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HHS Issues Advisory Opinion Regarding PREP Act Tort Liability Immunity During COVID-19 Pandemic

April 21, 2020

Under the Public Readiness and Emergency Preparedness Act (“PREP Act”), the Secretary of the U.S. Department of Health and Human Services (“HHS”) (“Secretary”) is authorized to issue declarations that provide tort liability immunity to particular individuals and entities against claims of loss caused by, arising out of, relating to, or resulting from the development, manufacturing, testing, distribution, administration, or use of medical countermeasures to a disease or health condition that the Secretary has deemed to be a present, or credible risk of a future, public health emergency (“PREP Act Declarations”).[1] Specifically, “covered persons” who are providing “covered countermeasures,” as those terms are defined in the PREP Act, are granted tort liability immunity. The PREP Act’s broad tort liability immunity does not extend to acts of willful misconduct. Furthermore, it is important to note that a PREP Act Declaration is distinct from the Secretary’s declaration of a public health emergency, as a PREP Act Declaration may provide tort liability immunity for activities both before and after a declared public health emergency.[2]

On March 10, 2020, the Secretary issued a PREP Act Declaration for medical countermeasures against COVID-19 (the “COVID-19 Declaration”).[3] HHS received a large number of requests to clarify the scope of tort liability immunity under the COVID-19 Declaration, particularly from individuals and entities supplying goods and services to the pandemic relief effort. Thus, on April 14, 2020, the HHS Office of the General Counsel issued an omnibus advisory opinion (the “Advisory Opinion”) to address these questions and concerns. Although the Advisory Opinion is not a final agency action or a final order, or binding as a matter of law, it provides the current views of the HHS General Counsel. The following is a brief summary of some of the highlights from the Advisory Opinion.

First, the Advisory Opinion provides that tort liability immunity applies where “covered persons” are engaging in activities that include: “(1) any arrangement with the federal government, or (2) any activity that is part of an authorized emergency response at the federal, regional, state, or local level.”[4] The HHS General Counsel clarifies that “[s]uch activities can be authorized through, among other things, guidance, requests for assistance, agreements, or other arrangements” and that PREP Act immunity may apply “regardless of whether state or local authorities have declared states of emergencies.”[5]

Second, the Advisory Opinion clarifies what constitutes “covered countermeasures” under the COVID-19 Declaration. Specifically, the Advisory Opinion states that “in order to meet the definition of a qualified pandemic or epidemic product, a product (1) must be used for COVID-19; and (2) must be (a) approved, licensed, or cleared by [the Food and Drug Administration (FDA)]; (b) authorized under an [Emergency Use Authorization (“EUA”)]; (c) described in [Emergency Use Instructions (“EUI”)]; or (d) used under either an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE).”[6] In addition, because there has been uncertainty in the industry regarding whether certain products (e.g., personal protective equipment (“PPE”)) are covered by EUAs, the advisory provides a link to a list of those products that are covered by EUAs, which will be regularly updated by HHS as the FDA issues additional EUAs.[7]

Third, the Advisory Opinion emphasizes that the broad scope of the PREP Act indicates that Congress did not intend to impose a strict-liability standard for determining whether a product is a “covered countermeasure” or whether a person is a “covered person” under the COVID-19 Declaration.[8] Thus, the Advisory Opinion clarifies that a person or entity that otherwise meets the requirements for PREP Act immunity will not lose that immunity—even if the product is not a “covered countermeasure” and/or the entity or person is not a “covered person”—if it was reasonable to believe, under the current, emergent circumstances, that the product was a “covered countermeasure” or that the person was a “covered person.”[9] The Advisory Opinion provides the example of a “covered person” who took reasonable steps to substantiate the authenticity of respirators, but later determined that some or all of the respirators were counterfeit, and explains that this person would be immune against a claim arising out of the use of a counterfeit respirator.[10] Another example in the Advisory Opinion relates to a pharmacist who had inadvertently allowed his license to expire, despite the pharmacy’s reasonable compliance measure to ensure current licensure. The HHS General Counsel explains that, under these circumstances, the pharmacist would be immune against a lawsuit relating to the COVID-19 test prescribed by that pharmacist.[11]

Finally, the Advisory Opinion states HHS’s view that all “covered persons” using or administering “covered countermeasures” should document all reasonable precautions they have taken to ensure safe use of the “covered countermeasures.”[12] The Advisory Opinion offers the example of a distributor of medical products that obtains PPE from a new supplier abroad in a good-faith effort to bring PPE to affected American communities. The HHS General Counsel encourages such distributors to make available to the purchaser information about the reasonable efforts the distributor had taken to ensure the quality of the PPE (e.g., assessing the supplier’s quality-control processes). By providing this information, hospitals and other providers purchasing the PPE are better able to make more informed decisions regarding its use.[13]

If you have any questions regarding tort liability immunity under the PREP Act during the COVID-19 public health emergency, please do not hesitate to contact any member of the Health Law Practice Group at Shipman & Goodwin LLP.

 

[1]42 U.S.C. § 247d-6d; see also “PREP Act Q & As,” Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services, https://www.phe.gov/Preparedness/legal/prepact/Pages/prepqa.aspx.

[2]“PREP Act Q & As,” Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services, https://www.phe.gov/Preparedness/legal/prepact/Pages/prepqa.aspx.

[3]“Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19,” 85 Fed. Reg. 15198 (Mar. 17, 2020).

[4]“Advisory Opinion on the Public Readiness and Emergency Preparedness Act and the March 10, 2010 Declaration under the Act,” Office of the General Counsel, U.S. Department of Health and Human Services, at 2, available at https://www.hhs.gov/sites/default/files/prep-act-advisory-opinion-april-14-2020.pdf.

[5]Id.

[6]Id. at 3-4.

[7]Id.

[8]Id. at 5-7.

[9]Id.

[10]Id. at 5.

[11]Id. at 7.

[12]Id. at 8.

[13]Id.

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