'Allergan v Athena': Medical Products And The Alchemy Of 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).

Battle Won - War in Jeopardy?

In litigation, facts matter and the facts in Allergan et al v Athena, favored Allergan. The impact of the December 30, 2013 ruling by the Federal Circuit Court may go beyond the facts of this case to bolster tort claims against manufacturers under the emerging doctrine of "parallel claims." Allergan may find an odd bedfellow in Plaintiffs' lawyers, whom it may be helping unwittingly and in unintended ways to undercut the defense of federal preemption and reliance on the doctrine of primary jurisdiction.

Allergan's claims involved California's Unfair Competition Law (UCL), California Business and Professions Code § 17200 et seq. Allergan was marketing a Food and Drug Administration (FDA) approved drug and, under the Food Drug and Cosmetic Act (the FDCA), Allergan was permitted to make treatment and mitigation claims concerning how the drug affects the structure and function of the body. Athena, on the other hand, was marketing a cosmetic and could only make claims to support the structure and function. Both products were similarly formulated and contained a prostaglandin derivative for the treatment of a condition that affects eyelash growth. At issue was whether Athena's claims concerning its RevitaLash product rendered it not a cosmetic but an unapproved new drug. The issue was not that the product was unsafe or not efficacious. Allergan claimed that Athena's marketing increased its market share to the financial detriment of Allergan.

On December 30, 2013 the Court of Appeals for the Federal Circuit issued an opinion in Allergan et al v Athena affirming the District Court's grant of summary judgment finding that Athena violated California's UCL by "marketing, distributing and selling, without regulatory approval, products that qualify as drugs." The Federal Circuit found jurisdiction over the California case concluding that "'patent law is a necessary element of one of the well-pleaded claims' in the complaint" even though the patent claims in the underlying case had been dismissed.

As is true in many states, California's Health Code (the California FDCA) mirrors and incorporates various provisions of the federal FDCA. While it is well recognized that the FDCA does not allow a private right of action for violations (21 U.S.C. § 337(a)), the Federal Circuit reasoned its way around the notion of federal primacy and preemption concluding that references in the complaint to the FDCA were merely "referential." There is no express preemption for cosmetics or drugs under the FDCA, as there is for medical devices, and the issue before the Court was whether the claims were impliedly preempted. Athena argued Buckman preemption; that Allergan's claims exist because of the FDCA and required deference to a determination by the FDA concerning whether Athena marketed a drug or a cosmetic.

Allergan argued that its state law claims merely "parallel" federal law and rely on a violation of the California FDCA.

Athena further argued that...