With crisis comes uncertainty, and even the best-intentioned regulations can leave those combatting the current COVID-19 public-health emergency out in the cold. Many have asked whether the recent Declaration under the Public Readiness and Emergency Preparedness Act1 (PREP Act) actually provides certain health care workers, drug makers, and medical device manufacturers with immunity for their role in this fight.
For this reason, on April 14, 2020, the U.S. Department of Health and Human Services (HHS) Office of General Counsel issued an advisory opinion ("Advisory Opinion") setting forth its view that federal immunity under the PREP Act may apply to certain persons employing certain countermeasures in the fight against COVID-19, even though they are technically not covered by the PREP Act, if one could have reasonably believed the persons or countermeasures were covered.
The PREP Act authorizes the Secretary of Health and Human Services (HHS) to declare that certain "covered persons" are immune from liability (i.e., loss sounding in tort or contract) for taking certain "covered countermeasures" that are necessary to combat a public-health emergency such as COVID-19. On March 10, 2020, Secretary of HHS Alex Azar issued such a declaration, effective February 4, 2020 ("Declaration").2
Under the Declaration, "covered persons" include, e.g., manufacturers, distributors, program planners, and qualified persons prescribing or administering covered countermeasures. And the Declaration defines "covered countermeasures" to include, e.g., federally approved drugs used to treat COVID-19 and federally approved devices used to prevent its spread. As we previously reported, on April 8th HHS issued guidance extending federal immunity under the PREP Act to licensed pharmacists administering approved COVID-19 testing.
HHS issued the most-recent Advisory Opinion after receiving numerous inquiries regarding whether a medical product is a "covered countermeasure," whether a person is deemed a "covered person," and whether a specific activity qualifies as use or administration of a "covered countermeasure." The Advisory Opinion sets forth the view that "[g]iven the broad scope of PREP Act immunity, Congress did not intend to impose a strict liability standard on covered persons for determining whether a product is a covered countermeasure."
Accordingly, the Advisory Opinion identifies at least two lists of covered measures issued by the FDA, which include various approved medical devices and therapeutics. It then set forth the view that:
- an entity or individual who complies with all other requirements of the PREP Act and the conditions of the Declaration will not lose PREP Act immunity—even if the medical product at issue is not a covered countermeasure—if that entity or individual reasonably could have believed that the product was a covered countermeasure;
- a person who complies with all other requirements of the PREP Act and the conditions of the Declaration will not lose PREP Act immunity—even if the person at issue is not a covered person—if the entity or individual reasonably could have believed that the person was a covered person.
The Advisory Opinion encourages all covered persons using or administering covered countermeasures to document the reasonable precautions they have taken to safely use the covered countermeasures.
The Advisory Opinion sets forth the current views of the Office of the General Counsel. It does not bind HHS or the federal courts, and it does not have the force or effect of law.
Footnotes
1 42 U.S.C. § 247d-6d.
2 For more on Secretary Azar's COVID-19 Declaration under the PREP Act, please see our previous coverage here.
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