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In re Celexa & Lexapro Mktg. & Sales Practices Litig.

United States Court of Appeals, First Circuit

February 20, 2015

FOREST LABORATORIES, INC. and FOREST PHARMACEUTICALS, INC., Defendants, Appellees RANDY and BONNIE MARCUS, on behalf of themselves and all other persons similarly situated, Plaintiffs, Appellants,


R. Brent Wisner, with whom Baum, Hedlund, Aristei & Goldman, P.C. and Pendley, Baudin & Coffin, LLP were on brief, for appellant.

Edwin G. Schallert, with whom Debevoise & Plimpton LLP and Sugarman, Rogers, Barshak & Cohen, P.C. were on brief, for appellee.

Before Lynch, Chief Judge, Selya and Kayatta, Circuit Judges.


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KAYATTA, Circuit Judge.

This appeal arises out of a putative class action against Forest Pharmaceuticals, the manufacturer of Lexapro, an antidepressant medication. Plaintiffs claim that Lexapro's FDA-approved drug label misleads California consumers by omitting material efficacy information, in violation of California's Consumer Legal Remedies Act (" CLRA" ), Cal. Civ. Code § 1750 et seq., False Advertising Law (" FAL" ), Cal. Bus. & Prof. Code § 17500 et seq., and Unfair Competition Law (" UCL" ), Cal. Bus. & Prof. Code § 17200 et seq. The district court dismissed these claims, finding them barred by California's safe harbor doctrine. See In re Celexa & Lexapro Mktg. Sales Practices Litig. (Marcus v. Forest Labs., Inc.), No. 13-11343-NMG, 2014 WL 866571 (D. Mass. March 5, 2014). See generally Cel-Tech Commc'ns, Inc. v. L.A. Cellular Tel. Co., 20 Cal.4th 163, 182, 83 Cal.Rptr.2d 548, 973 P.2d 527 (1999) (outlining California's safe harbor doctrine).

Expressing no view on the California safe harbor doctrine's applicability here, we instead find that federal law impliedly preempts these claims because the Federal Food, Drug, and Cosmetic Act (" FDCA" ), 21 U.S.C. § 301 et seq., prohibits Forest from independently changing its FDA-approved label as plaintiffs claim California law requires. See PLIVA, Inc. v. Mensing, 131 S.Ct. 2567, 2580-81, 180 L.Ed.2d 580 (2011). Therefore, we affirm the judgment dismissing the complaint.

I. Background

Lexapro belongs to a class of antidepressants known as selective serotonin reuptake inhibitors. Forest also manufactures Celexa, a drug with a chemical composition closely related to Lexapro. In 2002, the FDA first approved Lexapro to treat adults for depression. In 2008, Forest sought FDA approval for the use of Lexapro to treat major depressive disorder in adolescents.

A. FDA's Drug Approval Process

The FDA drug approval process is " onerous and lengthy." Mut. Pharm. Co., Inc. v. Bartlett, 133 S.Ct. 2466, 2471, 186 L.Ed.2d 607 (2013). The FDCA requires that drug manufacturers gain FDA approval prior to marketing or selling a drug in interstate commerce. See 21 U.S.C. § 355(a). To gain FDA approval,

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a drug manufacturer must submit either a new-drug application (" NDA" ), for a new drug, or a supplemental new-drug application (" sNDA" ), for a new treatment. See 21 C.F.R. § 314.1 et seq. NDAs and sNDAs are subject to the same approval requirements. See id. The NDA or sNDA must include " full reports of [all clinical] investigations which have been made to show whether . . . such drug is effective in use." 21 U.S.C. § 355(b)(1)(A). The FDA may only approve the drug if the NDA or sNDA provides " substantial evidence that the drug will have the effect it . . . is represented to have." Id. § 355(d)(5). As part of its showing that it has provided such substantial evidence, a manufacturer submits the results of " adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved." Id. § 355(d)(7).

In its evaluation of an NDA or sNDA, the FDA has discretion to determine that data from " one adequate and well-controlled clinical investigation," along with other " confirmatory evidence," are " sufficient to establish effectiveness." Id.; see 21 C.F.R. ยง 314.105(c) (" [The] FDA is required to exercise its scientific judgment to determine the kind and quantity of data and information an applicant is required to provide for a particular drug to meet the statutory standards." ) The FDA will not approve a drug if the NDA or sNDA lacks " substantial evidence that ...

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