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The PREP Act: Immunity from Liability in the Age of COVID-19

Out of all of the businesses that were severely impacted by the onset of the COVID-19 pandemic, perhaps no industry was more affected than that of healthcare providers. Due to the severe strain on resources and staff during the early phase of the pandemic, medical providers and other healthcare professionals found it extremely challenging to meet the needs of an increasingly ill public. To deter the anticipated spike in litigation against the medical industry related to the care of patients with COVID-19, the U.S. Department of Health and Human Services (HHS) issued an amendment to the Public Readiness and Emergency Preparedness Act (PREP Act) on February 4, 2020, applying the provisions and protections of the PREP Act to claims involving COVID-19.

The PREP Act shields from liability certain individuals and groups who qualify as “covered persons” only under specific circumstances and only if certain prerequisites are met. The PREP Act immunizes a “covered person” from legal liability for all claims for loss relating to the administration or use of a “covered countermeasure.” The requirements for PREP Act immunity break down into four elements: (1) the individual or entity must be a “covered person”; (2) the legal claim must be for a “loss”; (3) the loss must have a “causal relationship” with the administration or use of a covered countermeasure; and (4) the medical product that caused the loss must be a “covered countermeasure.” (42 USC 247d-6d (a)(1).) However, allegations of willful misconduct provide an exception to PREP Act immunity. (42 USC 247d-6d (d)(1).)

“Program planners” include Indian Tribes, state governments, and local governments who supervise programs that dispense, distribute, or administer covered countermeasures, or provide policy guidance, facilities, and scientific advice on the administration or use of such countermeasures. (42 USC 247d-6d (i)(6).) “Qualified persons” include licensed health professionals and other individuals authorized to prescribe, administer, or dispense “covered countermeasures” under state law, as well as other categories of persons identified by the Secretary in a PREP Act declaration. (42 USC 247d-6d(i)(8).)

PREP Act immunity applies to any claim for loss that has “a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use” of a covered countermeasure. (42 USC 247d-6d (a)(2)(B).) The PREP Act specifies four types of “covered countermeasures”: (1) a qualified “pandemic or epidemic product”; (2) a “security countermeasure”; (3) a drug, biological product, or device that the U.S. Food and Drug Administration (FDA) has authorized for emergency use; and (4) a “respiratory protective device” that is approved by the National Institute for Occupational Safety and Health (NIOSH). (42 USC 247d-6d (i)(1).)

In sum, while the PREP Act may be utilized as an impactful tool for liability immunity by those who qualify, it is also very specific in its requirements. It cannot be applied carte blanche as a dispositive defense to any lawsuit that merely mentions COVID-19 anecdotally, or otherwise does not trigger the protections of the PREP Act. With that in mind, any healthcare provider named in a lawsuit involving COVID-19 allegations would be wise to consider whether the PREP Act applies, because if so, it can be a very useful tool for an expedient and cost-effective dismissal.

The liability immunity for COVID-19 covered countermeasures is currently scheduled to extend through October 1, 2024. For additional information regarding the PREP Act and its applicability to claims involving COVID-19, please refer to the congressional report found at https://crsreports.congress.gov/product/pdf/LSB/LSB10443.