May 20, 2019— Pharmaceutical manufacturers can no longer try to establish preemption based on speculation about what the U.S. Food and Drug Administration (FDA) would have done in hypothetical situations. In Merck v. Albrecht, the U.S. Supreme Court concluded that “a drug manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law such that it was impossible to comply with both.” The Court held that “clear evidence” preemption requires an FDA action with the force of law that prohibits the manufacturer from adding an adequate warning.

Kellogg Hansen partner David Frederick argued the case for the Fosamax plaintiffs. He was joined on the brief by Kellogg Hansen partner Brendan Crimmins and associate Jeremy Newman. Mr. Frederick issued the following statement on the opinion: 

“This opinion protects access to justice for injured patients. It reaffirms Wyeth, which ensured patients can hold drug companies accountable when they fail to warn about side effects, and it provides the clarification the Third Circuit requested. Further, the opinion makes clear that preemption can be established only by a formal FDA action prohibiting the manufacturer from changing its warning label to add any adequate warning under state law.” 

The Court also held that the “clear evidence” preemption issue is for the judge, not the jury.  Because the Third Circuit had held that a jury should decide the question, the Supreme Court vacated the Third Circuit’s opinion and remanded for the Third Circuit to decide Merck’s preemption defense under the legal standards announced by the Court.

The case is Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290 (U.S.).