Appeal from the United States District Court for the District of Connecticut No. 24-cv-858, Kari A. Dooley, District Judge .

Before: LIVINGSTON, PÉREZ, and KAHN, Circuit Judges .

Defendant-Appellant-Cross-Appellee Pierre Kory, M.D., prescribed a drug called prednisone to treat Edward James Waters for COVID-19. It is well known that high doses of drugs like prednisone can contribute to peptic ulcer disease, especially in elderly patients like Waters. Kory failed to prescribe the medicines used to mitigate such side effects.

Waters ultimately suffered from a perforated ulcer and died due to organ failure. His estate sued Kory for negligence, a lack of informed consent in Waters’s treatment, and violations of the Connecticut Unfair Trade Practices Act (“CUTPA”).

Page 2At issue in this appeal is 1) whether the immunity provision of the Public Readiness and Emergency Preparedness Act (the 'PREP Act') precludes the claims for negligence and lack of informed consent, and 2) whether Waters's CUTPA claims are, at their core, claims for professional negligence and thus barred under Connecticut law. We answer both questions in the affirmative, and thus, all of Waters’s claims must be dismissed.

First, the negligence and lack of informed consent claims fall within the PREP Act's immunity provisions. Though this Court has not yet had the opportunity to articulate the PREP Act's causal relationship requirement, the statute's text makes clear that a wide range of claims based on the use or administration of covered countermeasures are barred. Today, we hold that there is “a causal relationship” between Kory’s prescription of prednisone and Waters’s death, and thus, the allegations are sufficient to trigger the PREP Act’s immunity provision.

Second, the CUTPA claim is foreclosed by Connecticut law. CUTPA claims against medical professionals must be targeted at the business or entrepreneurial aspects of the professionals’ practices. Waters’s CUTPA claim instead seeks to recover for harms caused by Kory’s alleged professional negligence.

Therefore, we AFFIRM the District Court’s dismissal of the CUTPA claim, REVERSE the District Court’s order denying Kory’s motion to dismiss based on PREP Act immunity, and REMAND for further proceedings consistent with this opinion.

STEVEN M. WARSHAWSKY, The Warshawsky Law Firm, Mount Kisco, NY, for Defendant-Appellant-Cross-Appellee.

AUSTIN BERESCIK-JOHNS, Law Office of Austin B. Johns, LLC, Hartford, CT, for Plaintiff-Appellee-Cross-Appellant .

Page 3MYRNA PÉREZ, Circuit Judge :

Defendant-Appellant-Cross-Appellee Pierre Kory, M.D., prescribed a drug called prednisone to treat Edward James Waters for COVID-19. It is well known that high doses of drugs like prednisone can contribute to peptic ulcer disease, especially in elderly patients like Waters. Kory failed to prescribe medicine used to mitigate these side effects.

Waters ultimately suffered from a perforated ulcer and died due to organ failure. His estate sued Kory for negligence, a lack of informed consent in Waters’s treatment, and violations of the Connecticut Unfair Trade Practices Act (“CUTPA”).

At issue in this appeal is 1) whether the immunity provision of the Public Readiness and Emergency Preparedness Act (the 'PREP Act') precludes the claims for negligence and lack of informed consent, and 2) whether Waters's CUTPA claims are, at their core, claims for professional negligence and thus barred under Connecticut law. We answer both questions in the affirmative, and thus, all of Waters’s claims must be dismissed.

First, the negligence and lack of informed consent claims fall within the PREP Act's immunity provisions. Though this Court has not yet had the Page 4opportunity to articulate the PREP Act's causal relationship requirement, the statute's text makes clear that a wide range of claims based on the use or administration of covered countermeasures are barred. Today, we hold that there is “a causal relationship” between Kory’s prescription of prednisone and Waters’s death, and thus, the allegations are sufficient to trigger the PREP Act’s immunity provision.

Second, the CUTPA claim is foreclosed by Connecticut law. CUTPA claims against medical professionals must be targeted at the business or entrepreneurial aspects of the professionals’ practices. Waters’s CUTPA claim instead seeks to recover for harms caused by Kory’s alleged professional negligence, and thus, we affirm the District Court’s dismissal of the claim.

Edward James Waters contracted COVID-19 around November 25, 2021.¹ After testing positive for COVID-19, Waters or his family 2 contacted Defendant Pierre Kory, M.D., who initiated treatment on December 5, 2021. Kory 'held himself out as a counter-culture expert regarding COVID-19 treatment” and had Page 5a “tele-health” practice for treating patients. J. App’x at 78. All of Kory’s sessions with Waters were conducted remotely.

Around the same time that he contracted COVID-19, Waters experienced a flare-up of gout and was treated with a drug called prednisone, which is a corticosteroid. Kory was aware that Waters had recently taken prednisone. Nevertheless, Kory prescribed Waters additional prednisone to treat his COVID19 infection, along with ivermectin (an antiparasitic), spironolactone (a diuretic), and dutasteride (a 5-alpha reductase inhibitor).

Despite Kory’s treatments, Waters was admitted to a hospital emergency room a week later for shortness of breath and low oxygen levels. Waters was hospitalized for four days and was treated with additional corticosteroids. Notably, he was also given a “proton pump inhibitor,” J. App’x at 73, which is used to 'counteract the well-known risk of developing peptic ulcer disease through a protracted course of high dose corticosteroids,” J. App’x at 75.

After he was released from the hospital, Waters’s condition improved. On December 18, 2021, Kory prescribed another round of prednisone, which Waters was instructed to take after the initial prescription from the hospital ran its course. In doing so, Kory did not personally review the details of Waters’s hospitalization Page 6and treatment. Nor did Kory prescribe a treatment, such as a 'proton pump inhibitor,” to mitigate the harmful side effects of the prednisone.

On December 29, 2021, Waters’s daughter called Kory to report that Waters was experiencing worsening abdominal pain. Kory proposed reducing the amount of prednisone Waters was taking.

The next day, Waters was again taken to the emergency room due to worsening abdominal pain and abdominal distension. Doctors 'immediately suspected a perforated ulcer of the stomach or duodenum” and their suspicions were confirmed through “an emergency exploratory laparotomy.” J. App’x at 75. Waters died as a result of multiple organ failure, and Plaintiff-Appellee-CrossAppellant Edward Waters, Jr. was named the Administrator of his estate.

The estate filed suit in Connecticut Superior Court, and Kory removed the case to the District of Connecticut based on diversity. In the operative Amended Complaint, the estate asserts three claims: 1) negligence, 2) lack of informed consent, and 3) a violation of CUTPA. Kory moved to dismiss the claims based on the immunity provided in the PREP Act, as well as on a theory that the Amended Complaint failed to state a viable CUTPA claim. The District Court dismissed the CUTPA claim but concluded that PREP Act immunity does not apply, and thus Page 7denied the motion to dismiss as to the remaining claims. Kory properly noticed an interlocutory appeal regarding the denial of PREP Act immunity. Upon the parties' request, the District Court certified a partial final judgment as to the CUTPA claim pursuant to Fed. R. Civ. P. 54(b), and Waters appealed the dismissal of that claim.

I. Appellate Jurisdiction

We must first assure ourselves that we have jurisdiction to consider these appeals. See Maye v. City of New Haven , 89 F.4th 403, 406 (2d Cir. 2023).

Per statute, we generally have jurisdiction over 'final decisions of the district courts,' see 28 U.S.C. § 1291, which are decisions that 'conclusively determine[] all pending claims of all the parties to the litigation, leaving nothing for the court to do but execute its decision,” Petrello v. White , 533 F.3d 110, 113 (2d Cir. 2008). The District Court’s order on appeal is plainly not a final decision, as it dismissed only one of three claims.

However, there are exceptions to the general rule. Two are relevant to this case: the collateral order doctrine and the District Court’s ability to certify a partial final judgment pursuant to Federal Rule of Civil Procedure 54(b).

Page 8We hold that the denial of a motion to dismiss on PREP Act immunity grounds is an immediately appealable collateral order.

“The collateral order doctrine . . . is a judicially created exception to the final decision principle; it allows immediate appeal from orders that are collateral to the merits of the litigation and cannot be adequately reviewed after final judgment.” In re Décor Holdings, Inc. , 86 F.4th 1021, 1026 (2d Cir. 2023) (per curiam) (quoting Germain v. Conn. Nat'l Bank , 930 F.2d 1038, 1039–40 (2d Cir. 1991)). “An order is final under the collateral order doctrine if it '(1) conclusively determine[s] the disputed question, (2) resolve[s] an important issue completely separate from the merits of the action, and (3) [is] effectively unreviewable on appeal from a final judgment.'' Id. (alterations in original) (quoting EM Ltd. v. Banco Cent. de la República Arg. , 800 F.3d 78, 87 (2d Cir. 2015)).

“[O]rders rejecting absolute immunity” are immediately appealable under the doctrine. See Will v. Hallock , 546 U.S. 345, 350 (2006). We have applied the doctrine to claims of immunities in various contexts. See, e.g. , Gingras v. Think Fin., Inc. , 922 F.3d 112, 119-20 (2d Cir. 2019) (tribal sovereign immunity); Rogers v. Petroleo Brasileiro, S.A. , 673 F.3d 131, 136 (2d Cir. 2012) (immunity under the Page 9Foreign Sovereign Immunities Act); see also Mitchell v. Forsyth , 472 U.S. 511, 530 (1985) (qualified immunity). That is because in such cases, “the central benefits” of “avoiding the costs and general consequences of subjecting public officials to the risks of discovery and trial” would be “effectively lost if a case is erroneously permitted to go to trial.” See P.R. Aqueduct & Sewer Auth. v. Metcalf & Eddy, Inc. , 506 U.S. 139, 143–44 (1993) (quoting Mitchell , 472 U.S. at 526).

However, not every appeal seeking review of a claimed right to avoid trial justifies application of the collateral order doctrine. See Van Cauwenberghe v. Biard , 486 U.S. 517, 524 (1988) (“[I]n some sense, all litigants who have a meritorious pretrial claim for dismissal can reasonably claim a right not to stand trial.'). Instead, “it is not mere avoidance of a 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.” See Will , 546 U.S. at 353. But “[w]hen 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.'' See Digit. Equip. Corp. v. Desktop Direct, Inc. , 511 U.S. 863, 879 (1994).

Page 10We have not yet decided whether an appeal of an order refusing to apply immunity under the PREP Act is subject to the collateral order doctrine. See Solomon v. St. Joseph Hosp. , 62 F.4th 54, 59 (2d Cir. 2023) (stating 'we need not decide whether Defendants’ interlocutory appeal is proper under the collateralorder doctrine'). We do so today.³ The District Court's denial of PREP Act immunity satisfies each of the three requirements for the collateral order doctrine.

First, the PREP Act bestows complete immunity from suit. See 42 U.S.C. § 247d-6d(a)(1). Thus, by denying PREP Act immunity, the District Court “purport[ed] to . . . conclusive[ly] determin[e] that [Kory] ha[s] no right not to be sued in federal court.” Cf. P.R. Aqueduct & Sewer Auth. , 506 U.S. at 140 (concluding that denials of Eleventh Amendment immunity are appealable collateral orders).

Second, as discussed below, Kory's PREP Act immunity defense is completely separate from the merits of Waters’s claim, as the immunity defense hinges on the use of a covered countermeasure. And the Supreme Court has explained the importance of an issue of immunity when such a policy 'is embodied in a constitutional or statutory provision,' as it is here. See Digit. Equip.

Page 11Corp. , 511 U.S. at 879. Thus, the merits of Waters’s claims have little to do with the important issue of the application of PREP Act immunity.

Third, because the statute bestows absolute immunity from suit, the entitlement it bestows is “effectively lost” if the defendant is made to “face the . . . burdens of litigation.” See Mitchell , 472 U.S. at 526–27; see also Liberty Synergistics Inc. v. Microflo Ltd. , 718 F.3d 138, 147 (2d Cir. 2013) (explaining that 'we must 'examine the nature of the right asserted with special care,' . . . to determine whether an 'essential aspect of the claim' is the right to avoid the burdens of litigation” (quoting Van Cauwenberghe , 486 U.S. at 525)). Thus, the District Court’s order is 'effectively unreviewable on appeal from a final judgment.' Mitchell , 472 U.S. at 527.

We therefore have jurisdiction over Kory’s appeal of the District Court’s ruling on PREP Act immunity, which pertains to Waters’s negligence and lack of informed consent claims.

The appeal of the dismissal of Waters's CUTPA claim is reviewable pursuant to Federal Rule of Civil Procedure 54(b). “Title 28 U.S.C. § 1291 affords federal courts ‘jurisdiction to hear timely appeals from final judgments or from Page 12partial final judgments entered pursuant to Fed. R. Civ. P. 54(b).’” Linde v. Arab Bank, PLC , 882 F.3d 314, 322–23 (2d Cir. 2018) (quoting Petrello , 533 F.3d at 113). Relevant here,

Rule 54(b) authorizes a district court to enter partial final judgment “when three requirements have been satisfied: (1) there are multiple claims or parties, (2) at least one claim or the rights and liabilities of at least one party has been finally determined, and (3) the court makes an ‘express[] determin[ation] that there is no just reason for delay’” of entry of final judgment as to fewer than all of the claims or parties involved in the action.

Id. (alterations in original) (quoting Acumen Re Mgmt. Corp. v. Gen. Sec. Nat'l Ins. Co. , 769 F.3d 135, 140 (2d Cir. 2014)).⁴ Applied to the CUTPA claim appeal, the first two requirements are straightforwardly satisfied. The CUTPA claim is distinct from Waters’s remaining two negligence claims, see Haynes v. Yale-New Haven Hosp. , 699 A.2d 964, 972 (Conn. 1997), and the District Court made a substantive determination that Waters's allegations are not cognizable under CUTPA and dismissed that claim.

Page 13We review the third requirement, a district court’s determination that there is no just reason for delay, for abuse of discretion. See Curtiss-Wright Corp. v. Gen. Elec. Co. , 446 U.S. 1, 10 (1980). A “district court generally should not grant a Rule 54(b) certification 'if the same or closely related issues remain to be litigated.'' Novick v. AXA Network, LLC , 642 F.3d 304, 311 (2d Cir. 2011) (citation modified) (quoting Harriscom Svenska AB v. Harris Corp. , 947 F.2d 627, 629 (2d Cir. 1991)). “Certification under Rule 54(b) should be granted only where there are ‘interest[s] of sound judicial administration’ and efficiency to be served,” see Hogan v. Consol. Rail Corp. , 961 F.2d 1021, 1025 (2d Cir. 1992) (citation modified) (quoting CurtissWright , 446 U.S. at 8), or “where ‘there exists some danger of hardship or injustice through delay which would be alleviated by immediate appeal,’” see id. (citation modified) (quoting Cullen v. Margiotta , 618 F.2d 226, 228 (2d Cir. 1980) (per curiam)).

Here, the District Court’s certification under Rule 54(b) was appropriately within its discretion. The District Court explained that refusing to review the dismissal of the CUTPA claim now risks contravening 'the policy against piecemeal appeals” given the collateral appeal of the PREP Act immunity issue; by certifying the dismissal of the CUTPA claim, the District Court ensured the Page 14entirety of its order will be reviewed at once. See Novick , 642 F.3d at 310; Hogan , 961 F.2d at 1025 (citing the ''interest[s] of sound judicial administration' and efficiency to be served” as warranting certification (alteration in original) (quoting Curtiss-Wright , 446 U.S. at 8)).

Because we conclude the District Court did not abuse its discretion in certifying partial final judgment of the CUTPA claim for our review, we have jurisdiction to consider that claim as well.

'When a district court denies immunity on a Rule 12(b)(6) motion to dismiss, we review the district court's denial de novo , accepting as true the material facts alleged in the complaint and drawing all reasonable inferences in plaintiffs’ favor.” Ogunkoya v. Monaghan , 913 F.3d 64, 67 (2d Cir. 2019) (quoting Warney v. Monroe County , 587 F.3d 113, 120 (2d Cir. 2009)). On the merits, we first conclude that Waters’s negligence and lack of informed consent claims are barred by the immunity provisions of the PREP Act.

Congress enacted the PREP Act “[t]o encourage the expeditious development and deployment of medical countermeasures during a public health emergency” by “limit[ing] legal liability for losses relating to the administration of Page 15medical countermeasures such as diagnostics, treatments, and vaccines.” Kevin J. Hickey, Cong. Rsch. Serv., LSB10443, The PREP Act and COVID-19, Part 1: Statutory Authority to Limit Liability for Medical Countermeasures 1 (2022).

'The PREP Act provides broad immunity '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’ during a public-health emergency.” Solomon , 62 F.4th at 58 (quoting 42 U.S.C. § 247d-6d(a)(1)).⁵

Only a 'covered person' is entitled to immunity. See 42 U.S.C. § 247d6d(a)(1). Most relevant to this appeal, a “covered person” is “a person or entity that is . . . a qualified person who prescribed, administered, or dispensed [a covered] countermeasure.” See id. § 247d-6d(i)(2)(B)(iv). A 'qualified person' includes “a licensed health professional or other individual who is authorized to prescribe, administer, or dispense [covered] countermeasures under the law of the Page 16State in which the countermeasure was prescribed, administered, or dispensed.” Id. § 247d-6d(i)(8)(A).

Additionally, the covered person must use a “covered countermeasure” for immunity to apply. The statute provides the Secretary of Health and Human Services ('HHS Secretary') with authority to publish a declaration that '(1) announces a disease or health condition is a public emergency and (2) defines appropriate covered countermeasures.” Solomon , 62 F.4th at 58 (citing 42 U.S.C. § 247d-6d(b)(1)). As relevant here, “[e]ffective February 4, 2020, the HHS Secretary declared 'COVID-19 . . . a public health emergency' and defined 'covered countermeasures’ in part as any ‘antiviral, drug, biologic, diagnostic, device, or vaccine used to treat, diagnose, cure, prevent, or mitigate COVID-19.'' Id. (quoting Declaration Under the PREP Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198, 15198-01 (Mar. 17, 2020)). The declaration clarifies that covered countermeasures 'must be 'qualified pandemic or epidemic products'' under the PREP Act, or 'drugs, biological products, or devices authorized for investigational or emergency use” under the Federal Food Drug and Cosmetic Act and the Public Health Service Act. See 85 Fed. Reg. at 15202. In turn, the PREP Act defines “qualified pandemic or epidemic product” as:

Page 17(i) a product manufactured, used, designed, developed, modified, licensed, or procured . . . (I) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or . . . (II) to limit the harm such pandemic or epidemic might otherwise cause; [or] . . . (ii) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or lifethreatening disease or condition caused by a product described in clause (i).

42 U.S.C. § 247d-6d(i)(7)(A).

Finally, the statute clarifies that 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, 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.

42 U.S.C. § 247d-6d(a)(2)(B).

In all, in order for immunity to apply to a given claim, the PREP Act generally requires 1) that the defendant be a 'covered person,' 2) that the defendant used or administered a “covered countermeasure,” and 3) that the use or administration of that countermeasure had 'a causal relationship' with the alleged loss.⁶

Page 18A. Covered Person

First, we conclude that Kory is a “covered person” under the statute because he is a 'licensed health professional . . . authorized to prescribe, administer, or dispense [covered] countermeasures under the law of [Connecticut].' See 42 U.S.C. § 247d-6d(i)(8)(A). He therefore may be entitled to immunity.

Kory is not licensed to practice medicine in Connecticut. However, Connecticut law provides that “[a]ny physician or surgeon residing out of this state who holds a current license in good standing in another state and who is employed to come into this state to treat, operate or prescribe for any injury, deformity, ailment or disease from which the person who employed such physician, or the person on behalf of whom such physician is employed, is suffering' may do so on a temporary basis for 'a period not to exceed thirty consecutive days.” See Conn. Gen. Stat. § 20-9(b)(5).

Kory is licensed in New York and Wisconsin. See J. App'x at 63. Additionally, the decedent or his family enlisted his services, and he provided Page 19those services for less than thirty days. See J. App'x at 72-74. Under Connecticut law, Kory is a 'qualified person,' and, if he uses or administers a 'covered countermeasure,” becomes a “covered person” within the scope of the PREP Act’s immunity provision. See 42 U.S.C. § 247d-6d(i)(2)(B)(iv), (i)(8)(A).⁷

It is indisputable that Kory used a covered countermeasure to treat the decedent. Indeed, at oral argument, Waters conceded that prednisone, which Kory prescribed to treat the decedent's COVID-19 infection, is a covered countermeasure under the PREP Act. See Oral Arg. at 13:50-14:07. And as discussed, the HHS Secretary defined covered countermeasures as any “drug . . . used to treat, diagnose, cure, prevent, or mitigate COVID-19.” See Solomon , 62 F.4th at 58 (quoting 85 Fed. Reg. at 15198-01).⁸

Finally, based on the face of the complaint, the relevant covered countermeasure (the prednisone) has a sufficient causal relationship with the alleged loss (the decedent’s death) to trigger immunity.

Waters alleges that Kory 'prescribed an unreasonably high dose of Prednisone and did so without proper consideration for gastrointestinal protection.” See J. App’x at 75. Waters insists that Kory should have “prescribe[d] [the decedent] a gastrointestinal prophylaxis with a proton pump inhibitor or H2 blocker to counteract the well-known risk of developing peptic ulcer disease.” Id. Kory’s decision to prescribe high doses of prednisone without prophylaxis, Waters alleges, led to the decedent's death. The question is whether these allegations evidence “a causal relationship” between Kory’s prescription of prednisone and the decedent’s death sufficient to trigger the PREP Act’s immunity provision. For the reasons explained below, they do.

First, contrary to Waters’s urging, we see no basis for interpreting the PREP Act to require that a covered countermeasure be the sole cause of an alleged loss. Nothing in the statute’s text indicates that Congress contemplated such a narrow Page 21causal tie between the use or administration of the covered countermeasure and the loss alleged. Instead, several aspects of the statute indicate that Congress could not have had a “sole cause” requirement in mind.

The PREP Act's coverage of not only the direct use of a covered countermeasure, but also several further removed acts in the administration of that countermeasure, all but forecloses a 'sole' cause requirement. See 42 U.S.C. § 247d-6d(a)(1); see id. § 247d-6d(a)(2)(B) (listing “the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use'). '[F]or example, the 'design, development,' 'manufacture,' and 'distribution' of a vaccine are multiple links removed in the chain of events from the ultimate injecting of an individual with a vaccine,” yet the PREP Act includes such acts in the scope of immunity, evincing an 'expansive causal relationship.' See Maney v. Brown , 91 F.4th 1296, 1300–01 (9th Cir. 2024) (quoting 42 U.S.C. § 247d-6d(a)(2)(B)). Along the same lines, we struggle to imagine a case in which a countermeasure’s labeling, packaging, or licensing can be the sole cause of a plaintiff's loss. By expressly indicating that eventsPage 22 “multiple links removed” from the ultimate loss may be covered, Congress plainly intended the statute’s causation requirements to be “expansive.” See id.

Additionally, the statute covers “either an affirmative countermeasure that addresses the public health emergency itself, or medical care to address a side effect of the affirmative countermeasure.” See Goins v. Saint Elizabeth Med. Ctr. , No. 22-6070, 2024 WL 229568, at *5 (6th Cir. Jan. 22, 2024) (citing 42 U.S.C. § 247d6d(i)(7)(A)(ii)). Medical care designed to address the side effects of a treatment, by definition, will never be the “sole” cause of a “loss.” The initial treatment, in response to which the subsequent care is implemented, will also retain some factual causal connection to the ultimate loss. After all, the subsequent side effects treatment never would have been prescribed absent the initial treatment. Thus, reading the PREP Act to require that the covered countermeasure in question be the “sole” cause of a loss runs contrary to the statute’s plain text.

Finally, the statute uses expansive language to describe the causal relationship required to trigger immunity, including claims for loss “relating to” the use or administration of a covered countermeasure. See 42 U.S.C. § 247d6d(a)(1). That broad language is inconsistent with a requirement that the countermeasure be the sole cause of the alleged loss. And in specifying the scope Page 23of the immunity provision, Congress merely required ' a causal relationship' between the covered countermeasure and the alleged loss. 42 U.S.C. § 247d6d(a)(2)(B) (emphasis added). Courts in a variety of contexts regularly use such language to encompass a broader range of connections than that of a “sole cause” connection. Cf., e.g. , Brown v. Parker Drilling Offshore Corp. , 410 F.3d 166, 176 (5th Cir. 2005); Frito-Lay, Inc. v. Loc. Union No. 137, Int’l Bhd. of Teamsters , 623 F.2d 1354, 1362-63 (9th Cir. 1980); Morrison v. Ayoob , 627 F.2d 669, 671-72 (3d Cir. 1980); Indus. Inv. Dev. Corp. v. Mitsui & Co., Ltd. , 594 F.2d 48, 55 (5th Cir. 1979).

In summary, a 'sole cause' requirement is inconsistent with Congress's intent as gleaned from the text of the PREP Act.

Having ruled out a “sole cause” requirement, we need not further define the precise contours of the causal relationship required to trigger PREP Act immunity. Under any remaining possible standard, Kory is entitled to immunity.

The statute’s general immunity provision provides a long list of covered connections; it states that immunity applies so long as the alleged claims for loss are “caused by, arising out of, relating to, or resulting from” the administration or use of a covered countermeasure. See 42 U.S.C. § 247d-6d(a)(1). The list, especially Page 24the statute’s inclusion of claims for loss merely “relating to” the use of a covered countermeasure, indicates that Congress was not particularly concerned with a tight causal relationship.⁹ See Hampton v. California , 83 F.4th 754, 762–63 (9th Cir. 2023) (explaining that the PREP Act '[a]t the very least' requires that 'the underlying use or administration of a covered countermeasure must have played s ome role in bringing about or contributing to the plaintiff's injury' (emphasis added)).

Here, as alleged, the prednisone directly and foreseeably caused the ulcers that perforated and led to the decedent’s death. See J. App'x at 75; see also J. App’x at 90 (claiming that the prednisone prescribed by Kory “caus[ed] a large duodenal ulcer which ultimately led to Mr. Waters’ untimely death” and that such ulcers are a 'well-known' side effect).¹⁰ Thus, Kory's use of a covered countermeasure played more than “some role” in Waters’s death; the prednisone was a factual and proximate cause. See Hampton , 83 F.4th at 762–63. We have no trouble concluding Page 25that such allegations more than trigger the PREP Act’s immunity provision, and therefore, Kory is entitled to immunity.¹¹

The District Court appropriately dismissed Waters’s CUTPA claim on the merits, and we review the dismissal de novo. See Elias v. Rolling Stone LLC , 872 F.3d 97, 104 (2d Cir. 2017).

CUTPA provides that '[n]o person shall engage in unfair methods of competition and unfair or deceptive acts or practices in the conduct of any trade or commerce.' Conn. Gen. Stat. § 42-110b(a). Connecticut courts look to the following factors to determine if a trade practice is unfair: '(1) whether the Page 26practice, without necessarily having been previously considered unlawful, offends public policy as it has been established by statutes, the common law, or other[wise] . . . ; (2) whether it is immoral, unethical, oppressive, or unscrupulous; (3) whether it causes substantial injury to consumers . . . .' See Ulbrich v. Groth , 78 A.3d 76, 100 (Conn. 2013) (citation modified).

“Medical malpractice claims recast as CUTPA claims cannot form the basis for a CUTPA violation. To hold otherwise would transform every claim for medical malpractice into a CUTPA claim.' Haynes , 699 A.2d at 974. '[T]he touchstone for a legally sufficient CUTPA claim against a health care provider is an allegation that an entrepreneurial or business aspect of the provision of services aside from medical competence is implicated, aside from medical malpractice based on the adequacy of staffing, training, equipment or support personnel.” Id.

Here, the CUTPA claim is premised entirely on Kory’s medical treatment of the decedent. The sole allegations relating to the entrepreneurial or business aspect of Kory’s medical practice explain that Kory was overly focused on growing his brand and business, and that “he could not devote adequate time to providing patients such as the plaintiff with proper medical care.” See J. App’x at 78. We agree with the District Court that such allegations look nothing like the cases in Page 27which Connecticut courts have recognized viable CUTPA claims against medical professionals. See Waters , 2025 WL 20556, at *7 (citing cases). Instead, where claims are premised on the notion that a component of the defendant’s business or entrepreneurial efforts weighed on the care that defendant was able to provide to the plaintiff, Connecticut courts have generally concluded that such claims are barred as recast medical malpractice claims. See, e.g. , Hayes , 699 A.2d at 974-75; Janusauskas v. Fichman , 826 A.2d 1066, 1076–77 & n.13 (Conn. 2003); Est. of Doe v. Pegasus Mgmt. Co. , No. CV030082729, 2004 WL 944767, at *1–2 (Conn. Super. Ct. Apr. 14, 2004) (granting motion to strike as insufficient an allegation that nursing home management company violated CUTPA because it was motivated by profit to admit new residents to the detriment of the safety of current residents). Therefore, the district court was correct to dismiss Waters’s CUTPA claim under Rule 12(b)(6) for failure to state a claim upon which relief can be granted.

We hold that 1) we have appellate jurisdiction over both parties’ appeals, 2) Kory is entitled to PREP Act immunity in relation to Waters’s negligence and lack of informed consent claims, and 3) Waters’s CUTPA claim is an improper attempt at recasting a medical malpractice claim. For the foregoing reasons, the District Page 28Court’s dismissal of the CUTPA claim is AFFIRMED , the denial of Kory’s motion to dismiss on the basis of PREP Act immunity is REVERSED , and we REMAND for further proceedings.