• Compliance
  • Insights
  • Higher Ed
  • K-12

Understanding the PREP Act and Potential Liability Immunity for COVID-19 Countermeasures

Heather Salko, Esq.
March 2021
An overview of potential federal and state liability immunity available to institutions

As part of COVID-19 prevention efforts, your institution may incorporate testing or consider providing or requiring vaccines for staff and students who qualify. You are likely wondering about liability risks and how to mitigate them when engaging in these prevention efforts.

This article provides an overview of potential federal and state liability immunity available to institutions. Use it during your discussions with counsel.

The PREP Act

The Public Readiness and Emergency Preparedness (PREP) Act is a federal law that provides immunity for certain actors when providing specific medical countermeasures as defined by law. To qualify for this affirmative defense to a claim, an institution must:

  1. Be a “covered person” as defined by the act
  2. Be faced with a claim for a covered “loss” within the act’s definition
  3. Have used a “covered countermeasure” listed in the act
  4. Show a “causal relationship” between the loss and the covered countermeasure’s use

To prepare your institution to best take advantage of potential immunity available under this complex set of rules if your institution provides COVID-19 testing and vaccinations, consult with legal counsel to ensure your actions comply with PREP Act requirements, related Act Declarations, Health and Human Services (HHS) Advisory Opinions, and appropriate HHS guidance.

Discuss with counsel navigating these issues:

  • Technical specifications of each element of the PREP Act, to ensure your institution adheres to all specific requirements
  • All medical countermeasures — including testing and vaccination — you are using; this will help you understand whether they qualify as covered countermeasures and your level of potential liability exposure and areas where guidance must be followed
  • HHS COVID-19 guidance and PREP Act Declarations requirements; HHS issued these to invoke the protections of the PREP Act, and the guidance and requirements must be followed to receive PREP Act protection

Willful Misconduct

One significant exception to immunity available in the PREP Act is for “willful misconduct” — an intentional act or omission to achieve a wrongful purpose. Whether your institution engaged in willful misconduct resulting in the loss of available immunity is likely to be subject to a factual dispute during litigation.

PREP Act Litigation

While there isn’t significant existing case law addressing the PREP Act to use as guidance regarding actions that would qualify for immunity, litigation is working its way through the court system in multiple jurisdictions.

As these cases continue and are resolved, they will provide more guidance on how courts are applying the PREP Act to determine:

  • Who qualifies for immunity
  • In what situations an institution qualifies
  • Limitations on the application of the PREP Act

Ensure your institution’s leaders understand how PREP Act litigation in your jurisdiction may impact the potential protection available to your institution.

State Immunity Statutes

In addition to the federal protections under the PREP Act, most states have enacted legislation providing legal immunity for certain actors in relation to preventive and remedial measures in response to COVID-19.

Again, consulting with your institution’s legal counsel is imperative so you understand any state immunity protection available and the circumstances that must exist to be eligible for immunity as well as the interplay between state and federal immunity requirements.

Other Risk-Shifting Measures

Whether or not the complex immunity calculation applies to your institution, you can take other risk mitigation and reallocation measures when providing testing, vaccines, or other COVID-19 responses on your campus.

In consultation with counsel, consider developing and implementing these additional options:

  • Vet all contracts. Carefully review contracts with third-party testing or vaccine providers. To insulate your institution as much as possible through contracting, require these vendors or partners to adhere to relevant HHS COVID guidance and PREP Act Declarations.
  • Require indemnification clauses. Insert strong indemnification language in any third-party contracts. If immunity isn’t available to your institution, it is important to protect your institution by shifting as much risk as possible to vendors who specialize in the service under contract.
  • Require informed consent. If your institution provides COVID-19 testing or vaccines, follow a robust informed consent practice and obtain a signed form prior to providing the test or vaccine. Document the consent interaction and keep the records.
  • Utilize waivers. While waivers aren’t always enforceable, consult with counsel and use a well-crafted waiver for any appropriate activities. Because use of waivers is subject to state law limitations and interpretations, conform any waivers to those requirements.
  • Evaluate malpractice insurance. If your institution’s staff are conducting the testing or administering a vaccine, ensure there is appropriate malpractice insurance coverage for their professional actions. Also ensure these medical professionals are properly licensed and following all applicable public health guidance.

Employment and Student-Related Limitations

Even if PREP Act or state law immunities are available, they may not apply to all aspects of COVID-19.

In particular, the PREP Act doesn’t apply to employment-related claims such as discrimination or retaliation claims relating to vaccine mandates. The same is also likely true for vaccine mandates for students.

While immunity may not be available, following available employment guidance from the Equal Employment Opportunity Commission and other relevant agencies, in consultation with counsel, will provide your institution with the best position to defend against employment or enrollment claims.

In sum, while certain immunities may be available to institutions for COVID-19 related response measures, consulting with counsel and adherence to relevant guidance are essential to dismissing or defending any claims.

Note for UE members: UE’s risk management advice is distinct from the coverage provided under its policies. To understand UE’s insurance coverage for COVID-19 testing and vaccination efforts, administrators responsible for your institution’s insurance program should read UE’s recent coverage advisory.

Additional Resources