April 16, 2015

First Circuit Decision Strengthens Preemption Defense in Name-Brand Pharmaceutical Litigation

On February 20, 2015, the U.S. Court of Appeals for the First Circuit affirmed the dismissal of plaintiffs’ state-law consumer protection claims against a name-brand pharmaceutical manufacturer, concluding they were impliedly preempted by the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq. (FDCA). See Marcus v. Forest Labs., Inc., No. 14-1290, 2015 WL 727970 (1st Cir. Feb. 20, 2015). This decision represents the first time since the Supreme Court’s decision in Wyeth v. Levine, 555 U.S. 555 (2009), that a federal appellate court has dismissed claims against a name-brand drug manufacturer pursuant to the “impossibility” preemption doctrine.

Case Background

In Marcus, plaintiffs filed a putative class action against Forest Laboratories (Forest), the manufacturer of name-brand pharmaceutical Lexapro, contending that the label overstated the product’s efficacy in treating major depressive disorder in adolescents. To establish efficacy for this indication, Forest previously had submitted to the Food and Drug Administration (FDA) the results of four clinical studies, two of which found no efficacy, and two of which found “positive efficacy that was statistically significant, but only barely so.” The FDA approved the indication in March 2009, and approved the text of the Lexapro label, finding it was not “false or misleading in any particular.” The district court granted Forest’s motion to dismiss, and the plaintiffs appealed.

Application of the Impossibility Preemption Doctrine

On appeal, the First Circuit found the plaintiffs’ state-law claims were impliedly preempted by the FDCA pursuant to the “impossibility” preemption doctrine. This doctrine recognizes that state law is preempted when it “requires a private party to violate federal law,” thus rendering it impossible to comply with both. In reaching its conclusion, the First Circuit examined the Supreme Court’s recent decisions governing the application of the “impossibility” preemption in pharmaceutical litigation.

  • In PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), the Supreme Court held that state-law claims against manufacturers of generic pharmaceuticals were preempted because FDA regulations require the warning labels of generic drugs and their name-brand counterparts to always be the same. Although generic manufacturers can modify the language of a warning label with FDA pre-approval, the Supreme Court held this was not enough to avoid preemption. Mensing, 131 S.Ct. at 2581 (“[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.”).
     
  • In contrast, the Supreme Court in Levine held that identical claims against a name-brand manufacturer were not preempted. Under the FDA’s Changes Being Effected (CBE) regulation, 21 C.F.R. § 314.70(c)(6)(iii), name-brand manufacturers under certain circumstances are permitted to independently modify the language of an FDA-approved label. Thus, where the CBE procedure is available, a state law penalizing name-brand manufacturers for not exercising their ability to modify their warning labels is not preempted.

Reconciling Mensing and Levine, the First Circuit held that “[t]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.” Marcus, 2015 WL 727970 at *6 (quoting Mensing, 131 S.Ct. at 2579).

In Marcus, the plaintiffs’ allegations of inadequate labeling were based upon information that the FDA had already considered in its approval of Lexapro — namely, the clinical studies purportedly showing no or minimal efficacy. Because the CBE procedure is only available to make changes that, among other things, are based on “newly acquired information,” 21 C.F.R. § 314.70(c)(6)(iii), the First Circuit concluded that the procedure was not available to Forest, as the plaintiffs’ claims were not premised upon “newly acquired information.” Accordingly, Forest could not have independently done what plaintiffs contended was required by California state law, and the plaintiffs’ claims were preempted.

Significance of the Ruling

The Marcus decision represents a significant victory for manufacturers because it is the first time since Levine was decided that a federal appellate court has applied “impossibility” preemption in the context of name-brand pharmaceuticals. Following Levine, district courts overwhelmingly rejected preemption arguments proffered by name-brand manufacturer defendants, even in cases where the CBE procedure was unavailable, preferring instead to limit the reasoning of Mensing to generic pharmaceuticals only. The Marcus decision parts from this line of cases, and breathes new life to the argument that implied preemption should apply — regardless of whether the product is name-brand or generic — when a manufacturer defendant cannot, without FDA approval, do what the plaintiffs contend should have been done under state law.

This article was originally published in the American Bar Association’s Mass Torts News & Developments. Reprinted with permission.

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