PREP Act Case Law and Its Application to Today’s COVID-19 Crisis

Over the last seven weeks, industry participants contributing to the COVID-19 pandemic response efforts have looked to the Public Readiness and Emergency Preparedness Act (the PREP Act), 42 U.S.C. § 247d-6d, for critical liability protections. Previously, our team has addressed PREP Act immunity as set forth in the March 10 COVID-19 Declaration issued by the Secretary of Health and Human Services (HHS), and in the non-binding April 14 HHS Advisory Opinion on the Public Readiness and Emergency Preparedness Act and the March 10, 2020 Declaration Under the Act, which explained the Declaration’s scope of coverage. Yet absent so far from these discussions is a crucial, in-depth analysis of existing PREP Act case law. In this article, we review the few available court decisions and assess how these cases should be applied in today’s context of the coronavirus crisis.

There have only been three cases that have substantively discussed the PREP Act, all of which arose from the 2009 H1N1 influenza public health emergency. Casabianca v. Mount Sinai Medical Center, 2014 WL 10413521 (NY Sup. Ct. 2014); Kehler v. Hood, 2012 WL 1945952 (E.D. MO 2012); and Parker v. St. Lawrence County Public Health Dept., 102 A.D.3d 140, 954 N.Y.S.2d 259 (App. Div. 3d. 2012). Two of these are New York state court cases, which would not be binding on any federal court.

Kehler v. Hood

In Kehler, Mr. and Mrs. Kehler sued a hospital and doctor for failing to obtain informed consent prior to the administration of the H1N1 vaccine, which plaintiffs alleged resulted in injury to Mr. Kehler. The defendants filed a third party claim against the vaccine manufacturer seeking indemnification and/or contribution if plaintiffs were to prevail on their claims.

The Missouri federal court found the PREP Act barred the claim against the vaccine manufacturer where the parties did not dispute that the manufacturer was protected by the PREP Act, nor did they allege that the manufacturer engaged in willful misconduct. Kehler, 2012 WL 1945952 at *3. That court then remanded the cases to state court against the doctor and hospital, despite the defendants’ argument that claims against them were likewise barred by the PREP Act, and thus federal question jurisdiction existed. Id. at *3-4. The court reasoned that the mere assertion of a federal statute as a defense to a claim did not give rise to a federal question, and suggested that plaintiffs’ state law claims of medical negligence were based on the conduct of defendants which occurred prior to the administration of the vaccine. Id. at *4.

It is unclear whether the Missouri court or any other federal court would make the same decision today given the guidance in the Advisory Opinion and the fact that there was apparently no willful misconduct alleged against the defendants. This opinion does serve as a word of caution to health care providers, however.

Casabianca v. Mount Sinai Medical Center

In Casabianca, the plaintiff alleged that the defendant hospital’s failure to administer the H1N1 vaccine to her husband led to his death. 2014 WL 10413421 at *1. The court noted that the H1N1 vaccine had been in short supply and that the defendant hospital was selectively administering it to high risk patients in accordance with guidelines established by the CDC and the New York State and City Departments of Health. Id. The decedent did not meet the criteria to receive the vaccine, so the defendant did not administer it to him. Id. Despite the defendant’s adherence to Centers for Disease Control and Prevention (CDC) and governmental guidelines, the court refused to extend PREP Act immunity. Rather, it found that the PREP Act was inapplicable because defendant Mount Sinai Medical Center never engaged in a recommended activity in furtherance of a covered countermeasure — that is, the hospital never actually “administered or used” the vaccine and did not meet the PREP Act’s threshold requirement. Id. at *5. Although Casabianca is a New York state case that read the PREP Act quite narrowly and is not binding on federal courts, it illustrates how a court might find the PREP Act inapplicable to non-use of scarce resources, such as ventilators or personal protective equipment, during the COVID-19 crisis.

Like Kehler, it is unclear whether a New York court would decide Casabianca the same way today. Although Casabianca correctly noted that the PREP Act applies only to claims related to “the administration to or the use by an individual of a covered countermeasure,” 42 U.S.C. § 247d-6d(a)(1), it could have construed the plaintiff’s claim as arising out of the wrongful “use” of a scarce vaccine on an individual other than the decedent. Indeed, the Declaration’s broad definition of “administration of a covered countermeasure” includes activities and decisions relating to delivery, which may be analogous here. 85 Fed. Reg. at 15200. A car accident or slip and fall injury that occurs due to improper management of a testing site or due to poor crowd control would likely be subject to immunity according to the Declaration. Id. It is easy to see how “administration” can be viewed broadly in such a scenario.

Similarly, an argument could be made that Mount Sinai Medical Center should also have been covered by PREP Act immunity where its action to not administer the vaccine arose out of and related to its administration of the covered countermeasure (vaccine) and was in accordance with guidelines established by the CDC and the New York State Department of Health. Accordingly, it will be important for defendants to argue in response to similar claims that a proper analysis under the PREP Act is whether the claim for loss is caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure. Id.

Parker v. St. Lawrence County Public Health Dept.

The third and final case, Parker v. St. Lawrence County Public Health Dept., is the only case of the three to actually conduct an in-depth analysis of preemption after a plaintiff was administered a covered countermeasure, and that court found that the PREP Act preempted plaintiff’s state law claims for negligence and battery. In Parker, the plaintiffs sued the county health department for administering the H1N1 vaccine to their child without parental consent. 102 A.D.3d 140, 954 N.Y.S.2d 259 (App. Div. 3d. 2012). In response, the defendant asserted the PREP Act’s immunity provisions as a complete defense against these claims. 102 A.D.3d at 142. While the state trial court denied defendant’s motion to dismiss, the appellate court concluded correctly that, because the PREP Act bars states from imposing requirements different from or conflicting with federal law and further declares “a covered person shall be immune from suit and liability under the Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to … an individual of a covered countermeasure,” the PREP Act immunity provisions preempted the plaintiffs’ claims. Id. at 142-143. Ultimately, given the breadth of the preemption clause and the immunity provision’s broad language, the court found that “Congress intended to preempt all state law tort claims arising from the administration of covered countermeasures….” Id. at 144.

Parker’s preemption analysis, which relied heavily on congressional intent and the urgent countermeasures necessary to address a national public health emergency, is particularly relevant in light of the non-binding Advisory Opinion and the multitude of supplies and devices being provided to states, hospitals, and other frontline health care providers. The Advisory Opinion suggests PREP Act immunity coverage will extend to “covered persons” possessing a reasonable belief they are providing a “covered countermeasure” in furtherance of a “recommended activity.” Advisory Opinion at 2. It further identifies state actors as Authorities Having Jurisdiction and defines “recommended activity” to include state emergency response activities. Id. As it relates to the COVID-19 pandemic response, and similar then to Parker, the PREP Act should be broadly interpreted to extend to activities providing much-needed supplies to states and hospitals, therefore preempting future state law claims where defendants assert PREP Act immunity. Thus, despite lingering questions regarding the COVID-19 Declaration’s scope, as clarified by the Advisory Opinion, Parker offers a foundation for a preemption defense and, perhaps, immunity protection to companies responding to this unprecedented public health emergency.

If you have questions about this article or whether you may be covered under the PREP Act’s immunity, please contact any of the authors.

As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.