Dressen v. AstraZeneca AB

Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 1 FILED United States Court of Appeals PUBLISH Tenth Circuit UNITED STATES COURT OF APPEALS July 23, 2026 Christopher M. Wolpert FOR THE TENTH CIRCUIT Clerk of Court _________________________________ BRIANNE DRESSEN, Plaintiff - Appellee, v. No. 24-4114 ASTRAZENECA AB, a Sweden corporation; ASTRAZENECA PHARMACEUTICALS LP, a Delaware Limited Partnership, Defendants - Appellants. _________________________________ Appeal from the United States District Court for the District of Utah (D.C. No. 2:24-CV-00337-RJS-CMR) _________________________________ Robert Reeves Anderson of Arnold & Porter Kaye Scholer LLP, Denver, CO (Arthur E. Brown and Alexander Cousins of Arnold & Porter Kaye Scholer LLP, New York, NY; Mathew M. Cannon and Kamie F. Brown of Ray Quinney & Nebeker P.C., Salt Lake City, UT; and Samuel I. Ferenc of Arnold & Porter Kaye Scholer LLP, Washington, DC, with him on the briefs), for Defendants-Appellants. Michael Connett of Siri & Glimstad LLP, Los Angeles, CA (Jason R. Hull and Anikka T. Hoidal of Marshall Olson & Hull, PC, Salt Lake City, UT; Catherine Cline of Siri & Glimstad LLP, Aventura, FL; and Aaron Siri of Siri & Glimstad LLP, New York, NY, with him on the brief), for Plaintiff-Appellee. _________________________________ Before HARTZ, TYMKOVICH, and BACHARACH, Circuit Judges. _________________________________ HARTZ, Circuit Judge. _________________________________  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 2 To encourage the development and use of new preventive and treatment measures during a health emergency declared by the federal government, the Public Readiness and Emergency Preparedness Act (the PREP Act) provides broad immunity from suit and liability to those providing such measures, such as developers of vaccines. This appeal concerns the scope of that immunity. At the height of the COVID-19 pandemic in 2020, Brianne Dressen participated in one of AstraZeneca’s 1 vaccine trials. Before doing so, she needed to sign an informed-consent form (the ICF). The form said that the company had an insurance policy to cover the costs of injuries caused by the vaccine, tests, or procedures. It also disclosed, however, that federal law may limit her right to sue for vaccine-related injuries. According to the form, the federal government had issued an order that, if applicable, could limit Dressen’s “right to sue [AstraZeneca] if [she is] injured or harmed while participating in [the] COVID-19 related clinical study.” Aplts. App., Vol. I at 62. Dressen suffered debilitating medical injuries after receiving the experimental vaccine. When AstraZeneca rejected her request for care and compensation, she filed this breach-of-contract suit. AstraZeneca moved to dismiss, claiming that it had immunity under the PREP Act. The district court denied the motion. It ruled that “[d]espite the [PREP Act’s] seemingly broad scope,” Dressen v. AstraZeneca AB, No. 2:24-cv-00337-RJS-CMR, 1 For convenience, we refer to Appellants collectively as AstraZeneca. 2  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 3 2024 WL 4666577, at *6 (D. Utah Nov. 4, 2024), it shields AstraZeneca only from claims for tortious conduct, not breach of contract, see id. at *9. Our view is different. Exercising jurisdiction under the collateral-order doctrine interpreting 28 U.S.C. § 1291, we reverse the district court and hold that the statute immunizes all claims for loss, including breach-of-contract damages. We must remand, however, for the district court to now consider whether AstraZeneca waived its immunity in the ICF. I. BACKGROUND A. The Informed-Consent Form In November 2020 Dressen received AstraZeneca’s experimental COVID-19 vaccine. Velocity Clinical Research, Inc. (Velocity) administered the trial on the company’s behalf. Before receiving the vaccine, Dressen signed AstraZeneca’s ICF, which described “her rights and responsibilities as a trial participant and disclosed possible side effects of the vaccine.” Dressen, 2024 WL 4666577, at *1. It provided (1) that AstraZeneca would reimburse Dressen for “time and travel in the amounts of $125.00 per each completed study visit and $30.00 for each completed phone call,” and (2) that a “study doctor” would “provide medical treatment or refer [Dressen] for treatment” if she became “ill or injured” during the study. Dressen, 2024 WL 4666577, at *1 (internal quotation marks omitted); see Aplts. App., Vol. I at 61. The ICF further told Dressen that AstraZeneca had an insurance policy to “cover the costs of research injuries as long as [she has] followed [the] study doctor’s instructions.” Id. at 62. It said that AstraZeneca “will pay the costs of medical 3  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 4 treatment for research injuries, provided that the costs are reasonable, and [Dressen] did not cause the injury [herself].” Id. The term research injuries was defined as injuries “caused by the vaccine, tests or procedures” but excluded “[i]njuries caused by [a patient’s] usual medical care.” Id. The ICF also disclosed that federal law may limit Dressen’s right to sue for vaccine-related injuries: Due to the coronavirus public health crisis, the federal government has issued an order [strictly speaking, a declaration] that may limit your right to sue if you are injured or harmed while participating in this COVID-19- related clinical study. If the order applies, it limits your right to sue the researchers, healthcare providers, any Sponsor or manufacturer or distributor involved with the Study. You may be prevented from making claims for injuries that have a causal relationship with the use of the investigational product in this Study, including, but not limited to, claims for death; physical, mental, or emotional injury, illness, disability, or condition; fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and loss of or damage to property, including business interruption loss. However, the federal government has a program that may provide compensation to you or your family if you experience serious physical injuries or death. If funds are appropriated by Congress, compensation for injuries may be available to you under this Countermeasures Injury Compensation Program. Id. (emphasis added). B. Statutory Background Congress passed the PREP Act in 2005 “[t]o encourage the expeditious development and deployment of medical countermeasures during a public health emergency,” such as the COVID-19 pandemic. Kevin J. Hickey, Cong. Rsch. Serv., 4  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 5 LSB10443, The PREP Act and COVID-19, Part 1: Statutory Authority to Limit Liability for Medical Countermeasures, Congressional Research Service 1 (2022), https://www.congress.gov/crs-product/LSB10443 [https://perma.cc/D5XE-5DY3]. It authorizes the Secretary of the United States Department of Health and Human Services (HHS) to issue a declaration to “limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines.” Id.; see 42 U.S.C. § 247d-6d(a)(1). The statute provides immunity for the provision of covered countermeasures by covered persons. “Covered countermeasures” include any “drug,” “biological product,” or “device,” id. § 247d-6d(i)(1), that is “manufactured,” “used,” or “developed” to “diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic[,] or . . . to limit the harm such pandemic or epidemic might otherwise cause,” id. § 247d-6d(i)(7)(A)(i). As relevant here, the term covered person includes “a manufacturer of [a covered] countermeasure” and “a distributor of such countermeasure.” Id. § 247d-6d(i)(2)(B)(i)–(ii). Vaccines, like the COVID-19 vaccine, are “covered countermeasures” under the statute, and AstraZeneca is a “covered person.” Under the Act, “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 the use by an individual of a covered countermeasure if a declaration [by the Secretary of HHS] has been issued with respect to such countermeasure.” Id. § 247d-6d(a)(1). The statute defines loss as 5  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 6 “any type of loss, including . . . (i) death; (ii) physical, mental, or emotional injury, illness, disability, or condition; (iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and (iv) loss of or damage to property, including business interruption loss.” Id. § 247d- 6d(a)(2)(A). The immunity extends to “any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure, including a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure.” Id. § 247d-6d(a)(2)(B) (emphasis added). The “sole exception” to this immunity is “an exclusive Federal cause of action” available for “death or serious physical injury proximately caused by willful misconduct” by a “covered person.” Id. § 247d-6d(d)(1) (emphasis added). The Act does, however, offer compensation to some injured recipients of covered countermeasures. It provides that an individual who suffers “serious physical injury or death” from the administration of a covered countermeasure may seek compensation from the Covered Countermeasure Process Fund (CCPF), see id. § 247d-6e, which is administered by the Countermeasures Injury Compensation Program (CICP), see Countermeasures Injury Compensation Program, Health Res. & Servs. Admin. (May 2026), https://www.hrsa.gov/cicp [https://perma.cc/LA4Q- JAE8]. 6  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 7 In sum, for the PREP Act to apply and immunize vaccine manufacturers like AstraZeneca, (1) the Secretary of HHS must first declare a public health emergency (2) the individual or entity seeking immunity must be a “covered person”; (3) the claim against the covered person must be for a “loss”; (4) the manufacturer must manufacture a product that is a “covered countermeasure”; and (5) the loss must bear a “causal relationship” with the administration or use of a covered countermeasure. 42 U.S.C. § 247d-6d(a)(1); id. § 247d-6d(a)(2)(B); see Hickey, Cong. Rsch. Serv., supra, at 1–2. The dispute here turns largely on the meaning of loss. In March 2020 the Secretary of HHS declared COVID-19 a public health emergency under the PREP Act, triggering statutory immunity. See Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198, 15201–02 (Mar. 17, 2020). In that declaration the Secretary recommended “the manufacture, testing, development, distribution, administration, and use of” covered countermeasures, including vaccines, “to treat, diagnose, cure, prevent, or mitigate COVID-19.” Id. at 15,201. The Secretary also declared that “[l]iability immunity as prescribed in the PREP Act . . . is in effect” for the activities he recommended. Id. C. District-Court Proceedings Dressen sued AstraZeneca, 2 alleging claims for breach of contract, including breach of the contractual duty of good faith and fair dealing, by allegedly failing to 2 Dressen also sued Velocity, raising the same claims. She later voluntarily dismissed Velocity from the suit. See Dressen, 2024 WL 4666577, at *2. 7  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 8 compensate her as promised in the ICF. See Dressen, 2024 WL 4666577, at *2. She alleged that AstraZeneca “had a contractual obligation (1) to ‘cover the costs’ of the research injury, including but not limited to medical costs; and (2) to provide medical care and/or refer [her] for medical care.” Aplts. App., Vol. I at 45 (Complaint) (internal quotation marks omitted). And she alleged that AstraZeneca breached its duty by acting with “unconscionable delay,” among other things. Id. at 46 (Complaint). She sought damages for the cost of her past and future medical care, lost income, household services, childcare expenses, and attorney fees, as well as emotional distress. AstraZeneca moved to dismiss the complaint for failure to state a claim. See Dressen, 2024 WL 4666577, at *1. The district court denied AstraZeneca’s motion because it determined that the PREP Act does not immunize against contract-based claims. See id. at *4–11. It reasoned that the “administration” or “use” of a covered countermeasure “cannot, by itself, cause a breach of contract” and the statute requires that a claim for loss be causally related to a covered countermeasure. Id. at *7 (internal quotation marks omitted). Dressen had a valid claim, in the district court’s view, because “AstraZeneca made a contractual promise to her that happened to involve the effects of a covered countermeasure,” and the company then breached that independent promise. Id. at *8. And for the same reason, the court held that PREP Act immunity did not protect against Dressen’s claim for a breach of the contractual duty of good faith and fair dealing. 8  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 9 The district court reserved ruling on whether the language in AstraZeneca’s ICF promising to cover the costs of participant’s research injuries waived the company’s statutory immunity. See id at *3 n.42 (“Because the court finds the PREP Act does not apply to claims for loss based on breach of contract, the court need not consider whether AstraZeneca waived its immunity”). Finally, the district court rejected the company’s arguments that Dressen’s breach-of-contract claims were time-barred and that she failed to state a claim for a breach of the duty of good faith and fair dealing, see id. at *3; neither issue has been raised on appeal. II. DISCUSSION We first confirm our jurisdiction under the collateral-order doctrine. We then hold that the PREP Act confers immunity from this suit. But we remand with directions to the district court to consider whether the language in AstraZeneca’s ICF waived that immunity. We do not, however, address Dressen’s alternative argument on appeal invoking equitable estoppel, as she did not preserve that argument in district court. A. Jurisdiction Under 28 U.S.C. § 1291, courts of appeals “shall have jurisdiction of appeals from all final decisions of the district courts . . . .” Ordinarily a final decision is one that “resolves the entire case—when it ends the litigation (on the merits or otherwise) and leaves nothing for the court to do but execute the judgment.” GEO Grp., Inc. v. Menocal, 607 U.S. 438, 443 (2026) (internal quotation marks omitted). But the Supreme Court, applying what is known as the collateral-order doctrine, has allowed 9  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 10 for immediate appeal of a small class of orders not resolving the entire case because they have “practical” finality. Id. (internal quotation marks omitted) (collateral-order doctrine gives § 1291’s finality requirement a “practical rather than a technical construction” (internal quotation marks omitted)). Such orders “are said to be too important to be denied review and too independent of the cause itself to justify waiting out the rest of the adjudication.” Mohamed v. Jones, 100 F.4th 1214, 1218 (10th Cir. 2024) (internal quotation marks omitted). The Court “identif[ies]” these immediately appealable orders “by category, not case-specific circumstances,” and it has “underscored” that this doctrine is “narrow, stringent, and of modest scope.” GEO Grp., 607 U.S. at 444 (internal quotation marks omitted). For an order to be appealable under the collateral-order doctrine, the order must satisfy “three non-negotiable conditions”: it must “(1) conclusively determine the disputed question, (2) resolve an important issue completely separate from the merits of the action, and (3) be effectively unreviewable on appeal from a final judgment.” Id. (internal quotation marks omitted). For the last condition, “the decisive consideration is whether delaying review until the entry of final judgment would imperil a substantial public interest or some particular value of a high order.” Mohawk Indus., Inc. v. Carpenter, 558 U.S. 100, 107 (2009) (internal quotation marks omitted). The appellant (here, AstraZeneca) bears the burden of showing that its appeal satisfies all three of these conditions. See In re Magic Circle Energy Corp., 889 F.2d 950, 954 (10th Cir. 1989) (“Because a party seeking to appeal on this basis 10  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 11 must show that all three requirements of the doctrine are satisfied, we need not address each if any one is not met”). Beginning with Digital Equipment Corp. v. Desktop Direct, Inc., 511 U.S. 863 (1994), the Supreme Court has expressed concern about inappropriate expansion of the collateral-order doctrine. In particular, the Court has tightened the third requirement. Recognizing that failure to promptly correct (through an interlocutory appeal) an adverse trial-court ruling will virtually always impair some interest, the Court has homed in on the interest at stake and its importance. See Digital Equip., 511 U.S. at 871–81. An insufficiently important interest cannot justify an interlocutory appeal even if that interest cannot be cured by victory in a later appeal. See id. at 872 (“[I]f immediate appellate review were available every . . . time [an error in district court could not be fully remedied by an appeal], Congress’s final decision rule would end up a pretty puny one, and so the mere identification of some interest that would be ‘irretrievably lost’ has never sufficed to meet the third . . . requirement”); see Mohawk Indus., 558 U.S. at 107 (“The justification for immediate appeal must . . . be sufficiently strong to overcome the usual benefits of deferring appeal until litigation concludes”). Still, some interests have been deemed sufficiently important to invoke the doctrine. For example, the Court has long recognized a right to appeal certain orders denying a government official’s claim of immunity, reasoning that such officials should not only be protected from liability but should also be protected from the burdens of litigation. See Mitchell v. Forsyth, 472 U.S. 511, 525 (1985) (“[T]he 11  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 12 denial of a substantial claim of absolute immunity is an order appealable before final judgment, for the essence of absolute immunity is its possessor’s entitlement not to have to answer for his conduct in a civil damages action”); id. at 526 (qualified immunity is an “entitlement [to] an immunity from suit” and the entitlement “is effectively lost if a case is erroneously permitted to go to trial”). In qualified- immunity cases, waiting for the end of the litigation to hear the issue on appeal undermines the substantial interest in protecting against the burdens of litigation. In contrast, the Court has more recently declined to apply the collateral-order doctrine to allow an appeal of an interlocutory order denying a claim of attorney- client privilege, in large part because of the limited need to resolve the issue before final judgment. See Mohawk Indus., 558 U.S. at 108 (acknowledging “the importance of the attorney-client privilege” but noting that “[t]he crucial question . . . is whether deferring review until final judgment so imperils the interest as to justify the cost of allowing immediate appeal of the entire class of relevant orders”). Rather than deciding on a case-by-case basis what interests are worth protecting through interlocutory appeals, the Court has declared that “the preferred means for determining whether and when prejudgment orders should be immediately appealable” is the rulemaking process via the Judicial Conference established by Congress. Id. at 113; see Swint v. Chambers Cnty. Comm’n, 514 U.S. 35, 48 (1995) (describing the statutory authority and the process for rulemaking). Considering the Court’s present view of the collateral-order doctrine, we must be cautious about applying it. Therefore, even though neither party challenges our 12  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 13 appellate jurisdiction in this case, we explain why we conclude that we do have such jurisdiction here. The first two requirements of the collateral-order doctrine are certainly satisfied. First, the district court conclusively held that the PREP Act does not immunize Dressen’s contract claims because the statute does not cover those claims. Second, the immunity question is important and independent of the merits of Dressen’s claim for relief. See Johnson v. Jones, 515 U.S. 304, 314 (1995) (an issue is separate from the merits if it is “significantly different from the fact-related legal issues that likely underlie the plaintiff’s claim on the merits”). As the Ninth Circuit recently stated, “[A] denial of PREP Act immunity resolves an important question separate from the merits. Whether PREP Act immunity applies turns on whether the claim for which immunity is asserted relates to the defendant’s use of certain medical countermeasures, a determination that generally will have no bearing on the merits of the underlying action.” Hampton v. California, 83 F.4th 754, 762 (9th Cir. 2023) (internal quotation marks omitted). As for the collateral-order doctrine’s third requirement, AstraZeneca claims that it will be irremediably injured if it must proceed to trial, even if later vindicated on liability. But because “virtually every right that could be enforced appropriately by pretrial dismissal might loosely be described as conferring a ‘right not to stand trial,’” the Supreme Court requires us “to view claims of a ‘right not to be tried’ with skepticism, if not a jaundiced eye.” Digital Equip., 511 U.S. at 873; see id. at 872 13  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 14 (“[T]he jurisdiction of the courts of appeals should not, and cannot, depend on a party’s agility in . . . characterizing the right asserted”). If, however, the asserted immunity does not spring from the creativity of an advocate but appears in positive law, the jaundice clears: “When a policy is embodied in a constitutional or statutory provision entitling a party to immunity from suit (a rare form of protection), there is little room for the judiciary to gainsay its ‘importance.’” Id. at 879. By deferring to Congress (or the Constitution) courts do not abdicate their responsibility to corral the notion of a final judgment. After all, the final-judgment rule is itself a creation of Congress. See 28 U.S.C. § 1291. No doubt Congress could explicitly provide for interlocutory appeals from a denial of statutory immunity. That Congress does so implicitly, albeit clearly, by using language conferring immunity from suit, is of no moment. The Supreme Court has never retreated from the proposition that on the “rare” occasion of “a constitutional or statutory provision entitling a party to immunity from suit,” the judiciary cannot “gainsay” that the asserted right to immunity from suit is sufficiently important to satisfy the third requirement of the collateral-order doctrine. Digital Equip., 511 U.S. at 879. What the Court has done, however, is to continue to view with great skepticism claims that an interest in avoiding trial (generally based on a statutory or common-law immunity from liability) is sufficiently important to support a right to avoid trial. See Van Cauwenberghe v. Biard, 486 U.S. 517, 524 (1988) (“The critical question . . . is whether the essence of the claimed right is a right not to stand trial” (internal quotation marks omitted)). 14  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 15 Typical is the opinion in Will v. Hallock, 546 U.S. 345 (2006). The defendants in that case were federal employees sued in an action under Bivens v. Six Unknown Federal Narcotics Agents, 403 U.S. 388 (1971). They invoked a provision of the Federal Tort Claims Act (FTCA) stating that if the government has prevailed on a suit under that Act, a later suit by the same claimant against government employees regarding the same subject matter is barred. See Will, 546 U.S. at 347–48. Following Digital Equipment, the Supreme Court examined whether the defendants’ “interest in avoiding trial” was of a sufficiently “high order” to satisfy the third prong of the collateral-order doctrine. Id. at 352. Comparing the right provided by the FTCA to the right conferred by res judicata doctrine, the Court rejected the claim of a right not to stand trial. See id. at 354–55. Nor has this court ever disregarded Digital Equipment’s directive not to “gainsay” the judgment of Congress by rejecting a statutory provision explicitly recognizing a right not to stand trial as insufficiently “importan[t]” to satisfy the third prong. 511 U.S. at 879. Our decision in United States ex rel. Fiorisce, LLC v. Colorado Technical University, Inc., 130 F.4th 811 (10th Cir. 2025), is not to the contrary. In that case we held that a district-court denial of immunity under the public-disclosure bar in the False Claims Act (FCA) could not be reviewed under the collateral-order doctrine. The FCA does not state that immunity under the public- disclosure bar includes an immunity from suit. And we explicitly rejected the argument “that the public disclosure bar is a right to avoid trial.” Id. at 820. Thus, a statutory right to avoid trial was not at issue. We recognize that Fiorisce said that 15  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 16 “the Supreme Court clarified that showing a right to avoid trial alone—even immunity—is insufficient to justify expanding the collateral order doctrine,” 130 F.4th at 818 (citing Will, 546 U.S. at 352-53). But to the extent that this statement concerns the impact on the collateral-order doctrine of a “right to avoid trial,” the statement is dictum, since the court held that there was no such right in that case. And in any event, our use of the word right, rather than interest, in that statement was nothing more than an inconsequential (for purposes of that case) slip of the tongue, as shown by the fact that the cited passage in Will refers to an interest in avoiding trial rather than a right to avoid trial. 3 Once Congress has declared that an interest in avoiding trial is of sufficient importance to create an immunity from suit, we must defer to that assessment. The PREP Act has one of those “rare” statutory provisions explicitly providing for immunity from suit. Digital Equip., 511 U.S. at 879. Its text is unambiguous: “[A] covered person shall be immune from suit and liability.” 42 U.S.C. § 247d-6d(a)(1) (emphasis added). Hence, delaying review until final 3 The relevant paragraph from Will states as follows: In each case [where the Supreme Court has recognized a collateral-order appeal based on an immunity from trial], some particular value of a high order was marshaled in support of the interest in avoiding trial: [listing those interests]. That is, it is not mere avoidance of trial, but avoidance of a trial that would imperil a substantial public interest, that counts when asking whether an order is effectively unreviewable if review is to be left until later. 546 U.S. at 352–53 (emphasis added, internal quotation marks omitted). 16  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 17 judgment would offend a congressionally recognized substantial public interest, and the third requirement of the collateral-order doctrine is satisfied. See Hampton, 83 F.4th at 762 (“[A]s an immunity from suit, the benefit of PREP Act immunity is effectively lost if a party is erroneously required to face the burdens of litigation” (ellipsis and internal quotation marks omitted)); Goins v. Saint Elizabeth Med. Ctr., No. 22-6070, 2024 WL 229568, at *5 (6th Cir. Jan. 22, 2024) (allowing interlocutory appeal on PREP Act immunity question “because the core point of immunity is its possessor’s entitlement not to have to answer for his conduct in a civil damages action” and “a statutory grant to a private entity of immunity from suit is imbued with a significant public interest . . . .” (internal quotation marks omitted)). B. Construing the PREP Act 1. The scope of the word loss As always, “[s]tatutory interpretation begins with the words in the statute.” Smith v. Bd. of Governors of the Fed. Rsrv. Sys., 73 F.4th 815, 820 (10th Cir. 2023) (internal quotation marks omitted). This court first considers “whether the language at issue has a plain and unambiguous meaning with regard to the particular dispute in the case.” Id. (internal quotation marks omitted). We determine “[t]he plainness or ambiguity” of a statute’s text “by reference to the language itself, the specific context in which that language is used, and the broader context of the statute as a whole.” Robinson v. Shell Oil Co., 519 U.S. 337, 341 (1997). “If the statute’s text is unambiguous, then its plain meaning controls, and our inquiry ends.” Smith, 73 F.4th at 820 (internal quotation marks omitted). 17  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 18 The PREP Act immunizes manufacturers and distributors of COVID-19 vaccines against “all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual” of such a vaccine. 42 U.S.C. § 247d-6d(a)(1) (emphasis added); see also id. § 247d-6d(a)(2)(B) (this immunity “applies to any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure” (emphasis added)). The statute defines the term loss as “any type of loss, including . . . (i) death; (ii) physical, mental, or emotional injury, illness, disability, or condition; (iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and (iv) loss of or damage to property, including business interruption loss.” Id. § 247d-6d(a)(2)(A) (emphasis added). i. Text Dressen argues that AstraZeneca is not entitled to immunity from her claims because her claims are breach-of-contract claims, not tort claims. We are not persuaded. We begin with the language of the statute. The PREP Act’s immunity provision says nothing about shielding covered persons from specific causes of action. Instead, the statute protects against particular “claims for loss.” 42 U.S.C. § 247d-6d(a)(1). A suit for breach of contract is as much a “claim” as a suit under tort law. To be sure, the term loss in the statute is limited. See id. § 247d-6d(a)(2)(B) (requiring causation). But Dressen makes no effort to show that the listed losses are recoverable only through tort claims. And there is irony, if not chutzpah, in her argument, since the statutory definition appears to 18  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 19 encompass many of the damages that she seeks through her contract claim in this case. Compare id. § 247d-6d(a)(2)(A) (defining loss to “include[] . . . (i) death; (ii) physical, mental, or emotional injury, illness, disability, or condition; (iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and (iv) loss of or damage to property, including business interruption loss”), with Aplts. App., Vol. I at 47–48 (Dressen’s prayer for relief seeking “economic damages, including, but not limited to, past and future medical expenses, past and future loss of household services, childcare expenses, past and future lost income, and past and future transportation costs; . . . non-economic damages, including emotional damages, that [Dressen] foreseeably suffered as a result of [AstraZeneca’s] breaches”; attorney fees; prejudgment interest; and “such other and further relief as the Court deems appropriate”). The very premise of her argument—that the losses enumerated in the statute are recoverable only through tort claims—is therefore contradicted by her own complaint. We further note that one type of injury listed in the PREP Act’s definition of loss for which Dressen does not seek damages—business-interruption loss—is regularly recovered when there is no claim of any tortious action. See, e.g., Monarch Casino & Resort, Inc. v. Affiliated FM Ins. Co., 85 F.4th 1034, 1036–37 (10th Cir. 2023) (casino operator sued commercial property insurer, alleging breach of contract following denial of coverage for business-interruption losses caused by COVID-19 and government orders); Goodwill Indus. of Cent. Okla., Inc. v. Phila. Indem. Ins., 21 F.4th 704, 709 n.2 (10th Cir. 2021) (similar). 19  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 20 Moreover, the statutory definition of loss encompasses “any type of loss.” 42 U.S.C. § 247d-6d(a)(2)(A) (emphasis added). Courts generally interpret the term any, and its semantic partner all, expansively. See, e.g., Ali v. Fed. Bureau of Prisons, 552 U.S. 214, 219 (2008) (“read naturally, the word any has an expansive meaning, that is, one or some indiscriminately of whatever kind” (brackets and internal quotation marks omitted) (emphasis added)); Allen v. Env’t Restoration, LLC, 32 F.4th 1239, 1244 (10th Cir. 2022) (noting “all means all” (internal quotation marks omitted)); Cohen v. JP Morgan Chase & Co., 498 F.3d 111, 117 (2d Cir. 2007) (“As the Supreme Court has frequently observed, use of the word ‘any’ in statutory text generally indicates Congress’s intent to sweep broadly to reach all varieties of the item[s] referenced”). Illustrative is the Supreme Court opinion in Norfolk & Western Railway Co. v. American Train Dispatchers’ Ass’n, 499 U.S. 117 (1991), which considered the scope of the Interstate Commerce Act (ICA), a statute designed to facilitate certain railroad-carrier consolidations. Congress exempted those mergers “from the antitrust laws and from all other law, including State and municipal law, as necessary to let that person carry out the transaction [for consolidation].” Id. at 127 (emphasis added) (internal quotes omitted) (quoting 49 U.S.C. § 11341(a) (1991)). As the Court observed, the phrase “all other law” was “clear, broad, and unqualified” and “indicates no limitation.” Id. at 128–29 (internal quotation marks omitted). The Court rejected the argument “that Congress did not intend the immunity clause to apply to contractual obligations,” such as a collective-bargaining agreement. Id. at 128. In 20  Appellate Case: 24-4114 Document: 49-1 Date Filed: 07/23/2026 Page: 21 doing so, it explained that the statute “means what it says: A carrier is exempt from all law as necessary to carry out an [agency]-approved transaction [that is, a sanctioned merger].” Id. at 129. The ICA limited the “all other law” language by qualifying the type of transactions covered by the statute (i.e., mergers approved by a specific regulator), not by limiting the category of law that the modifier “all” could encompass. Likewise, the PREP Act’s phrase “all claims for loss” is limited by the statute’s causation requirement, not by the category of the legal claim. To be sure, courts should avoid a “literal reading” of the term any when it would “dramatically separate the statute from its intended purpose.” Lewis v. United States, 523 U.S. 155, 160 (1998) (addressing the purpose of the Assimilated Crimes Act to fill gaps in federal law on federal enclaves); see Small v. United States, 544 U.S. 385, 388 (2005) (“convicted in any court” does not encompass foreign courts). But, as we discuss below (see § II.B.1.iv. on absurdity doctrine), Dressen does not (and cannot) show that interpreting the PREP Act to immunize covered persons against certain contract-based claims would do so here. It is also worth pointing out that if Congress wished to exclude contract claims from PREP Act immunity, it knew how to say so. Less than two months before it passed the PREP Act, Congress excepted contract claims from the immunity provision in the Protection of Lawful Commerce in Arms Act (PLCAA), 15 U.S.C. §§ 7901–7903. Compare PLCAA, Pub. L. No. 109-92, 119 Stat. 2095 (Oct. 26, 2005), with PREP Act, Pub. L. No. 109-148, div. C, 119 Stat. 2680, 2818–32 (Dec. 30, 2005). Like the PREP Act, the PLCAA is an immunity statute. It states that “[a]