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From Health Law Daily, February 24, 2015

Without new efficacy information, Lexapro® labeling claims fail under federal preemption

By Bryant Storm, J.D.

The First Circuit dismissed the labeling claims of two parents who brought a California consumer advertising lawsuit against the manufacturer of an antidepressant. The court held that the state law claims were preempted by federal law under the federal Food, Drug, and Cosmetics Act (FDC Act) (21 U.S.C. §301 et seq.) because there was no need or basis for the manufacturer to have changed the drug’s labeling (Marcus v. Forest Laboratories, Inc., February 20, 2015, Kayatta, W.).

Approval. Lexapro® and Celexa® are antidepressants manufactured by Forest Pharmaceuticals, Inc. They belong to the class of antidepressants known as selective serotonin reuptake inhibitors. Forest sought and gained approval for the sale and labeling of Lexapro and Celaxa through the FDA’s new-drug application (NDA) and supplemental NDA (sNDA) processes. As part of that process, through the evaluation of clinical studies to determine the safety and effectiveness of the drugs, the FDA determined that Lexapro and Celexa were safe and that the Lexapro labeling was not "false or misleading in any particular."

Lawsuit. Randy and Bonnie Marcus purchased Lexapro to treat their adolescent son's depression. According to their complaint, they elected to do so when they and their son’s physician overestimated the effectiveness of the drug as a result of the drug’s labeling. Upon determining that they had wasted money on a drug no more effective than a placebo, they brought a lawsuit under California law “on behalf of all other Californians who purchased Lexapro for an adolescent from March 2009 until present.” The lawsuit alleged that Forest omitted material efficacy information on Lexapro’s label in violation of California state consumer protection laws. In particular, the suit challenged “questionable data” from Lexapro and Celexa efficacy studies. The complaint sought an injunction to prevent Forest from continuing to sell Lexapro with its current label. A district court dismissed the case asserting that the claims were barred under a California safe harbor doctrine because the drugs had received FDA approval (see Safe harbor provision protects Celexa® and Lexapro® from liability, March 7, 2014).

Preemption. On appeal, Forest moved to dismiss the case under the safe harbor provision and on federal preemption grounds. The First Circuit did not consider the California safe harbor position and instead relied on federal preemption under the FDC Act to dismiss the case. The court reasoned that because both analyses relied on the federal preemption determination, the FDC Act was the appropriate place to start. The court reasoned that because the complaint sought to impose liability on Forest for what Lexapro’s labeling stated of failed to state, the complaint was effectively seeking to require a change in Lexapro’s labeling. The court concluded that because the FDA determined that Lexapro’s labeling was adequate, a state law action seeking to undermine that determination was preempted under the FDC Act’s preemption provision. The court concluded that Forest did not have the authority to change Lexapro’s label under the FDA’s Changes Being Effected (CBE) procedure because there was no new information available about Lexapro’s safety or efficacy which would have required a labeling change. Because Forest could not have changed Lexapro’s label to read as the complaint said it should, the court held that the claims were preempted by federal law.

The case is No. 14–1290.

Attorneys: Robert Brent Wisner (Baum Hedlund Aristei & Goldman PC) for Randy Marcus. Edwin G. Schallert (Debevoise & Plimpton LLP) for Forest Laboratories, Inc., and Forest Pharmaceuticals, Inc.

Companies: Forest Laboratories, Inc.; Forest Pharmaceuticals, Inc.

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