The U.S. Supreme Court's recent decision in Merck Sharpe & Dohme Corp. v. Albrecht, confirms that in all but exceptional circumstances, consumers can still recover after being injured by brand-name prescription drugs, and that preemption remains a “demanding defense.” __ U.S. __ (2019) (slip op. 13). In so ruling, however, the majority of the court added a new wrinkle to deciding preemption cases with its conclusion that judges, not juries, should decide whether federal drug regulation preempts state-law tort claims.

In the 9-0 decision, the Supreme Court vacated a decision by the Third Circuit that had revived 500 claims brought by plaintiffs who took Merck's brand-name drug Fosamax and suffered atypical femoral fractures between 1999 and 2010. The court's Merck decision did not reach the merits of whether the plaintiffs' claims were preempted by federal law; it only held that judges should make such determinations, and not juries. Id. at __ (slip op. 1). In coming to this conclusion, the majority opinion stressed the virtue of having judges determine such questions, which, as the majority explained, should lead to greater uniformity among courts. The decision itself, however, suggests that leaving the decision to judges and not juries is unlikely to lead to the uniformity hoped for, considering that the two concurring opinions came to the opposite conclusions on the merits of the matter.

Each of the plaintiffs in Merck brought state-law tort claims alleging that Merck failed to add an adequate warning of the risk of atypical femoral fractures to Fosamax's FDA-approved drug label. Despite the defense verdict in a bellwether trial, the district court issued an opinion finding that the bellwether plaintiff's failure-to-warn claim was preempted by federal law, which it later extended to all plaintiffs. In re Fosamax, MDL No. 2243, 2014 U.S. Dist. LEXIS 42253, *10, 47 (D.N.J. Mar. 26, 2016).

In deciding that federal law preempted the plaintiffs' failure-to-warn claims, the district court observed that, under the Supreme Court's decision in Wyeth v. Levine, 555 U.S. 555 (2009), the issue “was whether clear evidence existed that the FDA would not have approved a stronger warning to the Fosamax label, thereby warranting preemption[.]” Fosamax, 2014 U.S. Dist. LEXIS 42253, *19. The district court found that, under this standard, the FDA would not have approved a stronger warning and thus dismissed the plaintiffs' claims. Id. at *20.

The Third Circuit, however, construed the term “clear evidence” as denoting “a standard of proof,” which goes to “how difficult it will be for [a] manufacturer to convince the factfinder that the FDA would have rejected a proposed label change.” In re Fosamax Alendronate Sodium Prods. Liab. Litig., 852 F.3d 268, 285 (3d Cir. 2017). Proceeding from there, the Third Circuit held that “the question of whether the FDA would have rejected a proposed label change is a question of fact that must be answered by a jury.” Id. at 286.

But the Supreme Court adopted a different view: it held instead that preemption is for a judge to decide, not a jury. Merck, 587 U.S. at __ (slip op. 1). In so concluding, the majority explained that treating preemption “as a legal question for judges makes sense given the fact that judges are normally familiar with principles of administrative law” and that having judges decide the issue “should produce greater uniformity among courts.” Id. at __ (slip op. 16). Indeed, as the majority explained, “judges, rather than lay juries, are better equipped to evaluate the nature of the scope of an agency's determination.” Id.

Of course, there is some appeal to this rationale. But is it empirically true? The two concurring opinions suggest—and indeed, show—otherwise.

Justice Thomas, writing alone, reasoned in a concurring opinion that under the Supreme Court's “impossibility precedents, Merck's preemption defense fails.” Id. at __ (Thomas, J., concurring) (slip op. 1). Justice Thomas first notes there are two ways in which a manufacturer could satisfy its obligation of “ensuring that its warnings remain adequate as long as the drug is on the market.” Id. at __ (slip op. 3). The manufacturer could submit a Prior Approval Supplement (PAS) application, which requires FDA approval before the changes are made. Id. at __ (slip op. 3) (citing 21 CFR §314.70(b)). Or it could use the Changes Being  Effected (CBE) regulation to change the warning label immediately without prior approval. Id. at __ (slip op. 3-4) (citing 21 CFR §314.70(c)(6)(iii)). Proceeding from this, he then concludes that “Merck's impossibility pre-emption defense fails because it does not identify any federal law that 'prohibited [it] from adding any and all warnings … that would satisfy state law.” Id. at __ (slip op. 4). Justice Thomas does not end there though. After noting Merck's argument that the “FDA would have rejected a hypothetical labeling change submitted via the CBE process[,]” he concludes that “neither agency musings nor hypothetical future rejections constitute pre-emptive 'Laws' under the Supremacy Clause.” Id.

Justice Alito, on the other hand, in a concurring opinion joined by Chief Justice Roberts and Justice Kavanaugh, revealed a different perspective from Justice Thomas. Id. at __ (Alito, J., concurring) (slip op. 1). Tellingly, in what should be a red flag over the uniformity argument, Justice Alito began his concurring opinion noting his concern that the majority opinion's “discussion of the law and the facts may be misleading[.]” Id.

While Justice Thomas emphasizes that Merck could have resubmitted its PAS applications, sought a hearing, or changed its label at any time through the CBE process, Justice Alito instead focuses on the “extensive communication” between Merck and the FDA. For example, Justice Alito notes that while Merck's 2008 application was pending, an FDA official allegedly told a Merck employee that “more time will be need[ed] for the FDA to formulate a formal opinion.” Id. at __ (slip op. 4). Justice Alito also points to an email from the FDA that allegedly said that it would “close out” Merck's application if Merck “agree[d] to hold off on the [Precautions] language at this time.” Id. Then, as Justice Alito observed, in March 2010, the FDA issued a Safety Announcement that reported that “the data that the FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.” Id. at __ (slip op. 5). From this all, Justice Alito concludes that “for years the FDA was: aware of this issue, communicating with drug manufacturers, studying all relevant information, and instructing healthcare professionals and patients alike to continue to use Fosamax as directed.” Id. at __ (slip op. 6).

Is this clear evidence? Justice Alito arguably ignores, as the majority opinion explained, that for impossibility preemption to apply, the manufacturer must show that it “fully informed the FDA of the justifications for the warning” and that the FDA “informed the drug manufacturer that [it] would not approve changing the drug's label to include that warning.” Id. at __ (Breyer, J.) (slip op. 13). And that is not a bar Merck could clear, given that the FDA had explained that “Merck's 'justification' for the proposed change to the Precautions section was 'inadequate,' because '[i]dentification of “stress fractures” may not be clearly related to the atypical subtrochanteric fractures that have been reported in the literature.'” Id. at __ (slip op. 6). The FDA also invited Merck to “resubmit” its application. Id. Yet Merck did not. Instead, it withdrew its application and changed the Adverse Reactions section through the CBE process. But it “made no changes” to the Precautions section. Id.

So, in holding that judges should decide questions of preemption even where there are contested issues of fact, the Merck decision itself casts doubt on the presumption that judges, rather than juries, can better resolve such complicated issues given the conflicting perspectives shared by the nine Justices here. And while it is still too early to tell how this will all play out on remand and in other cases applying the holding, it does raise a practical question: how should judges make factual determinations in deciding preemption? Should there be a mini-trial where testimony is offered subject to cross-examination, or will courts decide the issue on the papers alone? Where credibility is an issue or proffered facts conflict, live testimony is indispensable to due process and fundamental fairness.

In the end, though, one thing remains clear from the Merck decision: state-law failure-to-warn claims are only preempted where there is clear evidence that the FDA would not have approved a change to a warning label. And, as the Merck majority explains, that is a high bar as the “possibility of impossibility [is] not enough.” Id. at __ (slip op. 13) (quoting PLIVA, Inc. v. Mensing, 564 U.S. 604, 625 n.8 (2011)).

Eric S. Pasternack is an associate with Cohen, Placitella & Roth in Red Bank. He focuses his practice on class action and environmental litigation.