Supreme Court Rules on Wyeth: State Law Claims Not Preempted

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On March 4, 2009, the U.S. Supreme Court issued its eagerly awaited decision in Wyeth v. Levine, U.S. Supreme Court No. 06 1249, 555 U.S. ____ (2009). In a 6-3 decision delivered by Justice Stevens, the Court held that federal law does not preempt Levine’s state law failure-to-warn claim concerning the adequacy of a prescription drug label. The Court also stated that a company may unilaterally add a stronger warning to a product label pursuant to the FDA’s “changes being effected” (“CBE”) regulation, and emphasized that a company—and not the FDA bears primary responsibility for drug labeling.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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