Merck Sharp & Dohme Corp. v. Albrecht

Background

A drug maker, Merck, sold Fosamax to treat osteoporosis. The FDA approved Fosamax’s label in 1995 without warning of a rare risk called atypical femoral fractures. Over time more reports linked long-term Fosamax use to those fractures, and more than 500 people who took the drug and later broke their thigh bones sued Merck under state law for failing to warn patients and doctors. Merck said federal law and FDA action prevented it from adding the warning.

Reasoning

The Court addressed whether deciding if federal law prevented a label change is a job for a judge or a jury. Relying on earlier cases, the Court said the “clear evidence” standard means the drug maker must show it fully informed the FDA of the reasons for the state-required warning and that the FDA told the maker it would not approve that change. Only formal FDA actions taken under its lawful authority can preempt state law, the Court said. Because interpreting agency action and law is legal work, a judge — not a jury — should decide this question.

Real world impact

The decision does not resolve whether Merck must pay damages; it vacated the appeals court ruling and sent the case back for further work under the clarified rule. But it narrows how defendants can claim federal preemption: courts will decide whether the FDA actually blocked a warning, and manufacturers must show explicit FDA disapproval based on information the manufacturer provided.

Dissents or concurrances

Several Justices wrote separate opinions. Justice Thomas stressed constitutional preemption principles; Justice Alito emphasized a 2007 statute that requires FDA review of new safety information and noted the agency’s own actions on Fosamax.