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COMMONWEALTH OF MASSACHUSETTS
SUFFOLK, SS. SUPERIOR COURT DEPARTMENT CIVIL ACTIOlir. 281
COMMONWEALTH OF MASSACHUSETTS,
Plaintiff, COMPLAINT
v.
ORTHO-MCNEIL-JANS S EN PHARMACEUTICALS, INC.
Defendant
INTRODUCTION
1. Attorney General Martha Coakley, on behalf of the Commonwealth of
Massachusetts, brings this civil action in the public interest against Ortho-McNeil-Janssen
Pharmaceuticals, Inc. ("Janssen"), pursuant to the Massachusetts Consumer Protection Act,
G.L. c. 93A, §4 and G.L. c. 12, §10. The Commonwealth alleges that Janssen engaged in
unfair and deceptive trade practices in marketing and selling Risperdal, an antipsychotic
medication generically known as risperidone. Specifically, the Commonwealth alleges
Janssen has harmed Massachusetts consumers by (1) promoting Risperdal for uses that were
neither approved by the U.S. Food and Drug Administration ("FDA") nor demonstrated to be
safe and effective for such medical purposes; (2) making misleading and deceptive statements
to Massachusetts health care professionals about the appropriate use•of its products, (3) failing
to disclose risks associated with Risperdal's use, particularly Risperdal's use in vulnerable
populations, the elderly and children; and (4) undermining drug safety in the Commonwealth
by unfairly circumventing rules governing the lawful promotion of pharmaceutical products.
The Commonwealth seeks to enjoin Janssen's unfair and deceptive conduct, to obtain
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disgorgement of ill-gotten gains and civil penalties, and to be awarded costs and other
appropriate relief as the Court deems just and proper.
JURISDICTION AND VENUE
2. This Court has jurisdiction over the subject matter of this action pursuant to G.L.
c. 93A, §4 and over Defendant pursuant to G.L. c. 223A, §3. Venue in this Court is proper
under G.L. c. 93A, §4 and G.L. c. 223, §5.
PARTIES
3. The Plaintiff is the Commonwealth of Massachusetts, represented by Martha
Coakley, Attorney General, who brings this action in the public interest.
4. The Defendant, Ortho-McNeil-Janssen Pharmaceuticals, Inc. ("Janssen"), is a
New Jersey corporation and has its principal place of business, in Titusville, N.J. At all times
relevant to this action, Janssen engaged in trade or commerce in the Commonwealth,
including the selling and marketing of Risperdal.
NOTICE
5. On May 6, 2011, the Attorney General notified Janssen of her intention to file this
suit and offered the Defendant an opportunity to confer regarding this action, in conformance
with G.L. c. 93A, §4.
FACTUAL ALLEGATIONS
Backaround
6. Health care providers are not prohibited from prescribing prescription drugs for
uses that have not been reviewed and approved by the FDA. However, in the United States,
pharmaceutical manufacturers may not promote their prescription products for any uses
(and/or dosages) that are not FDA-approved. In order to obtain FDA approval to market a
prescription drug for a particular use, a manufacturer must first establish that the drug is safe
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and effective for the proposed use. An FDA-approved use is often referred to as an
"indication" or an "on-label" use. An "off-label use," in contrast, is a use that has not been
determined by the FDA to be safe and/or effective.
7. In 1993, Janssen was at the forefront among pharmaceutical manufacturers in
obtaining FDA approval to market a new kind of antipsychotic medication called an atypical
antipsychotic.
8. Pharmaceutical manufacturers developed atypical antipsychotics as ostensibly
safer alternatives to conventional antipsychotic medications based on theories that these drugs
might be used to treat psychotic disorders without the same risks of producing serious side
effects, including extrapyramidal syndrome ("EPS") and tardive dyskinesia ("TD") 1 ,
associated with the conventional antipsychotic medications.
9. While Risperdal and other atypical antipsychotics purportedly reduced the risk of
EPS and TD associated with conventional antipsychotics, there were early signs that the
atypical antipsychotics also produced dangerous side effects, including weight gain, diabetes,
hyperglycemia, cardiovascular complications and other severe conditions.
10. In January 1994, Defendant began marketing and promoting Risperdal in
Massachusetts and across the United States.
11. At that time, the FDA approval was narrowly limited to Risperdal's use for the
management of the manifestations of psychotic disorders in adults.
12. In September 1997, the FDA denied Janssen's request for a pediatric indication
for Risperdal, stating that there was no justification for promoting Risperdal's use in children.
Tardive dyskinesia is a neurological disorder characterized by repetitive, involuntary, and purposeless movements including grimacing, tongue protrusion, lip smacking, rapid eye blinking and rapid movements of the arms, legs and trunk. Extrapyrarnidal syndrome is characterized by symptoms including a range of involuntary movements usually of the face and neck.
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13. In January 1999, the FDA denied Janssen's request for labeling regarding the use
of Risperdal in the treatment of "psychotic and behavioral disturbances in dementia," citing
Janssen's failure to "fully explore and explain what appeared to be an excess number of deaths
for risperidone [among study participants1"
14. In September 2000, the FDA approval for all atypical antipsychotics was changed
to specify that the atypicals were approved only for the "treatment of schizophrenia" in adults.
15. In March 2002, Janssen revised the Risperdal label to clarify that its approved use
was for the treatment of schizophrenia in adults only.
16. In 2003, the FDA approved Risperdal M-Tab (an orally dissolving form of
Risperdal) and Risperdal Consta (a long—acting injectible form of Risperdal) for the treatment
of schizophrenia in adults.
17. On December 4, 2003, the FDA approved Risperdal tablets and solution as
monotherapy for the short term treatment of acute manic or mixed episodes associated with
Bipolar I Disorder in adults, and as adjunctive therapy for the short term treatment of acute
manic or mixed episodes associated with Bipolar I disorder in adults.
18. There were no FDA-approved indications for Risperdal's use in children or
adolescents until October 2006. 2
19. The FDA has never approved the use of Risperdal by adults or children for
depression, anxiety, Attention Deficit Disorder ("ADD"), Attention Deficit and Hyperactivity
Disorder ("ADHD"), conduct disorder, sleep disorders, anger management, dementia,
Alzheimer's disease, mood enhancement or mood stabilization.
2 On October 2, 2006 the FDA approved Risperdal for the treatment of irritability associated with autistic disorder in children and adolescents. On August 22, 2007 the FDA approved Risperdal for the treatment of schizophrenia in adolescents ages 13-17, and for short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10-17.
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Janssen's Illegal Marketing Scheme
20. Despite the narrow FDA-approved indications for Risperdal, Janssen developed
and executed marketing and sales plans designed to promote Risperdal for uses that had not
been established to be safe and/or effective and to minimize the many risks associated with
Risperdal's use.
21. Janssen's promotion of Risperdal for off-label uses and its failure to disclose risks
associated with Risperdal made the drug a top-selling treatment for certain conditions
notwithstanding the lack of scientific evidence that Risperdal could be safely used to treat
these conditions.
22. From 1994 through September 2006, Janssen promoted Risperdal's use in
children and adolescents, even though Risperdal had not been established to be safe and
effective in children.
23. From September 1997 through September 2006, Janssen promoted Risperdal's
use in children and adolescents without disclosing that the FDA rejected a proposed pediatric
indication and without disclosing the risks associated with Risperdal's use in the pediatric
population and/or that Risperdal's use in children had not been adequately studied to assess
risks and benefits.
24. From 1994 onward, Janssen promoted Risperdal's use to treat dementia in elderly
patients, even though Risperdal was never established to be safe and effective for such a use.
25. From January 1999 onward, Defendant promoted Risperdal to treat elderly
dementia without disclosing to physicians that the FDA denied Janssen's request for a
dementia indication because of unaddressed safety concerns, including an increased risk of
death associated with Risperdal's use in elderly dementia patients.
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26. Janssen targeted its Risperdal marketing efforts at vulnerable populations —
children and the elderly — often by touting Risperdal's purported safety and/or favorable side
effect profile.
27. As a result of Janssen's marketing, Risperdal was for many years a top-selling
atypical antipsychotic in the elderly and pediatric market segments.
28. Janssen also illegally marketed Risperdal to treat, among other things, depression,
anxiety, obsessive compulsive disorder, conduct disorder, post-traumatic stress disorder, and
Alzhehner's disease, none of which were FDA-approved uses of the drug.
29. Janssen used a wide range of illegal tactics to promote the off-label use of
Risperdal. These included: promoting Risperdal to physicians (notably child psychiatrists and
primary care physicians) who primarily prescribed Risperdal for uses that had not been
approved by the FDA; providing these same physicians with thousands of free samples of
Risperdal; setting sales goals and creating incentives that motivated sales representatives to
promote Risperdal for unapproved uses; sponsoring and ananging speaker programs that
promoted unapproved uses; conducting sham consulting programs in which physicians were
paid to learn about Risperdal's unapproved uses; and rewarding physicians who prescribed
and promoted Risperdal for unapproved uses with lucrative consulting agreements.
Janssen Executives Created and/or Endorsed the Illegal Marketing Scheme
30. Defendant's plans to promote Risperdal for unapproved uses in children, for the
treatment of dementia in the elderly and for other conditions that had not been reviewed
and/or approved by the FDA were evaluated and endorsed by top Company executives.
31. In strategic and tactical planning documents, Janssen executives detailed their
efforts to target and exploit various off-label markets for Risperdal.
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32. As early as 1998, Company business plans explicitly called for expanding
Risperdal sales for unapproved, off-label uses.
33. In a 1999 business plan, executives declared the following objective for
Risperdal: "To be the first-line treatment for both psychotic and non-psychotic disorders. The
1999 objective is to regain market leadership position in schizophrenia and bipolar, achieving
sales of $853MM and market share of 26.6%." Exhibit 1 is a true and accurate copy of
Risperdal 1999 Business Plan Summary, as produced by Janssen, J.TRIS02593972. Risperdal
was not, at that time, approved to treat bipolar mood disorder or non-psychotic disorders.
34. In the same business plan, Company executives articulated the following strategic
vision: "Our focus in 1999 will be to increase the leadership of RISPERDAL as the most
effective atypical antipsychotic for first-line treatment of both psychotic and non-psychotic
disorders. These disorders include schizophrenia, schizoaffective disorder, bipolar disorder,
dementia and conduct disorders." Id. at JJRIS02593973. Risperdal has never been approved
by the FDA to treat dementia or conduct disorders.
35. The 2000 Risperdal business plan called for Risperdal to "be the antipsychotic
treatment of choice for both psychotic and non-psychotic disorders," notwithstanding the fact
that Risperdal had been approved only to treat the management of manifestations of psychotic
disorders at that time. Exhibit 2 is a true and accurate copy of Risperdal 2000 Business Plan
Summary, as produced by Janssen, J.TRE12950161. In the 2000 business plan, Company
officials articulated specific market share and sales goals for Risperdal's use to treat bipolar
mood disorder ($175 million in sales and a 32% market share) and dementia ($302 million
and 57% market share) even though Risperdal had not been approved to treat either condition
at that time. Id.
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36. Company business plans also reflected the prominent role the child and
adolescent market played in Risperdal's success.
37. In a 2001 Risperdal business plan, executives reported that "[a]lthough the
RISPERDAL Base business is rooted in the Schizophrenia marketplace, another fast-growing
portion of this market is in children and adolescents . . . . Use of RISPERDAL in this segment
has grown 50% in the past two years and Rxes [prescriptions] in this category account for
20% of overall Risperdal use." Exhibit 3 is a true and accurate copy of 2001 Risperdal Base
Business Plan, as produced by Janssen, DRErev00601258 at 00601260. At the time, the
Company aimed to grow "share in schizophrenia with an exit share of 20.0% and an exit share
in child/adolescent of 70%" and to "Protect and Expand Reach/Partnership with Key
Customer Base" including child/adolescents. Id. at BRErev00601261.
38. Janssen executives purposefully developed and exploited the markets for the
unapproved and off-label uses of Risperdal to treat dementia in the elderly and a range of
conditions afflicting children and adolescents and did so in spite of the known and potential
risks associated with Risperdal's use in these vulnerable populations.
39. Janssen's illegal marketing tactics made Risperdal a blockbuster drug — not
merely for the treatment of schizophrenia in adults (its approved use) — but for the treatment of
dementia in the elderly and a wide range of pediatric uses.
40. From 1995 through September 2006, Risperdal sales in Massachusetts alone
totaled hundreds of millions of dollars, according to the Company's records. Exhibit 4 is a
true and accurate copy of Janssen' s Risperdal sales figures for Massachusetts, as produced by
Janssen.
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Janssen Illegally Promoted Risperdal to Treat Elderly Dementia
41. Janssen began promoting Risperdal to treat dementia in the elderly in the mid-
1990s before receiving FDA approval to market Risperdal for such a use.
42. The Company sought to expand Risperdal's use to treat dementia by touting
Risperdal's purported safety in the elderly, notwithstanding a lack of scientific or clinical
evidence to support this claim.
43. To further advance its goal of expanding Risperdal's use to treat dementia in the
elderly, Janssen launched its ElderCare sales force in mid-1998.
44. The ElderCare sales force, which began with 85 sales representatives, focused
specifically on Risperdal's use to treat dementia in the elderly. As noted in a Risperdal 1999
Tactical Plan, which was prepared in December 1998, "dementia is another area of growth for
us" and "the ElderCare Sales Force is dedicated to that marketplace." Exhibit 5 is a true and
accurate copy of RISPERDAL (risperidone), 1999 Tactical Plan, December 1998, as produced
by Janssen, BRE02572877 at 02572917.
45. The ElderCare Sales Force quickly contributed to increased sales. According to a
1999 Risperdal business plan, which was prepared in late 1998, "LTC market is very
responsive to promotion. Sales growth indicates that this market has responded very
positively to the combined marketing and sales efforts launched in June. Since July, monthly
sales versus last year are up by 20%." Exhibit 1 at JJRIS02593980.
46. In January 1999, the FDA unequivocally denied Janssen's request for a dementia-
related indication, citing the Company's failure to address serious safety concerns.
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47. Specifically, the FDA was concerned that the elderly dementia patients taking
Risperdal in a Company-sponsored clinical study had a higher risk of death than those who
were taking placebo.
48. In a file memorandum dated January 19, 1999, Russell Katz, M.D., who was then
the FDA's Acting Director of the Division of Neuropharmacological Drug Products, noted
Janssen's apparent disregard of the increased mortality. Dr. Katz wrote, "[g]iven the
concerns about the possible increased mortality, and the firm's complete absence of attention
to this potential problem, I agree that it is appropriate to issue a Not Approvable letter at this
time expressing our concerns . . . ." Exhibit 6 is a true and accurate copy of a 1/19/1999
Memorandum from Russell Katz of the FDA, as produced by Janssen, BRIS00521950 at
00521954.
49. On January 20, 1999, Dr. Katz informed Janssen that its application to change
Risperdal's labeling would not be approved because of the Company's failure to fully evaluate
the safety of Risperdal's use to treat psychotic and behavioral disturbances in dementia.
Exhibit 7 is a true and accurate copy of a 1/20/99 Letter from Russell Katz of the FDA to Todd
D. McIntyre of Janssen, as produced by Janssen, JJRP00448003.
50. Dr. Katz wrote, "[t]he major obstacle to an approvable action on this supplement
was your failure to fully explore and explain what appeared to be an excess number of deaths
for risperidone [among study participants]." Id. at JJRP00448005.
51. In addition to denying Janssen's request to expand the Risperdal label to include
an indication for dementia, the FDA also sharply criticized the Company's promotion of
Risperdal in the eldercare marketplace.
52. In a January 5, 1999 letter to Company officials, FDA's Division of Drug
Marketing, Advertising and Communications (DDMAC) told Janssen that its Risperdal
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marketing campaign for geriatric patients included materials that are "false, misleading and/or
lacking in fair balance, and in violation of the Federal Food, Drug and Cosmetic Act and the
regulations promulgated thereunder." Exhibit 8 is a true and accurate copy of a 1/5/1999
Letter from Lisa Stockbridge of DDMAC to Todd McIntyre of Janssen, as produced by
Janssen, DRIS02820185. Among other things, officials at DDMAC told the Company:
Janssen is disseminating materials that state or imply that Risperdal has been determined to be safe and effective for the elderly population in particular. There is limited data on the use of Risperdal in the elderly, and the elderly population was not specifically studied in the clinical trials for Risperdal. Thus, presentations that focus on this population are misleading in that they imply that the drug has been found to be specifically effective in the elderly population.
Also, according to the approved product labeling (PI), there are safety considerations for Risperdal in the elderly population . . . . The safety of Risperdal in 'fragile" individuals or individuals with concomitant illnesses has not been evaluated in adequate and well-controlled studies.
Id.
53. Notwithstanding the FDA's refusal to approve a dementia-related indication for
Risperdal, its concerns about increased death associated with the use of Risperdal among
elderly dementia patients and its warning that Janssen's Risperdal marketing in the geriatric
marketplace was false and/or misleading, the Company's concerted effort to promote and sell
Risperdal to treat dementia in elderly patients continued and sales for dementia continued to
grow.
54. In a June 1999 e-mail, Ludwig Hantson, Group Director of Janssen's Central
Nervous System division, wrote to other Janssen executives that a major goal for 2000 was to
"strengthen our leadership position in dementia." Exhibit 9 is a true and accurate copy of
6/18/1999 E-Mail from Ludwig Hantson of Janssen, as produced by Janssen, BRE02444796.
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55. In the first 9 months of 1999, 50% of new Risperdal prescriptions were written to
treat dementia, and dementia accounted for approximately 55% of total sales. Exhibit 2 at
JJRE12950163.
56. A summary of the Risperdal 2000 Business Plan, dated November 24, 1999,
shows that the Company continued to focus on retaining Risperdal's status as the market
leader among antipsychotic drugs used to treat dementia in elderly patients. The summary
states: "[d]ementia share goal is 57% with sales of $302 MM." Exhibit 2 at BRE12950161.
57. The following year, Company officials reported that nearly half of all the
antipsychotic prescriptions written for dementia were for Risperdal and noted that "[t]he
brand's focus to date has been in dementia, the largest elderly segment," and pointed to
nursing homes and other long-term care settings as the primary targets for Risperdal sales.
Exhibit 10 is a true and accurate copy of RISPERDAL LTC/GERIATRICS, 2001Business Plan
Summary, as produced by Janssen, JJRE12951083 at 12951084.
58. Company officials attributed Risperdal's success in the eldercare market,
particularly sales for the treatment of dementia, to a study that was published in January 1999
that helped form the "foundation of the brand's medical education and promotional activities,"
and to the launch of the ElderCare sales force and the Long-Term Care Group in 1998, which
helped Janssen reach "LTC pharmacy providers, Nursing Homes, Primary Care and
Psychiatry with the critical messages concerning the benefits of Risperdal." Id. at
JJRE12951085.
59. Although Janssen was aware of the strict rules governing the dissemination and
use of clinical studies discussing unapproved uses, Janssen trained sales representatives to use
such studies, including the Katz study, as promotional tools.
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60. Sales representatives were provided with a "model script" describing how they
should use the Katz study with physicians to promote Risperdal's use to treat dementia.
According to company documents, sales representatives were told to say, "As you know,
Risperdal is currently not indicated for the treatment of dementia. However, the Katz study
evaluated Risperdal in 625 elderly patients suffering from behavioral disturbances associated
with dementia. This study clearly demonstrates that Risperdal lmg/day is highly effective and
safe in managing hostility and aggression in elderly patients with dementia." Exhibit 11 is a
true and accurate copy of Risperdal Key Reprints Workshop, Manager Guide, as produced by
Janssen, JJRE01284506 at 01284617; Exhibit 12 is a true and accurate copy of Risperdal 500
Gold: Pre-Launch Audiotape, Draft 1 — December 28, 2001, as produced by Janssen,
ERE04770749.
61. At the time these materials were prepared, Company officials were aware of — and
concealed the fact that — Risperdal's use to treat dementia in the elderly was associated with
an increased risk of death.
62. The Company did not inform Janssen sales representatives that the FDA denied
the proposed dementia indication because of unaddressed safety concerns.
63. The Company did not instruct its sales representatives to inform prescribers that
the FDA denied the proposed dementia indication because of unaddressed safety concerns, nor
did Janssen instruct sales representatives to inform prescribers that Risperdal was associated
with an increased risk of death in elderly dementia patients.
64. Following the FDA's explicit denial of a proposed indication for dementia,
Janssen's ElderCare sales force continued to focus their sales messages on Risperdal's use to
treat elderly dementia.
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65. In March 2000, Chris Fagnani, a regional business director for Janssen's
ElderCare Sales Force, told Anwar Feroz Siddiqi, who headed the ElderCare Sales Force
nationwide, that ElderCare sales representatives needed to be trained on Risperdal's use to
treat schizophrenia, not just its use to treat dementia.
66. In an e-mail to Anwar Feroz Siddiqi, Chris Fagnani wrote: "Schizophrenia
continues to come up in calls with physicians and pharmacists. The representatives would like
to be trained on schizophrenia in order to have more credibility in the eyes of their physicians
as a Risperdal expert not a Risperdal for Dementia expert. The FSD/RBD team needs to
evaluate if this is an option we feel is important enough to resolve or if this would distract the
representatives from their dementia focus." Exhibit 13 is a true and accurate copy of the
3/31/2000 E-Mail Chris Fagnani sent to Anwar Feroz Siddiqi, as produced by Janssen,
JJRE12868350.
67. Company documents show that Janssen sales representatives routinely
encouraged physicians to use Risperdal to treat dementia.
68. Sales representatives recorded how and when they promoted Risperdal to treat
dementia in a "call notes database" created and maintained by Janssen to track and monitor
sales representatives' sales calls on health care professionals.
69. The following is a sample of call notes prepared by Janssen sales representatives
who promoted Risperdal to Massachusetts prescribers. These calls notes are illustrative of the
Risperdal marketing pitches used by sales representatives in the field. Among other things,
the call notes recorded by sales representatives in Massachusetts reported the following
discussions with prescribers:
• An August 2, 2001 call note (000001446802) reports on a sales call with a Brookline doctor: "Reminded him of Risperdal .5mg bid for hostility and excitement in his
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dementia patients . . . ."
• A September 24, 2002 call note (4G7-E00) reports on a sales call with a Frarningham doctor: "Follow up w/ her regarding her treatment of dementia. See how ris worked for Dr Delacey's patient. Show cost comparison of Ris and haldol."
• A December 12, 2002 call note (F3N-7B6) reports on a sales call a Brockton nursing home official: "detailed don on diabetes issue with zyprexa and presented risp as first line options for geriatric patients with dementia."
A January 10, 2003 call note (F3N-AK8) reports on a sales call with a Quincy doctor: . . . also touched upon excellent safety profile of risp and rem. asked that is [sic]
patients do present early signs of dementia, consider rem as first line option and then risp for latter stages."
• An April 1, 2003 call note (F3Y-BZC) reports on a sales call with a Holyoke doctor: "Met with Dr. Kaskey for about fifteen minutes and we spoke about alot [sic]. We started around his use of Risperdal and what patient types he typically sees. we spoke about the mood and anxiety symptoms associated with Schizophrenia and dementia and how he could use Risperdal here. We spoke about starting the elderly at .25 and titrating to effect."
• A July 30, 2003 call note (KD6-MUS) reports on a sales call with a Brookline doctor: "Risperdal — doesn't use b/c refers severe psychosis. But he does treat depression and dementia. got him thinking about low dose usage."
Exhibit 14 is comprised of true and accurate copies of certain call records printed from the
Company's call notes database as produced by Janssen.
70. The call notes also show that Janssen continued to promote Risperdal as a
treatment for dementia even as the FDA's warnings about this use became more dire.
71. In April 2003, per the FDA, the Company changed the Risperdal label to add a
warning about cerebrovascular adverse events, including stroke, in elderly patients with
dementia, and sent a letter to health care providers advising them of the change in the label.
Exhibit 15 is a true and accurate copy of 4/16/2003 Letter from Christine Cote, as produced by
Janssen, JJCIDP00001468.
72. In response to the newly required warning, Janssen provided its sales force with
"Medical/Legal Talking Points" to deflect prescribers' concerns about prescribing Risperdal in
15
light of the new warning. Among other things, the sales representatives were instructed to tell
physicians:
It is my understanding that in a court of law, physicians are measured by adherence to accepted standards ofprofessional conduct in their community. This allows you the freedom to choose the best medication in your professional judgment, based on patient history and risk/benefit ratio, without being confined to FDA approved indications.
That being said, RISPERDAL is the most studied product in this category and the only product to prove efficacy in all studies conducted in this area. This may ultimately lead to an indication in dementia related psychosis for Risperdal. Clearly, if you are practicing evidence based medicine, this is an accepted standard ofprofessional conduct in the community.
Exhibit 16 is a true and accurate copy . of 5/28/2003 E-Mail from Roger Golden of Janssen, as
produced by Janssen, and attached RISPERDAL Medical/Legal Talking Points, as produced by
Janssen, JJRErev12947938, BRErev12947940.
73. Company sales representatives' efforts to minimize the risks articulated in the
FDA-required warnings were recorded in Janssen's call notes database. The following call
notes are illustrative of the ways Massachusetts sales representatives attempted to blunt the
FDA's warning:
• An April 29, 2003 call note (F26-GHX) reports on a sales call with an Acton doctor: "He had an issue with a patient who read the Boston Globe and wanted to stop Risperdal. I asked if he convinced them otherwise and he did not have a satisfactory response. He needs more work, asked if I could get him studies showing it is safe and effective in dementia, I said that I have already shown him a major one and that I would submit a MIR for others."
• An August 21, 2003 call note (EXV-11HO) reports on a sales call with a West Bridgewater doctor: "Dr. T still not comfortable with the CAE so went over the FDA reasoning for the warning and seperated [sic] the serious from the non serious and told him Risp still getting indication for dementia rel. psychosis."
Exhibit 17 is comprised of true and accurate copies of certain call records printed from the
16
Company's call notes database as produced by Janssen.
74. Janssen attained such a large market share in the dementia market because it made
a concerted effort to identify those physicians — often primary care physicians — who are most
likely to treat dementia and targeted them for the Company's illegal promotional efforts.
75. Janssen supplemented the efforts of the ElderCare sales force, which already was
detailing Risperdal to primary care physicians, by enlisting the 500 members of the 500 Gold
sales force to promote Risperdal to primary care physicians, as well.
76. Upon information and belief, 500 Gold sales representatives were required to
detail Risperdal to numerous Massachusetts physicians who had little, if any, history of
prescribing atypical antipsychotics, much less a likelihood of prescribing Risperdal to treat
schizophrenia or bipolar mood disorder. Janssen provided sales representatives with call plans
and physician target lists that included Massachusetts primary care physicians who rarely if
ever prescribed Risperdal or any other atypical antipsychotic and instructed sales
representatives to promote Risperdal to these physicians.
77. Janssen targeted thousands of primary care physicians for Risperdal promotion
even though primary care physicians rarely prescribe antipsychotic drugs to treat adult
schizophrenia. According to Company documents, more than half of the antipsychotic
prescriptions written for dementia are written by primary care physicians; only one quarter are
written by psychiatrists. Exhibit 18 is a true and accurate copy of Risperdal PAD, Market
Research Overview, as produced by Janssen, JJRE15129113 at 15129121.
78. Company documents also show that in 2004 less than 20 percent of the
prescriptions written for Risperdal by primary care physicians were for schizophrenia or
bipolar mood disorder, which were the only approved indications at that time. Id. at
JJRE15129148.
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79. In addition to direct promotion to primary care and eldercare physicians via sales
calls and the provision of samples, Janssen promoted Risperdal's use to treat dementia to
primary care and eldercare physicians via sham consulting meetings — Regional Advisory
Boards and Home Office Visits — in which prescribers were flown to Janssen's home office or
to "very nice locations" to discuss "multiple uses of Risperdal — schizophrenia, bipolar,
dementia and conduct disorder." Exhibit 19 is a true and accurate copy of Initial Product
Training: RISPERDAL Brand Overview, as produced by Janssen, JJRErev00577082 at
00577159.
80. Janssen promoted Risperdal to treat dementia in the elderly until at least the
spring of 2005, when the FDA required the Company, and the makers of all atypical
antipsychotics, to add a boxed warning to their labeling alerting health care providers and
patients of the increased risk of death among the elderly taking these drugs to treat dementia.
Exhibit 20 is a true and accurate copy of the 4/11/2005 FDA Public Health Advisory, as
produced by Janssen, HCIDP00001477.
81. Janssen notified health care providers of the addition of the boxed warning to its
label in May 2005. Exhibit 21 is a true and accurate copy of the 5/2005 Letter from Ramy
Mahmoud ofJanssen, as produced by Janssen, JJCIDP00001475.
82. The ElderCare sales force was disbanded in September 2005.
83. Janssen's illegal tactics and practices in the eldercare marketplace succeeded in
making Risperdal the top-selling antipsychotic for the treatment of dementia.
84. From 1998 through at least 2001, Risperdal sales to treat dementia accounted for
approximately 20 percent of total Risperdal sales. Exhibit 22 is a true and accurate copy of
11/7/2010 Risperdal Market Report — October 2000 Issue, as produced by Janssen,
JJRISrev02475929 at 02475933; Exhibit 23 is a true and accurate copy of a Business
18
Information Report, RISPERDAL, August 2003, as produced by Janssen, IIRE02222220 at
02222227.
85. Janssen created and then dominated the market for the use of atypical
antipsychotics for the treatment of elderly dementia. According to Company documents, from
1998 through at least 2004, among the antipsychotic medications, Risperdal consistently
obtained the largest market share in the dementia marketplace, often exceeding 50 percent of
the market. Exhibit 10 ERE12951085; Exhibit 24 is a true and accurate copy of a 12/19/2001
Risperdal Market Report — December 2001 Issue, as produced by Janssen, JJRISrev02483340
at 02483345; Exhibit 25 is a true and accurate copy Child and Adolescent & Other New
Business, 2003 Business Plan, July 29, 2002, as produced by Janssen, BRE00935734 at
00935758; Exhibit 18 at DRE15129120.
86. Sales of Risperdal to treat dementia in the elderly in Massachusetts and
nationwide generated hundreds of millions of dollars in sales for Janssen. Janssen obtained
these sales through its illegal marketing practices and its failure to inform health care
providers and patients of the true risks associated with Risperdal's use in this population.
Janssen Illegally Promoted Risperdal to Treat Children & Adolescents
87. Janssen began directly promoting Risperdal to child and adolescent psychiatrists
in 1994, when the product was first launched into the marketplace.
88. From January 1994 through September 2006, Janssen sales representatives
directly promoted Risperdal to thousands of child and adolescent psychiatrists and
pediatricians even though Risperdal was not approved to treat any pediatric conditions until
October 2006.
89. The details of these sales calls were recorded by sales representatives in Janssen's
call notes database.
19
90. The call notes database shows that from 1994 through February 1999, more than
100,000 sales calls were made on physicians whose primary specialty was identified as child
and adolescent psychiatry, including more than 3,000 sales calls that were made on child and
adolescent psychiatrists in Massachusetts. 3
91. Janssen targeted physicians who treat children for direct Risperdal promotion
after the FDA explicitly denied Janssen's request for a pediatric indication.
92. In 1997, in response to Janssen's 1996 request for a pediatric
indication, the FDA wrote:
To permit the inclusion of the proposed vague references to the safety and effectiveness in pediatric patients and the nonspecific cautionary advice about how to prescribe Risperdal for the unspecified target indications would serve only to promote the use of this drug in pediatric patients without any justification.
Exhibit 26 is a true and accurate copy of a 9/17/1997 Letter from Paul Leber of
the FDA to Todd D. McIntyre of Janssen, as produced by Janssen, JRIS01230685.
93. Janssen promoted pediatric use of Risperdal to Massachusetts prescribers without
disclosing that the FDA had rejected the proposed pediatric indication, citing, among other
things, the lack of evidence supporting such use.
94. According to Janssen documents, Risperdal was the market leader among
antipsychotic drugs used to treat children and adolescents, with 44.5 percent of the new
prescriptions and $85 million in sales, for the year that ended in April 2000. Company
officials reported that these sales came despite "lack of FDA approval in pediatric patients;
lack of clinical data to support atypical agent use in pediatrics/teenagers; acute side effects (ie
weight gain, lactation); [and] long-term side effects (ie, tardive dyskinesia.)" Exhibit 27 is a
3 The Company has not produced several years' worth of call notes. After 1999, the Company inconsistently tracked physician specialty data in the call notes database.
20
true and accurate copy of Risperdal, Pediatric Market Opportunity, August, 2000, as produced
by Janssen, JJRE07998936 at 07998948.
95. The Company also understood that Risperdal had unique disadvantages,
including, "more likely to cause extrapyramidal symptoms (EPS), including tremor and
stiffness; higher long-term risk of tardive dyskinesia (TD); more likely to cause increased
prolactin levels, gynecomastia, lactation; 4 [and] causes significant weight gain (which can be
advantageous in children with ADD who are often too thin)." Id. at IIRE07998951.
96. Despite Defendant's knowledge of the risks associated with prescribing Risperdal
to treat children and adolescents, and the lack of data supporting Risperdal's safety or efficacy
in this patient population, one of the marketing objectives for Risperdal in 2001 was to "grow
and protect share in children/adolescents" via medical education initiatives and "effective rep
targeting with a year-end exit share of 70%." Exhibit 3 at JJRErev00601261.
97. To achieve the corporate goal of expanding Risperdal's share in the child and
• adolescent marketplace, Janssen sales representatives were encouraged and trained to promote
Risperdal to physicians who primarily treat children under the age of 18.
98. According to a PowerPoint presentation included in a Janssen sales training
manual, sales representatives were given specific instructions regarding how to promote
Risperdal to child and adolescent psychiatrists. Exhibit 28, JJRISrev00434469 at 00434536-
00434537. Among other things, the presentation states that these physicians treat patients
under the age of 18 who most often are diagnosed with a "behavioral disorder" or a "mood
disorder." Id. Although the presentation noted that Risperdal was not indicated for use by
children and adolescents, representatives were advised to "[s]ell on symptoms not diagnosis,"
4 Increased prolactin levels, or hyperlactinemia, can result in reproductive dysfunction in both male and female patients as well as a decrease in bone density. Gynecomastia is an endocrine disorder characterized by excessive development of the breast in male patients.
21
as well as "utilize Medical Services for studies" and "position Risperdal as first line." Id.
Sales representatives were not instructed tell prescribers that there was insufficient data to
support Risperdal's use in children and adolescents.
99. Consistent with Company expectations, Janssen sales representatives routinely
illegally promoted Risperdal to physicians who treat children and adolescents and recorded
their interactions with these physicians in the call notes database maintained by Janssen.
100. A sampling of call notes shows that sales representatives promoted Risperdal's
use in children and did so long before Risperdal was FDA-approved to treat any conditions in
pediatric patients. The following call notes are illustrative of the marketing messages
presented by Janssen sales representatives to Massachusetts prescribers:
• An August 2, 2001 call note (000000244279 ) reports on a sales call with a Braintree doctor: ". . . . She is using Risperdal with great success in kids ala Biederman. She did mention galactarhea so I told her how Biederman is uSing Dostinex. She is going to get more info on this dopamine agonist. She is going to attend the 4 Seasons event."
• A December 5, 2001 call note (000000758930 ) reports on a sales call with a Rehoboth doctor: "Good call. Stuck to the basics of Risperdal of safety and efficacy in kids. He loves it here for agression . . . ."
• An August 16, 2002 call note (4YU-51J) reports on a sales call with a Hingham doctor: "Discussed how the whole key w/Risperdal is dosing especially for the type of patients that they see. Talked low dosing in children for hostility and agression [sic] as well as low dose for mood and anxiety. . . . ."
• A February 2, 2003 call note (K6F-4Q5) reports on a call with a Boston doctor: "Introduction and left a low dose message especially in kids . . . ."
• An October 6, 2003 call note (PTX-OSA ) reports on a call with a Holyoke doctor: "also disc. ris as solog agent and mtab for kids . . . ."
• An October 7, 2003 call note (K3W-Y8S) reports on a call with a New Bedford doctor: "Core message and discussed her using more rn-tab wioth [sic] some of the kids she treats."
• A June 10, 2004 call note (ZPU-AAV) reports on a call with a Fitchburg doctor: "We also discussed Risperdal for irritibility [sic], aggression and outbursts in
22
children. He comitted [sic] to using Risperdal for these symptoms. F/up with him re the outcomes on the next visit." Call Record, James Dunn to Paul Epstein, 6/10/2004
• A June 22, 2004 call note (10FE-OFM) reports on a call with a Salem doctor: "Disc'd Riseff & safety in adult, child and elderly pts . . . ."
• A July 30, 2004 call note (ZTW-LTX) reports on a call with an Agawam doctor: "said she was using ris lots for kids and geri's who are angry/impulsive/agitated. i said great — those are the most sensitive and it works . . . ."
Exhibit 29 is comprised of true and accurate copies of certain call records printed from the
Company's call notes database as produced by Janssen.
101. Janssen provided sales representatives with financial incentives to promote
Risperdal for the treatment of pediatric conditions.
102. Until at least 2005, sales representatives were rewarded for increasing sales of
Risperdal, regardless of whether those sales came from off-label uses, e.g., pediatricians
treating children for attention deficit hyperactivity disorder, or from on-label uses, e.g.,
psychiatrists treating adults for schizophrenia.
103. The Company further promoted Risperdal's use among children and adolescents
by providing thousands of samples of Risperdal to physicians who primarily treat children and
adolescents.
104. To increase Risperdal sales in the child and adolescent marketplace, Janssen also
paid psychiatrists who specialize in the treatment of children and adolescents to promote
Risperdal to their peers and/or to provide consulting services to Janssen.
105. The Company paid psychiatrists who treat children to attend "Child & Adolescent
Advisory Boards" and "Home Office Visits" that were little more than marketing
presentations aimed at — and resulting in — increased off-label usage of Risperdal in pediatric
patients.
23
106. Company documents show that the programs were designed to provide attendees
with detailed information on off-label uses and to solicit advice on various marketing topics,
including "barriers to prescribing atypical antipsychotic agents." Exhibit 30 is a true and
accurate copy of materials from Child & Adolescent Regional Advisors Meeting, July 12-14,
2002, Boston, Massachusetts, as produced by Janssen, ITRIS00369777 at 00369784.
107. Company documents show that the over-riding purpose of advisory board
programs and home-office visits was promotional.
108. As early as 1993, Company officials described advisory boards for Risperdal as
one of the means by which Janssen would "develop support for Risperdal among opinion
leaders down to the regional level," as well as a means to "identify and manage opinion
leaders with incompatible perspectives." Exhibit 31 is a true and accurate copy of PRODUCT
MARKET PLAN, RISPERDAL (risperidone) BRAND, First Draft: July 7, 1993, as produced
by Janssen, JJRIS01977637 at 01977664.
109. A Risperdal tactical plan for 1999 states that advisory boards are a tactic aimed at
"enhancing our relationship, but more importantly ensuring their endorsement for Risperdal."
Exhibit 5 at J.TRE02572935.
110. The Company paid numerous physicians $1,000 apiece to attend these so-called
advisory programs.
111. Janssen's documentation of physician feedback from the advisory board and
home-office visit programs shows that the programs succeeded as a marketing tactic in that
they encouraged physician-attendees to use Risperdal in children and teenagers.
112. In July 2002, a Child & Adolescent Regional Advisers meeting was held in
Boston. Among other things, physician-attendees reported afterwards that they were more
24
comfortable using Risperdal with children and that the forum taught them "how efficacious
and safe Risperdal is in the pediatric population." Exhibit 30 at BRIS00369803.
113. Similarly, in a report on the August 2002 Child & Adolescent Regional Advisers
Meeting held in Los Angeles, physicians reported, among other things, that the meeting
helped them overcome their reservations about prescribing Risperdal to children and would
result in an increase in prescriptions of Risperdal for pediatric use. One doctor also noted that
the venue was so spectacular, it made him uncomfortable because he considered it a working
meeting. Exhibit 32 is a true and accurate copy of materials from Child & Adolescent
Regional Advisors Meeting, August 16-18, 2002, Los Angeles, California, as produced by
Janssen, HR1S00126947 at 00126972, 00126974.
114. In Massachusetts, psychiatrists who specialize in the treatment of children and
adolescents were paid by Janssen to participate in these sham consulting programs or to
promote Risperdal's use in children.
115. Through direct off-label promotion to physicians, sham consulting arrangements
and other illegal marketing tactics, Janssen fueled explosive growth in the child and
adolescent marketplace.
116. Child and adolescent use of Risperdal increased from 10 percent of Risperdal's
overall use and $45 million in sales in 1997 to 21 percent of Risperdal's overall use and $178
million in sales in 2000. Exhibit 33 is a true and accurate copy of RISPERDAL Child and
Adolescent Market, Business Plan, July 2001, as produced by Janssen, ERErev07267899 at
07267903.
117. By April 2004, 26 percent of Risperdal patients were children and adolescents.
Exhibit 34 is a true and accurate copy of Risperdal Diagnosis Data Slide Deck, NDTI Data
MAT Through April 2004, as produced by Janssen, BREW 047858 at 03047890.
25
118. From the late 1990s through 2006, Janssen dominated the pediatric marketplace
for antipsychotics, with as much as a 50 percent market share (and higher) in this market
segment. Exhibit 25 at BRE00935738; Exhibit 27 at ITRE07998938; Exhibit 33 at
JJRErev07267904; Exhibit 35 is a true and accurate copy of RISPERDAL Child and
Adolescent Market, Business Plan, July 2001, as produced by Jassen, ITRIS01516018 at
01516048; Exhibit 36 is a true and accurate copy of 2004 Risperdal Business Plan, Market
Overview, as produced by Janssen, JJRE14736630 at 14736663.
119. Janssen knew that it was improper for sales representatives to promote Risperdal
to prescribers who do not treat adult patients who suffer from schizophrenia or bipolar mood
disorder. Yet, Janssen continued this Company-sponsored direct off-label promotion to
prescribers until at least early 2005.
120. In January 2005, Janssen implemented the Qualifying the Customer Initiative
("QCI"), in which sales representatives were instructed to ask each of their prescriber sales
targets if he or she treated any adult patients with schizophrenia or bipolar mood disorder, the
only two FDA-approved indications for Risperdal at that time. If a prescriber answered "no,"
then he or she was ostensibly removed from the sales representatives' target lists and call
plans and the prescriber would no longer be detailed regarding Risperdal. If a prescriber
answered "yes," that he or she had even a single adult patient with schizophrenia or bipolar
mood disorder, the prescriber was "qualified" as a target and could remain on the Company-
prepared target lists and call plans.
121. Among other things, sales representatives were told that QCI was being
implemented because "Janssen is very serious about the appropriate promotion of our products
within FDA approved indications." Exhibit 37 is a true and accurate copy of a 12/13/2004
Memorandum from Janet Vergis and Jeff Bailey of Janssen to All Janssen Eldercare and CNS
26
Sales Representatives, ROC 's and Field Sales Management, as produced by Janssen,
ITRE12846758; Exhibit 38 is a true and accurate copy of Communicating with Our
Customers, Janssen "Qualifiiing Customers" Initiative, December 2004, as produced by
Janssen, JJRE12846760.
122. Notwithstanding the low hurdle set for qualifying targets, i.e., the Company's
willingness to target a prescriber for Risperdal promotion even if 99 percent of his or her
patients are not adults with schi7ophrenia or bipolar mood disorder, the Company still
identified more than 1600 prescribers to be removed from sales representatives' call plans,
including approximately 60 prescribers in Massachusetts. Exhibit 39 is a true and accurate
copy of Qualiffing the Customer Initiative, 4/10/05 Update, asj produced by Janssen,
J1RE07989187. One of the Massachusetts prescribers identified for removal from
Massachusetts calls plans and target lists was a child and adolescent psychiatrist, who was
among the top 100 Risperdal prescribers in the Commonwealth in 2005. In addition,
numerous institutions, including Franciscan Children's Hospital in Brighton, Mass., were
removed from sales representatives' call plans as a result of the Qualifying the Customer
initiative because the institutions do not treat any adults.
123. Janssen's efforts to promote Risperdal's use in pediatric patients before receiving
FDA approval paid enormous dividends.
124. In Massachusetts, for each year from 2001 through 2005, child and adolescent
psychiatrists made up 20 percent or more of the top 100 Risperdal prescribers in the state.
125. Company documents show that from 2000 through 2005 Risperdal sales for
pediatric uses accounted for approximately 20 percent of all Risperdal sales. Exhibit 36 at
BRE14736663; Exhibit 33 at J.TRErev07267903; Exhibit 40 is a true and accurate copy of
27
Autism Overview, July 13, 2006, as produced by Janssen, JJRErev10658451 at 10658458.
Janssen Failed to Disclose Key Risks Associated with Risperdal Use
126. In addition to making misleading and deceptive statements to prescribers about
the risks associated with Risperdal's use by both children and the elderly, Janssen made
misleading and deceptive statements to prescribers about the risks of significant weight gain
and diabetes (and related conditions) associated with Risperdal's use.
127. Using numerous sales aids, flash cards, and reprints, Janssen misled and deceived
prescribers by (1) minimizing the risk that patients taking Risperdal would develop
hyperglycemia and diabetes or related conditions, (2) promoting Risperdal's purported safety
and (3) promoting Risperdal as a superior alternative to competing products.
128. As early as May 2000, the FDA put Janssen on notice that Risperdal and other
antipsychotics were associated with new onset diabetes mellitus and related conditions.
Exhibit 41 is a true and accurate copy of 5/1/2000 Letter from Russell Katz of the FDA to
Victoria Wagner-Weber of Janssen, as produced by Janssen, J.TRIS01231590.
129. In a May 1, 2000 letter, Dr. Russell Katz, of the FDA's Office of Drug
Evaluation, wrote to Janssen Research Foundation to report that FDA's review of adverse
events associated with Risperdal and other atypical antipsychotics showed "spontaneous
reports of new onset diabetes mellitus, non-ketonic hyperosmolar coma, and diabetic
ketoacidosis" and that "[t]his examination has revealed a number of these adverse experiences
in association with risperidone treatment." Id.
130. Dr. Katz requested extensive safety information from the Company to assist the
FDA "in fully evaluating the possibility that atypical antipsychotics may produce disturbances
in glucose metabolism." Id.
28
131. Notwithstanding the Company's knowledge that Risperdal was associated with an
increased risk of developing diabetes and related conditions, Janssen highlighted Risperdal's
safety in numerous marketing and promotional materials.
132. As early as 2000, Janssen sales representatives promoted Risperdal as better and
safer than its competitors, particularly with respect to weight gain and diabetes risk.
133. According to a Janssen "message tracking" audit in December 2000, in which
physicians were asked about the sales representatives' sales pitches, 28 percent of the
physicians interviewed reported that the main message they received from the Janssen sales
representative was that Risperdal caused less weight gain or did not induce weight gain; 22
percent remembered being told that Risperdal produced fewer or minimal side effects and 6
percent recalled being told that Risperdal was less likely to induce diabetes and that glucose
levels were not adversely affected from Risperdal's use. Exhibit 42 is a true and accurate copy
of Initial Product Training: RISPERDAL Brand Overview, as produced by Janssen,
JJRErev00564861 at 00564908.
134. By early 2002, the core sales message for Risperdal focused on its "excellent
safety profile," including "low risk of diabetes" and low weight gain. Exhibit 43 is a true and
accurate copy of Risperdal Cycle I Meeting CNS FSD/RBD, January 15, 2002, Princeton, NJ,
as produced by Janssen, BRErev03544948 at 03544973.
135. By late December 2002, 76 percent of the physicians queried in a Janssen
message tracking audit recalled that Janssen sales representatives told them that Risperdal has
a lower risk of diabetes and DKA than Zyprexa, a competing antipsychotic. Exhibit 44 is a
true and accurate copy of the Risperdal Message Recall, Presented January 21, 2003, as
produced by Janssen, JJRE10360817 at 10360834.
29
136. In 2003, through Janssen's "Weight of the Evidence" strategy, the Company
began to even more aggressively promote Risperdal as superior to its competitors because of
its purported low risk of diabetes.
137. The goal behind the Weight of the Evidence strategy was to "competitively sell
the metabolic advantages of Risperdal over Zyprexa." Exhibit 45 is a true and accurate copy
of RISPERDAL BRAND PRESENTATION, F t Cycle Meeting 2003, as produced by Janssen,
DRE00402716 at 00402732.
138. To implement the Weight of the Evidence Strategy, Janssen trained
representatives to highlight Risperdal's purported low risk and to promote only those clinical
studies that cast Risperdal in a more favorable light than other antipsychotics with respect to
diabetes risk.
139. Janssen provided sales representatives with copies of reprints of studies
performed by Koro et al., Gianfrancesco et al. and Coro et al. that were favorable to the
Company's "low-diabetes risk" message and instructed sales representatives to use these
reprints with prescribers.
140. Janssen sales representatives extolled to prescribers Risperdal's safety and/or
superiority over competing atypical antipsychotics due to the purportedly low risk of
developing diabetes. A sampling of Massachusetts call note records shows:
• A February 28, 2003 call note (EXV-HFZ) reports on a sales call with a Bourne doctor: "Hit on risp lack of diabetes next time hit on the safety profile . . . ."
• A May 16, 2003 call note (KOC-DU9) reports on a sales call with a Lynn doctor: "Disc low dose in place of ser[oquel]. Diabetes not a class effect. Issues w/ zyp[rexa] but not switching. Diabetes trifold."
• A July, 1 2003 call note (OPU-7MY) reports on a sales call with a New Bedford physician: ". . . showed him connelly reprint and said if you like the results you're getting with Zyprexa then you will really love Risperdal for the same reasons
30
without the worries of weight gain and diabetes. Left reprint behind for him . . . ."
• An October 6, 2003 call note (SVY-CE) reports on a sales call with a Boston doctor: "Because he treats so many kids and adolescents I tailered [sic] the message in that direction. Talked low dose Risperdal efficacy without excessive daytime sedation, weight gain or diabetes. Really went after Seroquel."
Exhibit 46 is comprised of true and accurate copies of certain call records printed from the
Company's call notes database as produced by Janssen.
141. Although Janssen had been promoting Risperdal's purported superiority over
competing products on the diabetes issue since at least 2002, in September 2003, the FDA
advised Johnson & Johnson and the manufacturers of the competing atypical antipsychotics
that the labels for all of the atypical antipsychotics needed to be revised to warn of the class-
wide risk of hyperglycemia and diabetes mellitus. Exhibit 47 is a true and accurate copy of
9/11/2003 Letter from Russell Katz of the FDA to Claude McGowan of Johnson & Johnson, as
produced by Janssen, BRIS00924766.
142. The FDA's Russell Katz wrote in pertinent part:
/Tie believe the safe use of Risperdal can be enhanced by informing prescribers that and patients about [adverse] events. Increased attention to the signs and symptoms of diabetes mellitus may lead to earlier detection and appropriate treatment, and thus reduce the risk for the most serious outcomes . . . .
Areas that require additional research include, but are not limited to, identification of subpopulations at greatest risk for diabetes mellitus adverse events, exploration of the relative risk for diabetes mellitus adverse events among the different antipsychotics, and evaluation of potential mechanisms of action.
Id.
143. The FDA proposed changing the Risperdal label to include the statement: "The
available data are insufficient to provide reliable estimates of differences in hyperglycemia
related adverse event risk among marketed atypical antipsychotics." Id. This statement
negated Janssen's claims about Risperdal's purported superiority.
31
144. Janssen revised the Risperdal label, but it did not include the FDA's statement
about the insufficiency of the data regarding the relative risks among the atypical
antipsychotics.
145. Janssen thereafter made a concerted effort to downplay and distort the new FDA
warnings
146. In a November 2003 letter Janssen sent to healthcare providers, including more
than 21,000 healthcare providers in Massachusetts, Ramy Mahmoud, MD, Vice President of
CNS Medical Affairs for Janssen Pharmaceuticals Inc., advised providers of the label change,
stressed that the warning was being applied to all atypical antipsychotics and added:
Hyperglycemia- related adverse events have infrequently been reported in patients receiving RISPERDAL. Although confirmatory research is still needed, a body of evidence from published peer-reviewed epidemiology research suggests that Risperdal is not associated with an increased risk of diabetes when compared to untreated patients or patients treated with conventional antipsychotics. Evidence also suggests that RISPERDAL is associated with a lower risk of diabetes than some other studied atypical antipsychotics.
Exhibit 48 is a true and accurate copy of 11/10/2003 Letter from Ramy Mahmoud of Janssen, as
provided by Janssen, JJRE12245687.
147. The November 2003 Janssen letter squarely contradicted the FDA's view that
"the available data are insufficient to provide reliable estimates of differences in
hyperglycemia-related adverse event risk among marketed atypical antipsychotics," and,
instead, repeated Janssen's misleading marketing message that Risperdal is a low-risk drug
and safer than its competitors. Exhibit 47 at JJRIS00924766.
148. In addition to sending the November 2003 letter to 600,000 physicians
nationwide, Janssen sales representatives individually informed 70,000 health care providers
of the label change. Exhibit 49 is a true and accurate copy of 11/26/2003 Letter from Susan
32
Merchant of Johnson & Johnson to Russell Katz of the FDA, as produced by Janssen,
JJRE03462625.
149. Sales representatives were trained to inform health care providers about the label
change while downplaying the risks of hyperglycemia and diabetes mellitus by sticking to the
marketing message that Risperdal has a "low risk for diabetes." Exhibit 50 is a true and
accurate copy of DIABETES PACKAGE INSERT REVISION BACKGROUNDER,
RISPERDAL (risperidone), October 30, 2003, as produced by Janssen, JJRE01245322 at
01245342.
150. Sales representatives were instructed that if a physician challenged them about
Risperdal's safety, the sales representative should highlight three studies favorable to
Janssen's point of view (Gianfrancesco, Caro and Koro) and the sales aid, which noted
"RISPERDAL's low rate of diabetes (0.2%) and minimal weight gain." Id. See also Exhibit
51, a true and accurate copy of New Indication Bipolar Mania, as produced by Janssen,
ITRE12748397.
151. In the late fall of 2003 and into the spring of 2004, Janssen sales representatives
made thousands of sales calls on physicians, driving home the message that Risperdal was
safer than other atypical antipsychotics and/or presented a "low risk" of diabetes, a message
that deceptively blunted the warning Janssen was required to add to its label.
152. Call notes by Massachusetts sales representatives chronicled their discussions
with physicians about the new warning and their efforts to minimize the warning by
continuing to emphasize Risperdal's purported superiority. A sampling of Massachusetts call
notes shows:
• A November, 10, 2003 call note (EXV-1B76) reports on a sales call with a Brewster pharmacist: "Discussed the new diabetes letter and PI and able to see that folks are quite consistent with the understanding that the problem is not with risp but it is with
33
zyp. She does feel fine."
• A November 11, 2003 call note (F3N-1G70) reports on a call with a Brockton physician: ". . . . gave him diabetes letter and he affirmed that this was not a big issue with risperdal. pete — should one of us give him tfi-fold on next call just to reassure him that it is not an issue?
• A November 14, 2005 call note (K5X-1215) reports on a call with a Lowell physician: "Risperdal PI change, asked me if all agents are included, sd yes, but risp incidence is lowest, esp vs zyprexa, risk of diabetes, DKA, he sd he had no concerns b/c doesn't rx these meds, told him he rxs seroquel & he sd he didn't, sold risperdal for better REM sleep (didn't have sleep study in car w/me) . . . . he asked me why I was telling him this b/c he doesn't rx this class & won't be convinced to, neutralized by telling him that J& J is an ethical company & has asked us to share the info w/all health care professionals . . . ."
• A November 14, 2003 call note (KD6-YIB) reports on a sales call with a Brighton physician: "only gave me time to go over risp calss [sic] change letter . . . . Doc seemed unphased [sic] by news, but reacted positively to news risp had 4x less diabetes than zyprexa."
• A July 14, 2004 call note (Y3K-R3Z) reports on a sales call with a Springfield physician: "Call him to the carpet in response to our discussion. 'Dr haines, in our meeting a while back you said that you'd try risperdal in place of zyprexa for you [sic] patients due to the less chance of wgt. gain and diabetes. Have you done this. Why or why not?' "
Exhibit 52 is comprised of true and accurate copies of certain call records printed from the
Company's call notes database as produced by Janssen.
153. Defendants' efforts to portray Risperdal as safer than competing drugs, and a drug
that presented a "low risk" for diabetes earned a strong rebuke from the FDA's Division of
Drug Marketing, Advertising and Communications (DDMAC), which regulates prescriptiOn
drug advertising.
154. In an April 2004 warning letter to the chief executive of Janssen Pharmaceutica,
and copied to the chief executive of Johnson & Johnson Pharmaceutical Research &
Development LLC, Thomas Abrams, the director of DDMAC, advised the companies that
Janssen's November 10, 2003 letter to health care providers was "false and misleading" in
34
violation of the Food, Drug & Cosmetic Act and that it "minimizes risks associated with
Risperdal and claims that Risperdal is safer than other atypical antipsychotics, when this has
not been established by substantial evidence or substantial clinical experience." Exhibit 53 is a
true and accurate copy of the 4/19/2004 Letter from Thomas W Abrams of the FDA to Ajit
Shetty of Janssen, as produced by Janssen, JJRE04044373.
155. In his warning letter, Mr. Abrams also noted that the studies cited in Janssen's
November 2003 letter, ostensibly to support the claim that Risperdal is safer than other drugs,
"do not represent the weight of the pertinent scientific evidence. That evidence . . . indicates
an increased risk of hyperglycemia-related adverse events and diabetes with Risperdal. In
addition, [the letter] does not accurately describe the results of the cited studies. Two of the
studies actually show an increased risk of diabetes and hyperglycemia with Risperdal." Id.
BRE04044375.
156. Three months later, in July 2004, Janssen distributed a new letter to health care
prescribers, advising them of the April 2004 warning letter and providing "corrected"
information about the change in label. Exhibit 54 is a true and accurate copy of 7/21/2004
Letter from Ramy Mahmoud of Janssen, as produced by Janssen, BRE12629735.
157. By failing to inform prescribers of the actual risks associated with Risperdal's
use, Janssen put Massachusetts consumers at risk of developing diabetes and hyperglycemia
and related conditions.
158. By minimizing diabetes risk, by failing to disclose the risks associated with
Risperdal's use in children and to treat elderly dementia, and by promoting Risperdal for uses
that had not been approved by the FDA and/or demonstrated to be safe and effective, Janssen
— over a period of many years — put profits ahead of patient safety.
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FIRST CAUSE OF ACTION
(Violations of the Consumer Protection Act, G.L. c. 93A, §2 and the Regulations Promulgated Thereunder)
159. The Commonwealth incorporates by reference the allegations of paragraphs 1
through 158 of the Complaint as if fully alleged herein.
160. Defendant engaged in unfair and deceptive trade practices and violated G.L. c.
93A through numerous acts and practices, including, without limitation, the following:
a. omitting and/or concealing material facts regarding Risperdal's efficacy and safety in
its communications with Massachusetts health care providers and consumers;
b. concealing, omitting or minimizing the side effects and risks associated with
Risperdal's use, particularly when used in pediatric or elderly patients;
c. promoting Risperdal for use in children and adolescents without FDA approval
and/or without adequate scientific and clinical support that Risperdal could be used
safely or effectively with children and adolescents;
d. promoting Risperdal's use in children and adolescents without disclosing the risks
associated with such use;
e. promoting Risperdal to treat elderly dementia notwithstanding the FDA's
determination that Risperdal could not be established as safe for such use;
f. promoting Risperdal to treat elderly dementia without disclosing the FDA's denial of
a proposed dementia indication;
g. promoting Risperdal to treat elderly dementia without disclosing the risks associated
with such use;
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h. promoting Risperdal to treat anxiety, conduct disorder, aggression and anger,
Alzheimer's disease and other conditions when such uses were not reviewed and
approved by the FDA, nor established to be safe and effective for such uses;
i. failing to disclose the risks of developing diabetes and related conditions that are
associated with Risperdal's use;
j. providing physicians with sham consulting agreements that were thinly veiled
payments to promote the consultants' prescribing of Risperdal for off-label uses;
k. paying physicians to hear promotional messages about uses of Risperdal that were not
reviewed or approved by the FDA.
161. Defendant knew or should have known it was committing unfair or deceptive
trade practices in violation of G.L. c. 93A, § 2.
162. Each of the Defendant's unfair, deceptive and/or anticompetitive acts was a
distinct violation of G.L. c. 93A.
PRAYER FOR RELIEF
WHEREFORE, the Commonwealth respectfully requests that this Court grant the
following relief:
163. After a trial on the merits:
a. Declare that Defendant has engaged in unfair and deceptive acts and practices in
violation of G.L. c. 93A, §2, and the regulations promulgated thereunder;
b. Permanently enjoin Defendant from engaging in unfair and anticompetitive trade
practices, including promoting its products for uses that have not been approved by
the FDA and/or found to be safe and effective for the promoted use, and detailing and
providing samples to health care providers who do not primarily and customarily
prescribe the promoted products for FDA-approved uses;
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c. Order Defendant to disgorge all payments received from the sale of Risperdal as a
result of its unlawful marketing;
d. Order Defendant to pay civil penalties of up to $5,000 for each and every violation of
G.L. c. 93A;
e. Award Plaintiff costs and attorneys fees, pursuant to G.L. c. 93A; and
f. Grant all other relief as the Court may deem just and proper.
Dated: August 1, 2011
Respectfully submitted,
COMMONWEALTH OF MASSACHUSETTS By its Attorney, MARTHA COAKLEY ATTORNEY GENERAL
*Ia'ctraiZ:" Sarah Ragland, BBO # 654875 Wendoly Langlois, BBO # 654442 Emiliano Mazlen, BBO #600912 Thomas O'Brien, BBO # 561863 Assistant Attorneys General, Health Care Division Office of Attorney General Martha Coakley One Ashburton Place Boston, MA 02108 - (617) 727-2200
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