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.
42 U.S.C. §247d-6d(b)(8).
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 certain “immunity” language precluding “any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure.” 2024 WL 4666577, at *4 (quoting 42 U.S.C. §247d-6d(a)(2)(B). But, of course, the requisite “causal relationship” existed in Dressen – but for the alleged injuries from the plaintiff’s receipt of the defendant’s experimental vaccine, there would be no lawsuit.
Ignoring the PREP Act’s actual language, Dressen purports to give “a more targeted meaning” to the PREP Act’s broad “relate to” causation language. Id. at *5. Dressen relies on a Ninth Circuit case, involving testing of prison inmates – not vaccines – that had held:
The surrounding verbal phrases − “caused by,” “arising out of,” and “resulting from,” § 247d-6d(a)(1) − all connote some type of causal relationship. At the very least, then, for PREP Act immunity to apply, the underlying use or administration of a covered countermeasure must have played some role in bringing about or contributing to the plaintiff’s injury.
Hampton v. California, 83 F.4th 754, 764 (9th Cir. 2023). In stark contrast to the outdated tests in Hampton, all of the injuries claimed in Dressen stemmed directly from the administration of a PREP Act “covered countermeasure” – the experimental vaccine. That was what the claimed contract was for.
Dressen relied on a couple of other entirely distinguishable “contract” cases, Fusion Diagnostic Laboratories, LLC. v. Atila Biosystems, Inc., 2024 WL 3024915 (D.N.J. June 17, 2024), and WorkCare, Inc. v. Plymouth Medical, LLC, 2021 WL 4816631 (C.D. Cal. Aug. 20, 2021). 2024 WL 4666577, at *6. Neither decision involved a contract under which anyone was administered a “covered countermeasure.” Instead, both involved disputes between commercial entities involved in the production of such countermeasures. See Fusion Diagnostic, 2024 WL 3024915, at *5 (“Plaintiff does not allege loss from the ‘administration to or the use by an individual’ of a covered countermeasure, but rather sues as a buyer seeking to hold the seller liable for the sale of allegedly defective Covid tests”); WorkCare, 2021 WL 4816631, at *4-5 (making a “promise . . . to replace unusable tests” was “not engag[ing] in the ‘administration’ of covered countermeasures”). Because the COVID tests in both Fusion Diagnostic and WorkCare were defective, they simply could not be “administered” in the first place. That obviously wasn’t the case in Dressen, where the entire purpose of the claimed contract – part of a medical informed consent form – was to induce the “administration” of the vaccine, which it did. Thus, despite admitting that the plaintiff did “not provide the court a textual basis for her argument that § 247d-6d(a) excludes breach of contract claims from its scope,” 2024 WL 3024915, at *7, Dressen simply invented its own implausible argument.
Dressen’s statutory analysis is patently flawed, and indeed utterly ignores the actual text of both the PREP Act and the HHS emergency declaration, which draw no distinctions between types of causes of action. The other reasons offered in Dressen for allowing liability did not even claim to respect what Congress enacted in the PREP Act.
First, Dressen claims that only the breach of contract, and not the administration of the experimental vaccine, “caused” the plaintiff’s damages. Id. at *7-8. To quote Shania Twain, “that don’t impress us much.” Take away the vaccine, and there are no damages. All of the damages that the plaintiff claimed involve medical treatment for the asserted vaccine-related injury:
[Plaintiff’s] need for medical care and medication “skyrocketed” after receiving the vaccine. [Plaintiff] and her husband repeatedly sought reimbursement for these costs from [defendant]to little or no avail. . . . [Defendant] corresponded several times with [plaintiff], confirming receipt of medical records, seeking more information about [plaintiff’s] providers, and informing [plaintiff it] was in the process of evaluating her claims.
Id. at *2 (emphasis added). Dressen was never a contract case. It was always a tort case – seeking tort damages – dressed up in contract garb in order to fool the court. In that it succeeded.
Thus, no vaccination = no damages. That is pure “but for” causation, not merely concurrent causation. Moreover, concurrent cause in Utah law depends on foreseeability.
An intervening negligent act does not automatically become a superseding cause that relieves the original actor of liability. The earlier actor is charged with the foreseeable negligent acts of others. Therefore, if the intervening negligence is foreseeable, the earlier negligent act is a concurring cause. This includes situations where negligent or other wrongful conduct of others should reasonably be anticipated.
Godesky v. Provo City Corp., 690 P.2d 541, 545 (Utah 1984). The act in Dressen that the decision claimed to be noncausal is the administration of the “covered countermeasure.” That’s way, way more than merely “foreseeable,” since the entire purpose of the contract that the plaintiff claimed was breached was to induce the vaccination.
Immunity under the PREP Act turns on whether a “covered countermeasure” was “administered” – not whether that countermeasure “was defective,” whether the labeling was “deceptive,” or how it was advertised. 2024 WL 3024915, at *9. There is indeed “fundamental[] confus[ion]” in Dressen, id., but that confusion does not lie with either the defendant’s arguments or the PREP Act.
Scratch one flattop.
The next rationale Dressen offers is that something in the PREP Act’s “statutory scheme” as a whole “suggests” that “only tort-like losses” are covered by the Act’s immunity and preemption. Id. at *9-10. That argument necessarily posits that the express terms of the Act are somehow not controlling. That, again, is a blatant legal no-no. E.g., St. Jeor v. Kerr Corp., 353 P.3d 137, 140 (Utah 2015) (“declin[ing a] request to look to the spirit of the [enactment] rather than the text itself”); Jordan Credit Union v. Sullivan, 520 P.3d 929, 931 (Utah App. 2022) (“to credit this position would require us to ignore the plain language” of the enactment “which we cannot do”). It’s also factually incorrect because, as already discussed, all of the claimed “losses” were for plaintiff’s medical care and personal injury, and therefore were “tort-like.”
This argument is based on an overreading of an allowed claim under the PREP Act that the plaintiff didn’t even make – one for “willful misconduct.” Dressen, 2024 WL 3024915, at *10. Dressen contends that this exception means that the PREP Act as a whole does not immunize contract claims because the exception concerns “an aggravating factor in tort.” Id. The logic that, because Congress provided an exception for an aggravated tort, it somehow expressed an intent to limit the immunity it simultaneously granted to “non-willful tortious conduct,” id., is frankly hard to follow. By far the most logical understanding of this extremely limited exception, is that the broad immunity means exactly what it said, and that the only exception is the one expressly stated, rather than some sub rosa unexpressed intent to limit the immunity/preemption in some other way not mentioned at all in the exception.
Send another flattop to the bottom.
The next rationale in Dressen is another version of ignoring the letter of the law under the pretext of pursuing its spirit. In version 2.0, the excuse is that “immunizing” a defendant from “contract claims . . . runs counter to the purpose of the PREP Act.” Id. at *10-11. Here’s the argument:
The sanctity of contract is precisely what allegedly induced [plaintiff] to participate in [the] clinical trial involving a experimental vaccine. It is generally in the public interest to enforce valid contracts and make parties live up to their agreements. If the PREP Act immunized deceptive contractual inducement and sanctioned illusory promises, then no one would agree to undertake the high-risk activities that are critical during public health emergency responses.
2024 WL 3024915, at *11 (footnotes omitted).
That argument finds no support in the PREP Act’s actual text, and doesn’t make much practical sense, either. Hundreds of millions of people received COVID vaccines under Emergency Use Authorizations. Next to none of them did so pursuant to the sort of “contract” alleged in Dresser. No deterrence existed. People received COVID-19 vaccinations, not in reliance on any financial incentive, but because these vaccines were the best defense against a dangerous new disease that ultimately killed over a million Americans. The assertion that indemnification makes any difference in vaccine use is not just entirely speculative, but simply contrafactual.
This argument is also contra-statutory. It invokes the “absurdity doctrine,” id. at *1, which, as we have discussed elsewhere, is a straightforward plea to jettison statutory text when a literal interpretation purportedly leads to “absurd results.” But there is nothing “absurd” here, nor are the claimed contractual promises “illusory,” as Dressen repeatedly asserts – also without any basis. A remedy remains, specifically the express terms of the aforementioned contractual disclaimer through which “the parties agreed federal law may limit [plaintiff’s] right to sue:
You may be prevented from making claims for injuries . . . including, but not limited to, claims for death; physical, mental, or emotional injury, illness, disability. . . . However, the federal government has a program that may provide compensation to you or your family if you experience serious physical injuries. . . . [C]ompensation for injuries may be available to you under this Countermeasures Injury Compensation Program.
Dressen, 2024 WL 3024915, at *1. That’s the remedy every vaccine recipient has if all else fails – equally available to everyone in the country. The PREP Act is like the Vaccine Act. It replaces remedies that plaintiffs could otherwise seek in court with a statutory compensation system. See, e.g., 86 Fed. Reg. at 21211-12 (discussing this program in the context of declaring the original COVID emergency). The plaintiff in Dressen is trying to get more than her share of relief by making an immunized claim in “contract” rather than tort.
Scratch the last flattop.
Thus, we view Dressen in the same way we have described a number of other egregiously incorrect decisions – as committing “spherical error,” that is, error no matter how one looks at it.