Merck v. Albrecht: Impossibility Preemption Defense as a Question of Law and Guidance on the “Clear Evidence” Standard.
A decade ago in Wyeth v. Levine, the Supreme Court held that drug manufacturers, when faced with state tort suits alleging failure to warn, had to produce “clear evidence” that the FDA would have rejected any additional warning required by state law to succeed on the affirmative defense of impossibility preemption. 555 U.S. 555 (2009). Responding to a call for guidance on the “clear evidence” standard by the Third Circuit, the Supreme Court granted certiorari in Merck v. Albrecht. 587 U.S. ___, 139 S.Ct. 1668, 1676 (2019).
In Albrecht, the Court held that “clear evidence” is “evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” Id. at 1672. The Supreme Court held that this inquiry requires a judge to “simply ask himself or herself whether the relevant federal and state laws ‘irreconcilably conflict.’” Albrecht, 139 S.Ct. at 1679. The Court also clarified that preemption is solely “a question for the judge to decide, not a jury.” Id. at 1672.
The impossibility preemption defense arose in Albrecht in the context of the FDA-approved pharmaceutical, Fosamax, a prescription drug meant to prevent and to treat osteoporosis in postmenopausal women. Fosamax nevertheless increased the risk of certain types of bone fractures. Id. at 1673. The FDA, however, did not require the original Fosamax label (approved in 1995) to include a warning of that theoretical risk, even though Merck brought those considerations to the FDA’s attention, pre- and post-approval. As the science developed, in 2011, the FDA required the Fosamax label to warn about atypical femoral fractures. The respondents in Albrecht were individuals who took Fosamax and developed such a fracture in the interim and sued Merck for failing to warn them of the risk.
In the lower court, Merck moved for summary judgment on federal preemption grounds, which the court granted. The court concluded that the FDA’s rejection of Merck’s 2008 Prior Approval Supplement (PAS), regarding a warning about the risk of “stress fractures,” constituted “clear evidence” federal law prevented Merck from complying with a state-law duty to warn of the atypical femoral fracture. See id. at 1675. The Third Circuit declined to follow the trial court’s “clear evidence” conclusion and ruled that whether the FDA would have rejected an additional warning was a question of fact for the jury. Id. at 1676.
The Supreme Court granted Merck’s cert petition in view of a Circuit split “concerning the application of Wyeth.” Id. The majority, led by Justice Breyer, stated that even though the FDA has the authority to order manufacturers to amend product labels, the manufacturers bear the ultimate responsibility to provide a warning that adequately describes a known risk connected with a particular drug. Id. at 1677. Justice Breyer also found that judges are better positioned than juries to apply legal skills to undisputed facts, to make rulings on the nature and scope of an agency’s determination, and to understand and interpret agency decisions in the context of complicated statutory and regulatory law. Id. at 1679-80. Moreover, Breyer concluded that some relevant “contested brute facts” would be properly “subsumed within an already tightly circumscribed legal analysis” that would not warrant submission to a jury for fact-finding. Id. Notably, the Court refused to address what disapproval methods by the FDA constitute a final agency action carrying preemptive effect—a determination left to the lower courts on remand. Id. at 1679.
In a concurring opinion, Justice Alito (joined by Justices Roberts and Kavanaugh) criticized the majority opinion as “misleading,” noting that the FDA does not only have the authority to order manufacturers to amend labels, but, pursuant to 21 USC Section 355(o)(4)(A), it has the duty to do so when “the Secretary becomes aware of new [material] information.” Id. at 1684 (Alito, J., concurring); see also 21 U.S.C. § 355. Although generally agreeing with the Court’s new definition of “clear evidence,” the FDA’s duty, Justice Alito wrote, would alter the “clear evidence” analysis because any decision by the FDA declining an additional warning could logically be seen as a final determination that the label change was unjustified. Albrecht, 139 S.Ct. at 1684-85. According to Justice Alito, the FDA’s duty applies regardless of whether the particular manufacturer informs the FDA of the justifications for a warning mandated by state law or whether the FDA communicates to the drug manufacturer that the label change would not be approved. Id.
In another concurring opinion, Justice Thomas concluded that the FDA’s letter responding to Merck’s 2008 PAS did not constitute a final agency action with preemptive effect. Id. at 1683. Although Justice Thomas gave a narrower definition to finality in agency actions, he would expand the scope of preemption to any state law that logically contradicts federal law, even if it is theoretically possible to comply with both. Id. at 1681.
Irrespective of the final arbiter of a label’s propriety, the Court’s new guidance on what constitutes “clear evidence” does not appear to lower the bar for establishing the defense. The Court’s decision in Albrecht re-affirms its view set forth a decade ago in Wyeth that “[i]mpossibility preemption is a demanding defense.” Id. at 1678.