Yesterday, the Sixth Circuit issued its decision in Fulgenzi v. PLIVA, Inc., a case involving a state law claim for failure to warn against a generic drug manufacturer. Case No. 12-3504 (6th Cir. March 13, 2013). The court held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label, creating a narrow exception to the preemption defense established by PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).
In Mensing¸ the Supreme Court held that failure-to-warn claims against generic drug manufacturers were preempted. The Court reasoned that, because federal law requires generic manufacturers to maintain the “same” labels as that of the branded drug, generic manufacturers cannot independently change their drugs’ labels.
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Topics: Drug Manufacturers, Failure To Warn, FDCA, Generic Drugs, Labeling, PLIVA v Mensing, Preemption
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