Supreme Court rules for drug manufacturer in FDA warning case
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Supreme Court rules for drug manufacturer in FDA warning case

The US Supreme Court ruled Monday for Merck, Sharp & Dohme that federal preemption of drug warnings is a question for judges.

Merck, Sharp & Dohme manufactures the drug Fosamax to treat and prevent osteoporosis in older women. The drug has had a Food and Drug Administration (FDA) label approved since 1995, but the label has only included warnings about femoral fractures since 2010. The Respondents are 500 individuals claiming that under state law, Merck, Sharp & Dohme had a duty to warn them of potential femoral fractures. Merck, Sharp & Dohme claim that any such warning would have conflicted with the FDA rules regarding the labeling and approval of drugs and was thus federally preempted.

The court reviewed the case and ultimately decided that judgment of federal preemption of drug warnings was a decision for judges rather than juries. Specifically judges would have to review whether there was “clear evidence” that a proposed label change under state law would be denied by the FDA. The judgment was unanimous, but there were two concurring opinions. Justice Clarence Thomas wrote a concurrence to argue against the “physical impossibility” standard set out by the majority. Justice Samuel Alito wrote another concurrence joined by Chief Justice John Roberts and Justice Brett Kavanaugh to join in the judgment but express concerns about the clarity of the majority’s legal standard.