Contemplating Pliva v. Mensing


Federal laws governing the labeling of generic drugs preempt state law failure-to-warn claims against generic drug manufacturers, according to the U.S. Supreme Court’s 5-4 opinion in Pliva Inc. v. Mensing, No. 09-993 on June 23, 2011.

Justice Clarence Thomas, writing for the majority, held that federal law requires generic labeling to be the same as the U.S. Food and Drug Administration-approved labeling of the corresponding brand-name drug, making it impossible for generic manufacturers to simultaneously comply with federal labeling requirements and state laws requiring a generic manufacturer to update warnings on generic labeling if the generic manufacturer believes that a stronger warning label is necessary. Thus, federal law preempts state law tort claims.

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