Products Liability Law Daily Seventh Circuit refuses to reopen Paxil® labeling case
Monday, March 9, 2020

Seventh Circuit refuses to reopen Paxil® labeling case

By David Yucht, J.D.

The impossibility preemption doctrine was not repudiated by the U.S. Supreme Court’s Albrecht decision and is still available, under certain circumstances, to drug manufacturers faced with inadequate labeling claims.

The U.S. Court of Appeals for the Seventh Circuit upheld a district court’s refusal to reopen a Paxil® inadequate labeling case. The appellate panel agreed that there was no significant change in the law concerning the impossibility preemption doctrine since the dismissal of an inadequate labeling claim filed by an estate based on the suicide of a depression patient who was prescribed Paxil® (Dolin v. GlaxoSmithKline LLC, March 6, 2020, Hamilton, D.).

In June 2010, a patient was prescribed Paxil, the brand-name version of the drug paroxetine, to treat depression. The prescription was filled with a generic paroxetine product. Six days after beginning the medication, the patient died by suicide. Federal law would have preempted a state-law claim against the generic manufacturer of the pills. Consequently, the estate sued GlaxoSmithKline (GSK), the manufacturer of the brand-name drug, on the theory that GSK was legally responsible for the content of the labeling for all paroxetine products, no matter who made and sold them; that GSK had negligently omitted an adult suicide risk on the drug label; and that the negligent omission had caused the patient’s death. The estate won a $3-million jury verdict in federal district court.

On appeal, the judgment was reversed because the appellate court found that the claim against GSK was preempted under the impossibility preemption doctrine [see Products Liability Law Daily’s August 23, 2018 analysis]. GSK had attempted to change the Paxil label under pertinent Food and Drug Administration (FDA) regulations in 2007 to add an adult suicide warning but the FDA rejected that change. The estate’s petition for certiorari to the Supreme Court was denied [see Products Liability Law Daily’s May 30, 2019 analysis]. Thereafter, the estate filed a motion in district court to set aside the judgment dismissing its case on the ground that the law had changed so that GSK could no longer establish its defense of impossibility preemption. The district court denied that motion and the estate appealed. GSK filed a motion for sanctions, asserting that the appeal was frivolous.

Preemption. Finding that the district court did not abuse its discretion in refusing to set aside the judgment, the appellate court denied this appeal. The estate argued that the defense of impossibility preemption was significantly limited by the U.S. Supreme Court in the 2019 Albrecht case (Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019)) [see Products Liability Law Daily’s May 20, 2019 analysis] and consequently GSK could no longer establish this defense to inadequate labeling liability. Judgments may not be reopened except for "compelling and extraordinary circumstances." The appellate court found that Albrecht did not repudiate the impossibility preemption doctrine, but rather clarified it. Albrecht held that this defense applies when there is "clear evidence" demonstrating that a drug company fully advised the FDA of the reasons for the need to update a warning under state law and that "the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change." Albrecht also held that the issue of preemption must be decided by a judge, and not a jury. Additionally, only agency actions taken pursuant to congressional mandate can shield a manufacturer from liability.

The appellate court determined that its prior decision applying impossibility preemption to shield GSK from liability would have been the same under Albrecht. GSK had advised the FDA of why it wanted to add an adult-suicidality warning to its label in 2006, but the FDA unambiguously rejected this warning. Additionally, there was no proof that GSK failed to offer newly acquired evidence to the FDA after the agency rejected its proposal. In short, Albrecht "did not break new ground that would [have] change[d] the result in this case." Because the appellate court determined, among other things, that the estate’s appeal was not frivolous but, rather, was reasonable and based on a colorable argument, the court refused to assess sanctions.

The case is No. 19-2547.

Attorneys: Bijan Esfandiari (Baum, Hedlund, Aristei & Goldman, PC) for Wendy B. Dolin. Andrew T. Bayman (King & Spalding LLP), Sarah M. Harris (Williams & Connolly LLP) and Alan Scott Gilbert (Dentons US LLP) for GlaxoSmithKline LLC f/k/a SmithKline Beecham Corp.

Companies: GlaxoSmithKline LLC f/k/a SmithKline Beecham Corp.

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