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

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81. These involuntary movements are known as extrapyramidal symptoms (EPS), thatinclude, but are not limited to, tardive dyskinesia, tardive dystonia, tardive akathisia,Parkinsonism, Neuroleptic Malignant Disorder, and Reglan-induced tremors.Reglan/Metoclopramide has also been associated with central nervous system disorders,depression with suicidal ideation, visual disturbances, and memory loss.82. Tardive dyskinesia, tardive akathisia, and tardive dystonia are seriousneurological movement disorders that result in the involuntary and uncontrollable movements ofthe head, neck, face, arms, and/or trunk, as well as, involuntary facial grimacing and tonguemovements, including tongue thrusting, tongue chewing, extreme anxiety and restlessness and/orother involuntary movements.83. There is no cure for any of these EPS disorders caused byReglan/metoclopramide.84. Reglan/metoclopramide can also cause an aggravation in preexisting conditions.85. The link between neuroleptic drugs, such as Reglan/metoclopramide, andinvoluntary movements has been known from as far back as 1973. 6Between 1973 and presentday, dozens upon dozens of studies have specifically evidenced the direct connection betweenthe long term, pediatric, and/or short term use of Reglan and/or metoclopramide and involuntarymovement disorders.86. The ―indications‖ (recommended uses) listed in the product labeling forReglan/metoclopramide include adult short-term therapy of symptomatic gastroesophageal refluxand acute and recurrent diabetic gastric stasis.6 Crane GE (September 1973). "Is tardive dyskinesia a drug effect?". Am J Psychiatry 130 (9): 1043–4.- 36 -Case ID: 100101997
87. The ―indications‖ (recommended uses) listed in the product labeling forReglan/metoclopramide specified therapy for up to twelve (12) weeks in adults, forgastroesophageal reflux (heartburn), and specified no durational limit in therapy for gastric stasisor gastroparesis (bloating).88. At no point in time has Metoclopramide been shown to be either efficacious orsafe when used for long term treatment.89. Patients who used Reglan/metoclopramide for longer periods of time were at anunreasonably dangerous increased risk of developing one or more severe and permanentneurological movement disorders, significantly and substantially greater than disclosed orsuggested in the product labeling for the drug or in any other materials disseminated by thedefendants to either the medical community or the public.B. Reglan/Metoclopramide Regulatory Background90. In 1979, A.H. Robins Company, Inc. gained approval for Reglan injectionthrough the United States Food & Drug Administration.91. A.H. Robins Company, Inc. gained approval for Reglan tablets through theUnited States Food & Drug Administration (―FDA‖) on December 30, 1980.92. In 1989, A.H. Robins Company, Inc. merged with and into a corporation whollyownedby Defendants Wyeth LLC and Wyeth Pharmaceuticals, Inc. (then known as theAmerican Home Products Corporation), whereupon the name of the wholly-owned subsidiarycorporation was changed to A.H. Robins Company, Inc., under which name it continued to carryon its business activities, including the manufacture, promotion, and sale of Reglan and otherdrugs, until August 1998, when it was absorbed into its parent corporation, where it survivedonly as an unincorporated division, also known as the A.H. Robins Company.- 37 -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: 76. In addition, Philadelphia Count
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 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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