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...
