Merck Sharp & Dohme Corp. v. Albrecht
587 U.S. 299, 139 S. Ct. 1668 (2019)
Rule of Law:
The question of whether federal law pre-empts a state-law failure-to-warn claim is a question of law for a judge to decide, not a jury. To establish impossibility pre-emption, a drug manufacturer must show, through clear evidence, that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, explicitly informed the manufacturer that it would not approve a change to the drug's label to include that warning.
Facts:
- Merck Sharp & Dohme (Merck) manufactures Fosamax, a drug used to treat and prevent osteoporosis in postmenopausal women.
- Fosamax and other bisphosphonates work by slowing the breakdown of old bone cells, which can, in rare cases, increase the risk of atypical femoral fractures.
- The Fosamax label approved by the FDA in 1995 did not warn of the risk of atypical femoral fractures, despite Merck scientists' theoretical concerns during preapproval clinical trials.
- After 1995, Merck began receiving adverse event reports and observed scholarly articles documenting connections between long-term Fosamax use and atypical femoral fractures.
- In 2008, Merck applied to the FDA to change Fosamax's label to add language regarding 'low-energy femoral shaft fracture' in the Adverse Reactions section and a warning about 'stress fractures' in the Precautions section.
- The FDA approved the change to the Adverse Reactions section but rejected Merck's proposal for the Precautions section, stating Merck's justification was 'inadequate' and that 'stress fractures' might not be clearly related to the atypical subtrochanteric fractures reported.
- Merck subsequently withdrew its application for the Precautions section change and made no changes to that section at that time.
- A warning about 'atypical femoral fractures' did not appear on the Fosamax label until 2011, when the FDA ordered the change based on its own analyses, again rejecting Merck's proposed use of 'stress fracture' as misleading for serious atypical fractures.
- More than 500 individuals who took Fosamax and suffered atypical femoral fractures between 1999 and 2010 sued Merck, alleging state-law failure-to-warn claims.
- One respondent, 70 years old in 2009, took Fosamax for approximately 10 years, heard a popping sound while unlocking her front door, and her left leg suddenly gave out, requiring surgery to repair an atypical femoral fracture.
Procedural Posture:
- Respondents, individuals who suffered atypical femoral fractures after taking Fosamax, filed separate tort actions in federal court, invoking federal diversity jurisdiction, alleging state-law failure-to-warn claims against Merck Sharp & Dohme (Merck).
- Merck moved for summary judgment, arguing that the state-law failure-to-warn claims were pre-empted by federal law.
- The District Court for the District of New Jersey granted summary judgment in favor of Merck, agreeing with its pre-emption argument.
- The Court of Appeals for the Third Circuit vacated the District Court's judgment and remanded the case, holding that 'clear evidence' for pre-emption was a standard of proof for a jury to conclude that it was highly probable the FDA would have rejected a proposed label change, and this was a question of fact.
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Issue:
Does the question of whether federal law pre-empts a state-law failure-to-warn claim against a brand-name drug manufacturer, based on the FDA's rejection of a label change, present a question of fact for a jury or a question of law for a judge, and what constitutes 'clear evidence' for such pre-emption?
Opinions:
Majority - Justice Breyer
Yes, the question of impossibility pre-emption in a state-law failure-to-warn claim is a question of law for a judge, not a jury, and 'clear evidence' requires showing the manufacturer fully informed the FDA of the warning's justifications and the FDA explicitly informed the manufacturer it would not approve the change. The Court affirmed its holding in Wyeth v. Levine that state-law failure-to-warn claims are pre-empted only when there is “clear evidence” that the FDA would not have approved the warning state law required. The Court clarified that impossibility pre-emption is a demanding defense, and the federal Changes Being Effected (CBE) regulation generally permits manufacturers to unilaterally update labels to “add or strengthen a warning” with “newly acquired information” about a causal association, without prior FDA approval. Therefore, a drug manufacturer will not ordinarily be able to show an actual conflict. To establish 'clear evidence,' the manufacturer must demonstrate two things: (1) that it fully informed the FDA of the justifications for the warning required by state law, and (2) 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. The Court concluded that determining agency disapproval is a legal question for a judge, not a jury, because it involves the construction and interpretation of written instruments and agency decisions within a complex statutory and regulatory context, tasks for which judges are better equipped and which promote uniformity. Any subsidiary factual disputes relevant to this legal determination are to be resolved by the judge.
Concurring - Justice Thomas
Yes, the question of pre-emption is one of law for the judge, and Merck’s impossibility pre-emption defense fails under the Court’s precedents because no federal law prohibited the warning. Justice Thomas reiterated his skepticism regarding the 'physical impossibility' standard for pre-emption, favoring a 'logical contradiction' standard, but applied the Court’s existing framework. He emphasized that for pre-emption to occur, there must be a 'Law of the United States' that directly conflicts with state law. The FDA's 2009 'complete response' letter, which expressed concerns about Merck's proposed warning, was merely 'tentative or interlocutory' and not a final agency action with the force of law. He stressed that hypothetical agency rejections or informal agency communications do not constitute pre-emptive 'Laws.' Since Merck could have used the CBE process to add the warning at any time, it was possible to comply with both state and federal law, meaning no actual conflict existed. Therefore, Merck's defense failed because it could not point to any statute, regulation, or final agency action with the force of law that prohibited it from adding the state-law-required warnings.
Concurring in judgment - Justice Alito
Yes, the pre-emption question is one of law to be decided by the courts, not a question of fact for a jury. Justice Alito concurred in the judgment but expressed concern that the majority's opinion was misleading. He highlighted 21 U.S.C. § 355(o)(4)(A), enacted in 2007 (after the events in Wyeth), which obligates the FDA to initiate label changes if it becomes aware of new safety information that should be included. He argued that if the FDA declines to require a label change despite receiving and considering information about a new risk, it implies a determination that a label change was unjustified, and this action should be relevant to the pre-emption analysis. He noted that the 'clear evidence' phrase in Wyeth was a 'rhetorical flourish' and that the judge's task is simply to determine if state and federal laws 'irreconcilably conflict,' without applying evidentiary standards. He criticized the majority for not acknowledging the existence of the Prior Approval Supplement (PAS) process, which often requires prior FDA approval for label changes. He also contended that the majority's factual summary was one-sided, omitting details about extensive communications between Merck and the FDA and the FDA's ongoing safety review that, for years, did not find a 'clear connection' between Fosamax and atypical femoral fractures.
Analysis:
This decision significantly clarifies the high bar for brand-name drug manufacturers seeking to use impossibility pre-emption as a defense in state-law failure-to-warn cases. By firmly establishing the pre-emption inquiry as a question of law for judges and precisely defining the 'clear evidence' standard, the Court aims to ensure consistent application of federal drug labeling regulations across jurisdictions. The ruling reinforces the manufacturer's ongoing responsibility for the safety of its drug labels, even under FDA oversight, making it more challenging for them to shift liability by claiming the FDA implicitly prevented a warning. This approach is likely to limit successful pre-emption defenses, potentially increasing brand-name drug manufacturers' exposure to state tort claims.
