and after, through their own studies and unpublished studies by independent investigators, thatthe frequency of side effects reported in the label for Reglan understated the risks of using thedrug. These defendants were also aware that doctors frequently and inappropriately overprescribedReglan or metoclopramide for long term, pediatric, and/or short term use that was notsafe as prescribed through information obtained for the purpose of marketing and promotion.108. DRUG COMPANY DEFENDANTS had knowledge, either through their ownstudies, or through publicly available published literature that their metoclopramide labelsunderstated the frequency at which side effects occurred, and that patients were commonly beingprescribed metoclopramide for longer than 12 weeks, for pediatric use and/or in situations wherethe metoclopramide use was not safe for patients. 7Defendants had actual knowledge, throughtheir own studies and/or studies by independent investigators, that nearly one-third of all patientswho used the drug, whether in its name brand or generic versions, received it on doctor’sprescriptions for 12 months or longer, rather than 12 weeks or less. 8Defendants also had actualknowledge, through research by independent investigators, that the frequency of tardivedyskinesia and other extrapyramidal side effects of Reglan and generic metoclopramide inpatients who receive the drug for long term use is approximately 100 times greater than disclosedin the package inserts for Reglan and generic metoclopramide and in the Physician’s DeskReference monograph for Reglan brand metoclopramide. 9Defendants also knew, or through the7 See Jankovic, Joseph. ―Metoclopramide-Induced Movement Disorders: A Review of the Literature‖; Archives ofInternal Medicine, 1989.; Stewart, Ronald. ―An Analysis of Inappropriate <strong>Long</strong>-Term Use in the Elderly‖; Annalsof Pharmacology, 1992.; Yassa & Jeste, in 1992,8 Kaplan S, Staffa JA, Dal Pan GJ. Duration of therapy with metoclopramide: a prescription claims data study.Pharmacoepi Drug Saf 2007; 16: 878-881.9 Linda Ganzini, MD; Daniel E. Casey, MD; William F. Hoffman, PhD, MD; Anthony L. McCall, MD, PhD, ThePrevalence of Metoclopramide-Induced Tardive Dyskinesia and Acute Extrapyramidal Movement Disorders, ArchIntern Med. 1993;153(12):1469-1475; Sewell DD, Kodsi A, Caligiuri M, Jeste DV: Metoclopramide and TardiveDyskinesia. Biological Psychiatry 36:630-632, 1994.- 42 -Case ID: 100101997
exercise of reasonable care should have known, that many patients who use Reglan or genericmetoclopramide products are not able to effectively metabolize metoclopramide and that as aforeseeable consequence of their inability to effectively metabolize it, those patients have agreater risk of developing serious and permanent injuries.109. The DRUG COMPANY DEFENDANTS were aware that their individual andcollective failure to communicate to the medical community and physicians information knownto them about the risks of long term and other metoclopramide therapy would be likely to resultin serious injury to patients who received the drug in accordance with prescriptions issued byphysicians who were unaware of this information. By failing to communicate this information tothe medical community or the FDA, the DRUG COMPANY DEFENDANTS acted in willfuland wanton disregard of the rights of persons in the Plaintiffs’ class, and this conduct causedserious injury to the Plaintiffs.110. As a manufacturer of prescription drug products, specifically Reglan and/orgeneric metoclopramide, each of the DRUG COMPANY DEFENDANTS has a duty toadequately communicate warnings to physicians and the medical community (or to patients whocould be expected to take the drug) and to exercise due care to conduct safety surveillance for thedrug and otherwise ensure that the warnings they are required to disseminate about the drug areaccurate and adequate, and that these warnings are effectively communicated to physicians,pharmacists, and patients using the drug.111. Each of the DRUG COMPANY DEFENDANTS breached its duty to ensure thatadequate warnings were provided to the medical community, Plaintiffs’ physicians, Plaintiffs,and/or other foreseeable metoclopramide users similarly situated, in that they failed to:- 43 -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: prescribed by physicians, most of w
- 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 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