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Guidance COVID-19

Federal PREP Act Liability Protections for COVID-19 Vaccination

January 9, 2021

Overview

Local health departments play a crucial role in prescribing and administering COVID-19 vaccines and in supervising and administering COVID-19 vaccination programs. This new role has raised questions about the liability protections available to local health departments and their employees under the Federal PREP Act.

Question: If a local health department employee administers a COVID-19 vaccine, to what extent are the employee and the health department protected from liability under the Federal PREP Act?

Answer: The Federal PREP Act provides liability protection to local health departments and their employees for “Recommended Activities” associated with “Covered Countermeasures” such as administering FDA-authorized vaccines. The “sole exception” to the PREP Act’s liability protection is for death or injury caused by a Covered Person’s willful misconduct. Absent willful misconduct, an injured party’s only remedy is to seek compensation through the Countermeasures Injury Compensation Program (CICP). Thus, the Federal PREP Act provides liability protection to local health departments and their employees for prescribing and administering FDA-authorized COVID-19 vaccines as well as for supervising and administering COVID-19 vaccination programs.

The federal Public Readiness and Emergency Preparedness (PREP) Act authorizes the Secretary of the U.S. Department of Health and Human Services (HHS) to issue a Declaration of a public health emergency to protect “Covered Persons” from liability for claims relating to “Recommended Activities” involving “Covered Countermeasures.” The HHS Secretary first issued a PREP Act Declaration relating to COVID-19 on March 17, 2020, with amendments issued on April 15, 2020, June 8, 2020, August 24, 2020, and December 9, 2020. The full COVID-19 PREP Act Declaration, as amended, is provided in the December 9 amendment. While the COVID-19 PREP Act Declaration protects a wide variety of individuals and entities from liability associated with activities related to the COVID-19 pandemic, we describe only the most relevant provisions below.

Under the COVID-19 PREP Act Declaration, as amended:

  • Covered Persons include “program planners” and “qualified persons,” as well as their officials, agents, and employees.
    • Program planners include State, local, or tribal governments and their employees who supervise or administer a program relating to “the administration, dispensing, distribution, provision, or use” of a Covered Countermeasure.
    • Qualified persons include “a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures” under State law.
    • Qualified persons also include those authorized as part of the public health and medical response of an “Authority Having Jurisdiction” following a declaration of emergency (discussed further below).
  • Covered Countermeasures include vaccines developed and administered to prevent transmission of SARS-CoV-2, as well as any device used to administer the vaccine, as long as the countermeasure has received an appropriate FDA approval/authorization.
  • Recommended Activities include “the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures.” “Administration of the Covered Countermeasure” is defined broadly in the Declaration to include not only “physical provision of the countermeasures to recipients,” but also “activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures,” as well as management and operation of countermeasure programs or distribution locations.

The Declaration’s liability protections are limited to specified distribution channels, including those involving (1) federal agreements or (2) activities authorized in connection with the public health and medical response of an Authority Having Jurisdiction (e.g., a State or local health department) “to prescribe, administer, deliver, distribute, or dispense Covered Countermeasures,” if the agency has declared an emergency to administer and use Covered Countermeasures. For more information about the meaning of “program planner” and “Authority Having Jurisdiction” under the COVID-19 PREP Act Declaration, see the HHS General Counsel’s Advisory Opinion incorporated into the COVID-19 PREP Act Declaration via the December 9 amendment. The COVID-19 PREP Act Declaration also provides liability protections for private distribution channels in specified circumstances.

The current version of the COVID-19 PREP Act Declaration explicitly extends immunity to situations in which a Covered Countermeasure is not administered to certain individuals due to a limited supply. Specifically, the amended Declaration provides that “where there are limited Covered Countermeasures, not administering a Covered Countermeasure to one individual in order to administer it to another individual” can qualify for PREP Act protection under the COVID-19 Declaration if all other requirements are met (emphasis in original).

Note that several courts have recently declined to apply PREP Act immunity to situations in which Covered Persons have allegedly failed to implement appropriate COVID-19 protocols and provide personal protective equipment (PPE) to employees, interpreting the PREP Act as applying only to claims connected to the use of—but not the failure to use—covered countermeasures. However, these decisions were issued under prior versions of the COVID-19 Declaration that did not include the above-quoted language and, for the most part, focused on quality of care issues rather than supply shortages.

Nevertheless, it is not entirely clear whether the courts in these cases were interpreting the PREP Act alone or as extended by the COVID-19 Declaration; thus, it is possible that a court could disavow the HHS Secretary’s authority to extend PREP Act immunity to a Covered Person who does not administer a countermeasure, even due to limited supply. See also Casabianca v. Mount Sinai Med. Ctr., Inc., 2014 N.Y. Slip Op. 33583 (N.Y.Sup.Ct. 2014) (refusing to apply PREP Act immunity to a Covered Person’s failure to administer an H1N1 vaccine due to a vaccine shortage, even though the decision aligned with federal and state guidance; however, it appears the H1N1 PREP Act Declaration did not include similar language to the COVID-19 Declaration language quoted above).

For more information about the PREP Act, see the Michigan Department of Health and Human Services document, The Public Readiness and Preparedness Act (PREP): What you need to know. Note that state laws may provide additional liability protection to local health departments and/or their employees when performing health department functions.

The Network for Public Health Law provides information and education about laws related to the public’s health. We do not provide legal representation or provide advice on a particular course of action.