United States: Supreme Court Rules That Judges Must Decide Preemption Of Failure-To-Warn Claims

On May 20, 2019, the Supreme Court of the United States issued a rare unanimous decision in Merck Sharp & Dohme Corp. v. Albrecht, et al., holding that judges, not juries, must decide whether state law failure-to-warn claims against brand-name drug manufacturers are preempted by the FDA’s labeling regulations. In so holding, the Court further clarified the preemption standard set forth in an earlier decision, Wyeth v. Levine, concluding that such claims are preempted where a drug manufacturer can show “that it 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 changing the drug’s label to include that warning.”


Merck’s case arose out of allegations that Fosamax, a drug for the treatment and prevention of osteoporosis, led to femur fractures and similar injuries in patients, and that Merck had failed to adequately warn of those potential risks.  

Merck argued that the patients’ failure-to-warn claims were preempted because the FDA had previously rejected its proposed revision to the Fosamax label that would have warned prescribing physicians of the risk of femoral fractures. Ultimately, the United States District Court for the District of New Jersey agreed and dismissed the claims of several hundred plaintiffs as preempted by the FDA’s refusal to accept Merck’s proposed label change.

On appeal, the Third Circuit Court of Appeals reversed, finding there was not “clear evidence” that the FDA’s rejection of Merck’s proposed label change foreclosed Merck from suggesting to the FDA a differently worded modification to its Fosamax labeling. The Third Circuit also went a step further. It held that whether “clear evidence” exists of the FDA’s rejection of a manufacturer’s proposed label change is a question for a jury, not a judge, to decide. This ruling, which had the effect of reinstating the dismissed cases, was appealed to the Supreme Court, which granted certiorari to decide these important issues.

In the Supreme Court

Justice Breyer authored the Court’s opinion, joined by the unexpected coalition of Justices Thomas, Ginsburg, Sotomayor, Kagan and Gorsuch. Justices Alito and Thomas concurred in separate opinions, with Chief Justice Roberts and Justice Kavanaugh joining Justice Alito’s opinion. The Court’s decision reversed the Third Circuit, reasoning, “We stated 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 state law requires. We here decide that a judge, not the jury, must decide the pre-emption question.”  

The reasons given for this conclusion were relatively straightforward. First, “The question [of preemption] often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute,” and, to the extent any facts are disputed, “these factual questions [are] subsumed within an already tightly circumscribed legal analysis.” Second, “judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination” due to their experience in the “construction of written instruments,” as well as their understanding of “agency decisions in light of the governing statutory and regulatory context” and “principles of administrative law.”

Although the Third Circuit had opined that Wyeth’s “clear evidence” standard is often viewed as an evidentiary hurdle for litigants—surpassing the preponderance-of-the-evidence standard typically applied in civil cases, but less demanding than the beyond-a-reasonable-doubt standard in criminal cases—the Supreme Court found, in the context of a preemption analysis, that this determination is one of law for the trial court to decide, and not a factual matter appropriate for a jury. In eschewing any further elaboration on Wyeth’s “clear evidence” formulation, the Court explained, “We do not further define Wyeth’s use of the words ‘clear evidence’ in terms of evidentiary standards, such as ‘preponderance of the evidence’ or ‘clear and convincing evidence’ and so forth, because… courts should treat the critical question not as a matter of fact for a jury but as a matter of law for the judge to decide. And where that is so, the judge must simply ask himself or herself whether the relevant federal and state laws irreconcilably conflict.”

Practical Implications of the Court’s Decision

While the Albrecht decision brings much-needed clarity to the brand drug preemption analysis first articulated in Wyeth v. Levine, it does not significantly expand the scope or application of that doctrine, as many in the pharmaceutical industry had hoped; in fact, it may have narrowed the range of preemptable cases. The decision reiterates that, for federal preemption to apply, the burden remains on drug manufacturers to fully inform the FDA of the justification for the strengthened warning purportedly required by state law. The FDA must, in turn, inform the manufacturer that it does not approve “that warning.” From a public policy standpoint, it is helpful that the Supreme Court’s decision encourages drug companies to make fulsome disclosures to the FDA supporting a label change consistent with state law requirements. However, it remains to be seen if products liability plaintiffs’ counsel may now seek to utilize the Court’s preemption requirements to argue that state law required a label change more stringent than those proposed by a manufacturer to the FDA. Ultimately, however, the trial court—applying state law, a careful consideration of the relevant evidence and good science to this determination—will likely reach the right and just result in such cases.

Drug manufacturers are encouraged to consult their products liability counsel for a further discussion of the issues addressed in this Alert.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.

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