the sales
of its dangerous opioids. As set forth below, Endo conveyed these deceptive messages in training of its
sales force and recruited speakers, who in turn conveyed them to physicians; in a misleading journal
supplement; and in unbranded advertising.
i. Endo's Sales Force and Deceptive Sales Training
Endo's promotion of Opana ER relied heavily on in-person marketing, including to
City prescribers. Endo had an aggressive detailing program. In the first quarter of 2010 alone, sales
representatives made nearly 72,000 visits to prescribers nationwide to detail Opana ER, Between 2007
and 2013 •L'' ndo - spent between- $3 -million- and- $10 . million each quarter -to .promote opioids _through its
sales force.
Endo's sales representatives, like those of the other Defendants, targeted physicians to
deliver sales messages that were developed cenrtally and deployed uniformly across thc country. These
sales representatives were critical in transmitting Endo's marketing strategies and talking points to
individual prescribers.

141

Endo specifically directed its sales force to target physicians who would prescribe its
drugs to treat chronic pain. For example, an Opana Brand Tactical Plan dated August, 2007 aimed to
increase "Opana ER business from [the Primary Care Physician] community" more than 45% by the
end of that year. Indeed, Endo sought to develop strategies that would be most persuasive to primary
care doctors—strategies that sought to influence the prescribing behavior of primary care physicians
through the use of subject matter experts. A February 2011 Final Report on Opana ER Growth
Trends, for example, predicted that Endo's planned "[u]se of Pain Specialists as local thought leaders
should affect increased primary care adoption."
Endo trained its sales force to make a number of misrepresentations to physicians
nationwide, including to physicians in Lorain. Endo's sales representatives were trained to represent to
these prescribers that Opana ER would help patients regain function they had lost to chronic pain; that
Endo opioids had a lower potential for abuse because they were "designed to be crush resistant,"
despite the fact that "clinical significance of INTAC Technology or its impact on abuse/misuse ha[d]
not been established for Opana ER;" and that drug seeking behavior was a sign of undertreated pain
rather than addiction.
Endo knew that its marketing reached physicians repeatedly because it tracked their
exposure. Internal Endo documents dated August 23, 2006 demonstrate that the following percentages
of physicians would view an Endo journal insert (or paid supplement) at least 3 times in an 8 month
period: 86% of neurologists; 86% of rheumatologists; 85% of oncologists; 85% of anesthesiologists;
70% of targeted primary care physicians; and 76% of OB/GYNs.
Endo was not only able to reach physicians through its marketing, but also
successfully impart its marketing messages. The company found that its promotional materials
tripled prescribers' ability to recall the sales message and doubled their willingness to prescribe
Opana ER in the future. This was true of marketing that contained deceptions.
142

For example, according to internal Endo documents, up to 10% of physicians it
detailed were able to recall, without assistance, the message that Opana ER had "Minimal/less
abuse/misuse" potential than other drugs. The Endo message that prescribers retained was a plain
misrepresentation: that use of Opana ER was unlikely to lead to abuse and addiction. Although
Opana ER always has been classified under Schedule II as a drug with a "high potential for abuse",
the largest single perceived advantage of Opana ER, according to a survey of 187 physicians who
reported familiarity with the drug, was "perceived low abuse potential," cited by 15% of doctors as an
advantage. Low abuse potential was among the deceptive messages that City prescribers received,
and retained, from Endo sales representatives.
Endo's own internal documents acknowledged the misleading nature of these
statements, conceding that "Opana ER has an abuse liability similar to other opioid analgesics as
stated in the [FDA-mandated] box warning." A September 2012 Opana ER Business Plan similarly
stated that Endo needed a significant investment in clinical data to support comparative
effectiveness, scientific exchange, benefits and unmet need, while citing lack of "head-to-head data"
as a barrier to greater share acquisition.
Nevertheless, Endo knew that its marketing was extremely effective in turning
physicians into prescribers. Nationally, the physicians Endo targeted for in-person marketing
represented approximately 84% of all prescribers of Opana ER in the first quarter of 2010.
Endo also observed that the prescribers its sales representatives visited wrote nearly three times
as many prescriptions per month for Opana ER as those physicians who were not targeted for
Endo's marketing-7.4 prescriptions per monthversus 2.5. The. most heavily targeted
prescribers wrote nearly 30 prescriptions per month. Internal Endo documents from May 2008
indicate that Endo expected that each of its sales representatives would generate 19.6

143

prescriptions per week by the end of 2008. As summarized by a February 2011 report on
Opana ER growth trends, Endo's "[a]ggressive detailing [is] having an impact."
More broadly, Endo's sales trainings and marketing plans demonstrate that its
sales force was trained to provide prescribers with misleading information regarding the risks
of opioids when used to treat chronic pain. Foremost among these messages were misleading
claims that the risks of addiction, diversion, and abuse associated with opioids—and Endo's
products in particular—were low, and lower than other opioids.
a) Endo's Sales Force Deceptively Minimized the Risks of Addiction
Associated with Chronic Opioid Therapy.
By way of illustration, Endo's Opana ER INTAC Technology Extended-Release Sell
Sheet Implementation Guide, which instructs Endo sales personnel how to effectively "support key
messages" related to the marketing of Opana ER, states that it is an "approved message" for sales
representatives to stress that Opana ER was "designed to be crush resistant," even though this
internal document conceded that "the clinical significance of INTAC Technology or its impact on
abuse/misuse has not been established for Opana ER."
Other Endo documents acknowledged the limitations on Opana ER's INTAC
technology, c.onceding that while Opana ER may be resistant to pulverization, it can still be
"ground" and "cut into small pieces" by those looking to abuse the drug.
Endo's claims about the crush-resistant design of Opana ER also made their way 10
the company's press releases. A January 2013 article in Pain Medicine News, based in part on an Endo
press release, described Opana ER as "crush-resistant." This article was posted on the Pain _Medicine
News website, which was accessible to City patients and prescribers.
The only reason to promote the crush resistance of Opana ER was to persuade
doctors that there was less risk of abuse, mist:Ise, and diversion of the drug. The idea that Opana ER
144

was less addictive than other drugs was the precise message that City prescribers took from Endo's
marketing.
On May 10, 2013 the FDA warned Endo that there was no evidence that Opana ER's
design "would provide a reduction in oral, intranasal, or intravenous abuse" and that the postmarketing data Endo had submitted to the FDA "are insufficient to support any conclusion about
the overall or route-specific rates of abuse." Even though it was rebuked by the FDA, Endo
continued to market Opana ER as having been designed to be crush resistant, knowing that this
would (falsely) imply that Opana actually was crush resistant and that this crush-resistant quality
would make Opana ER less likely to be abused.
Endo's sales training and the promotional materials distributed by its sales
representatives also minimized the risk of addiction. Endo also circulated education materials that
minimized the risk of addiction. For example, Endo circulated an education pamphlet with the Endo
logo titled "Living with Someone with Chronic Pain," which implied, to persons providing care to
chronic pain patients, that addiction was not a substantial concern by stating that "[m]ost health care
providers who treat people with pain agree that most people do not develop an addiction problem."
This pamphlet was downloaaable from Endo's website and accessible to City prescribers.
Endo's sales training also misrepresented the risks of addiction associated with Endo's
products by implying that Opana's prolonged absorption would make it less likely to lead to abuse.
For example, a presentation-titled "Deliver_the Difference_for the Opana Brand in POA II" sets out
that one of the "[k]ey [m]essages" for the Endo sales force was that Opana ER provides "[s]table,
steady-state plasma levels for true 12-hour dosing that lasts." Endo's sales representatives used this
messaging to imply to City prescribers that Opana ER provided "steady state" pain relief, making
Opana less likely to incite euphoria in patients and less likely to lead to addiction.

145

468. Endo further instructed its sales force to promote the misleading concept of
"pseudoaddiction,"—i.e., that drug-seeking behavior was not cause for alarm, but merely a
manifestation of undertreated pain. In a sales training document titled "Understanding the Primary
Care MD and their use of Opioids," Endo noted that the "biggest concerns" among primary care
physicians were "prescription drug abuse (84.2%), addiction (74.9%), adverse effects (68%), tolerance
(60.7%), and medication interaction (32%)." In response to these concerns, Endo instructed its sales
representatives to ask whether their customers were "confus[ing] 'pseudo-addiction' with 'drugseekers" and how confident they were that their health care providers "know these differences
(Tolerance, Dependence, Addiction, Pseudo- Addiction. . .)."
b) Endo's Sales Force Deceptively Implied that Chronic Opioid
Therapy Would Improve Patients' Ability to Function.
In addition to their deceptive messages regarding addiction, Endo's promotional
materials and sales trainings also misleadingly claimed that patients using opioids for the long- term
treatment of chronic pain would experience improvements in their daily function. In reality, longterm opioid use has not been shown to, and does not, improve patients' function, and, in fact, is
often accompanied by serious side effects that degrade function. Endo's own internal documents
acknowledged that claims about improved quality of life were unsubstantiated "off label claims."
Nevertheless, Endo distributed product advertisements that suggested that using
Opana ER to treat chronic pain would allow patients -to-perform-demanding -tasks -like- work-as -a—
chef. One such advertisement states prominently on the front: "Janice is a 46-year-old chef with
chronic low back pain. She needs a treatment option with true 12-hour dosing." The advertisement
does not mention the "moderate to severe pain" qualification in Opana ER's indication, except in
the fine print. These advertisements were mailed to prescribers and distributed by Endo's sales force
in detailing visits, which would have included Endo representatives' visits to prescribers.

146

In a 2007 Sales Tool that was intended to be shown by Endo sales personnel to
physicians during their detailing visits, Endo highlighted a hypothetical patient named "Bill," a 40year-old construction worker who was reported to suffer from chronic low back pain. According to
the Sales Tool, Opana ER will make it more likely that Bill can return to work and support his
family.
Similarly, training materials for sales representatives from March 2009 ask whether it is
true or false that "[t]he side effects of opioids prevent a person from functioning and can cause
more suffering than the pain itself." The materials indicate that this is "[flaIse" because "[t]he overall
effect of treatment with opioids is very favorable in most cases."
A sales training video dated March 8, 2012 that Endo produced and used to train its
sales force makes the same types of claims. A patient named Jeffery explains in the video that he
suffers from chronic pain and that "chronic pain 1. . .] reduces your functional level." Jeffery claims
that after taking Opana ER, he "can go out and do things" like attend his son's basketball game and
"[t]here's no substitute for that." This video was shown to Endo's sales force, which adopted its
misleading messaging in its nationwide sales approach, including the approach it used in Lorain.
Claims of improved functionality were central to Endo's marketing efforts for years. A
2012 Endo Business Plan lists ways to position Opana ER, and among them is the claim that Opana
ER will help patients "[m]aintaint] normal functionality, sleep, [and] work/life/performance
productivity" and have a positive "[e]ffect on social relationships." Indeed, that business plan describes
the "Opana ER Vision" as "[t]o make the Opana franchise (Opana ER, Opana, Opana Injection) the
choice that maximizes improvement in functionality and freedom from the burden of moderate-tosevere pain."

147

c) Endo's Sales Force Deceptively presented the Risks and Benefits of
Opioids to Make Them Appear Safer Than Other Analgesics
Endo further misled patients and prescribers by downplaying the risks of opioids in
comparison to other pain relievers. For example, in Lorain and elsewhere, Endo distributed a
presentation titled Case Challenges in Pain Management: Opioid Therapy for Chronic Pain. This study held out
as a representative example one patient who had taken NSAIDs for more than eight years and, as a
result, developed "a massive upper gastrointestinal bleed." The presentation recommended treating
this patient with opioids instead. By focusing on the adverse side effects of NSAIDs, while omitting
discussion of serious side effects associated with opioids, this presentation misleadingly portrayed the
comparative risks and benefits of these drugs.
Endo distributed Case Challenges in Pain Management: Opioid Therapy for Chronic Pain to
116,000 prescribers in 2007, including primary care physicians.
Endo's Speakers Bureau Programs Deceptively Minimked the Risks of Addiction
Associated with Chronic Opioid Therapy
In addition to its sales representatives' visits to doctors, Endo also used deceptive
science and speaker programs to spread its deceptive messages.
Endo leaned heavily on its speakers' bureau programs. In 2008 alone, Endo spent
nearly $4 million to promote up to 1,000 speakers programs around the country. Endo contracted
with a medical communications firm to operate its speakers bureau program, planning to hold a total
of 500 "fee-for-service . . . peer-to-peer promotional programs" for Opana ER in just the second
half of 2011, including dinners, lunches and breakfasts. These programs were attended by sales
representatives, revealing their true purpose as marketing, rather than educational, events.
Endo's internal reporting stated that the "return on investment" turned positive 8-12
weeks after such programs. Endo measured that return on investment in numbers of prescriptions

148

written by physicians who attended the events. One internal Endo document concluded: "[w]e
looked at the data for [the] 2011 program and the results were absolutely clear: physicians who came
into our speaker programs wrote more prescriptions for Opana ER after attending than they had
before they participated. You can't argue with results like that."
These speakers bureau presentations included the very same misrepresentations Endo
disseminated through its sales representatives. A 2012 speaker slide deck for Opana ER— on which
Endo's -recruited speakers were trained and to which they were required to adhere to in their
presentations—misrepresented that the drug had low abuse potential, in addition to suggesting that
as many as one-quarter of the adult population could be candidates for opioid therapy.
In addition, a 2013 training module directed speakers to instruct prescribers that
"OPANA ER with INTAC is the only oxymorphone designed to be crush resistant" and advised
that "[t]he only way for your patients to receive oxymorphone ER in a formulation designed to be
crush resistant is to prescribe OPANA ER with INTAC." This was a key point in distinguishing
Opana ER from competitor drugs. Although Endo mentioned that generic versions of
oxymorphone were available, it instructed speakers to stress that "[t]he generics are not designed to
be crush resistant." This was particularly deceptive given that Opana ER was not actually crushresistant.
In 2009, Endo wrote a talk titled The Role of Opana ER in the Manasement of Chronic Pain.
The talk included a slide titled "Use of Opioids is Recommended for Moderate to Severe Chronic
Noncancer Pain," which cited the AAPM/APS Guidelines—and their accompanying misstatements
regarding the likelihood of addiction (by claiming that addiction risks were manageable regardless of
patients' past abuse histories) while omitting their disclaimer regarding the lack of supporting
evidence in favor of that position. This dangerously misrepresented to doctors the force and utility
of the 2009 Guidelines.
149

483. The misleading messages and materials Endo provided to its sales force and its
speakers were part of a broader strategy to convince prescribers to use opioids to treat their patients'
pain, irrespective of the risks, benefits, and alternatives. This deception was national in scope and
included Lorain. Endo's nationwide messages would have reached City prescribers in a number of
ways. For example, they were carried into Lorain by Endo's sales representatives during detailing visits
as well as made available to City patients and prescribers through websites and ads. They also have
been delivered to City prescribers by Endo's paid speakers, who were required by Endo policy and by
FDA regulations to stay true to Endo's nationwide messaging.
Endo's Misleading Journal Supplement
In 2007, Endo commissioned the writing, and paid for the publishing of a supplement
available for CME credit in the Journal of Family Practice called Pain Management Dilemmas in
Primary Care: Use of Opioids, and it deceptively minimized the risk of addiction by emphasizing the
effectiveness of screening tools. Specifically, it recommended screening patients using tools like the
Opioid Risk Tool or the Screener and Opioid Assessment for Patients with Pain. It also falsely
claimed that, through the use of tools like toxicology screens, pill counts, and a "maximally
structured approach," even patients at high risk of addiction could safely receive chronic opioid
therapy. Endo distributed 96,000 copies of this CME nationwide, and it was available to, and was
intended to, reach City prescribers.
iv. Endo's Deceptive Unbranded Advertising
Endo also used unbranded advertisements to advance its goals. By electing to focus
on unbranded marketing, Endo was able to make claims about the benefits of its opioids that the
FDA would never allow in its branded materials. The chart below compares an Endo unbranded
statement with one of Endo's FDA-regulated, branded statements:

150

Opana ER Advertisement
(2011/2012/2013) (Branded)

Living with Someone
with Chronic Pain
(2009)(Unbranded)

Endo advertisement

Patient education material created by Endo

"[C]ontains oxymorphone, an opioid agonist
and Schedule II controlled substance with an
abuse liability similar to other opioid
agonists, legal or illicit."

"Most health care providers who treat people
with pain agree that most people do not
develop an addiction problem."

"All patients treated with opioids require
careful monitoring for signs of abuse and
addiction, since use of opioid analgesic
products carries the risk of addiction
even under appropriate medical use."

b. Endo's Deceptive Third-Party Statements
Endo's Efforts were not limited to directly making misrepresentations through its
marketing materials, its speakers, and its sales force. Endo believed that support for patient advocacy
and professional organizations would reinforce Endo's position as "the pain management
company."
Prior to, but in contemplation of, the 2006 launch of Opana ER, Endo developed a
"Public Stakeholder Strategy." Endo identified "tier one" advocates to assist in promoting the
approval and acceptance of its new extended release opioid. Endo also intended to enlist the support
of organizations that would be "favorable" to schedule II opioids from a sales perspective and that
engaged in, or had the potential to advocate for, public policy. Endo sought to develop its
relationships with these organizations through its funding. In 2008, Endo spent $1 million per year
to attend conventions of these pro-opioid medical societies, including meetings of AAPM, APS, and
the American Society of Pain Management Nursing ("ASPMN").

151

APF's ability to influence professional societies and other third parties is demonstrated
by its approach to responding to a citizens' petition filed with the FDA by the Physicians for
Responsible Opioid Prescribing (the "PROP Petition"). The PROP petition, filed by a group of
prescribers who had become concerned with the rampant prescribing of opioids to treat chronic
pain, asked the FDA to require dose and duration limitations on opioid use and to change the
wording of the approved indication of various long-acting opioids to focus on the severity of the
pain they are intended to treat.
The PROP Petition set off a flurry of activity at Endo. It was understood that Endo
would respond to the petition but Endo personnel wondered "[s]hould we [ . . . ] consider filing a
direct response to this [citizens' petition] or do you think we are better served by working through
our professional society affiliations?" One Endo employee responded: "My sense is the societies are
better placed to make a medical case than Endo." Endo's Director of Medical Science agreed that "a
reply from an external source would be most impactful." These communications reflected Endo's
absolute confidence that the professional societies would support its position.
i. .APF
One of the societies with which Endo worked most closely was APF. Endo provided
substantial assistance to, and exercised editorial control, over the deceptive and misleading messages
that APF conveyed through its National Initiative on Pain Control ("NIPC"). Endo was one of
APF's biggest financial supporters, providing more than half of the $10 million APF received from
opioid manufacturers during its lifespan. Endo spent $1.1 million on the NIPC program in 2008
alone, funding earmarked in part, for the creation of CMF, materials that were intended to be used
repeatedly.
Endo's influence over APF's activities was so pervasive that APF President Will Rowe
reached out to Defendants—including Endo—rather than his own staff, to identify potential
152

authors to answer a 2011 article critical of opioids that had been published in the Archives of
Internal Medicine. Personnel from Defendants Purdue, Endo, Janssen, and Cephalon worked with
Rowe to formulate APF's response which was ultimately published.
Documents also indicate that Endo personnel were given advance notice of the
materials APF planned to publish on its website and provided an opportunity to comment on the
content of those materials before they were published. For example, in early July of 2009, APF's
Director of Strategic Development wrote to Endo personnel to give them advance notice of content
that APF planned to be "putting . . . up on the website but it's not up yet." The Endo employee
assured the sender that she "w[ould] not forward it to anyone at all" and promised that she would
"double delete it' from [her] inbox." In response, APF's Director of Strategic Development replied
internally with only four words: "And where's the money?"
At no time was Endo's relationship with APF closer than during its sponsorship of
the NIPC. Before being taken over by APF, the NIPC was sponsored by Professional Postgraduate
Services which the Accreditation Council for Continuing Medical Education determined to be a
"commercial interest" and could no longer serve as a sponsor. In response, Endo reached out to
APF. An August 2009 document titled "A Proposal for the American Pain Foundation to Assume
Sponsorship of the National Initiative on Pain Control," pointed out that "[flor the past 9 years, the
NIPC has been supported by unrestricted annual grants from Endo Pharmaceuticals, Inc."
According to_this document,_APF's sponsorship of the NIPC "[o]ffers the APF a likely opportunity
to generate new revenue, as Endo has earmarked substantial funding: $1.2 million in net revenue for
2010 to continue the NIPC." Further, sponsorship of the APF would "[p]rovidel] numerous
synergies to disseminate patient education materials," including "[h]andouts to attendees at all live
events to encourage physicians to drive their patients to a trusted source for pain education—the
APF website."
153

A September 14, 2009 presentation to APF's board contained a materially similar
discussion of NIPC sponsorship, emphasizing the financial benefit to APF from assuming the role
of administering NIPC. The proposal "offer[ed] a solution to continue the development and
implementation of the NIPC initiative as non-certified. . . yet independent education to physicians
and healthcare professionals in the primary care setting, while providing the APF with a dependable,
ongoing source of grant revenue." A number of benefits related to NIPC sponsorship were listed,
but chief among them was "a likely opportunity [for APF] to generate new revenue, as Endo has
earmarked substantial funding: $1.2 million in net revenue for 2010 to continue the NIPC."
Internal Endo scheduling documents indicate that "NIPC module curriculum
development, web posting, and live regional interactive workshops" were Endo promotional tasks in
2010. Endo emails indicate that Endo personnel reviewed the content created 6y NIPC and
provided feedback.
Behind the scenes, Endo exercised substantial control over NIPC's work. Endo
exerted its control over NIPC by funding NIPC and APF projects; developing, specifying, and
reviewing content; and taking a substantial role in the distribution of NIPC and APF materials,
which in effect determined which messages were actually delivered to prescribers and consumers.
As described below, Endo projected that it would be able to reach tens of thousands of prescribers
nationwide through the distribution of NIPC materials.
497. From 2007—until_at_least_2011,_Endo_also meticulously_tracked the distribution of
NIPC materials, demonstrating Endo's commercial interest in, and access to, NIPC's reach. Endo
knew exactly how many participants viewed NIPC webinars and workshops and visited its website,
Painknowledge.com. Endo not only knew how many people viewed NIPC's content, but what their
backgrounds were (e.g., primary care physicians or neurologists). Endo's access to and detailed
understanding of the composition of the audience at these events demonstrates how deeply Endo
154

was involved in NIPC's activities. Moreover, Endo tracked the activities of NIPC—ostensibly a
third party—just as it tracked its own commercial activity.
498. Endo worked diligently to ensure that the NIPC materials it helped to develop would
have the broadest possible distribution. Endo's 2008 to 2012 Opana Brand Tactical Plan indicates
that it sought to reach 1,000 prescribers in 2008 through live NIPC events, and also to "[1]everage
live programs via enduring materials and web posting." Endo also planned to disseminate NIPC's
work by distributing two accredited newsletters to 60,000 doctors nationwide for continuing
education credit and by sponsoring a series of 18 NIPC regional case-based interactive workshops.
Endo had earmarked more than one million dollars for NIPC activities in 2008 alone.
499. In short, NIPC was a key piece of Endo's marketing strategy. Indeed, internal APF
emails question whether it was worthwhile for APF to continue operating NIPC given that NIPC's
work was producing far more financial benefits for Endo than for APF. Specifically, after Endo
approved a $244,337.40 grant request to APF to fund a series of NIPC eNewsletters, APF personnel
viewed it as "[g]reat news," but cautioned that "the more I think about this whole thing, [Endo's]
making a lot of money on this with still pretty slender margins on [APF's] end." APF's commitment to
NIPC's "educational" mission did not figure at all in APF's consideration of the value of its work, and
Endo's motive and benefit were never in doubt.
a) Misleading Medical Education
500. NIPC distributed a series of eNewsletter CMEs focused on "key topic[s] surrounding
the use of opioid therapy" sponsored by Endo. These newsletters were edited by KOL Dr. Fine and
listed several industry-backed KOLs, including Dr. Webster, as individual authors. Endo estimated
that roughly 60,000 prescribers viewed each one. These CMEs were available to, and would have
been accessed by, City prescribers. Before-and-after surveys, summarized in the chart below, showed

155

that prescriber comfort with prescribing opioids ranged from 27% to 62% before exposure to the
CME, and from 76% to 92% afterwards:
Topic
Patient Selection and Initiation of Opioid
Therapy as a Component of Pain Treatment
Informed Consent and Management Plans to
Optimize Opfold Therapy for Chronic Pain
Risk Stratification and Evaluation of High-Risk
Behaviors for Chronic Opioid Therapy
Integration of Nonpharmacologic and
Multidisciplinary Therapies Into the Opioid
Treatment Plan
Addressing Patients Concerns Associated
With Chronic Pain Treatment and Opioid Use
Opioid Therapy in Patients With a History of
Substance Use Disorders
Urine Drug Testing: An Underused Tool
Appropriate Documentation of Opioid Therapy:
The Emergence of the 4As and Trust and
Verify as the Paradigm
Opioid Rotation
Discontinuing Opiold Therapy: Developing and
Implementing an "Exit Strategy"

Comfort level prior

Comfort level after

47%

8770.

48%

81%

28%

76%

42%

85%.

62%

92%

35%

85%

54%
44%

86%
86%

27%
37%

92%
.90%

to reading the article

reading the article

.

Endo documents made it clear that the persuasive power of NIPC speakers was
directly proportional to their perceived objectivity. Accordingly, Endo personnel directed that, when
giving Endo-sponsored talks, NIPC faculty would not appear to be "Endo Speakers." Nevertheless,
the two parties understood that Endo and NIPC shared a common "mission to educate physicians"
and working "through the APF . . . [wa]s a great way to work out . . .probkms that could have been
there without the APF's participation and support."
The materials made available on and through NIPC included misrepresentations. For
example, Endo worked with NIPC to sponsor a series of CMEs titled Persistent Pain in the Older Patient
and .Persistent Pain in the Older Adult. These CMEs misrepresented the prevalence of addiction by stating
that opioids have "possibly less potential for abuse" in elderly patients than in younger patients, even
though there is no evidence to support such an assertion. Moreover, whereas withdrawal symptoms

156

are always a factor in discontinuing long-term opioid therapy, Persistent Pain in the Older Adult also
misleadingly indicated that such symptoms can be avoided entirely by tapering the patient's does by
10-20% per day for ten days. Persistent Pain in the Older Patient, for its part, made misleading claims that
opioid therapy has been "shown to reduce pain and improve depressive symptoms and cognitive
functioning." NIPC webcast these CMEs from its own website, where they were available to, and were
intended to reach, City prescribers.
b) Pain Knowledge
Working with NIPC enabled Endo to make a number of misleading statements
through the NIPC's website, Painknondedge.com. Endo tracked visitors to PainKnowledge.com and used
Painknowledge.com to broadcast notifications about additional NIPC programming that Endo helped
to create.
APP made a grant request to Endo to create an online opioid "tool kit" for NIPC and
to promote NIPC's website, Painknowledge.com. In so doing, APF made clear that it planned to
disseminate Defendants' misleading messaging. The grant request expressly indicated APF's intent to
make misleading claims about functionality, noting: "Some of these people [in chronic pain] may be
potential candidates for opioid analgesics, which can improve pain, function, and quality of life."
Endo provided $747,517 to fund the project.
True to APF's word, Painknowledge.com misrepresented that opioid therapy for chronic
pain would lead to _improvements_in_patients' ability to function. Specifically, in 2009 the website
instructed patients and prescribers that, with opioids, a patient's "level of function should improve"
and that patients "may find [they] are now able to participate in activities of daily living, such as work
and hobbies, that [they] were not able to enjoy when [their] pain was worse."
Painknondedge.com also deceptively minimized the risk of addiction by claiming that
"[p]eople who take opioids as prescribed usually do not become addicted." Painknowledge.com did not
157

stop there. It deceptively portrayed opioids as safe at high doses and also misleadingly omitted
serious risks, including the risks of addiction and death, from its description of the risks associated
with the use of opioids to treat chronic pain.
Endo was the sole funder of Painknowledge.com, and it continued to provide that
funding despite being aware of the website's misleading contents.
c) Exit Wounds
Finally, Endo also sponsored APF's publication and distribution of Exit Wounds, a
publication aimed at veterans that also contained a number of misleading statements about the risks,
benefits, and superiority of opioids to treat chronic pain. Exit Wounds was drafted by Derek
Mcginnis." Medical Writer X was frequently hired by a consulting Firm, Conrad & Associates LLC,
to write pro-opioid marketing pieces disguised as science. Medical Writer X's work was reviewed and
approved by drug company representatives, and he felt compelled to draft pieces that he admits
distorted the risks and benefits of chronic opioid therapy in order to meet the demands of his drug
company sponsors.
Exit Wounds is a textbook example of Medical Writer X's authorship on drug
companies' behalf. The book misrepresented the functional benefits of opioids by stating that opioid
medications "increase your level of functioning" (emphasis in original).
Exit Wounds also misrepresented that the risk of addiction associated with the use of
opioids to treat chronic pain was low. It claimed that "lliong experience with opioids shows that
people who are not predisposed to addiction are. very unlikely to become addicted to opioid pain
medications."
Finally, Exit Wounds misrepresented the safety profile of using opioids to treat chronic
pain by omitting key risks associated with their use. Specifically, it omitted warnings Of the risk of

158

interactions between opioids and benzodiazepines—a warning sufficiently important to be included
on Endo's FDA-required labels. Exit Wounds also contained a lengthy discussion of the dangers of
using alcohol to treat chronic pain but did not disclose dangers of mixing alcohol and opioids—a
particular risk for veterans.
As outlined above, Endo exercised dominance over APF and the projects it undertook
in an effort to promote the use of opioids to treat chronic pain. In addition, as outlined above,
Medical Writer X's work was being reviewed and approved by drug company representatives,
motivating him to draft pro-opioid propaganda masquerading as science. Combined, these factors
gave Endo considerable influence over the work of Medical Writer X and over APF. Further, by
paying to distribute Exit Wounds, Endo endorsed and approved its contents.
. Other Front Groups: FSMB, AAPM, and AGS
In addition to its involvement with APF, Endo worked closely with other third-party
Front Groups and KOLs to disseminate deceptive messages regarding the risks, benefits, and
superiority of opioids for the treatment of chronic pain. As with certain APF publications, Endo in
some instances used its sales force to directly distribute certain publications by these Front Groups
and KOLs, making those publications "labeling" within the meaning of 21 C.F.R.5 1.3(a).
In 2007, Endo sponsored FSMB's Responsible Opioid Prescribing, which in various ways
deceptively portrayed the risks, benefits, and superiority of opioids to treat chronic pain. Responsible
Opioid Prescribing was dra fte.d by "Dr. Fishman."
Endo spent $246,620 to help FSMB distribute Responsible Opioid Prescribing Endo
approved this book for distribution by its sales force. Based on the uniform and nationwide
character of Endo's marketing campaign, and the fact that Endo purchased these copies specifically
to distribute them, these copies were distributed to physicians nationwide, including physicians in
Lorain.
159

In December 2009, Endo also contracted with AGS to create a CME to promote the
2009 guidelines tided the Pharmacological Management of Persistent Pain in Older Persons with a $44,850
donation. These guidelines misleadingly claimed that "the risks [of addiction] are exceedingly low in
older patients with no current or past history of substance abuse," as the study supporting this
assertion did not analyze addiction rates by age. They also stated, falsely, that "[a]ll patients with
moderate to severe pain. . . should be considered for opioid therapy (low quality of evidence, strong
recommendation)" when in reality, opioid therapy was only an appropriate treatment for a subset of
those patients, as recognized by Endo's FDA-mandated labels.
AGS's grant request to Endo made explicit reference to the CME that Endo was
funding. Endo thus knew full well what content it was paying to distribute, and was in a position to
evaluate that content to ensure it was accurate, substantiated, and balanced before deciding whether
or not to invest in it. After having sponsored the AGS CME, Endo's internal documents indicate
that Endo's pharmaceutical sales representatives discussed the AGS guidelines with doctors during
individual sales visits.
Endo also worked with AAPM, which it viewed internally as "Industry Friendly," with
Endo advisors and speakers among its active members. Endo attended AAPM conferences, funded
its CMEs, and distributed its publications.
A talk written by Endo in 2009 and approved by Endo's Medical Affairs Review
Cornmitteetitled-The Role olOpana ER in the Management of chronic Pain, includes_a_slide titled Use of

Although they were given slightly different names by each Defendant, each Defendant employed a
committee that could review and approve materials for distribution. These committees included
representatives from all relevant departments within Defendants' organizations, including the legal,
compliance, medical affairs, and marketing departments. The task of these review committees was to
scrutinize the. marketing materials Defendants planned to distribute and to ensure that those materials
were scientifically accurate and legally sound. Tellingly, these committees were called to review only
materials that created a potential compliance issue for the company, an implicit recognition by
defendants that they ultimately would be responsible for the content under review.
143

160

Opioids is Recommended for Moderate to Severe Chronic Noncancer Pain. That slide cites the AAPM/APS
Guidelines, which contain a number of misstatements and omits their disclaimer regarding the lack of
supporting evidence. This talk dangerously misrepresented to doctors the force and utility of the 2009
Guidelines. Furthermore, Endo's internal documents indicate that pharmaceutical sales
representatives employed by Endo, Actavis, and Purdue discussed treatment guidelines with doctors
during individual sales visits.
Key Opinion Leaders and Misleading Science
Endo also sought to promote opioids for the treatment of chronic pain through the
use of key opinion leaders and biased, misleading science.
Endo's 2010 publication plan for Opana ER identified a corporate goal of making
' Opana ER the second-leading branded product for the treatment of moderate-to-severe chronic
pain (after OxyContin). Endo sought to achieve that goal by providing "clinical evidence for the use
of Opana ER in chronic low back pain and osteoarthritis," and subsequently successfully had articles
on this topic published.'"
In the years that followed, Endo sponsored articles authored by Endo consultants and
Endo employees, which argued that the metabolic pathways utilized by Opana ER, compared with
other opioids, were less likely to result in drug interactions in elderly low back and osteoarthritis pain
patients. In 2010, Endo directed its publication manager to reach out to a list of consultants

" These studies suffered from the limitations common to the opioid literature—and worse. None of
the comparison trials lasted longer than three weeks. Endo also commissioned a six-month, open label
trial during which a full quarter of the patients failed to find a stable dose, and 17% of patients
discontinued, citing intolerable effects. In open label trials, subjects know which drug they are taking;
such trials are not as rigorous as double-blind, controlled studies in which neither the patients nor the
examiners know which drugs the patients are taking.
1

161

conducting an ongoing Endo-funded study, to assess their willingness to respond to an article* that
Endo believed emphasized the risk of death from opioids, "without fl fair balance."146
Endo's reliance on flawed, biased research is also evident in its 2012 marketing
materials and strategic plans. A 2012 Opana ER slide deck for Endo's speakers bureaus—on which
these recruited physician speakers were trained and to which they were required to adhere—
misrepresented that the drug had low abuse potential and suggested that as many as one-quarter of
the adult population could be candidates for opioid therapy. Although the FDA requires such
speaker slide decks to reflect a "fair, balance" of information on benefits and risks, Endo's slides
reflected one-sided and deeply biased information. The presentation's 28 literature citations were
largely to "data on file" with the company, posters, and research funded by, or otherwise connected
to, Endo. Endo's speakers relayed the information in these slides to audiences that were unaware of
the skewed science on which the information was based.
A 2012 Opana ER Strategic Platform Review suffered from similar defects. Only a
small number of the endnote referenced in the document, which it cited to indicate "no gap" in
scientific evidence for particular claims, were to national-level journals. Many were published in
lesser or dated journals, and written or directly financially supported by opioid manufacturers. Where
the strategy document did cite independent, peer-reviewed research, it did so out of context. For
example, it cited a 2008 review article on opioid efficacy for several claims, including that "treatment
of chronic pain reduces pain and improves functionality," but it ignored the article's overall focus on
the lack of consistent effectiveness of opioids in reducing pain and improving functional status.147

145 Susan Okie, A Flood of Opioids, a Rising Tide of Deaths, 363 New Engl. J. Med. 1981 (2010),
finding that opioid overdose deaths and opioid prescriptions both increased by roughly 10-fold from
1990 to 2007.
146 Endo did manage to get a letter written by three of those researchers, which was not published.
147 Andrea M. Trescot et al., Opioids in the management of non-cancer pain: an Update of American
Society of the Interventional Pain Physicians, Pain Physician 2008 Opioids Special Issue, 11:S5-S62.

162

Notwithstanding Endo's. reliance upon dubious or cherry-picked science, in an Opana
ER brand strategy plan it internally acknowledged the continuing need for a significant investment in
clinical data to support comparative effectiveness. Endo also cited a lack of "head-to-head data" as a
barrier to greater share acquisition, and the "lack of differentiation data" as a challenge to addressing
the "#1 Key Issue" of product differentiation. This acknowledged lack of support did not stop
Endo from directing its sales representatives to tell prescribers that its drugs were less likely to be
abused or be addictive than other opioids.
Endo also worked with various KOLs to disseminate various misleading statements
about chronic opioid therapy. For example, Endo distributed a patient education pamphlet edited by
KOL Dr. Russell Portenoy titled Understandingyour Pain: Taking Oral Opioid Analgesics. This pamphlet
deceptively minimized the risks of addiction by stating that "[a]ddicts take opioids for other reasons
[than pain relief], such as unbearable emotional problems," implying that patients who are taking
opioids for pain are not at risk of addiction.
Understanding your Pain: Taking Oral Opioid Analgesics also misleadingly omitted any
description of the increased risks posed by higher doses of opioid medication. Instead, in a Q&A
format, the pamphlet asked "[i]f I take the opioid now, will it work later when I really need it?" and
responded that "[t]he dose can be increased... [y]ou won't 'run out' of pain relief."
Dr. Portenoy received research support, consulting fees, and honoraria from Endo for
editing-Understanding .Your-Pain and other projects.
Understanding Your Pain was available on Endo's website during the time period of this
Complaint and was intended to reach City prescribers.

163

Endo similarly distributed a book written by Dr. Lynn Webster titled Avoiding Opioid
Abuse While Managing Pain, which stated that in the face of signs of aberrant behavior, increasing the
dose "in most cases. . . should be the clinician's first response."
A slide from an Opana ER business plan contemplated distribution of the book as
part of Endo's efforts to "[i]ncrease the breadth and depth of the OPANA ER prescriber base via
targeted promotion and educational programs." The slide indicates that the book would be
particularly effective "for [the] PCP audience" and instructed "[s]ales representatives [to] deliver[ the
book] to participating health care professionals." The slide, shown below, demonstrates Endo's
express incorporation of this book by a KOL into its marketing strategy:

11., nrirti:
., rs.,0,

.;1:s. -1
•., 1 2 .!;pii ...,s:t i qii
.

.IJj,

r! !-4-41"
.- .11,5tle:kle,

.
axe ir.

6 -:,Al

,

.. 1
!! 1,4!1=-3'f.:r44..- ., " i-..-W: 1

-o

14:4
--t,"
e

,
$ VrTNNINII?.. ,., Kri:i 000,Kri,

,:. 3 ' ,-11 F ,71
Increase tho breadth end
depth of lho OPANA ER ...

Ij

Filo° co n
4,4,.
_it
re0 Ma I
i
0 pLAii 00 tin

is

S"

1

..ci.

J.

e
44
• I V

at

15

?I q

d

I

4 0;10 0

ktI

.It

fti1iFJJ ]1

1 ,-.:4.;.
;.

....

"1...2.r, .

A.. , Id 'it
'17 :IF IliM4 'PIE
.gy

.

1 t
4
, ,

r

vi

.

s • i•L .4-Ik ....
. I
,.• ilIN.:0•.! k! ffibtrphiiiirmiels.
:
AVOidEll ,
..
.t.t 's.
A 1
el fl tyt

:.,,.
-,•

.
7,,,

!e 4A n
1-

Pr?
'1
ki
* 0.
11
cm91 r .0
iiiiiii
nikkir' i
4•0 SaI&fPS
tat,v a1ell
''
, 1_
Profesiôia
....,

oducational programs

11j

.1.

:.. rt) :thtf•-

:

7,-,

:il,
7 1
0 . trlA . —.1-7 , 13;11.Pritligle '' Afia
!1
- Accolcorafir7g Our Growth "

'4

•

532. Endo Documents indicate that, around 2007, the company purchased at least 50,000
copies of the book for distribution. Internal Endo documents Demonstrate that the book had been
approved for distribution by Endo's sales force, and that Endo had fewer than 8,000 copies on hand
in March of 2013. Based on the nationwide and uniform character of Endo's marketing, and the
book's approval for distribution, this book was available to and was intended to reach prescribers.
164

c. Endo's Deceptive Statements to City Prescribers and Patients
Endo also directed the dissemination of the misstatements described above to City
patients and prescribers, including through its sales force, speakers bureaus, CMEs, and the
Painknowledge.ann web site.
Consistent with their training, Endo's sales representatives delivered all of these
deceptive messages to City prescribers.
Endo also directed misleading marketing to City prescribers and patients through the
APF/NIPC materials it sponsored, reviewed, and approved. For example, Endo hired a New Yorkbased KOL to deliver a CME titled Managing Persistent Pain in the Older Patient on April 27, 2010. As
described above, this CME misrepresented the prevalence of addiction in older patients and made
misleading claims that chronic opioid therapy would improve patients' ability to function. An email
invitation to the event and other NIPC programs was sent to "all healthcare professionals" in APF's
database.
The significant response to Painknowledge.corn also indicates that those websites were
viewed by City prescribers, who were then exposed to the site's misleading information regarding the
effect of opioids on patients' ability to function and the deceptive portrayal of the risks of opioids.
As of September 14, 2010, Painknowledge.com had 10,426 registrants, 86,881 visits, 60,010 visitors, and
364,241 page views. Upon information and belief, based on the site's nationwide availability, among

the site's visitors were City patients -and .prescribers _who_were_then_exposed_to_the_site's_misleading
information regarding the effect of opioids on patients' ability to function and the deceptive
portrayal of the risks of opioids.
Endo knew that the harms from its deceptive marketing would be felt in Lorain. It
saw workers' compensation programs as a lucrative opportunity, and it promoted the use of opioids
for chronic pain arising from work-related injuries, like chronic lower back pain. Endo developed
165

plans to "[d]rive demand for access through the employer audience by highlighting cost of disease
and productivity loss in those with pain; [with a] specific focus on high-risk employers and
employees." In 2007, Endo planned to reach 5,000 workers' compensation carriers to ensure that
Opana ER would be covered under disability insurance plans. Endo knew or should have known
that claims for its opioids would be paid for by the City's workers' compensation program.
4. Janssen
Janssen promoted its branded opioids, including Duragesic, Nucynta, and Nucynta
ER, through its sales representatives and a particularly active speakers program. Deceptive messages
regarding low addiction risk and low prevalence of withdrawal symptoms were a foundation of this
marketing campaign. Janssen also conveyed other misrepresentations including that its opioids could
safely be prescribed at higher doses and were safer than alternatives such as NSAIDs.
Janssen supplemented these efforts with its own unbranded website, as well as thirdparty publications and a Front Group website, to promote opioids for the treatment of chronic pain.
These materials likewise made deceptive claims about addiction risk, safety at higher doses, and the
safety of alternative treatments. They also claimed that opioid treatment would result in functional
improvement, and further masked the risk of addiction by promoting the concept of
pseudoaddiction.
Based on the highly coordinated and uniform nature of Janssen's marketing, Janssen
conveyed_these_deceptiVe_messages to City prescribers. The materials that Janssen generated in
collaboration with third-parties also were distributed or made available in Lorain. Janssen distributed
these messages, or facilitated their distribution, in Lorain with the intent that City prescribers and/or
consumers would rely on them in choosing to use opioids to treat chronic pain.

166

a. Janssen's Deceptive Direct Marketing
Janssen joined the other Defendants in propagating deceptive branded marketing that
falsely minimized the risks and overstated the benefits associated with the long-term use of opioids
to treat chronic pain. Like the other Defendants, Janssen sales representatives visited targeted
physicians to deliver sales messages that were developed centrally and deployed identically across the
country. These sales representatives were critical in transmitting Janssen's marketing strategies and
talking points to individual prescribers. In 2011, at the peak of its effort to promote Nucynta ER,
Janssen spent more than $90 million on detailing.
Janssen's designs to increase sales through deceptive marketing are apparent on the
face of its marketing plans. For example, although Janssen knew that there was no credible scientific
evidence establishing that addiction rates were low among patients who used opioids to treat chronic
pain, its Nucynta Business Plans indicated that one of the "drivers" to sell more Nucynta among
primary care physicians was the "[1]ow perceived addiction and/or abuse potential" associated with
the drug. However, there is no evidence that Nucynta is any less addictive or prone to abuse than
other opioids, or that the risk of addiction or abuse is low. Similarly, Janssen knew that there were
severe symptoms associated with opioid withdrawal including, severe anxiety, nausea, vomiting,
1
hallucinations, and delirium, yet Janssen touted the ease with which patients could come off opioids.
i. Janssen's Deceptive Sales Training
Janssen's sales force was compensated based on the number of Nucynta prescriptions
written in each sales representative's territory. Janssen encouraged these sales representatives to
maximize sales of Nucynta and meet their sales targets by relying on the false and misleading
statements described above.
For example, Janssen's sales force was trained to trivialize addiction risk. A June 2009
Nucynta training module warns that physicians are reluctant to prescribe controlled substances like
167

Nuycnta because of their fear of addicting patients, but this reluctance is unfounded because "the
risks . . are [actually] much smaller than commonly believed." Janssen also encouraged its sales
force to misrepresent the prevalence of withdrawal symptoms associated with Nucynta. A Janssen
sales training PowerPoint titled "Selling Nucynta ER and Nucynta" indicates that the "low incidence
of opioid withdrawal symptoms" is a "core message" for its sales force. The message was touted at
Janssen's Pain District Hub Meetings, in which Janssen periodically gathered its sales force
personnel to discuss sales strategy.
545. This "core message" of a lack of withdrawal symptoms runs throughout Janssen's
sales training materials. For example, Janssen's "Licensed to Sell" Facilitator's Guide instructs those
conducting Janssen sales trainings to evaluate trainees, in part, on whether they remembered that
"[w]ithdrawal symptoms after abrupt cessation of treatment with NUCYNTA ER were mild or
moderate in nature, occurring in 11.8% and 2% of patients, respectively" and whether they were able
to "accurately convey" this "core message." Janssen further claimed in 2008 that "low incidence of
opioid withdrawal symptoms" was an advantage of the tapentado molecule.
546.. Similarly, a Nucynta Clinical Studies Facilitator's Guide instructs individuals training
Janssen's sales representatives to ask trainees to describe a "key point"—that "83% of patients
reported no withdrawal symptoms after abruptly stopping treatment without initiating alternative
therapy"—"as though he/he is discussing it with a physician."
This misrepresentation regarding withdrawal was one of the key messages Janssen
imparted to employees in the "Retail ST 101 Training" delivered to Nucynta sales representatives.
Indeed, training modules between 2009 and 2011 instruct training attendees that
"most patients [who discontinued taking Nucynta] experienced no withdrawal symptoms" and "[n]o
patients experienced moderately severe or severe withdrawal symptoms."

168

During the very time Janssen was instructing its sales force to trivialize the risks of
addiction and withdrawal associated with the use of Nucynta to treat chronic pain, it knew or should
have known, that significant numbers of patients using opioids to treat chronic pain experienced
issues with addiction. Janssen knew or should have known that its studies on withdrawal were
flawed and created a misleading impression of the rate of withdrawal symptoms and, as a result, the
risk of addiction.
The misleading messages and materials Janssen provided to its sales force were part of
a broader strategy to convince prescribers to use opioids to treat their patients' pain, irrespective of
the risks, benefits, and alternatives. This deception was national in scope and included Lorain.
Janssen's nationwide messages reached City prescribers in a number of ways, including through its
sales force in detailing visits, as well as through websites and ads. They were also delivered to City
prescribers by Janssen's paid speakers, who were required by Janssen policy and by FDA regulations
to stay true to Janssen's nationwide messaging.
Janssen's Deceptive Speakers Bureau Programs
Janssen did not stop at disseminating its misleading messages regarding chronic opioid
therapy through its sales force. It also hired speakers to promote its drugs and trained them to make
the very same misrepresentations made by its sales representatives.
jansse.n's speakers worked from slide decks—which they were required to present—
reflecting -the -deceptive-information—about-the -risks, -benefits, _ and _ superiority_ o f _opioids _outlined
above. For example, a March 2011 speaker's presentation titled A New Peripective For Moderate to Severe
Acute Pain Relief: A Focus on the Balance of Efficaty and Tolerabilii set out the following adverse events
associated with use of Nucynta: nausea, vomiting, constipation, diarrhea, dizziness, headache,
anxiety, restlessness, insomnia, myalgia, and bone pain. It completely omitted the risks of misuse,
abuse, addiction, hyperalgesia, hormonal dysfunction, decline in immune function, mental clouding,
169

confusion, and other known, serious risks associated with chronic opioid therapy. The presentation
also minimized the risks of withdrawal by stating that "more than 82% of subjects treated with
tapentadol IR reported no opioid withdrawal symptoms."
553. An August 2011 speaker presentation titled New Perspectives in the Management of Moderate
to Severe Chronic Pain contained the same misleading discussion of the risks associated with chronic
opioid therapy. It similarly minimized the risks of withdrawal by reporting that 86% of patients who
stopped taking Nucynta ER "abruptly without initiating alternative opioid therapy" reported no
withdrawal symptoms whatsoever. The same deceptive claims regarding risks of adverse events and
withdrawal appeared in a July 2012 speaker's presentation titled Powerful Pain Management: Proven
Across Multiple Acute and Chronic Pain Models.
These speakers presentations were part of Janssen's nationwide marketing efforts.
Upon information and belief, a number of these events were available to and were intended to reach
Lorain prescribers.
Janssen 's Deceptive Unbranded Advertising
Janssen was aware that its branded advertisements and speakers programs would face
regulatory scrutiny that would not apply to its unbranded materials, so Janssen also engaged in direct,
unbranded marketing.

—556.-- Orie such— unbranded- project was Janssen's- -creation—and - -maintenance -of-- Prescriberesponsibly.com (last updated July 2, 2015), a website aimed at prescribers and patients that claims
that concerns about opioid addiction are "overstated." A disclaimer at the bottom of the website states
that the "site is published by Janssen Pharmaceuticals, Inc., which is solely responsible for its content."
This website was available to and intended to reach City prescribers and patients.

170

b. Janssen's Deceptive Third-Party Statements
Janssen's efforts were not limited to directly making misrepresentations through its
sales force, speakers' bureau, and website. To avoid regulatory constraints and give its efforts an
appearance of independence and objectivity, Janssen obscured its involvement in certain marketing
activities by "collaborat[ind with key patient advocacy organizations" to release misleading
information about opioids.
i. AAPM and AGS — Finding iRelief: Pain Management for Older Adults
Janssen worked with AAPM and AGS to create a patient education guide entitled
Finding Relief Pain Management for Older Adults (2009). In doing so, Janssen contracted with a medical
publishing firm, Conrad & Associates, LLC. The content was drafted by a writer ("Medical Writer X")
hired by Conrad & Associates and funded by Janssen. These materials were reviewed, in detail, by
Janssen's medical-legal review team, which conducted detailed reviews and gave him editorial feedback
on his drafts, which was adopted in the published version.
Medical Writer X understood, without being explicitly told, that since his work was
funded and reviewed by Janssen, the materials he was writing should aim to promote the sale of more
drugs by overcoming the reluctance to prescribe or use opioids to treat chronic pain. He knew that the
publication was undertaken in connection with the launch of a new drug and was part of its
promotional effort. Medical Writer X knew of the drug company's sponsorship of the publication, and
he would go to the company's website to learn about the drug being promoted. He also knew that his
clients—including Janssen—would be most satisfied with his work if he emphasized that: (a) even
when used long-term, opioids are. safe and the risk of addiction is low; (b) opioids are effective for

171

s

chronic pain; and (c) opioids are under-prescribed because doctors are hesitant, confused, or face other
barriers.'"
560.

Finding Relief is rife with the deceptive content. FindingRelief misrepresents that opioids

increase function by featuring a man playing golf on the cover and listing examples of expected
functional improvement from opioids, like sleeping through the night, returning to work, recreation,
sex, walking, and climbing stairs. The guide states as a "fact" that "opioids may make it easier for
people to live normally" (emphasis in the original). The functional claims contained in Finding Relief are
textbook examples of Defendants' use of third parties to disseminate messages the FDA would not
allow them to say themselves. Compare, e.g.:
Branded Advertisement That Triggers an
FDA Warning Letter (2008)'49
Improvement in Daily Activities Includes:
Walking on a flat surface
Standing or sitting
Climbing stairs
Getting in and out of bed or bath
Ability to perform domestic duties
with:
Seemingly Independent Publication: "Finding Relief: Pain
Management for Older Adults"
(Final Authority, Janssen 2009):
Your recovery will be measured by how well you reach functional
goals such as
Sleeping without waking from pain
- • --Walking-more; or with less pain — - —
Climbing stairs with less pain
medical Writer X now acknowledges that the lists of adverse effects from chronic opioid use in the
publications he authored, which excluded respiratory depression, overdose, and death and minimized
addiction, were, "ridiculous" and "prime examples" of leaving out facts that the pharmaceutical
company sponsors and KOLs knew at the time were true. His writings repeatedly described the risk of
addiction as low. Medical Writer X stated that he understood that the goal was to promote opioids and,
as a result, discussing addiction would be "counterproductive."
349 This advertisement drew an FDA Warning Letter dated March 24, 2008. Though the advertisement
was by drug company King, it is used here to demonstrate the types of claims that the FDA regarded
as unsupported.
148

172

Returning to work
Enjoying recreational activities
Having sex
Sleeping in your own bed
FindingRelief also trivialized the risks of addiction describing as a "myth" that opioids
are addictive, and asserting as fact that Imjany studies show that opioids are rarely addictive when used
properly for the management of chronic pain."
Finding Relief further misrepresented that opioids were safe at high doses by listing dose
limitations as "disadvantages" of other pain medicines and omitting any discussion of risks from
increased doses of opioids. The publication also falsely claimed that it is a "myth" that "opioid doses
have to be bigger over time."
Finally, Finding Relief deceptively overstated the risks associated with alternative forms
of treatment. It juxtaposed the advantages and disadvantages of NSAIDs on one page, with the
"myths/facts" of opioids on the facing page. The disadvantages of NSAIDs are described as involving
"stomach upset or bleeding," "kidney or liver damage if taken at high doses or for a long time,"
"adverse reactions in people with asthma," and "increase[d] . . .risk of heart attack and stroke."
Conversely, the only adverse effects of opioids listed by Finding Relief are "upset stomach or
sleepiness," which the brochure claims will go away, and constipation. The guide never mentions
addiction, overdose, abuse, or other serious side effects of opioids.
Janssen was not merely a passive sponsor of Finding Relief Instead, Janssen exercised
control over its content and provided substantial assistance to AGS and AAPM to distribute it. A
"Copy Review Approval Form" dated October 22, 2008 indicates that key personnel from janssen's
Advertising & Promotion, Legal, Health Care Compliance, Medical Affairs, Medical Communications,
and Regulatory Departments reviewed and approved Finding Relief All six Janssen personnel approving

173

the publication checked the box on the approval form indicating that Finding Refrefwas "Approved
With Changes." After the publication was modified at the behest of Janssen personnel, Janssen paid to
have its sales force distribute 50,000 copies of Finding Relief throughout the nation. Thus, Finding Relief
is considered labeling for Janssen's opioids within the meaning of 21 C.F.R. 5 1.3(a).
AAPM purchased and distributed copies of Finding Relief to all of its members,
including those who reside in Lorain.
Finding Reliefs author, Medical Writer X, later said it was clear, from his position at the
intersection of science and marketing, that the money paid by drug companies to the KOLs and
professional and patient organizations with which he worked, distorted the information provided to
doctors and patients regarding opioids. The money behind these and many other "educational" efforts
also, he believes, led to a widespread lack of skepticism on the part of leading physicians about the
hazards of opioids. It also led these physicians to accept, without adequate scrutiny, published studies
that, while being cited to support the safety of opioids, were, in fact, of such poor methodological
quality that they would not normally be accepted as adequate scientific evidence.
AGS — Misleading Medical Education
AGS's CME promoting the 2009
Janssen also worked with AGS on another project—:
guidelines for the Pharmacological Management of Persistent Pain in Older Persons. These guidelines falsely
claimed that "the risks [of addiction] are exceedingly low in older patients with no current or past
history of substance abuse" although the study supporting this assertion did not analyze addiction rates
by age. They also stated falsely, that "[a]ll patients with moderate to severe pain . . . should be
considered for opioid therapy (low quality of evidence, strong recommendation)." Based on Janssen's
control over AGS's Finding Relief, Janssen also would have exercised control over this project as well.

174

m.

APF

Janssen also worked with APF to carry out its deceptive marketing campaign.
Documents obtained from one of Janssen's public relations firms, Ketchum, indicate that Janssen and
the firm enlisted APF as part of an effort to "draft media materials and execute [a] launch plan" for
Janssen's drugs at an upcoming meeting of the AAPM. Janssen also drew on APF publications to
corroborate claims in its own marketing materials and its sales training. Janssen personnel participated
in a March 2011 call with APF's "Corporate Roundtable," in which they worked with APF and drug
company personnel to develop strategies to promote chronic opioid therapy. APF personnel spoke
with Janssen employees who "shar[ed] expertise from within their company for [a] public awareness
campaign."
Their joint work on the "Corporate Roundtable" demonstrates the close collaboration
between Janssen and APF in promoting opioids for the treatment of chronic pain. APF President Will
Rowe also reached out to Defendants—including Janssen— rather than his own staff, to identify
potential authors to answer a 2011 article critical of opioids that had been published in the Archives of
Internal Medicine. Additional examples of APF's collaboration with Janssen are laid out below:
a) Let's Talk Pain
Most prominent among these efforts was the Let's Talk Pain website. Janssen
sponsored Let's Talk Pain in 2009, acting in conjunction with APF, American Academy of Pain
Management, and American Society of Pain Management Nursing. Janssen financed and
orchestrated the participation of these groups in the website.
Janssen exercised substantial control over the content. of the Let's Talk Pain website.
Janssen's internal communications always referred to Let's Talk Pain as promoting tapentadol, the
molecule it sold as Nucynta and Nucynta ER. Janssen regarded Let's Talk Pain and another website—
Presaibereiponsiqy.com— as integral parts of Nucynta's launch:
175

PR Communication Plan for NUCY
UNMET NEEDS

•

PAIN LEADRSHIP

FFERENTlATE'

, ,STRONG EFFICACY AND
AVG LIn AB LE GI TOLE RABI Ur/ PR OFIL

Promote clinical evidence for NUCYNTA ER with data-driven press releases (Q2-Q4)
PDUFA Date with various media using KOLs (Top-tier media, Social media) (Q3)

REUTERS 4
VUSA
TODAY

PAINMEINCINENEWS

A mriimq
:,,ii;
Patin 4C11

goCietzt
—

gi..,r4 et,
EAMILV PI IVMCIANS
1111 ... ;144.1 44•• •0•44.4

Art exhibit featuring art from chronic pain patients at HCP-focused PAINWeek(Sep)
Other (Blogger briefing in Q3, Testimonial of chronic pain patients, Online media
briefing on pain management)

Smart Moves, Smart choices
Prescribe responsibly
Let's talk Pain

Janssen documents also reveal that Janssen personnel viewed APF and AAPM as
"coalition members" in the fight to increase market share.
To this end, Janssen and APF entered into a partnership to "keep pain and the
importance of responsible pain management top of mind" among prescribers and patients. They
agreed to work to reach "target audiences" that included patients, pain management physicians,
s- -ieThf die roles-Janssen-assumed- in- the process- was-to "[r]eview,
primary care physicians, arid KOL- .-01
provide counsel on, and approve materials." Janssen did in fact review and approve material for the
Let's Talk Pain website, as evidenced by the following edits by a Janssen executive to the transcript of a
video that was to appear on the site:

176

edit out of video

Shaffer: This Is what has allowed me to continue to function. It is what
allowed me to have somewhat of a normal life, is the opioids.
But, enJ I J.
11e

t,ut I
tfrWK, but

el SU I IOW

that III tktdbdtieUL

d

y, II

6 Anderson: Afitt-Ittefrie-ifete. The job of the physician that's prescribing

The final version of the video on Let's Talk Pain omitted the stricken language above.
This review and approval authority extended to the Let's Talk Pain website. Emails
between Janssen personnel and a consultant indicate that, even though the L.,et's Talk Pain website was
hosted by APF, Janssen had approval rights over its content. Moreover, emails describing Janssen's
review and approval rights related to Let's Talk Pain indicate that this right extended to "major changes
and video additions."
As a 2009 Janssen memo conceded, "Nile Let's Talk Pain Coalition is sponsored by
PriCara, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc." and "Pie Coalition and Pricara
maintain editorial control of all Let's Talk Pain materials and publications" (emphasis added).
A 2011 Consulting Agreement between Janssen and one of APF's employees, relating
to the dissemination of national survey data, demonstrates the near-total control Janssen was
empowered to exercise over APF in connection with the Let's Talk Pain website, including requiring
APF to circulate and post Janssen's promotional content. The agreement required APF to "participate
in status-calls betweenjanssen, APF, AAPM,ASPMN, - an& Ketchum as requested by Janssen" and
required APF to "respond to requests to schedule status calls within 48 hours of the request"
(emphasis in original). APF also was required to "Iir]eview and provide feedback to media materials,
including a press release, pitch email, a key messages document, and social media messages, within
one week of receipt" (emphasis in original).

177

The agreement further required APF to provide a summary of the survey results in
APF's PAIN MONITOR e-newsletter, post a link to the survey results on APF's Facebook page, send
out tweets related to the survey, serve as a spokesperson available for media interviews, "[s]hare
information with any media contacts with whom APF has existing relationships to promote the
announcement of the national survey findings," identify at least two patient spokespersons to talk
about the survey data, and include the survey results in "any future APF materials, as appropriate."
Tellingly, "any ideas made or conceived by [APF] in connection with or during the performance" of
the Agreement "shall be the property of, and belong to, [anssen]."
Janssen also exercised its control over Let's Talk Pain. Janssen was able to update the
Let's Talk Pain website to describe its corporate restructuring and Janssen personnel asserted their
control over "video additions" by reviewing and editing the interview touting the functional benefits of
opioids. Given its editorial control over the content of Let's Talk Pain, Janssen was, at all times, fully
aware of—and fully involved in shaping—the websitc's content's°
Let's Talk Pain contained a number of misrepresentations.
For example, Let's Talk Pain misrepresented that the use of opioids for the treatment of
chronic pain would lead to patients regaining functionality. Let's Talk Pain featured an interview
claiming that opioids were what allowed a patient to "continue to function." This video is still available
today on YouTube.com and is accessible to Lorain prescribers and patients.
In 2009, Let's Talk Pain also promoted the concept of "pseudoaddiction," which it
described as patient behaviors that may occur when pain is under-treated" but differs "from true
addiction because such behaviors can be resolved with effective pain management" (emphasis added).
Let's Talk Pain was available to, and was intended to, reach Lorain patients and prescribers.
It bears noting that Janssen does not publicly identify its role in creating Let's Talk Pain's content.
Instead, Let's Talk Pain represents that "coalition members" develop the content that appears on the
website and lists Janssen as the only sponsor of that coalition.

15°

178

b) Exit Wounds
Janssen also engaged in other promotional projects with and through APF. One such
project was the publication and distribution of Exit Wounds, which, as described above, deceptively
portrayed the risks, benefits, and superiority of opioids to treat chronic pain. Exit Wounds was drafted
by "Medical Writer X." It is fully representative of his work on behalf of drug companies.
Janssen gave APF substantial assistance in distributing Exit Wounds in Lorain and
throughout the nation by providing grant money and other resources.
c. Janssen's Deceptive Statements to Lorain Prescribers and Patients
Janssen also directed the misstatements described above to Lorain patients and
prescribers, including through CMEs, its sales force, and recruited physician speakers.
i. Janssen's Deceptive Medical Education Programs in Lorain
Janssen sponsored CMEs and talks attended by City prescribers.
Janssen's Deceptive Detailing Practices in Lorain
The experiences of specific prescribers confirm both that Janssen's national marketing
campaign included the misrepresentations, and that the company disseminated these same
misrepresentations to Lorain prescribers and consumers. In particular, these prescriber accounts reflect
that Janssen detailers claimed that Nucynta was "not an opioid" because it worked on an "alternate
receptor";151 claimed that Janssen's drugs would be less problematic for patients because they had antiabuse properties and were "steady state"; claimed that patients on Janssen's drugs were less susceptible
to withdrawal; omitted or minimized the risk of opioid addiction; claimed or implied that opioids were

151 The FDA-approved labels for both Nucynta and Nucynta ER describe the tapentadol molecule as
an "opioid agonist and a Schedule II controlled substance that can be abused in a manner similar to
other opioid agonists, legal or illicit."

179

safer than NSAIDs; and overstated the benefits of opioids, including by making claims of improved
function.
5. Purdue
Purdue. promoted its branded opioids—principally, Oxycontin, Butrans, and
Hysingla—and opioids generally in a campaign that consistently mischaracterized the risk of addiction
and made deceptive claims about functional improvement. Purdue did this through its sales force,
branded advertisements, promotional materials, and speakers, as well as a host of materials, produced
by its third-party partners, most prominently APP. Purdue's sales representatives and advertising also
misleadingly implied that OxyContin provides a full 12 hours of pain relief, and its allied Front Groups
and KOLs conveyed the additional deceptive messages about opioids' safety at higher doses, the safety
of alternative therapies, and the effectiveness of addiction screening tools.
Based on the highly coordinated and uniform nature of Purdue's marketing, Purdue
conveyed these deceptive messages to Lorain prescribers. The materials that Purdue generated in
collaboration with third parties also were distributed or made available in Lorain. Purdue distributed
these messages, or facilitated their distribution, in Lorain with the intent that Lorain prescribers and/or
consumers would rely on them in choosing to use opioids to treat chronic pain.
a. Purdue's Deceptive Direct Marketing
Like the other Defendants, Purdue directly disseminated deceptive branded and
unbranded marketing focused on minimizing the risks associated with the long-term use of opioids to
treat chronic pain. Purdue directed these messages to prescribers and consumers through its sales force
and branded advertisements.
Purdue engaged in in-person marketing to doctors in Lorain. Purdue had 250 sales
representatives in 2007, of whom 150 were devoted to promoting sales of OxyContin full time. Like
the other Defendants' detailers, Purdue sales representatives visited targeted physicians to deliver sales
180

messages that were developed centrally and deployed, identically, across the country. These sales
representatives were critical in delivering Purdue's marketing strategies and talking points to individual
prescribers.152 Indeed, Endo's internal documents indicate that pharmaceutical sales representatives
employed by Endo, Actavis, and Purdue discussed the AAPM/APS Guidelines, which as discussed
above deceptively concluded that the risk of addiction is manageable for patients regardless of past
abuse histories, with doctors during individual sales visits.
Purdue's spending on detailing reached its nadir in 2006 and 2007, as the company
faced civil and criminal charges for misbranding OxyContin. Since settling those charges in 2007,
however, Purdue has sharply increased its quarterly spending on promotion through its sales force,
from under $5 million in 2007 to more than $30 million by the end of 2014.
Purdue also marketed its drugs through branded advertisements which relied on,
among other deceptive tactics, misleading statements about the efficacy and onset of OxyContin.
Purdue marketed its drug as effective for 12 hours while knowing that these claims were misleading
because, for many patients, the pain relief lasted for as little as eight hours, leading to end-of-dose
failure and withdrawal symptoms. This prompted doctors to prescribe, or patients to take, higher or
more frequent doses of opioids, all of which increased the risk of abuse and addiction.
For example, a "Conversion and Titration Guide" submitted to the FDA and
distributed to physicians by Purdue, prominently referred to "Q1 2h OxyContin Tablets," meaning that

each_tablet_was.intended_to "offer_._._._every-twelve-hour dosing." Other marketing materials directed
at physicians and disseminated across the country in 2006 touted that OxyContin's "12-hour
AcroContin Delivery System" was "designed to deliver oxycodone over 12 hours," which offered

But Purdue did not stop there. It also tracked around 1,800 doctors whose prescribing patterns
demonstrated a probability that they were writing opioid prescriptions for addicts and drug dealers.
Purdue kept the program secret for nine years and, when it finally did report information about these
suspicious doctors to law enforcement authorities, it only did so with respect to 8% of them.
152

181

patients "life with Q1214 relief." Those same marketing materials included a timeline graphic with little
white paper pill cups at "8AM" and, further down the line, at "8PM" only. They also proclaimed that
OxyContin provided "Consistent Plasma Levels Over 12 Hours" and set forth charts demonstrating
absorption measured on a logarithmic scale, which fraudulently made it appear that levels of
oxycodone in the bloodstream slowly taper over a 12-hour time period.
Purdue advertisements that ran in 2005 and 2006 issues of the Journal of Pain depicted a
sample prescription for OxyContin with "Q12h" handwritten. Another advertisement Purdue ran in
2005 in the Journal of Pain touted OxyContin's "Q12h dosing convenience" and displayed two paper
dosing cups, one labeled "8 am" and one labeled "8 pm," implying that OxyContin is effective for the
12-hour period between 8 a.m. and 8 p.m. Similar ads appeared in the March 2005 Clinical Journal of
Pain.
Purdue continued to include prominent 12-hour dosing instructions in its branded
advertising, such as in a 2012 Conversion and Titration Guide, which states: "Because each patient's
treatment is personal / Individualize the dose / Q12h OxyContin Tablets."
As outlined above, however, these statements are misleading because they fail to make
clear that a 12-hour dose does not equate to 12 hours of pain relief. Nevertheless, Purdue's direct
marketing materials have misleadingly claimed OxyContin offers 12 hour "dosing convenience."
As described below, these deceptive statements regarding the efficacy of OxyContin
were also carried into Lorain by•Purdue's detailers.
Purdue's direct marketing materials also misrepresented that opioids would help
patients regain functionality and make it easier for them to conduct everyday tasks like walking,
working, and exercising.
For example, in 2012, Purdue disseminated a mailer to doctors titled "Pain vignettes."
These "vignettes" consisted of case studies describing patients with pain conditions that persisted over
182

a span of several months. One such patient, "Paul," is described as a "54-year-old writer with
osteoarthritis of the hands," and the vignettes imply that an OxyContin prescription will help him
work. None of these ads, however, disclosed the truth—that there is no evidence that opioids improve
patients' lives and ability to function and that there was substantial evidence to the contrary.
Some of the greatest weapons in Purdue's arsenal, however, were unbranded materials
it directly funded and authored. These were in addition to the unbranded materials, described below,
that Purdue channeled through third parties.
In 2011, Purdue published a prescriber and law enforcement education pamphlet titled
Providing Relief Preventing Abuse, which deceptively portrayed the signs—and therefore the prevalence—
of addiction. However, Purdue knew, as described above, that OxyContin was used non-medically by
injection less than less than 17% of the time. Yet, Providing Relief PreventingAbuse prominently listed
side effects of injection like skin popping and track marks as "Indications of Possible Drug Abuse"—
downplaying much More prevalent signs of addiction associated with OxyContin use such as asking
for early refills, making it seem as if addiction only occurs when opioids are taken illicitly.
Providing Relief Preventing Abuse also deceptively camouflaged the risk of addiction by
falsely supporting the idea that drug-seeking behavior could, in fact, be a sign of "pseudoaddiction"
rather than addiction itself. Specifically, it noted that the concept of "pseudoaddiction" had "emerged
in the literature" to describe "[drug-seeking behaviors] in patients who have pain that has not been
effectively_treated." Nowhere in Providing Relief _Preventing Abuse did Purdue disclose the lack of
scientific evidence justifying the concept of "pseudoaddiction," or that the phrase itself had been
coined by a Purdue vice president.
Providing Relief Preventing Abuse was available nationally and was intended to reach
Lorain prescribers. As described below, the deceptive statements in Providing Relief Preventing Abuse

183

regarding addiction were the very same messages Purdue directed at Lorain prescribers through its
sales force.
Purdue also disseminated misrepresentations through two of its unbranded websites, In
the Face of Pain and Partners Against Pain.
Consistent with Purdue's efforts to portray opioid treatment as "essential" for the
proper treatment of chronic pain and label skepticism related to chronic opioid therapy as an
"inadequate understanding" that leads to "inadequate pain control," In the Face of Pain criticized policies
that limited access to opioids as being "at odds with best medical practices" and encouraged patients to
be "persistent" in finding doctors who will treat their pain. This was meant to imply that patients
should keep looking until they find a doctor willing to prescribe opioids.
In the Face of Pain was available nationally and was intended to reach Lorain prescribers.
Purdue also used its unbranded website Partners Against Pain to promote the same
deceptive messages regarding risk of addiction and delivered by its sales representatives. On this
website, Purdue posted Clinical Issues in Opioid Prescribing, a pamphlet that was copyrighted in 2005.
Purdue also distributed a hard-copy version of this pamphlet. Clinical Issues in Opioid Prescribing claimed
that "illicit drug use and deception" were not indicia of addiction, but rather indications that a patient's
pain was undertreated. The publication indicated that Ip]seudoaddiction can be distinguished from
true addiction in that the behavior's resolve when the pain is effectively treated." In other words,
Purdue suggested that when faced with drug-seeking behavior from their patients, doctors should
prescribe more opioids—turning evidence of addiction into an excuse to sell and prescribe even more
drugs.
Purdue's misleading messages and materials were part of a broader strategy to convince
prescribers to use opioids to treat their patients' pain, irrespective of the risks, benefits, and
alternatives. This deception was national in scope and included Lorain. As described above, Purdue's
184

nationwide messages would have reached City prescribers in a number of ways. For example, they
were carried into Lorain by Purdue's sales representatives during detailing visits as well as made
available to Lorain patients and prescribers through websites and ads, including ads in prominent
medical journals. They would have also been delivered to Lorain prescribers by Purdue's paid speakers,
who were required by Purdue policy and by FDA regulations to stay true to Purdue's nationwide
messaging.
b. Purdue's Deceptive Third-Party Statements
Purdue's efforts were not limited to making misrepresentations through its own sales
force and its own branded and unbranded marketing materials. As described above, Purdue knew that
regulatory constraints restricted what it could say about its drugs through direct marketing. For this
reason, like the other Defendants, Purdue enlisted the help of third parties to release misleading
information about opioids. The most prominent of these was APF.
i. APF
a) Purdue's Control of APF
Purdue exercised considerable control over APF, which published and disseminated
many of the most blatant falsehoods regarding chronic opioid therapy. Their relationship, and several
of the APF publications, is described in detail below.
Purdue exercised its dominance over APF over many projects and years. Purdue was
.APF's second-biggest donor, with donations totaling $1.7 million. Purdue informed APF that the grant
money reflected Purdue's effort to "strategically align its investments in nonprofit organizations that
share [its] business interests," making clear that Purdue's funding depended upon APF continuing to
support Purdue's business interests. Indeed, Purdue personnel participated in a March 2011 call with
APF's "Corporate Roundtable," where they suggested that APF "[s]end ambassadors to talk about
pain within companies and hospitals." Thus, Purdue suggested what role APF could play that would
185

complement its own marketing efforts. On that call, Purdue personnel also committed to provide APF
with a list of "industry state advocates" who could help promote chronic opioid therapy, individuals
and groups that, upon information and belief, APF reached out to. Purdue personnel remained in
constant contact with their counterparts at APF.
This alignment of interests was expressed most forcefully in the fact that Purdue hired
APF to provide consulting services on its marketing initiatives. Purdue and APF entered into a
"Master Consulting Services" Agreement on September 14, 2011. That agreement gave Purdue
substantial rights to control APF's work related to a specific promotional project. Moreover, based on
the assignment of particular Purdue "contacts" for each project and APF's periodic reporting on their
progress, the agreement enabled Purdue to be regularly aware of the misrepresentations APF was
disseminating regarding the use of opioids to treat chronic pain in connection with that project. The
agreement gave Purdue—but not APF—the right to end the project (and, thus, APF's funding) for any
reason. This agreement demonstrates APF's lack of independence and its willingness to surrender to
Purdue's control and commercial interests, which would have carried across all of APF's work.
Purdue used this agreement to conduct work with APF on the Partners Against Pain
website. Partners Against Pain is a Purdue-branded site, and Purdue holds the copyright.
However, its ability to deploy APF on this project illustrates the degree of control
Purdue exercised over APF. In 2011, it hired an APF employee to consult on the Partners Against Pain
rollout, to orchestrate the media campaign associated with the launch of certain content on the
website, and to make public appearances promoting the website along with a celebrity spokesperson;
paying this consultant $7,500 in fees and expenses for 26 hours of work. Purdue would require this
consultant to "to discuss and rehearse the delivery of [Purdue's] campaign messages" and Purdue
committed that "[m]essage points will be provided to [the] Consultant in advance and discussed on [a

186

planned] call." At all times, decisions regarding the final content on the Partners Against Pain website
were "at the sole discretion of Purdue."
APF also volunteered to supply one of its staff (a medical doctor or a nurse
practitioner) to assist Purdue as a consultant and spokesperson for the launch of one of Purdue's
opioid-related projects, Understanding & Coping with Lower Back Pain, which appeared on Partners Against
Pain. One of the consultants was APF's paid employee, Mickie Brown. The consultant's services would
be provided in return for a $10,000 consulting fee for APF and $1,500 in honoraria for the
spokesperson. All documents used by the consultant in her media appearances would be reviewed and
approved by individuals working for Purdue. It was not until later that APF worried about "how
Purdue sees this program fitting in with our [existing] grant request."
Given the financial and reputational incentives associated with assisting Purdue in this
project and the direct contractual relationship and editorial oversight, APF personnel were acting
under Purdue's control at all relevant times with respect to Partners Against Pain.
APF acquiesced to Purdue's frequent requests that APF provide "patient
representatives" for Partners against Pain. Moreover, APF staff and board members and Front Groups
ACPA and AAPM, among others (such as Dr. Webster), appear on Inthfaceoftmin.com as "Voices of
•

Hope"—"champions passionate about making a difference in the lives of people who live with pain"
and providing "inspiration and encouragement" to pain patients. APF also contracted with Purdue for
a project on hack pain in which, among other things, it provided a patient representative who agreed to
attend a Purdue-run "media training session."
According to an Assurance of Voluntary Compliance ("AVC") entered into between
the New York Attorney General and Purdue Pharma on August 19, 2015, Inthefaceoffiain.com received
251,648 page views between March 2014 and March 2015. With the exception of one document linked
to the website, Inthefaceoffiain.com makes no mention of opioid abuse or addiction. Purdue's copyright
187

appears at the bottom of each page of the website, indicating its ownership and control of its content.
There is no other indication that 11 of the individuals who provided testimonials on Intbeface0ain.com
received payments, according to the AVC, of $231,000 for their participation in speakers programs,
advisory meetings and travel costs between 2008 and 2013. The New York Attorney General found
Purdue's failure to disclose its financial connections with these individuals had the potential to mislead
consumers.
Nowhere was Purdue's influence over APF so pronounced as it was with the APF's
"Pain Care Forum" ("PCF"). PCF was and continues to be run not by APF, but by Defendant
Purdue's in-house lobbyist, Burt Rosen. As described by a former drug company employee, Rosen
exercised full control of PCF, telling them "what do do and how to do it." This control allowed him,
in turn, to run APF as, in accordance with Rosen's thinking, "PCF was APF, which was Purdue." PCF
meets regularly in-person and via teleconference, and shares information through an email listserv.
In 2011, APF and another third-party advocacy group, the Center for Practical
Bioethics, were considering working together on a project. Having reviewed a draft document
provided by the Center for Practical Bioethics, the APF employee cautioned that "this effort will be in
cooperation with the efforts of the PCF" and acknowledged that "I know you have reservations about
the PCF and pharma involvement, but I do believe working with them and keeping the lines of
communications open is important." The Center for Practical Bioethics CEO responded by indicating
some confusion about whom to speak with, asking "Ns Burt Rosen the official leader" and reflecting
what other sources have confirmed.
In 2007, the PCF Education Subgroup, consisting of drug companies Purdue and
Alpharma, and Front Groups APF and ACPA (self-described as "industry-funded" groups), developed
a plan to address a perceived "lack of coordination" among the industry and pro-opioid professional
and patient organizations. PCF members agreed to develop simplified "key" messages" to use for
188

public education purposes. Their messages were reflected in programs like NIPC's Let's Talk Pain (put
together by Endo and APF), and Purdue's In the Face of Pain.
When the FDA required drug companies to fund CMEs related to opioid risks in
accordance with its 2009 REMS, Purdue, along with these Front Groups, worked through the PCF to
ensure that, although it was mandatory for drug companies to fund these CMEs, it would not be
mandatory for prescribers to attend them. A survey was circulated among Defendants Endo, Janssen,
and Purdue, which predicted that the rates of doctors who would prescribe opioids for chronic pain
would fall by 13% if more than four hours of mandatory patient education were required in
accordance with the REMS. With a push from PCF, acting under Purdue's direction, the CMEs were
not made mandatory for prescribers.
.APF showed its indebtedness to Purdue and its willingness to serve Purdue's corporate
agenda when APF chairman Dr. James N. Campbell testified on the company's behalf at a July 2007
hearing before the Senate Judiciary Committee "evaluating the propriety and adequacy of the
OxyContin criminal setdement."153 Despite its ostensible role as a patient advocacy organization, APF
was willing to overlook substantial evidence—resulting in the jailing of Purdue executives—that
Purdue blatantly, despite its clear knowledge to the contrary, told physicians and patients that
OxyContin was "rarely" addictive and less addictive than other opioids. Like Purdue, APF ignored the
truth about opioids and parroted Purdue's deceptive messaging. Dr. Campbell testified that addiction
was a "rare problem" for chronic pain patients and asserted: "Mhe scientific evidence suggests that
addiction to opioids prescribed by legitimate chronic non-cancer pain patients without prior histories
Evaluating the Proprieg and Adequag of the 0.xycontin Criminal Settlement: Before the S. Comm.
On the Judiciary, 110th Cong. 46-50, 110-116 (2007) (statements of Dr. James Campbell, Chairman,
APF). Purdue was also able to exert control over APF through its relationships with APF's leadership.
Purdue-sponsored KOI,s Russell Portenoy and Scott Fishman chaired APF's board. Another APF
board member, Perry Fine, also received consulting fees from Purdue. APF board member Lisa Weiss
was an employee of a public relations firm that worked for both Purdue and APF. Weiss, in her dual
capacity, helped vet the content of the Purdue-sponsored Poligmaker's Guide, which is described below.
189

of substance abuse using the medication as directed is rare. Furthermore, no causal effect has been
demonstrated between the marketing of OxyContin and the abuse and diversion of the drug." There
was, and is, no scientific support for those statements.
APF President Will Rowe reached out to Defendants—including Purdue—rather than
his own staff, to identify potential authors to answer a 2011 article critical of opioids that had been
published in the Archives of Internal Medicine..
Purdue's control over APF shaped, and was demonstrated by specific APF, pro-opioid
publications. These publications had no basis in science and were driven (and can only be explained)
by the commercial interest of pharmaceutical companies—Purdue chief among them.
b) A Policymaker's Guide
Purdue provided significant funding to and was involved with APF's creation and
dissemination of A Poligmaker's Guide to Understanding Pain & Its Management; originally published in
2011 and still available online. A Policymaker's Guide to Understanding Pain & Its Management
misrepresented that there were studies showing that the use of opioids for the long-term treatment of
chronic pain could improve patients' ability to function.
Specifically, A Poligmaker's Guide to Understanding Pain ef7 Its Management claimed that
"multiple clinical studies" demonstrated that "opioids . . . are effective in improving [d]aily function,
[p]sychological health [and] [o]verall health-related quality of life for people with chronic pain" and
implied that these studies established that the use of opioids long-term led to functional improvement.
The study cited in support of this claim specifically noted that there were no studies demonstrating the
safety of opioids long-term and noted that "[f]or functional outcomes, the other [studied] analgesics
were significantly more effective than were opioids."154

154 Andrea D. Furlan et al., Opioids for chronic noncancer pain: a meta-ana/ysis of effectiveness and
side effects, 174(11) Can. Med. Ass'n J. 1589 (2006).

190

The Poligmaker's Guide also misrepresented the risk of addiction. It claimed that pain
had generally been "undertreated" due to Imlisconceptions about opioid addiction" and that "less
than 1% of children treated with opioids become addicted."
Moreover, the Poligmaker's Guide attempted to distract doctors from their patients'
drug-seeking behavior by labeling it as "pseudoaddiction," which, according to the guide, "describes
patient behaviors that may occur when pain is undertreated." Like Partners Against Pain, A Poligmaker's
Guide noted that "[p]seudo-addiction can be distinguished from true addiction in that this behavior
ceases when pain is effectively treated." The similarity between these messages regarding
"pseudoaddiction" highlights the common, concerted effort behind Purdue's deceptive statements.
The Poligmaker's Guide further misrepresented the safety of increasing doses of opioids
and deceptively minimized the risk of withdrawal. For example, the Poligmaker's Guide claimed that
"[s]ymptoms of physical dependence" on opioids in long-term patients "can often be ameliorated by
gradually decreasing the dose of medication during discontinuation" while omitting the significant
hardship that often accompanies cessation of use. Similarly, the Poligmaker's Guide taught that even
indefinite dose escalations are "sometimes necessary" to reach adequate levels of pain relief while
completely omitting the safety risks associated with increased doses.
Purdue provided substantial monetary assistance toward the creation and dissemination
of the Poligmaker's Guide, providing APF with $26,000 in grant money. APF ultimately disseminated
Poligmaker's-Guide-on -behalf of_Defendants, including Purdue. Purdue was not only kept abreast of the
content of the guide as it was being developed, but, based on the periodic reports APF provided to
Purdue regarding its progress on thc Poligmaker's Guide, had editorial input of the contents.
The Poligmaker's Guide was posted online and was available to, and intended to reach
Lorain prescribers and consumers. As described below, the deceptive statements in Poligmaker's Guide

.191

regarding addiction and functionality were the very same messages Purdue directed at Lorain through
its own sales force.
c) Treatment Options: A Guide for People Living with Pain
Purdue's partnership with APP did not end with the Poligmaker's Guide. Purdue also
substantially assisted APP by beginning to sponsor Treatment Options: A Guide for People Living with Pain
in 2007: Based on Purdue's control of other APF projects, Purdue also would have exercised control
over Treatment Options.
Treatment Options is rife with misrepresentations regarding the safety and efficacy of
opioids. For example, Treatment Options misrepresents that the long-term use of opioids to treat chronic
pain could help patients function in their daily lives by stating that, when used properly, opioids "give
[pain patients] a quality of life [they] deserve."
Further, as outlined above, Treatment Options claims that addiction is rare and that,
when it does occur, it involves unauthorized dose escalations, patients who receive opioids from
multiple doctors, or theft, painting a narrow and misleading portrait of opioid addiction.
Treatment Options also promotes the use of opioids to treat long-term chronic pain by
denigrating alternate treatments, most particularly NSAIDs. Treatment Options notes that NSAIDs can
be dangerous at high doses and inflates the number of deaths associated with NSAID use,
distinguishing opioids as having less risk. According to Treatment Options, NSAIDs are different from
opioids because opioids have "no ceiling dose." This lack of ceiling is considered to be beneficial as
some patients "need" larger doses of painkillers than they are currently prescribed. Treatment Options
warns that the risks associated with NSAID use increased if NSAIDs are "taken for more than a
period of months," but deceptively omits any similar warning about the risks associated with the longterm use of opioids.

192

Treatment Options was posted online and remains online today. It was available to and
intended to reach Lorain prescribers and patients. As described below, the deceptive statements in
Treatment Options regarding addiction and functionality echo the messages Purdue directed at Lorain
through its own sales force. Purdue also engaged in other promotional projects with and through APP.
One such project was the publication and distribution of Exit Wounds, which, as described above,
deceptively portrayed the risks, benefits, and superiority of opioids to treat chronic pain.
Purdue provided APF with substantial assistance in distributing Exit Wounds in Lorain
and throughout the nation by providing grant money and other resources.
Purdue's Work with Other Third Par* Front Groups and KO.Ls
Purdue also provided other third-party Front Groups with substantial assistance in
issuing misleading statements regarding the risks, benefits, and superiority of opioids for the long-term
treatment of chronic pain.
a) FSMB — Responsible Opioid Prescribing
In 2007, Purdue sponsored FSMB's Responsible Opioid Prescribing, which, as described
above, deceptively portrayed the risks, benefits, and superiority of opioids to treat chronic pain.
Responsible Opioid Prescribing also was drafted by Dr. Scott Fishman.
Purdue spent $150,000 to help FSMB distribute Responsible Opioid Prescribing. The book
was distributed nationally, and was available to and intended to reach prescribers in Lorain.

193

b) AGS — Pharmacological Management of Persistent Pain in Older
Persons
Along with Janssen, Purdue worked with the AGS on a CME to promote the 2009
guidelines for the Pharmacological Management of Persistent Pain in Older Persons. As discussed above, these
guidelines falsely claimed that "the risks [of addiction] are exceedingly low in older patients with no
current or past history of substance abuse" as the study supporting this assertion did not analyze
addiction rates by age. They also stated, falsely, that 141 patients with moderate to severe pain should
be considered for opioid therapy (low quality of evidence, strong recommendation)."
Controversy surrounding earlier versions of AGS guidelines had taught AGS that
accepting money directly from drug companies to fund the guidelines' development could lead to
allegations of bias and "the appearance of conflict." Accordingly, AGS endeavored to eliminate "the
root cause of that flack" by turning down commercial support to produce the 2009 Guidelines. Having
determined that its veneer of independence would be tarnished if it accepted drug company money to
create the content, AGS decided to develop the guidelines itself and turn to the drug companies for
funding to distribute the pro-drug company content once it had been created. As explained by AGS
personnel, it was AGS's "strategy that we will take commercial support to disseminate [the 2009
Guidelines] if such support is forthcoming." AGS knew that it would be difficult to find such support
unless the report was viewed favorably by opioid makers.
AGS sought and obtained grants from 12;ndo and Purdue to distribute Pharmacological
Management of Persistent Pain in Older Persons. As a result, the publication was distributed nationally, and
was available to and was intended to reach Lorain prescribers. Indeed, internal documents of another
Defendant, Endo, indicate that pharmaceutical sales representatives employed by Purdue discussed

194

treatment guidelines that minimized the risk of addiction to opioids with doctors during individual
sales visits.155
c) Chronic Pain Management and Opioid Use: Easing Fears, Managing Risks,
and Improving Outcomes
646. Purdue sponsored a 2012 CME program called Chronic Pain Management and Opioid Use:
Easing Fears, Managing Risks, and Improving Outcomes. The presentation deceptively instructed doctors
that, through the use of screening tools, more frequent refills, and other techniques, high-risk patients
showing signs of addictive behavior could be treated with opioids. This CME was presented at various
locations in the United States and is available online today.
d) Managing Patient's Opioid Use: Balancing the Need and Risk
647. Purdue also sponsored a 2011 CME taught by KOL Lynn Webster via webinar titled
Managing Patient's Opioid Use: Balancing the Need and Risk. This presentation also deceptively instructed
prescribers that screening tools, patient agreements, and urine test prevented "overuse of
prescriptions" and "overdose deaths." At the time, Dr. Webster was receiving significant funding from
Purdue. Versions of Dr. Webster's Opioid Risk Tool appear on, or are linked to, websites run by
Purdue (and other Defendants). The webinar was available to and was intended to reach Lorain
prescribers.
e) Path of the Patient, Managing Chronic Pain in Younger Adults at Risk for
Abuse
648. Purdue also sponsored a CME program entitled Path of the Patient, Managing Chronic Pain
in Younger Adults at Risk . for Abuse. Path of the Patient was devoted entirely to the message of treating

As described above, Purdue also provided substantial support for the AAPM/APS guidelines. The
1997 AAPM and APS consensus statement The Use of Opioids for the Treatment of Chronic Pain was
authored by one of its paid speakers, and 14 out of 21 panel members who drafted the AAPM/APS
Guidelines received support from Defendants Janssen, Cephalon, Endo, and Purdue.
155

195

chronic pain with opioids. Although the program purported to instruct a treating physician how to
manage chronic pain in younger adults at risk for abuse, it does no such thing.
This "educational" program, addressing treatment of a population known to be
particularly susceptible to opioid addiction, presents none of the alternative treatment options
available, only discussing treatment of chronic pain with opioids.
In a role-play in Path of the Patient, a patient who suffers from back pain tells his doctor
that he is taking twice as many hydrocodone pills as directed. The doctor reports that the pharmacy
called him because of the patient's early refills. The patient has a history of drug and alcohol abuse.
Despite these facts, the narrator notes that, because of a condition known as "pseudoaddiction," the
doctor should not assume his patient is addicted even if he persistently asks for a specific drug, seems
desperate, hoards medicine, or "overindulges in unapproved escalating doses." The doctor in the roleplay treats this patient by prescribing a high-dose, long-acting opioid. This CME was available online
and was intended to reach City prescribers.
f) Overview of Management Options
Purdue also sponsored a CME titled Overview of Management Options issued by the
American Medical Association in 2003, 2007, and 2013 (the latter of which is still available for CME
credit). The CME was edited by KOL Russel Portcnoy, among others. It deceptively instructs
physicians that NSAIDs and other drugs, but not opioids, are unsafe at high doses. In reality, the data
indicates that patients on high doses of opioids are more likely to experience adverse outcomes than
patients on lower doses of the drugs. Dr. Portenoy received research support, consulting fees, and
honoraria from Purdue (among others), and was a paid Purdue consultant. This CME was presented
online in the United States and was available to Lorain prescribers.

196

Purdue's Misleading Science
Purdue also misrepresented the risks associated with long-term opioid use by
promoting scientific studies in a deceptive way. In 1998, Purdue funded two articles by Dr. Lawrence
Robbins, which showed that between 8% and 13% of the patients he studied became addicted to
opioids—a troubling statistic for Purdue, whose market, and marketing, depended upon the claim that
opioids were rarely addictive.156 Purdue had these articles placed in headache-specific journals where
they would be less likely to be encountered by pain specialists or general practitioners. The first of
these articles has been cited a mere 16 times; the second does not even appear on Google scholar. Five
years later, Purdue funded a study of OxyContin in diabetic neuropathy patients, which was published
in 2003. Notwithstanding the fact that that Purdue-funded studies, testing Purdue's own drugs, had
previously indicated that addiction rates were between 8% and 13%, Purdue's 2003 article reached
back to the 1980 Porter-Jick Letter to support its claim that OxyContin was not commonly addictive.
This article was placed in a prominent pain journal and has been cited 487 times. m While this article
was drafted over a decade ago, it continues to be relied upon to further the misrepresentations that
opioids are not addictive.
a) Purdue's Deceptive Statements to Lorain Prescribers and Patients
Purdue directed the dissemination of the misstatements described above to Lorain
patients and prescribers through the Front Groups, KOLs, and publications described above, as well
as through its sales force in Lorain and through advertisements in prominent medical journals. The
deceptive statements distributed through each of these channels reflect a common theme of

Lawrence Robbins, Long-Acting Opioids for Severe Chronic Daily Headache, 10(2) Headache Q. 135
(1999); Lawrence Robbins, Works in Progress: Oxycodone CR, a Long-Acting Opioid, for Severe
Chronic Daily Headache, 19 Headache Q. 305 (1999).
157 C. Peter N. Watson et al., Controlled-release oxycodone relieves neuropathic pain: a randomied
controlled trial I painful diabetic neuropathy, 105 Pain 71 (2003).
156

197

misrepresenting the benefits of Purdue's opioids, unfairly portraying the risks of addiction associated
with their use, and deceptively implying that they would improve patients' ability to function.
The deceptive message that OxyContin provided 12 hours of pain relief was not only
available to, and intended to, reach Lorain prescribers through nationally circulated advertising, but
was also carried directly into the offices of Lorain doctors by Purdue's sales representatives.
Likewise, the deceptive messages minimizing addiction were not only directed at Lorain
patients and prescribers through the publications circulated above, but were also disseminated directly
by Purdue's sales force.
Purdue also used its sales force to disseminate misleading statements about the ability
of opioids to improve functionality.
Purdue's national marketing campaign included the misrepresentations described above
and the company disseminated these same misrepresentations to Lorain prescribers and consumers. In
particular, these prescriber accounts reflect that Purdue detailers omitted or minimized the risk of
opioid addiction; claimed that Purdue's drugs would be less problematic for patients because they had
extended release mechanisms, were tamper proof, and were "steady state"; claimed that OxyContin
would provide 12 hours of pain relief; represented that screening tools could help manage the risk of
addiction; minimized the symptoms of withdrawal; claimed or implied that opioids were safer than
NSAIDs; and overstated the benefits of opioids, including by making claims of improved function.
658. A survey of a sample_of.physicians„who_reported_the.messages that they retained from
detailing visits and other promotional activity, documented that Purdue sales representatives from at
least between 2008 and 2012, promoted OxyContin as being effective for a full 12 hours. Purdue sales
representatives also promoted OxyContin as improving patients' sleep (an unsubstantiated functional
improvement) to an orthopedic surgeon in 2006 and to a physicians' assistant in 2013. Purdue sales
representatives also told internists that the reformulation of OxyContin prevented illegal drug use and
198

that the formulation was 'less addicting," rather than being harder to adulterate. In 2011 Purdue sales
representatives also claimed that the sustained-release property of OxyContin reduced patient "buzz,"
which is neither based on scientific evidence nor true.
The same survey indicated that Purdue sales representatives promoted its Schedule III
opioid Butrans as having low or little abuse potential.
F. The Result of Defendants' Fraudulent Scheme
Through their direct promotional efforts, along with those of the third-party Front
Groups and KOLs they assisted and controlled, and whose seemingly objective materials they
distributed, Defendants accomplished exactly what they set out to do: change the institutional and
public perception of the risk-benefit assessments and standard of care for treating patients with
chronic pain. As a result, Lorain doctors began prescribing opioids long-term to treat chronic pain—
something most would never have considered prior to Defendants' campaign.
But for the misleading information disseminated by Defendants, doctors would not, in
most instances, have prescribed opioids as medically necessary or reasonably required to address
chronic pain.
1. Defendants' ,Fraudulent and Deceptive Marketing of Opioids Directly Caused
Harm to Lorain.
In the first instance, the City was damaged directly, through its payments of false claims
for chronic opioid therapy by (a) partially funding a medical insurance plan for its employees and (b) its
workers' compensation program.
Defendants' marketing of opioids caused health care providers to prescribe, and the
City, through partially funding a medical insurance plan for its employees and its workers'
compensation program, to pay for prescriptions of opioids to treat chronic pain. Because of
Defendants' unbranded marketing, health care providers wrote and the City paid for prescriptions of

199

opioids for chronic pain that were filled not only with their drugs, but with opioids sold by other
manufacturers. All of these prescriptions were caused by Defendants' fraudulent marketing and
therefore all of them constitute false claims. Because, as laid out below, the City is obligated to cover
medically necessary and reasonably required care, it had no choice but to pay for these false and
fraudulent claims.
The fact that the City would pay for these ineligible prescriptions was both the
foreseeable and intended consequence of Defendants' fraudulent marketing scheme. Defendants set
out to change the medical and general consensus supporting chronic opioid therapy with the intention
of encouraging doctors to prescribe, and government payors such as Lorain, to pay for long-term
prescriptions of opioids to treat chronic pain despite the absence of genuine evidence supporting
chronic opioid therapy and the contrary evidence regarding the significant risks and limited benefits
from long-term use of opioids.
a. Increase in Opioid Prescribing Nationally
Defendants' scheme to change the medical consensus regarding opioid therapy for
chronic pain was greatly successful. During the year 2000, outpatient retail pharmacies filled 174
million prescriptions for opioids nationwide, rising to 257 million in 2009.158
Opioid prescriptions increased even as the percentage of patients visiting doctors for
pain remained constant. A study of 7.8 million doctor visits between 2000 and 2010 found that opioid
_prescriptions increased from 11.3% to_19.6% of visits, as NSAID and acetaminophen prescriptions fell
_
_
from 38% to 29%, driven primarily by the decline of NSAID use.159

158 Office of National Drug Control Policy, 2011 Prescription Drug Abuse Prevention Plan, Whitehouse.gov, (no
longer available on whitehouse.gov ), https://obamawhitehouse.archives.goviondcp/prescription-drug-abusel
159 Matthew Daubresse et al., Ambulafiny Diagnosis and Treatment of Nonmalignant Pain in tbe United
States, 2000-2010, 51(10) Med. Care 870 (2013).

200

Approximately 20% of the population between the ages of 30 and 44 and nearly 30%
of the population over 45 have used opioids. Indeed, "[o]pioids are the most common means of
treatment for chronic pain."16° From 1980 to 2000, opioid prescriptions for chronic pain visits
doubled. This resulted not from an epidemic of pain, but an epidemic of prescribing. A study of 7.8
million doctor visits found that prescribing for pain increased by 73% between 2000 and 2010—even
though the number of office visits in which patients complained of pain did not change and
prescribing of non-opioid pain medications decreased For back pain alone—one of the most
common chronic pain conditions—the percentage of patients prescribed opioids increased from 19%
to 29% between 1999 and 2010, even as the use of NSAIDs or acetaminophen declined and referrals
to physical therapy remained steady—and climbing.
This increase corresponds with, and was caused by, Defendants' massive marketing
push. As reflected in the chart below, according to data obtained from a marketing research company,
Defendants' spending on marketing of opioids nationwide—including all of the drugs at issue here—
stood at more than $20 million per quarter and $91 million annually in 2000. By 2011, that figure hit its
peak of more than $70 million per quarter and $288 million annually, an increase of more than threefold. By 2014, the figures dropped to roughly $45 million per quarter and $182 million annually, as
Defendants confronted increasing concerns regarding opioid addiction, abuse, and diversion, and as
Janssen, which accounted for most of the spending reduction, prepared to sell its U.S. rights to
Nucynta and Nucynta ER. Even so, Defendants still spent double what they had spent in 2000 on
opioid marketing.

160

Deborah Grady et al., Opioids for Chronic Pain, 171(16) Arch. Intern. Med. 1426 ( 2011).
201

All Promotional Spending on Non-Injectable Oploielsl?y All Defendants (Quarterly)
I 580,000,000
1 •
370;0Ql:000

.

ssc000poo

; $30,000,000

i $40 coo ow

; 530,000,000

; 520,090m0

810,000,000

$0 •
;1 2 3

4...1

2 3 4 1 2 34 1 2.3 4 1.2 3 41 2 3 4:1 2 3 4.1.2 3 4,1 2 3 .4-1 3 3 4 1 2 3 4 1..2 341 2 3 4.1 2 3 4 1 2.3 4..1

2009 2001 2002 2033 2004 2005 ; 2008 2007 2008 2009 .2010 2011 ; 2012 2013 2014 .2015

Defendants' opioid detailing visits to individual doctors made up the largest
component of this spending, with total detailing expenditures more than doubling between 2000 and
2014 to $168 million annually.
Each Defendant's promotional spending reflects its participation in this marketing
blitz. Between 2000 and 2011:
Actavis's promotional spending, which was virtually nonexistent in the 20042008 period, began to sharply rise 2009. The third quarter of 2011 saw a peak
of $3 million at one point in 2011 and nearly $7 million for the year, as shown
below:

202

+

-•

All Promotional Spending on Non-Injectable Oploic4 by Defendant Actavis (Quarterly)
$0090,000

•
!1 2 3 4.1 2.3 41 2 3 41 2 3 4 , 1 2 3 43 2 3 41 2.3 4.!3 2 3 4•1 2 3 4:1 2 3 4 1 2 3 4:1 2 3.4:1 2 3 4 1 2 3 4.1 2 3 4 , 1

2014 2015
2012 2013 .
; 2000 2031 2002 2003 ' 2004 2005 2006 i 2007 2003 2009 2030. 2011

Cephalon's quarterly spending steadily climbed from below $1 million in 2000 to
more than $4 million in 2014 (and more than $13 million for the year), including
a peak, coinciding with the launch of Fentora, of nearly $9 million half way
through 2007 (and more than $27 million for the year), as shown below:

. 203

All Promotional Spending on Non-Injectable Opioids by Defendant Cephalon (Quarterly)
S10.000000

$9.000,000

$8,0ciAMO

57.000,000

sc000sica

55,000,000

$4,000,000

;
$3,000,000

52,030,000

$1,000,000

12 3 4.1 2 3 41 2 3 41 2 34 1 23 41 2 3 4,1 .2 3 4 1 2 3412 34 1 2 3 4.1 23 41 2 3 4 , 1 23 4:1 2 3 4!1 2 3 4..3 i
2000 2031 2002 2003 2004 2005 2006 2007 2002 2009 2010 2011 ; 2012 2013 2014 2015

Endo 's quarterly spending went from the $2 million to $4 million range from
2000 to 2004 to more than $10 million following the launch of Opana ER in
mid-2006 (and more than $38 million for the year in 2007) and more than $8
million coinciding with the launch of a reformulated version in 2012 (and nearly
$34 million for the year):

204

Promotion0 Spending on Non-Injectable Oploids bV.DefepOnPlOP (Quarterly)
$12,003,000 •

510,000,000

$8-

56,000,000

$4;000,000

5?,000,0.00 • •

.
.
.
. .
60
1 2 3 4 1.2 3 4 1 2 3 4-1 2 3 43 2 3 4 1 2 3 41 2 3 41 2 3 4 1 2 3 4:1 2 3 4.1 2 3 4 1.2 3 4•1 2 3 4,1 2 3 4:3 2 3 41
2000 2001 .2902 2003 2004 2005 2006 2007 2008 2009. 2010 2011 2012 2013 2014 2015

Janssen's quarterly spending dramatically rose from less than $5 million in 2000
to more than $30 million in 2011, coinciding with the launch of Nucynta ER
(with yearly spending at $142 million for 2011) as shown below:

205

. .

,

All Promotional Spending on Non-Injectable Opioids by Defendant Janssen (Quarterly)
54$,000,000

5i0.000 .000
.
.

$3$P00,000

530,000,000

525,000.000

$29!
090,909

$15,000,000

510,000,000 -

; $6,000k000

$0 .
1 2 34 1 2 3 4 1 2 34 12 3 4 1 2 A 4'1 2 34 1 2 3 4 1 2 3 4 1 2 3- 4'1. 2 3 41 23 4 1 23 412 34 1 23 4:1 2 3 4,1
.2005 2006 2007 2008 ! nop 2010 2011 8012 2013 2014 2015 .
.2000 2001 2002 2003 2004

Purdue's quarterly spending notably decreased from 2000 to 2007, as Purdue
came under investigation by the Department of Justice, but then spiked to above
$25 million in 2011 (for a total of $110 million that year), and continued to rise,
as shown below:

206

,

All promotional Spending on Non-Injectable Dolt)Ids by Defendant Purdue (Quarterly)
5so,opopoo

$45000000

1.$49,000,000

, $35,000,000

$30,000.000

$25,000,000

i 520.000,000'

1.s15.000.00*

$10,000,000

55,000000
$0
:1 2 3 4:1 2 3 4:1 2 3 4 1 2 3 4:1 2 3 4.1 2 3 4 2 3 4 1 2 3 4 1 2 3 4.1 2 3 4.1 2 3, 4 1 2 3 4.1 2 3 4 1 2 3 4 1 2 3 4 1
2006 2005 2010 2011 2012 2013 2014 2015 '
2000 2001 2002 2003 2004 2005 2006 200'

a. The City's Increased Spending on Opioids
As a direct and foreseeable consequence of Defendants' wrongful conduct, Plaintiff
has been required to spend significant dollars each year in its efforts to combat the public nuisance
created by Defendants' deceptive marketing campaign. Plaintiff has incurred, and continues to incur,
costs related to opioid addiction and abuse, including, but not limited to, health care costs, criminal
justice and victimization costs, social costs, and lost productivity costs. Defendants' misrepresentations
regarding the safety and efficacy of long-term opioid use proximately caused injury to Plaintiff and its
residents.

i. Defendants' Misrepresentations Were Material
Defendants' misrepresentations were material to, and influenced, the City's decisions to
pay claims for opioids for chronic pain (and, therefore, to bear its consequential costs in treating
overdose, addiction, and other side effects of opioid use). In the first instance, the City would not have
207

been presented with, or paid, claims for opioids that would not have been written but for Defendants'
fraudulent and deceptive marketing. Second, the City has demonstrated that Defendants' marketing is
material by taking further steps to ensure that the opioids are only prescribed and covered when
medically necessary or reasonably required.
As laid out above, Defendants' misrepresentations related to the City's requirement
that medical treatments be medically necessary or reasonably required — a condition of payment for
any medical treatment under the City's health plans and workers' Compensation program. But for
Defendants' fraudulent and deceptive marketing, prescribers would have accurately understood the
risks and benefits of opioids and would not have prescribed opioids where not medically necessary or
reasonably required to treat chronic pain. Misrepresentations as to, for example, whether patients were
likely to become addicted to the drug, would be able to resume life activities, and would experience
long-term relief were not minor or insubstantial matters, but the core of prescribers' decision-making.
It is the City's practice not to pay claims that are not medically necessary or reasonably
required. However, the City would not have known whether a prescriber had made an informed
judgment that a particular claim for opioids was medically necessary or reasonably required, or,
conversely had acted under the influence of Defendants' fraudulent and deceptive marketing. It is not
clear from the face of a claim whether: (1) the patient suffered from cancer or another terminal
condition, for example, where long-term prescribing was medically necessary or appropriate; or (2) the
prescriber was exposed to Defendants' marketing materials, treatment guidelines, or education
programs, or visited by a drug representative who engaged in affirmative misrepresentations or
omissions, for example.

208

. The Cio's Increased Costs Correlate mith Defendants' Promotion
The City's spending on opioids rose along with Defendants' spending to promote
opioids. That spending had a direct impact on opioid use (and its consequences in abuse, addiction,
and overdose) in Lorain.
It is also distressing (and a sign of further problems ahead) that the drop in opioid
prescribing beginning in 2014 has been accompanied by a corresponding increase in Defendants'
promotional spending, which is headed towards a new high, despite evidence of the grave toll that
opioids are taking on law enforcement, public health, and individual lives.
2. Defendants' Fraudulent and Deceptive Marketing of Opioids Directly Caused
Harm to Lorain Consumers.
a. Increased Opioid Use Has Led to an Increase in Opioid Abuse, Addiction, and
Death
Nationally, the sharp increase in opioid use has led directly to a dramatic increase in
opioid abuse, addiction, overdose, and death. Scientific evidence demonstrates a very strong
correlation between therapeutic exposure to opioid analgesics, as measured by prescriptions filled, and
opioid abuse. "Deaths from opioid overdose have risen steadily since 1990 in parallel with increasing
prescription of these drugs."161 Prescription opioid use contributed to 16,917 overdose deaths
nationally in 2011—more than twice as many deaths as heroin and cocaine combined; drug poisonings
now exceed motor vehicle accidents as a cause of death. More Americans have died from opioid
overdoses than from participation in the Vietnam War.
Contrary to Defendants' misrepresentations, most of the illicit use stems from prescribed
opioids; in 2011, 71% of people who abused prescription opioids got them through friends or
relatives", not from drug dealers or the internet. According to the CDC, the 80% of opioid patients

Deborah Grady et al., Opioids for Chronic Pain, 171(16) Arch. Intern. Med. 1426 ( 2011).

161

209

who take low-dose opioids from a single prescriber (in other words, who are not illicit users or
"doctor-shoppers") account for 20% of all prescription drug overdoses.
Death statistics represent only the tip of the iceberg. According to 2009 data, for every
overdose death that year, there were nine abuse treatment admissions, 30 emergency department visits
for opioid abuse or misuse, 118 people with abuse or addiction problems, and 795 non-medical users.
Nationally, there were more than 488,000 emergency room admissions for opioids other than heroin in
2008 (up from almost 173,000 in 2004).
Emergency room visits tied to opioid use likewise have sharply increased in Lorain.
Widespread opioid use and abuse in Lorain are problems even when they do not result
in injury or death. Opioid addiction is affecting residents of all ages, ethnicitics, and socio-economic
backgrounds in the City. Many addicts start with a legal opioid prescription—chronic back pain,
fibromyalgia, or even dental pain—and do not realize they are addicted until they cannot stop taking
the drugs.
These glaring omissions, described consistently by counselors and patients, mirror and
confirm Defendants' drug representatives' own widespread practice, as described above, of omitting
any discussion of addiction from their sales presentations to physicians or in their "educational"
materials.
b. Increased Opioid Use Has Increased Costs Related to Addiction Treatment
Lorain -has - opioid -treatment -programs, _ Substance_ Alternative _Clinics, _thatprovide a
comprehensive treatment program for persons addicted to heroin or other opioids.
In addition to intense counseling, many treatment programs prescribe additional drugs
to treat opioid addiction. Nationally, in 2012, nearly 8 billion prescriptions of the two drugs commonly
used to treat opioid addiction—buprenorphine/naloxone and naltrexone—were written and paid for.

210

Studies estimate the total medical and prescription costs of opioid addiction and diversion to public
and private healthcare payors to be $72.5 billion.
c. Increased Opioid Use Has Fueled An Illegal Secondary Market for Narcotics and
the Criminals Who Support It
Defendants' success in extending the market for opioids to new patients and chronic
conditions has created an abundance of drugs available for criminal use and fueled a new wave of
addiction, abuse, and injury. Defendants' scheme supplies both ends of the secondary market for
opioids—producing both the inventory of narcotics to sell and the addicts to buy them. One
researcher who has closely studied the public health consequences of opioids has found, not
surprisingly, that a "substantial increase in the nonmedical use of opioids is a predictable adverse effect
of substantial increases in the extent of prescriptive use."" It has been estimated that the majority of
the opioids that are abused come, directly or indirectly, through doctors' prescriptions.
A significant black market in prescription opioids also has arisen, not only creating and
supplying additional addicts, but fueling other criminal activities.
In addition, because heroin is cheaper than prescription painkillers, many prescription
opioid addicts migrate to heroin. Self-reported heroin use nearly doubled between 2007 and 2012,
from 373,000 to 669,000 individuals. In 2010, more than 3,000 people in the U.S. died from heroin
overdoses, also nearly double the rate in 2006. Nearly 80% of those who used heroin in the past year
had previously abused prescription opioids. Patients become addicted to opioids and then move on to
heroin because these prescription drugs are roughly four times more expensive than heroin on the
street. In the words of one federal DEA official, "Who would have ever thought in this country it
would be cheaper to buy heroin than pills . . . [t]hat is the reality we're facing."'

162 G. Caleb Alexander et al., Rethinking Opioid Prescribing to Protect Patient Safety and Public Health,
308(18) JAMA 1865 (2012).
163
Matt Pearce & Tina Susman, Philip Seymour Hoffman's death calls attention to rise in heroin use,

211

That reality holds true in Lorain. According to addiction programs, a typical course sees
addicts requesting more and more opioids from their doctors, who eventually cut them off. Many
addicts then doctor-shop for additional prescriptions, and when that source runs out, turn to the
streets to buy opioids illicitly. A significant number become heroin addicts. Addiction treatment
programs, whose patient populations vary, reported rates of patients who had switched from
prescription opioids to heroin ranging from half to 95%. Those addicts who do reach treatment
centers often do so when their health, jobs, families and relationships reach the breaking point, or after
turning to criminal activity such as prostitution and theft to sustain their addiction. Unfortunately, few
are successful in getting and staying clean; repeated relapse is common.
3. Defendants' Fraudulent Marketing Has Led to Record Profits
While the use of opioids has taken an enormous toll on Lorain and its residents,
Defendants have gained blockbuster profits. In 2012, health care providers wrote 259 million
prescriptions for opioid painkillers 164 —roughly one prescription per American adult. Opioids
generated $8 billion in revenue for drug companies just in 2010.
Financial information—where available—indicates that Defendants each experienced
a material increase in sales, revenue, and profits from the fraudulent, misleading, and unfair market
activities laid out above. Purdue's OxyContin sales alone increased from $45 million in 1996 to $3.1
billion in 2010. In 2010, Research Firm Frost & Sullivan projected an increase to $15.3 billion in
overall revenue from opioid sales by 2016.

L.A. Times, Feb. 3, 2014, http://articles.latimes.com/2014/ feb/03/nation/la-na-heroin-surge20140204.
164
Press Release, Center for Disease Control, Opioid painkiller prescribing varies widely among states: Where you
live makes a difference (July 1, 2014), https://www.cdc.govimedia/releases/2014/p0701-opioid-painkiller.html
212

4. Defendants Fraudulently Concealed Their Misrepresentations
At all times relevant to this Complaint, Defendants took steps to avoid detection of,
and fraudulently conceal, their deceptive marketing and conspiratorial behavior.
First, and most prominently. Defendants disguised their own roles in the deceptive
marketing of chronic opioid therapy by funding and working through patient advocacy and
professional front organizations and KOLs. Defendants purposefully hid behind these individuals and
organizations to avoid regulatory scrutiny and to prevent doctors and the public from discounting their
messages.
While Defendants were listed as sponsors of many of the publications described in this
Complaint, they never disclosed their role in shaping, editing, and exerting final approval over their
content. Defendants exerted their considerable influence on these promotional and "educational"
materials.
In addition to hiding their own role in generating the deceptive content, Defendants
manipulated their promotional materials and the scientific literature to make it appear as if they were
accurate, truthful, and supported by substantial scientific evidence. Defendants distorted the meaning
or import of studies they cited and offered them as evidence for propositions they did not actually
support. The true lack of support for Defendants' deceptive messages was not apparent to the medical
professionals who relied upon them in making treatment decisions, nor could they have been detected
by the City.
Thus, while the opioid epidemic was evident, Defendants, in furtherance of their
respective marketing strategies, intentionally concealed their own role in causing it. Defendants
successfully concealed from the medical community, patients, and health care payers facts sufficient to
arouse suspicion of the existence of claims that the City now asserts. The City was not alerted to the

213

existence and scope of Defendants industry-wide fraud and could not have acquired such knowledge
earlier through the exercise of reasonable diligence.
696. Through their public statements, marketing, and advertising, Defendants' deceptions
deprived the City of actual or presumptive knowledge of facts sufficient to put them on notice of
potential claims.
FIRST CAUSE OF ACTION
CONSUMER SALES PRACTICES
CHAPTER 1345 OHIO REVISED CODE
(AGAINST ALL DEFENDANTS)
Plaintiff incorporates the allegations within all prior paragraphs within this Complaint
as if they were fully set forth herein.
Defendants violated Chapter 1345. Of the Ohio Revised Code, because they engaged
unfair and deceptive acts or practices and/or unconscionable consumer sales acts and practices in this
state.
This Cause of Action is brought in the public interest under the Ohio Consumer Sales
Practices Act ("CSPA"), R.C. 1345.01, el seq., and seeks a declaratory judgment that Defendants have
violated the CSPA, an injunction enjoining Defendants' misrepresentations described in this
Complaint, restitution to the City who on behalf of consumers paid for opioid prescriptions for
chronic pain and therefore have been damaged by Defendants' conduct, and civil penalties. Between
2006-and-2016,-Ohio consumers spent over. $200. million, on Defendants' opioids.
The CSPA prohibits, in connection with consumer transactions, unfair, deceptive or
unconscionable consumer sales practices that mislead consumers about the nature of the, product they
are receiving. Specifically, the CSPA prohibits sellers from representing: that the subject of a consumer
transaction has sponsorship, approval, performance characteristics, accessories, uses, or benefits that it
does not have. R.C. 1345.02(B)(1).
214

In addition, Section 109:4-3-10 of the Ohio Administrative Code, interpreting the
CSPA, makes it a deceptive act or practice for a supplier, in connection with a consumer transaction to
"[m]ake any representations, claims, or assertions of fact, whether orally or in writing, which would
cause a reasonable consumer to believe such statements are true, unless, at the time such
representations, claims or assertions are made, the supplier possesses or relies upon a reasonable basis
in fact such as factual, objective, quantifiable, clinical or scientific data or other competent or reliable
evidence which substantiates such representations, claims, or assertions of fact."
Further, under R.C. 1345.07(A)(3)(c), the following acts are deemed to be deceptive
pursuant to cases located within the Attorney General's Public Inspection File ("PIF"):
Making any express or implied statement in connection with the marketing or
advertisement of any product that is false, or has the capacity, tendency or effect of
deceiving or misleading consumers; or omitting any material information such that the
express or implied statement deceives or tends to deceive consumers. State of Ohio ex rd.
Rogers v. Airborne Health, Inc., Case No. 08-CVH-1217848 (Ct. Cmnin. Pleas, Franklin
Cty).
Making any representation, in connection with the marketing or advertising of a
product, about research that has been performed, including but not limited to, any
representation that a product has been clinically tested unless at the time the claim is
made, competent and reliable scientific evidence exists substantiating such claim.
Airborne Health.
Making in connection with the marketing or advertising of a product. Any . . .
statements or representations concerning a product that materially contradict or
conflict with any other statements or representations the Defendants made about such
Product and rend such statements or representations misleading and/or deceptive.
Airborne Health.
Making, or causing to be made, any written or oral claim that is false, misleading or
deceptive. State of Ohio ex rel. Michael DeWine v. Amgen Inc., Case No. 15CV7216 (Ct.
Cmmn. Pleas, Franklin Cty).
Representing that any product has any sponsorship, approval, characteristics,
ingredients, uses, benefits, quantities, or qualities that it does not have. Amgen Inc.
Representing that any product has any sponsorship, characteristics, ingredients, uses,
benefits, quantities, or qualities that it does not have. Amgen, Inc.

215

Making in a promotional context an express or implied representation, not approved or
permitted for use in the labeling or under the FDCA, that a product is better, more
effective, useful in a broader range of conditions or patients, safer, has fewer, or less
incidence of, or less serious side effects or contraindications than has been
demonstrated by competent and reliable scientific evidence, whether or not such
express or implied representation is made by comparison with another drug or
treatment, and whether or not such a representation or suggestion is made directly or
through use of published or unpublished literature, a quotation, or other reference.
Amgen Inc.
Presenting information from a study in a way that implies that the study represents
larger or more general experience with a product than it actually does. Amgen Inc.
Misleadingly presenting favorable information or conclusion(s) from a study that is
inadequate in design, scope, or conduct to furnish significant support for such
information or conclusion(s) for information that may be material to an HCP
prescribing decision when presenting information about a clinical study regarding a
product. Amgen Inc.
Making, or causing to be made, any written or oral claim, directly or by promotional
speakers, that is false, misleading, or deceptive regarding any FDA approved product,
including, but not limited to, any false, misleading, or deceptive claim when comparing
the efficacy or safety of two products. State of Ohio ex rel. Michael DeWine v. Pfizer Inc.,
Case No. 12 CV 15188 (Ct. Cmmn. Pleas, Franklin Cry.).
Making any claim, directly or by promotional speakers, comparing the safety or efficacy
of a product to another product when they claim is not supported by substantial
evidence. Pfizer Inc.
Making any claim, directly or by promotional speakers, that contradicts or minimizes a
precaution, warning, or adverse reaction that is described in product labeling. Pfizer Inc.
As alleged herein, each Defendant, at all times relevant to this Complaint, violated the
CSPA by making deceptive representations about the use of opioids to treat chronic non-cancer pain.
Each Defendant also omitted or concealed material facts and failed to correct prior misrepresentations
and omissions about the risks and benefits of opioids. Each Defendant's omissions rendered even
their seemingly truthful statements about opioids deceptive.
Defendant Purdue made and/or disseminated deceptive statements, including, but not
limited to, the following:

216

Creating, sponsoring, and assisting in the distribution of patient education materials
distributed to Oho consumers that contained deceptive statements;
Creating and disseminating advertisements that contained deceptive statements
concerning the ability of opioids to improve function long-term and concerning the
evidence supporting the efficacy of opioids long-term for the treatment of chronic
non-cancer pain;
Disseminating misleading statements concealing the true risk of addiction and
promoting the deceptive concept of pseudoaddiction through Purdue's own unbranded
publications' and on internet sites Purdue operated that were marketed to and
accessible by consumers;
Distributing brochures to doctors, patients, and law enforcement officials that included
deceptive statements concerning the indicators of possible opioid abuse;
Sponsoring, directly distributing, and assisting in the distribution of publications that
promoted the deceptive concept of pseudoaddiction, even for high-risk patients;
Endorsing, directly distributing, and assisting in the distribution of publications that
presented an unbalanced treatment of the long-term and dose-dependent risks of
opioids versus NSAIDs;
Providing significant financial support to pro-opioid KOL doctors who made
deceptive statements concerning the use of opioids to treat chronic non-cancer pain;
Providing needed financial support to pro-opioid pain organizations that made
deceptive statements, including in patient education materials, concerning the use of
opioids to treat chronic non-cancer pain;
Assisting in the distribution of guidelines that contained deceptive statements
concerning the use of opioids to treat chronic non-cancer pain and misrepresented the
risks of opioid addiction;
Endorsing and assisting in the distribution of CMEs containing deceptive statements
concerning the use of opioids to treat chronic non-cancer pain;
Developing and disseminating scientific studies that misleadingly concluded opioids are
safe and effective for the long-term treatment of chronic non-cancer pain and that
opioids improve quality of life, while concealing contrary data;
Assisting in the dissemination of literature written by pro-opioid KOLs that contained
deceptive statements concerning the use of opioids to treat chronic noncancer pain;
Creating, endorsing, and supporting the distribution of patient and prescriber education
materials that misrepresented the data regarding the safety and efficacy of opioids for
217

the long-term treatment of chronic non-cancer pain, including known rates of abuse
and addiction and the lack of validation for long-term efficacy;
Targeting veterans by sponsoring and disseminating patient education marketing
materials that contained deceptive statements concerning the use of opioids to treat
chronic non-cancer pain;
Targeting the elderly by assisting in the distribution of guidelines that contained
deceptive statements concerning the use of opioids to treat chronic non-cancer pain
and misrepresented the risks of opioid addiction in this population;
Exclusively disseminating misleading statements in education materials to Ohio
hospital doctors and staff while purportedly educating them on new pain standards;
Making deceptive statements concerning the use of opioids to treat chronic noncancer
pain to Ohio prescribers through in-person detailing; and
Withholding from Ohio law enforcement the names of prescribers Purdue believed to
be facilitating the diversion of its products, while simultaneously marketing opioids to
these doctors by disseminating patient and prescriber education materials and
advertisements and CMEs they knew would reach these same prescribers.
705. Defendant Endo made and/or disseminated deceptive statements, including, but not
limited to, the following:
Creating, sponsoring, and assisting in the distribution of patient education materials that
contained deceptive statements;
Creating and disseminating advertisements that contained deceptive statements
concerning the ability of opioids to improve function long-term and concerning the
evidence supporting the efficacy of opioids long-term for the treatment of chronic
non-cancer pain;
Creating and disseminating paid advertisement supplements in academic journals
promoting chronic opioid therapy as safe and effective for long term use•for high risk
patients;
Creating and disseminating advertisements that falsely and inaccurately conveyed the
impression that Endo's opioids would provide a reduction in oral, intranasal, or
intravenous abuse;
Disseminating misleading statements concealing the true risk of addiction and
promoting the misleading concept of pseudoaddiction through Endo's own unbranded
publications and on internet sites Endo sponsored or operated;

218

Endorsing, directly distributing, and assisting in the distribution of publications that
presented an unbalanced treatment of the long-term and dose-dependent risks of
opioids versus NSAIDs;
Providing significant financial support to pro-opioid KOLs, who made deceptive
statements concerning the use of opioids to treat chronic non-cancer pain;
Providing needed financial support to pro-opioid pain organizations — including over $5
million to the organization responsible for many of the most egregious
misrepresentations — that made deceptive statements, including in patient education
materials, concerning the use of opioids to treat chronic non-cancer pain;
Targeting the elderly by assisting in the distribution of guidelines that contained
deceptive statements concerning the use of opioids to treat chronic non-cancer pain and
misrepresented the risks of opioid addiction in this population;
Endorsing and assisting in the distribution of CMEs containing deceptive statements
concerning the use of opioids to treat chronic non-cancer pain;
Developing and disseminating scientific studies that deceptively concluded opioids are
safe and effective for the long-term treatment of chronic non-cancer pain and that
opioids improve quality of life, while concealing contrary data;
Directly distributing and assisting in the dissemination of literature written by proopioid KOLs that contained deceptive statements concerning the use of opioids to treat
chronic non-cancer pain, including the concept of pseudoaddiction;
Creating, endorsing, and supporting the distribution of patient and prescriber education
materials that misrepresented the data regarding the safety and efficacy of opioids for
the long-term treatment of chronic non-cancer pain, including known rates of abuse and
addiction and the lack of validation for long-term efficacy; and
Making deceptive statements concerning the use of opioids to treat chronic noncancer
pain to Ohio prescribers through in-person detailing.
706. Defendant Janssen made and/or disseminated deceptive statements, including, but not
limited to, the following:
Creating, sponsoring, and assisting in the distribution of patient education materials
that contained deceptive statements;
Directly disseminating deceptive statements through intemet sites over which Janssen
exercised final editorial control and approval stating that opioids are safe and effective
for the long-term treatment of chronic non-cancer pain and that opioids improve
quality of life, while concealing contrary data;

219

Disseminating deceptive statements concealing the true risk of addiction and
promoting the deceptive concept of pseudoaddiction through internet sites over which
Janssen exercised final editorial control and approval;
Promoting opioids for the treatment of conditions for which Janssen knew, due to the
scientific studies it conducted, that opioids were not efficacious and concealing this
information;
Sponsoring, directly distributing, and assisting in the dissemination of patient education
publications over which Janssen exercised final editorial control and approval, which
presented an unbalanced treatment of the long-term and dose dependent risks of
opioids versus NSAIDs;
Providing significant financial support to pro-opioid KOLs, who made deceptive
statements concerning the use of opioids to treat chronic non-cancer pain;
Providing necessaiy financial support to pro-opioid pain organizations that made
deceptive statements, including in patient education materials, concerning the use of
opioids to treat chronic non-cancer pain;
Targeting the elderly by assisting in the distribution of guidelines that contained
deceptive statements concerning the use of opioids to treat chronic non-cancer pain
and misrepresented the risks of opioid addiction in this population;
Targeting the elderly by sponsoring, directly distributing, and assisting in the
dissemination of patient education publications targeting this population that contained
deceptive statements about the risks of addiction and the adverse effects of opioids,
and made false statements that opioids are safe and effective for the long-term
treatment of chronic non-cancer pain and improve quality of life, while concealing
contrary data;
Endorsing and assisting in the distribution of CMEs containing deceptive statements
concerning the use of opioids to treat chronic non-cancer pain;

Directly distributing and assisting in the dissemination of literature written by proopioid KOLs that contained deceptive statements concerning the use of opioids to
treat chronic non-cancer_pain, including the. concept ofpseudoaddiction;
Creating, endorsing, and supporting the distribution of patient and prescriber education
materials that misrepresented the data regarding the safety and efficacy of opioids for
the long-term treatment of chronic non-cancer pain, including known rates of abuse
and addiction and the lack of validation for long-term efficacy;
_Targeting veterans 1_2y sponsoring and disseminating patient education marketing
_ _ _ _ _ _ _ .
materials that contained deceptive statements concerning the use of opioids to treat
chronic non-cancer pain; and
220

Making deceptive statements concerning the use of opioids to treat chronic noncancer
pain to Ohio prescribers through in-person detailing.
707. Defendant Cephalon made and/or disseminated untrue, false and deceptive statements,
including, but not limited to, the following:
Creating, sponsoring, and assisting in the distribution of patient education materials
that contained deceptive statements;
Sponsoring and assisting in the distribution of publications that promoted the
deceptive concept of pseudoaddiction, even for high-risk patients;
Providing significant financial support to pro-opioid KOL doctors who made
deceptive statements concerning the use of opioids to treat chronic non-cancer pain
and breakthrough chronic non-cancer pain;
Developing and disseminating scientific studies that deceptively concluded opioids are
safe and effective for the long-term treatment of chronic non-cancer pain in
conjunction with Cephalon's potent rapid-onset opioids;
Providing needed financial support to pro-opioid pain organizations that made
deceptive statements, including in patient education materials, concerning the use of
opioids to treat chronic non-cancer pain;
Endorsing and assisting in the distribution of CMEs containing deceptive statements
concerning the use of opioids to treat chronic non-cancer pain;
Endorsing and assisting in the distribution of CMEs containing deceptive statements
concerning the use of Cephalon's rapid-onset opioids;
Directing its marketing of Cephalon's rapid-onset opioids to a wide range of doctors,
including general practitioners, neurologists, sports medicine specialists, and workers'
compensation programs, serving chronic pain patients;
Making deceptive statements concerning the use of Cephalon's opioids to treat chronic
non-cancer pain to Ohio prescribers through in-person detailing and speakers bureau
events, when such uses are unapproved and unsafe; and
Making deceptive statements concerning the use of opioids to treat chronic noncancer
pain to Ohio prescribers through in-person detailing and speakers bureau events.
708. Defendant Actavis made and/or disseminated deceptive statements, including, but not
limited to, the following:

221

Making deceptive statements concerning the use of opioids to treat chronic noncancer
pain to Ohio prescribers through in-person detailing;
Creating and disseminating advertisements that contained deceptive statements that
opioids are safe and effective for the long-term treatment of chronic noncancer pain
and that opioids improve quality of life;
Creating and disseminating advertisements that concealed the risk of addiction in the
long-term treatment of chronic, non-cancer pain; and
Developing and disseminating scientific studies that deceptively concluded opioids are
safe and effective for the long-term treatment of chronic non-cancer pain and that
opioids improve quality of life while concealing contrary data.
These deceptive representations and concealments were reasonably calculated to
deceive the City and City consumers, were made with the intent to deceive the City and Ohio
consumers, and did in fact deceive the City and City consumers, who paid for prescription opioids for
chronic pain.
As described more specifically above, Defendants' representations and concealments
constitute a course of conduct which continues to this day.
But for these deceptive representations and concealments of material fact, City
consumers would not have incurred significant of dollars in overpayments.
As a direct and proximate cause of Defendants' deceptive conduct, City consumers
have been injured in an amount to be determined at trial.
Plaintiff and its residents have been injured by reason of Defendants' violation of
chapter 1345 of the Ohio Revised Code.
SECOND CAUSE OF ACTION
DECEPTIVE TRADE PRACTICES
CHAPTER 4165 OHIO REVISED CODE
(AGAINST ALL DEFENDANTS)
Plaintiff incorporates the allegations within all prior paragraphs within this Complaint
as if they were fully set forth herein.
222

Defendants violated Chapter 4165 of the Ohio Revised Code, because they engaged in
deceptive trade practices in this state.
Plaintiff and its residents have been injured by reason of Defendants' violation of
Chapter 4165 of the Ohio Revised Code.
THIRD CAUSE OF ACTION
PUBLIC NUISANCE
OHIO PRODUCT LIABILITY ACT ("PLA")OHIO REVISED CODE CHAPTER 2307.71 et seq. AND COMMON LAW
(AGAINST ALL DEFENDANTS)
Plaintiff incorporates the allegations within all prior paragraphs within this Complaint
as if they were fully set forth herein.
718.. Defendants, individually and acting through their employees and agents, and in concert
with each other, have intentionally, recklessly, or negligently engaged in conduct or omissions which
endanger or injure the property, health, safety or comfort of a considerable number of persons in
Lorain by their production, promotion, and marketing of opioids for use by residents of Lorain.
Defendants' conduct is not insubstantial or fleeting. It has caused deaths, serious
injuries, and a severe disruption of public peace, order and safety; it is ongoing, and it is producing
permanent and long-lasting damage.
Defendants' conduct constitutes a public nuisance.
721. Defendants' -conduct - directly - and-proximately -caused-injury - to -Plaintiff-and -its
residents.
722. Plaintiff-and its residents suffered special injuries distinguishable from those suffered
by the general public.

223

FOURTH CAUSE OF ACTION
FRAUD
(AGAINST ALL DEFENDANTS)
Plaintiff incorporates the allegations within all prior paragraphs within this Complaint
as if they were fully set forth herein.
Defendants, individually and acting through their employees and agents, and in concert
with each other, made misrepresentations and omissions of facts material to Plaintiff and its residents
to induce them to purchase, administer, and consume opioids as set forth in detail above.
Defendants knew at the time that they made their misrepresentations and omissions
that they were false.
Defendants intended that Plaintiff and its residents would rely on their
misrepresentations and omissions.
Plaintiff and its residents reasonably relied upon Defendants' misrepresentations and
omissions.
The Defendants' intentionally did not alter or correct the disseminated information
they knew to be fraudulent.
By reason of their reliance on Defendants' misrepresentations and omissions of
material fact Plaintiff and its residents suffered actual pecuniary damage.
Defendants' conduct was willful, wanton, and malicious and was directed at the public
.generally.
FIFTH CAUSE OF ACTION
UNJUST ENRICHMENT
(AGAINST ALL DEFENDANTS)
Plaintiff incorporates the allegations within all prior paragraphs within this Complaint
as if they were fully set forth herein.
224

As an expected and intended result of their conscious wrongdoing as set forth in this
Complaint, Defendants have profited and benefited from opioid purchases made by Plaintiff and its
residents.
In exchange for the opioid purchases, and at the time Plaintiff and its residents made
these payments, Plaintiff and its residents expected that Defendants had provided all of the necessary
and accurate information regarding those risks and had not misrepresented any material facts regarding
those risks.
Defendants have been unjustly enriched at the expense of Plaintiff.
SIXTH CAUSE OF ACTION
NEGLIGENCE
(AGAINST DISTRIBUTOR DEFENDANTS)
Plaintiff incorporates the allegations within all prior paragraphs within this Complaint
as if they were fully set forth herein.
Distributor Defendants have a duty to exercise reasonable care in the distribution of
opioids.
Distributor Defendants breached this duty by failing to take any action to prevent or
reduce the distribution of the opioids.
As a proximate result, Distributor Defendants and its agents have caused Lorain to
incur excessive costs related to diagnosis, treatment, and cure of addiction or risk of addiction to
opioids, the City has borne the massive costs of these illnesses and conditions by having to provide
necessary medical care, facilities, and services for treatment of City residents.
Distributor Defendants were negligent in failing to monitor and guard against thirdparty misconduct and participated and enabled such misconduct.

225

Distributor Defendants were negligent in disclosing to Lorain suspicious orders for
opioids pursuant to the aforementioned Ohio statutes.
Distributor Defendants' acts and omissions imposed an unreasonable risk of harm to
others separately and/or combined with the negligent and/or criminal acts of third parties.
Distributor Defendants are in a class of a limited number of parties that can legally
distribute opioids, which places it in a position of great trust by the City.
743 The trust placed in Distributor Defendants by Lorain through the license to distribute
opioids in Lorain creates a duty on behalf of Distributor Defendants to prevent diversion of the
medications it supplies to illegal purposes.
A negligent and/or intentional violation of this trust poses distinctive and significant
dangers to the City and its residents from the diversion of opioids for non-legitimate medical purposes
and addiction to the same by consumers.
Distributor Defendants were negligent in not acquiring and utili7ing special knowledge
and special skills that relate to the dangerous activity in order to prevent and/or ameliorate such
distinctive and significant dangers.
Distributor Defendants are required to exercise a high degree of care and diligence to
prevent injury to the public from the diversion of opioids during distribution.
Distributor Defendants breached their duty to exercise the degree of care, prudence,
watchfulness, and vigilance commensurate to the dangers involved in the transaction of its.business
Distributor Defendants are in exclusive control of the management of the opioids it
distributed to pharmacies and drug stores in Lorain.
Lorain is without fault and the injuries to the City and its residents would not have
occurred in the ordinary course of events had Distributor Defendants used due care commensurate to
the dangers involved in the distribution of opioids.
226

PRAYER FOR RELIEF
WHEREFORE, Plaintiff demands judgment against defendants, jointly and severally, as to
the FIRST, SECOND, THIRD, FOURTH, FIFTH, and SIXTH Causes of Action, awarding Plaintiff
in amounts likely to exceed $25,000:
i. compensatory damages in an amount sufficient to fairly and completely compensate
Plaintiff for all damages;
treble damages, penalties and costs pursuant to Ohio Revised Code Sections
1345.09(B));
Punitive Damages;
Interest, Costs and Disbursements;
That Defendants be enjoined from, directly or indirectly through KOLs, Front Groups
or other third parties, continuing to misrepresent the risks and benefits of the use of
opioids for chronic pain, and from continuing to violate Ohio law;
Such and further relief as this Court may deem just and proper;
That the Court order such other and further relief as the Court deems just.
JURY DEMAND
Plaintiff demands a trial by jury on all claims to the maximum number of jurors permitted by
law.

Dated: June 28, 2017
Cleveland, Ohio

John R. Clirnaco (0011456)
David M. Cuppage (0047104)
Margaret M. Metzinger (0065624)
CLIMA CO, WILCOX, PECA,
& GAROFOLI, C.O., L.P.A.
55 Public Square, Suite 1950
Cleveland, Ohio 44113
-andC
.

Pl4n(
Paul .J. Nap (To be admitted pro hac vice)
Joseph L. Ciaccio (To be admitted pro hac vice)
Salvatore C. Badala (To be admitted pro hac vice)
NAPOLI SHKOLNIK, PLLC
400 Broadhollow Road — Suite 350
Melville, New York 11747
Attornys for Plaintiff

228