The US Supreme Court has issued its decision in Merck Sharp & Dohme Corp. v. Albrecht (In re Fosamax), vacating the Third Circuit's judgment and remanding for further proceedings. (See here and here for prior alerts from DLA Piper's team and for more detailed explanation of the action's background).
On May 20, all nine members of the Court agreed that preemption of failure-to-warn claims is a legal question decided by a judge, not a factual question decided by a jury. The majority opinion recognized that scenarios may exist where the legal determination of preemption will depend in part on the resolution of some facts. But the Court held that these factual disputes, such as whether the drug manufacturer submitted all material information to the FDA, are not for a jury to resolve. Rather, courts facing such a task "may have to resolve subsidiary factual disputes that are part and parcel of the broader legal question." Op. 16-17. Because the Third Circuit had treated preemption as a factual question, the Court vacated its judgment and remanded.
The Court, however, did not stop at that dispositive issue. The Albrecht decision instead clarified and substantially narrowed the scope of preemption under the Wyeth v. Levine “clear evidence” standard. The Court stated that preemption is limited to circumstances where (1) “the drug manufacturer fully informed the FDA of the justifications for the warning required by state law,” by “submitt[ing] all material information to the FDA” and (2) the FDA “informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” Op. 2, 16.
The Court, moreover, limited preemption to situations where FDA actually rejected the proposed labeling change through formal decision-making. Specifically, for its actions to have preemptive effect, the FDA must have communicated its disapproval of a warning through action "taken pursuant to FDA's congressionally delegated authority." Op. 15. To illustrate the point, the Court gave several examples of official FDA acts that could preempt state-law failure-to-warn claims, including "disapproval of a warning by means of notice-and-comment rulemaking," "formally rejecting" a warning label in a complete response letter, denial of a New Drug Application because of a false or misleading label, or label changes requested by the agency. Op. 15. Notably, the Court's examples do not include FDA journal publications, FDA advisory committee determinations, or informal correspondence with manufacturers on proposed labeling changes.
In addition, in the common situation where FDA fails to take action or where no new label was proposed, the Court's decision likely forecloses the argument that the FDA would have rejected a new warning. Op. 13-14 (noting that the "possibility of impossibility" is not enough for preemption); Op. 14 ("The existence of a hypothetical or potential conflict is insufficient to warrant the preemption of the state statute"). The Court's opinion underscores that preemption applies only where "federal and state laws 'irreconcilably conflict.’" Op. 14 (quoting Rice v. Norman Williams Co., 458 U.S. 654 (1982)); see id. (opining that "a drug manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law such that it was impossible to comply with both").
Further raising the bar to a successful preemption defense, the Court suggested that the preemptive effect of any FDA decision may depend on "what information the FDA had before it," and whether "the drug manufacturer submitted all material information to FDA." Op. 16. The Court recognized that "litigants may dispute" these threshold questions, and it will be for the judge to decide "contested brute facts" about the "meaning and effect of an agency decision." Id. This requirement opens the door to arguments by plaintiffs that the FDA acted on the basis of incomplete information.
All that said, the Court acknowledged that, under the Changes Being Effected (CBE) regulations, "manufacturers cannot propose a [label] change that is not based on reasonable evidence." Op. 14 (citing 21 C.F.R. 314.70(c)(6)(iii)(A)). The decision leaves unresolved, however, how courts should proceed when a genuine dispute arises over whether such evidence exists, ie, where the plaintiff failed to identify (a) "newly acquired information" or (b) "reasonable evidence" of a causal association with the relevant risk. See Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir. 2019) (finding failure-to-warn claim preempted where plaintiffs "do not plausibly allege the existence of newly acquired information that could have justified Defendants' revising the . . . label through the CBE regulation"). While the Albrecht decision suggests the bar is high for such arguments to succeed, it did not foreclose preemption on that basis.
Four justices authored or joined concurring opinions. Justice Clarence Thomas joined the Court's majority opinion in full, but also wrote separately to explain his doubt as to the ultimate merits of Merck's preemption defense. On the other hand, Justice Samuel Alito, along with Chief Justice John Roberts and Justice Brett Kavanaugh, joined the majority's judgment and wrote separately to explain why the evidence supported Merck's claim of an impossibility-preemption defense.