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

e satisfied that the proposed labeling includes data and information about risks and side effects,test results for the drug, results of animal studies, results of clinical studies, and the drug’sbioavailability, and other matters, adequate to enable physicians or other like foreseeableprescribers to use the drug safely.98. Federal law requires one who owns or holds an FDA-approved NDA to ensure atall times that the drug’s labeling is and remains accurate and adequate, to conduct safetysurveillance of adverse events for the drug, and to periodically and at other times report to theFDA data related to the safety of the drug and/or to the accuracy of the labeling.99. Reglan and generic metoclopramide have not been approved by the FDA for longtermuse or pediatric use.100. The BRAND NAME DEFENDANTS failed to fully, truthfully and accuratelydisclose to the FDA (and failed to disseminate to the medical community or to the public) dataand information bearing substantially and substantively on the safe use of Reglan andmetoclopramide.C. Misrepresentations and Failure to Communicate Adequate Warnings101. Through dissemination of inaccurate and misleading information about Reglanand metoclopramide in materials including the product labeling for Reglan, as distributed bysales representatives (with product samples) and as published in the Physicians’ Desk Reference,defendant Wyeth knowingly, intentionally, and negligently, directly or indirectly, misledphysicians, including Plaintiffs’ physicians, and the medical community in general, about therisks of tardive dyskinesia and other EPS in long term use and pediatric use of the drug. After2002, no product labeling information or other information about the drug was published tophysicians or the medical community, in the Physicians’ Desk Reference or otherwise, by any of- 39 -Case ID: 100101997