Hogan Lovells Wins Crucial Pharmaceutical Labeling Case for Bristol-Myers Squibb and Pfizer

Washington, D.C., 29 March 2019 – International law firm Hogan Lovells won a decisive victory in the Second Circuit on behalf of Bristol-Myers Squibb and Pfizer. The ruling in Gibbons v. Bristol-Myers Squibb (No. 17-2638) protects pharmaceutical companies from costly and unwarranted discovery in product liability cases that conflict with federal requirements and protects defendants’ rights to a federal forum in cases brought between diverse parties.

In a pair of 2017 rulings, U.S. District Court Judge Denise Cote dismissed dozens of substantially identical complaints asserting that Eliquis’s label did not adequately warn about the risk of bleeding. Adopting the arguments made by Bristol-Myers Squibb and Pfizer’s trial team, the court held that the plaintiffs’ claims were facially preempted.  In a bid to avoid the same fate, another group of plaintiffs voluntarily dismissed their federal-court suits and re-filed them in Delaware state court, where they were removed and transferred to the MDL.  The plaintiffs appealed, challenging the propriety of the removals and the District Court’s preemption ruling.

Hogan Lovells was retained to lead the appeal, and to work with DLA Piper on it. Neal Katyal argued the case in November 2018 before a three-judge panel that included Circuit Judges Debra Ann Livingston, Susan L. Carney, and Richard J. Sullivan.

In a unanimous decision issued on March 26, 2019, the panel concluded that the plain text of the removal statute authorizes “snap removal,” in which a home-state defendant removes state-court actions before service is effected. The panel also held as a matter of first impression that, in order to state a failure-to-warn claim that is not preempted by federal law, a plaintiff must plead a labeling deficiency that the defendant could have corrected without obtaining the FDA’s prior approval.

The decision settles a longstanding intra-circuit split over the scope of the forum-defendant rule, which bars in-state defendants from removing state-court cases on diversity grounds once they have been “properly joined and served.” 28 U.S.C. §1441(b)(2). And it offers trial courts crucial guidance on how to apply federal preemption principles at the pleading stage in cases challenging prescription-drug labeling.

The panel’s holdings will be critical to corporate defendants and to pharmaceutical companies, in particular. The Second Circuit is just the second federal appellate court to address the increasingly common practice of snap removals, which have become an important tactic to counter forum shopping by the plaintiffs’ bar. And the panel’s preemption ruling makes clear that a defendant’s ability to comply with alleged state law requirements without first seeking federal approval is an element of the plaintiff’s claim, and not merely an affirmative defense.

Katyal was assisted by Hogan Lovells senior associates Eugene A. Sokoloff and Mitchell P. Reich. They were joined on the brief by DLA Piper’s Loren H. Brown, Cara D. Edwards and Lucas P. Przymusinski, who led the trial team.

About Hogan Lovells

Hogan Lovells is a leading global legal practice providing business-oriented legal advice and high-quality service across its exceptional breadth of practices to clients around the world.

“Hogan Lovells” or the “firm” is an international legal practice that includes Hogan Lovells US LLP and Hogan Lovells International LLP. For more information, see www.hoganlovells.com.

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