On November 27, 2009, the United States Court of Appeals for the Eighth Circuit held that failure to warn claims directed at generic pharmaceutical manufacturers are not preempted by federal law.

In Mensing v. Wyeth, Inc., No. 08-3850, 2009 WL 4111209 (8th Cir. Nov. 27, 2009), the plaintiff alleged failure to warn and misrepresentation claims against a number of manufacturers of the antiemetic drug Reglan and its generic form, alleging that the medication caused her to develop a severe neurological disorder. The generic manufacturers moved to dismiss the action on the basis that the plaintiff’s state-law tort claims were preempted by the Food, Drug and Cosmetic Act (FDCA). Specifically, the generic manufacturers claimed that federal law required the generic labels to be the “same as” those used for the name brand drug, and that the plaintiff’s theory of liability, if endorsed by the Court, would require them to deviate from the drug label prescribed for Reglan -- i.e., that it would be “a physical impossibility” for them to comply with both the state and federal laws. The district court agreed with the generic manufacturers, and the plaintiff appealed to the Eight Circuit.

The Eighth Circuit reversed the district court’s ruling addressing preemption and held that the plaintiff’s claims against the generic manufacturers were not preempted by federal law and could proceed. The Court rejected the argument that the FDCA impliedly preempted state law tort claims relating to the labeling of the drug, and determined that the generic manufacturers could comply with both federal and state law. The Court noted that the generic manufactures could have proposed a label change to the name brand drug label or suggested that the FDA send out a warning letter to health care professionals, and explained that uncertainty as to what the FDA’s response might be did not support a finding of impossibility. There also was no clear evidence in the record suggesting that the FDA would have rejected a labeling proposal from the generic manufacturers. The Eight Circuit also rejected the generic manufacturers’ argument in the alternative that failure to warn claims, if permitted, would obstruct the objectives and purposes of relevant federal law, pointing out that “[t]he generic defendants were not compelled to market [the drug]. If they realized their label was insufficient but did not believe they could even propose a label change, they could have simply stopped selling the product.”

Mensing v. Wyeth comes on the heels of Wyeth v. Levine, 129 S.Ct. 1187 (2009), where the Supreme Court ruled that failure to warn claims against name brand manufacturers are not preempted by the FDCA.

To view a copy of the Eighth Circuit’s decision, please click here.

To read a discussion of Wyeth v. Levine, please click here.