Federal Preemption of Failure to Warn Claims Against Generic Drug Companies


Three recent district court decisions ? from Minnesota, California and Florida ? have created a division in the federal courts on whether products liability claims against generic pharmaceutical manufacturers are preempted by federal law. In all of the decisions, the courts rejected attempts by the plaintiffs to argue that the FDA's labeling regulations allow both brand and generic drug manufacturers to unilaterally modify warnings under a Changes Being Effected ("CBE") supplement, finding that federal law does not permit such changes by a generic drug manufacturer.

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Published In: Products Liability Updates, Toxic Torts Updates

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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