First Circuit Affirms Preemption of State-Law Claim for Consumer Fraud

labelIn a key preemption ruling late last month, the United States Court of Appeals for the First Circuit affirmed the dismissal of a putative class action. The First Circuit affirmed dismissal where the plaintiffs alleged consumer fraud, holding that state-law claims for false or misleading labeling are preempted by federal law. Read the full decision here.

The First Circuit’s ruling built upon recent United States Supreme Court decisions holding that state-law claims aimed at generic drug labeling are preempted by applying this important defense to makers of brand named drugs.


In May 2012, the plaintiffs, Randy and Bonnie Marcus, filed their class claims in California federal district court, seeking to represent a class of consumers who purchased the antidepressant Lexapro for use by an adolescent after early 2009. The plaintiffs claim involved Lexapro purchased for their adolescent son. Lexapro had been approved in 2002 for treatment of major depression in adults, and, in 2008, the FDA extended approval of the drug for use by adolescents. Despite its approval, plaintiffs allege that Lexapro’s labeling overstates the drug’s efficacy for adolescents because the clinical trials submitted to the FDA as part of the supplemental new drug application were, allegedly, manipulated to show a statistically significant difference over placebo that was unproven.

The complaint alleges that material efficacy information was omitted from the product’s labeling in violation of California’s consumer protection statutes. After the action was transferred to a multidistrict litigation pending in Massachusetts federal court, In re Celexa and Lexapro Marketing and Sales Practices Litigation, the drug’s manufacturer moved to dismiss. The motion was based both on a California safe harbor provision that prohibits courts from finding practices unlawful where Congress or the state legislature permits them, and on federal preemption. Though the trial court dismissed the action based on the safe harbor law, the First Circuit affirmed based on implied preemption without reaching the safe harbor issue.

The Preemption Ruling

The Court of Appeals based its holding on the fact that it would be impossible for Lexapro’s manufacturer to have complied with federal law if it had to comply with the changes to the labeling plaintiffs claim were required by state law.

The First Circuit began by describing the extensive process by which the FDA receives and considers new drug applications and supplemental applications. The approval process includes determinations under the federal Food, Drug and Cosmetics Act (“FDCA”) that there is substantial evidence of the drug’s purported efficacy and that the proposed labeling of the drug is not false or misleading. The court noted that FDA approval of Lexapro for adolescent use was based on a supplemental new drug application that relied upon positive studies and a specific finding that the labeling was appropriate and compliant with the FDCA.

The claims in the litigation would have required a change to Lexapro’s labeling, so the court explained the two pertinent avenues for a brand name drug manufacturer to change labeling of an approved product. The first involves obtaining FDA approval for the proposed change prior to product distribution with the new labeling information. The second derives from so-called Changes Being Effected (“CBE”) regulations which permit certain types of labeling changes without approval through a supplement showing that the change both reflects newly acquired information and that it is for the purposes of accomplishing one of five objectives. Those objectives involve concepts of need to add or strengthen a contraindication or warning, including about drug dependence, or to strengthen instructions to further safe use of the drug or to eliminate unsupported efficacy claims.

The court applied several consequential United States Supreme Court preemption precedents from the past six years, including, Wyeth v. Levine, 555 U.S. 555 (2009) and PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). Wyeth involved the rejection of preemption where a state-law claim charged that a brand name drug manufacturer had become aware of a risk post-approval, and, thus the CBE regulations permitted the strengthening of the warning information before obtaining new FDA approval.

PLIVA, decided two years after Wyeth, sustained a preemption defense of a generic manufacturer because of the “sameness” requirement. Essentially, the court in PLIVA found that the generic manufacturer was required to ensure their label was the same as the brand name drug’s FDA approved label and coupled with the fact that the CBE process is unavailable to generic drug makers, they could not have changed their label under federal law. PLIVA limited Wyeth to situations where the defendant could have independently made a labeling change under federal law that was required by state law. The Lexapro court noted that because CBE changes rely upon newly acquired information, a state law requiring proactivity regarding such new information does not act as a second guess of the FDA’s initial judgment as to approval and label content.

Applying these principles, the First Circuit scoured the complaint and found that the plaintiffs had not identified new information that was unavailable to the FDA. The information presented was comprised of two post-approval articles, but those were not shown to be based on any new data as to efficacy of the drug in treating major depressive disorders in adolescents. Indeed one was an article critical of the FDA’s approval of Lexapro that contained no information of which the FDA was unaware during its evaluation of the supplemental NDA. Thus, the article represented a clear second guessing of the agency’s judgment. Likewise, as to the plaintiffs’ claim that one study submitted in support of drug approval had been manipulated, the court noted that the plaintiffs had not shown that the same assertion was unknown to FDA prior to its approval of the labeling. The court also referenced admissions by the plaintiffs’ attorney during oral argument confirming that the labeling change sought was based on efficacy information known to the FDA during the approval process.

In light of this, there was no lawful way for Lexapro’s manufacturer to have used the CBE procedure to alter the labeling in the manner the plaintiffs claimed was required by California consumer fraud laws. Thus the state-law claims were held impliedly preempted by federal law.


The In re Celexa and Lexapro decision has broad implications for brand name drug manufacturers. The decision makes clear that the defense is not one reserved only for generic drug manufacturers. In addition, the decision reaffirms the availability of the preemption defense where zealous plaintiffs seek to use state laws to challenge alleged failures to unilaterally revise FDA-approved labeling. Where plaintiffs seek to capitalize on criticisms of existing drug approvals based on information known to the FDA during the approval process, manufacturers can be comforted by the First Circuit’s ruling that second guessing is not fodder for altered or strengthened labels.

Pharmaceutical defendants facing state-law challenges to their labeling would be wise to carefully study the First Circuit’s review of the record and scientific analysis associated with determining whether the purportedly new information was truly new. By doing so, brand name pharmaceutical manufacturers can best position themselves to take advantage of the preemption defense and effectively cut off consumer class and other plaintiffs at an early stage.

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