Allergan v Athena: Medical Products Liability And Parallel Claims

Allergan v Athena: Medical Products Liability and Parallel Claims

There is something inherently troubling when a prescription drug manufacturer argues in favor of parallel claims under state law, but that is what happened in Allergan et al. v Athena, No. 2013-1286, 2013 U.S. App. LEXIS 25746 (Fed. Cir. Dec. 30, 2013) (here).

On December 30, 2013, the Court of Appeals for the Federal Circuit issued an opinion in Allergan affirming the California District Court's grant of summary judgment, finding that Athena violated California's Unfair Competition Law (UCL) by "marketing, distributing and selling, without regulatory approval, products that qualify as drugs."

California's Health Code (the California FDCA) mirrors and incorporates various provisions of the federal Food Drug and Cosmetic Act (FDCA). Relying on Wyeth v. Levine, 555 U.S. 555 (2009), Allergan argued that the claims were not preempted where simultaneous compliance with state and federal law is possible, and where the state law is not an obstacle to the realization of federal goals. The Federal Circuit ruled that the FDCA does not impliedly preempt California UCL claims where the claims rely on the California FDCA and not the federal FDCA. However, when a manufacturer's claims render a product a new drug, FDA approval is required to market the product using those claims. According to the Federal Circuit, "[w]e do not find a clear purpose by Congress to preempt the state law claim at issue." The Court distinguished the Supreme Court opinion in Buckman v Plaintiffs' Legal Committee, 531 U.S. 341 (2001) finding that unlike state laws directed at health and safety, fraud on the FDA claims exist "solely by virtue of the FDCA disclosure requirements" and warranting finding federal pre-emption of a state law cause of action." Id at 347, 352.

The Parallel Claim

The definition of a "drug" under the California FDCA mirrors that of the FDCA, i.e. whether a substance is a drug is determined by the manufacturer's "intended use." "Intended use," however, is a term defined under the FDA regulations, not California state law. Under the federal regulations, the FDA determines a manufacturer's intended use of its product "by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article, including labeling claims, advertising matter, or oral or written statements by such persons or their representatives." 28 CFR 201.128. A product is an unapproved new drug...