The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13, 2013). In doing so, the court created a narrow exception to the preemption defense established by Pliva Inc. v. Mensing, 131 S. Ct. 2567 (2011).

Liability for Generic Manufacturers After Mensing -

In Mensing¸ the U.S. Supreme Court held that failure-to-warn claims against generic drug manufacturers were preempted because it was impossible to comply with both state and federal law. The court reasoned that, because federal law requires generic manufacturers to maintain the “same” labels as that of the branded drug, it is impossible for generic manufacturers to independently change their drugs’ labels to avoid liability for failure-to-warn claims under state law.

Originally published in Law360 on April 04, 2013.