1 1 (September 21, 2020)

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                   Resarh Service

The PREP Act and COVID-19: Limiting

Liability for Medical Countermeasures

Updated September 21, 2020
To encourage the expeditious development and deployment of medical countermeasures during a public
health emergency, the Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the
Secretary of Health and Human Services (HHS) to limit legal liability for losses relating to the
administration of medical countermeasures such as diagnostics, treatments, and vaccines. In a declaration
effective February 4, 2020 (the HHS Decclaration), the Secretary of HHS invoked the PREP Act and
declared Coronavirus Disease 2019 (COVID-19) to be a public health emergency warranting liability
protections for covered countermeasures. Under the HHS Declaration, covered persons are generally
immune from legal liability (i.e., they cannot be sued for money damages in court) for losses relating to
the administration or use of covered countermeasures against COVID- 19. The sole exception to PREP Act
immunity is for death or serious physical injury caused by willful misconduct. However, individuals
who die or suffer serious injuries directly caused by the administration of covered countermeasures may
be eligible to receive compensation through the Countermeasu'es Injury Compen ation Program.
Courts have characterized PREP Act immunity as sweeping. It applies to all types of legal claims under
state and federal law. For example, under state tort law, individuals who suffer injuries caused by the
intentional or negligent acts or omissions of another person may generally sue that person to recover
monetary compensation. Thus, in the health care context, if a health care provider negligently administers
a drug or device that causes a foreseeable injury to a patient, the injured person may be able to sue the
provider for compensation under state tort law.
Federal laws such as the PREP Act may preempt state tort laws-as well as other state and federal laws-
in certain contexts. Preemptive federal legislation displaces state law to alter the usual liability rules or
immunize certain individuals from liability. In the PREP Act, Congress made the judgment that, in the
context of a public health emergency, immunizing certain persons and entities from liability was
necessary to ensure that potentially life-saving countermeasures will be efficiently developed, deployed,
and administered. This Sidebar reviews the structure of the PREP Act and the HHS Declaration to explain
the scope of this liability immunity as it applies to COVID-19 countermeasures.

                                                                 Congressional Research Service

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