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On May 20, the U.S. Supreme Court issued its latest opinion on preemption in cases involving prescription medications, Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290 (U.S. May 20, 2019). In Albrecht, the Court provided guidance on applying the test for implied preemption that it previously articulated in Wyeth v. Levine, 555 U.S. 555 (2009), which held that failure-to-warn claims against drug manufacturers are preempted if there is “clear evidence” that the FDA would reject the warnings allegedly required under state law. Albrecht held that the clear evidence determination is one for a court to make, not a jury. Albrecht also clarified the definition of “clear evidence,” but it did not apply its formulation of the clear evidence test to the facts at hand, and the precise circumstances in which clear evidence can be found will remain contested among practitioners in pharmaceutical cases.
The Albrecht opinion offers the following takeaways:
The opinion resolves the issue of who decides what is “clear evidence” in a preemption case.
While the Court clarified its clear evidence test as requiring official agency decision-making, it did not precisely resolve what actions (or even inaction) by the FDA would have preemptive effect.
Albrecht involved claims by plaintiffs in the Fosamax multidistrict litigation, who alleged that the labeling for Fosamax, a medication used to treat osteoporosis, did not adequately warn of the risk of bone fractures. The MDL court held that the plaintiffs’ claims were preempted as a matter of law, concluding that the regulatory record supported a finding of clear evidence that the FDA would have rejected any label change on fractures before the FDA’s decision to require a label change in 2010. See Albrecht, slip op. at 8. The Third Circuit reversed, holding that the question of whether there was “clear evidence” was a question of fact for the jury to decide, and further holding that a “factfinder must conclude that it is highly probable that the FDA would not have approved a change to the drug’s label.” See id. at 9. The Supreme Court granted certiorari.
The Albrecht Opinion
All nine Supreme Court justices agreed that the clear evidence test presents a question of law for the court to decide. Justice Breyer, writing for the majority (joined by Justices Thomas, Ginsburg, Sotomayor, Kagan and Gorsuch), explained that “judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination” and “to understand and to interpret agency decisions in light of the governing statutory and regulatory context.” Id. at 16. The Court accordingly rejected the Third Circuit’s attempt to define clear evidence “in terms of evidentiary standards.” Id. at 14. The Court noted that, in applying the clear evidence test, judges may need to resolve ancillary factual disputes between the parties, such as “whether the drug manufacturer submitted all material information to the FDA.” Id. at 16.
The Court also defined “clear evidence” (which it had not done explicitly in Levine) as “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.” Id. at 1-2, 13. The Court, while recognizing that the “question of disapproval ‘method’” was not now before it, expressed its view that, in order for the FDA’s disapproval of a label change to have preemptive effect, the FDA’s decision must be in the form of an “agency action taken pursuant to the FDA’s congressionally delegated authority.” Id. at 15. As examples, the Court cited statutes and regulations that empower the FDA “to communicate its disapproval of a warning by means of notice-and-comment rulemaking” and to “formally reject a warning label,” and emphasized the FDA’s rejection of labeling submitted through the “Changes Being Effected” or “CBE” process. Id. at 14-15. The Court did not apply the clear evidence test to the specific facts of Fosamax, a task which it left to the Third Circuit on remand.
In a concurring opinion joining in the judgment only, Justice Alito (joined by Chief Justice Roberts and Justice Kavanaugh) took issue with the majority’s formulation of the clear evidence test. He emphasized the FDA’s statutory duty to consider whether new safety information justifies a label change under the 2007 revisions to the Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(o)(4)(A), regardless of “whether the relevant drug manufacturer, as opposed to some other entity or individual, brought the new information to the FDA’s attention.” Albrecht, slip op. at 2 (Alito, J. concurring).
Justice Alito further reasoned that FDA inaction after receiving this information could support a finding of preemption because “the logical conclusion is that the FDA determined that a label change was unjustified.” Id. Justice Alito also noted that the majority had emphasized a manufacturer’s ability to implement drug labeling changes via the CBE process, but did not acknowledge “that a manufacturer may (and in many circumstances, must) submit a Prior Approval Supplement.” Id. at 3.
Justice Alito’s concurrence also criticized the majority’s “one-sided account” of the regulatory history of Fosamax, which, in his opinion, did not provide a sufficient description of the careful study and attention that the FDA paid to the bone fracture safety issue. Id. at 4-6. He noted that, in an amicus curiae brief submitted by the Solicitor General, the FDA itself took the position that the “FDA’s decision not to require a label change prior to October 2010 reflected the FDA’s determination that a new warning should not be included in the labeling of the drug.” Id. at 6 (internal quotations omitted).
Justice Thomas also filed a separate concurring opinion, in which he rejected outright “Merck’s primary argument . . . that the FDA would have rejected a hypothetical labeling change submitted via the CBE process.” Albrecht, slip op. at 4 (Thomas, J. concurring). In Justice Thomas’s view, “neither agency musings nor hypothetical future rejections” have preemptive effect under the Supremacy Clause. Id.
Albrecht definitively settled a lingering debate in prescription drug cases, holding that the preemption question is one for a court, not a jury. Further, the Court’s reasoning should apply in any preemption case, even when the inquiry may require resolution of disputed facts. Albrecht also attempted to clarify the clear evidence standard, but, because the Court did not apply the standard to the facts of the case, it has left room for debate as to precisely when this standard is met. While three concurring Justices pointed out that there remains a question of whether agency inaction, in the face of a statutory duty to act, can establish preemption, the majority’s emphasis on congressionally delegated agency action will, no doubt, be the subject of litigation and future development.
Kenneth J. King is a partner in Pepper Hamilton’s Health Sciences Department, a team of 110 attorneys who collaborate across disciplines to solve complex legal challenges confronting clients throughout the health sciences spectrum. Mary Margaret Spence is a senior attorney in the Health Sciences Department.
The material in this publication was created as of the date set forth above and is based on laws, court decisions, administrative rulings and congressional materials that existed at that time, and should not be construed as legal advice or legal opinions on specific facts. The information in this publication is not intended to create, and the transmission and receipt of it does not constitute, a lawyer-client relationship.