Supreme Court strongly reaffirms 2009 no-preemption decision in Wyeth v. Levine

The Supreme Court issued its decision today in Merck Sharp & Doehm v. AlbrechtJustice Breyer wrote the controlling opinion, representing the views of six Justices. Justice Alito wrote an opinion concurring in the judgment, representing the views of three justices.

Justice Breyer described the issues this way:

We stated in Wyeth v. Levine that state law failure-to warn claims [regarding prescription drugs] are pre-empted by the Federal Food, Drug,and Cosmetic Act and related labeling regulations when there is “clear evidence” that the FDA would not have approved the warning that state law requires. 555 U. S., at 571. We here decide that a judge, not the jury, must decide the pre-emption question. And we elaborate Wyeth’s requirements along the way.  

This ruling thus reverses the Third Circuit, which held the "clear evidence" question was a factual one for the jury. But, more importantly in my mind, the Court forcefully reaffirmed that impossibility preemption is a demanding defense under Wyeth v. Levine. Under today's decision, plaintiffs will continue to be able to pursue the vast majority of state-law damages claims alleging that a prescription drug manufacturer failed to warn of hazards associated with the drug. That is, preemption will rarely be a barrier to state-law failure-to-warn claims leveled against the manufacturers of prescription drugs.

Here are Merck's key takeaways on that score (all direct quotes from today's majority decision, except the bracketed material):

We then said [in Wyeth] that, nonetheless, “absent clear evidence that the FDA would not have approved a change to Phenergan’s label [the label at issue in Wyeth], we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements.” Ibid. (emphasis added [by Justice Breyer]). *** 

In a case like Wyeth [and like this one], 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. ***

[A]s we have cautioned many times before, the “possibility of impossibility [is] not enough.” PLIVA, Inc. v. Mensing, 564 U. S. 604,625, n. 8 (2011) (internal quotation marks omitted). Consequently, we have refused to find clear evidence of such impossibility where the laws of one sovereign permit an activity that the laws of the other sovereign restrict or even prohibit. See, e.g., Barnett Bank of Marion Cty., N. A. v. Nelson, 517 U. S. 25, 31 (1996); Michigan Canners & Freezers Assn., Inc. v. Agricultural Marketing and Bargaining Bd., 467 U. S. 461, 478, and n. 21 (1984). ***

We do note, however, that the only agency actions that can determine the answer to the pre-emption question, of course, are agency actions taken pursuant to the FDA’s congressionally delegated authority. The Supremacy Clause grants “supreme” status only to the “the Laws of the United States.” U. S. Const., Art. VI, cl. 2. And preemption takes place “‘only when and if [the agency] is acting within the scope of its congressionally delegated authority, . . . for an agency literally has no power to act, let alone pre-empt the validly enacted legislation of a sovereign State, unless and until Congress confers power upon it.’” New York v. FERC, 535 U. S. 1, 18 (2002) (some alterations omitted). Federal law permits the FDA to communicate its disapproval of a warning by means of notice-and-comment rulemaking setting forth labeling standards, see, e.g., 21 U. S. C. §355(d); 21 CFR §§201.57, 314.105; by formally rejecting a warning label that would have been adequate under state law, see, e.g., 21 CFR §§314.110(a), 314.125(b)(6); or with other agency action carrying the force of law, cf., e.g., 21 U. S. C. §355(o)(4)(A). The question of disapproval “method” is not now before us. And we make only the obvious point that, whatever the means the FDA uses to exercise its authority, those means must lie within the scope of the authority Congress has lawfully delegated.

Justice Breyer's opinion was joined by Justices Thomas, Ginsburg, Sotomayor, Kagan, and Gorsuch. Justice Alito's opinion concurring in the judgment was joined by Chief Justice Roberts and Justice Kavanaugh.

UPDATE: If you have any doubt that the drug industry actually lost today and that the industry's principal objective was to make it easier for drug-company defendants to win impossibility-preemption defenses — and to weaken Wyeth — that doubt will be erased by reading Merck's cert petition




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