This blog has discussed Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019), and its progeny on multiple occasions. We provided a quick take when Albrecht was issued; discussed the decision’s possible ramifications here and here; expressed consternation at certain parts of the decision; reported here and here on how it is viewed by the plaintiffs’ bar; and analyzed cases applying Albrecht here, here, and here. And if that weren’t enough, Bexis has published an article on the decision.

Today, we provide a short report on a new law review article that takes a defense-friendly look at Albrecht and some of the open issues that survive it. The article is Victor E. Schwartz & Christopher E. Appel, Where’s the Beef?: A Guide to Judges on Preemption of State Tort Litigation Involving Branded Drugs, 89 U. Cin. L. Rev. 597 (2021).

The one true holding of Albrecht is that the “question of pre-emption is one for a judge to decide, not a jury.” Albrecht, 139 S. Ct. at 1672.

Everything else is dicta, but also where most of the action is.

Schwartz and Appel begin by recounting the Supreme Court’s recent pharmaceutical-preemption quadrilogy: Wyeth v. Levine, 555 U.S. 555 (2009); PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011); Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013); and, of course, Albrecht itself.

Central to their recounting is Wyeth’s holding that a failure-to-warn claim implicating a branded drug is not preempted “absent clear evidence that the FDA would not have approved” the labelling change purportedly required by state law. 555 U.S. at 571. That holding, say Schwartz and Appel, “is the predicate for the Court’s decision in Albrecht.” 89 U. Cin. L. Rev. at 599. Indeed, the decision addresses Wyeth’s “clear evidence” standard at the outset. It says—according to the Court, “holds”—that “‘clear evidence’ is evidence that shows the court that the drug manufacturer 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 a change to the drug’s label to include that warning.” Albrecht, 139 S. Ct. at 1672.

Having set the stage, Schwartz and Appel then turn to “a number of outstanding issues that will likely play out in lower courts in the wake of” Albrecht. 89 U. Cin. L. Rev. at 609.

That much remains to be decided was signaled by Albrecht itself, where “[t]wo concurring opinions offered widely divergent views on how lower courts might apply the ‘clear evidence’ exception.” 89 U. Cin. L. Rev. at 607. On the one hand, Schwartz and Appel note, Justice Thomas expressed the view that “preemption could only be obtainable where the FDA has issued a final ruling rejecting a manufacturer’s application to change a warning or has issued a supplemental ruling formally rejecting a warning change made unilaterally by the manufacturer pursuant to the CBE process.” Id. They contrast Justice Thomas’s “narrow view” with Justice Alito’s “more pragmatic approach,” which would consider not only formal agency actions with the force of law but also other FDA “communications” and conduct. Id. at 608.

According to Schwartz and Appel, given that divergence, “[t]he most important outstanding issue following Albrecht is what communication, action, or inaction by the FDA is sufficient to satisfy the ‘clear evidence’ exception.” 89 U. Cin. L. Rev. at 609.

Arguing that Albrecht does not expressly require “a formal agency ruling rejecting a manufacturer’s” proposed labeling change (89 U. Cin. L. Rev. at 610), Schwartz and Appel identify various post-Albrecht decisions that have found “clear evidence” that the FDA would have disapproved of a labeling change purportedly required by state law even though the agency did not formally reject a labeling change proposed by a manufacturer. They helpfully recount cases finding “clear evidence” in FDA inaction; in contemporaneous FDA approval of warnings other than those supposedly required by state law; and in the FDA’s denial of a citizen’s petition.

Schwartz and Appel also explain why, from a policy perspective, courts should be willing to find “clear evidence” even in the absence of formal FDA action rejecting a manufacturer’s proposed labeling change. “It is,” they say, “not difficult to imagine how problematic and disruptive” it would be if formal rejection were required before state-law failure-to-warn claims were preempted:

Risk-adverse branded drug manufacturers unsure about a potential need for an added warning would have an incentive to pursue warning changes more readily through the CBE process just so the FDA formally repudiates the warning change after it has been made, which would establish a clear basis to preempt failure-to-warn claims. As a result, branded drug warnings could experience increased volatility through back-and-forth labeling changes introduced by the manufacturer and rejected by the FDA, creating confusion for prescribing physicians and impeding patient safety.

89 U. Cin. L. Rev. at 611.

Finally, noting that “the Court in Wyeth may have created an impression that a branded drug manufacturer is generally free to unilaterally change a warning if and when it sees fit,” Schwartz and Appel emphasize that “FDA regulations make plain that the circumstances” under which the CBE regulation may be used “are limited.” 89 U. Cin. L. Rev. at 616–17. They stress that the CBE regulation may be invoked only “in light of ‘newly acquired information’” and that “the newly acquired information must provide ‘reasonable evidence of a causal association’” between the drug and “a ‘clinically significant adverse reaction[].’” Id. at 617. They then cite to various cases finding failure-to-warn claims preempted because the manufacturer could not avail itself of the CBE regulation.

With that summary, we express our thanks to Schwartz and Appel for their helpful article.