'Fully Informing' The FDA

One of the more peculiar things about Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019) ("Albrecht"), is the almost off-hand way that the majority (made up mostly of justices that have opposed preemption in closer cases) wandered away from the procedural preemption issues that the Court was actually deciding (whether the jury has any role in preemption decisions and whether a "clear and convincing" evidence standard applied), to redefine what had been known (after Wyeth v. Levine, 555 U.S. 555 (2009) ("Levine")) as the "clear evidence" standard. They did so even after expressly cautioning up front that "The question of disapproval 'method' is not now before us." Albrecht, 139 S. Ct. at 1679. So we now have this:

[I]n [Levine], we confronted that question in the context of a particular set of circumstances. . . . In a case like [Levine], showing that federal law prohibited the drug manufacturer from adding a warning that would satisfy state law requires the drug manufacturer to 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.

Id. at 1687 (to avoid confusion, the Blog's naming conventions use plaintiff names for important cases when the defendant's name is common; the Supreme Court uses whichever is first in the caption). At the same time, the Court also described the relevant test much more simply − whether "the relevant federal and state laws 'irreconcilably conflic[t].'" Id. at 1679

There are quite a few issues with Albrecht's longer "definition" - if that's what it is. First, in light of the Court's reminder about Levine's "particular set of circumstances," what is a case "like" Levine? Plaintiffs trying to say that every fact pattern is "like" Levine have failed in the early going. As previously mentioned, the Tenth Circuit in Cerveny v. Aventis, Inc., ___ F. Appx. ___, 2019 WL 3763441 (10th Cir. Aug. 9, 2019), rejected the plaintiffs' argument that only a "manufacturer's" actions could be considered under this definition with the retort that a case involving a third-party citizen petition inducing FDA action was not "like" Levine.

[Plaintiffs] contend that Albrecht "dictates that only labeling changes sought by the manufacturer can lead to preemption . . . But we note that Albrecht prefaced its requirement that "[the drug manufacturer] fully informed the FDA . . ." as applying "[i]n a case like [Levine], and noted that "in [Levine, [the Court] confronted [preemption] in the context of a particular set of circumstances." And here, [plaintiffs'] case involves a particular set of circumstances with a key difference. . . . Here, [defendant] argues a different ground . . . − the FDA's unequivocally having rejected [a] citizen petition advocating for the warning that [plaintiffs]now assert. We see nothing in [Levine] or excluding [defendant] from justifying preemption on this basis.

Id. at *3 n.9 (citations omitted).

A second court, in North Dakota, recently rejected similar plaintiff-side arguments as "nonsensical" for similar reasons:[Plaintiff's]

[Plaintiff] argues that, under [Albrecht], the FDA's decision not to change a medication's labeling triggers [Levine] preemption only if the manufacturer itself proposed the change. . . . This Court does not read [Albrecht] so narrowly. [Plaintiff's] argument ignores [Albrecht's] explicit warning that "[t]he question of disapproval 'method' is not now before us." . . . [Albrecht] did not involve agency "actions" or "methods" similar to this case. . . . [Albrecht] certainly did not decide whether other agency actions, such as the denial of a Citizen Petition, would be sufficient. . . . Where the FDA has already rejected a proposed label or warning change, as it did in this case, there is no reason why the "impossibility" of a subsequent change would depend on whether the earlier change was proposed by the manufacturer as opposed to a third party or the FDA itself. Regardless of who submitted the proposed warning or labeling change, the FDA has already decided that the relevant evidence and policies do not meet the standard to justify a change.

State v. Purdue Pharma L.P., 2019 WL 3776653, at *2-3 (N.D. Dist. July 22, 2019).

Another issue (among several) stemming from Albrecht's definitional dictum, as to which no subsequent precedent yet exists, is what does it mean for "the drug manufacturer to show that it fully informed the FDA of the justifications" for not using the warning that the plaintiff now wants. The rest of this post is devoted to that question.

In light of the Albrecht Court's longer definition - as opposed to its basic "irreconcilable conflict" statement - we expect plaintiffs to make arguments that squarely implicate the Court's prior decision in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). Buckman employed conflict preemption to bar agency fraud claims against FDA-regulated products, largely for institutional reasons: (1) the FDCA explicitly prohibits private parties from enforcing the FDCA, id. at 349 n.4; (2) states have not "traditionally" been in the business of "policing" the adequacy of regulated entities' submissions to the FDCA, id. at 347; and (3) FDA is "empowered to require additional necessary information," id. at 349...