Just in. United States Supreme Court rules unanimously in Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290, slip op. (U.S. May 20, 2019) (“Albrecht”), that the Third Circuit got it wrong in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017). However, the majority opinion, by Justice Breyer, is limited and draws the support of members of the Court who are usually anti-preemption. That says two things. First, the Third Circuit was so far off the wall that its extreme anti-preemption position could not be stomached by anyone. Second, if the analysis had been by a generally pro-preemption majority, rather than one with the opposite inclinations, the reasoning could have been a lot better.
Because the majority opinion has the votes of Thomas, Ginsberg, Sotomayor, Kagan and Gorsuch, it is limited to cleaning up the Third Circuit’s mess and does not decide the ultimate question of preemption on the existing facts. Albrecht, slip op. at 17 (vacating and remanding, but not deciding the underlying preemption decision). Once again (as with Wyeth v. Levine, 555 U.S. 555 (2009)), the “facts” are surprisingly malleable. The majority (for reasons we’ll get into) omits a great deal of the regulatory history, and are called to task for that in Justice Alito’s concurring opinion (for Roberts, C.J., and Kavanaugh).
First, the Albrecht majority offers a more detailed definition of “clear evidence” under Wyeth v. Levine, 555 U.S. 555 (2009), rejecting the Third Circuit’s “clear and convincing” standard:
“[C]lear 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, slip op. at 1-2 (emphasis added); see also id. at 13 (satisfying this test would “show that federal law prohibited the drug manufacturer from adding a warning that would satisfy state law”). This definition avoids situations where the FDA was “fully informed” (or not) by someone else, such as through a third-party Citizen’s Petition. The majority doesn’t reach facts not before it. See id. at 12 (emphasizing importance of “record” facts).
The dividing line for preemption in branded prescription drug cases continues to be whether the provisions of the FDA’s “changes being effected” (“CBE”) regulation are satisfied by the facts of the case. Id. at 3-4, 14. That regulation requires “newly acquired information” and, further, “manufacturers cannot propose a change that is not based on reasonable evidence.” Id. at 14 (citing various parts of CBE regulation). However, “in the interim, the CBE regulation permits changes, so 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.” Id. But what about what was done here – a Prior Approval Supplement (“PAS”), which is an alternative to a CBE label change? Very little was said about that by the majority.
Second, the majority ruled that preemption – as had always been the case before Fosamax, remains a question “primarily of law” for courts, not juries, to decide. “We here decide that a judge, not a judge, must decide the pre-emption question.” Id. at 9.
[T]he question is a legal one for the judge, not a jury. The question often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute. Moreover, judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination. . . . And judges are better suited than are juries to understand and to interpret agency decisions in light of the governing statutory and regulatory context. To understand the question as a legal question for judges makes sense given the fact that judges are normally familiar with principles of administrative law. Doing so should produce greater uniformity among courts; and greater uniformity is normally a virtue when a question requires a determination concerning the scope and effect of federal agency action.
Albrecht, slip op. at 16 (citations and quotation marks omitted). Whatever factual questions might exist in a particular case are “subsumed within an already tightly circumscribed legal analysis” and decided by the judge. Id. at 17. So that issue’s over with.
Third, as a consequence of preemption being a legal question, the Albrecht majority also eliminated the Third Circuit’s peculiar “clear and convincing evidence” standard as superfluous:
We do not further define [Levine’s] use of the words “clear evidence” in terms of evidentiary standards, such as “preponderance of the evidence” or “clear and convincing evidence” and so forth, because, . . . courts should treat the critical question not as a matter of fact for a jury but as a matter of law for the judge to decide.
Albrecht, slip op. at 14. Rather, “the judge must simply ask himself or herself whether the relevant federal and state laws irreconcilably conflict.” Id. (citation and quotation marks omitted). FDA action establishing preemption may occur by “notice-and-comment rulemaking,” “formally rejecting a warning label,” or any “other agency action carrying the force of law.” Id. at 15 (citing, inter alia, 21 U.S.C. §355(o)(4)(A), concerning FDA acting on its own accord).
Albrecht was necessary because the Court did a lousy job in Wyeth v. Levine, 555 U.S. 555 (2009), articulating what it held about impossibility preemption. For the last decade, courts have struggled to apply a counterfactual preemption standard requiring “clear evidence” – an undefined term − that FDA “would have” rejected a proposed warning change that in fact was never submitted. Post-Levine decisions have been all over the lot about how strictly to apply Levine’s “would not have approved” standard.
But in Albrecht, the FDA had actually refused to allow a warning about the risk at issue. Piling absurdity on top of absurdity, the Third Circuit had denied preemption even then – where the FDA actually rejected what plaintiffs demanded – making impossibility preemption truly impossible. Fosamax, as it was called before reaching the Supreme Court, was awful enough that we ranked it the worst decision of the year in 2017. Not surprisingly, the defendant sought certiorari in the Supreme Court. The FDA agreed on how badly the Third Circuit had erred, and the Solicitor General filed supporting amicus briefs, both on the writ and on the merits. In the Supreme Court, the Third Circuit’s rationale could not garner even one vote.
The Supreme Court also agreed (at least sub silentio) that Levine was poorly reasoned. Albrecht spent an extraordinary four pages of the opinion just “describing [Levine],” Albrecht, slip op. at 10-13, which would hardly have been necessary had Levine made more sense. We note that, conspicuously absent from that description is any express reference to any “presumption” (as opposed to the older “assumption”) against preemption.
In addition to the main points above, another highlight of the Supreme Court’s decision in Albrecht is express recognition of “overwarning” as a reason for the FDA’s labeling requirements:
The hierarchy of label information is designed to “prevent overwarning” so that less important information does not “overshadow” more important information. It is also designed to exclude “[e]xaggeration of risk, or inclusion of speculative or hypothetical risks,” that “could discourage appropriate use of a beneficial drug.”
Albrecht, slip op. at 3 (quoting 73 Fed. Reg. 49603, 49605-06 (Aug. 22, 2008) & 73 Fed. Reg. 2848, 2851 (FDA Jan. 16, 2008)).
Justice Thomas’ concurring opinion explains some of the oddities of the Albrecht decision. Basically, he doesn’t accept an FDA “complete response letter” as a form of “law” that can be preemptive. Albrecht, slip op. at 5 (“the letter was not a final agency action with the force of law, so it cannot be ‘Law’ with pre-emptive effect”) (Thomas, J. concurring). We think that’s why the majority’s discussion of the regulatory history of Fosamax, compared to the concurrence, is so limited. There is a lot of regulatory activity in between actual FDA actions. To get Thomas’s vote, the majority omitted it. Justice Thomas didn’t like what the Third Circuit had done, but wasn’t a pro-preemption vote either. On that issue, Justice Thomas wrote only for himself.
Justice Alito (plus Roberts, C.J., and Kavanaugh) concurred only in the result because of “concern that its discussion of the law and the facts may be misleading on remand.” Albrecht, slip op. at 1 (Alito concurrence). Most of this objection has to do with the majority’s slanted version of the facts, id. at 4-5, something that also recalls Levine, and not in a good way. However, the concurrence also highlights §355(o)(4)(A) – which as we noted was merely cited by the majority – because “if the FDA declines to require a label change despite having received and considered information regarding a new risk, the logical conclusion is that the FDA determined that a label change was unjustified.” Id. at 2. The concurrence would go further than the majority, addressing the “who else” question under this section: “The FDA’s duty does not depend on whether the relevant drug manufacturer, as opposed to some other entity or individual, brought the new information to the FDA’s attention.” Id. Conversely, on the actual facts before the Court in Albrecht, Justice Alito was nonplussed by the majority’s failure to discuss the “Prior Approval Supplement” route of changing warnings. Id. at 3-4.
Justice Alito agrees with the majority that Levine’s use of “clear evidence” was “merely a rhetorical flourish.” Id. at 3. “Standards of proof, such as preponderance of the evidence and clear and convincing evidence, have no place in the resolution of this question of law.” Id.
So now what?
The one thing that’s definitively been put to bed by Albrecht is the notion of preemption as a question of fact to be decided by juries. That is gone, and Albrecht’s ruling on this point will apply to all forms of implied preemption no matter what the product, since implied preemption is trans-statutory. Also gone is the notion of a “clear and convincing” evidence standard.
If one is seeking clarity, that is as far as Albrecht will take you. “Clear evidence” now has a new, post-Levine definition, but as Justice Alito discussed, that definition has some issues with it – most significantly with respect to the role of Citizen’s Petitions. As for the redefined “clear evidence” standard, plaintiffs will be henceforth argue over what it means to “fully inform” the FDA. OK, but not cited anywhere in Albrecht was Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), which has a lot to say about what plaintiffs can and can’t assert about sufficiency of submissions to the FDA. The FDA also has to act for there to be “clear evidence,” but that’s been less of an issue historically, as Levine pretty much ended FDA inaction cases. Another thought we have is that Albrecht has next to nothing to do with design defect claims, since there is no CBE regulations for design changes.
More than anything else, Albrecht reminds that Justice Thomas has very quirky views on preemption. Even in a case like this one, where the anti-preemption position of the circuit court was way out in left field, there are reversals and there are reversals. Albrecht is the kind of reversal that leaves both sides with only half a loaf.