The Eighth Circuit Court of Appeals has reinstated claims for economic injury brought against the maker of a hypertension medication, finding that allegations of adulteration and failure to comply with federal regulations were not impliedly preempted by the Federal Food, Drug, and Cosmetic Act. LeFaivre v. KV Pharm. Co., No. 10-1326 (8th Cir., decided January 19, 2011).
The putative class complaint alleged that the company breached its implied warranty of merchantability and violated the state Merchantability Practices Act and further alleged that the company admitted product adulteration in a consent decree with the Food and Drug Administration (FDA).
The appeals court agreed with the plaintiff that the district court’s finding of implied preemption was contrary to Wyeth v. Levine, 129 S. Ct. 1187 (2009). According to the court, state law has long been regarded as “a complementary form of drug regulation” and that “state law offers an additional, and important layer of consumer protection that complements FDA regulation.” The court noted that it would not be impossible for the defendant to comply with both federal and state law, thus precluding a finding of conflict preemption, and also said that the state-law claims were not fraud-on-the-FDA claims, to the extent that they focus on harm allegedly perpetrated against consumers rather than the FDA.