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

113. Since 1985, GENERIC DEFENDANTS have manufactured, packaged, marketed,sold, distributed, and labeled generic versions of Reglan known as generic metoclopramide.114. Per the provisions and procedures established under Subsections (a) and (j) ofFDCA §505, as amended by the Hatch-Waxman Amendments, an ANDA for a generic versionof metoclopramide is and has been required to include proposed labeling for the drug that is thesame in all material respects to the labeling approved for the so-called Reference Listed Drug(RLD), which was Reglan.115. GENERIC DEFENDANTS submitted ANDAs for generic versions of the drugthat proposed labeling materially the same as the FDA-approved product labeling for Reglan.116. As holders of ANDAs for generic versions of the drug, GENERICDEFENDANTS, are and have been required by federal law to ensure continuously that thelabeling for their metoclopramide products contained accurate information regarding the drug’sintended uses, including common uses other than those described in the drug’s ―indications‖; toconduct post market safety surveillance; to review all adverse drug event information (ADE), tomake timely revisions to the labeling of the labels for their metoclopramide products afterrevisions were made to the RLD; and to ensure that important information regarding the safety oftheir drug products was communicated to the medical community and consumers. GENERICDEFENDANTS were required by federal law to report to the FDA significant informationdiscovered in the course of the fulfillment of its obligations as holders of ANDAs for genericversions of a drug, as outlined above, bearing on the risk and/or frequency of side effects causedby metoclopramide.117. GENERIC DEFENDANTS were also required to ensure that the existing labelswere effectively communicated to physicians and patients. An adequate warning requires both- 45 -Case ID: 100101997