25-76(L)
Waters v. Kory
In the
United States Court of Appeals
for the Second Circuit
August Term 2025
Argued: January 12, 2026
Decided: August 26, 2026
No. 25-76(L), 25-524(XAP)
PIERRE KORY, M.D.,
Defendant-Appellant-Cross-Appellee,
v.
EDWARD WATERS, JR., ADMINISTRATOR OF THE ESTATE OF EDWARD JAMES WATERS,
Plaintiff-Appellee-Cross-Appellant.
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”).
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
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.
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MYRNA 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
3
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, and thus, we
affirm the District Court’s dismissal of the claim.
BACKGROUND
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
1 The facts are drawn from the operative complaint and are accepted as true for purposes of our review. See Schiebel v. Schoharie Cent. Sch. Dist., 120 F.4th 1082, 1092 (2d Cir. 2024). 2 The operative complaint does not allege precisely who contacted Kory. Instead, it merely states that “Mr. Waters or his family reached out to Dr. Kory.” See J. App’x at 72.
4
a “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
5
and 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
6
denied 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.
DISCUSSION
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).
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A. Collateral Order Doctrine
We 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
8
Foreign 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).
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We 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.
3 In recognizing that a denial of PREP Act immunity is an appealable collateral order, we agree with the circuits that have decided the issue in a precedential decision. See Dressen v. AstraZeneca AB, 182 F.4th 1232, 1240 (10th Cir. 2026); Hampton v. California, 83 F.4th 754, 762 (9th Cir. 2023); see also Goins v. Saint Elizabeth Med. Ctr., No. 22-6070, 2024 WL 229568, at *4–5 (6th Cir. Jan. 22, 2024) (unpublished).
10
Corp., 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.
B. Rule 54(b)
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
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partial 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.
4 As part of the third requirement, district courts must generally “provide ‘a brief, reasoned explanation’” for their decision to certify partial final judgment. See In re Energetic Tank, Inc., 110 F.4th 131, 148 (2d Cir. 2024) (quoting Scottsdale Ins. Co. v. McGrath, 88 F.4th 369, 378 (2d Cir. 2023)). We may excuse the lack of an explanation where the reasons for Rule 54(b) judgment are obvious and a remand “would result only in unnecessary delay in the appeal process.” See id. (quoting Brown v. Eli Lilly & Co., 654 F.3d 347, 355 (2d Cir. 2011)).
12
We 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
13
entirety 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.
II. PREP Act Immunity
“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
14
medical 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
5 Individuals whose claims in court are barred by the statute are not left without recompense; “the PREP Act establishes a Covered Countermeasure Process Fund to compensate ‘eligible individuals for covered injuries directly caused by the administration or use of a covered countermeasure pursuant to such declaration.’” Solomon v. St. Joseph Hosp., 62 F.4th 54, 58 (2d Cir. 2023) (quoting 42 U.S.C. § 247d-6e(a)). Thus, rather than proceeding to court, those harmed by conduct covered by the PREP Act’s immunity provisions may seek compensation through the established administrative fund.
15
State 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:
16
(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
6 “The PREP Act contains one exception to immunity for claims ‘for death or serious physical injury proximately caused by willful misconduct.’” Solomon, 62 F.4th at 58 (quoting 42 U.S.C. § 247d-6d(d)(1)).
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A. 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
The United States District Court for the District of Columbia has exclusive jurisdiction over claims brought pursuant to the willful misconduct exception. See 42 U.S.C. § 247d-6d(e)(1). In Solomon, we found that the PREP Act’s willful misconduct cause of action does not constitute field preemption for medical malpractice claims; but contrary to Waters’s arguments, that holding has no bearing on this case as there is no preemption issue at bar. See Solomon, 62 F.4th at 61 & n.4 (“Instead, the PREP Act principally creates an immunity scheme. And immunity has no bearing on complete preemption, which is a jurisdictional doctrine, not a preemption-defense doctrine.”).
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those 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
B. Covered Countermeasure
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
7 Even if Kory had treated the decedent for longer than thirty days, Waters concedes that a series of executive orders pertaining to the COVID-19 pandemic excused any deficiency in meeting the Connecticut medical licensure requirements. See Waters Br. at 34. Therefore, we need not address Waters’s argument that Kory’s treatment properly continued after the permitted period by virtue of the “continuing treatment doctrine” under Connecticut law. Regardless, the continuing treatment doctrine applies to extend the limitations period for bringing medical malpractice claims, see Bednarz v. Eye Physicians of Cent. Conn., P.C., 947 A.2d 291, 298–99 (Conn. 2008); Waters points to no precedent applying the doctrine in the context of assessing the lawfulness of an out-of-state physician’s practice in Connecticut.
8 Notably, neither the statute nor the Secretary’s declaration limits a covered countermeasure to drugs specifically designed and produced to treat a certain disease like COVID-19. Thus, it does not matter that prednisone is also used to treat other ailments; here, it was “used to treat” Waters’s COVID-19 infection, and thus, constitutes a covered countermeasure.
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C. A Causal Relationship
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.
1. PREP Act Immunity Does Not Require Sole Causation
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
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causal 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 events
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“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
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of 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.
2. The Allegations In This Case State “A Causal Relationship”
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
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the 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
some 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
9 Despite the evident broad scope of the statute, we agree with the Ninth Circuit that the statute’s inclusion of “relating to” must be read in its context, and that the statute requires at least some causal link. See Hampton, 83 F.4th at 764 (“It is not enough that some countermeasure’s use could be described as relating to the events underpinning the claim in some broad sense.”).
10 Allegations of causation need not be as direct and foreseeable as those here to confer immunity. Again, Congress cast a wide net with the language of the PREP Act, and this case does not present reason to ascertain the minimum relationship required to trigger immunity.
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that such allegations more than trigger the PREP Act’s immunity provision, and
therefore, Kory is entitled to immunity. 11
III. CUTPA
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
11 Kory’s failure to prescribe a prophylaxis does not change our conclusion.
The District Court’s decision to deny immunity hinged on the distinction between the prednisone prescription and Waters’s focus on Kory’s failure to prescribe a mitigating prophylaxis. It reasoned that “Dr. Kory’s alleged failure to mitigate against the harmful effects of high doses of corticosteroids is sufficiently alleged to be a ‘distinct and independent cause’ of Mr. Waters’ death, even though the corticosteroids were prescribed to treat COVID-19.” See Waters v. Kory, No. 3:24-CV-00858, 2025 WL 20556, at *5 (D. Conn. Jan. 2, 2025) (quoting Mills v. Hartford Healthcare Corp., 298 A.3d 605, 634 (Conn. 2023)). But Kory’s administration of a covered countermeasure “in and of itself, dictate[d]” whether Kory also needed to prescribe a prophylaxis. See id. at *4 (quoting Mills, 298 A.3d at 632). The failure to prescribe prophylaxis, therefore, cannot be described as distinct and independent of the covered countermeasure: prednisone. We therefore do not need to decide whether a complaint’s focus on a distinct and independent cause of the alleged loss matters for purposes of PREP Act immunity.
Moreover, Kory’s failure to prescribe a prophylaxis does not mean this case is premised on the failure to use or administer a covered countermeasure. Several circuits have agreed that where a plaintiff alleges loss caused by a failure to use or administer a covered countermeasure (like the failure to administer a vaccine or implement masking requirements), the claims are not barred by the PREP Act. See Schleider v. GVDB Operations, LLC, 121 F.4th 149, 163 (11th Cir. 2024) (citing cases). But here, unlike in those cases, Waters alleges that the loss is, in fact, causally connected to the affirmative use or administration of a covered countermeasure: prednisone.
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practice, 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
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which 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.
CONCLUSION
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
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Court’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.
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