We recently came across the law review article, E. Lindenfeld, “Clear Evidence Clarified,” 75 Food & Drug L.J. 346 (2020). Since it cited and critiqued a number of our blogposts, we thought it was appropriate to reply.
Our initial impression is that the Lindenfeld article is comparatively reasonable – that is, compared to some prior P-side analysis of Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), we’ve seen. We do note a significant omission, however. The phrase “newly acquired information” appears only once in the article, 75 Food & Drug L.J., at 348, and only in passing. Thus, the article tacitly buys into the other side’s largely rejected position that there is no separate basis for preemption based on this prong of the FDA’s changes being effected (“CBE”) regulation. However, since the article does not analyze this issue, we won’t either, except to say that courts have just about universally treated lack of “newly acquired information” as an independent basis for preemption, also decided as an issue of law under Albrecht, with the plaintiff having the initial burden of identifying the “information” that allegedly satisfied this requirement. E.g., Knight v. Boehringer Ingelheim Pharmaceuticals, Inc., ___ F.3d ___, 2021 WL 41897, at *5-6 (4th Cir. Jan. 6, 2021); In re Avandia Marketing., Sales & Products Liability Litigation, 945 F.3d 749, 760 (3d Cir. 2019); Boone v. Boehringer Ingelheim Pharmaceuticals, Inc., 239 A.3d 1175, 1194 n.33 (Conn. 2020); see generally our post here.
Turning to what the Lindenfeld article does discuss, it focuses (p. 355) on the Supreme Court’s explication of the “clear evidence” requirement in Albrecht: that in cases “like” Wyeth v. Levine, 555 U.S. 555 (2009), a defendant must have evidence “show[ing] 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.” 139 S. Ct. at 1678. Except for one thing. . . .
That thing is the Lindenfeld article’s complete omission of Albrecht’s limitation of this reasoning to cases “like” Levine. Thus, the article conclusively assumes that all “clear evidence” cases are “like” Levine – which would be OK for a P-side piece, except we object to this being done sub silentio. Maybe that approach will prevail, but right now, the only on-point precedent is to the contrary. Cerveny v. Aventis, Inc., 783 Fed. Appx. 804, 808 n.9 (10th Cir. Aug. 9, 2019) (case was not “like” Levine because of third-party regulatory activity that independently caused the FDA to reject the same warning the plaintiff had proposed. Admittedly, that’s a only footnote in a non-precedential decision, but it’s the only thing so far on this particular point.
The Lindenfeld article parses Albrecht’s language into five parts: “[(1)] the drug manufacturer [(2)] fully informed the FDA [(3)] of the justifications for the warning required by state law [(4)] and that the FDA, in turn, informed the drug manufacturer [(5)] that the FDA would not approve changing the drug’s label to include that warning,” which it characterizes as “extremely positive” from the plaintiff’s point of view. 75 Food & Drug L.J., at 356. Since the Blog designated this part of Albrecht our sixth worst case for 2019, we don’t entirely disagree.
The Lindenfeld article’s first proposition is that Albrecht effectively threw out Levine’s requirement of “clear evidence” that the FDA “would have rejected” the label change that any particular plaintiff is advocating – calling “hypothetical preemption” “nearly dead,” and arguing instead that the defendant must “actually” have proposed, and had rejected, the same label change that the plaintiff wanted. 75 Food & Drug L.J. at 356. That, of course, is akin to saying no “clear evidence” preemption ever – because what plaintiff’s counsel will be so inept not to propose something different than what the FDA is already on record as having nixed? If the Court in Albrecht had intended there to be no preemption, then it would have said so, and the opinion would have been a lot shorter. This overstatement ties in, we think, to the article’s prior 86ing of Albrecht’s prefatory “like Levine” limiting language. A lot of cases aren’t “like” Levine and thus can involve the FDA “informing” manufacturers (including defendants) of rejected warning language even in the absence of a particular entity’s submission. Two such examples are rejections of citizen’s petitions (what happened in the Cerveny case cited above) and FDA implementation of classwide labeling covering multiple similar drugs in one fell swoop.
Another example is the FDA’s “own” inaction under 21 U.S.C. §355(o), which the Lindenfeld article mentioned earlier (pp. 349-50), but then does not discuss again until much later. If the FDA was sitting on “new safety information” that would have authorized it under §355(o) to “promptly notify” a defendant manufacturer of the need for a label change and did nothing, then that would seem like a good basis for concluding, in the absence of an actual submission, that the FDA “would have” rejected a label change under the original Levine version of the “clear evidence” test. There’s no law on this fact pattern yet, and it might not be forthcoming, because the cleanest route to preemption on this set of facts appears to be the “newly acquired information” prong of the CBE regulation, rather than making essentially the same argument based on §355(o).
In any event, the Lindenfeld article’s almost interment of the Levine version of “clear evidence” seems to us, at minimum, to be premature. “Albrecht is better understood as a clarification of the impossibility standard in [Levine] rather than as a repudiation of it.” Dolin v. GlaxoSmithKline LLC, 951 F.3d 882, 888 (7th Cir. 2020.
[I]t should not always be the case that simple inaction by the FDA in light of submitted data will always be “clear evidence” that the FDA would reject a particular warning. In this case, however, in light of the known issues and the ongoing give-and-take between [the defendant] and the FDA on these issues . . . the FDA’s continued inaction does represent clear evidence under these facts.
Ridings v. Maurice, 444 F. Supp.3d 973, 998 (W.D. Mo. 2020) (emphasis original). We think there’s life in this part of Levine yet.
The next proposition of the Lindenfeld article is that the preemptive “force” of an FDA rejection of a citizen petition “is uncertain.” 75 Food & Drug L.J. at 357. That’s true, and always has been. Some courts have allowed plaintiffs another bite at the apple, even after some plaintiff-side group tried and failed – under identical scientific standards − to get the FDA to make the same label change. But as the article conceded, id. at 358 & n.117, several appellate decisions (including the...
