Wyeth v. Levine: No Federal Preemption for Drug Labeling

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The Supreme Court yesterday decided Wyeth v. Levine, the long-awaited decision on preemption of state court product liability claims against the pharmaceutical manufacturers. In a 6 to 3 decision, the Supreme Court determined that the foundation of federal regulation for pharmaceuticals is that the drug manufacturer has the responsibility for the adequacy of its warnings. The decision by Justice Stevens, joined by Kennedy, Souter, Ginsburg and Breyer, rejected Wyeth’s argument that it was impossible to comply both with FDA regulations on warnings and with a state law duty, imposed by jury verdict, that a stronger warning against a particular method of administration of the drug was required. The Supreme Court also rejected, over a rigorous dissent, the proposition that state court product liability claims obstructed the purposes and objectives of the federal drug labeling regulations.

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