Merck Sharp & Dohme Corp. v. Albrecht
139 S. Ct. 1668
| SCOTUS | 2019Background
- Merck manufactured Fosamax, a bisphosphonate approved by the FDA in 1995 to treat/prevent osteoporosis; its original label did not warn of "atypical femoral fractures."
- Postapproval adverse reports and literature suggested a possible causal link between long-term Fosamax use and atypical femoral fractures; Merck and the FDA debated label changes from about 2008–2011.
- In 2008 Merck submitted a Prior Approval Supplement proposing language for both the Adverse Reactions and Precautions/Warnings sections; FDA approved the Adverse Reactions change but rejected Merck’s proposed Precautions language as inadequate.
- Merck withdrew the PAS and used the CBE process to change Adverse Reactions but did not add the Precautions warning; the FDA ultimately required explicit atypical femoral fracture warnings in 2011.
- Over 500 plaintiffs (respondents) sued Merck in state tort actions alleging failure to warn; Merck defended on impossibility preemption grounds, claiming the FDA would have prevented the state-law-required label change.
- District Court granted summary judgment for Merck on preemption; Third Circuit reversed and held (1) the jury must decide whether FDA would have rejected a labeling change and (2) "clear evidence" is a high-probability factual standard. The Supreme Court granted certiorari.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the question whether FDA would have disapproved a proposed label change is a question for judge or jury | Plaintiffs: preemption turns on factual disputes about what FDA would have done; jury should decide disputed facts | Merck: preemption is a legal impossibility question; judge should decide as a matter of law | Court: legal question for judge (with subsidiary factual findings by judge as needed) |
| What constitutes the "clear evidence" standard from Wyeth | Plaintiffs: Wyeth requires a high factual showing the FDA would have rejected the change; courts/juries should apply an evidentiary standard | Merck: "clear evidence" means the manufacturer must show the FDA would have prohibited the change; judge applies law | Court: "clear evidence" is not an evidentiary label (preponderance/clear-and-convincing); judge must determine whether federal and state law irreconcilably conflict by assessing whether manufacturer fully informed FDA and FDA affirmatively disapproved the change |
| Whether Merck established impossibility preemption here | Plaintiffs: Merck failed to show it fully informed FDA of the state-law-justified warning and that FDA affirmatively would have forbidden it | Merck: FDA communications and prior rejection of Merck’s PAS indicate FDA would have rejected any CBE adding the warning | Court: Remanded—preemption is a judicial legal determination; Merck must show it fully informed FDA and FDA in turn informed Merck it would not approve the change (district/court of appeals must apply standard) |
| Proper scope of agency actions that can preempt state law | Plaintiffs: only final agency actions with force of law can preempt state tort duties | Merck: informal agency statements and correspondence can show FDA disapproval | Court: only agency actions taken pursuant to congressionally delegated authority and carrying legal force can establish preemption; tentative/interlocutory agency communications are insufficient alone |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (state-law failure-to-warn claims not preempted absent "clear evidence" FDA would have rejected the change)
- Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) (impossibility preemption occurs when compliance with both federal and state requirements is impossible)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (possibility of impossibility is insufficient; must compare federal and state duties)
- Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996) (judges, not juries, interpret written instruments; analogy for judge-decided legal questions involving agency terms)
- Rice v. Norman Williams Co., 458 U.S. 654 (1982) (preemption requires irreconcilable conflict; hypothetical or potential conflict insufficient)
- Bennett v. Spear, 520 U.S. 154 (1997) (distinguishing final agency action from tentative/interlocutory communications)