Clear Evidence Clarified

Eric Lindenfeld


In 2009, the Supreme Court introduced the “clear evidence” standard for the defense of federal preemption in the pharmaceutical products liability context. For the next ten years, the contours of the standard were inconsistently applied by courts. The Supreme Court’s 2019 decision in Merck Sharp & Dohme Corp. v. Albrecht offers significant clarity to litigants. While certain issues remain unaddressed by the Court, it is clear that the newly stated rule dramatically limits defendants’ ability to assert the clear evidence standard. The rule is a positive step for consumer safety, provides a clear, administrable bright line, and is not unreasonably broad.