State of New Hampshire v. Purdue Pharma L.P. et al
NOTICE OF REMOVAL from Merrimack County Superior Court, NH, case number 217-2017-CV-00402 (filing fee $400, receipt number 0102-1561627) filed by The Purdue Frederick Company Inc., Purdue Pharma Inc., Purdue Pharma L.P.. Answer Follow Up on 10/6/2017. The court only follow up date DOES NOT include 3 additional days that may apply per FRCP 6(d) and FRCrP 45(c). State Court Record Follow Up 9/29/2017. (Attachments: # 1 Exhibit A: State Court Docket and Redacted Complaint, # 2 Exhibit B: Notice of Conventional Filing, # 3 Exhibit C: Notice of Removal to Counsel, # 4 Exhibit D: Notice of Removal to State Court, # 5 Civil Cover Sheet) Complaint includes a claim under the NH Consumer Protection Act. A copy of the Complaint has been sent to the NH Attorney General via an automatic Notice of Electronic filing.(Deane, W.)
MERRIMACK SUPERIOR COURT
CASE NO. 217-2017-CV-00402
State of New Hampshire v Purdue Pharma, L.P., Purdue
Pharma Inc., and The Purdue Frederick Company
Location: Merrimack Superior Court
Judicial Officer: Kissinger, John C, JR
Filed on: 08/08/2017
Case Type: Complaint for Injunction
Boffetti, James T., ESQ
State of New Hampshire
Purdue Pharma Inc.
Vicinanzo, David Andrew,
Purdue Pharma, L.P.
Vicinanzo, David Andrew,
The Purdue Frederick Company
Vicinanzo, David Andrew,
Deane, W. Daniel, ESQ
EVENTS & ORDERS OF THE COURT
Complaint - SEALED Supplemental Folder - REDACTED received 8/8/2017
Summons on Complaint
Purdue Pharma, L.P.
Purdue Pharma Inc.
The Purdue Frederick Company
Return of Service
Filed by: Attorney Boffetti, James T., ESQ
SEALED in Supplemental Folder; REDACTED received 8/23/2017
Acceptance of Service
David A. Vincinanzo, Esq., obo Defendants, Purdue Pharma, LP, Purdue Pharma, Inc., and
the Purdue Frederick Company
Purdue Pharma, LP, Purdue Pharma Inc., The Purdue Frederick Company
Filed by: Attorney Vicinanzo, David Andrew, ESQ
Counsel for: Purdue Pharma, LP, Purdue Pharma Inc., The Purdue Frederick Company
PAGE 1 OF 2
Printed on 09/12/2017 at 12:52 PM
MERRIMACK SUPERIOR COURT
CASE NO. 217-2017-CV-00402
Filed by: Co-Counsel - Defendant/Respondent Deane, W. Daniel, ESQ
Counsel for: Purdue Pharma, LP, Purdue Pharma Inc., The Purdue Frederick Company
Motion to Extend Time to Answer
Filed by: Attorney Vicinanzo, David Andrew, ESQ; Co-Counsel - Defendant/Respondent
Deane, W. Daniel, ESQ
Defendants' Assented-to Motion for Extension of Time to Answer or Otherwise Plead
Granted (Judicial Officer: Kissinger, John C, JR )
Answer and Appearance
Have App(s), Ans ext @#7
PAGE 2 OF 2
Printed on 09/12/2017 at 12:52 PM
THE STATE OF NEW HAMPSHIRE
STATE OF NEW HAMPSHIRE
PURDUE PHARMA, L.P.;
PURDUE PHARMA INC.; and
THE PURDUE FREDERICK COMPANY
NOW COMES the State of New Hampshire ("State"), by and through the Attorney
General's Office, and complains as follows against the above-captioned Defendants.
JURISDICTION AND VENUE
Purdue Engaged In a Long-Running Campaign of Deception to Create and
Sustain a Market for Its Opioids.
Purdue Used the Medical Community's Increased Focus on Pain as
a Springboard for Its Deceptive Marketing.
Purdue Seeded the Science Regarding the Efficacy and Risks of
Opioids with Flawed and Biased Research
Purdue Worked with Professional Associations to Create
Treatment Guidelines that Overstated the Benefits and Understated
the Risks of Opioids
From 2011 to the Present, Purdue's Marketing in New Hampshire Has
Continued to Misrepresent the Risks and Benefits of Opioids.
Purdue Has Falsely Trivialized or Failed to Disclose the Known,
Serious Risk of Addiction.
Purdue Has Grossly Overstated the Benefits of Chronic Opioid
Therapy While Failing to Disclose the Lack of Evidence
Supporting Long-Term Use.
Purdue Has Misleadingly Promoted OxyContin as Supplying
Twelve Hours of Pain Relief
Purdue Also Engaged In Other Unlawful and Fraudulent Conduct by
Failing to Report Suspicious Prescribing
By Increasing Opioid Prescriptions and Use, Purdue's Deceptive
Marketing Scheme Has Fueled the Opioid Epidemic and Significantly
Harmed New Hampshire and Its Citizens
Although Purdue Knew That Its Marketing Of Opioids Was False And
Misleading, The Company Fraudulently Concealed Its Misconduct
CAUSES OF ACTION
PRAYER FOR RELIEF
Purdue Pharma, L.P., Purdue Pharma Inc. and The Purdue Frederick Company
(collectively, "Defendants" or "Purdue") manufacture, market, and sell prescription opioid pain
medications, including the brand-name drugs OxyContin, Butrans, and Hysingla ER. Although
other brand-name opioids are available—along with widely prescribed generics like oxycodone
and hydrocodone—Purdue for 20 years has been the leading force in the prescription opioid
market, both nationwide and in New Hampshire.
Prescription opioids are narcotics. They are derived from and possess properties
similar to opium and heroin, which is why they are regulated as controlled substances.' Like
1 Since 1970, opioids have been regulated under the Controlled Substances Act ("CSA").
Controlled substances are categorized in five schedules, ranked in order of their potential for
abuse, with Schedule I the highest. The CSA imposes a hierarchy of restrictions on prescribing
and dispensing drugs based on their medicinal value, likelihood of addiction or abuse, and safety.
Opioids generally have been categorized as Schedule II or Schedule III drugs. Schedule II drugs
have a high potential for abuse, have a currently accepted medical use, and may lead to severe
psychological or physical dependence; 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
heroin, prescription opioids work by binding to receptors on the spinal cord and brain,
dampening the perception of pain. Opioids also can create a euphoric high, which can make
them addictive, and at higher doses, they can slow the user's breathing, causing potentially fatal
respiratory depression. Further, most patients receiving more than a few weeks of opioid therapy
will experience withdrawal symptoms—including severe anxiety, nausea, headaches, tremors,
delirium, and pain—if opioid use is delayed or discontinued. These symptoms may persist for
months, or even years, after a complete withdrawal from opioids, depending on length of use.
When using opioids continuously, patients grow tolerant to their analgesic effects—requiring
progressively higher doses and increasing the risks of withdrawal, addiction, and overdose.
These adverse effects were well-recognized in the medical community. Before
the 1990s, opioids typically were used only to treat short-term acute pain or for palliative (endof-life) care because they were considered too addictive and debilitating for long-term use.2 This
prevailing understanding sharply limited the market for prescription opioids.
As Purdue developed OxyContin in the mid-1990s, it knew that to realize
blockbuster profits, it needed to change the perception of opioids to permit and encourage the use
of opioids not just for acute and palliative care, but also long-term for chronic conditions, like
back pain, migraines, and arthritis. Purdue both fostered and capitalized upon the concepts that
pain was undertreated and pain treatment should be a higher priority of health care providers,
which paved the way for increased prescribing of opioids for chronic pain. Purdue piggybacked
on these initiatives to promote opioids generally, and its opioids in particular, as safe, effective,
and appropriate for even long-term use for routine pain conditions. Specifically, Purdue
psychological dependence. 21 U.S.C. § 812. OxyContin and Hysingla ER are Schedule II
drugs; Butrans is a Schedule III drug.
In this Complaint, "chronic pain" means non-cancer pain lasting three months or longer.
misrepresented the risk of addiction as modest, manageable, and outweighed by the benefits of
Purdue spent hundreds of millions of dollars on promotional activities and
materials that falsely denied or trivialized the risk of addiction and overstated the benefits of
opioids. These activities, conducted nationally and in New Hampshire, included directly
marketing Purdue opioids to prescribers through advertising, websites, and in-person sales calls.
Purdue also relied upon continuing medical education ("CME") treatment guidelines and other
publications and programs by patient advocacy groups
professional associations, and physicians that were flawed and
misleading, but seemed independent and therefore credible.
Purdue's marketing scheme, which occurred alongside similar, smaller-scale
efforts of other opioid manufacturers, was resoundingly successful. Between 80% and 90% of
opioids (measured by weight) used today are for chronic pain,
Although Purdue and three of its executives pleaded guilty to federal criminal
charges for deceptive conduct in 2007, and reached civil settlements with 26 states and the
District of Columbia that same year,3 the damage was done. Chronic opioid therapy—the
prescribing of opioids long-term to treat chronic pain—has been a commonplace, and often firstline, treatment since at least the mid-2000s. Numerous New Hampshire physicians interviewed
by the State described absorbing, whether on the job, in residency, or in medical school, the twin
New Hampshire did not enter a settlement with Purdue Pharma.
understandings that compassionate treatment of pain required prescribing opioids and that
patients receiving opioids for legitimate pain conditions are unlikely to become addicted.
To this day, Purdue not only purposely benefits from its earlier misconduct, but
persists in disseminating the same types of misleading messages that previously earned it
censure. From 2011 to the present—the principal focus of this Complaint—Purdue maintained
and expanded the market for its opioids in New Hampshire. First, Purdue continued to
deceptively portray the risks and benefits of chronic opioid therapy, particularly the risk of
addiction. Second, Purdue failed to correct, and thus was able to build upon and profit from, its
prior misrepresentations. Purdue's current misrepresentations, which echo and rely upon its past
deceptive marketing, allowed it to benefit from— and obligated it to correct— its past
misconduct. Purdue also sought through its public presentations to distance itself from its past
misconduct and to build confidence in its more recent marketing by falsely promoting the safety
of its abuse-deterrent ("AD") formulations and its efforts to rein in the diversion and abuse of
opioids, while privately failing to report suspicious prescribing, including in New Hampshire.
Specifically, both before and since 2011, Purdue has falsely and misleadingly: (1)
continued to downplay the serious risk of addiction,' including by claiming that signs of
addiction instead reflected undertreated pain; (2) overstated the effectiveness of screening tools
in preventing addiction, giving prescribers unwarranted confidence they could safely prescribe
opioids; (3) denied or failed to disclose the greater risks of opioids at higher doses; and (4)
exaggerated the effectiveness of AD opioids to prevent abuse and addiction. As to benefits,
4 Addiction is classified as a spectrum of "substance use disorders" that range from
misuse and abuse of drugs to addiction. Patients suffer negative consequences wherever they fall
on this spectrum. In this Complaint, "addiction" refers to the entire range of substance abuse
Purdue has (1) falsely claimed that chronic opioid therapy would improve patients' function and
quality of life, even though there was—and still is—no good evidence to support these claims
and significant evidence to the contrary; and (2) misleadingly promoted OxyContin as providing
a full 12 hours of pain relief, when the effect wears off well before 12 hours in many patients—
causing patients to experience a "crash" and fueling a cycle of higher dose prescribing, addiction,
and overdose.5 By overstating the benefits of opioids, and understating their very serious risks,
Purdue was able to rebalance the scale in favor of prescribing its opioids.
Purdue knew that its longstanding and ongoing misrepresentations of the risks and
benefits of opioids were not supported by or were directly contrary to the scientific evidence.
Indeed, the falsity of its representations regarding the risks and functional benefits of opioids has
been confirmed by the U.S. Food and Drug Administration (FDA) and the Centers for Disease
Control and Prevention (CDC), including by the CDC in its 2016 Guideline for Prescribing
Opioids for Chronic Pain ("2016 CDC Guideline"), which exhaustively reviewed the evidence
Opioids vary by duration. Long-acting or extended-release opioids ("ER/LA") purport
to provide continuous opioid therapy for extended periods. Purdue's OxyContin, Hysingla ER,
and Butrans are all long-acting opioids. In addition, opioids may be taken in short-acting
formulations, also known as immediate release ("IR") opioids, which last approximately 4-6
hours. While it once was thought that ER/LA opioids were not as susceptible to abuse and
addiction as short-acting ones, this view has been discredited. The FDA has required makers of
ER/LA opioids to adopt "Risk Evaluation Mitigation Strategies" because the drugs present a
"serious public health crisis of addiction, overdose, and death." FDA, Risk Evaluation and
Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids (Aug. 2014),
available at http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.
In 1998, Purdue's OxyContin FDA label advised that it was less addictive than short-acting
opioids, but this claim was removed by 2001. OxyContin's label now states, as do all labels of
Schedule II ER/LA opioids, that the drug "exposes users to risks of addiction, abuse, and misuse,
which can lead to overdose and death."
As alleged herein, Purdue's marketing violates the prohibition in RSA 358-A:2 against
deceptive acts or practices. Purdue also is governed by FDA rules requiring truthful marketing
Purdue's deceptive marketing, which drove prescribing not only of Purdue
opioids but of opioids as a class, has opened the floodgates to opioid prescribing, use and abuse.
Opioids are now among the most prescribed class of drugs. In 2015, health care providers wrote
enough opioid prescriptions to medicate every American around the clock for three weeks. On
an average day, more than 650,000 opioid prescriptions are dispensed in the U.S. In New
Hampshire, in 2012, there were 72 opioid prescriptions for every 100 residents. From October
2014 to September 2015, between 12 and 15.3 million doses of narcotic pain relievers were
dispensed in the state each quarter.
Purdue accounts for much of the prescribing of branded opioids in New
. In 2015, Purdue reaped an
estimated $2.4 billion in revenue, virtually all of it from the sale of opioids.
Rather than compassionately helping patients, this explosion in opioid use—and
in Purdue's profits—has come at the expense of chronic pain patients. The CDC concluded in
2016 that "for the vast majority of [chronic pain] patients, the known, serious, and too-often-fatal
risks [of opioids] far outweigh the unproven and transient benefits."7 As one doctor stated:
"This was an experiment on the population of the United States. It wasn't randomized, it wasn't
controlled, and no data was collected until they started gathering death statistics."
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
balance the drug's benefits and risks. 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. See 21 U.S.C. § 352(a); 21 C.F.R. §§ 1.21(a), 202.1(e)(3), 202.1(e)(6).
Thomas R. Frieden et al., Reducing the Risks of Relief — The CDC Opioid-Prescribing
Guideline, 374 New Eng. J. Med. 1501-04 (2016).
As a direct result of Purdue's marketing and its dangerously false message that
opioids are not addictive but beneficial for chronic pain, the nation is now swept up in what the
CDC called a "public health epidemic" and what the U.S. Surgeon General deemed an "urgent
health crisis."8 The increased volume of prescribing correlates directly to skyrocketing
addiction, overdose, and death; secondary black markets for diverted prescription opioids as well
as heroin and fentanyl; and the social and economic consequences of each of these problems.
Across the country, 91 people die from an opioid-related overdose every day and
over 1,000 patients are treated in emergency departments for misusing them. Far more are swept
into a cycle of addiction and abuse with which they will struggle their entire lives. As many as 1
in 4 patients who receive prescription opioids long-term for chronic pain in primary care settings
struggles with addiction. In 2014, almost 2 million Americans were addicted to prescription
opioids and another 600,000 to heroin. From 1999 to 2015, more than 194,000 people died in
the U.S. from overdoses related to prescription opioids— more than the number of Americans
who died in the Vietnam War.
The outcomes in New Hampshire are equally catastrophic— and getting worse.
In 2016, the Deputy Administrator of the DEA called New Hampshire "ground zero" of the
opioid epidemic. There were 438 fatal overdoses in the state in 2015, more than double the
number in 2012. Per capita, New Hampshire is second in the nation in overdose deaths. Rates of
substance abuse treatment admissions are up sharply, and based on interviews with addiction
treatment providers, demand for help far exceeds their resources.
8 Daniel Sosin, Examining the Growing Problems of Prescription Drug and Heroin
Abuse, CDC (Apr. 29, 2014), http://www.cdc.gov/washington/testimony/2014/t20140429.htm.;
Vivek H. Murthy, Letter from the Surgeon General (July 27, 2017), http://turnthetiderx.org.
While opioids have been diverted through illicit prescribing and sales, it is the
regular, legitimate prescribing of opioids that created and fueled this crisis. A study of 254
accidental opioid overdose deaths in Utah found that 92% of decedents had been receiving
prescriptions from health care providers for chronic pain. Sales to patients who doctor shop (or
visit multiple doctors to hide illicit or over-use) constitute roughly 1% of opioid volume— barely
a rounding error.
Purdue's conduct has violated, and continues to violate, the Consumer Protection
Act's prohibitions on deceptive acts and practices and unfair competition, RSA 358-A:2, as well
as common-law prohibitions against unjust enrichment and creation of a public nuisance.
This Complaint arises from a multi-year investigation conducted by the New
Hampshire Attorney General's Office, delayed by challenges to the Office's use of outside
counsel to assist in its investigation since rejected by the New Hampshire Supreme Court. As
part of that investigation, the Department interviewed physicians, addiction treatment specialists,
and other health care providers statewide; took testimony from or interviewed former Purdue
employees; obtained data from Medicaid, state health plans, and private insurers; reviewed
hundreds of thousands of pages of documents; and gathered information from other state
officials, the FDA, and the Drug Enforcement Administration ("DEA").
The State seeks an order requiring Purdue to cease its unlawful promotion of
opioids, to correct its misrepresentations, and to abate the public nuisance its deceptive
marketing has created. The State furthers seek a judgment requiring Purdue to pay civil
penalties, restitution, disgorgement, and fees or costs permitted under law.
The State of New Hampshire brings this action through its Attorney General's
Office. Under the Consumer Protection Act, the Attorney General may bring an action in the
name of the State for injunctive relief, restitution, and penalties where, as here, he "has reason to
believe that trade or commerce declared unlawful by this chapter has been, is being or is about to
be conducted" by any person, including partnerships and corporations. RSA 358-A:4, III; RSA
The State also has standing parens patriae to protect the health and well-being,
both physical and economic, of its residents and its municipalities. Opioid use and abuse has
affected a substantial segment of the population of New Hampshire.
PURDUE PHARMA L.P. is a limited partnership organized under the laws of
Delaware. PURDUE PHARMA INC. is a New York corporation with its principal place of
business in Stamford, Connecticut, and THE PURDUE FREDERICK COMPANY is a Delaware
corporation with its principal place of business at One Stamford Forum, 201 Tresser Boulevard,
Stamford, CT, 06901-3431.
Purdue manufactures, promotes, sells, and distributes opioids such as OxyContin,
MS Contin, Dilaudid, Dilaudid HP, Butrans, Hysingla ER, and Targiniq ER in the United States
and New Hampshire. OxyContin is Purdue's best-selling opioid. Since 2009, Purdue's annual
sales of OxyContin have fluctuated between $2 and $3 billion.
JURISDICTION AND VENUE
The Court has subject matter jurisdiction over this action under RSA 491:7 and
The Court has personal jurisdiction over Defendants because they regularly
transact business in New Hampshire, and the claims asserted herein arise from their business
conducted in New Hampshire.
Venue in this Court is proper because Defendants are all non-residents. RSA
507:9; RSA 358-A:4, III(a).
Purdue Engaged In a Long-Running Campaign of Deception to Create and Sustain
a Market for Its Opioids.
Beginning in the late 1990s, Purdue presented OxyContin—and later its other
opioids—as the solution to the problem of chronic pain. Through marketing that was as
pervasive as it was deceptive, Purdue convinced health care providers both that the risks of longterm opioid use were overblown and that the benefits, in reduced pain and improved function and
quality of life, were proven.
The result was that by the mid-2000s, the medical community had abandoned its
prior caution, and opioids were entrenched as an appropriate—and often the first—treatment for
chronic pain conditions. Purdue not only marketed OxyContin for chronic pain conditions, but
targeted primary care physicians (along with nurse practitioners and physician assistants), who
were most likely to see patients with chronic pain conditions and least likely to have the training
and experience to evaluate Purdue's marketing and patients' pain conditions. Its deceptive
marketing created a cadre of doctors who looked for pain and treated it with opioids, and, as a
result, an even broader cohort of patients who expected and required opioids. This laid the
groundwork for today's epidemic of opioid abuse, injury, and death. It skewed the medical and
public understanding of opioids to minimize their risks and exaggerate their benefits—a
distortion that Purdue failed to correct, and continues to benefit from. It also provided the base
on which Purdue's equally deceptive post-2011 marketing was built.
To spread its false and misleading messages supporting chronic opioid therapy,
Purdue marketed its opioids directly to health care providers and patients nationwide and in New
Hampshire. It did so principally through its sales force—sales representatives, also known as
"detailers," who made in-person sales calls to prescribers in which they misleadingly portrayed
chronic opioid therapy.
This misinformation included, most prominently, deceptive statements about the
risk of addiction. For example, as the United States Department of Justice found in resolving
criminal charges against Purdue in 2007, sales representatives had "falsely told some health care
providers that OxyContin had less euphoric effect and less abuse potential than short-acting
opioids."9 Similarly, the sales force was taught, and passed on to health care providers, that
opioids are not addictive when legitimately prescribed.
New Hampshire prescribers interviewed by the State recalled hearing
then from Purdue detailers the messages that the drug was steady-state (for less euphoria), that
the risk of addiction was low, and that pain patients would not become addicted.
9 United States v. The Purdue Frederick Company, Inc., et al., 1:07-cr-00029 (W.D.
Va.), Criminal Information, at ¶ 24
Purdue also engaged in widespread advertising of OxyContin, including both
print ads in medical journals and videos distributed directly to physicians. These ad campaigns,
too, deceptively portrayed both the risks and benefits of chronic opioid therapy. For example, in
1998 and 2000, Purdue distributed thousands of copies of a video to doctors that made the
unsubstantiated claim that opioid addiction occurred in less than 1% of patients. In 2003, the
FDA warned Purdue about ads that ran in the Journal of the American Medical Association,
expressing concern that they would lead to ill-considered prescribing of OxyContin because the
body of the ad text nowhere referred to the "serious, potentially fatal risks associated with
OxyContin."1 ° And a 2005 ad that ran in the Journal of Pain misleadingly implied long-term
improvement in patients' pain, function, and quality of life, touting OxyContin as an "aroundthe-clock analgesic . . . for an extended period of time" and featuring a man and boy fishing
under the tagline "There Can Be Life With Relief."
Purdue also falsely promoted OxyContin as if it were effective for a full 12 hours
and provided "steady state" relief, less likely than other opioids to create a cycle of crash and
cravings that fueled addiction and abuse. As noted in Section IV.B.3, Purdue's promotion of
OxyContin as a 12-hour drug was critical to establish its market advantage over other
competitors and justify its higher price. Its advertising included claims that OxyContin provides
"Consistent Plasma Levels Over 12 Hours" and included a chart depicting plasma levels on a
logarithmic scale. The chart, as shown below, minimized the steep decline in OxyContin's
effectiveness over 12 hours by depicting 10 mg in a way that it appeared to be half of 100 mg in
the table's y-axis, making the absorption rate appear more steady or consistent:
1° Letter from Thomas Abrams to Michael Friedman, Executive Vice President and Chief
Operating Officer, Purdue Pharma L.P. (Jan. 17, 2003)
For moderato to severe pain when a continuous, around-the-clock
analgesic is needed for an extended period of time
Consistent Plasma Levels Over 12 Hours
Plasma concentrations tngirrit) over time of various dosage strengths
• OxyContle 80 end
180 mg Tablets FOR
USE ONLY IN °Mit/TOLERANT PATIENTS
requiring minimum daily
dosages of 160 trig end
320 mg, respectively.
These tablet strengths
may cause fatal respiratory depression when
administered to patients'
not previously exposed
Steady state achieved within 24 to 36 hours
Purdue communicated these deceptions through an extensive marketing
campaign—including an expanded sales force compensated on the basis of increased sales,
thousands of paid speakers and events for prescribers, websites and coupons aimed at patients,
and giveaways of CDs, fishing hats, and plush toys and other items.11 These sales strategies
coalesced behind a single message that opioids could be safely prescribed and used, even longterm, without causing patients to become addicted, overdose, and die.
Purdue's efforts to trivialize the risk of addiction were, and remain, at odds with
the scientific evidence, as recently confirmed by the FDA and CDC. Studies have shown that at
least 8-12%, and as many as 30% or even 40% of long-term users of opioids experience
11 According to DEA, Purdue's use of branded promotional items was unprecedented
among Schedule II opioids, and was an indicator of Purdue's aggressive and inappropriate
marketing of OxyContin. GAO, OxyContin Abuse and Diversion and Efforts to Address the
Problem, at 25 (Dec. 2003).
problems with addiction. In requiring a new black-box warning on the labels of all IR opioids in
March 2016, similar to the warning already required for ER/LA opioids, the FDA emphasized
the "known serious risk of . . . addiction"—"even at recommended doses of all opioids."I2
That same month, after a "systematic review of the best available evidence" by a panel excluding
experts with conflicts of interest, the CDC also published guidelines ("2016 CDC Guideline") for
prescribing opioids for chronic pain.13 The CDC found that "[o]pioid pain medication use
presents serious risks, including overdose and opioid use disorder" (a diagnostic term for
addiction).14 The CDC also emphasized that "continuing opioid therapy for 3 months
substantially increases risk for opioid use disorder."I5 As confirmed by the CDC in its 2016
Guideline, there is "extensive evidence" of the "possible harms of opioids (including opioid use
disorder [an alternative term for opioid addiction])."
Likewise, Purdue's claims that long-term use of opioids improves patient function
and quality of life find no support in the literature, as also recently confirmed by the CDC. There
were and are no controlled studies of the use of opioids beyond 16 weeks, and there is no
evidence that opioids improve patients' pain and function long-term. On the contrary, the
available evidence indicates opioids are not effective to treat chronic pain, and may worsen
12FDA announces safety labeling changes and postmarket study requirements for
extended-release and long-acting opioid analgesics, FDA (Sep. 10, 2013); see also FDA, FDA
announces enhanced warnings for immediate-release opioid pain medications related to risks of
misuse, abuse, addiction, overdose and death, FDA (Mar. 22, 2016),
13 Deborah Dowell, M.D., Tamara H. Haegerich, PhD., and Roger Chou, M.D., CDC
Guideline for Prescribing Opioids for Chronic Pain — United States, 2016, (Mar. 18, 2016)
MMWR Recomm. Rep. 2016;65 (No. RR-1), at 2 ("2016 CDC Guideline").
2016 CDC Guideline at 2.
Id. at 21.
patients' health. A 2006 study of studies found that "[fl or functional outcomes, . . . other [nonaddictive] analgesics were significantly more effective than were opioids."16 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 one pain specialist observed, "[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."17 Studies of patients with lower back pain and
migraine headaches, for example, have consistently shown that patients experienced
deteriorating function over time, as measured by ability to return to work or physical activity,
pain relief, rates of depression, and subjective quality-of-life measures. Analyses of workers'
compensation claims have found that workers who take opioids are almost four times more likely
to reach costs over $100,000, owing to greater side effects and slower returns to work; that
receiving an opioid for more than seven days increased patients' risk of being on work disability
one year later; and that an opioid prescription as the first treatment for a workplace injury
doubled the average length of the claim.
Andrea D. Furlan, Opioids for chronic noncancer pain: a meta-analysis of
effectiveness and side effects, 174(11) Can. Med. Ass'n J. 1589-94 (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 pre-screened 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 Prescription Opioids and High-Risk Opioids in US
Veterans of Iraq and Afghanistan, 307(9) J. Am. Med. Ass'n 940-47 (2012).
Andrea Rubenstein, Are we making pain patients worse?, Sonoma Medicine (Fall
Assessing the state of the science, the CDC found in its 2016 Guideline that there
was "[n]o evidence show[ing] a long-term benefit of opioids in pain and function versus no
opioids for chronic pain with outcomes examined at least 1 year later (with most placebocontrolled randomized trials [less than or equal to] 6 weeks in duration)"18 and advised that
"there is no good evidence that opioids improve pain or function with long-term use."19 The
Guideline further acknowledged that "nonopioid pharmacologic therapies (including
acetaminophen [and] [non-steroidal anti-inflammatory drugs ("NSAIDs")] . . .) are effective for
chronic pain" and "are not generally associated with substance use disorder" or significant risk of
Thus, the CDC concluded that "[w]hile benefits for pain relief, function and
quality of life with long-term opioid use for chronic pain are uncertain, risks associated with
long-term opioid use are clearer and significant."21 According to the CDC, "for the vast majority
of patients, the known, serious, and too-often-fatal risks far outweigh the unproven and transient
benefits [of opioids for chronic pain]."22
Because Purdue's claims regarding chronic opioid therapy had no scientific
support, it created the illusion that they did. Purdue buttressed its direct promotion of its opioids
with an array of marketing approaches that bolstered the same deceptive messages by filtering
them through seemingly independent and objective sources. Purdue recruited and paid physician
2016 CDC Guideline at 15.
Id. at 20.
Id. at 17-18.
Id. at 18.
See Thomas R. Frieden, M.D., M.P.H. and Debra Howry, M.D., M.P.H., Reducing the
Risks of Relief— The CDC Opioid-Prescribing Guideline, New Eng. J. Med. (Apr. 21, 2016), at
1503 (article announcing 2016 CDC Guideline).
speakers to present talks on opioids to their peers at lunch and dinner events. It funded biased
research and sponsored CME that misleadingly portrayed the risks and benefits of chronic opioid
therapy. It collaborated with professional associations and pain advocacy organizations, such as
the American Pain Foundation ("APF"), to develop and disseminate pro-opioid educational
materials and guidelines for prescribing opioids. And it created "unbranded" websites and
materials, copyrighted by Purdue but implied to be the work of separate organizations, that
echoed Purdue's branded marketing.
Among these tactics, all of which originated in the late 1990s and early 2000s,
three stand out for their lasting influence on opioid prescribing nationwide and in New
Hampshire: Purdue's capture, for its own ends, of physicians' increased focus on pain treatment;
its efforts to seed the scientific literature on chronic opioid therapy; and its corrupting influence
on authoritative treatment guidelines issued by professional associations.
Purdue Used the Medical Community's Increased Focus on Pain as a Springboard
for Its Deceptive Marketing.
As Purdue developed OxyContin in the mid-1990s, it was able to both foster and
capitalize on a movement in the medical community to make pain treatment a priority for all
patients. Early pro-opioid researchers such as Dr. Russell Portenoy, a pain management
specialist who received Purdue research support and was a Purdue consultant, discounted the risk
of addiction and, in Dr. Portenoy's words, advocated that "opioid maintenance therapy [could]
be a safe, salutary and more humane alternative" to not treating patients with chronic pain.
In the late 1990s, the American Pain Society ("APS"), headed by Dr. Portenoy,
pushed to make pain the "fifth vital sign"—an indicator doctors should monitor alongside blood
pressure, temperature, heartbeat and breathing. APS, like Dr. Portenoy, received substantial
funding from Purdue.
In 2001, the Joint Commission on the Accreditation of Healthcare Organizations
("JCAHO"), which accredits hospitals and other health care programs across the United States,
issued pain treatment standards. These called for assessment of pain in all patients and in each
physician-patient interaction, and made accreditation decisions contingent on institutions having
policies in place to accomplish this.
JCAHO licensed Purdue—alone—to distribute certain educational videos about
how to comply with the new pain management standards and a book about pain management,
which were also available for purchase from JCAHO's website. Purdue also funded and
disseminated the publication How to Meet the JCAHO Pain Standards, which encourages
discussing opioids in positive terms ("patient is not on opioids," not "patient denies opioid use")
and identifies several pro-opioid pain advocacy groups as resources.
Both the "pain as the fifth vital sign" campaign and the JCAHO pain management
standards have been widely integrated into medical practice. Numerous New Hampshire health
care providers—including many who were unaware of Purdue's involvement—credit these
initiatives for "swinging the pendulum" toward overprescribing of opioids.
Purdue Seeded the Science Regarding the Efficacy and Risks of Opioids with
Flawed and Biased Research.
Rather than find a way to rigorously test the safety and efficacy of opioids for
long-term use, Purdue created scientific support for its marketing claims by sponsoring studies
that were methodologically flawed, biased, and drew inappropriate conclusions from prior
evidence. It then published studies with favorable outcomes and suppressed the problematic
ones. The result was a body of literature whose primary purpose was to support the use of
opioids for chronic pain, but was passed off as legitimate scientific research. Subsequent studies
then cited—and continue to cite—this research to insidious effect: the body of evidence on
which physicians rely to prescribe opioids now fully incorporates Purdue's skewed science.
For example, Purdue-sponsored studies and marketing materials that cited them
regularly made claims that "the risk of psychological dependence or addiction is low in the
absence of a history of substance abuse." One such study, published in the journal Pain in 2003
and widely referenced since (with 584 citations in Google Scholar), ignored previous Purduecommissioned research showing addiction rates between 8% and 13%—far higher than Purdue
acknowledged was possible. Purdue relegated those earlier studies showing higher addiction
rates to headache journals, where it knew they would be less widely read, particularly by primary
care physicians and pain specialists, its primary audience. Instead, to support the claim that
OxyContin rarely was addictive, the Pain article reached back to a 1980 letter to the editor—not
an article, but a letter.
That letter, J. Porter & H. Jick, Addiction Rare in Patients Treated with Narcotics,
302(2) New Eng. J Med 123 (1980) ("Porter-Jick Letter"), is reproduced in full below. It does
not reflect any study, but simply describes a review of the charts of hospitalized patients who had
received opioids. The letter notes that the review found almost no references to signs of
ADDICT/ON RARE IN PATIENTS TREATED
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,' 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.
Waltham, MA 02154
Boston Collaborative Drug
Boston University Medical Center
I. Jick H, Miettinen OS, Shapiro S, Lewis OP. Siskind Y, Slone D.
Comprehensive drug surveillance. JAMA_ 1970; 213:1455-60.
2. Miller RR. Jick H. Clinical effects of meperidine in hospitalized medical
patients. J Clin Pharmacol. 1978; 18:180-8.
addiction, though there is no indication that caregivers were instructed to assess or document
signs of addiction. Because the opioids were administered in a hospital, there was no risk of
patients increasing their use.
The Porter-Jick Letter has become a mainstay in scientific literature, with 985
citations in Google Scholar. Purdue has referenced the letter in its own marketing brochures.
Yet Purdue fails to disclose both the nature of the citation (a letter, not a study) and any of its
serious limitations. In fact, Dr. Jick complains that the letter has been misused years later by
drug companies "that were pushing out new pain drugs" and used his letter to conclude that their
new opioids were not addictive, "[b]ut that's not in any shape or form what we suggested in our
In the same vein, an analysis published in the New England Journal of Medicine
("NEJM") in June 2017 noted that citation of the Porter-Jick Letter significantly increased after
the introduction of OxyContin and that three-quarters of the articles referencing the Letter cited it
"as evidence that addiction was rare in patients treated with opioids."23 The authors concluded:
"We believe that this citation pattern contributed to the North American opioid crisis by helping
to shape a narrative that allayed prescribers' concerns about the risk of addiction associated with
long-term opioid therapy." In June, the NEJM took the unusual step of adding this note to its
electronic copy of the Letter: "For reasons of public health, readers should be aware that this
letter has been 'heavily and uncritically cited' as evidence that addiction is rare with opioid
23 Pamela TM Leung et al., A 1980 Letter on the Risk of Opioid Addiction. 376.22 New
Eng. J. of Med., 2194-95 (2017).
Purdue's efforts to continue to develop science that would support its marketing
efforts continued beyond this early foundation
Purdue Worked with Professional Associations to Create Treatment Guidelines
that Overstated the Benefits and Understated the Risks of Opioids.
Treatment guidelines were particularly important to Purdue in securing
acceptance for chronic opioid therapy. They are relied upon by doctors, especially general
practitioners and family doctors who have no specific training in treating 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. Purdue financed and collaborated, in particular, with two groups
on guidelines that have been, and continue to be, broadly influential in New Hampshire and
APS and the American Academy of Pain Medicine each received substantial
funding from Purdue. From 2009 to 2012, APS received nearly $500,000;
The societies issued a consensus statement in 1997, The Use of Opioids for the
Treatment of Chronic Pain, that 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 and later became a senior executive for
the company. Dr. Portenoy was the sole consultant. The consensus statement 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 guidelines in 2009 ("AAPM/APS Guidelines") and
continued to recommend the use of opioids to treat chronic pain. Six of the 21 panel members
who drafted the AAPM/APS Guidelines, including Dr. Portenoy, received support from Purdue,
and another 8 received support from other opioid manufacturers.
The AAPM/APS Guidelines promote opioids as "safe and effective" for treating
chronic pain. The panel made "strong recommendations" despite "low quality of evidence," and
concluded that the risk of addiction is manageable for patients, even patients with a prior history
of drug abuse. One panel member, Dr. Joel Saper, Clinical Professor of Neurology at Michigan
State University and founder of the Michigan Headache & Neurological Institute, resigned from
the panel because of his concerns that the AAPM/APS Guidelines were influenced by
contributions that drug companies, including Purdue, made to the sponsoring organizations and
Dr. Gilbert Fanciullo, a retired professor at Dartmouth College's Geisel School of
Medicine who serves on the New Hampshire Board of Medicine and served on the AAPM/APS
Guidelines panel, has since described them as "skewed" by Purdue and other drug companies
and "biased in many important respects," including its high presumptive maximum dose, lack of
suggested mandatory urine toxicology testing, and claims of a low risk of addiction.
The AAPM/APS Guidelines are still available online, were reprinted in the
Journal of Pain, have been a particularly effective channel of deception and have influenced not
only treating physicians, but also the body of scientific evidence on opioids. According to
Google Scholar, they have now been cited 1,647 times in academic literature.
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, including New Hampshire's, have the power to license
doctors, investigate complaints, and discipline physicians. The FSMB finances opioid- and painspecific programs through grants from Purdue and other pharmaceutical manufacturers.
In 1998, the FSMB developed Model Guidelines for the Use of Controlled
Substances for the Treatment of Pain ("FSMB Guidelines"), which FSMB acknowledged were
produced "in collaboration with pharmaceutical companies," including Purdue.
Guidelines described opioids as "essential" for treatment of chronic pain, including as a first-line
option, failed to mention risks of respiratory depression and overdose, and addressed addiction
only to state that "inadequate understandings" of addiction can lead to "inadequate pain control."
They also warn that doctors would face discipline for inadequate treatment of pain.
A 2004 iteration of the FSMB Guidelines and the 2007 book adapted from them,
Responsible Opioid Prescribing, repeat these same claims. The book also claimed that opioids
would improve patients' function and advanced the dangerous, unsubstantiated concept of
"pseudoaddiction"—the idea that signs of addiction, including shopping for doctors willing to
newly write or refill prescriptions for opioids or seeking early refills, may actually reflect
undertreated pain that should be addressed with more opioids.
The 2016 CDC Guideline rejects the concept of pseudoaddiction. The Guideline
nowhere recommends that opioid doses be increased if a patient is not experiencing pain relief.
To the contrary, the Guideline explains that "[p]atients who do not experience clinically
meaningful pain relief early in treatment . . . are unlikely to experience pain relief with longerterm use," 24 and that physicians should "reassess pain and function within 1 month" in order to
decide whether to "minimize risks of long-term opioid use by discontinuing opioids" because the
patient is "not receiving a clear benefit."25
Another opioid manufacturer has repudiated the concept of pseudoaddiction. In
finding that "[t]he pseudoaddiction concept has never been empirically validated and in fact has
been abandoned by some of its proponents," the New York Attorney General, in its 2016
settlement with Endo Pharmaceuticals over deceptive marketing, reported that "Endo's Vice
President for Pharmacovigilance and Risk Management testified . . . that he was not aware of any
research validating the `pseudoaddiction' concept" and acknowledged the difficulty in
CDC Guideline at 13.
Id at 25.
distinguishing "between addiction and `pseudoaddiction.'"26 Consistent with this testimony,
Endo agreed not to "use the term `pseudoaddiction' in any training or marketing" in New York.
Responsible Opioid Prescribing was sponsored by Purdue, among other opioid
The FSMB website describes the book as the "leading continuing medical
education (CME) activity for prescribers of opioid medications." In all, more than 163,000
copies of Responsible Opioid Prescribing were distributed to state medical boards, including
4,100 in New Hampshire. Numerous New Hampshire prescribers interviewed by the State
recalled receiving and reviewing the book, and several specifically cited it as a resource on
which they relied.
From 2011 to the Present, Purdue's Marketing in New Hampshire Has Continued to
Misrepresent the Risks and Benefits of Opioids.
From 2011 to the present, Purdue has built upon its deceptive marketing that
established chronic opioid therapy as commonplace and reaped Purdue massive revenues from
OxyContin and its other opioids. Purdue has continued to omit discussion of the serious risks of
opioids and lack of evidence supporting long-term opioid use—thereby failing to correct its prior
deceptions, to its benefit—and to affirmatively misrepresent the risks and benefits of opioids.
26 Attorney General of the State of New York, In the Matter of Endo Health Solutions
Inc., Assurance No.: 15-228 (Mar. 1, 2016).
Purdue has accomplished much of this through its New Hampshire sales force and
the publications they disseminated. Since the launch of OxyContin, Purdue has relied heavily on
its sales representatives to market its opioids directly to prescribers, and that practice continues.
By establishing personal relationships with
doctors, Purdue's sales representatives are able to disseminate their misrepresentations in
targeted, one-on-one settings that allows them to differentiate Purdue's opioids and to address
individual prescribers' concerns about prescribing opioids for chronic pain.
Since the launch of OxyContin, Purdue's sales representatives have visited
hundreds if not thousands of health care providers in New Hampshire. Purdue was the most
frequent detailer of any opioid drug in New Hampshire and was responsible for 2 out of every 3
opioid detailing visits in the state.
Most of these prescribers were visited repeatedly; one
prescriber recalled seeing representatives for Butrans several times per week.
Deploying in New Hampshire the same marketing tactics and messages it deploys
nationwide, Purdue has used its sales force to continue to misrepresent the risks and benefits of
its opioids. Specifically, from 2011 to the present Purdue has continued, as described below, to:
(1) misrepresent the serious risk of addiction; (2) overstate the benefits of chronic opioid therapy,
while failing to disclose the lack of evidence supporting long-term use; (3) misleadingly promote
OxyContin as providing 12 hours of pain relief; and (4) misrepresent Purdue's role in addressing
illicit or inappropriate prescribing.
Purdue Has Falsely Trivialized or Failed to Disclose the Known, Serious Risk of
To convince New Hampshire prescribers and patients that opioids are safe,
Purdue has continued to deceptively minimize and fail to disclose the risks of long-term opioid
use, particularly the risk of addiction. These misrepresentations, which are described below,
reinforced each other and created the dangerously misleading impressions that: (1) patients
receiving opioid prescriptions for pain would not become addicted; (2) even patients who
seemed addicted likely were not; they had undertreated pain and just needed more opioids; (3)
patients at greatest risk of addiction could be identified, that all other patients could safely be
prescribed opioids, and that even high risk patients could be prescribed opioids if closely
managed; (4) prescribers could increase opioid doses indefinitely without added risk; and (5) the
abuse-deterrent formulations of Purdue's opioids both prevent abuse and overdose and are
inherently less addictive. Each of these misrepresentations has been debunked by the FDA and
Omitting, trivializing, and mischaracterizing addiction risk
Based on interviews with New Hampshire prescribers and Purdue's former
employees, Purdue's sales representatives have regularly omitted from their sales conversations
any discussion of the risk of addiction from long-term use of opioids. These omissions, which
are false and misleading in their own right, rendered even seemingly truthful statements about
opioids false and misleading, especially in light of Purdue's prior misrepresentations regarding
the risk of addiction. In addition, by failing to correct this earlier misinformation, Purdue's
representatives let stand the dangerous impression that patients who receive chronic opioid
therapy for legitimate pain conditions are unlikely to become addicted.
Where they have brought up the topic of addiction, Purdue's sales representatives,
reviving precisely the conduct underpinning the company's 2007 criminal plea, have emphasized
to New Hampshire prescribers that ER/LA opioids (which include OxyContin, Butrans, and
Hysingla ER) provide a slow-onset, stable dose without "peaks and valleys"—falsely implying
that these opioids are safer because they do not produce the euphoric high that fosters addiction.
In a 2011 sales training document, Purdue acknowledged that the "peaks and valleys" message
seen in a review of sales representative call notes was "problematic"—confirming both that the
statements were made and that they were false. Yet Purdue's sales force has continued to make
this misrepresentation, which is particularly deceptive given that for many patients, OxyContin
does not provide an even 12 hours of pain relief and will cause patients to experience a crash (or
valley) hours before they are due to take their next pill, as described in Section IV.B.3.
Purdue deceptively undermines evidence that opioids are addictive by suggesting
or stating that the risk of addiction is not general, but limited to specific, high-risk patients. By
appropriately screening patients, doctors can identify patients who are likely to become addicted,
and safely prescribe to everyone else. This allows Purdue to discount general concerns or
warnings regarding addiction, which can be set aside when prescribers were confident about their
own patients. These assurances are false and unsafe, especially given that prescribers cannot
accurately predict which patients at higher risk of addiction. See Section IV.B.1.b, infra.
Promotional materials and other publications Purdue has disseminated or made
available in New Hampshire have included similar messages minimizing the risk of addiction.
Purdue, through its unbranded imprint Partners Against Pain,27 promoted
pseudoaddiction through at least 2013 on its website.
Based on interviews with prescribers, Partners Against Pain
materials have been widely viewed and disseminated in New Hampshire and had
. Several prescribers specifically recalled visiting the website, downloading
materials, or seeing Partners Against Pain brochures.
Providing Relief Preventing Abuse, a pamphlet published by Purdue in 20111.
for prescribers and law enforcement shows pictures of the
stigmata of injecting or snorting opioids—skin popping, track marks, and perforated nasal
Partners Against Pain consists of both a website, styled as an "advocacy community"
for better pain care, and medical education resources distributed to prescribers by the sales force.
It has existed since at least the early 2000s and has been a vehicle for Purdue to downplay the
risks of addiction from long-term opioid use. One early pamphlet, for example, answered
concerns about OxyContin's addictiveness by claiming: "Drug addiction means using a drug to
get 'high' rather than to relieve pain. You are taking opioid pain medication for medical
purposes. The medical purposes are clear and the effects are beneficial, not harmful."
septa—under the heading "Indications of Possible Drug Abuse." In fact, opioid addicts who
resort to these extremes are uncommon; the far more typical reality is patients becoming
dependent and addicted through oral use.28 These depictions misleadingly reassure doctors that,
as long as they do not observe those extreme signs, they need not worry that their patients are
abusing or addicted to opioids. Purdue made Providing Relief Preventing Abuse available to
sales representatives to show or leave with prescribers, including, on information and belief,
New Hampshire prescribers.
Purdue had a particularly close relationship with APF, which produced numerous
publications that falsely and misleadingly portrayed the risks and benefits of opioids. Purdue
was APF's second-biggest donor, with donations totaling
Purdue grant letters informed APF that Purdue's contributions reflected the company's
effort to "strategically align its investments in nonprofit organizations that share [its] business
interests," suggesting that funding depended on APF continuing to support Purdue's objectives.
28 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 only 4-17% of the time.
Purdue also sponsored A Policymaker's Guide to Understanding Pain & Its
Management, a 2011 APF publication that claimed that pain generally had been "undertreated"
due to "[m]isconceptions about opioid addiction" and asserted, without basis, that "less than 1%
of children treated with opioids become addicted." A Policymaker's Guide also perpetuated the
misleading concept of pseudoaddiction. At least one New Hampshire prescriber received it and
it is still available online.29
Purdue provided substantial funding to and closely collaborated with APF in
creating A Policymaker's Guide. Purdue provided a $26,000 grant for its development and
distribution and kept abreast of the content of the guide as it was formulated. On information
and belief, based on Purdue's close relationship with APF and the periodic reports APF provided
to Purdue about the project, Purdue had editorial input into A Policymaker's Guide.
Purdue also maintained a website, www.inthefaceofpain.com, that downplayed the
risks of chronic opioid therapy. In the Face of Pain, which Purdue deactivated in October 2015
following an investigation by the New York Attorney General, was another example of
unbranded marketing; although it featured the Purdue copyright at the bottom of each page, the
site did not refer to Purdue products in particular and cultivated the "impression that it [was]
neutral and unbiased."30
In the Face of Pain asserted that policies limiting access to opioids are "at odds
with best medical practices" and encouraged patients to be "persistent" in finding doctors who
General of the State of New York, In the Matter of Purdue Pharma L.P.,
Assurance No.: 15-151 (August 19, 2015).
will treat their pain. While a document linked from the website briefly mentioned opioid abuse,
the site itself did not—not once—mention the risk of addiction, a risk so significant that it
requires a black -box warning on its drug labels. At the same time, the website contained
testimonials from several dozen physician "advocates" speaking positively about opioids but
failed to disclose that from 2008 to 2013, 11 of these advocates received a total of $231,000 in
payments from Purdue.31
As laid out in Section IV.A.2, Purdue's claims regarding addiction are contrary to
longstanding scientific evidence, and its failures to disclose the risk of addiction are material
given both the magnitude of the risk and the grave consequences of addiction.
Overstating the efficacy of screening tools
Purdue has falsely instructed New Hampshire prescribers and patients that
addiction risk screening tools, patient contracts, urine drug screens, and similar strategies allow
health care providers to safely prescribe opioids to patients, including patients predisposed to
addiction, and has failed to disclose the lack of evidence that these strategies will mitigate
Such misrepresentations make health care providers more comfortable prescribing
opioids to their patients, and patients more comfortable starting chronic opioid therapy. These
misrepresentations were especially insidious because Purdue aimed them at general practitioners
and family doctors who lack the time and expertise to closely manage higher-risk patients on
opioids. Moreover, these misrepresentations were critical to assure doctors, who were beginning
to see or hear about the rising tide of opioid addiction, that they could safely prescribe opioids in
General of the State of New York, In the Matter of Purdue Pharma L.P.,
Assurance No.: 15-151 (August 19, 2015).
their own practices and that addiction was not unavoidable, but the result of other prescribers
failing to rigorously manage and weed out problem patients.
Purdue conveyed these messages in its in-person sales calls. One former Purdue
sales representative in New Hampshire acknowledged discussing with health care providers that
they could screen out patients at high risk of addiction through urine tests and patient contracts.
Prescribers reported being encouraged to use screening tools, and many prescribers said they
used screening tools and patient opioid agreements to manage addiction risk.
One of these is the "Opioid Risk Tool" created by prominent opioid advocate Dr.
. It is a five question, one-minute
screening tool that relies on patient self-reporting of a personal history of substance abuse, sexual
abuse, or "psychological disease"— particularly unlikely given the sensitive topic and the nature
of addiction—to purportedly allow doctors to manage the risk of opioid abuse and addiction.
Purdue also has promoted screening tools as a reliable means to manage addiction
risk in CME and scientific conferences attended by or available to New Hampshire prescribers.
Purdue sponsored a 2011 CME taught by Dr. Lynn Webster titled Managing
Patient's Opioid Use: Balancing the Need and Risk. This presentation deceptively instructed
prescribers that screening tools, patient agreements, and urine tests prevented "overuse of
prescriptions" and "overdose deaths."
Purdue funded 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. At least one New Hampshire prescriber recalls reviewing this CME.
Purdue uses its involvement in the College on the Problems of Drug Dependence
("CPDD"), which promotes scientific research and professional development to support
addiction prevention professionals, to promote the idea that addiction risk can be managed. A
Purdue employee served on the CPDD board of directors. Purdue has been able to present an
outsized number of talks—with very different messages from non-Purdue talks—at each CPDD
conference. One of Purdue's consistent themes is that "bad apple" patients, not opioids, are the
source of the addiction crisis, and that once those patients are identified, doctors can safely
prescribe opioids without addicting patients. These were national conferences attended by
hundreds of addiction treatment specialists from across the country, including, upon information
and belief, from New Hampshire.
The 2016 CDC Guideline confirms the falsity of Purdue's claims about the utility
of patient screening and management strategies in managing addiction risk. The Guideline notes
that there are no studies assessing the effectiveness of risk mitigation strategies—such as
screening tools or patient contracts—"for improving outcomes related to overdose, addiction,
abuse, or misuse." The Guideline recognizes that available risk screening tools "show insufficient
accuracy for classification of patients as at low or high risk for [opioid] abuse or misuse" and
counsels that doctors "should not overestimate the ability of these tools to rule out risks from
long-term opioid therapy." (Emphasis added.)
Failing to disclose increased risk of higher doses
Purdue has falsely claimed to New Hampshire prescribers and consumers that
opioids could be taken in ever-increasing strengths to obtain pain relief, without disclosing that
higher doses increased the risk of addiction and overdose. Further, as described in more detail in
Section IV.B.3, Purdue encouraged doctors to prescribe higher doses, rather than prescribe
OxyContin more frequently than twice-a-day—despite knowing that OxyContin frequently did
not provide 12 hours of relief.
unless doctors felt comfortable
prescribing increasingly high doses of opioids, they may not have maintained patients on the
These omissions were false and misleading in their own right and also failed to
correct Purdue's earlier misinformation regarding higher doses, letting stand the dangerous
impression that prescribers could increase the dose without added risk.
Purdue and Purdue-sponsored publications and CMEs available in New
Hampshire also misleadingly suggested that higher opioid doses carried no added risk.
Through at least June 2015, Purdue's In the Face of Pain website promoted the
notion that if a patient's doctor did not prescribe what, in the patient's view, was a sufficient
dose of opioids, the patient should find another doctor who would.
A Policymaker 's Guide, the 2011 publication on which Purdue collaborated with
APF, taught that dose escalations are "sometimes necessary," even unlimited ones, but did not
disclose the risks from high dose opioids. This publication was distributed to at least one New
Hampshire prescriber and is still available online.
Purdue sponsored a CME titled Overview of Management Options and issued by
the American Medical Association ("AMA") in 2013. The CME was edited by Dr. Russell
Portenoy, who received research support, honoraria, and consulting fees from Purdue. It
misleadingly instructed physicians that NSAIDs (like ibuprofen) are unsafe at high doses
(because of risks to patients' kidneys), but did not disclose risks from opioids at high doses.32
This CME was presented online, was available nationwide, and was viewed by at least one New
Hampshire prescriber. It was available online via the AMA through 2014.
These claims conflict with the scientific evidence. Patients receiving high doses
of opioids as part of long-term opioid therapy are three to nine times more likely to suffer
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 opioids' 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.
As confirmed by the CDC in its 2016 Guideline, the "[b]enefits of high-dose
opioids for chronic pain are not established" while the "risks for serious harms related to opioid
32 While there is evidence of adverse effects from NSAIDs at higher doses, the CME was
misleading in that it highlighted the risk from higher doses for one class of drugs, while omitting
it for opioids.
therapy increase at higher opioid dose."' More specifically, the CDC explains that "there is
now an established body of scientific evidence showing that overdose risk is increased at higher
opioid doses."34 The CDC also states that "there is an increased risk for serious harms related to
long-term opioid therapy that appears to be dose-dependent."35 That is why the CDC advises
doctors to "avoid increasing doses" above 90 morphine milligram equivalents per day.36
Among Medicaid patients in New Hampshire, nearly half of patients taking
OxyContin from 2011-2015 were taking the equivalent of the CDC's maximum dose or higher.
OxyContin's highest dose, 80 mg twice per day, is more than twice the CDC's recommended
ceiling (and, as discussed in section IV.B.3, many patients take the drug more frequently).
Overstating the efficacy of abuse-deterrent properties
By the mid-2000s, rampant addiction to and abuse of OxyContin had emerged in
the public eye. Rather than acknowledge that these problems were the inevitable result of
widespread prescribing of OxyContin for chronic pain, Purdue claimed that abuse and addiction
resulted from diversion, with abusers snorting or injecting the drugs. Purdue proposed a solution
in the form of a coating to make the drug more difficult to crush and added elements to make it
unsuitable for injection.
CDC Guideline at 22.
Id, at 24.
Id. at 19. The 2016 CDC Guideline reinforces earlier findings announced by the FDA.
In 2013, the FDA acknowledged "that the available data do suggest a relationship between
increasing opioid dose and risk of certain adverse events." For example, the FDA noted that
studies "appear to credibly suggest a positive association between high-dose opioid use and the
risk of overdose and/or overdose mortality."
Id. at 16.
This reformulated OxyContin was approved by the FDA in April 2010. However,
the FDA noted that "the tamper-resistant properties will have no effect on abuse by the oral route
(the most common mode of abuse)."37 It was not until 2013 that the FDA, in response to a
Citizen Petition filed by Purdue, permitted reference to the abuse-deterrent properties in the
label. When Hysingla ER (extended-release hydrocodone) launched in 2014, the product
included similar AD properties.
Purdue has engaged and continues to engage in deceptive marketing of its AD
opioids—i.e., reformulated OxyContin and Hysingla ER. Purdue sales representatives regularly
use the so-called abuse-deterrent properties of Purdue's opioids as a primary selling point to
differentiate those products from their competitors. Specifically, Purdue detailers: (1) claim that
Purdue's AD formulation prevents tampering and that its AD products cannot be crushed or
snorted; (2) claim that Purdue's AD opioids prevent or reduce opioid abuse, diversion, and
addiction; (3) assert or suggest that Purdue's AD opioids are "safer" than other opioids; and (4)
fail to disclose that Purdue's AD opioids do not impact oral abuse or misuse and that its AD
properties are and can be easily overcome.
These statements and omissions by Purdue are false and misleading and are
inconsistent with the FDA-approved labels for Purdue's AD formulations — which indicate that
abusers seek them because of their high likability when snorted, that their AD properties can be
defeated, and that they can be abused orally notwithstanding their abuse-deterrent properties, and
which do not indicate that AD formulations prevent or reduce abuse, misuse, or diversion.
NDA 22-272 OxyContin, Division Director Summary Review for Regulatory Action
(Dec. 30, 2009),
Purdue knew and should have known that "reformulated OxyContin is not better
at tamper resistance than the original OxyContin"38 and is still regularly tampered with and
abused. Websites and message boards used by drug abusers, such as bluelight.org and reddit,
also report a variety of ways to tamper with OxyContin and Hysingla ER, including through
grinding, microwaving then freezing, or drinking soda or fruit juice in which a tablet is
dissolved. A publicly available Citizen Petition submitted to the FDA in 2016 by a drug
manufacturing firm challenged Purdue's abuse-deterrent labeling based on the firm's ability to
easily prepare OxyContin to be snorted or injected. The Attorney General's Office witnessed a
demonstration of these methods.
A 2015 non-Purdue
study also shows that many opioid addicts are abusing Purdue's AD opioids through oral intake
or by defeating the AD mechanism. Indeed, one-third of the patients in the study defeated the
AD mechanism and were able to continue inhaling or injecting the drug. To the extent that the
abuse of Purdue's AD opioids was reduced, those addicts simply shifted to other drugs such as
This conclusion was embedded, but misleadingly not acknowledged, in a 2013
article presented by Purdue employees based on review of data from poison control centers.39
The authors' stated finding — that AD OxyContin can reduce abuse — ignores important negative
findings. Data reported in the study reveals that abuse merely shifted to other drugs and that,
In re OxyContin, 1:04-md-01603-SHS, Docket No 613, Oct. 7, 2013 hr'g, Test. of Dr.
Mohan Rao, 1615:7-10.
Changes in oxycodone and heroin exposures in the National Poison Data System after
introduction of extended-release oxycodone with abuse-deterrent characteristics
when the actual incidence of harmful exposures was calculated, there were more harmful
exposures to opioids (including heroin) after the reformulation of OxyContin. Finally, the article
highlights in a pull -out box that AD still preserves "analgesic benefit to patients," but does not
present any data that supports this conclusion. In short, the article appears biased towards
emphasizing advantages and ignoring disadvantages of AD OxyContin—reflecting the same
pattern of tilting scientific research and literature to support the promotion of opioids discussed
in Section IV.A.2.
The 2016 CDC Guideline confirms that "[n]o studies" support the notion that
"abuse-deterrent technologies [are] a risk mitigation strategy for deterring or preventing abuse,"
noting that the technologies "do not prevent opioid abuse through oral intake, the most common
route of opioid abuse, and can still be abused by nonoral routes." Tom Frieden, the Director of
the CDC, has further reported that his staff could not find "any evidence showing the updated
opioids [AD formulations] actually reduce rates of addiction, overdoses, or death." 40
Purdue knew that promotion of AD opioids as reducing abuse or addiction was
not supported by evidence.
40 Perrone, Drugmakers push profitable, but unproven, opioid solution, 12/15/16.
In 2015, claiming a need to further assess its data, Purdue abruptly withdrew a
supplemental new drug application related to reformulated OxyContin one day before FDA staff
were to release their assessment of the application. The staff review preceded a FDA advisory
committee meeting related to new studies by Purdue "evaluating the misuse and/or abuse of
reformulated OxyContin" and whether those studies "have demonstrated that the reformulated
product has a meaningful impact on abuse."4I The fact that such data has never been presented
to the FDA gives rise to an inference that the data would not have supported claims that
OxyContin's AD properties have not reduced abuse or misuse.
Yet despite the qualifying language in Purdue's label and its own evidence — and
lack of evidence — regarding the impact of its AD formulations in reducing abuse, Dr. J. David
Haddox, the Vice President of Health Policy for Purdue, falsely claimed in 2016 that the
evidence does not show that Purdue's AD opioids are being abused in large numbers.
In New Hampshire, Purdue's sales representatives have made claims about abuse
deterrence that go well beyond the drugs' labeling. Even before the 2013 changes to the
OxyContin label, Purdue representatives in New Hampshire emphasized OxyContin's purported
41 Meeting Notice, Joint Meeting of the Drug Safety and Risk Management Advisory
Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of
Meeting, May 25, 2015, 80 FR 30686.
AD properties to prescribers as a featured selling point. Both before and after the labeling
changes, representatives stated or implied that reformulated OxyContin was difficult to abuse or
divert, though there has been no approved language label or evidence supporting the claim that
OxyContin is less'likely to be diverted. A Bedford physician recalled being told by a Purdue
sales representative OxyContin is "as impossible as can be to use in a non-oral formulation."
And a Newport doctor described the abuse-deterrence message as "a hard sell"—"not subtext,
but overt text." Representatives made the same claims about Hysingla ER. Purdue
representatives also have stated or implied to New Hampshire prescribers that opioids with AD
properties are less likely to be sought after and less addictive and did not disclose, despite their
promotion of AD, that even AD formulations are subject to oral abuse, can be tampered with,
and shift abuse to other opioids. Purdue also promoted its abuse-deterrence heavily to third party
payors that covered New Hampshire patients.
The recollections of New Hampshire prescribers about such marketing claims are
corroborated by data obtained from a market research and analytics company that performs
promotional message tracking in the pharmaceutical industry. The data consist of verbatim
messages from detailing activity to a sample of prescribers based on the panelists' perception of
the main message of the promotion. The responses received by the research company are
reported word-for-word as "verbatims." Verbatims for the 2011-2014 period show Purdue
detailers in the Northeast emphasizing the "low" or "no" abuse potential of OxyContin. Given
the consistency of sales messages, which are centrally controlled and directed, it is reasonable to
infer that deceptive messages delivered to prescribers in the Northeast region were delivered to
New Hampshire providers, as well.
As described in Section IV.C, infra, Purdue has claimed that its introduction of
AD opioids reflects and furthers its commitment to help address the opioid crisis. However,
Purdue's development and (misleading) promotion of AD opioids seems driven by Purdue's
effort to preserve its profits, not to rein in opioid misuse. Generic versions of OxyContin, which
became available in February 2011, threatened to erode Purdue's share of the long-acting opioid
market and the price Purdue could charge. Through a Citizen Petition, Purdue was able to secure
a determination by the FDA in April 2013 that original OxyContin should be removed from the
market as unsafe (lacking AD properties), and thus non-AD generic copies could not be sold. As
a result, Purdue extended its branded exclusivity for OxyContin for as long as the patent
protection on the AD formulation coating remains in place.42
According to FDA's "Orange Book," the latest any patent for OxyContin expires is
August 24, 2027.
Purdue's false and misleading marketing of the benefits of its AD formulation has
preserved and expanded its sales of its opioids by persuading doctors who might have curtailed
their prescribing to continue writing prescriptions of opioids and switch to Purdue's abusedeterrent formulations in the mistaken belief that AD formulated opioids are safer. It also
allowed prescribers to discount evidence of opioid addiction and abuse and attribute it to other,
less safe opioids—i.e., it allowed them to believe that while patients might abuse, become
addicted to, or die from other, non-AD opioids, Purdue's opioids did not carry that risk.
Purdue Has Grossly Overstated the Benefits of Chronic Opioid Therapy While
Failing to Disclose the Lack of Evidence Supporting Long-Term Use.
To convince New Hampshire prescribers and patients that opioids should be used
to treat chronic pain, despite the unavoidable risk of addiction, Purdue had to persuade them that
there is a significant upside to long-term opioid use. But as the 2016 CDC Guideline makes
clear, there is "insufficient evidence to determine the long-term benefits of opioid therapy for
chronic pain." (Emphasis added.) In fact, the CDC found that "[n]o evidence shows a long-term
benefit of opioids in pain and function versus no opioids for chronic pain with outcomes
examined at least 1 year later (with most placebo-controlled randomized trials < 6 weeks in
duration)" and that other treatments were more or equally beneficial and less harmful than longterm opioid use. The FDA, too, has recognized the lack of evidence to support long-term opioid
use. In 2013, the FDA stated that it was "not aware of adequate and well-controlled studies of
opioids use longer than 12 weeks." As a result, the CDC recommends that opioids be used not in
the first instance and only after prescribers have exhausted alternative treatments.
Nevertheless, building on its earlier marketing, Purdue has continued to tout the
purported benefits of long-term opioid use, while falsely and misleadingly suggesting that these
benefits were supported by scientific evidence.
Based on interviews with former employees and New Hampshire prescribers,
Purdue sales representatives regularly do not disclose in their sales conversations the lack of
evidence supporting long-term use. One former Purdue sales representative in New Hampshire
recalled that he "discussed use of the medication for as long as the patient was in pain," but he
never raised with prescribers the fact that opioid clinical trials were limited to use lasting 12 to
16 weeks. Another former sales representative similarly acknowledged that she did not discuss
with prescribers what evidence there was to support use beyond 12 to 16 weeks.
The OxyContin "Conversion and Titration Guide" distributed by sales
representatives to New Hampshire prescribers likewise misleadingly promotes long-term use. A
2007 version of that guide recommended that "the need for opioid therapy should be reassessed
periodically (e.g., every 6 to 12 months) as appropriate for patients on chronic therapy," but did
not disclose the absence of evidence supporting safety and efficacy of use for 6-12 months. The
2012 version of this guide distributed in New Hampshire omits the parenthetical "(eg, every 6 to
12 months)," but it still conveys that chronic opioid therapy is appropriate without disclosing the
lack of evidence for use beyond 12 weeks, and without correcting the previous misinformation
Purdue conveyed to prescribers.
Purdue also has published misleading studies to enhance its view that opioids are
effective long-term for chronic pain conditions. One study, promisingly titled Treatment of
Osteoarthritis Pain with Controlled Release Oxycodone or Fixed Combination Oxycodone Plus
Acetaminophen Added to Nonsteroidal Antiinflammatory Drugs: A Double Blind, Randomized,
Multicenter, Placebo Controlled Trial, asserts that OxyContin is safe and effective for chronic
pain condition osteoarthritis. The study, sponsored by Purdue, involved providing oxycodone
for 30 days, and then randomizing participants and providing provide placebo, IR oxycodone
with acetaminophen (like Percocet), or OxyContin. Only 107 of the 167 patients went on to the
second phase of the study and most who withdrew left because of adverse events (nausea,
vomiting, drowsiness, dizziness or headache) or ineffective treatment. Despite relating to a
chronic condition, opioids were provided only short-term. The authors even acknowledge that
the "results... should be confirmed in trials of longer duration to confirm the role of opioids in a
chronic condition such as OA [osteoarthritis]."43 Yet, the authors conclude, "This clinical
experience shows that opioids were well tolerated with only rare incidence of addiction and that
tolerance to the analgesic effects was not a clinically significant problem when managing
patients with opioids longterm". This statement is not supported by the data — a substantial
number of patients dropped out because of adverse effects, there was no reported data regarding
addiction, and the study was not long-term. Like other Purdue studies, this one seems
Purdue recognized its own lack of competent evidence that opioids are
appropriate and useful long-term
43 Smith, S. R., et al. "Comparative pain reduction of oral non-steroidal anti-inflammatory
drugs and opioids for knee osteoarthritis: systematic analytic review." Osteoarthritis and
cartilage 24.6 (2016): 962-972.
The plan then identified the proposed title and authors for studies to support that
message and target journals in which to publish these studies.
Purdue also has claimed--also without evidence--that long-term opioid use will
improve patients' daily function and quality of life. Based on interviews with prescribers,
Purdue's sales representatives have regularly delivered this message in their sales calls.
Purdue and Purdue-sponsored materials distributed or available in New
Hampshire reinforce this message. The 2011 publication A Policymaker 's Guide erroneously
claimed that "multiple clinical studies have shown that opioids are effective in improving daily
function and quality of life for chronic pain patients." A series of medical journal advertisements
for OxyContin in 2012 presented "Pain Vignettes"—case studies featuring patients with pain
conditions persisting over several months—that implied functional improvement. For example,
one advertisement described a "writer with osteoarthritis of the hands" and implied that
OxyContin would help him work more effectively.
These claims of functional improvement were both unsubstantiated by and
contrary to the scientific evidence at the time. The FDA and other federal agencies have made
this clear for years. 45 Most recently, the 2016 CDC Guideline concluded that "there is no good
The FDA has warned other drug makers that claims of improved function and quality
of life were misleading. See, Warning Letter from Thomas Abrams, Dir., FDA Div. of Mktg.,
Adver., & Commc'ns, to Doug Boothe, CEO, Actavis Elizabeth LLC (Feb. 18, 2010), available
at (rejecting claims that the opioid Kadian had an "overall positive impact on a patient's work,
physical and mental functioning, daily activities, or enjoyment of life."); Warning Letter from
Thomas Abrams, Dir., FDA Div. of Mktg., Adver., & Commc'ns, to Brian A. Markison,
Chairman, President and Chief Executive Officer, King Pharmaceuticals, Inc. (March 24, 2008),
(finding the claim that "patients who are treated with [Avinza (morphine sulfate ER)] experience
an improvement in their overall function, social function, and ability to perform daily activities .
. . has not been demonstrated by substantial evidence or substantial clinical experience."). The
FDA's warning letters were available to Purdue on the FDA website.
evidence that opioids improve pain or function with long-term use."46 (Emphasis added.) The
CDC also noted that the risks of addiction and death "can cause distress and inability to fulfill
major role obligations."47 As a matter of common sense (and medical evidence), drugs that can
kill patients or commit them to a life of addiction or recovery do not improve their function and
quality of life.
Purdue Has Misleadingly Promoted OxyContin as Supplying Twelve Hours of
To convince New Hampshire prescribers and patients to use OxyContin, in
particular, Purdue has misleadingly promoted the drug as providing 12 continuous hours of pain
relief with each dose. In reality, OxyContin does not last for 12 hours in many patients, a fact
Purdue has known since the product's launch. Purdue points to labeling that it sought from the
FDA, and for which the company is legally responsible, directing 12 -hour dosing. Purdue
sought that dosing, despite knowing that it was inadequate for—and dangerous to—many
patients, in order to maintain a competitive advantage over more-frequently dosed opioids. Yet
Purdue has gone well beyond the label's instructions to take OxyContin every 12 hours by
affirmatively claiming that OxyContin lasts for 12 hours and by failing to disclose that
OxyContin fails to provide 12 hours of pain relief to many patients.
These misrepresentations, which Purdue has made since 1996 and continues to
make through the present day, are particularly dangerous because the inadequate dosing helps
CDC Guideline at 20.
fuel addiction, as laid out below. Purdue has doubled down on both its misstatements and the
resulting harm to patients by suggesting to prescribers that the solution to end-of-dose failure is
not more-frequent dosing but higher doses—which themselves pose greater risks, as discussed in
OxyContin has been FDA-approved for twice-daily—"Q12"—dosing frequency
since its debut in 1996. Yet it was a business decision that drove the company to submit
OxyContin for approval with 12-hour rather than 8-hour dosing and to promote OxyContin as
providing 12 hours of pain relief.
Under FDA guidelines for establishing dosing, Purdue merely had to show that
OxyContin lasted for 12 hours for at least half of patients, and Purdue submitted a single study
that cleared that bar. While the OxyContin label indicates that "[t]here are no well-controlled
clinical studies evaluating the safety and efficacy with dosing more frequently than every 12
hours," the reason is that Purdue has not conducted any such studies.
From the outset, Purdue leveraged 12-hour dosing to promote OxyContin as
providing continuous, round-the-clock pain relief with the convenience of not having to wake to
take a third or fourth pill. The 1996 press release for OxyContin touted 12-hour dosing as
providing "smooth and sustained pain control all day and all night." But the FDA has never
48 At the time of OxyContin's launch, the only ER/LA opioids available were morphine
tablets or fentanyl patches, regarded as more powerful than necessary for moderate pain.
Additional ER/LA opioids came on the market in 2006 with the introduction of Opana ER
(oxymorphone); Nucynta ER (tapentadol) in 2011; and Zohydro ER (hydrocodone) in 2013.
approved such a marketing claim. To the contrary, the FDA found in 2008, in response to a
Citizen Petition by the Connecticut Attorney General, that a "substantial number" of chronic pain
patients taking OxyContin experienced "end of dose failure"—i.e., little or no pain relief at the
end of the dosing period.
As described in paragraph 33, Purdue also disseminated to prescribers a chart that
was designed to demonstrate the constant release of OxyContin's active ingredient, through the
end of the dosing period. However, Purdue manipulated that chart to compress the y-axis and
show a less steep decline in OxyContin's effect.
Moreover, Purdue itself long has known, dating to its development of OxyContin,
that the drug wears off well short of 12 hours in many patients. In one early Purdue clinical
trial, a third of patients dropped out because the treatment was ineffective. Researchers changed
the rules to allow patients to take supplemental painkillers—"rescue medication"—in between
OxyContin doses. In another study, most patients used rescue medication, and 95% resorted to it
at least once. In other research, the drug wore off in under 6 hours in 25% of patients and in
under 10 hours in more than 50%.
End-of-dose failure renders OxyContin even more dangerous because patients
begin to experience distressing psychological and physical withdrawal symptoms, followed by a
euphoric rush with their next dose—leading to a cycle that fuels a craving for OxyContin. For
this reason, Dr. Theodore Cicero, a neuropharmacologist at the Washington University School of
Medicine in St. Louis, has called OxyContin's 12-hour dosing "the perfect recipe for
addiction."49 Many patients will exacerbate this cycle by taking their next dose ahead of
Harriet Ryan, 'You Want a Description of Hell?' OxyContin's 12-Hour Problem,"
Los Angeles Times, May 5, 2016 http://www.latimes.com/projects/oxycontin-partl/
schedule or resorting to a rescue dose of another opioid, increasing the overall amount of opioids
they are taking.
Purdue has remained committed to 12-hour dosing not because it is true but
because it is key to OxyContin's market dominance and comparatively high price; without this
advantage, the drug had little to offer over less expensive, short-acting opioids. In a 2004 letter to
the FDA, Purdue acknowledged that it had not pursued approval for a recommendation of more
frequent dosing in the label (e.g. every 8 hours) because 12-hour dosing was "a significant
Without appropriate caveats, promotion of 12-hour dosing by itself is misleading
because it implies that the pain relief supplied by each dose lasts 12 hours, which Purdue knew to
be untrue for many, if not most, patients. FDA approval of OxyContin for Q12 dosing does not
give Purdue license to misrepresent the duration of pain relief it provides to patients, which
Purdue knew was not 12 hours; moreover, Purdue had a responsibility to correct its label to
reflect appropriate dosing, to disclose to prescribers what it knew about OxyContin's actual
duration, and not to promote more dangerous higher dosing, rather than increased frequency of
use, just because of its marketing advantage.50
Yet, based on interviews with former Purdue employees and New Hampshire
prescribers, 12-hour dosing—without further explanation—has been and remains a principal
feature of Purdue's marketing.
Moreover, based on interviews with prescribers, Purdue sales representatives in
50 Kadian, an opioid manufactured by Allergan, was designed to be taken once a day, but
the label acknowledges and advises dosing of up to every 12 hours for certain patients.
New Hampshire have gone even farther than promoting dosing, falsely stating in sales calls that
OxyContin provides a full 12 hours of pain relief.
According to the former regional sales manager, Purdue was aware of complaints
by physicians, including physicians in New Hampshire, that OxyContin does not supply 12 hours
of pain relief in some patients. Purdue also was aware of some physicians' practice of
prescribing OxyContin more frequently than 12 hours—a common occurrence, according to
interviews with New Hampshire prescribers.
Purdue's promoted solution to this problem is to increase the dose, rather than the
frequency, of prescriptions, even though higher dosing carries its own risks—including increased
danger of addiction, overdose, and death. It is like flying a plane higher, knowing that it will
take longer to crash, rather than fueling more frequently to prevent the crash; in the context of
OxyContin, it means that patients will experience higher highs and lower lows, increasing their
craving for their next pill. Nationwide, based on an analysis by the Los Angeles Times, more
than 52% of patients taking OxyContin longer than three months are on doses greater than 60
milligrams per day—which converts to the 90 milligrams of morphine equivalent that the 2016
CDC Guideline urges prescribers to "avoid" or "carefully justify." As noted above, an analysis
of New Hampshire's own Medicaid data indicates 49% of OxyContin users were on this
dangerous dose. Moreover, 41% of OxyContin prescriptions paid for by New Hampshire's
Medicaid program were for more frequent than 12-hour dosing.
interviews with prescribers and a former Purdue employee, Purdue's representatives offered this
advice in their sales calls to New Hampshire physicians. But this advice was not accompanied
by appropriate warnings regarding increased risk of addiction associated with increased doses, as
discussed in Section IV.B.1.c.
Purdue Also Engaged In Other Unlawful and Fraudulent Conduct by Failing to
Report Suspicious Prescribing.
Purdue has deceptively and unfairly failed to report to New Hampshire authorities
illicit or suspicious prescribing of its opioids, even as it has publicly and repeatedly touted its
"constructive role in the fight against opioid abuse," including its commitment to AD opioids
and its "strong record of coordination with law enforcement."' Purdue went so far as to convert
evidence of opioid abuse into a promotional opportunity.
Purdue, Setting The Record Straight On OxyContin's FDA Approved Label, May 5,
2016, http://www.purduepharma.com/news-media/get-the-facts/setting-the-record-straight-onoxycontins-fda-approved-label/; Purdue, Setting The Record Straight On Our Anti-Diversion
Programs, July 11, 2016, http://www.purduepharma.com/news-media/get-the-facts/setting-therecord-straight-on-our-anti-diversion-programs/.
As described in Section IV.B.1, Purdue's public stance long has been that "bad
apple" patients and drug diversion to illicit secondary channels—and not widespread prescribing
of OxyContin and other opioids for chronic pain—are to blame for widespread addiction and
abuse. To address the problems of illicit use and diversion, Purdue promotes its funding of
various drug abuse and diversion prevention programs and introduction of AD opioids. This
allows Purdue to present itself as a responsible corporate citizen while continuing to profit from
the commonplace prescribing of its drugs, even at high doses for long-term use.
At the heart of Purdue's public outreach is the claim that it works hand-in-glove
with law enforcement and government agencies to combat opioid abuse and diversion. Purdue
has consistently trumpeted this partnership since at least 2008, and the message of close
cooperation features in virtually all of Purdue's recent pronouncements in response to public
scrutiny of opioid abuse.
Touting the benefits of AD formulations, Purdue's website asserts: "[W]e are
acutely aware of the public health risks these powerful medications create . ... That's why we
work with health experts, law enforcement, and government agencies on efforts to reduce the
risks of opioid abuse and misuse .
Purdue's statement on "Opioids Corporate
Responsibility" likewise states that "[f]or many years, Purdue has committed substantial
52 Purdue website, Opioids With Abuse-Deterrent Properties, http://www.purduepharma.
resources to combat opioid abuse by partnering with . . . communities, law enforcement, and
government."' And, responding to criticism of Purdue's failure to report suspicious prescribing
to government regulatory and enforcement authorities, the website similarly proclaims that
Purdue "ha[s] a long record of close coordination with the DEA and other law enforcement
stakeholders to detect and reduce drug diversion."54
These public pronouncements create the misimpression that Purdue is proactively
working with law enforcement and government authorities, nationwide and in New Hampshire,
to root out drug diversion, including the illicit prescribing that can lead to diversion. It aims to
distance Purdue from its past conduct in deceptively marketing opioids, which gave rise to its
2007 criminal plea, and make its current marketing seem more trustworthy and truthful. In fact,
Purdue has consistently failed to report suspicious prescribing it observed to authorities,
facilitating, rather than closely coordinating with law enforcement to stop, opioid diversion.
Purdue can track distribution and prescriptions of its opioids down to the retail
and prescriber level.
Through its extensive network of sales representatives, Purdue also has a window into
53 Purdue website, Opioids Corporate Responsibility, http://www.purduepharma.com/
news-media/op io ids-corporate-responsibility/
54 Purdue, Setting The Record Straight On Our Anti-Diversion Programs, July 11, 2016,
http://www.purduepharma.com/news-media/get-the-facts/setting-the-record-straight-on-our-antidiversion-programs/. Contrary to its public statements. Purdue seems to have worked behind the
scenes to rush back against law enforcement.
the practices of countless doctors and can identify those whose waiting rooms are overcrowded,
whose parking lots have numerous out-of-state vehicles, whose patients seem young and healthy
or homeless—among other red flags of diversion.
Purdue has identified those doctors— internally. Since at least 2002, Purdue has
maintained a database of health care providers suspected of inappropriately prescribing
OxyContin or other opioids. According to Purdue, physicians could be added to this database
based on observed indicators of illicit prescribing such as excessive numbers of patients, cash
transactions, patient overdoses, and unusual prescribing of the highest-strength pills (80 mg
OxyContin pills or "80s," as they were known on the street, were a prime target for diversion).
Purdue has said publicly that "[o]ur procedures help ensure that whenever we
observe potential abuse or diversion activity, we discontinue our company's interaction with the
prescriber or pharmacist and initiate an investigation."55 According to Purdue, health care
providers added to the database no longer are detailed, and sales representatives receive no
compensation tied to these providers' prescription.
Yet, Purdue failed to cut off these providers' opioid supply at the pharmacy
level—meaning Purdue continued to generate sales revenue from their prescriptions—and failed
to report these providers to state medical boards or law enforcement. Data Purdue possessed and
concerns flagged by its own employees, wholesalers, and other sources identified hundreds of
suspicious pharmacies each year. Yet, in an interview with the Los Angeles Times, which first
55 Purdue, Setting The Record Straight On Our Anti-Diversion Programs, July 11, 2016,
reported this story, Purdue's former senior compliance officer acknowledged that in five years of
investigating suspicious pharmacies, the company never stopped the supply of its opioids to a
pharmacy, even where Purdue employees personally witnessed the diversion of its drugs, and
regularly failed to report suspicious orders to the DEA.
The same was true of prescribers. Despite its knowledge of illicit prescribing,
Purdue did not report its suspicions, for example, until years after law enforcement shut down a
Los Angeles clinic that Purdue's district manager described internally as "an organized drug
ring" and that prescribed more than 1.1 million OxyContin tablets. Some of the pills diverted
while Purdue stood by are alleged to have reached New Hampshire. The New York Attorney
General's settlement with Purdue specifically cited the company for failing to adequately address
Federal regulation requires manufacturers of controlled substances to monitor and
report suspicious conduct. See 21 U.S.C. 823(e); 21 C.F.R. 1301.74(b). In fact, the DEA in
2006 and 2007 sent letters to manufacturers and wholesalers of opioids, including Purdue,
reminding them of their legal "obligation to design and operate a system to disclose . . .
suspicious orders of controlled substances," to inform the DEA "of suspicious orders when
discovered," and to "maintain effective controls against diversion" of controlled substances.
Registrants' "responsibility does not end merely with the filing of a suspicious order report.
Registrants must conduct an independent analysis of suspicious orders prior to completing a sale
to determine whether the controlled substances are likely to be diverted from legitimate
In New Hampshire, Purdue not only failed to share information on suspicious
prescribing with DEA, but failed to conduct any investigations of prescribers.
The failure to report or investigate suspicious prescribers did not reflect a lack of
suspicious conduct. On information and belief, based on analyses of New Hampshire
prescription data, there are at least 6 additional prescribers over the past 5 years whom Purdue
could and should have investigated for suspicious prescribing based on Purdue's own criteria and
data. These prescribers stood out from others based on either their overall volume of
prescribing, the high numbers or ratios of 80 mg OxyContin prescribed, or both.
Only recently did Purdue provide information to the Board of Medicine about its
internal database of suspicious prescribers, and only after the Board affirmatively requested it.
In a September 2, 2016 letter to the Board, Purdue identified 13 health care providers who, it
said, had been added to its internal no-call database over the years. According to Purdue, all 13
names were added to the list based on licensing actions brought by the Board or on media reports
regarding potential misconduct—i.e., none were added based on Purdue-initiated investigations.
By Increasing Opioid Prescriptions and Use, Purdue's Deceptive Marketing Scheme
Has Fueled the Opioid Epidemic and Significantly Harmed New Hampshire and Its
Purdue's misrepresentations have prompted New Hampshire health care providers
to prescribe, patients to take, and payors to cover opioids for the treatment of chronic pain.
Through its early marketing, it set out to—and did— overcome barriers to widespread
prescribing of opioids for chronic pain with deceptive messages about the risks and benefits of
long-term opioid use. Through its continued deceptive marketing from 2011 to the present, it
has both benefited from and built upon its prior misrepresentations, sustaining and expanding a
market for its opioids.
Purdue's deceptive marketing substantially contributed to an explosion in the use
of opioids. Approximately 20% of the population between the ages of 30 and 44, and nearly
30% of the population over 45, have used opioids. Opioids are the most common treatment for
chronic pain, and 20% of office visits now include the prescription of an opioid.
Both historically and currently, Purdue accounts for the lion's share of sales of
brand name opioids.
In New Hampshire for the
period 2011-15, Purdue accounted for 43% of branded opioid prescription fills under Medicaid,
55% in the state employee health plan, and
. New Hampshire Medicaid spent $3.5 million on OxyContin from
2011-2015, with 7,886 prescriptions.
The increase in prescribing opioids corresponds with Purdue's marketing push.
As shown in the chart below, according to data obtained from a marketing research company,
Purdue's spending nationwide on marketing of opioids—including all of the drugs at issue
here—stood at roughly $15 million per quarter in 2000. Its spending actually decreased from
2000 to 2007, as the company came under investigation by the U.S. Department of Justice and
various state attorneys general. But by 2010, with the introduction of Butrans and reformulated
All Promotional Spending on Non-Injectable Opioids by Defendant Purdue (Quarterly)
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 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
OxyContin, Purdue ramped up its marketing once again. In 2011, Purdue's marketing spiked to
more than $25 million per quarter, and by the end of 2015, with the introduction of Hysingla ER,
it soared to more than $40 million per quarter.
By far, the largest component of this spending was sales representative visits to
individual prescribers, with total detailing expenditures rising from roughly $45 million annually
in 2000 to more than $108 million in 2014. Purdue's marketing expenditures in New Hampshire
are not available, but they can be expected to be consistent with the national data.
Purdue devotes these resources to detailing—notwithstanding increasing efforts of
hospitals and physician practice groups to restrict access—because it knows that in-person
marketing works. The effects of sales calls on prescribing behavior are well-documented in the
literature, including in a 2009 study correlating the nearly 10-fold increase in OxyContin
prescriptions between 1997 and 2002 to Purdue's doubling of its sales force and trebling of sales
Physicians often are unwilling to acknowledge any impact of detailing on their
prescribing, but some recognized its effect. According to one Carroll County doctor detailed by
Purdue, "if they tell you about [the drug], the next time you see a patient, you think about it. It
imprints." She believed that the detailing caused her to prescribe Butrans because the drug was
"fresh in her mind" when she saw a patient with pain. Another physician from Amherst, who
also was detailed by Purdue, noted: "I ask myself if it affects my prescribing. You bet it does.
If it didn't, they wouldn't do it."
Through third parties, however, Purdue continues to obfuscate the manifest link
between detailing and access to opioids. For example, the Purdue-funded Center for Lawful
Access and Abuse Deterrence maintains a fact sheet on its website labeling as "myth" the notion
that "[i]ncreased access to controlled substances is directly related to . . . aggressive marketing
tactics to prescribers by pharmaceutical sales representatives."
Even physicians who assiduously avoid direct pharmaceutical marketing have
been influenced through more subtle channels. One such physician interviewed by the State had
decided on principle, years ago, to eliminate contact with sales representatives. In 2007, he
began treating a patient with a rare disorder that caused inflammation and excruciating pain
inside her eye. Because he had not prescribed opioids for chronic pain before, he educated
himself by reading publications and taking CME. Among these were the Purdue-influenced
book Responsible Opioid Prescribing and the Purdue-sponsored CMEs Chronic Pain
Management and Opioid Use: Easing Fears, Managing Risks, and Improving Outcomes and
Overview of Management Options—which collectively minimized the risk of addiction,
suggested that patients at higher risk could be successfully managed, and implied that opioids
were safe at high doses, as described in Section IV.B. Four years after he initiated chronic
opioid therapy (with oxycodone and a fentanyl patch), the patient overdosed and died. That
doctor has since vacated his medical license in resolution of disciplinary proceedings.
The vast new market for opioids is sustained today not only by Purdue's ongoing
marketing, but also by its past, deception-fueled success in establishing opioids as a first-line
treatment for chronic pain—through patients who believe they will not become addicted, addicts
who demand more drugs, and health care providers who refill opioid prescriptions that maintain
dependence and addiction in the belief they are doing the best for their patients or have no other
option but to prescribe more opioids. Purdue's marketing of opioids as the answer to pain
reinforces the psychological incentives for doctors who, like the ophthalmologist, want to make
their patients feel better—if they provide opioids, the patient is satisfied; if they do not, they face
a patient who feels underserved and may, with Purdue's encouragement, seek another doctor
The sharp increase in opioid use resulting from Purdue's marketing has led
directly to a dramatic increase in opioid abuse, addiction, overdose, and death throughout the
United States, including in New Hampshire. Young adults (ages 18-25), in particular, are using
prescription painkillers non-medically at higher rates in New Hampshire than the rest of the
Representing the NIH's National Institute of Drug Abuse in hearings before the
Senate Caucus on International Narcotics Control in May 2014, Dr. Nora Volkow explained that
"aggressive marketing by pharmaceutical companies" is "likely to have contributed to the
severity of the current prescription drug abuse problem."
In August 2016, U.S. Surgeon General Vivek Murthy published an open letter to
physicians nationwide, enlisting their help in combating this "urgent health crisis" and linking
that crisis to deceptive marketing. He wrote that the push to aggressively treat pain, and the
"devastating" results that followed, had "coincided with heavy marketing to doctors . .
of [whom] were even taught—incorrectly—that opioids are not addictive when prescribed for
Scientific evidence demonstrates a close link between opioid prescriptions and
opioid abuse. For example, a 2007 study found "a very strong correlation between therapeutic
exposure to opioid analgesics, as measured by prescriptions filled, and their abuse," with
particularly compelling data for extended release oxycodone—i. e., OxyContin.57
In a 2016 report, the CDC explained that "[o]pioid pain reliever prescribing has
quadrupled since 1999 and has increased in parallel with [opioid] overdoses." Patients receiving
opioid prescriptions for chronic pain account for the majority of overdoses. For these reasons,
the CDC concluded that efforts to rein in the prescribing of opioids for chronic pain are critical
"to reverse the epidemic of opioid drug overdose deaths and prevent opioid-related morbidity."58
Opioids are involved in 40% of all fatal drug overdoses, including overdoses due
to illegal drugs. Drug poisonings now exceed motor vehicle accidents as a cause of death.
According to the CDC, between 1999 and 2014, more than 165,000 people died in the United
States from prescription-related overdoses. In New Hampshire, drug overdose deaths have
spiked from 163 to 438 in 2015, and 91% of those deaths were opioid-related.
Overdose deaths represent only the tip of the iceberg.
In New Hampshire,
opioid- and heroin-related emergency department visits were 2,067 in 2015 and increased 26% in
See n.8, supra.
57 Theodore J Cicero et al., Relationship between therapeutic use and abuse of opioid
analgesics in rural, suburban, and urban locations in the United States. 16.8
Pharmacoepidemiology and drug safety, 827-40 (2007).
CDC, January 1, 2016 Morbidity and Mortality Weekly Report; Rudd, Rose A., et al.
"Increases in drug and opioid overdose deaths—United States, 2000-2014." American Journal of
Transplantation 16.4 (2016): 1323-1327.
2016. There was a similar spike in emergency medical technicians' administration of naloxone—
the emergency antidote to opioid overdose—with use rising from 1,050 in 2013 to 1,921 in 2015
and to 2,724 in 2015. In 2014, health care costs related to opioid abuse in New Hampshire
exceeded $107 million.
Rising opioid use and abuse have had negative social and economic consequences
far beyond overdoses. According to a 2016 study by a Princeton economist, unemployment
increasingly is correlated with prescription painkiller use. Nearly half of surveyed men not in the
labor force said they took painkillers daily, and two-thirds of them were on prescription
medications—compared to just 20% of employed men who reported taking painkillers. Worse
still, many of those taking painkillers still said they experienced pain daily.
There are also swelling costs from the growing universe of medications aimed at
treating secondary effects of opioids—including not only addiction and overdose, but also side
effects like constipation and sedation. According to a recent analysis by The Washington Post,
working age women and men on opioids are much more likely to have four or more prescriptions
from a physician (57% and 41%, respectively) than are their counterparts who do not take
opioids (14% and 9%, respectively). These secondary-effects medications—essentially, drugs to
treat the effects of opioids—generated at least $4.6 billion in spending in 2015, on top of $9.57
billion in spending on opioids themselves. In addition, there are also the costs of dispensing
opioids— in office visits to obtain refills, count pills, or obtain toxicology screens to monitor
The deceptive marketing and overprescribing of opioids also have had a
significant detrimental impact on children in New Hampshire. The overprescribing of opioids
for chronic pain has given young children access to opioids, nearly all of which were prescribed
for adults in their household. In New Hampshire, roughly 1 in 5 teenagers has abused
prescription drugs. Five children younger than 10 and 176 teenagers between the ages of 10 and
19 had opioid-related emergency room visits in New Hampshire in 2016.
Even infants have not been immune to the impact of opioid abuse. There has
been a dramatic rise in the number of infants who are born addicted to opioids due to prenatal
exposure and suffer from neonatal abstinence syndrome ("NAS," also known as neonatal opioid
withdrawal syndrome, or "NOWS"). These infants painfully withdraw from the drug once they
are born and cry nonstop from the pain and stress of withdrawal, experience convulsions or
tremors, have difficulty sleeping and feeding, and suffer from diarrhea, vomiting, and low weight
gain, among other serious symptoms. The long-term developmental effects are still unknown,
though research in other states has indicated that these children are likely to suffer from
continued, serious neurologic and cognitive impacts, including hyperactivity, attention deficit
disorder, lack of impulse control, and a higher risk of future addiction. When untreated, NAS
can be life-threatening. In 2009, more than 13,000 infants in the United States were born with
NAS, or about one every hour. In New Hampshire, the number of infants born with NAS rose
from just 21 in 2002 to 182 in 2009.Total births with drug exposure reached 504 in 2015, an
increase of 37% from the previous year. In 2015, Memorial Hospital in North Conway reported
that the percentage of pregnant women presenting with opioid dependence had skyrocketed,
prompting the hospital to institute a coordinated treatment program to reduce NAS and treat the
mothers' addiction. A similar program is in place at Dartmouth-Hitchcock Medical Center. Two
Manchester hospitals reported that, between them, there were more than 100 babies born with
NAS in 2016.
The number of children removed from homes with substance abuse problems
went from 85 in 2010 to 329 in 2015—a 387% increase. "The opioid crisis is the biggest
contributor when looking at what's changed," said one official. There are not only more children
requiring assistance, but more children with complex needs who will not have a stable home to
which to return. The City of Manchester referred more than 2,500 people to a student assistance
program in 2016.
Opioids now outpace other sources of addiction in demand for substance abuse
treatment. In New Hampshire, the percentage of individuals entering state-funded substance
abuse treatment for oxycodone (the only prescription opioid reported) has sharply risen, while
admissions for alcohol, cocaine, marijuana, and heroin have either decreased or remained stable.
This data echoes the experience of treatment specialists interviewed by the State, who say that
prescription opioid abuse is driving increased demand for addiction treatment. While statefunded treatment admissions related to other drugs have remained stable or fallen, oxycodone
(the active ingredient in OxyContin) admissions have risen. From 2007-2013, the last years for
which data are available, state Medicaid spending on drugs to counter overdose or addiction
increased six-fold. These drugs were prescribed once per 36 opioid prescriptions in 2007 and
once every 9 prescriptions in 2013.
New Hampshire Medicaid
Oploid Analgesics & Overdose/Dependence Treatment Rx/Year
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