About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline

1 1 (April 8, 2020)

handle is hein.crs/govcwzq0001 and id is 1 raw text is: 









                  Resarh Servi kM-





The PREP Act and COVID-19: Limiting

Liability for Medical Countermeasures



April 8, 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 February 4,
2020 Declaration (the HHS Declaration), 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 Countermeasures Injury Compensation 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.
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
                                                                 https://crsreports.congress.gov
                                                                                   LSB10443

CRS Lega Sidebar
Prepaed for Membeivs and
Cornm ittees  o4 Cor~qress  ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Contact us for annual subscription options:

Already a HeinOnline Subscriber?

profiles profiles most