In re: Avandia Marketing, Sales & Prods. Liab. Litig. (UFCW Local 1776)—civil—reversal—Restrepo

Here is the introduction of today’s opinion reversing summary judgment in favor of  pharmaceutical giant GlaxoSmithKline in one front of its running battle over liability for its diabetes drug Avandia:

Plaintiffs, two health benefit plans (“Plans”), appeal the District Court’s grant of summary judgment in favor of Defendant, GlaxoSmithKline LLC (“GSK”), the manufacturer of the prescription drug Avandia. The Plans brought suit against GSK under various state consumer-protection laws and the Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. ch. 96 (“RICO”), based on, among other things, GSK’s marketing of Avandia. The District Court granted summary judgment in favor of GSK on the Plans’ claims, finding, in relevant part, that (i) the Plans’ state-law consumer-protection claims were preempted by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. ch. 9 (“FDCA”); (ii) the Plans had failed to identify a sufficient “enterprise” for purposes of RICO; and (iii) the Plans’ arguments related to GSK’s alleged attempts to market Avandia as providing cardiovascular “benefits” were “belated.” The Plans assert that the District Court erred in granting summary judgment, and we agree.

Applying the guidance recently provided by the Supreme Court in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019), we hold that the Plans’ state-law consumer-protection claims are not preempted by the FDCA. With respect to their RICO claims, the Plans should have been given the opportunity to seek discovery prior to the District Court’s granting summary judgment on such claims. Further, from the inception of this litigation, the Plans’ claims have centered on GSK’s marketing of Avandia as providing superior cardiovascular outcomes—in other words, cardiovascular benefits—as compared to other forms of treatment, and therefore, the District Court’s refusal to consider the Plans’ “benefits” arguments was in error because those arguments were timely raised. Therefore, for the reasons that follow, we will reverse in part and vacate in part the order of the District Court granting summary judgment in favor of GSK, and we will remand to the District Court for further proceedings consistent with this opinion.

Joining Restrepo were Smith and Ambro. Arguing counsel were Thomas Sobol of Massachusetts for the appellents and Jay Lefkowitz of Kirkland & Ellis for the appellee.