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Merck Sharp & Dohme Corp. v. Albrecht

Supreme Court of the United States · 2019 · Civil Procedure

Civil ProcedureFederal PreemptionFDA Labelingpreemptionimpossibility preemptionfailure to warnFDAdrug labeling

Facts

Merck manufactured Fosamax, and the FDA-approved label originally did not warn of atypical femoral fractures. In 2008, Merck sought preapproval to add language referring to 'low-energy femoral shaft fracture' in Adverse Reactions and a longer Precautions discussion focused on 'stress fractures'; the FDA approved the Adverse Reactions addition but rejected the Precautions proposal as inadequately justified and invited resubmission. Merck withdrew the application, used the CBE process only for the Adverse Reactions change, and made no change to the Precautions section. Respondents, who took Fosamax between 1999 and 2010 and suffered atypical femoral fractures, claimed state law required a stronger warning, while Merck argued federal law preempted those claims because the FDA would not have approved the warning.

Issue

Whether, in a state-law failure-to-warn suit against a brand-name drug manufacturer, the question whether the FDA would have rejected a warning required by state law is a question for the judge or the jury. Also, what showing satisfies Wyeth's requirement of 'clear evidence' that the FDA would not have approved the warning.

Rule

The preemption question is for a judge, not a jury. In a case like this one, a drug manufacturer establishes Wyeth 'clear evidence' only by showing that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, acting pursuant to its congressionally delegated authority, informed the manufacturer that it would not approve a label change including that warning; the judge then asks whether federal and state law irreconcilably conflict.

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One of 10 multiple-choice questions for this case. Pick an answer to see why.

In Phoenix, Nora Kim sues Redwood Therapeutics over injuries allegedly caused by its brand-name arthritis drug. Redwood argues the claims are preempted because the FDA once reviewed the drug's label years earlier and did not require the stronger warning that Arizona law allegedly demanded, but Redwood never submitted the later studies and adverse-event analyses supporting that stronger warning to the FDA.

Which is the strongest argument against Redwood's impossibility-preemption defense?

Explanation. The manufacturer must show it fully informed the FDA of the justifications for the warning required by state law and that the FDA informed the manufacturer it would not approve that warning. If Redwood never submitted the later studies and analyses supporting the stronger warning, it cannot establish the kind of actual conflict required for impossibility preemption. The Court described this as a demanding defense and rejected reliance on speculation about what the FDA might have done. (Derived from Merck Sharp & Dohme Corp. v. Albrecht (1668).)