Generic Drug Manufacturers Post-ANDA Approval Duties With Reference To Labeling Changes: Viability of Federal Preemption Defense Post-Levine


The U.S. Supreme Court's decision in Wyeth v. Levine, 129 S.Ct. 1187 (2009), found that plaintiffs' state-law based failure-to-warn claims were not preempted in the context of drugs manufactured by innovator manufacturers. The Levine decision, however, left unanswered the question of whether its findings are applicable in the context of claims brought against generic drug manufacturers. Accordingly, while the Levine decision is precedential in cases involving brand drug manufacturers, it does not necessarily forecast an identical holding when plaintiffs' claims are directed at generic drug manufacturers.

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