April 15, 2020

HHS Issues Advisory Opinion on PREP Act Declaration Immunity

On April 14, 2020, the General Counsel for the Department of Health & Human Services (HHS) issued an Advisory Opinion (the Opinion) concerning the Public Readiness and Emergency Preparedness Act (the PREP Act) and the March 10, 2020 Declaration issued pursuant to the PREP Act to address questions about the scope of immunity conferred under the two during the COVID-19 pandemic. The Opinion is in response to numerous requests for advisory opinions on whether various activities qualify for PREP Act immunity. While the Opinion is not a final agency action or order nor binding as a matter of law, it serves to illuminate the current views of the General Counsel. A copy of the Opinion can be found here.

 As background, on March 10, 2020, Alex M. Azar II, Secretary of HHS, issued a Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d), to provide immunity for “Covered Persons” engaging in “Recommended Activities” involving “Covered Countermeasures” against COVID-19 (the Declaration).  More information about this Declaration, and the immunity conferred pursuant to the PREP Act can be found here.

This omnibus Opinion provides guidance on who qualifies as a “Covered Person,” whether or not a particular product should be considered a “Covered Countermeasure,” clarifies the limitations of the immunity conferred, and outlines what standard may be applied to an entity seeking to invoke these protections in the future. The highlights of the Opinion can be summarized as follows:

  • The Opinion Broadly Interprets the Activities With Immunity. The General Counsel advises that immunity applies where covered persons are engaged in activities that include (a) any arrangement with the federal government (not just a federal contract) or (b) any activity that is “part of an authorized emergency response at the federal, regional, state, or local level.” See the Opinion, at 2. The Opinion further clarifies that an Authority Having Jurisdiction may “authorize”  activities through guidance documents, requests for assistance, agreements or “other arrangements,” and that immunity granted by the PREP Act may apply regardless of whether a state or local authority has declared a state of emergency. Id.
  • The Opinion Clarifies Limitations of PREP Act Immunity. The Opinion clarifies that PREP Act immunity is not absolute – it only applies to claims for personal injury or damage to property and would not apply to enforcement actions brought by the federal government or claims under federal law for equitable relief. The Opinion also highlights, however, that PREP Act immunity must be read “in light of the PREP Act’s broad, express-preemption provision.” Id.
  • The Opinion Offers Guidance on What Products Are “Covered Countermeasures.” The Opinion highlights that it would be “too numerous to list” every product that might be considered a “Covered Countermeasure.” Id. at 3. It does, however, provide a list of products (such as various diagnostic tests, sterilization and decontamination products and systems, multiple types of ventilators and related accessories, and personal protective equipment (PPE) such as respirators and face shields) that are already subject to an Emergency Use Authorization (EUA), and advises that this list will be updated as the Food and Drug Administration (FDA) issues additional EUAs.1 
  • The Opinion Confirms That an Authority Having Jurisdiction Can Broaden Who Might Be Considered a “Covered Person” Entitled to Immunity. The Opinion outlines that HHS would be considered an Authority Having Jurisdiction, but that HHS is not the only Authority Having Jurisdiction, and that any public agency or its delegate with legal responsibility or authority to respond to the COVID-19 pandemic may authorize a person or entity to act as a “Covered Person.” Id. at 6. The Opinion also provides a helpful example of a pharmacist qualifying as a “Covered Person” in certain circumstances.
  • The Opinion Safeguards Those With Reasonable Beliefs About Qualifying as a “Covered Countermeasure” or “Covered Person.” The Opinion clarifies that Congress did not intend to impose strict liability standards on individuals or entities when attempting to discern if a product is a “Covered Countermeasure,” and/or if a person or entity is a “Covered Person.” The Opinion states that a person or entity that otherwise meets the requirements for PREP Act immunity should not lose that immunity if they mistakenly believed the product involved was a “Covered Countermeasure,” and/or that they were a “Covered Person,” if that person or entity could have reasonably believed that the product was a “Covered Countermeasure” and/or that they were a “Covered Person.” Id. at 7. 
  • The Opinion Stresses “Covered Persons” Should Take Reasonable Precautions. While the PREP Act confers broad immunity for claims of loss absent “willful misconduct,” the Opinion stresses that HHS would like to encourage all “Covered Persons” using a “Covered Countermeasure” to “take reasonable precautions” to ensure safe use of products and make information available to end users to “provide greater transparency” when possible. Id. at 8.

The Opinion concludes by asserting that persons seeking PREP Act immunity are responsible for determining whether their products are “Covered Countermeasures,” whether a person or entity is a “Covered Person,” whether reasonable precautions have been taken to facilitate the safe use of a “Covered Countermeasure,” and, in general, whether immunity applies to them and their activities. Id. at 9. 

For more information about this Opinion, PREP Act immunity, and/or other issues related to Product Liability and Mass Torts, please contact any of the authors, any member of the Faegre Drinker Product Liability Mass Tort COVID-19 Task Force and/or Faegre Drinker’s Government Contracts team

  1. Id. at 3-4. The Opinion also notes that the definitions of “Covered Countermeasure” contained within the Declaration are sufficiently broad to accommodate the amendment to the PREP Act that was made by the Coronavirus Aid, Relief, and Economic Security (CARES) Act § 3103, Pub. L. No. 116-136 (March 27, 2020). However, the Opinion states that for clarity purposes, the Secretary has issued an amendment to the Declaration effective March 27, 2020, that will be published in the Federal Register on April 15, 2020. Id. at 3, n.5. 

As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.

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