In Fulgenzi v. PLIVA, Inc.,711 F.3d 578 (6th Cir. 2013) (No. 12-3504), the Sixth Circuit addressed the question whether federal law preempts a lawsuit against a generic drug maker in which the plaintiff alleges that the defendant drug maker had failed to update its warnings so as to parallel newly-approved warnings for the branded equivalent of its generic drug. The court concluded that it did not. Rather, federal law requires the generic drug maker to update its warning, and a plaintiff can state a claim for failure to update warnings based on a state law that is not preempted by federal law.
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Preemption argument rejected in failure to update warnings case
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