Brown v. Stryker Corporation et al

Filing 1

COMPLAINT against Stryker Corporation, Stryker Sales Corporation ( Filing fee $ 350 receipt number 4059603.) assigned to Judge Michael J. Davis per Master list and referred to Magistrate Judge Steven E. Rau, filed by Bill B. Brown, Jr. (Attachments: # 1 Civil Cover Sheet) (RLR) [Transferred from Minnesota on 1/9/2012.]

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MINNESOTA
BILL B. BROWN, JR.,
Plaintiff,
v.
STRYKER CORPORATION and
STRYKER SALES CORPORATION,
Defendants.

)
)
) File No. _____________________
)
)
) COMPLAINT
) AND JURY DEMAND
)
)
)

NOW COMES the Plaintiff, Bill B. Brown, Jr., by and through his attorneys, and
for his Complaint and Jury Demand against the Defendants, alleges and states as follows:
INTRODUCTION
1.

Pain pumps are Class II medical devices that surgeons used to manage post-

operative pain. Orthopedic surgeons used pain pumps after surgery to deliver, by way of
a catheter, continuous doses of pain relief anesthetic for several days directly into the
shoulder.
2.

The pumps first used in the 1990s had limited amounts of anesthetic, and

surgeons placed the pain pump catheter in the muscle or outside the shoulder joint. Over
the years, however, the manufacturers increased the anesthetic capacity of the pumps
(high volume), and with the knowledge and encouragement of the pain pump
manufacturers, surgeons began to insert the catheter directly into the shoulder joint space.
3.

Continuous injection of these anesthetics directly into the shoulder joint can

cause serious and permanent damage to the shoulder joint cartilage. The damage occurs
when the anesthetic kills the chondrocytes (cartilage cells) and causes cartilage to

degenerate progressively. Patients injured by pain pumps develop a condition called
“chondrolysis,” which is the complete or nearly complete loss of cartilage in the shoulder
joint. It is an irreversible, disabling, and extremely painful condition.

These patients

typically require additional surgeries, including complete shoulder joint replacement. As
written in the medical literature, “the prognosis for these shoulders is grim.”1
4.

The pain pump companies manufactured and marketed these devices

without doing a single study to determine the safety of high-volume pain pumps, or what
damage could be caused when physicians placed the catheter directly into the shoulder
joint space. Instead, the pain pump manufacturers encouraged orthopedic surgeons to use
the pumps and anesthetics, in tandem, in an untested and dangerous manner.
5.

Beginning in the late 1990s, the pain pump manufacturers sought approval

from the Food and Drug Administration (FDA) for the placement of the pain pump
catheter directly in the shoulder joint space (intra-articular).
6.

The FDA repeatedly rejected applications requesting the pain pump

manufacturers’ specific orthopedic and intra-articular indications for use.
7.

Knowing the pain pumps were not cleared for these uses, the pain pump

manufacturers, nevertheless actively promoted the pain pumps for these exact off-label
uses through a variety of marketing activities including direct representations made by
sales representatives, catheter placement guides, ads, and presentations.

1

Petty, D.H. et al., Glenohumeral Chondrolysis After Shoulder Arthroscopy, Am. J. Sports Med. 32:(2)509 (2004).

2

8.

On November 13, 2009 and as updated on February 16, 2010, the FDA

made clear that no infusion pump had ever been cleared by FDA to deliver intra-articular
infusions of local anesthetics and should not be used for this purpose.
9.

The United States Department of Justice is currently investigating at least

one pain pump manufacturer for the alleged off-label promotion of its pain pumps.
10.

Had the pain pump manufacturers not promoted the products off-label, end

users would not have justifiably relied to patients’ detriment.
11.

Although the FDA rejected pain pump manufacturers’ applications for

orthopedic and intra-articular placement for lack of safety information, pain pump
manufacturers chose not to advise physicians about the dangers of using their products in
this manner, chose not to advise patients of these risks, chose not to tell physicians that
their FDA applications were rejected, and continued to sell and market their pumps with
reckless indifference – all to the detriment of thousands of patients generally, and to the
detriment of Mr. Brown in particular.
12.

On November 13, 2009, the FDA issued a directive in which it noted that

pain pumps and the anesthetics used in them were defective for their failure to warn
regarding the risk of shoulder chondrolysis and directed pain pump and anesthetic
manufacturers to include such warnings. The FDA also noted that the information on
dose administration was insufficient in so far as there was no information about
maximum daily dose or intra-articular use with pain pumps. Further, the FDA directive
confirmed that the intra-articular use of pain pumps was not and never had been approved
by the FDA. Although this FDA directive was based upon reported adverse events of
3

chondrolysis, this information was known or knowable to the pain pump and anesthetic
manufacturers.
13.

Several safety signals have existed in the literature since at least 1933 and

emerged within several pain pump manufacturers’ internal files alerting the companies to
the risks associated with intra-articular use of their pain pumps.
14.

By the time of Mr. Brown’s surgery, multiple scholarly studies were

published demonstrating the toxic effects of pain pump anesthetics on shoulder cartilage.
By at least 2003 surgeons were reporting incidents of chondrolysis after pain pump use.
In late 2005 and early 2006, the pain pump industry also knew that Dr. Charles L. Beck,
an orthopedic surgeon, had been reporting to the scientific community some very
disturbing findings. He found a significant number of his shoulder patients developed
chondrolysis following intra-articular placement of a pain pump catheter and he
associated these injuries with the use of intra-articular pain pumps.
15.

Had the Defendants conducted those studies that the FDA required back in

the 1990s, as they were obligated to do, they would easily have determined that exposure
to local anesthetics administered through pain pumps over time in the shoulder is
exceedingly dangerous and contraindicated. Had they performed the appropriate tests
timely, Mr. Brown’s physician would not have used a pain pump in the joint space, and
Mr. Brown would not have suffered the devastating effects of shoulder chondrolysis.
PARTIES

4

16.

Plaintiff, Bill B. Brown, Jr. (hereinafter sometimes referred to as “Mr.

Brown or “Plaintiff”), is a citizen of the State of New York, residing at 1192 Walton
Avenue, Apartment C-4, Bronx, New York 10452.
17.

Defendants,

Stryker

Corporation

and

Stryker

Sales

Corporation

(hereinafter collectively referred to as “Stryker” or “Defendants”), are Michigan
corporations with their principal place of business at 2825 Airview Boulevard,
Kalamazoo, Michigan 49002. Stryker designs, manufactures, and develops pain pumps.
At all times relevant hereto, Stryker was engaged in Minnesota in the testing,
manufacturing, labeling, marketing, distributing, promoting and selling of infusion pain
pumps.
JURISDICTION AND VENUE
18.
U.S.C.

The Court has subject matter jurisdiction over this action pursuant to 28
§ 1332. Plaintiff is a resident and citizen of the State of New York and

Defendants Stryker Corporation and Stryker Sales Corporation are Michigan corporations
and citizens with their principal place of business in Kalamazoo, Michigan. The parties
are therefore diverse in citizenship.
19.

This Court has personal jurisdiction over Defendants pursuant to M.S.A. §

543.19, in that, at all relevant times described herein, Defendants: (a) transacted business
in the state of Minnesota; and/or (b) committed acts in Minnesota causing injury.
Defendants are corporations maintaining sufficient minimum contacts with this judicial
district to subject the corporations to personal jurisdiction here.

5

20.

Plaintiff’s claim for relief exceeds $75,000.00, exclusive of interest and

costs, therefore satisfying the amount in controversy requirement.
FACTUAL ALLEGATIONS
A. Case Specific Facts
21.

In April of 2006, Plaintiff, Bill B. Brown, Jr., was a 34 year old man living

in Orlando, Florida when he consulted with orthopedic surgeon, Randy S. Schwartzberg,
M.D., regarding a problem he was experiencing with his left shoulder. On April 4, 2006,
Dr. Schwartzberg recommended surgical intervention. Mr. Brown agreed.
22.

On May 24, 2006, Mr. Brown underwent arthroscopic surgery on his left

shoulder for a SLAP and Bankart repair at the Orlando Regional Medical Center-Lucerne
Medical Center. During surgery, Dr. Schwartzberg observed that Mr. Brown’s articular
cartilage on his left glenoid was in “good condition.”

Following surgery, Dr.

Schwartzberg inserted a “pain pump,” specifically a Stryker Pain Pump, PN 500-140,
into Mr. Brown’s shoulder joint to continuously infuse local anesthetic into the joint
space. The pain pump continuously infused 100 mL of 0.5% Bupivacaine plain directly
into Mr. Brown’s left shoulder joint, for 48 hours or more following his surgery.
23.

Initially, Mr. Brown progressed as expected. However, on October 12,

2006 Mr. Brown returned to Dr. Schwartzberg with complaints of pain, clicking and
decreased range of motion of his left shoulder. Over the course of several months Dr.
Schwartzberg treated Mr. Brown conservatively with a home exercise program, antiinflammatory and pain medications as well as an injection into the shoulder.

6

24.

After relocating to New York, Mr. Brown established care with internist

Darren Esposito, M.D. of Bronx, New York in June of 2009. Still experiencing pain in
his left shoulder, Dr. Esposito ordered an MRI and referred Mr. Brown to an orthopedic
surgeon for an evaluation and possible treatment.
25.

Mr. Brown consulted orthopedic surgeon, Stanley Liebowitz, M.D., at the

Orthopaedic Specialists of Greater New York on April 12, 2010. After reviewing the
September 4, 2009 MRI, Dr. Liebowitz recommended surgery.
26.

On June 1, 2010, Mr. Brown underwent a second arthroscopic surgery of

his left shoulder at Beth Israel Medical Center--Petrie Division in Manhattan, New York.
Dr. Liebowitz’s colleague at Orthopaedic Specialists, orthopedic surgeon Thomas A.
Scilaris, M.D., performed the surgery. During surgery, Dr. Scilaris’ inspection of the
glenohumeral joint revealed “extensive grade 4 glenohumeral articulation changes
essentially entire glenoid labrum and humeral head.” Dr. Scilaris also observed “central
grade 4 cartilaginous changes” and multiple loose bodies and cartilage.
27.

A few days after surgery, Mr. Brown returned to Dr. Scilaris for a post-

operative examination.

Dr. Scilaris informed Mr. Brown that he suffered from

“significant bone on bone destruction of the articular cartilage in the glenohumeral joint”
and would require additional treatment and surgery in the future. It was also during this
visit in June of 2010, that his physician informed him of the association between pain
pumps and chondrolysis.
28.

The continuous injection of anesthetic drugs over time directly into Mr.

Brown’s shoulder after his May 24, 2006 surgery subsequently caused him serious and
7

permanent cartilage damage. As a result, Mr. Brown suffered a narrowing of the joint
space and/or a condition called "glenohumeral chondrolysis," which is the complete or
nearly complete loss of cartilage in the shoulder joint, an irreversible, disabling, and
extremely painful condition. Mr. Brown currently has and will continue to have difficulty
doing the most basic tasks of everyday living. He will require additional surgeries,
including possible shoulder transplants, insertion of an artificial shoulder and/or total
shoulder replacements, as a result of the narrowing of the joint space and/or chondrolysis
caused by the dangerously defective pain pump. Mr. Brown’s daily life is consumed with
the devastation of a destroyed shoulder and the prospects of a life of pain and medication.
He will suffer lost income, loss of career options, a loss of enjoyment of life, and other
damages, all of which were avoidable.
B. Stryker’s Misconduct
29.

Stryker misled both the medical community and the public at large,

including the Plaintiff herein, by promoting its pain pumps for off-label uses that FDA
had not cleared.
30.

Stryker sought FDA clearance for an indication for use in intra-articular

spaces and knew that the FDA refused to approve such an indication for use without a
submission of data by Stryker evidencing the safety and effectiveness of such use. On
June 5, 2001, FDA cleared Stryker’s pain pump application, but without Stryker’s request
for use in the joint space.
31.

Stryker received package inserts from local anesthetic manufacturers, as

evidenced by an April 10, 2000 letter from Abbott, and Stryker knew that the local
8

anesthetics its pain pumps were designed to use had not been approved by the FDA for
continuous intra-articular infusion.
32.

Stryker’s paid consultant, Lonnie Paulos, M.D. advised Stryker in

approximately June of 2000 about what Stryker would need to do in order to establish the
validity and safety of its pain pumps for orthopedic uses, including patient-controlled
trials for efficacy and animal studies for safety, specifically regarding the effect on tissues
following orthopedic procedures. Despite this information, Stryker did not undertake the
recommended testing.
33.

Stryker was informed on July 6, 2000 by its pharmaceutical company

contact that it did not have FDA approval for intra-articular use of its pain pumps, and
that it would be required to obtain a cumbersome IND (Investigational New Drug) study
to obtain approval for intra-articular use.
34.

Despite knowing that neither its pain pumps, nor the drugs in them were

FDA approved for intra-articular use, Stryker promoted them for this specific indication
for use.
35.

Stryker disregarded FDA’s repeated refusal to approve for intra-articular

uses the pain pumps that it marketed by promoting the product off-label through direct
representations to end users and promotional materials.
36.

Stryker’s own consultant Dr. Lonnie Paulos testified on August 15, 2008

that when the Pain Pump first came out, the Stryker sales reps would approach doctors in
the operating room and encourage them to use the devices intraarticularly in the knee and
shoulder.
9

37.

Stryker also developed and disseminated catheter placement guides,

including a spreadsheet indicating the joint space as an area for catheter placement, which
was used during sales trainings to illustrate the use of the pain pump in various surgeries.
38.

Stryker instructed its sales representatives in its Guide to Selling Pain

Pumps to coach surgeons on catheter placement.
39.

Stryker further misled both the medical community and the public at large,

including the Plaintiff herein, by making false representations about the safety of its
products.

Stryker downplayed, understated and/or disregarded its knowledge of the

serious and permanent side effects associated with the use of its products, despite the
existence of information available to Stryker that should have demonstrated that Stryker
products were likely to cause serious injuries to product users.
40.

Stryker actually and consciously considered whether intra-articular use of

its pumps would be safe; however, Stryker conducted no testing to determine whether
intra-articular use of its pumps would be safe; nor did Stryker conduct a reasonable
search of the available medical literature to see whether common and foreseeably used
anesthetics such as Marcaine were toxic to cartilage.
41.

In January 2001, without conducting any tests or studies for safety, Stryker

made a change to its Pain Pump 1 to 1.5, revision G to increase the size of the reservoir to
270cc. Stryker increased the volume of its pumps because its “customers wanted to be
able to infuse more medication when using the Pain Pump.”
42.

Stryker’s own functional specifications for its pain pump listed “medical

toxicity” as a “potential company risk” which deserved “more investigation in terms of
10

all possible drugs intended to use and their indications for use;” yet, Stryker consciously
designed its pain pump for intra-articular use without conducting any tests for safety.
43.

Stryker had actual knowledge from its customer preference trials of its pain

pump that there were concerns about “toxicity” and excessive flow rate that would
expose Stryker to litigation.
44.

Despite being aware that its pain pumps were unapproved for intra-articular

uses, Stryker did not notify physicians that the safety of use of the pain pumps in a joint
space was unknown, had not been studied and had not been tested by Stryker; yet,
Stryker and its sales representatives promoted its pain pumps for use in the joint space.
As Dr. Lonnie Paulos testified on August 15, 2008, Stryker sales reps would approach
doctors in the operating room and encourage them to use the devises intraarticularly in
the knee and shoulder.
45.

As evidenced by internal correspondence dated October 25, 2006, with

regard to PainPump 1, 85% of Stryker’s business came from orthopedics.
46.

Stryker made Mr. Brown and other patients like him unknowing, unwilling

and unconsenting test subjects of the safety of intra-articular use of its pumps.
47.

Even after Stryker was notified on February 11, 2005 and February 15,

2005 by its own orthopedic consultant of dozens of cases of cartilage injury associated
with pain pump use, it did nothing except to continue marketing and sales of its pumps,
for well than one year afterwards. Stryker did not enter any of these cases into Stryker’s
complaint database.

11

48.

Stryker’s outrageous conduct, as alleged herein and throughout this

Complaint, demonstrates reckless indifference to the rights of others, including Plaintiff,
Bill B. Brown, Jr.
49.

Stryker was aware that its promotion of its pain pumps for intra-articular

and orthopedic use was unapproved; nonetheless, Stryker acted in conscious disregard of
that risk by promoting its pain pumps for those uses.
50.

Stryker had a subjective and objective appreciation of the risk of harm to

which Mr. Brown and others were exposed, including that its pain pumps posed a serious
risk of harm to shoulder cartilage.
51.

Despite known risks, in addition to promoting off-label uses, Stryker failed

to warn of known and/or knowable risks in conscious disregard of the rights and safety of
others, including Mr. Brown.
52.

At the time of manufacture or distribution of its pain pumps, Stryker had

actual knowledge that its pain pumps were defective and that there was substantial
likelihood that the defect would cause injury that is the basis of this action, and Stryker
willfully disregarded that knowledge in the manufacture or distribution of its pain pumps.
53.

Even after Stryker was notified by its own orthopedic consultant of dozens

of cases of cartilage injury associated with pain pump use, it did nothing except to
continue marketing and selling its pumps, for well over one year afterwards, further
corroborating a prolonged course of conduct of wanton, willful, malicious, deliberate,
conscious, reckless, and flagrant disregard for the safety, rights, and interests of Mr.
Brown and others like him.
12

54.

Stryker’s conduct was intentional, reckless, wanton, willful and/or

outrageous, and said conduct was committed with gross negligence, deliberate disregard
of, and deliberate, callous and reckless indifference to Mr. Brown’s rights, interests,
welfare and safety. Stryker misled both the medical community and the public at large,
including Mr. Brown, by making false representations about the safety of its products.
Stryker downplayed, understated and/or disregarded its knowledge of the serious and
permanent side effects associated with the use of its products despite available
information demonstrating these products were likely to cause serious side effects to the
users.
55.

Stryker was or should have been in possession of evidence demonstrating

that its products caused serious side effects. Nevertheless, it continued to market the
products by providing false and misleading information with regard to safety and
efficacy.
56.

Stryker failed to provide warnings that would have dissuaded medical

providers from using the pain pumps and anesthetics thus depriving medical providers
and consumers from weighing the true risks against the benefits of using these products.
57.

As a direct and proximate cause of Stryker’s misconduct, Mr. Brown

suffered and will continue to suffer injuries, damages, and losses as alleged herein.
STATUTE OF LIMITATIONS AND
FRAUDULENT CONCEALMENT
58.

Any applicable statutes of limitations have been tolled by the knowing and

active concealment and denial of the facts by Stryker. Mr. Brown and his physicians
13

were kept in ignorance of vital information essential to the pursuit of these claims,
without any fault or lack of diligence on their part. Mr. Brown could not reasonably have
known or become aware of the dangerous nature of and the unreasonable adverse side
effects associated with the intra-articular use of infusion pain pumps with commonly used
anesthetics following shoulder surgeries prior to his post-operative visit with Dr. Scilaris
in June of 2010 when he was informed of the association between pain pumps and
chondrolysis.
59.

Because of Stryker’s refusal to conduct appropriate studies to determine the

safety of anesthetics on cartilage, and because of its failure to apprise physicians of
information it held secretive within its companies, Mr. Brown was deprived of evidence
of a causal connection between the injury and Stryker’s pain pumps and their negligent
acts and omissions until his post-operative visit with Dr. Scilaris following the June 2010
surgery. As such, Stryker fraudulently concealed the existence of a cause of action from
Mr. Brown, as illustrated in the paragraphs that follow.
60.

Stryker is and was under a continuing duty to disclose the true character,

quality, and nature of its pain pumps. Because of Stryker’s concealment of the true
character, quality and nature of its pain pumps, Stryker is estopped from relying on any
statute of limitations defense.
61.

Stryker knew that its pumps were not approved for use in joints, and that its

pumps were being used in the joint.
a. Stryker attempted to gain FDA approval for use of its pain pump in the
joint space on March 28, 2001. At that time, Stryker indicated that it knew
14

that the FDA had required the original manufacturer of the predicate device
for Stryker’s pump to remove such an indication from its label.
b. FDA approved Stryker’s pump on June 5, 2001, but without the indication
for use in the joint space.
62.

Undaunted, Stryker fully intended to and did market its pain pumps to

orthopedic surgeons, including Mr. Brown’s, for use in the joint space, despite FDA’s
denial of such indication.
a. As indicated in the deposition of Dr. Lonnie Paulos, Stryker fraudulently
concealed the dangerous nature of its pain pumps by affirmatively telling
orthopedic surgeons that pain pumps could be used in the intra-articular
joint space.
b. In July 2000, Stryker met with Purdue Pharma to discuss combining Purdue
Pharma’s anesthetics with Stryker’s pain pumps. During that meeting,
Stryker informed Purdue Pharma that Stryker’s pain pumps were to be used
in the joint space. In response, Purdue Pharma informed Stryker that its
anesthetics were not approved for intra-articular injection.

Stryker

fraudulently concealed this fact from consumers and the medical
community when it marketed its pain pumps to orthopedic surgeons for
continuous infusion of local anesthetics into the joint space.
c. Stryker continued to unlawfully market its pain pumps even after consumer
preference trials indicated in October 2000 that surgeons were concerned
about toxicity.
15

63.

As early as 2001, Stryker fraudulently concealed the dangerous nature of its

pain pumps by withholding the information regarding FDA’s denial of the orthopedic or
intra-articular indications from its sales representations, its research and development
personnel, its operations management personnel, its regulatory quality personnel, its plant
management personnel, its engineering personnel, its marketing personnel and its product
management personnel. Stryker withheld this information knowing that its pumps were
being designed and marketed for use in the joint space. For example, in 2001, Danielle
Lopez, a Stryker marketing associate, retyped a spreadsheet she received upon taking her
position that indicated the glenohumeral joint space as an area for catheter placement.
She then used that spreadsheet during sales trainings to illustrate how to use the pain
pump in various surgeries.
64.

Stryker’s marketing product manager knew that doctors were using the pain

pump intra-articularly in 2003 and 2004, and at least some of Stryker’s regulatory
personnel knew that this was not a cleared indication for use.
65.

On November 3, 2005, in an attempt to conceal the dangerous nature of its

pain pumps from consumers and the medical community, Stryker provided false and
misleading information to FDA in response to FDA’s request for information about
chondrolysis, in that Jennifer Hoffman, Stryker’s Regulatory Affairs Representative
misrepresented that there had only been 7 reported events of chondrolysis associated with
the use of pain pumps when in fact, Ms. Hoffman and Stryker had known since February
2005 of as many as 30 events of chondrolysis associated with the use of pain pumps. For
example,
16

a. In 2003, Stryker sales representative and later sales manager, Don Kelley
was informed by a physician and Stryker consultant, Dr. Lonnie Paulos, of
injury to a patient’s joint that was associated with the patient’s use of a pain
pump.
b. On August 11, 2005, Dr. Charles Beck notified Stryker of 13 patients with
post shoulder surgery chondrolysis with Stryker pain pumps.
c. On February 11, 2005, Dr. Paulos informed Brady Shirley, Vice President
of Sales, of additional cases of chondrolysis and warned that Stryker should
consider changing its label.
d. On February 15, 2005, Dr. Paulos informed Stryker that he knew of at least
30 cases of chondrolysis associated with the use of pain pumps.
66.

Stryker fraudulently concealed the dangerous nature of its pain pumps from

consumers and the medical community when Steven Docsa, Stryker’s Clinical Monitor,
affirmatively stated on March 3, 2005 that Stryker should do nothing in response to
physician reports of chondrolysis and Stryker’s own consultant, Dr. Paulos’, suggestion
that Stryker undertake an animal study to test the safety of its pumps on cartilage. Docsa
took this position despite the suggestion by other personnel, including Jennifer Hoffman,
that the complaints should be entered into Stryker’s quality assurance system, SuPER,
and despite Stryker’s policies and procedures, which required that complaints, even if
they did not meet FDA’s reporting requirements should be entered into SuPER.
67.

Stryker’s policies and procedures, and federal law, required Stryker to

follow-up and investigate the injuries reported by Dr. Paulos, including getting specific
17

information, including dates of events, the specific injury, how the product was being
used, how the patient was doing, and if follow-up treatment was needed. However,
Stryker failed to respond to Dr. Paulos’ communications.
68.

Stryker attempted to further conceal the dangerous nature of its pain pumps

when on January 19, 2006 Ms. Hoffman contacted Dr. Beck regarding a study Dr. Beck
was publishing regarding the association of pain pumps and chondrolysis. At that time,
Ms. Hoffman asked Dr. Beck if he could emphasize that the pump were not the cause of
chondrolysis. Ms. Hoffman’s intent, as documented affirmatively in the communication
to Dr. Beck was to deflect the cause of chondrolysis from the Stryker PainPump. Dr.
Beck responded that his professional opinion was that it was the combination of volume,
pressure, and medication that were implicated.
69.

Stryker fraudulently concealed the dangerous nature of its pain pumps in

October 2006 when Stryker sales managers failed to provide information to Stryker sales
reps that was contained within a document circulated by Stryker personnel who attended
two medical conventions discussing the association between chondrolysis and pain
pumps. The document, or “hot sheet,” noted that pain pumps were indicated for infusion
only through particular routes, not including intra-articular, and advised readers to
discuss this information with customers. Stryker sales managers never distributed the
information to its sales reps.
70.

In November 2006, Stryker prepared a form letter to doctors regarding

chondrolysis, however, the letter mischaracterized the dangers of the pain pump when
used in the joint space by indicating that no clinical studies directly linked the pain
18

pumps to chondrolysis. The letter failed to state that the FDA, for lack of safety, never
would have approved such a study, as there was already extant literature suggesting that
such use was unsafe. The letter also mischaracterized Stryker’s pain pumps by stating
that the pumps were not indicated for intra-articular delivery without stating that such use
had been specifically denied by the FDA. Finally, Stryker did not send the letter out to
physicians unless a physician requested it. In fact, the Stryker employees tasked with
sending the letters out cannot recall whether any letters actually were sent.
71.

In December 2006, Stryker held a training for new sales reps and in that

meeting did not inform the new reps that pain pumps were not cleared for use in the joint
space, despite the fact that Stryker knew that its representatives were present in the
operating rooms, prepared the pain pumps for the surgeons, and instructed the surgeon on
how to use the pump.
72.

In October 2007, Stryker fraudulently concealed the dangerous nature of its

pain pumps by indicating on its package insert that animal and in vitro studies suggested
a relationship between local anesthetics and chondrocyte toxicity; but, then proceeded to
undermine that information by stating that no clinical studies have shown such toxicity.
Further, Stryker did not recall any of its existing labels.
73.

To date, Stryker sales representatives are not aware of any warning from

Stryker to doctors against placing the catheter in the joint space.

19

CAUSES OF ACTION
COUNT I -- NEGLIGENCE
74.

Plaintiff incorporates by reference all other paragraphs of this Complaint as

if fully set forth herein at length, and further alleges:
75.

At all times relevant to this action, Stryker had a duty to exercise

reasonable care, and to comply with the existing standards of care, in its preparation,
design, research, development, manufacture, inspection, labeling, marketing, promotion
and sale of the pain pumps and the anesthetics used in the pumps, which Stryker
introduced into the stream of commerce, including a duty to ensure that users would not
suffer from unreasonable, dangerous or untoward adverse side effects.
76.

At all times relevant to this action, Stryker had a duty to warn all health

care providers and consumers of the risks, dangers, and adverse side effects of pain
pumps and the anesthetics used in the pumps.
77.

At all relevant times, Stryker knew or reasonably should have known that

the pain pumps were unreasonably dangerous and defective when used as directed and as
designed, including but not limited to the following particulars:
a. Commonly used anesthetics likely to be used in its pain pumps, such as
Marcaine with or without epinephrine, were harmful to human and animal
articular cartilage when infused continuously over time;
b. Use of the pain pump to deliver local anesthetic to or near the joint space
had not been cleared by the FDA, and in fact, had been specifically rejected
by the FDA;
20

c. Continuous injection of high volumes of such medications, through a
catheter, directly into the joint space, for two days or more, had not been
adequately tested for safety or effectiveness; and
d. The risk of narrowing of the joint space, chondrolysis and other serious
post-operative problems associated with using the pain pump as designed
and instructed outweighed the possible benefits of such use.
78.

Based on what Stryker knew or reasonably should have known as described

above, it deviated from principles of due care, deviated from the standard of care, and
were otherwise negligent in one or more of the following particulars:
a. In failing to conduct those tests and studies necessary to determine that the
use of pain pumps directly into the shoulder was dangerous to shoulder
cartilage and contraindicated for use;
b. In failing to instruct or warn the medical community that the safety of the
pain pump with continuously injected anesthetic had not been established
for use in the shoulder;
c. In failing to disclose to the medical community that continuous injection of
commonly used anesthetics such as sensorcaine, with or without
epinephrine, over two days or more, into the shoulder, may cause serious
and permanent injury to the joint cartilage;
d. In failing to include a precaution against placing the catheter of the pain
pump in the shoulder;

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e. In failing to provide to the medical community adequate instructions for the
safe use of the devices with continuously injected anesthetics;
f. In failing to disclose to the medical community that the effectiveness of
pain pumps with continuously injected anesthetic was uncertain for use in
the shoulder;
g. In failing to disclose to the medical community that no tests had been ever
done to determine the safety of using the pain pump in the shoulder;
h. In negligently misrepresenting and failing to disclose, in the course of its
business, material facts concerning the risks it pain pumps and anesthetics
posed to patients, particularly those using the products for pain relief
following shoulder surgery;
i. Manufacturing a product to be used with continuously injected anesthetic,
designed to directly inject into the shoulder commonly used anesthetics
associated with damage to articular cartilage;
j. Manufacturing a product designed to deliver, over time, dangerously high
doses of anesthetic drugs directly into shoulder tissue; and
k. Promoting pain pumps and continuously injected anesthetics for use in the
shoulder joint space after the FDA had considered and rejected such an
indication.
79.

Stryker

violated

statutes,

rules

and

manufacturing, marketing, and/or testing of its pain pumps.

22

ordinances

concerning

the

80.

At all relevant times, Stryker knew or reasonably should have known that

the anesthetics used in the pain pumps were unreasonably dangerous and defective when
used as directed and designed, including but not limited to the following particulars:
a. Commonly used anesthetics likely to be used in its pain pumps, such as
Marcaine with or without epinephrine, were harmful to human and animal
articular cartilage when infused continuously over time;
b. Use of the pain pump to deliver local anesthetic to or near the joint space
had not been cleared by the FDA, and in fact, had been specifically rejected
by the FDA;
c. Continuous injection of high volumes of such medications, through a
catheter, directly into the joint space, for two days or more, had not been
adequately tested for safety or effectiveness; and
d. The risk of narrowing of the joint space, chondrolysis and other serious
post-operative problems associated with using the pain pump as designed
and instructed outweighed the possible benefits of such use.
81.

The product defects alleged above were a substantial contributing cause of

the injuries and damages suffered by Mr. Brown that would not have occurred but for the
use of the product.
82.

The injuries and damages suffered by the Mr. Brown was the reasonably

foreseeable result of Stryker’s negligence.
83.

Stryker under-reported, underestimated and downplayed the serious danger

of intra-articular pain pumps.
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84.

Despite the fact that Stryker knew or should have known that intra-articular

use of pain pumps following shoulder surgeries caused unreasonably dangerous side
effects, Stryker continued to market, manufacturer, distribute and/or sell the pain pumps
to consumers, including Mr. Brown.
85.

Had Stryker performed those tests and studies necessary to determine that

pain pumps and their anesthetics should not be used directly in the shoulder before Mr.
Brown’s

physician used a pain pump following his surgery, as it was required to do,

Mr. Brown would not have developed chondrolysis and suffered the injuries and damages
described with particularity above.
86.

Stryker is directly liable for the negligent conduct of its actual and/or

ostensible employees, servants, and agents, who include, but are not limited to, its sales
representatives. The negligent conduct of these employees, servants, and actual and/or
ostensible agents, jointly and severally, caused and/or increased the risk of harm of, and
the grievous injuries and damages sustained by Mr. Brown.
87.

Stryker knew or should have known that consumers like Mr. Brown would

foreseeably suffer injury, and/or be at increased risk of suffering injury as a result of
Defendants’ failure to exercise ordinary care, as set forth above.
88.

As a direct and proximate cause of Stryker’s negligence, Mr. Brown

suffered the permanent loss of cartilage in his shoulder, resulting in severe pain and
discomfort of the shoulder, loss of use and function of the shoulder and arm, and
requiring additional surgical intervention. Mr. Brown will also require future medical
care, including physical therapy, pain management, additional shoulder surgeries as he
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ages, including but not limited to, joint and/or shoulder replacements. In addition, Mr.
Brown has suffered mental distress and anguish and suffered permanent impairment of
the use and function of his affected upper extremities, and other damages.

COUNT II -- NEGLIGENT MISREPRESENTATION
89.

Plaintiff incorporates by reference all other paragraphs of this Complaint as

if fully set forth herein at length, and further alleges:
90.

Stryker and its sales representatives, in the course of its business,

negligently misrepresented and failed to disclose material facts concerning the risks that
its pumps and anesthetics posed to patients, particularly those using the products for pain
relief following shoulder surgery.
91.

Stryker and its sales representatives made material misrepresentations and

concealments to Dr. Schwartzberg when they marketed their product to him but failed to
provide any warning that their pain pumps were neither cleared nor approved for
orthopedic or intra-articular use, or provide any other warning to him regarding the risks
to cartilage as a result of placing a pain pump into his patients’ shoulder joints following
shoulder surgeries.
92.

Stryker knew or should have known, under the circumstances, that those

misrepresentations were false.
93.

Those misrepresentations and concealments by Stryker were made with the

intent to advertise, market, and sell pain pumps and anesthetics off-label.

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94.

Stryker failed to exercise reasonable care of competence in obtaining or

communicating truthful and accurate information to Mr. Brown and his physicians, and
failed to comply with the existing standard of care.
95.

Stryker is directly liable for the negligent conduct of its actual and/or

ostensible employees, servants, and agents, who include, but are not limited to, its sales
representatives. The negligent conduct of these employees, servants, and actual and/or
ostensible agents, jointly and severally, caused and/or increased the risk of harm of, and
the grievous injuries and damages sustained by Mr. Brown.
96.

Mr. Brown and his physicians justifiably relied on the misrepresentations

and concealments, and as a direct and proximate result of such reliance, Mr. Brown
suffered and will continue to suffer injuries, damages, and losses as alleged herein.
COUNT III -- FRAUD
97.

Plaintiff incorporates by reference all other paragraphs of this Complaint as

if fully set forth herein at length, and further alleges:
98.

Stryker blatantly and intentionally distributed false information, including

but not limited to assuring the public, Mr. Brown, his physicians, hospitals, and
healthcare professionals that the pain pumps and/or bupivacaine products were safe for its
intended use in the shoulder joints.
99.

Stryker had a duty when disseminating information to the public to

disseminate truthful information and a parallel duty not to deceive the public and the
Plaintiff, as well as his healthcare providers.

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100.

Stryker and its agents and sales representatives knowingly, intentionally,

directly and/or impliedly made material misrepresentations to Mr. Brown, his physicians,
and to the public that pain pumps and the anesthetics used in the pumps were safe for use
following shoulder surgeries, such as Mr. Brown’s. Plaintiff does not allege fraud on the
FDA.
101.

The representations by Stryker’s agents and sales representatives were in

fact false, as pain pumps and the anesthetics used in the pumps were not safe for human
use following shoulder surgeries, and instead proximately caused narrowing of the joint
space, glenohumeral chondrolysis and other injuries and/or adverse side effects.
102.

Stryker was aware since at least June 5, 2001 that FDA had not cleared its

pain pumps for use in the joint space because it then received approval from FDA to
market the pain pumps without the specific indication for use intra-articular included.
103.

Stryker was aware since at least April 10, 2000 based on a letter from

Abbott Laboratories that the local anesthetics Stryker’s pain pumps were designed to use
had not been approved by the FDA for continuous intra-articular infusion.
104.

This was confirmed on July 6, 2000 by its pharmaceutical company contact

that it did not have FDA approval for intra-articular use of its pain pumps, and that it
would be required to obtain a cumbersome IND (Investigational New Drug) study to
obtain approval for intra-articular use.
105.

Despite knowing that neither its pain pumps, nor the drugs in them were

FDA approved for intra-articular use, Stryker promoted them for this specific indication
for use.
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106.

Stryker marketed these products off-label through direct representations to

end users and promotional materials.
107.

Stryker’s own consultant Dr. Lonnie Paulos testified on August 15, 2008

that when the Pain Pump first came out, the Stryker sales reps would approach doctors in
the operating room and encourage them to use the devices intraarticularly in the knee and
shoulder.
108.

Stryker also developed and disseminated catheter placement guides,

including a spreadsheet indicating the joint space as an area for catheter placement, which
was used during sales trainings to illustrate the use of the pain pump in various surgeries.
109.

Stryker instructed its sales representatives in its Guide to Selling Pain

Pumps to coach surgeons on catheter placement.
110.

Stryker further misled both the medical community and the public at large,

including the Plaintiff herein, by making false representations about the safety of its
products.

Stryker downplayed, understated and/or disregarded its knowledge of the

serious and permanent side effects associated with the use of its products, despite the
existence of information available to Stryker that should have demonstrated that its
products were likely to cause serious injuries to product users.
111.

When Stryker’s agents and sales representatives made the foregoing

representations they knew those representations were false, deceptive, and misleading,
and they made those false representations with the intent to defraud, deceive, and
mislead.

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112.

Mr. Brown, his physicians, and the public justifiably relied upon the

foregoing misrepresentations and reasonably believed the misrepresentations to be true,
and in justifiable reliance upon these misrepresentations, were induced to prescribe and
use its pain pumps and the continuously injected anesthetics.
113.

At the time the representations were made, Mr. Brown and/or his healthcare

providers did not know the truth, with regard to the dangerous and serious health and/or
safety concerns of the pain pumps.
114.

Had Mr. Brown known the true facts with respect to the dangerous and

serious health and/or safety concerns of the pain pumps, Mr. Brown would not have
purchased, used and/or relied on Stryker’s pain pumps.
115.

Stryker’s aforementioned conduct constitutes fraud and was committed

and/or perpetrated willfully, wantonly and/or purposely on the Plaintiff.
116.

Stryker is directly liable for the negligent and/or fraudulent conduct of its

actual and/or ostensible employees, servants, and agents, including, but are not limited to,
its sales representatives. The negligent and/or fraudulent conduct of these employees,
servants, and actual and/or ostensible agents, jointly and severally, caused and/or
increased the risk of harm of, and the grievous injuries and damages sustained by Mr.
Brown.
117.

As a result of the fraud of Stryker’s agents and sales representative, Mr.

Brown suffered and will continue to suffer injuries, damages and losses as alleged herein.
118.

Stryker’s reckless and intentional concealment from Mr. Brown and his

physicians that pain pumps and the anesthetics used in the pumps were not safe for
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human use following shoulder surgery, and cause narrowing of the joint space and/or
glenohumeral chondrolysis, was oppressive, extreme, malicious, fraudulent, and
outrageous conduct in that such conduct was and is so outrageous in character and so
extreme in degree that it goes and went beyond all possible bounds of decency and is
atrocious and utterly intolerable in a civilized community.
119.

As a direct and proximate result of Stryker’s outrageous conduct, Mr.

Brown suffered and will continue to suffer injuries, damages, and losses as alleged
herein.
COUNT IV -- STRICT PRODUCTS LIABILITY
120.

Plaintiff incorporates by reference all other paragraphs of this Complaint as

if fully set forth herein at length, and further alleges:
121.

Stryker placed its pain pumps into the stream of commerce.

122.

Mr. Brown purchased and/or ultimately obtained a pain pump from Stryker.

123.

Mr. Brown was given the pain pump as prescribed by his physicians in a

manner that Stryker intended its products to be used.
124.

Stryker’s pain pumps were defective and unreasonably dangerous when

they entered the stream of commerce such that the foreseeable risks exceeded the benefits
associated with the design and/or formulation of the products.
125.

Stryker’s pain pumps were defective in design and/or formulation because,

when they left Stryker’s hands, the foreseeable risks of use following shoulder surgery
exceeded the benefits associated with the design and/or formulation.

30

126.

The pain pumps were expected to and did reach Mr. Brown without

substantial change in condition. Alternatively, the pain pumps manufactured and/or
supplied by Stryker were defective in design or formulation because when they left
Stryker’s hands, they were unreasonably dangerous and more dangerous than an ordinary
consumer would expect.
127.

The pain pumps were defective due to inadequate warning and/or

inadequate clinical trials, testing and study, and inadequate reporting regarding the results
of such studies.
128.

The pain pumps were defective due to inadequate pre- and post-marketing

warning or instruction because, after Stryker knew or should have known of the risk of
injury from its products, it failed to provide adequate warnings to the medical community
and patients, and continued to promote the products as safe and effective.
129.

The pain pumps manufactured, distributed, tested, sold, marketed,

advertised and represented defectively by Stryker were a substantial factor in bringing
about Mr. Brown’s injuries that would not have occurred but for the use of the product.
130.

As a direct and proximate result of the defective condition of Stryker’s

products, Mr. Brown suffered and will continue to suffer injuries, damages, and losses as
alleged herein.
COUNT V -- STRICT LIABILITY – FAILURE TO WARN
131.

Plaintiff incorporates by reference all other paragraphs of this Complaint as

if fully set forth herein at length, and further alleges:

31

132.

Stryker manufactured pain pumps and placed them into the stream of

commerce in a defective and unreasonably dangerous condition such that the foreseeable
risks exceeded the benefits associated with the design and/or formulation of the products.
133.

Stryker’s products were defective due to inadequate warning and/or

inadequate clinical trials, in vivo and in vitro testing and study, and inadequate reporting
regarding the results.
134.

Stryker’s pain pumps and anesthetics were defective due to inadequate

post-marketing warning or instruction because, after Stryker knew or should have known
of the risk of injury from its pain pumps and anesthetics, Stryker failed to provide
adequate warnings to the medical community and patients, and continued to promote the
products as safe and effective.
135.

The defective warnings were a substantial factor in bringing about the

injuries to Ms. Brown that would not have occurred but for the use of the product.
136.

As a direct and proximate cause of the defective condition of Stryker’s

products, specifically its failure to warn and its other negligence, carelessness, and other
wrongdoing and actions described herein, Mr. Brown suffered those injuries and damages
as described with particularity above.
COUNT VI – BREACH OF IMPLIED WARRANTY
137.

Plaintiff incorporates by reference all other paragraphs of this Amended

Complaint as if fully set forth herein at length, and further alleges:
138.

Stryker placed its pain pumps into the stream of commerce.

139.

Mr. Brown purchased and/or ultimately obtained a pain pump from Stryker.
32

140.

Mr. Brown was given a pain pump as prescribed by his physicians in a

manner that Stryker intended its products to be used.
141.

Stryker impliedly warranted that its pain pumps were of merchantable

quality and safe and fit for the use for which they were intended.
142.

Stryker breached its implied warranty in that its pumps were defective and

unreasonably dangerous when they entered the stream of commerce such that the
foreseeable risks exceeds the benefits associated with the design and/or formulation of
the products.
143.

Stryker breached its implied warranty in that its pain pumps were defective

in design and/or formulation because when they left Stryker’s hands, the foreseeable risks
of use following shoulder surgery exceeded the benefits associated with the design and/or
formulation.
144.

The pain pumps were expected to and did reach Mr. Brown without

substantial change in condition. Alternatively, the pain pumps manufactured and/or
supplied by Stryker were defective in design or formulation because when they left
Stryker’s hands, they were unreasonably dangerous and more dangerous than an ordinary
consumer would expect.
145.

The pain pumps were defective due to inadequate warning and/or

inadequate clinical trials, testing and study, and inadequate reporting regarding the results
of such studies.
146.

The pain pumps were defective due to inadequate pre- and post-marketing

warning or instruction because, after Stryker knew or should have known of the risk of
33

injury from its products, it failed to provide adequate warnings to the medical community
and patients, and continued to promote the products as safe and effective.
147.

Stryker’s breach of implied warranty, including the fact that the pain pumps

were manufactured, distributed, tested, sold, marketed, advertised and represented
defectively by Stryker, was a substantial factor in bringing about Mr. Brown’s injuries
that would not have occurred but for the use of the product.
148.

Stryker’s breach of implied warranty with respect to its defective warnings

were a substantial factor in bringing about the injuries to Mr. Brown that would not have
occurred but for the use of the product.
149.

Mr. Brown relied on the skill and judgment and implied warranty of

Stryker that its pain pumps were of merchantable quality and safe and fit for the use for
which they were intended.
150.

Contrary to Stryker’s implied warranty, its pain pumps were not of

merchantable quality and were neither safe nor fit for the use for which they were
intended, in that they had serious risks of harm and dangerous propensities when put to
their intended use, and would instead cause severe injuries to users of the pain pumps,
including Mr. Brown.
151.

As a result of Stryker’s breach of implied warranty, Mr. Brown suffered

and will continue to suffer injuries, damages, and losses as alleged and described herein.
PRAYER FOR RELIEF
WHEREFORE, Plaintiff prays for judgment against the Stryker Defendants as
follows:
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Of Counsel:
Irwin B. Levin, Esquire
Greg L. Laker, Esquire
Jeff S. Gibson, Esquire
Cohen and Malad, LLP
One Indiana Square, Suite 1400
Indianapolis, Indiana 46204
[phone]

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