Products Liability Law Daily Widow of Paxil® user asks High Court to review impossibility preemption conflict within the appellate courts
Thursday, January 3, 2019

Widow of Paxil® user asks High Court to review impossibility preemption conflict within the appellate courts

By Pamela C. Maloney, J.D.

The widow of a man who killed himself while taking the generic version of the prescription anti-depressant Paxil® has asked the U.S. Supreme Court to review a decision by a panel for the U.S. Court of Appeals for the Seventh Circuit vacating a $3-million jury award in her favor. The widow argued that the Seventh Circuit’s decision was in direct conflict with a similar decision by the Third Circuit. The Seventh Circuit had concluded that the state-law negligence claim on which the drug developer’s liability had been based was federally preempted because the U.S. Food and Drug Administration (FDA) had rejected the company’s repeated attempts to add a warning regarding the risk of suicide in adults taking the drug [see Products Liability Law Daily’s August 23, 2018 analysis] (Dolin v. GlaxoSmithKline, LLC, petition filed December 19, 2018).

In support of her request for review, the widow cited Wyeth v. Levine, 555 U.S. 555 (2009), in which the Supreme Court had opined that although impossibility preemption was a demanding defense, the High Court could not conclude that it was impossible for a drug manufacturer to comply with both federal and state requirements, absent clear evidence that the FDA would not have approved a change to a drug’s label. In this case, the Seventh Circuit found preemption even though an FDA expert had testified that the manufacturer was permitted to add its drug-specific suicide warning to the drug’s label and the FDA had advised the manufacturer to submit its drug-specific warning using a procedure that allowed manufacturers to strengthen warnings. According to the widow, the Seventh Circuit failed to appreciate the heightened evidence required under Wyeth, and that in concluding that no reasonable jury could find that the FDA would have approved an adult-suicidality warning, the appellate court had failed to review the evidence in a light most favorable to the widow.

Arguing that the Seventh Circuit’s decision raised an issue of recurring importance—the federal preemption of common law pharmaceutical products liability a claim—the widow noted that the Seventh Circuit’s decision conflicted directly with that of the Third Circuit in Merck v. Albrecht, which the High Court has agreed to review [see Products Liability Law Daily’s June 28, 2018analysis]. In Albrecht, the Third Circuit held that the patients who developed atypical femoral fractures allegedly as a result of their use of the drug Fosamax® to treat osteoporosis provided sufficient evidence for a reasonable jury to conclude that the FDA would have approved a properly-worded warning about the risk of thigh fractures, or, at minimum, to conclude that the odds of FDA rejection of a label change were less than highly probable, which was enough under Wyeth for the patients to defeat the manufacturer’s argument that the failure to warn claims were preempted as a matter of law. Given the factual similarities between Albrecht and the present case, the petition suggested that the High Court’s resolution of Albrecht likely would provide needed guidance to the courts below on how to assess a preemption defense in the context of the facts presented. Therefore, the widow recommended that her petition be held by the court pending the disposition of Albrecht, which is scheduled for oral argument on January 7, 2019. Following resolution of the Albrecht petition, the widow requested that the Seventh Circuit’s ruling be vacated by the Supreme Court and remanded for further proceedings in the Seventh Circuit.

In her petition, the widow presented the following question for review: "Does federal law prevent a drug manufacturer from enhancing its label to reflect truthful risks revealed in its clinical trials when the relevant FDA regulations allow a manufacturer to make unilateral labeling changes and when the FDA encouraged the manufacturer to utilize those regulations to submit an appropriate labeling change?"

The case is No. Docket 18-803.

Attorneys: Bijan Esfandiari (Baum Hedlund Aristei & Goldman, PC) for Wendy B. Dolin.

Companies: GlaxoSmithKline LLC

MainStory: TopStory DrugsNews PreemptionNews WarningsNews

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