Merck Sharp & Dohme Corp. v. Albrecht
587 U.S. 299
SCOTUS2019Background
- Fosamax (alendronate), a Merck bisphosphonate, was FDA‑approved in 1995; the original label did not warn of "atypical femoral fractures."
- Post‑approval reports and literature suggested a possible causal link between long‑term Fosamax use and rare atypical femoral fractures; Merck received adverse event reports and internal concern documents.
- In 2008 Merck sought FDA approval to add language referencing "low‑energy femoral shaft"/"stress fractures"; FDA approved an Adverse Reactions change but rejected proposed Precautions language as inadequately justified.
- Merck withdrew its PAS, later used the CBE process to update Adverse Reactions but did not add the Precautions language; in 2011 FDA ordered a Warnings/Precautions change expressly referencing "atypical femoral fractures."
- Over 500 plaintiffs who suffered atypical femoral fractures between 1999–2010 sued Merck under state failure‑to‑warn law; Merck asserted federal impossibility preemption because the FDA would have rejected a state‑required label change.
- District Court granted summary judgment for Merck on preemption; Third Circuit vacated and treated "clear evidence"/disapproval as a factual question for a jury; Supreme Court granted certiorari.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state failure‑to‑warn claims are preempted when federal law would have forbidden the state‑required label change | State law required Merck to warn of atypical femoral fractures; no final FDA action prohibited such a warning, so no preemption | Federal law preempts because FDA would have rejected any attempt to add the warning (based on prior FDA communications and 2009 rejection) | Preemption available only upon "clear evidence" that FDA would have forbidden the change; that requires showing Merck fully informed FDA of the justifications and FDA affirmatively informed Merck it would not approve the change |
| What constitutes "clear evidence" that the FDA would not have approved a label change | (Respondents) Wyeth protects state tort remedies absent clear proof of FDA disapproval; plaintiffs need not prove administrative records | (Merck) "Clear evidence" can be shown by FDA rejections and communications indicating likely disapproval | "Clear evidence" means the manufacturer fully informed FDA of the justifications for the warning and the FDA in turn informed the manufacturer it would not approve the label change (agency actions with force of law) |
| Whether the question of agency disapproval is for judge or jury | Plaintiffs: factual question (what FDA would have done) for jury | Merck: factual determination also appropriate for judge? (argued preemption at summary judgment) | Court: question is primarily one of law for the judge, though subsidiary factual disputes (e.g., what was submitted to FDA) are resolved by the judge as part of the legal inquiry |
| What agency actions can preempt state law | Plaintiffs: only final agency actions with force of law preempt | Defendant: communications and prior rejections suffice to show impossibility | Only agency actions taken pursuant to congressionally delegated authority and carrying legal force (e.g., formal rejection, rulemaking, orders) can establish preemption; informal musings do not suffice |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (state failure‑to‑warn claims not preempted absent clear evidence FDA would have forbidden label change)
- Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) (impossibility preemption when it is impossible to comply with both federal and state requirements)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (possibility of impossibility is insufficient; narrow standards for impossibility preemption)
- New York v. FERC, 535 U.S. 1 (2002) (agency preemption only when acting within congressionally delegated authority)
- Rice v. Norman Williams Co., 458 U.S. 654 (1982) (preemption requires irreconcilable conflict between federal and state law)
- Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996) (construction of written instruments and interpretation of agency actions is a legal task for judges)
- Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U.S. 318 (2015) (courts may resolve subsidiary factual disputes when deciding predominantly legal questions)
- Bennett v. Spear, 520 U.S. 154 (1997) (distinguishing final agency action from tentative or interlocutory communications)