Free Download: Keller & Heckman Litigation Alert: 8th Circuit Finds Adulterated Drug Claims Not Preempted

Consumers can sue a drug company for selling a drug that was not manufactured pursuant to good manufacturing practices (GMP) and was, thus, "adulterated" under the Food, Drug and Cosmetic Act (FDCA). Such claims are not preempted by federal law, said the Eighth Circuit Court of Appeals. (Allen LeFaivre v. KV Pharmaceutical Company, et al., 8th Cir., No. 10-1326, 1/19/2011.)

LeFaivre brought a class action lawsuit against KV Pharmaceutical Company and others (KV), alleging that KV failed to manufacture its hypertension drug in compliance with federal regulations and was in breach of the implied warranty of merchantability and other state laws. The suit was based, in part, on a Consent Decree between the Food and Drug Administration (FDA) and KV settling the FDA's civil allegations that the drug was not made in compliance with cGMP and, thus, was "adulterated" pursuant to the FDCA. Under the Consent Decree, KV agreed to destroy the remaining stock of adulterated drugs and issue a recall for all stocks of the adulterated product. The Consent Decree did not require KV to distribute its recall notice to individual purchasers of the medication, and it did not do so. KV moved to dismiss LeFaivre's lawsuit, alleging that his state law claims were preempted by federal law because the claims were based entirely on violations of federal regulations. The District Court granted the motion to dismiss.

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