EUA “Option to Refuse” Is Not a § 1983 Right: Tenth Circuit Rejects Private Enforcement of EUA, PREP Act, and 10 U.S.C. § 980 in Vaccine-Mandate Suits

Introduction

In a published decision, the Tenth Circuit in Timken v. South Denver Cardiology Associates (consolidated with Sweeney v. University of Colorado Hospital Authority) affirmed dismissal of wide-ranging challenges brought by former healthcare employees terminated for declining COVID-19 vaccination. The employees eschewed religious or medical exemptions and argued instead that a suite of federal provisions—the FDA’s Emergency Use Authorization (EUA) statute, the Public Readiness and Emergency Preparedness (PREP) Act, and 10 U.S.C. § 980—created individual rights to refuse “unlicensed” or “investigational” drugs and to “legally effective informed consent,” enforceable via 42 U.S.C. § 1983. They also pressed Fourteenth Amendment equal-protection and due-process claims, an unconstitutional-conditions theory, a Spending Clause theory, and a state-law third-party beneficiary contract claim premised on CDC Provider Agreements. Finally, they argued the district courts erred by entering judgment without affording leave to amend.

Applying the Supreme Court’s recent articulation of the stringent standard for recognizing § 1983-enforceable rights in federal statutes, the Tenth Circuit rejected each of the employees’ theories. The court held that the EUA statute’s “option to accept or refuse” language regulates the Secretary of Health and Human Services (HHS) and vaccine administrators—not employers—and does not contain the clear, rights-creating terms § 1983 requires. The court likewise found the PREP Act’s liability shield and preemption clause do not create individual rights and, in any event, the Act’s exclusive remedial scheme forecloses § 1983 enforcement. And 10 U.S.C. § 980 is a condition on Defense Department spending, not a source of individual rights. Constitutional claims failed under rational-basis review, and the court found no error in the trial courts’ refusal to sua sponte grant leave to amend where plaintiffs never sought it before judgment.

The decision cements cross-circuit alignment with the Fifth and Ninth Circuits and clarifies, within the Tenth Circuit, that neither the EUA statute, the PREP Act, nor § 980 confers private rights enforceable under § 1983 to resist employer vaccination requirements.

Summary of the Opinion

Section 1983 statutory claims: The EUA statute (21 U.S.C. § 360bbb-3), the PREP Act (42 U.S.C. § 247d-6d, -6e), and 10 U.S.C. § 980 do not unambiguously create individual rights enforceable under § 1983.
EUA: The “option to accept or refuse” language is directed to HHS and vaccine administrators; it does not regulate employer–employee relationships and lacks rights-creating terminology.
PREP Act: The Act’s preemption clause is not rights-creating and runs only to “requirements under this section” (§ 247d-6d), not to § 247d-6e; the Act’s exclusive cause of action for willful misconduct causing death or serious injury forecloses § 1983 suits.
10 U.S.C. § 980: This is a spending restriction on DoD research funds requiring informed consent; it contains no rights-creating language and was not plausibly implicated on the pleadings.
Constitutional claims: Equal-protection and substantive due-process challenges to vaccine mandates were reviewed under rational-basis scrutiny and failed; procedural due process and several theories were waived by inadequate briefing or abandonment.
Unconstitutional conditions: Without an underlying constitutional violation, the doctrine does not apply.
Spending Clause: Reframed as statutory § 1983 theories; spending-power enactments require clear, unambiguous rights-creating terms, which are absent here.
Contract claim: The third-party beneficiary theory under CDC Provider Agreements was inadequately briefed and waived; a new FWA-based theory was not pleaded and is waived.
Leave to amend: District courts did not abuse discretion by entering judgment without sua sponte leave to amend where plaintiffs never moved to amend pre-judgment; post-judgment amendment requires first vacating the judgment under Rule 59(e).
Disposition: Affirmed in full; alignment with the Fifth and Ninth Circuits on substantially similar claims.

Analysis

Precedents Cited and Their Influence

The court’s framework is anchored in the Supreme Court’s § 1983 jurisprudence:

Medina v. Planned Parenthood S. Atl., 145 S. Ct. 2219 (2025): Establishes a “stringent and demanding” standard for recognizing § 1983-enforceable rights in statutes. A statute must have an “unmistakable focus on individuals like the plaintiff” and use “clear and unambiguous rights-creating terms.” It is “rare” for statutes to meet this bar.
Health & Hospital Corp. of Marion County v. Talevski, 599 U.S. 166 (2023): Demonstrates what rights-creating language looks like, pointing to the FNHRA’s text explicitly denominating “residents’ rights.” Used as a contrast to the EUA and PREP Act, which lack such rights-focused phrasing.
Gonzaga Univ. v. Doe, 536 U.S. 273 (2002), and Pennhurst State School & Hospital v. Halderman, 451 U.S. 1 (1981): Spending-power statutes are “in the nature of a contract,” and rights enforceable by § 1983 require clear notice to the grantee. Typical remedies are administrative (e.g., terminating funds), not private damages suits.
City of Rancho Palos Verdes v. Abrams, 544 U.S. 113 (2005), and Blessing v. Freestone, 520 U.S. 329 (1997): A statute’s comprehensive remedial scheme can displace § 1983 enforcement.
Ashcroft v. Iqbal, 556 U.S. 662 (2009): Pleading standard—complaints must state a plausible claim.
Rational-basis rubric: Brown v. Montoya, 662 F.3d 1152 (10th Cir. 2011) (tiers of scrutiny), with the court also invoking classic due-process rubrics distinguishing procedural and substantive claims (Hyde Park Co. v. Santa Fe City Council, 226 F.3d 1207 (10th Cir. 2000)).
Unconstitutional conditions doctrine: Koontz v. St. Johns River Water Mgmt. Dist., 570 U.S. 595 (2013); Regan v. Taxation with Representation of Washington, 461 U.S. 540 (1983)—there must be an underlying constitutional right being burdened.
Appellate waiver and pleading practice: Paycom Payroll, LLC v. Richison, 758 F.3d 1198 (10th Cir. 2014); Utah Animal Rights Coalition v. Salt Lake County, 566 F.3d 1236 (10th Cir. 2009); Tele-Communications, Inc. v. Commissioner, 104 F.3d 1229 (10th Cir. 1997).
Amendment practice: Young v. Colorado Dep’t of Corrections, 94 F.4th 1242 (10th Cir. 2024) (no sua sponte leave absent a request); Calderon v. Kansas Dep’t of SRS, 181 F.3d 1180 (10th Cir. 1999) (post-judgment amendment requires vacatur under Rule 59(e)); Cohen v. Longshore, 621 F.3d 1311 (10th Cir. 2010) distinguished.

The panel also noted concordant outcomes: Pearson v. Shriners Hospitals for Children, Inc., 133 F.4th 433 (5th Cir. 2025), Curtis v. Inslee, 2025 WL 2827880 (9th Cir. Oct. 6, 2025), and district decisions such as Boyd v. Shriners Hospital for Children (W.D. Pa. 2024).

Legal Reasoning

1) Statutory § 1983 Theories

EUA statute (21 U.S.C. § 360bbb-3). Plaintiffs argued that the EUA’s requirement that HHS impose conditions “designed to ensure individuals … are informed … of the option to accept or refuse” an EUA product creates an individual right to refuse and to be informed of consequences, enforceable against employers via § 1983. The court disagreed on two independent grounds:

Textual focus and addressee: The statute empowers and constrains HHS in granting EUAs and regulates the administrator–recipient relationship. It says nothing about employer policies or employment consequences. It lacks an “unmistakable focus” on employees as rights-holders against their employers.
Rights-creating language: The provision does not speak in the language of “rights,” “privileges,” or “immunities.” Its “option” phrasing is oblique and embedded in a regulatory grant of authority to HHS, unlike Talevski’s FNHRA provisions that explicitly enumerate “residents’ rights.” Under Medina’s stringent standard, the EUA does not unambiguously create a § 1983-enforceable right.

PREP Act (42 U.S.C. § 247d-6d, -6e). Plaintiffs contended the PREP Act’s preemption clause and § 247d-6e’s references to the “voluntary nature” of programs conferred an enforceable right against workplace vaccination mandates. The court rejected this:

No rights-creating language: The preemption clause is a shield for covered persons implementing countermeasures; it does not speak to recipients’ rights. Section 247d-6e’s “voluntary” phrasing does not unambiguously create individual rights under Medina.
Limited preemption: By its terms, § 247d-6d(b)(8) preempts state and local requirements “under this section” (i.e., § 247d-6d). It does not extend to § 247d-6e’s education/voluntariness provisions. Thus, even if § 247d-6e were rights-creating (it is not), the preemption clause would not displace contrary state or local rules.
Exclusive remedial scheme: The Act creates a sole, exclusive federal cause of action for willful misconduct causing death or serious physical injury and channels claims through a defined process. That comprehensive scheme forecloses § 1983 suits. Plaintiffs alleged neither willful misconduct nor the requisite injury.

10 U.S.C. § 980. This statute limits DoD spending on human-subject research absent informed consent. The court found it does not create § 1983 rights:

Pleading defect: Plaintiffs did not plausibly allege DoD funds were used to research on them or tie any defendant to such use.
Nature of the statute: As a spending restriction on a federal agency, it lacks rights-creating terms focused on individuals and thus fails Medina’s test. The normal remedy for violation would be funding consequences, not private damages suits.

Other sources. Plaintiffs referenced CDC Provider Agreements, Federalwide Assurances (FWAs), the Belmont Report, 45 C.F.R. part 46, and the ICCPR. The district courts deemed those theories abandoned or conceded when not defended below; on appeal they were waived. The panel also noted these materials are not federal statutes, a threshold defect for § 1983 statutory-rights claims.

2) Constitutional § 1983 Theories

Equal Protection. Sweeney alleged discriminatory treatment of employees who exercised the “option” to refuse vaccination. The court treated vaccination status as a non-suspect classification and applied rational-basis review. Slowing COVID-19 spread in healthcare settings is a legitimate interest, and employee vaccination mandates are rationally related to that interest. Sweeney did not meaningfully contest the rationale on appeal, and the claim failed. Timken waived her equal-protection theory by not briefing it.

Substantive and Procedural Due Process.

Procedural due process: Sweeney’s claim was deemed abandoned at the motion-to-dismiss stage and was not revived on appeal.
Substantive due process: The complaints framed the liberty interest as a right to continued employment without vaccination, invoking Lochner-era freedom of contract language. That is not a fundamental right; rational-basis scrutiny applies. For the same reasons as the equal-protection claim, the mandates survive. New bodily-integrity or informed-consent theories were raised post-judgment or for the first time on appeal and were not considered.

Unconstitutional Conditions. This doctrine applies only if the government pressures a waiver of a constitutional right it could not directly abridge. Because plaintiffs failed to establish any underlying constitutional violation, the claim fails.

3) “Spending Clause” Claim

Plaintiffs styled a separate constitutional claim under the Spending Clause. The panel properly reframed it as statutory § 1983 theories governed by Medina/Talevski. As noted, spending-power enactments rarely create § 1983 rights and require unambiguous rights-creating language. Neither the EUA (enacted under the Commerce Clause), the CDC Provider Agreement or 45 C.F.R. § 46.122 (not statutes), nor § 980 (which lacks rights-creating terms) satisfies that standard. The claim therefore fails.

4) Breach of Contract (Sweeney only)

Sweeney argued UCHA employees were third-party beneficiaries of CDC Provider Agreements. The district court dismissed for conclusory pleading under Colorado law. On appeal, Sweeney offered only a single, unsupported paragraph without identifying specific contractual rights or relevant authority, and separately raised an unpleaded FWA-based theory. Both issues were treated as waived.

5) Leave to Amend

Both district courts entered judgment upon granting motions to dismiss. Sweeney moved post-judgment under Rule 59(e) (alternatively seeking leave to amend); the district court denied the motion. The Tenth Circuit affirmed:

No sua sponte obligation: Absent a request to amend, district courts may dismiss without granting leave sua sponte.
Post-judgment posture: A party seeking to amend after judgment must first obtain vacatur of judgment; Sweeney did not establish grounds under Rule 59(e).
Timken made no pre- or post-judgment request to amend; any argument for leave was therefore waived and, in any event, fails under Young.

Impact and Practical Significance

For § 1983 statutory-rights litigation: Timken operationalizes the Supreme Court’s Medina framework in the pandemic context, reiterating that statutory text must unambiguously and expressly create individual rights to be privately enforceable under § 1983. Regulatory conditions and administrative programs—even those framed to protect recipients—will not suffice absent rights-creating language. Litigants should expect an uphill battle in converting public-health statutes into private-rights instruments.

EUA and employer mandates: The EUA’s “option to refuse” is not a shield against employer mandates. The statute addresses HHS’s authorization conditions and the administrator–recipient interface; it does not circumscribe employers’ policies. This removes a frequently asserted statutory foundation for challenges to employment vaccination rules.

PREP Act scope: The panel’s careful parsing of § 247d-6d and § 247d-6e narrows preemption arguments premised on “voluntariness.” More broadly, the Act’s exclusive cause of action for willful misconduct resulting in severe injury or death forecloses repackaging collateral complaints (like employment termination) as § 1983 claims. Plaintiffs seeking remedies related to covered countermeasures must navigate the Act’s channeling provisions or other applicable legal regimes (e.g., Title VII religious accommodation or ADA medical accommodation claims, which were not at issue here).

Spending-power conditions: The decision underscores that spending conditions generally do not create privately enforceable rights; the ordinary remedy remains administrative enforcement. Parties relying on programmatic agreements (e.g., CDC Provider Agreements) face an additional barrier because such instruments are not statutes and, absent clear third-party-beneficiary intent and state-law pleading sufficiency, do not support damages suits by employees.

Constitutional challenges to health mandates: Absent a suspect classification or interference with a fundamental right, vaccination policies in healthcare settings will continue to be assessed under rational-basis review—a forgiving standard easily satisfied by infection-control objectives. Attempts to reframe employment consequences as deprivations of bodily integrity or informed consent must be clearly pleaded from the outset; new theories cannot be introduced post-judgment or on appeal.

Pleading and appellate practice: Timken is a cautionary tale on waiver and preservation. Arguments not defended in opposition to motions to dismiss are deemed abandoned; perfunctory briefing leads to waiver on appeal. If amendment is desired, plaintiffs should move for leave before judgment; courts are not required to offer sua sponte amendment opportunities.

Cross-circuit uniformity: With the Fifth and Ninth Circuits issuing similar outcomes, national coherence is emerging on the non-enforceability of EUA/PREP Act provisions via § 1983 in mandate litigation. This reduces forum-shopping incentives and increases predictability for healthcare employers and public-health agencies.

Complex Concepts Simplified

What makes a statute enforceable via § 1983? A federal statute supports a § 1983 claim only if its text clearly and unambiguously creates individual rights—not merely benefits or interests—and focuses on protecting a defined class of persons. If the statute has a detailed remedial scheme, that can displace § 1983 even if a right exists.
Why doesn’t the EUA’s “option to refuse” create a right against employer mandates? Because the EUA regulates HHS and vaccine administrators, ensuring recipients are informed of options and risks. It does not limit employer policies or create employee-centered rights. The phrase “option to refuse” is not the kind of explicit rights-language courts require.
PREP Act preemption and exclusivity—what do they mean? The Act broadly immunizes covered persons from liability for administering countermeasures and preempts conflicting state requirements under § 247d-6d. It also creates a single, exclusive federal cause of action for willful misconduct causing severe harm, funneled through a specific process. That exclusivity blocks alternative suits under § 1983.
Spending Clause statutes as “contracts.” Laws that grant funds with conditions are treated like contracts between the federal government and grantees. Unless Congress clearly says individuals can sue to enforce those conditions, the remedy for noncompliance is typically federal administrative action (e.g., terminating funds), not private litigation.
Rational-basis review in mandate cases. If a policy does not target a suspect class (like race) or burden a fundamental right (like speech), courts ask only whether there is any conceivable legitimate purpose and a rational connection between the policy and that purpose. Public-health rationales in clinical settings usually satisfy this test.
Unconstitutional conditions—when does it apply? The government cannot condition a benefit (like a job) on waiving a constitutional right. But to use this doctrine, the claimant must first show a constitutional right was actually burdened. Absent a right, the doctrine has no foothold.
Leave to amend after dismissal. Courts do not have to offer amendment opportunities sua sponte. To amend after a dismissal, a party must ask for leave; to amend after judgment, the party must first persuade the court to reopen the case (e.g., under Rule 59(e)).

Conclusion

Timken provides a clear, comprehensive blueprint for evaluating pandemic-era challenges under § 1983. The Tenth Circuit, applying Medina and Talevski, holds that neither the EUA statute’s “option to refuse,” the PREP Act’s preemption and voluntariness provisions, nor 10 U.S.C. § 980’s informed-consent condition creates unambiguous, private rights enforceable by § 1983. It further confirms that healthcare vaccination mandates survive rational-basis scrutiny under equal protection and substantive due process, and that the unconstitutional-conditions doctrine does not apply absent a predicate constitutional infringement. On the procedural plane, Timken underscores the importance of preserving arguments, properly pleading theories in the complaint, and timely seeking leave to amend.

In the broader legal landscape, the decision consolidates an emerging consensus among the circuits, tightening the path for employees seeking to transform federal public-health frameworks into individually enforceable rights and reinforcing the high bar for statutory private-rights actions in the wake of Medina. For employers and public-health authorities, Timken offers predictable guidance; for litigants, it offers a roadmap of what § 1983 can—and cannot—do in future public-health emergencies.