Unanimous decision of the U.S. Supreme Court confirming its 2009 decision in Wyeth v. Levine that state law “failure to warn” claims are pre-empted by the Federal Food, Drug, and Cosmetic Act and related labeling regulations when there is “clear evidence” that the FDA would not have approved the warning required by the state law. The Supreme Court also found that as a matter of law, a judge, and not a jury, is the appropriate party to determine a pre-emption claim.
Respondents who took Merck’s Fosamax drug to treat and prevent osteoporosis between 1999 and 2010 sued Merck for damages alleging that state “failure to warn” laws imposed a legal duty on Merck to warn respondents and their doctors about the risk of atypical femoral fractures associated with the drug’s use. Merck’s defense alleged that state failure-to-warn laws were pre-empted by FDA law and that the FDA’s rejection of Merck’s attempt in 2008 to add a warning of “stress fractures” demonstrated that the FDA would also have rejected any attempt by Merck to warn of the risk of atypical femoral fractures associated with the drug.
The district court agreed with Merck’s pre-emption argument and granted summary judgment to Merck. The Third Circuit Court of Appeals vacated and remanded, concluding that the Supreme Court opinion in Wyeth v. Levine controlled state law failure-to-warn claims when there is “clear evidence” that the FDA would not have approved a label change. The Third Circuit noted that the clear-evidence standard had led to varying lower-court applications and requested that the Supreme Court clarify the doctrine.
Merck’s osteoporosis drug Fosamax was approved in 1995 and contained no risk warning for atypical femoral fractures. In 2008, after receiving adverse event reports indicating that long-term Fosamax users were suffering atypical femoral fractures, and after reviewing scholarly articles and case studies, Merck applied to the FDA for preapproval to add “low-energy femoral shaft fracture” to the Adverse Reactions section of the Fosamax label and to cross-reference a discussion in the Precautions section that focused on the risk of stress fractures associated with Fosamax. The FDA approved the proposed change to the Adverse Reactions section, but rejected the proposal to cross-reference to the Precautions section, indicating that Merck’s justification for the change to the Precautions section was inadequate. Merck withdrew the application and made the change to the Adverse Reactions section through the “Changes Being Effected” (CBE) process set forth in FDA regulations.
Based on its own analyses, the FDA subsequently ordered Merck to add a warning about “atypical femoral fractures” to the Fosamax label. Merck disagreed with the FDA and proposed language referring to the risk of “stress fractures.” The FDA rejected that language, and ultimately, in 2011, Merck and the FDA agreed to the addition of a discussion of atypical femoral fractures in the Warnings and Precautions section of the label. The label does not include reference to “stress fractures.”
In the Merck opinion, the Supreme Court reviewed its decision in Wyeth. In Wyeth, the Court rejected Wyeth’s argument that state failure-to-warn claims were pre-empted by federal law. The Court noted that (i) Congress had not intended FDA oversight to be the exclusive means of ensuring drug safety, (ii) manufacturers must provide adequate labeling and warnings as to drug risks and (iii) manufacturers bear ultimate responsibility for updating their labels prior to obtaining FDA approval. In finding against Wyeth, the Court concluded that the company had a duty under state law to provide a warning that adequately described the risks associated with its product and could have done so using the CBE regulation before receiving FDA approval.
The Court in Merck assumed there was sufficient evidence to find that Merck violated state law by failing to add a warning about atypical femoral fractures to the Fosamax label. However, the Court noted that Merck would need to demonstrate it had fully informed the FDA of the justifications for the warning required by state law, and that the FDA had informed Merck that the FDA would not approve changing the drug’s label to include the warning. The Court explained that this determination is not a fact finding for the jury, but rather a matter of law for a judge to decide.
The Supreme Court vacated the judgment of the Third Circuit and remanded the case for further proceedings consistent with its opinion.