Litigation Advisory – Generic Drug Preemption – Pliva v. Mensing, No. 09-993 (June 24, 2011)

Supreme Court Finds Impossibility Preemption for FailureTo-Warn Claims Against Generic Drug Manufacturers

On June 23, 2011, the Supreme Court added another split decision to its long line of seemingly irreconcilable opinions on federal preemption of state-law product liability claims involving federally regulated products. In a 5-4 decision authored by Justice Thomas, the Court held in Pliva v. Mensing, No. 09-993, that state failure-to-warn claims involving generic drugs are preempted by the federal Food, Drug and Cosmetic Act (“FDCA”) . The Court majority held that it is impossible for a generic drug manufacturer to comply both with a state tort
duty requiring additional warnings on product labeling and federal requirements that prohibit generic drug manufacturers from using warnings that differ in any substantive way from the from the brand-name drug manufacturer’s federally-approved labeling.

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