Merck Sharp & Dohme Corp. v. Albrecht
The Supreme Court ruled that judges, not juries, must decide whether federal drug regulators would have rejected a proposed warning label change when a drug maker argues that federal law made it impossible to add a warning state law required.
The Court also clarified that a drug manufacturer wins this defense only by showing it fully told the FDA the reasons for the warning and that the FDA specifically told the company it would not approve adding that warning.
“The complexity of the preceding discussion of the law helps to illustrate why we answer this question by concluding that the question is a legal one for the judge, not a jury.”
The Court's core holding that judges, not juries, decide the preemption question.
How it got here: A federal trial court sided with Merck on preemption; the Third Circuit vacated and sent the case back, holding a jury must decide the issue; Merck appealed to the Supreme Court.
The Case in Depth
What happened
More than 500 people who took the osteoporosis drug Fosamax, made by Merck Sharp & Dohme, developed rare "atypical femoral fractures." They sued Merck under state law, arguing it should have warned them and their doctors about this risk earlier than it did. Merck said federal law prevented it from adding that warning before the FDA required one in 2010.
The question before the Court
When a drug company says federal regulators would have rejected a warning the state wanted on the label, should a judge or a jury decide that?
Why it matters
This ruling affects thousands of drug-injury lawsuits nationwide by taking the preemption question away from juries and giving it to judges, who will apply a more demanding, uniform standard for when federal law shields a drug company from state failure-to-warn claims. That can make it harder for injured patients to get to a jury trial at all.
What changes now
The case returns to the Third Circuit, which must now apply the legal standard the Supreme Court laid out — judge decides preemption, using the "fully informed the FDA / FDA said no" test — rather than sending the question to a jury. The lower courts still need to determine whether Merck's evidence meets that standard, so the underlying lawsuits are not yet resolved.
What this does not decide
The Court did not decide whether Merck actually violated any state-law duty to warn, or whether Merck's preemption defense ultimately succeeds on these facts. It only decided who decides the preemption question (judges) and clarified what showing is required, leaving application to the lower court on remand.
Concurrences and dissents
Concurrence — Justice Thomas
Justice Thomas joined the majority but wrote separately to voice skepticism that 'physical impossibility' is even the right test for preemption, preferring a 'logical contradiction' approach rooted in the Supremacy Clause's original meaning. He argued that even under existing precedent, Merck's defense fails because Merck never identified any federal law—rather than mere agency musings or hypothetical rejections—that actually barred it from adding the warning.
Concurrence — Justice Alito
Justice Alito, joined by the Chief Justice and Justice Kavanaugh, agreed only that the preemption question is one of law for judges, not the majority's broader discussion. He argued the majority's account of the law was skewed for barely mentioning a 2007 statute requiring the FDA to initiate label changes on its own, and that its recitation of the facts was one-sided, omitting extensive FDA-Merck communications after 2009.
How the Court got there
The legal reasoning, step by step
- The Court explained that a drug company can only win an 'impossibility preemption' defense — meaning it was legally impossible to satisfy both federal and state law — by showing federal law actually barred it from adding any version of the required warning.
- To make that showing, the manufacturer must prove it fully informed the FDA of the reasons supporting the state-law warning and that the FDA specifically told the manufacturer it would not approve adding that warning.
- The Court held this determination is a question of law for judges, not a factual question for juries, because it mainly requires interpreting what an FDA decision meant and whether it fits undisputed facts — work courts are better equipped to do than lay juries.
- The Court reasoned that judges are more experienced construing agency and other official documents and that treating the question as legal promotes more consistent outcomes across different courts facing similar FDA records.
- The Court acknowledged that some underlying factual disputes, such as what information a manufacturer actually gave the FDA, may still need resolving, but treated those as subsidiary facts folded into the judge's legal analysis rather than issues for a jury.
Doctrinal impact
Cases affected by this decision
Reaffirms Wyeth v. Levine (555 U. S. 555)
The Court kept Wyeth's 'clear evidence' preemption rule but clarified it is a legal test for judges, not a factual standard for juries.