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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