Who Are “Covered Persons” Under the PREP Act – Q&A

As discussed in our previous article, which can be found here, on March 10, 2020, the Health and Human Services Department issued a Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), that provides liability immunity to certain qualified individuals and entities (“covered persons”) engaged in the manufacture, testing, development, distribution, administration and use of medical countermeasures against COVID-19. Below are some commonly asked questions relating to the PREP Act.

Who is a “covered person”?
The term “Covered Person” includes the United States and manufacturers, distributors, program planners, qualified persons and their officials, agents and employees, as those terms are defined in the PREP Act. 42 U.S.C. § 247d-6d(i)(2).

Can the PREP Act apply to non-U.S. manufacturers and distributors?
Yes. As defined in the PREP Act, the terms “manufacturer” and “distributor” are not limited to entities that are domiciled in the United States. 42 U.S.C. § 247d-6d(i)(3), (4).

Can the PREP Act apply to component part manufacturers?
Yes. The definition of “manufacturer” in the PREP Act includes component part manufacturers. Specifically, the term “manufacturer” includes “a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a covered countermeasure.” 42 U.S.C. § 247d-6d(i)(4)(B).

Aside from manufacturers and distributors, who else is a “covered person” under the PREP ACT?
In addition to manufacturers and distributors, the PREP Act affords liability immunity to a person or entity who is “a program planner of [a] countermeasure” or “a qualified person who prescribed, administered, or dispensed [a] countermeasure.” 42 U.S.C. § 247d-6d(i)(2)(B)(iii), (iv).

The term “program planner” includes “other person[s] who supervised or administered a program with respect to the administration, dispensing, distribution, provision or use of a security countermeasure or a qualified pandemic or epidemic product, including a person who has established requirements, provided policy guidance, supplied technical or scientific advice or assistance or provides a facility to administer or use a covered countermeasure in accordance with [the Secretary’s declaration].” 42 U.S.C. § 247d-6d(i)(6). Under the Declaration, “[A] private sector employer or community group or other ‘person’ can be a program planner when it carries out the described activities.”

The term “qualified person” means: “(A) a licensed health professional or other individual who is authorized to prescribe, administer or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered or dispensed; or (B) a person within a category of persons so identified in a declaration by the Secretary.” 42 U.S.C. § 247d-6d(i)(8). Regarding subsection (B), the Declaration specifies that “qualified persons” include “[a]ny person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction. . . to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency[.]”

Has there been any reported case law addressing who is a “covered person” under the PREP Act in relation to the COVID-19 pandemic?
Not at this point, though several complaints that have been filed against health care providers and others alleging personal injuries as a result of the COVID-19 outbreak have subsequently been removed to federal courts on the basis that PREP Act preemption and immunity presents a federal question pursuant to 28 U.S.C. § 1331. E.g., Estate of Joseph Maglioli, et al. v. Andover Subacute Rehabilitation Center I, et al, No. 2:20-cv-06605 (D.N.J.); Parker v. St. Jude Operating Company, LLC, No. 3:20-cv-01325 (D. Oregon); Anson v. HCP Prairie Village KS OpCo LLC, et al., No. 20-cv-2346 (D. Kansas). Believe it or not, we are still in the relatively early stages of COVID-19 litigation. As these cases and others work their way through the trial courts, and eventually appellate courts, we can expect to see case law addressing some of the issues discussed above.

What if I am unsure whether my business qualifies as a “covered person” under the PREP Act?
In an April 17, 2020 (as modified on May 19, 2020) Advisory Opinion issued by the General Counsel of the Health and Human Services Department, the Department indicated it did not believe Congress intended to impose a strict liability standard on an entity or person for the purpose of determining whether such entity or person is a “covered person” under the Act. Per this Advisory Opinion, a person who complies with all other requirements of the PREP Act and the conditions of the Secretary’s 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 the person was a covered person. However, the Department cautioned that persons seeking PREP Act immunity are responsible for determining whether a person or entity is a covered person, whether reasonable precautions have been taken to facilitate the safe use of covered countermeasures and, in general, whether PREP Act immunity applies to them and their activities. 

Separate from the PREP Act, some individual states have also passed legislation granting certain businesses immunity protection from civil liability during the pandemic. For example, the Georgia COVID-19 Pandemic Business Safety Act, which was signed into law on August 5, provides that businesses and health care providers cannot be held liable for injuries or deaths related to coronavirus treatment, exposure or infection unless it can be established that a defendant committed gross negligence or willful misconduct.

Further, the U.S. Senate is currently debating the Safe to Work Act, which would impose additional and significant hurdles for workers, customers and patients who want to sue businesses and health care providers over coronavirus-related injuries. 

If you have questions concerning the PREP Act, state specific or other proposed legislation, and/or their potential applicability to you, please reach out to the Ice Miller COVID-19 Task Force for more information.

This publication is intended for general information purposes only and does not and is not intended to constitute legal advice. The reader should consult with legal counsel to determine how laws or decisions discussed herein apply to the reader’s specific circumstances.