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Recent Developments Since <i>Pliva v. Mensing</i>

By Joseph G. Falcone and Michael R. Kelly
August 29, 2013

In PLIVA v. Mensing, 131 S.Ct. 2567 (2011), a 5-4 majority of the Supreme Court held that federal regulations applicable to generic pharmaceuticals preempt state law claims alleging that the manufacturers failed to warn consumers of the drug's risks. Together with Wyeth v. Levine, 555 U.S. 555 (2009), in which the Court allowed failure-to-warn claims to proceed against a manufacturer of brand-name medications, the Court's decisions have been interpreted to establish different preemption rules for generic- and branded-drug makers based on the different obligations these manufacturers face under federal law.

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