Legal Sidebari
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.
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The Public Readiness and Emergency Preparedness Act
Scope of Immunity from Liability
For the PREP Act to apply, the Secretary of HHS must determine that a disease or other threat to health
constitutes a public health emergency, or that there is a credible risk of such an emergency. The Secretary
shall consider the desirability of encouraging the design, development, testing, manufacture, and use of
countermeasures in determining whether to issue a PREP Act declaration. (A PREP Act declaration is
distinct from the Secretary’s power to declare a public health emergency under Section 319 of the Public
Health Service Act, which has a separate set of legal implications. The Secretary of HHS made the
Section 319 declaration for COVID-19 on January 31, 2020.) The Secretary must publish the PREP Act
declaration in the Federal Register and identify for each countermeasure the particular disease, time
period, population, and geographical area that the declaration covers.
If within the scope of the declaration, 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 thus break down into four elements: (1) the individual or entity must be a “covered
personâ€; (2) the legal claim must be for a “lossâ€; (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.â€
First, the PREP Act defines a covered person to include: (i) the United States; (ii) manufacturers and
distributors of covered countermeasures; (iii) “program plannersâ€; and (iv) “qualified persons†who
prescribe, administer, or dispense covered countermeasures. 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. 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.
Employees and agents of all these persons and entities are also covered persons.
Second, PREP Act immunity reaches “all claims for loss†under federal and state law. Loss is broadly
defined to mean “any type of loss,†including (i) death; (ii) physical, mental, or emotional injury, illness,
disability, or condition; (iii) fear of such injury, including medical monitoring costs; and (iv) loss of or
damage to property, including business interruption loss. This language would seem to include, at a
minimum, most state law tort, medical malpractice, and wrongful death claims arising from the
administration of covered countermeasures.
Third, the loss must have a causal relationship to the administration and use of a covered countermeasure.
As with the other elements, the PREP Act’s causation language sweeps broadly. 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.
Fourth, the medical product at issue must be a covered countermeasure. The PREP Act specifies three
general types of covered countermeasures: (i) a qualified “pandemic or epidemic productâ€; (ii) a “security
countermeasureâ€; and (iii) a drug, biological product, or device that the U.S. Food and Drug
Administration (FDA) has authorized for emergency use. (As discussed below, Congress recently added a
fourth category specifically for respiratory protective devices.) A pandemic or epidemic product includes
any drug, biological product, or device developed “to diagnose, mitigate, prevent, treat, or cure a
pandemic or epidemic†that FDA has approved, licensed, or authorized for emergency use. Security
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countermeasure refers to a drug, biological product, or device used “to diagnose, mitigate, prevent, or
treat harm from any biological, chemical, radiological, or nuclear agent†identified by the Secretary of
Homeland Security as a material threat to national security. The final category of covered countermeasure
includes drugs, biological products, and devices that FDA has authorized for use outside of the ordinary
regulatory process through an Emergency Use Authorization (EUA). FDA has made wide use of its
emergency authorities in response to the COVID-19 pandemic, issuing EUAs for certain in vitro
diagnostic products (i.e., tests for COVID-19), personal protective equipment (e.g., respirators), and
devices modified for use as ventilators.
The “Willful Misconduct†Exception
If a claim is within the PREP Act’s scope, a covered person is generally immune from legal liability. The
“sole exception†to immunity is when a covered person proximately causes death or serious physical
injury to another person through willful misconduct. A serious physical injury must be life threatening,
permanently impair a body function, permanently damage a body structure, or require medical
intervention to avoid such permanent impairment or damage. Willful misconduct requires that the covered
person acted (i) intentionally to achieve a wrongful purpose; (ii) knowingly without legal or factual
justification; and (iii) in disregard of a known or obvious risk that is so great as to make it highly probable
that the harm will outweigh the benefit.
The process by which an injured person (or their representative) may prove willful misconduct under the
PREP Act is limited in several ways. Before filing a suit claiming willful misconduct, the injured person
must first seek compensation through the Countermeasures Injury Compensation Program (see below),
and they cannot sue if they elect to receive that compensation. If they choose to file a lawsuit, injured
persons may sue only in the U.S. District Court for the District of Columbia. Such lawsuits must meet
heightened standards for pleading and discovery, and are subject to procedural provisions generally
favorable to defendants. Injured persons must prove willful misconduct by clear and convincing evidence
(a higher standard than in a typical civil case), and recovery for noneconomic damages such as pain and
suffering is limited.
The Countermeasures Injury Compensation Program
An individual seriously injured or killed by the administration of a covered countermeasure, whether or
not as a result of willful misconduct, may seek compensation through the Countermeasures Injury
Compensation Program (CICP). CICP is a regulatory process administered by HHS’s Health Resources
and Services Administration. CICP’s procedures and eligibility determinations are governed by HHS
regulations pursuant to the PREP Act. In general, eligible individuals (or their survivors) who suffer death
or serious physical injury directly caused by the administration of a covered countermeasure may receive
reimbursement for reasonable medical expenses, loss of employment income, and survivor benefits in the
case of death. Serious physical injuries under CICP are generally limited to those that warrant
hospitalization or led to a significant loss of function or disability. Congress funds CICP awards through
emergency appropriations to the Covered Countermeasure Process Fund.
CICP is distinct from the National Vaccine Injury Compensation Program, which provides compensation
for injuries caused by most vaccines routinely administered in the United States, such as childhood
vaccines (e.g., MMR, polio, hepatitis A) and non-pandemic seasonal influenza vaccines. By contrast,
CICP only applies to countermeasures covered by a PREP Act declaration of a public health emergency,
such as those issued for COVID-19, pandemic influenza (e.g., the 2009 H1N1 “swine fluâ€), and the Ebola
virus.
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HHS’s COVID-19 Declaration
On February 4, 2020, the Secretary of HHS invoked the PREP Act and determined that COVID-19
constitutes a public health emergency. The HHS Declaration therefore authorizes PREP Act immunity for
the “manufacture, testing, development, distribution, administration, and use†of covered
countermeasures. This immunity applies to all covered persons as defined in the PREP Act, including any
person authorized by state and local public health agencies (or an EUA) to “prescribe, administer, deliver,
distribute or dispense†covered countermeasures. Covered countermeasures include “any antiviral, any
other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure,
prevent, or mitigate COVID-19.†The “administration†of a covered countermeasure includes “physical
provision of the countermeasures†to patients, as well as “activities and decisions directly relating
to . . . delivery, distribution and dispensing of†the countermeasures. The HHS Declaration provides PREP
Act immunity “without geographic limitation,†beginning on February 4, 2020 and ending as late as
October 1, 2025.
Recent Congressional Actions on COVID-19 Countermeasures Liability
Three recent congressional enactments in response to the COVID-19 pandemic, all now signed into law,
relate to the scope of immunity for individuals engaged in the COVID-19 response.
Section 6005 of the Families First Coronavirus Response Act and Section 3103 of the Coronavirus Aid,
Relief, and Economic Security Act (CARES Act) amend the PREP Act to clarify that certain “personal
respiratory protective devices†(such as N95 respirators) are covered countermeasures. To be covered by
the PREP Act, the respiratory protective device must be: (i) approved by the National Institute for
Occupational Safety and Health (NIOSH) under 42 C.F.R. Part 84; and (ii) determined by the Secretary of
HHS to be a priority for use during a public health emergency. (FDA issued an EUA on March 2, 2020 for
the use of NIOSH-approved filtering respirators intended for general use in healthcare settings, and
expressed its view that the PREP Act covered these respirators prior to the amendment because of their
medical use.)
Section 3215 of the CARES Act contains an independent immunization from liability for volunteer health
care professionals responding to the COVID-19 pandemic. Under Section 3215, licensed health care
professionals are generally immune from state or federal liability for harm they cause in the course of
providing health care services in response to the COVID-19 public health emergency as a volunteer, if
they act within the scope of their license and in good faith. There are two exceptions to this immunity: (1)
if the volunteer health care professional’s acts constituted willful or criminal misconduct, gross
negligence, reckless misconduct, or a conscious flagrant indifference to the rights or safety of the
individual harmed; or (2) if the volunteer health care professional rendered health care services under the
influence of drugs or alcohol. Section 3215 immunity may overlap with PREP Act immunity or extend
beyond it in some cases (such as situations not involving a covered countermeasure).
Finally, both the CARES Act and the Coronavirus Preparedness and Response Supplemental
Appropriations Act (CPRSA) appropriate funding that HHS may use for the Covered Countermeasure
Process Fund. CPRSA appropriates $3.1 billion to the Secretary of HHS to respond to COVID-19,
including the development and purchase of countermeasures and vaccines, while allowing these funds to
“be transferred to, and merged with†the Covered Countermeasure Process Fund. Similarly, the CARES
Act appropriates $27 billion to the Secretary of HHS for similar purposes, again providing that the
Secretary may transfer these funds to the Covered Countermeasure Process Fund.
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Author Information
Kevin J. Hickey
Legislative Attorney
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