Effectively Navigating PREP Act Case Law – The Products Liability Perspective


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.

The other PREP Act cases, Kehler v. Hood, Case No. 4:11CV1416 FRB, 2012 WL 1945952 (E.D. Mo. 2012), and Casabianca v. Mount Sinai Med. Ctr., Inc., 2014 NY Slip Op 33583(U), 2014 N.Y. Misc. LEXIS 5998, did not rule on the ultimate merits of the PREP Act’s federal immunity defense from use of a covered countermeasure. In Kehler, the plaintiff alleged that the physician-defendants failed to obtain informed consent prior to the administration of the H1N1 vaccine. In dismissing the manufacturer, the court stated that “[t]he parties do not dispute that third-party defendant Novartis, the alleged manufacturer of the H1N1 vaccine at issue here, is protected by the PREP Act and is absolutely immune from liability for any type of loss caused by the vaccine.”

The only issue decided by the Kehler court was whether federal question jurisdiction still existed since the manufacturer, which originally removed the case to federal court based on federal question jurisdiction under the federal officer statute, was no longer a party. The court held that because the plaintiff’s particular claims against the physicians were based on state law, not federal law, federal question jurisdiction was lacking. The court acknowledged there may be exceptions permitting removal in other circumstances, and did not consider the full scope of the PREP Act, including the federal fund established to compensate certain individuals who may be injured by a countermeasure. See U.S. Dept. of Health and Human Services Advisory Opinion on the Public Readiness and Emergency Preparedness Act and the March 10, 2020, Declaration under the Act, dated April 14, 2020 (HHS Advisory Opinion). The Kehler court did not rule on the viability of the PREP Act’s immunity defense and made no finding on the applicability of the defense to the physician-defendants, an issue to be decided upon remand.

The other case, Casabianca, did not involve the use of a covered countermeasure under the PREP Act. The plaintiff alleged malpractice against his physicians for allegedly failing to administer the covered countermeasure vaccine. The court explained that the PREP Act’s immunity provisions require that a covered countermeasure be administered for the PREP Act to apply. The court held that malpractice claims arising from the failure to administer the countermeasure were outside the scope of the PREP Act immunity provisions for the H1N1 virus.

As with Kehler, Casabianca did not rule on the merits of the PREP Act’s immunity defense for a covered countermeasure, and the court’s general rule that an activity or countermeasure must be covered by the PREP Act is an individual question that will need to be answered on a case-by-case basis and in light of the HHS Advisory Opinion commenting that immunity under the PREP Act should be broadly conferred in the case of COVID-19.

Because neither Kehler nor Casabianca considered the underlying merits of the PREP Act immunity defense based on use of a covered countermeasure, their application, if any, is very limited. Parker is particularly instructive because the court considered the merits of the immunity defense from use of a covered countermeasure and correctly held that state law tort claims were preempted and barred by federal law.

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About the Author: Emmanuel Brown

Emmanuel L. Brown is a litigation associate who represents major pharmaceutical and medical device companies in complex civil litigation, including mass tort and single-plaintiff actions.

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