Oral argument was held on Monday in Merck v. Albrecht (In re Fosamax) at the United States Supreme Court. The bulk of the argument focused on the specific language in Merck's proposed labeling change and the wording and scope of the FDA's Complete Response Letter rejecting that proposed change.
None of the justices indicated a desire to upset the Wyeth v. Levine framework – rather, it seems likely that the Supreme Court will issue a decision applying Wyeth to the particular facts of this case. The argument suggested that reversal is likely, but that the vote will be close, and the decision will likely be narrow.
It appears from the questioning that Merck has at least four votes for reversal, at least on the narrow facts presented in this case. Justice Samuel A. Alito, who un-recused himself at the merits stage, appeared the most vocal in favor of preemption. Justice Neil M. Gorsuch, Justice Stephen G. Breyer and Chief Justice John Roberts appeared to be leaning in Merck's direction, but each had concerns about how a pro-preemption ruling might create what Justice Gorsuch called a "moral hazard" by providing an incentive to manufacturers to flood the FDA with data, draft "inartful" labels to delay warnings or fail to disclose to FDA data of adverse outcomes. In light of those concerns, any decision reversing may be crafted narrowly to avoid creating obvious loopholes.
A potential fifth vote for Merck would have to come from either Justice Brett M. Kavanaugh or Justice Clarence Thomas, neither of whom provided much content for augury. Justice Kavanaugh posed a single question; asking Merck's counsel whether the company would lose if the Court read the FDA's Complete Decision Letter to pertain only to stress fractures, as that term was understood by prescribers. That question may reveal that Justice Kavanaugh has some skepticism that the FDA's letter effectively barred Merck from changing the label to address atypical femoral fractures. He may be satisfied, however, by Merck's argument that its submission to FDA defined "stress fractures" to encompass the atypical femoral fracture risk. Justice Thomas, per his usual practice, asked no questions during argument. In the past, Justice Thomas has interpreted implied preemption more narrowly than the other conservative justices.
Justice Elena Kagan's questioning suggests that she is likely a vote on the plaintiffs' side. Justice Kagan appeared particularly concerned about how the court may interpret what the FDA intended when it rejected Merck's proposed label change. She expressed doubt that a court should speculate about whether FDA fully considered similar or related risks not expressly addressed by the FDA. Rather, Justice Kagan suggested that she would not find preemption unless the FDA's decision made apparent that it considered the specific risk in question and found insufficient evidence to support the proposed label change. Nonetheless, Justice Kagan did not foreclose the possibility that she would find that the factual record in this case met that more stringent standard.
Justice Sonia Sotomayor appeared almost certainly a vote against preemption and will likely vote to affirm. Justice Sotomayor indicated that she viewed any ambiguity in the agency action as foreclosing a preemption defense. Justice Ruth Bader Ginsburg was absent, but the Chief Justice stated that she will participate in the ultimate decision. If past decisions are any indication, she is likely to be in the anti-preemption camp.
Although the argument did not focus on this question, the majority of justices appeared poised to view the preemptive effect of a Complete Response Letter as a legal question decided by a judge, rather than a factual question decided by a jury. We therefore predict that a broad coalition of justices would agree that the Third Circuit was incorrect on this procedural issue.
The plaintiffs did not dispute that point. Plaintiffs instead argued the Third Circuit's judgment could be affirmed without deciding that issue because, in their view, the absence of preemption can be found a matter of law.
Finally, neither the Court nor the litigants focused on the standard of proof for preemption under Wyeth. The Third Circuit interpreted Wyeth to require proof by "clear and convincing" evidence that the FDA would have rejected a proposed or modified label.
Manufacturers and the Solicitor General have disagreed, and argue that preemption should be decided under the normal "preponderance of the evidence standard" for civil cases. If the Court agrees that preemption is a legal question, this final issue may be moot.
Learn more about the implications of this case by contacting any of the authors.