The U.S. Supreme Court’s 2019 decision in Merck Sharp & Dohme, Inc. v. Albrecht, 139 S.Ct. 1668 (2019), discussed here and here addressed impossibility preemption in label change lawsuits. In Albrecht, the Supreme Court purported to clarify the standard arising from Wyeth v. Levine, 555 US 555 (2009) that a labeling claim against a manufacturer is preempted for “impossibility” if there is “clear evidence” that the FDA would have rejected a manufacturer’s proposed label change. Albrecht explained that impossibility preemption requires the “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.” But Albrecht left unclear what the “clear evidence” showing entails and left open several important questions about how it is to be applied.

The Seventh Circuit recently considered some of these uncertainties in Dolin v. GlaxoSmithKline LLC, 2020 WL 1074812 (7th Cir. March 6, 2020) (Dolin II).

Background

The plaintiff sued GlaxoSmithKline (GSK), the manufacturer of the antidepressant Paxil, after her husband committed suicide soon after starting treatment with a generic version of the drug. The generic manufacturer was protected by preemption under PLIVA. Inc. v. Mensing, 564 U.S. 604 (2011). The plaintiff therefore sought to hold GSK liable as an innovator under Illinois state law. The jury awarded the plaintiff $3 million.

The Seventh Circuit reversed, finding the plaintiff’s claim preempted under federal law governing labeling requirements for the drug. The court declined to reach the question whether Illinois law supports the innovator liability theory. Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. 2018) (Dolin I).

The clear evidence issue arises from the standard for impossibility prevention as applied to state lawsuits claiming inadequacy in prescription drug labels. State law is preempted if it was impossible for the manufacturer to both (1) comply with state law by adding the warning demanded by the plaintiff and (2) comply with federal law governing drug labeling. Federal law requires prescription drug manufacturers to obtain FDA approval before changing a drug label, but recognizes an exception — the “changes being effected” regulation. That exception allows a manufacturer unilaterally to change the label, subject to FDA disapproval, if the change would enhance safety because newly acquired information supports a causal association between the drug and a disease. 21 C.F.R. 314.70(c)(6), (7). Under Wyeth, the manufacturer can demonstrate this impossibility if there is “clear evidence” that FDA would have rejected the proposed label change.

Dolin I concluded that the plaintiff’s claims were preempted because GSK did attempt to change the label on Paxil to address adult suicidality, the FDA rejected the change and GSK thereafter did not acquire any new evidence of causality. This was clear evidence that the FDA would not have allowed the warning allegedly required under state law. The Supreme Court denied the plaintiff’s petition for a writ of certiorari eight days after it decided Albrecht. The plaintiff then asked the district court for relief from the judgment under Federal Rule of Civil Procedure 60(b), arguing Albrecht changed the law and the claim was not preempted. The district court denied the motion. The plaintiff appealed.

Dolin II

In Dolin II, the Seventh Circuit affirmed, declining to reinstate the verdict. The court held that Albrecht did not change the law, but only clarified Wyeth’s preemption standard. The court relied on Albrecht’s statement that it was holding that the judge, not the jury, decides preemption, and “elaborating” on Wyeth’s requirements. The court reasoned: “This is the language of ordinary evolution and clarification in case law, not reversal and overruling.”

The court also held that its decision would have been the same under Albrecht. The record showed that (1) GSK disclosed the relevant data underlying its proposed adult-suicidality warning to the FDA and (2) the FDA, acting pursuant to congressionally delegated authority, unambiguously rejected the warning.

The court also addressed how Albrecht might have modified the clear evidence standard.

• First, the court suggested that Wyeth’s language implied “that the defendant may be able to satisfy the standard without showing that it actually requested a change for the label and that the FDA rejected it.” But Albrecht’s language enunciating the standard “implies that the manufacturer must have actually requested a change and that the FDA rejected it.” The court did not need to resolve this tension, as GSK had sought to change the label and the FDA had rejected the effort.
• Second, the court read Albrecht “to signal that the FDA’s rejection must have acted [sic] ‘pursuant to the FDA’s congressionally delegated authority’” and to indicate that some less formal communications with the FDA might not have preemptive effect. But the court did not need to resolve this either, as the formal order requiring a class-wide warning omitting adult-suicidality risk satisfied any reasonable reading of Albrecht.
• Most importantly, Dolin II recognized that the U.S. Supreme Court has not yet had occasion to apply the clear evidence standard. The High Court postulated the standard in Wyeth, but the record there lacked any evidence that FDA would reject the proposed warning. In Albrecht, after discussing the standard, the Court remanded for its application by the lower courts. As previously explained, the assorted opinions issued in Albrecht reveal a Court seemingly sharply divided on how the preemption issue should turn out.

Dolin II may be an important post-Albrecht data point, but ultimately offers little guidance on how the clear evidence standard will evolve in Albrecht’s wake. Questions surrounding how the label change issue must be presented to the FDA and how it must be addressed by the FDA in order to qualify for preemption will continue to be litigated and percolate in the lower courts. Cases wrestling with these issues will warrant close scrutiny.