Tenth Circuit holds EUA and PREP Act do not create § 1983-enforceable rights; healthcare vaccine mandates survive constitutional attack

Introduction

This consolidated appeal from the District of Colorado arises out of terminations of healthcare workers who declined to comply with COVID-19 vaccination policies in 2021. In separate suits, employees of the University of Colorado Hospital Authority (UCHA), a state entity, and South Denver Cardiology Associates (SDCA), a private practice, alleged that federal law—principally the Food, Drug, and Cosmetic Act’s Emergency Use Authorization (EUA) provision, the Public Readiness and Emergency Preparedness (PREP) Act, and 10 U.S.C. § 980—conferred individual rights to refuse “unlicensed” or “investigational” drugs and to receive “legally effective informed consent,” enforceable via 42 U.S.C. § 1983. They also asserted constitutional claims under the Fourteenth Amendment, a Spending Clause theory, an unconstitutional-conditions claim, and (in Sweeney) a third-party beneficiary contract claim based on CDC program agreements. Both district courts dismissed; the Tenth Circuit affirmed.

The panel (Judge Tymkovich writing, joined by Judges Bacharach and Phillips) squarely holds that the cited federal statutes and related federal instruments do not unambiguously create individual rights enforceable through § 1983—an increasingly demanding threshold after the Supreme Court’s decisions in Health & Hospital Corp. v. Talevski (2023) and Medina v. Planned Parenthood S. Atlantic (2025). The court also rejects the constitutional theories (equal protection, substantive and procedural due process, unconstitutional conditions), finds the contract claim waived, and concludes the district courts did not abuse their discretion in entering judgment without sua sponte leave to amend.

Summary of the Opinion

Section 1983 statutory claims: No privately enforceable rights arise from (i) the FDCA’s EUA provision (21 U.S.C. § 360bbb-3), (ii) the PREP Act (42 U.S.C. § 247d-6d and -6e), or (iii) 10 U.S.C. § 980. The EUA’s “option to accept or refuse” language is a condition on agency authorization and provider disclosures, not a rights-creating mandate limiting employers. The PREP Act’s preemption and immunity scheme lacks rights-creating terms and includes an exclusive federal cause of action that is incompatible with § 1983. Section 980 is a spending restriction on DoD funds, not an individual-rights grant.
Constitutional § 1983 claims: Equal Protection and substantive Due Process challenges to the mandates are reviewed under rational basis (vaccination status is a non-suspect classification; “continued employment without vaccination” is not a fundamental right). The policies easily satisfy rational basis given the legitimate interest in slowing COVID-19 spread in healthcare facilities. Procedural due process and some substantive theories were deemed waived or raised too late.
Spending Clause “claim”: Misframed; the § 1983 enforceability analysis still requires clear, unambiguous, rights-creating language—which is absent in the sources invoked.
Unconstitutional conditions: No predicate constitutional right was burdened; claim fails.
Contract theory (Sweeney): Third-party beneficiary claim predicated on CDC Provider Agreements was inadequately briefed and waived; the FWA-based argument was new on appeal and also waived.
Leave to amend: No abuse of discretion in entering judgment without sua sponte leave. Plaintiffs did not seek leave to amend before judgment; post-judgment relief was properly denied.

Detailed Analysis

Precedents Cited and Their Influence

Medina v. Planned Parenthood S. Atlantic, 145 S. Ct. 2219 (2025): Controls the § 1983 framework for statutory-rights claims. It requires plaintiffs to identify statutory text that “clearly and unambiguously uses rights-creating terms” with an “unmistakable focus on individuals like the plaintiff,” a “stringent and demanding” test met rarely.
Health & Hosp. Corp. v. Talevski, 599 U.S. 166 (2023): Confirms that § 1983 can enforce rights created by Spending Clause statutes, but only where the statute unmistakably speaks in rights-creating terms, as the FNHRA did with repeated “residents’ rights” language. Talevski is used as a contrast: FNHRA stated individual rights expressly; the EUA and PREP Act do not.
Gonzaga Univ. v. Doe, 536 U.S. 273 (2002) and Pennhurst State School & Hospital v. Halderman, 451 U.S. 1 (1981): Emphasize that Spending Clause statutes resemble contracts: private enforcement is available only with clear notice of rights and remedies; the usual remedy for noncompliance is federal funding action, not private suits.
City of Rancho Palos Verdes v. Abrams, 544 U.S. 113 (2005) and Blessing v. Freestone, 520 U.S. 329 (1997): Even when a statute creates an enforceable right, § 1983 is displaced if Congress provides a comprehensive, incompatible remedial scheme. Applied here to the PREP Act’s exclusive cause of action.
Equal protection and due process standards: Brown v. Montoya (10th Cir. 2011) on tiers of scrutiny; Hyde Park Co. v. Santa Fe City Council (10th Cir. 2000) differentiating procedural and substantive due process.
Unconstitutional conditions: Koontz v. St. Johns River Water Mgmt. Dist., 570 U.S. 595 (2013) and Regan v. Taxation With Representation of Washington, 461 U.S. 540 (1983): doctrine requires the government to be unable to constitutionally command the condition directly.
Pleading and amendment: Ashcroft v. Iqbal, 556 U.S. 662 (2009) on plausibility; Young v. Colorado Dep’t of Corr., 94 F.4th 1242 (10th Cir. 2024) (no sua sponte leave absent request), Calderon v. Kansas Dep’t of Social & Rehab. Servs., 181 F.3d 1180 (10th Cir. 1999) (post-judgment amendment requires reopening), and Cohen v. Longshore, 621 F.3d 1311 (10th Cir. 2010) (distinguishable).
Alignment with other circuits: The panel notes that the Fifth and Ninth Circuits have affirmed dismissals of nearly identical EUA/PREP Act § 1983 claims. See Pearson v. Shriners Hosps. for Children, Inc., 133 F.4th 433 (5th Cir. 2025); Curtis v. Inslee, No. 24-1869, 2025 WL 2827880 (9th Cir. Oct. 6, 2025).

Statutory § 1983 claims

1) EUA provision (21 U.S.C. § 360bbb-3)

The EUA statute empowers the HHS Secretary to authorize emergency use of unapproved medical products and to impose “conditions of authorization,” including disclosure to recipients of the option to accept or refuse and any consequences of refusal. The court’s analysis is two-fold:

Who is addressed: The statutory focus is on the Secretary’s authorization and on the provider-recipient interface (what the recipient must be told), not on employers or employment consequences. It says nothing about limiting employer mandates.
No rights-creating language: The text does not use “rights,” “privileges,” or “immunities” language. Its reference to a recipient’s “option” appears within conditions the Secretary must set for emergency authorization. By contrast to Talevski’s FNHRA, which repeatedly enumerated “residents’ rights,” the EUA does not unambiguously confer an individual right enforceable via § 1983.

Accordingly, plaintiffs cannot leverage the EUA’s “option to accept or refuse” into a § 1983 right against employment vaccination policies.

2) PREP Act (42 U.S.C. §§ 247d-6d and 247d-6e)

The PREP Act’s core functions are to (i) confer immunity for the manufacture, distribution, and administration of covered countermeasures during a declared emergency and (ii) impose a preemption clause forbidding contrary state or local requirements.

No rights-creating terms: The preemption clause is not addressed to countermeasure recipients and contains no individual-rights language. Plaintiffs’ attempt to import an EUA “right to refuse” fails because the EUA does not create such a right.
“Voluntariness” in § 247d-6e(c): The provision tasks the Secretary with ensuring education about “the voluntary nature of the program,” but this language still lacks the clear, rights-creating terms required by Medina/Talevski. And even if it did, the PREP Act’s preemption clause, by its terms, applies only to conflicts with “this section” (§ 247d-6d), not § 247d-6e.
Exclusive remedial scheme displaces § 1983: The PREP Act specifies the “sole exception” to immunity: an exclusive federal cause of action for death or serious physical injury proximately caused by willful misconduct, subject to detailed procedures and remedies. Allowing § 1983 claims to enforce other alleged PREP Act “rights” would undermine that exclusive scheme. Plaintiffs did not allege injuries within the exclusive cause of action and therefore cannot proceed under § 1983.

3) 10 U.S.C. § 980

Section 980 restricts the Department of Defense’s use of appropriated funds for research on human subjects absent informed consent (with a narrow beneficial exception). The court finds two independent defects:

No factual fit: Plaintiffs did not allege DoD funding or DoD-conducted research on them, nor defendants’ responsibility for such conduct.
No rights-creating language: The provision conditions federal spending; it does not unambiguously confer an individual right enforceable via § 1983. The typical remedy for noncompliance with spending conditions is administrative (funding withdrawal), not private litigation.

Constitutional § 1983 claims

Equal Protection

Sweeney alleged that punishing only those who exercised a supposed statutory option to refuse vaccination violated equal protection. The district court treated vaccination status as a non-suspect classification and applied rational basis review; Sweeney did not meaningfully contest this on appeal. The Tenth Circuit agrees with rational basis review and recognizes a legitimate governmental interest in limiting COVID-19 spread in healthcare facilities; the mandates are rationally related to that interest.

Due Process (procedural and substantive)

Procedural due process: Sweeney argued she had a protected property interest in her public employment and did not receive a hearing. The district court held she abandoned the claim by not responding to dismissal arguments; the Tenth Circuit treats it as waived.
Substantive due process: The complaints framed the asserted liberty as a “right to continued employment without receiving the COVID-19 vaccine,” even citing Lochner v. New York. That is not a fundamental right. Under rational basis, the mandates pass muster. New theories on appeal (e.g., bodily autonomy or investigational-drug refusal as fundamental rights) were not in the pleadings and are not considered.

Spending Clause

Plaintiffs styled a “Spending Clause” claim based on the CDC Program, EUA statute, 10 U.S.C. § 980, and 45 C.F.R. § 46.122. The court clarifies that there is no freestanding Spending Clause cause of action; § 1983 enforceability still turns on whether the specific statute clearly and unambiguously creates individual rights. That bar is not met here. Moreover, the EUA is grounded in the Commerce Clause, and the Provider Agreement and 45 C.F.R. § 46.122 are not statutes at all. Only § 980 is a spending statute, and it does not create a § 1983 right.

Unconstitutional Conditions

The doctrine applies only if the government could not constitutionally demand the condition outright. Because the plaintiffs failed to establish a burden on any constitutional right (equal protection or due process), their unconstitutional-conditions theory necessarily fails.

Contract claim (Sweeney)

Sweeney argued she was a third-party beneficiary of CDC Provider Agreements and FWAs. The district court dismissed the Provider Agreement theory for lack of specific contractual rights and intent to benefit; on appeal the argument was inadequately briefed and deemed waived. The FWA theory was not pleaded and cannot be raised for the first time on appeal.

Leave to amend

Both district courts entered judgment upon dismissal. The Tenth Circuit affirms: under Rule 15, courts need not sua sponte grant leave to amend absent a request. Sweeney did not seek leave before judgment and failed to establish grounds to reopen under Rule 59(e); Timken never sought leave at all. Young v. Colorado Dep’t of Corrections confirms that plaintiffs can and should ask to amend in response to a motion to dismiss, by separate motion before judgment, or in a motion to reconsider coupled with a proposed amendment—none of which occurred here.

Complex Concepts Simplified

§ 1983-enforceable right: Not every federal law can be enforced through § 1983. The statute must plainly speak in rights-creating terms that focus on individuals (e.g., “residents’ rights”), not on agencies, funding conditions, or broad regulatory goals.
EUA “option to accept or refuse”: This is a disclosure condition the HHS Secretary must ensure in emergency authorizations. It governs what vaccine administrators tell recipients. It is not a personal right that overrides employer policies.
PREP Act exclusivity: The Act largely immunizes countermeasure participants. It allows a single, exclusive federal action only for willful misconduct causing death or serious physical injury. Other harms do not open private litigation channels.
Spending Clause statutes as “contracts”: When Congress gives funds with conditions, the recipient government must clearly understand any private liabilities it accepts. Absent clear notice of rights and remedies, individuals usually cannot sue; the federal government’s remedy is to adjust or withdraw funds.
Rational basis review: If a classification is not suspect and no fundamental right is implicated, a law or policy is constitutional so long as it is rationally related to a legitimate governmental interest—a low bar that COVID-19 health measures typically meet in healthcare settings.
Waiver and preservation: Arguments not raised in the district court or not developed in opening appellate briefs are usually waived and will not be addressed on appeal.
Leave to amend: Courts generally grant leave when justice requires, but plaintiffs must ask. Without a request (and especially after judgment), courts have no obligation to invite amendment.

Practical Implications and Impact

Closure of EUA- and PREP-based § 1983 theories: The Tenth Circuit joins other circuits in foreclosing the use of the EUA and PREP Act to create privately enforceable rights under § 1983 against vaccination mandates. Plaintiffs cannot repackage “informed consent” or “investigational drug refusal” as EUA- or PREP-based rights claims.
PREP Act remedial channeling: The exclusive willful-misconduct cause of action remains the only opening through the PREP Act immunity shield; § 1983 cannot be used to circumvent that tight gateway.
Constitutional challenges to healthcare mandates: Within the Tenth Circuit, vaccination-status classifications receive rational basis review; continued employment without vaccination is not a fundamental right. Public health rationales in medical settings will ordinarily suffice.
State-action questions often unnecessary: The panel did not reach whether a private employer like SDCA was a state actor because the claims failed on the merits anyway—signaling that similar suits may be resolved without litigating the state-action issue.
Alternative pathways remain distinct: This case does not address Title VII (religious accommodation) or ADA medical accommodation claims—common avenues in employment vaccine litigation. Those statutory regimes have their own elements and remedies.
Third-party beneficiary theories are uphill: CDC Provider Agreements and FWAs are unlikely to support employee third-party beneficiary claims absent clear contract language manifesting an intent to confer enforceable rights on employees.
Pleading discipline matters: Preserve arguments at each stage; develop them with supporting authority in opening briefs; request leave to amend before judgment or in a proper post-judgment motion with a proposed amendment.
Future emergency countermeasures: The court’s interpretation of EUA “option” and PREP Act voluntariness provisions will resonate beyond COVID-19, shaping litigation over future emergency-use products and employer policies governing their use.

Conclusion

Sweeney v. University of Colorado Hospital Authority (consolidated with Timken v. South Denver Cardiology Associates) marks a significant clarification in the Tenth Circuit: the FDCA’s EUA provision and the PREP Act do not unambiguously create individual rights enforceable through § 1983. Nor does 10 U.S.C. § 980. The panel’s analysis, grounded in the Supreme Court’s recent § 1983 jurisprudence (Medina and Talevski), reinforces a high threshold for converting federal statutes and programmatic instruments into private rights. On the constitutional side, vaccination mandates in healthcare settings readily survive rational basis review, and the unconstitutional-conditions doctrine cannot succeed without a predicate constitutional right.

The opinion aligns with other circuits’ treatment of similar claims and provides clear guidance to litigants and lower courts: EUA “option” language and PREP Act preemption/immunity tools are not personal rights vehicles; employment vaccination policies by public healthcare entities, framed to advance infection control, are constitutionally sound under rational basis; and procedural rigor in pleading and amendment is indispensable. As a result, challenges to healthcare vaccine mandates premised on EUA/PREP-based § 1983 theories will face steep odds in the Tenth Circuit going forward.