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

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proper language describing the nature and rate of the risk, the nature of the harm that might beencountered and the ways to avoid that harm. In order to be an adequate warning, the drugprescriber and user must be made aware of those warnings – requiring effective communicationof the warnings. Printing a label, yet never distributing the label to the physician and patient, isnot sufficient to warn the user of the danger. GENERIC DEFENDANTS had many differentways to ensure that the actual warning language was effectively communicated to physicians andpatients – both through proper delivery of the existing RLD label, along with other FDAapproved means of communication that did not require language different from the RLD label.GENERIC DEFENDANTS failed to deliver the label, or to otherwise effectively communicatethe warnings in the label, to physicians and patients.118. The GENERIC DEFENDANTS breached their duty to effectively communicatewarnings to the medical community generally, Plaintiffs’ physicians, Plaintiffs, and/or otherforeseeable users of their metoclopramide products similarly situated, in that they failed to:a. ensure that warnings they disseminated or relied on to be disseminated tothe medical community, Plaintiff’s physician, or to the Plaintiff andother foreseeable users similarly situated, were actually and effectivelycommunicated to physicians and patients.b. Evaluate and understand the uses of their product, to identify thatsignificant numbers of physicians and patients were using themetoclopramide in a fashion contrary to warnings in the label, andbeing harmed by such use, thus confirming that the warnings were noteffectively being communicated to the physicians and patients.c. Failure to keep abreast of knowledge regarding the safety of their drugproducts, and to properly research, test and market theirmetoclopramide products, review all adverse drug event information(ADE) related to the use of Reglan or generic metoclopramide andreport to the FDA, physicians (and/or to the public) significant dataregarding efficacy or safety of the drug, including the nature andfrequency of side effects and/or the existence of additional warnings..d. periodically review all medical literature pertaining to metoclopramide useand effects and report to the FDA, physicians (and/or to the public)significant data concerning neurological side effects.- 46 -Case ID: 100101997
e. independently monitor the sales of Reglan and metoclopramideproducts and the medical literature concerning metoclopramide, whichwould have alerted them to the fact that the drug was widely overprescribed as a result of inadequate warnings in the package insertsfor metoclopramide products and PDR monographs for Reglan.f. Engage in responsible testing, research, and pharmacovigilancepractices regarding their Reglan and metoclopramide products,including a failure to perform studies which would accuratelydetermine the risks attendant to both short and long-termmetoclopramide use and a failure to engage in marketing practicesdesigned to minimize the risks associated with metoclopramide.F. FDA Black Box Warning119. Despite having extensive knowledge of the extreme risks associated with the drugas well as the absolute duty to properly and adequately warn foreseeable users, the DRUGCOMPANY DEFENDANTS failed to make reasonable efforts to ensure that accurate andadequate information regarding metoclopramide was provided to the medical community,physician’s and consumers, or to inform the FDA of the need for changes to its label.Defendants failed entirely to communicate any information in a manner calculated to properlyand adequately warn physicians and the medical community of the risks associated withmetoclopramide use.120. The FDA, sua sponte, on February 26, 2009, exercising new agency powersgranted under §901(a) of the Food and Drug Administrative Amendments of 2007, which addeda subsection (o) to FDCA §505, 21 USC §355(o), ordered the addition of a black box warning tothe labeling for Reglan/metoclopramide, highlighting the high risk of tardive dyskinesia withlong term, high dose, or pediatric use of metoclopramide, even after the drugs are no longertaken. The purpose of this black box warning was to both improve the strength of the warningand to ensure that the warning was effectively communicated to both physicians and patients.- 47 -Case ID: 100101997
Page 1 and 2: IN RE ::COURT OF COMMON PLEASPHILAD
Page 4: Sears Tower - Suite 5500Chicago, IL
Page 7 and 8: 4 Penn Center, Suite 8001600 John F
Page 9 and 10: 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: 113. Since 1985, GENERIC DEFENDANTS
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 and 62: 166. As lawful consumers of Reglan
Page 63 and 64: duration of use - confirming they w
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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