Category: Practice of Law

Effectively Navigating PREP Act Case Law – The Products Liability Perspective

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Since the federal Public Readiness and Emergency Preparedness Act (the PREP Act) was enacted by Congress in 2005, only a few courts have substantively commented on the Act’s requirements. The PREP Act provides federal immunity against state law tort claims to covered entities that manufacture covered countermeasures used to fight diseases and viruses declared as national emergencies, such as COVID-19.

The pivotal case substantively applying the PREP Act’s immunity defense is Parker v. St. Lawrence County Pub. Health Dept., 102 A.D.3d 140 (N.Y. App. Div. 2012). The Parker court held that because the plaintiffs’ daughter was administered a covered countermeasure to prevent the H1N1 virus, their state law claims for negligence were preempted and barred by the PREP Act’s immunity provisions. To date, no reported decision has permitted traditional state law tort claims against a manufacturer for the alleged use of a covered countermeasure under the PREP Act.

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Preparing for the COVID-19 Immunity Preemption Defense

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As manufacturers of vaccines, pharmaceutical medicines, ventilators and respirators engage substantial resources and ramp up production to help fight COVID-19, many have presumably done so under the immunity protections afforded by the federal Public Readiness and Emergency Preparedness Act (the PREP Act codified at 42 USC §247d-6d), and Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). Because of industry-wide uncertainty surrounding PREP Act immunity and the need for immediate and urgent action on the part of manufacturers, the U.S. Department of Health and Human Services (HHS) recently issued a non-binding Advisory Opinion explaining the scope of PREP Act coverage, its immunity provisions in the context of COVID-19 countermeasures, and informal guidance on the preemptive effect of the federal law.

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Seventh Circuit Finds Preemption in Reversing Generic Paxil Verdict Against GSK, But Passes on Deciding Innovator Liability Issues

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In a much-anticipated ruling on the appeal of a $3 million verdict against GlaxoSmithKline (GSK) in a wrongful death case involving the Paxil generic, paroxetine, the U.S. Court of Appeals for the Seventh Circuit reversed on Wednesday and held that the plaintiff’s claims were preempted under Wyeth v. Levine, 555 U.S. 555 (2009). Dolin v. GlaxoSmithKline LLC, No. 17-3030, slip op. at 25 (7th Cir. August 22, 2018). The appellate court’s decision was also notable in that the court ruled on the preemption issues without addressing whether Illinois law would permit a claim of “innovator liability” against brand manufacturer GSK when the plaintiff had only taken generic paroxetine manufactured by a different company. Id.

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