Key Takeaways
The Fosamax cert petition presents the U.S. Supreme Court with an opportunity to clarify whether state-law failure-to-warn claims can proceed against a pharmaceutical manufacturer where the manufacturer informed FDA of the alleged risk and FDA formally denied a request to add a warning about the risk to the drug’s label.
Six years after the U.S. Supreme Court last addressed impossibility preemption in prescription drug failure-to-warn cases, it is being called on to clarify the contours of the doctrine in the same MDL, In re Fosamax. See Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019).
On remand, the district court granted summary judgment, finding claims that the labeling for Fosamax should have warned of certain atypical femoral fractures were preempted under Albrecht’s two-part test. The test requires a showing that: (1) the manufacturer fully disclosed to FDA the reasons supporting the warning, and (2) FDA informed the manufacturer it would not approve adding the warning to the label. Id. at 303. Following briefing covered in a previous edition of Re:Torts, the Third Circuit reversed, holding preemption is appropriate only where the record “is abundantly clear that it is impossible for a manufacturer to comply with both federal and state law.” In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., 118 F.4th 322, 356 (3d Cir. 2024). Merck has now filed a petition for a writ of certiorari, seeking guidance on how FDA labeling decisions should be evaluated under the second step of Albrecht. Petition, Merck Sharp & Dohme Corp. v. Albrecht, No. 24-977 (“Pet.”).
By requiring any ambiguity in an FDA labeling response letter to be resolved “in a manner that disfavors pre-emption,” In re Fosamax, 118 F.4th at 355, Merck argues the Third Circuit applied a novel “heavy Albrecht presumption” evidentiary standard “that would leave a jury no choice but to find that the manufacturer could not have secured FDA approval for a label change,” Pet. 14.
Merck and its amici highlight concerns that allowing state-law claims to proceed after the FDA has explicitly rejected the label change at issue will “undermine the FDA’s cooperative regulatory process, increase drug costs, or trigger a flood of counterproductive overwarning.” See Pet. at 32. They also point to the potential for the “heavy Albrecht” standard to encourage plaintiffs to both second-guess regulatory decisions and engage in forum shopping.
Merck’s petition asks the Court to address whether a pharmaceutical manufacturer may be held liable for failure to warn of a risk even after it asked FDA to approve a warning and FDA denied the request without mandating any alternative warning. Plaintiffs’ response, filed on May 12, argues that the Third Circuit correctly held that FDA’s “ambiguous” rejection of proposed warning language did not prohibit the submission of additional warnings under Albrecht. Resp. 12. Merck’s reply was filed May 23. The Court may issue a decision on cert as early as June 2025.
