Right before their term ended, the Supreme Court of the United States issued a ruling in Merck Sharp & Dohme Corp. v. Albrecht et al., regarding state failure-to-warn claims and whether they should be pre-empted by federal law. The unanimous SCOTUS ruling centers around a class of more than 500 individuals who previously took the osteoporosis drug Fosamax and suffered atypical femoral fractures from 1999 to 2010. The individuals sued Merck under state law that imposed a duty by Merck to warn the patients and their doctors about the risk of fractures. Merck defended the case, arguing that the state failure-to-warn claims should be dismissed because they are pre-empted by federal law.
In its defense, Merck noted that it had proposed adding a warning to the drug’s label related to the risk of stress fractures, but that the United States Food and Drug Administration (FDA) rejected the proposal because the company’s use of “stress fractures” may have been considered a more minor type of fracture than what some patients experienced and what was being reported in the literature. It wasn’t until 2011 a warning about “atypical femoral fractures” appeared on the Fosamax label.
The District Court agreed with Merck’s pre-emption argument and granted summary judgment to the company, but the Third Circuit vacated the summary judgment and remanded the case back to the District Court. The Court of Appeals recognized that pre-emption analysis is controlled by Wyeth v. Levine, which held that a state failure-to-warn claim is not pre-empted when there is “clear evidence” that the FDA would not have approved a change to the label. The Court of Appeals suggested that the “clear evidence” standard led to varying applications and a clarification by SCOTUS may help lower courts be more consistent.
SCOTUS found that judges – not juries – are better able to evaluate the nature and scope of an agency’s determination. Furthermore, “[w]hile contested brute facts will sometimes prove relevant to a court’s legal determination about the meaning and effect of an agency decision, such factual questions are subsumed within an already tightly circumscribed legal analysis and do not warrant submission alone or together with the larger pre-emption question to a jury.”
In addition to finding that the question of pre-emption should be decided by a judge, SCOTUS also held that “clear evidence” should be defined as “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.”
In a concurring opinion, Justice Clarence Thomas noted that the FDA’s response letter related to Merck’s prior approval supplement application to add certain language regarding fractures to the Adverse Reactions and the Warnings and Precautions sections of Fosamax’s label “was not a final agency action with the force of law, so it cannot be ‘Law’ with pre-emptive effect. Merck’s argument that the 2009 letter and other agency communications suggest that the FDA would have denied a future labeling change fares no better: hypothetical agency action is not ‘Law.’”
Thomas went on to note that Merck added atypical femoral fractures to the Adverse Reactions section through the FDA’s “changes being effected” process, which also could have enabled Merck to add language to the Warnings and Precautions section. Had Merck opted to take that action, “it could have satisfied its federal and alleged state-law duties—meaning that it was possible for Merck to independently satisfy both sets of duties.”