Marcus v. Forest Pharms., Inc., No. 14-1290 (1st Cir. 2015)
Annotate this CaseIn this putative class action against the manufacturer of Lexapro, Forest Pharmaceuticals, Inc., Plaintiffs claimed that Lexapro’s FDA-approved drug label misleads California consumers by omitting material efficacy information in violation of California’s Consumer Legal Remedies Act, False Advertising Law, and Unfair Competition Law. As relief, Plaintiffs requested that the court permanently enjoin Forest from continuing to sell or market Lexapro with its current drug label and to direct Forest to seek FDA approval of a new drug label. The district court dismissed the complaint, concluding that claims were barred by California’s safe harbor doctrine. The First Circuit affirmed the judgment dismissing the complaint but on other grounds, holding that federal law impliedly preempts Plaintiffs’ claims because the federal Food, Drug, and Cosmetic Act prohibits Forest from independently changing its FDA-approved label to read as Plaintiffs say it should have read in order to comply with California Law.
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