From our very first post back in early 2020 on preclusive power of the PREP Act, 42 U.S.C. §247d-6d, we were impressed by the scope of its combined preemption and immunity language. There, we quoted the language from the HHS secretary’s emergency declaration:
[A] covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure.
Quoting 85 Fed. Reg. 15198, 15199 (HHS March 17, 2020).
The statutory language itself is just as broad. The PREP Act provides that a “qualified countermeasure” includes any “biological product” (such as vaccines) used “to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease).” 42 U.S.C. §247d-6d(a)(2)(A)(i). The statute also contains strong “liability protections” for “covered countermeasures” and “covered persons,” which are defined terms:
(1) Covered countermeasure
The term “covered countermeasure” means −
(A) a qualified pandemic or epidemic product (as defined in paragraph (7)); . . . . [or]
(C) a . . . biological product . . . that is authorized for emergency use in accordance with [pertinent portions of the FDCA.]
42 U.S.C. §247d-6d(i)(1). The term “biological product” includes vaccines. 42 U.S.C. §262(i)(1).
(2) Covered person
The term “covered person”, when used with respect to the administration or use of a covered countermeasure, means −. . .
(B) a person or entity that is −
(i) a manufacturer of such countermeasure;
(ii) a distributor of such countermeasure;. . . or
(v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv).
42 U.S.C. §247d-6d(i)(2). Obviously, a vaccine manufacturer is a “covered person.”
For both “covered persons” and “covered countermeasures” the Act provides extensive preemption:
(8) Preemption of State law
During the effective period of a declaration . . ., or at any time with respect to conduct undertaken in accordance with such declaration, no State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that −
(A) is different from, or is in conflict with, any requirement applicable under this section; and
(B) relates to the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under this section or any other provision of this chapter, or under the Federal Food, Drug, and Cosmetic Act.
This statutory language reflects “clear congressional intent that the prescribed remedies be exclusive.” Mitchell v. Advanced HCS, L.L.C., 28 F.4th 580, 587 (5th Cir. 2022). “To encourage voluntary participation in the distribution of these countermeasures, the Secretary of [HHS] invoked the [PREP Act], to provide legal immunity for the individuals and organizations who provided these countermeasures to the public.” Leonard v. Alabama State Board of Pharmacy, 61 F.4th 902, 905 (11th Cir. 2023). The relevant legislative history demonstrates that Congress enacted the PREP Act in 2005:
To encourage the expeditious development and deployment of medical countermeasures during a public health emergency . . . [by] authoriz[ing] the [HHS] Secretary to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines. . . . In the PREP Act, Congress made the judgment that, in the context of a public health emergency, immunizing certain persons and entities from liability was necessary to ensure that potentially life-saving countermeasures will be efficiently developed, deployed, and administered.
“The PREP Act & COVID-19, Part 1: Statutory Authority to Limit Liability for Medical Countermeasures” 1, 1 (Cong. Res. Serv. April 13, 2022) (available here) (emphasis added). See, e.g., Cannon v. Watermark Retirement Communities, Inc., 45 F.4th 137, 139 (D.C. Cir. 2022) (quoting this publication). “The purpose of the PREP Act, as supplemented by the amended PREP Act declaration, was to encourage covered providers to implement covered countermeasures as quickly and broadly as reasonably possible without fear of liability.” Mills v. Hartford Healthcare Corp., 298 A.3d 605, 630 (Conn. 2023) (citation omitted). “Under this plain, clear, and unambiguous language, the PREP Act was designed to prevent lawsuits that would arise from the physical provision of covered countermeasures to the end-user.” Pugh v. Okuley’s Pharmacy & Home Medical, 224 N.E.3d 619, 2023 WL 5862281, at *3 (Ohio App. Sept. 11, 2023).
All of which brings us to the peculiar decision in Dressen v. AstraZeneca AB, 2024 WL 4666577 (D. Utah Nov. 4, 2024). Despite all of Congress’ belt-and-suspenders language in the PREP Act intended to preclude personal injury claims involving anti-pandemic vaccines (and other “covered countermeasures”), Dressen refused to dismiss just such a cause of action.
We think the Dressen decision is wrong, for the following reasons.
The “facts” – check, that, the plaintiff’s allegations, which the court had to accept as true – sound troubling. Allegedly (and we highly doubt any of this is actually true), the plaintiff enrolled in the vaccine manufacturer defendant’s clinical trial. Plaintiff claims that she signed an “informed consent form” promising certain benefits “if [plaintiff] became ill or injured while participating” in the study. 2024 WL 4666577, at *1 (footnote omitted). However, that same form contained a PREP Act disclaimer of liability, which the opinion quoted in full. Id. That disclaimer included specific notice that “compensation for injuries may be available to you under this Countermeasures Injury Compensation Program.” Id. We discussed this program (abbreviated CICP) here and here. Plaintiff claimed, first, that the experimental vaccine injured her and, second, “breach of contract” when the defendant vaccine manufacturer refused to pay her what she demanded. Id. at *2.
Dressen “f[ound] the text of the PREP Act exempts contractual violations from its scope of immunity.” Id. at *3. Where that “text” is, or what it might say, we frankly don’t know.
We’ve quoted, above, both the relevant statutory text, 42 U.S.C. §247d-6d(b)(8), and the language of the HHS emergency declaration, 85 Fed. Reg. 15198, 15199 (HHS March 17, 2020), and neither of them draw any distinction between tort and contract. The statute preempts “any provision of [state] law” and the declaration proclaims immunity from “with respect to all claims for loss.” Tellingly, when discussing the PREP Act, Dressen omits this language. Instead, it focuses on...
