PAUL JULIAN MANEY; GARY CLIFT; GEORGE W. NULPH; THERON D. HALL; DAVID HART; SHERYL LYNN SUBLET; FELISHIA RAMIREZ, personal representative for the Estate of Juan Tristan, individually, on behalf of a class of other similarly situated v. KATE BROWN, Governor, and COLETTE PETERS; HEIDI STEWARD; MIKE GOWER; MARK NOOTH; ROB PERSSON; KEN JESKE; STATE OF OREGON; PATRICK ALLEN; JOE BUGHER; GARRY RUSSELL
No. 22-35218
No. 22-35219
United States Court of Appeals, Ninth Circuit
February 1, 2024
Opinion by Judge Sung
D.C. No. 6:20-cv-00570-SB; Argued and Submitted April 20, 2023, Portland, Oregon
FOR PUBLICATION
UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT
OPINION
Stacie F. Beckerman, Magistrate Judge, Presiding
Before: Johnnie B. Rawlinson, Carlos T. Bea, and Jennifer Sung, Circuit Judges.
Opinion by Judge Sung
SUMMARY*
PREP Act Immunity
Reversing the district court‘s denial of Oregon State Governor Kate Brown and Director of the Oregon Health Authority Patrick Allen‘s motion to dismiss a claim brought by Oregon state inmates for damages stemming from defendants’ assignment of a lower priority COVID-19 vaccination tier to state inmates than to correctional officers, the panel held that defendants were immune from liability for the vaccination prioritization claim under the Public Readiness and Emergency Preparedness (“PREP“) Act.
At the start of the COVID-19 pandemic, Governor Brown and Director Allen, both responsible for crafting the state‘s response to the virus‘s spread, established priority tiers to guide the state‘s vaccine rollout, and assigned state prison inmates to a lower priority vaccination tier than correctional officers.
On March 17, 2020, the Secretary of Health and Human Services issued a declaration announcing that COVID-19 constituted a public health emergency and that immunity as prescribed in the PREP Act was in effect for the “manufacture, testing, development, distribution, administration, and use of” covered countermeasures.
The panel held that the statutory requirements for PREP Act immunity were met with respect to the vaccine prioritization damages claim because the “administration” of a covered countermeasure includes prioritization of that countermeasure when its supply was limited. The panel further concluded that the PREP Act‘s provisions extend immunity to persons who make policy-level decisions regarding the administration or use of covered countermeasures.
The panel next held that the PREP Act provides immunity from suit and liability for constitutional claims brought under
COUNSEL
Robert A. Koch (argued), Senior Assistant Attorney General; Denise G. Fjordbeck, Assistant Attorney General; Benjamin Gutman, Solicitor General; Ellen F. Rosenblum, Oregon Attorney General; United States Department of Justice, Salem, Oregon; R. Kyle Busse and Kerry J. Shepherd, Markowitz Herbold PC, Portland, Oregon; for Defendant-Appellant.
Nadia H. Dahab (argued), Sugerman Dahab, Portland, Oregon; David F. Sugerman, David F. Sugerman Attorney PC, Portland, Oregon; Juan C. Chavez, Brittney Plesser, Franz Bruggemeier, Alex Meggitt, and Benjamin Haile, Oregon Justice Resource Center, Portland, Oregon; for Plaintiffs-Appellees.
OPINION
SUNG, Circuit Judge:
At the start of the COVID-19 pandemic, the Governor of Oregon, Kate Brown, and the Director of the Oregon Health Authority (“OHA“), Patrick Allen, were responsible for crafting the state‘s response to the novel virus‘s rapid spread. When COVID-19 vaccines first became available, Brown and Allen established priority tiers to guide the state‘s vaccine rollout, and they assigned state prison inmates to a lower priority vaccination tier than correctional officers. This appeal concerns the affected inmates’ claim for damages allegedly caused by this vaccine prioritization.
BACKGROUND
I
“Congress passed the PREP Act in 2005 to encourage during times of crisis the development and deployment of medical countermeasures (such as diagnostics, treatments, and vaccines) by limiting legal liability relating to their administration.” Hampton v. California, 83 F.4th 754, 762 (9th Cir. 2023) (cleaned up). The statute gives “covered person[s]” immunity “from suit and liability” for claims “caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure.”
The Act‘s immunity lies dormant until the Secretary of Health and Human Services “makes a determination that a disease... constitutes a public health emergency” and “make[s] a declaration, through publication in the Federal Register,” that the Act‘s immunity “is in effect.”
On March 17, 2020, the Secretary issued a declaration announcing that COVID-19 “constitutes a public health emergency” and that “immunity as prescribed in the PREP Act” was “in effect” for the “manufacture, testing, development, distribution, administration, and use of” covered countermeasures. Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198, 15201 (Mar. 17, 2020). The Secretary broadly defined “covered countermeasures” to include “any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19.” Id. at 15202.
II
Plaintiffs are current and former inmates—or “adults in custody” (“AICs“) of the Oregon Department of Corrections, or their personal representatives, who contracted COVID-19 while in custody in Oregon prisons. Tragically, COVID-19 caused or contributed to the deaths of some inmates. In April 2020, Plaintiffs filed a class action complaint under
Meanwhile, development of the first COVID-19 vaccines progressed rapidly, culminating in FDA approval of a vaccine in December 2020. On December 9, 2020, the Secretary amended the COVID-19 declaration for the fourth time. See Fourth Amendment to the Declaration Under the
The Oregon Health Authority then published guidance recommending phased allocation of the vaccines. In Phase 1A, healthcare personnel, residents in long-term care facilities, and corrections officers were eligible for vaccines. In Phase 1B, teachers, childcare workers, and persons age 65 or older were eligible. Neither phase categorically covered AICs, but AICs who met the eligibility criteria were prioritized for vaccination on the same terms as the general population. For example, all AICs who were 65 or older were eligible for vaccination in Phase 1B. The Governor‘s initial rollout of the vaccines was consistent with OHA‘s guidance.
In response, Plaintiffs amended their complaint to add class claims for injunctive relief and damages, alleging that the vaccine prioritization of corrections officers, but not all AICs, violated the Eighth Amendment‘s prohibition against cruel and unusual punishment. On February 2, 2021, the district court certified a provisional class of all AICs who had not yet been offered a vaccine and granted Plaintiffs preliminary injunctive relief, ordering the immediate prioritization of approximately 11,000 AICs for vaccination. Defendants complied with the court‘s order.
In September 2021, when vaccines were no longer scarce, the district court dismissed as moot Plaintiffs’ claim for injunctive relief because all Oregonians (ages twelve and over) were eligible to receive a COVID-19 vaccine and vaccine supply in Oregon exceeded demand. Plaintiffs’ damages claims, however, remained.
In November 2021, Brown and Allen each moved to dismiss Plaintiffs’ vaccine prioritization damages claim, contending that it is barred by the PREP Act. The district court denied both motions, and Defendants filed this interlocutory appeal. Although Plaintiffs’ action involves additional claims and defendants, the only issue presented in this appeal is whether the PREP Act bars Plaintiffs’ vaccine prioritization damages claim against Brown and Allen.
DISCUSSION
I
We have jurisdiction over Defendants’ immediate appeal of the district court‘s denial of PREP Act immunity. Hampton, 83 F.4th at 761-62 (holding that a denial of PREP Act immunity is immediately appealable under the collateral order doctrine).
We review de novo the denial of a motion to dismiss under
II
We first consider whether the statutory requirements for PREP Act immunity are met with respect to Plaintiffs’ vaccine prioritization damages claim. We then address Plaintiffs’ argument that, regardless of whether those requirements are met, the PREP Act does not bar federal constitutional claims brought under
A
To determine whether Plaintiffs’ vaccine prioritization damages claim meets the PREP Act‘s requirements for immunity, we begin with the statutory text. The Act‘s immunity provision states:
Subject to the other provisions of this section, a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure.
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.
Plaintiffs concede that both Defendants are covered persons, that COVID-19 vaccines are covered countermeasures, and that Plaintiffs seek damages for losses allegedly caused by Defendants’ decisions to give corrections officers and others vaccine priority before AICs. Thus, the only question is whether Plaintiffs’ vaccine prioritization claim falls within the scope of covered claims as defined in
For the following reasons, we conclude that the vaccine prioritization claim falls within the scope of covered claims because “administration” of a covered countermeasure includes prioritization of that countermeasure when its supply is limited.
The PREP Act does not explicitly define what it means to administer a countermeasure to an individual under
Consistent with the text of subsections (a)(1) and (a)(2)(B), the Secretary‘s Declaration defines “administration” to include both “physical provision of the countermeasures to recipients” and, in relevant part, “activities and decisions directly relating to ... management and operation of countermeasure programs.” 85 Fed. Reg. at 79197. The Declaration further explains: “Where there are limited Covered Countermeasures, not administering a Covered Countermeasure to one individual in order to administer it to another individual can constitute ‘relating to . . . the administration to . . . an individual’ under
Plaintiffs do not challenge the validity of the Declaration‘s definition of “administration” or its interpretation of that term as including prioritization of scarce countermeasures. Moreover, that interpretation is consistent with the statutory text, as well as our decision in Hampton. In that case, we held that “the PREP Act provides immunity only from claims that relate to ‘the administration to or the use by an individual of a covered countermeasure—not such a measure‘s non-administration or non-use.” Hampton, 83 F.4th at 763 (emphasis in original). However, we distinguished prioritization of a scarce countermeasure from non-administration or non-use, and we explained that, “for a countermeasure with limited availability, administering the countermeasure to one person could mean withholding it from another.” Id.
Plaintiffs concede that the Declaration extends PREP Act immunity to claims arising from a “failure to administer” a COVID-19 vaccine to a particular individual when that omission occurred in the context of an individualized prioritization decision. They argue, however, that PREP Act immunity does not extend to “policy-level” failure-to-administer claims. We disagree.
Several of the PREP Act‘s provisions expressly show Congress‘s intent to extend immunity to persons who make policy-level decisions regarding administration or use of covered countermeasures and do not directly administer countermeasures to particular individuals. The Act defines the term “covered person,” “when used with respect to the administration or use of a covered countermeasure,” to include a “program planner of such countermeasure.”
Plaintiffs cite the Secretary‘s Declaration, but they do not specifically identify any provisions that expressly or impliedly exclude policy-level prioritization decisions from the scope of immunity. Plaintiffs appear to rely on the fact that the Declaration used an “example” involving an individualized prioritization decision to illustrate when “not administering” a covered countermeasure could be protected by the Act. See 85 Fed. Reg. at 79197. But the use of an illustrative example does not limit the scope of immunity to the circumstances of that example.
B
We next consider whether the PREP Act provides immunity from suit and liability for constitutional claims brought under
Section 1983 “is a mechanism for vindicating federal statutory or constitutional rights.” Stilwell v. City of Williams, 831 F.3d 1234, 1240 (9th Cir. 2016) (citing Baker v. McCollan, 443 U.S. 137, 144 n.3 (1979)). Specifically,
Congress, however, may “specifically foreclose[] a remedy under
The PREP Act expressly states, in relevant part, that “a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure.”
The PREP Act covers “all claims for loss” related to the administration or use of covered countermeasures. “The use of ‘all’ indicates a sweeping statutory reach.” AK Futures LLC v. Boyd St. Distro, LLC, 35 F.4th 682, 690-91 (9th Cir. 2022). Of course, the PREP Act limits the scope of covered claims to those related to the administration or use of covered countermeasures.
The Act also carves out one “exception to the immunity” provided for in
Plaintiffs assert that the PREP Act does not expressly foreclose
Plaintiffs also briefly argue that, even if the PREP Act forecloses a remedy under
CONCLUSION
Under the PREP Act, defendants Brown and Allen are entitled to immunity from suit and liability with respect to Plaintiffs’ vaccine prioritization damages claim. We reverse the district court‘s denial of Brown‘s and Allen‘s motions to dismiss that claim and remand for further proceedings consistent with this opinion.
REVERSED and REMANDED.4