First Circuit Finds Federal Preemption of State Tort Claims That Conflict With A Medication’s FDA-Approved Labeling & Warnings

An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted claims that Lexapro’s U.S. Food and Drug Administration (FDA) approved drug labeling misleads California consumers and violates state laws against false advertising and unfair competition. In doing so, the Court focused on interpreting Wyeth v. Levine, 555 U.S. 555 (2009) in light of PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011). The Court held that these two cases “draw [a line] between [labeling] changes that can be independently made… and changes that require prior FDA approval.” Based on its analysis of FDA’s prescription drug labeling regulations, the Court determined that a manufacturer can make certain labeling changes independently and without prior FDA approval only when new information is presented which was not available at the time of FDA’s review and approval of the labeling at issue. Accordingly, “Wyeth effectively reserves the launch of new drugs to the expertise of FDA, but then preserves a wide scope for the states in requiring manufacturers to respond to information not considered by the FDA.” A state law duty to initiate a change “is therefore not by its nature a second guess of an FDA judgment.” Because the Plaintiffs failed to allege the existence of new information, and argued instead that the requested labeling change should be based on information FDA already considered, the Court determined that the Plaintiffs’ tort claims based in state law were preempted under the FDCA.

Background -

Lexapro, the medication at issue in the case, is an FDA-approved antidepressant manufactured by Forest Laboratories, Inc. FDA first approved Lexapro in 2002 to treat depression in adults. In 2008, FDA approved Lexapro to treat major depressive disorder in adolescents. Plaintiffs argued that Lexapro was no more effective for adolescents than a placebo because FDA approved Lexapro for adolescent use on the basis of only two clinical trials that displayed statistically significant, but very limited efficacy, and extrapolation from adult data. Plaintiffs alleged that Lexapro’s FDA-approved labeling overstated the medication’s efficacy for adolescents because Forest supposedly manipulated Lexapro’s efficacy data, and the efficacy data did not actually show a true statistically significant difference from placebo, thereby misleading California consumers by omitting material efficacy information, in violation of California’s Consumer Legal Remedies Act (“CLRA”), False Advertising Law (“FAL”), and Unfair Competition Law (“UCL”). Forest denied the claims. The District Court dismissed the claims, finding them barred by California’s safe harbor doctrine, which prohibits the courts from condemning actions permitted by the legislature, including Congress. Having made its determination on the safe harbor provision, the District Court did not reach the issue of preemption. On appeal, the Circuit Court affirmed the dismissal on the basis of federal preemption without considering California’s safe harbor doctrine.