Key Points

  • PREP Act immunity applies based on the type of injury alleged, not the category of legal claim pleaded.
  • Cities implementing COVID-19 testing and masking policies qualify as 'program planners' and thus 'covered persons' under the PREP Act.
  • COVID-19 saliva tests and face masks constitute 'covered countermeasures' under the HHS declaration and FDA emergency use authorizations.
  • The Ninth Circuit clarified that its Hampton decision did not establish a per se rule that COVID-19 tests are covered countermeasures—that was a party concession, not a holding.
  • Loper Bright does not permit courts to disregard HHS definitions when Congress expressly delegated authority to the agency.

The U.S. Court of Appeals for the Ninth Circuit ruled Monday that a city's COVID-19 testing and masking policy for unvaccinated employees is shielded by the federal Public Readiness and Emergency Preparedness Act, holding that the sweeping immunity provision applies based on the type of injury a plaintiff alleges rather than the category of legal claim pleaded.

A unanimous three-judge panel affirmed the dismissal of a 21-count lawsuit brought by Jonathan Schmidt, a forensic specialist in the Pasadena Police Department, who alleged that the city's requirement that unvaccinated workers submit to weekly saliva tests and wear masks in shared spaces violated his constitutional rights and created a hostile work environment.

Writing for the panel, Judge Ana de Alba held that the City of Pasadena and its employees qualify as "covered person[s]" under the PREP Act, that COVID-19 saliva tests and face masks constitute "covered countermeasure[s]" under the HHS Secretary's declaration and FDA emergency use authorizations, and that Schmidt's allegations establish the causal connection required for immunity.

The decision corrects what the panel described as the district court's misreading of the PREP Act's causation requirement. "The district court focused on the types of legal claims Schmidt pleads rather than the type of injury he alleges," Judge de Alba wrote. "This was incorrect."

The district court below had found that PREP Act immunity barred only two of Schmidt's claims—those alleging deprivation of a property interest in his DNA—while allowing the remainder to proceed on the theory that his claims "primarily involve reputational harms" rather than the physical or emotional injuries the statute covers.

The Ninth Circuit disagreed. Adopting reasoning from the Tenth Circuit's recent decision in Dressen v. AstraZeneca AB, the panel held that the PREP Act's causation requirement, not the category of legal claim, limits the scope of immunity. Because Schmidt alleged that he suffered "emotional and physical harm" as a direct result of complying with the city's COVID-19 safety policies, and because his complaint rested on the assertion that the city deprived him of property interests in his DNA, the causal relationship required for immunity was satisfied across all claims.

The PREP Act, enacted by Congress in 2005, "provides immunity from federal and state law claims relating to the administration of certain medical countermeasures during a declared public health emergency," the court explained, citing its own prior precedent. "The scope of immunity is broad," Judge de Alba wrote, quoting the Third Circuit.

The panel walked through the three statutory elements required for immunity: that the defendant be a covered person, that the product at issue be a covered countermeasure, and that the plaintiff's alleged injuries be "caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure."

On the first element, the court held that the city qualifies as a "program planner" because it made "policy-level decisions regarding administration or use of covered countermeasures" when it issued its vaccine-or-test-and-mask mandate. The individually named defendants likewise qualify as covered persons because they are "person[s] who supervised or administered a program with respect to the administration" of those countermeasures.

On the second element, the panel rejected Schmidt's argument that the saliva tests were not authorized under the relevant emergency use authorization. The court found that "[n]othing in the EUA summary expressly limits the use of Ultimate DX's diagnostic tool under the EUA to particular collection methods." Face masks also constitute covered countermeasures, the court held, because they are included in the HHS declaration's definition as a "respiratory protective device" used to "prevent" the transmission of the virus, and the FDA granted a broad emergency use authorization covering them.

In a footnote, Judge de Alba clarified that the Ninth Circuit's prior decision in Hampton v. California did not establish a categorical rule that COVID-19 tests are covered countermeasures. "Our statement in Hampton was limited to explaining that the parties in that case had conceded that COVID-19 tests were 'covered countermeasures,'" she wrote. "Sufficient factual allegations are still necessary for a Defendant to establish their entitlement to immunity under the PREP Act."

The court also dispatched Schmidt's argument that the Supreme Court's 2024 decision in Loper Bright Enterprises v. Raimondo permitted the panel to disregard the HHS Secretary's definitions. Even after Loper Bright, courts "must respect when Congress has 'expressly delegated to an agency the authority to give meaning to a particular statutory term,'" Judge de Alba wrote, and Schmidt had not alleged that the PREP Act's grant of authority was ambiguous or that HHS acted outside its statutory bounds.

Schmidt had been placed on unpaid administrative leave in fall 2021 for refusing to test and mask after receiving a religious exemption from the city's vaccine requirement. He returned to work in November 2021 after agreeing to comply, but alleged that the policy created a hostile work environment by revealing his unvaccinated status. The city rescinded the policy in March 2022.

The panel also affirmed the district court's denial of Schmidt's motion for reconsideration, finding that the evidence he submitted in support—including expert declarations—was available before the court dismissed his earlier complaint and therefore did not qualify as newly discovered. The court further rejected Schmidt's challenges to the district judge's refusal to recuse and to his denial of Rule 11 sanctions against the city's lawyers.

Schmidt was represented by Vasu Vijayraghavan. The city was represented by Matthew B. Nazareth of Meyers Nave.

The case is Schmidt v. City of Pasadena, No. 25-488, in the U.S. Court of Appeals for the Ninth Circuit.