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Sixth Circuit Issues Ruling on Generic Drugs and Preemption

Posted in Recent Cases

Yesterday, in Fulgenzi v. PLIVA, Inc., the Sixth Circuit handed down an interesting decision concerning generic drugs and preemption. The case involved a failure to warn claim against a generic manufacturer.  The Court recognized that the Supreme Court had recently held that generic manufacturers could not be held liable consistent with preemption concerns because federal law requires that their labels mirror the labels of brand drugs. See PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).  In this case, however, the brand manufacturer updated its label, but the plaintiff alleged that the generic manufacturer failed to follow suit.  That made all the difference to the Sixth Circuit.

The preemption question turned on whether it was “impossible” for the manufacturer to simultaneously comply with both state and federal law.  Here, it was not impossible for the manufacturer to comply with federal and state law, according to the Court, because it was required to update its label in order to comport with federal law. At the same time, the Court recognized limits to plaintiff’s failure to warn claim – the plaintiff is only allowed to argue that the warning was inadequate to the extent that it fell short of the branded update, and that the failure to update the language proximately caused her injuries.

This case is interesting for a number of reasons, not least of which is that it could have some impact on the upcoming U.S. Supreme Court arguments set for next week that will further explore the scope and limits of Mensing.