Third Amended Master Long Form Complaint - Dispute Resolution ...

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epresentatives (called detail men), sponsored education and continuing education programs andseminar speakers, the planning, sponsorship, ghost-writing, and arranged publication of nonscientificand misleading medical research, and dissemination of the Reglan labeling withproduct samples distributed by detail men and by publication in the PDR—fraudulently andfalsely overstated the benefits and safety of the drug and concomitantly downplayed the risks inits use, thereby inducing physicians, including Plaintiffs’ physicians, through reasonable butmisplaced reliance on those misrepresentations, to prescribe long-term metoclopramide therapyfor chronic heartburn and bloating, in lieu of other, safer alternatives, and inducing consumerpatients, like Plaintiffs, to purchase and use Reglan and/or generic metoclopramide as prescribed,thus exposing them to an undisclosed substantial risk of involuntary movements, aggravation ofpreexisting injuries, other injuries, and death.173. When Schwarz Pharma purchased the NDA in 2001, they initiated an internalevaluation of the accuracy and completeness of the label. From their own internal investigation,Schwarz Pharma confirmed that the true incidence rate of EPS or TD was as much as 100 timesgreater than what was stated in the label written by Wyeth; nevertheless, Schwarz Pharma nevercorrected this significant understatement of the rate of risk, and never communicated tophysicians that the label was terribly inaccurate.Further, Schwarz Pharma’s internalinvestigation confirmed that a significant population of physicians had no appreciation for theduration of use warnings – and instead were ignorantly keeping patients on the drug for longterm use. Schwarz Pharma took years to correct any warnings about duration of use – and whenthey did attempt to strengthen the warning, Schwarz Pharma never published the label. In otherwords, they never even attempted to warn physicians or patients of the new language regarding- 62 -Case ID: 100101997
duration of use – confirming they were fully aware of the problem and injuries of long term use,and consciously chose to do nothing to correct the prescribing habits of physicians.174. Defendants misrepresentations, by knowingly false statement and omission,specifically include but are not limited to, the misrepresentations as set forth in the generalallegations section of this <strong>Complaint</strong> and the following:24. They intentionally concealed or withheld fromdisclosure that the pre-clinical and clinical testing andpost-marketing surveillance were inadequate todetermine the safety and side effects of Reglancompared to the use of alternative drugs in the sameclass or to the use of no drug;25. They intentionally concealed and/or withheld fromdisclosure data showing that Reglan and/or genericmetoclopramide use, particularly in long term therapy,dramatically increase the risk for involuntarymovements and other injuries and death, eithercompared to the use of alternative drugs in the sameclass or to the use of no drug;26. They intentionally concealed and/or withheld from theinformation they disseminated about Reglan data aboutthe potential and actual risks, and nature, scope,severity, and duration of any serious side effects of thisdrug, including without limitation, the risk ofinvoluntary movements, other injuries and death, eithercompared to the use of alternative drugs in the sameclass or compared to the use of no drug;27. They concealed and/or withheld, from the informationthey disseminated about Reglan, past and present factsof which they were aware, as specifically with Wyeth,as early as the 1980s, and as late as 2004 for SchwarzPharma, including the degree of actual likelyassociation between the use of metoclopramide anddangerous side effects, including involuntarymovements;175. The above-described acts and/or omissions of defendants were performedwillfully, intentionally, and with reckless disregard for the safety of the consuming public,including the Plaintiffs.- 63 -Case ID: 100101997
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IN RE ::COURT OF COMMON PLEASPHILAD
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Sears Tower - Suite 5500Chicago, IL
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4 Penn Center, Suite 8001600 John F
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Northstar Rx LLC4971 Southridge Blv
Page 11 and 12: Richmond Pharmaceuticals, Inc.3510
Page 13 and 14: Jersey 07940. Defendant regularly c
Page 15 and 16: 12. Defendant Baxter Healthcare Cor
Page 17 and 18: with process via The Hague Conventi
Page 19 and 20: Pharmaceuticals USA, Inc. on Decemb
Page 21 and 22: Case Management Order No. 1, Defend
Page 23 and 24: 34. Defendant Watson Laboratories,
Page 25 and 26: through its registered agent for se
Page 27 and 28: 47. Defendant VistaPharm, Inc. is a
Page 29 and 30: labeling, and design of metoclopram
Page 31 and 32: metoclopramide not yet known by Pla
Page 33 and 34: packaging and/or advertising the ph
Page 35 and 36: 76. In addition, Philadelphia Count
Page 37 and 38: 87. The ―indications‖ (recommen
Page 39 and 40: e satisfied that the proposed label
Page 41 and 42: prescribed by physicians, most of w
Page 43 and 44: exercise of reasonable care should
Page 45 and 46: 113. Since 1985, GENERIC DEFENDANTS
Page 47 and 48: e. independently monitor the sales
Page 49 and 50: disfigurement, disability, pain and
Page 51 and 52: care industry and consumers, includ
Page 53 and 54: associated with the ordinary, expec
Page 55 and 56: 146. The Reglan and/or generic meto
Page 57 and 58: 158. Each of the DRUG COMPANY DEFEN
Page 59 and 60: 22. They failed to implement proper
Page 61: 166. As lawful consumers of Reglan
Page 65 and 66: involuntary movements, aggravation
Page 67 and 68: DEFENDANTS professed to Plaintiffs
Page 69 and 70: COUNT VIII - UNFAIR AND DECEPTIVE T
Page 71 and 72: loss: the difference between the pr
Page 73 and 74: 214. BRAND NAME DEFENDANTS knew, or
Page 75 and 76: 217. Alternatively or in addition,
Page 77 and 78: 224. In addition, DRUG COMPANY DEFE
Page 79 and 80: 237. The representatives of Deceden
Page 81 and 82: 248. Plaintiffs also allege that th
Page 83 and 84: d) They continued to promote the sa
Page 85: (G)Such other relief as is deemed j
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