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Can Failure-to-Warn Claims Against Generic Drug Manufacturers Be Preempted?

By Sharon Caffrey, Alan Klein and Paul M. da Costa

This year, the U.S. Supreme Court in Wyeth v. Levine, 555 U.S. ___ (March 4, 2009), considered for the first time the preemption of state law-based claims in pharmaceutical product liability cases and held that the Food and Drug Administration's (FDA) approval of a drug label does not preempt state law failure-to-warn claims. Although the case involved a brand drug, the Court's decision was vital in determining the availability and scope of the preemption defense for both brand and generic drug manufacturers. Prior to the Court's decision, several federal and state courts addressed preemption in the context of claims against generic drug manufacturers. An analysis of these decisions indicates that the courts' various interpretations of the FDA's Changes Being Effected (CBE) labeling supplement regulations, 21 C.F.R. ' 314.70(c), are crucial to their ultimate holdings. In Wyeth v. Levine, the Supreme Court of Vermont's holding of no preemption relied heavily on its interpretation of the CBE regulation.

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