The Public Readiness and Emergency Preparedness Act (PREP Act) may provide immunity to product manufacturers and premises owners who face liability from their administration or use of antivirals, drugs, biologics, diagnostics, devices, or vaccines used to treat, diagnose, cure, prevent, or mitigate COVID-19.

The PREP Act

Congress passed the Public Readiness and Emergency Preparedness Act (PREP Act) in 2005 and later codified it under Title 42 U.S. Code § 247d-6d in 2012. The PREP Act was designed to encourage drug manufacturers to rapidly produce vaccines, which would protect American citizens during a public health crisis. To ensure this goal, once the Secretary of the Department of Health and Human Services (HHS) invokes a declaration of a public health emergency, the PREP Act provides broad tort immunity to covered individuals from claims arising out of the administration of drugs, devices, or other countermeasures meant to mitigate the impact of the public health emergency. The HHS declared the COVID-19 pandemic a public health emergency in March of 2020. Accordingly, COVID-19 falls under the PREP Act’s purview. While the PREP Act provides certain immunities, questions have arisen as to when those immunities apply and the extent of such immunity.

Interpreting the PREP Act and COVID-19

In early 2021, a California federal court attempted to answer questions regarding PREP Act immunity and COVID-19 liability. It ruled that the PREP Act provided immunity to a senior living community facility because it “maintained policies and procedures for monitoring staff infection rates and maintained an operations plan to return to normal.” Garcia v. Welltower OpCo Grp. LLC, et al., 2021 WL 492581 (C.D. Cal. Feb. 10, 2021). The Garcia Court stated: “when a party attempts to comply with federal guidelines . . . concerning the COVID-19 pandemic[,] the PREP Act would provide complete preemption.”

The Garcia Case

In Garcia, Gilbert Garcia, a resident of a senior living facility, tested positive for COVID-19 on June 20, 2020 and died on July 3, 2020. The Garcia court found that following the Governor of California’s issuance of a state of emergency, the facility “initially allowed (but discouraged visitors),” “announced a resumption of group dining,” and “arranged for Garcia to have his hair cut by a third-party barber as well, despite the no-visitor policy.” Id. at *1-2. Further, the Garcia decision stated that “[o]n June 26, 2020, [facility] management sent a notice indicating that they had not had a confirmed COVID-19 case for 14 days, and therefore were beginning to move to a more relaxed phase of their operations plan . . . despite Garcia’s positive test result.” Id. at *2.

This led Garcia’s family to file suit in state court alleging elder abuse and neglect, wrongful death, and intentional infliction of emotional distress under California law. After removal to federal court, the U.S. District Court for the Central District of California held that the PREP Act completely preempted the plaintiffs’ state law claims, creating a federal cause of action to which the defendants were immune under the PREP Act. See id. at *10. In extending liability protections to the senior living community defendants, the Court highlighted the HHS Office of General Counsel’s advisory opinion from January 8, 2021, which clarified it is only when an individual fails to make any decisions whatsoever in response to the COVID-19 pandemic, that PREP Act immunity does not apply.

Future Liability for COVID-19 Measures

Indeed, courts have consistently held that the PREP Act does not provide immunity for COVID-19 liability where the claimed loss is caused by the defendant’s failure to act or take any preventative measures. See e.g., Robertson v. Big Blue Healthcare, Inc., 2021 WL 764566 (D. Kan. Feb. 26, 2021); Goldblatt v. HCP Prairie Village KS OPCO LLC, 2021 WL 308158 (D. Kan. Jan. 1, 2021). The Goldblatt Court noted that an alleged inaction or failure to administer a countermeasure could fall within PREP Act immunity if coupled closely with an act of administration to another. However, the Garcia decision has potentially opened the door for broad immunity to be applied in claims where a plaintiff alleges harm resulting from a defendant’s actions aimed at limiting the spread of COVID-19. These actions include the use of a drug, biological product, device, respiratory protective device, or vaccine. Consequently, product manufacturers and premises owners who are sued under such claims in state court should consider removing the claims to federal court and seeking immunity under the PREP Act.