July 23, 2019 Articles

Searching for “Clear Evidence” in the Wake of Albrecht

The ruling failed to provide the degree of clarity that many in the industry had hoped for.

By Elie Biel

Last month, the U.S. Supreme Court decided Merck Sharp & Dohme Corp. v. Doris Albrecht, 139 S. Ct. 1668 (2019), a case that presented a rare opportunity for the Court to weigh in on the Third Circuit’s controversial decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), as well as clarify and build upon its decade-old decision in Wyeth v. Levine, 555 U.S. 555 (2008), the landmark case that established that a drug manufacturer could be immunized from liability under a state-based failure-to-warn theory if “clear evidence” existed that the Food and Drug Administration (FDA) would not have approved the plaintiff’s preferred product warning label. Unfortunately, while the Court unanimously vacated the Third Circuit’s decision, the ruling failed to provide the degree of clarity that many in the industry had hoped for. 

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