Clear Evidence Clarified

Abstract

In 2009, the Supreme Court in Wyeth v. Levine articulated a standard of federal preemption for failure-to-warn claims in the brand name drug context. Specifically, the Court ruled that a defendant could only be afforded the benefit of federal preemption if it could present “clear evidence” that the warning which plaintiffs argued should have been included on the label would have been rejected by FDA. Over the next decade, courts took wildly divergent approaches to Levine’s clear evidence standard, creating uncertainty amongst plaintiffs and defendants alike. Courts disagreed, for example, on whether FDA denial of the warning must be actual or hypothetical. Moreover, courts applying the clear evidence standard disagreed on the relevance and import of similar drug label rejections, years-old label rejections for the same drug, scientific literature, independent FDA studies, emails, correspondence, or materials buried in thousand-page submissions. The confusion spawned a labyrinth of conflicting rulings and decade worth of confusing and inconsistent precedent. It has also generated a significant amount of scholarship, including scholarship by this author, calling on the high court to revisit and rearticulate the standard. Recognizing, perhaps, that clarification of the clear evidence standard was long overdue, in May 2019, the Supreme Court issued a ruling in Merck Sharp & Dohme Corp. v. Albrecht, with major impact on the product liability landscape. Most significantly, the Court rejected the use of hypothetical preemption, clarifying that clear evidence requires that defendants show that FDA actually and expressly rejected the warning which plaintiffs argued was necessary under state tort law standards. The Court’s newly articulated five-part test also establishes that in order to receive the benefit of federal preemption, defendants must demonstrate that they provided FDA all material and relevant information. While certain nuances were left unaddressed by the Court, and certain interpretive issues have been hotly debated amongst the first wave of commentators, the newly stated rule provides much needed clarification on the clear evidence inquiry. This clarification is especially important given that the standard’s application is most common in high stakes, consolidated litigation involving thousands of lawsuits and some of the most innovative and complex drugs and devices ever sold. This paper proceeds in five Parts. Part I provides a background on the federal regulatory regime governing prescription drugs, including the mechanisms available to manufactures and FDA to supplement a brand name drug’s label. Part II briefly lays the groundwork of the evolution of federal preemption principles in the brand name preemption context, including the foundation of the clear evidence standard. Part III explains the conflicting applications of the traditional clear evidence standard, and then progresses into the genesis and holding of the Supreme Court decision in Albrecht. Part IV then analyzes the Supreme Court’s holding, carefully detangling and examining the language of the newly stated rule, as well as forecasting its prospective interpretation and application. Having concluded that the newly stated rule, at the minimum, dramatically limits defendants’ ability to assert the clear evidence standard. Part V analyzes its potential policy implications. The paper concludes that Albrecht’s new rule is a positive step for consumer safety, offers consistency, will not overburden FDA, and is not overly-draconian.