Today we discuss a putative class action in which the named plaintiffs are a registered nurse who refuses to take a basic precaution to protect her vulnerable patients and a mother who is more interested in displaying her livestock than protecting her neighbors. Brought on behalf of all New Mexico residents who are equally selfish, the plaintiffs sought an injunction barring the state from enforcing a public health order that requires (with limited exceptions) all hospital, nursing-home, assisted-living-facility, adult-day-care, rehabilitation-facility, and prison workers, all employees of the governor’s office, and all who would enter the New Mexico State Fair grounds to be vaccinated against the SARS-CoV-2 virus, which causes COVID-19. The plaintiffs asserted various constitutional and statutory claims. In a thorough and trenchant decision, Valdez v. Grisham, — F. Supp. 3d —-, 2021 WL 4145746 (D.N.M. 2021), a federal district court rejected them all. That is consistent with long-standing precedent and other recent decisions—as we discussed here, here, and here.
The plaintiffs’ first claim was that requiring them to be vaccinated with “experimental” vaccines violated the FDCA. The claim was predicated on the fact that, at the time suit was filed, the three SARS-CoV-2 vaccines available in the United States—the Pfizer/BioNTech, Moderna, and Johnson & Johnson vaccines—had not received full FDA approval and were instead being distributed and administered under Emergency Use Authorizations (EUAs). The plaintiffs claimed that requiring them to be vaccinated violated the terms of the vaccines’ EUAs, which require that those receiving each vaccine be informed of its “benefits and risks” and “of the option to accept or refuse” its administration. 2021 WL 4145746, at *4.
The court rejected the plaintiffs’ FDCA claim.
Implicitly responding to the plaintiffs’ assertion that the vaccines were “experimental,” the court recited at the outset both the extensive testing that each had undergone before the EUAs were granted, including “at least one well-designed Phase 3 clinical trial that demonstrate[d] the vaccine’s safety and efficacy in a clear and compelling manner,” and the fact that “[c]omprehensive data collected since the three vaccines received EUA status demonstrates that they are safe and highly effective in preventing infection and severe illness, and that serious adverse side effects from the vaccines are exceedingly rare.” 2021 WL 4145746, at *1. The court further observed that, “despite Plaintiffs’ protestation to the contrary, the FDA has now given its full approval—not just emergency use authorization—to the Pfizer vaccine” for administration to those 16 and older. Id. at *4. That did not moot the plaintiffs’ statutory claim, however, because the livestock-display-over-human-health plaintiff asserted the claim on behalf of not only herself but also her 11- and 12-year-old children, who were also keen to “show their animals” at the state fair. Id. at *2.
Addressing the merits of the plaintiffs’ FDCA claim, the court found that there were none. It explained that although the EUAs issued pursuant to the FDCA require “medical providers” administering the vaccines to inform would-be recipients of the risks associated with each vaccine and their right to refuse it, the EUAs do not prohibit the state from requiring individuals, duly informed by their medical providers, to be vaccinated. Id. at *4. In so holding, the court cited both Bridges v. Houston Methodist Hosp., 2021 WL 2399994, at *2 (S.D. Tex. 2021), which rejected a nearly-identical anti-vaxxer claim on the ground that the FDCA “neither expands nor restricts the responsibilities of private employers” and “does not confer a private opportunity to sue the government,” and a recent Department of Justice Office of Legal Counsel memorandum opinion concluding that the FDCA’s informed-consent provision “specifies only that certain information be provided to potential vaccine recipients and does not prohibit entities from imposing vaccination requirements.”
Having dispensed with their statutory claim, the court proceeded to dispense with the plaintiffs’ constitutional claims—brought under the Due Process, Equal Protection, and Contract Clauses.
Asserting a violation of their right to substantive due process, the plaintiffs alleged that they “‘have [constitutionally] protected liberty interests’ ‘in their right to live without governmental interference,’ their right ‘to bodily integrity,’ their right ‘to raise their children as they see fit,’ and their right ‘to engage in their chosen professions,’ and that because the state’s public health order is ‘not narrowly tailored,’ it violates these substantive due process rights.” 2021 WL 4145746, at *5.
Relying on well-established constitutional precedent, the court explained that a two-part analytic framework applies when a legislative enactment or executive action is challenged on substantive due-process grounds. The first step is to identify the “fundamental liberty interest” purportedly at issue. The second step is to determine whether that interest “is ‘deeply rooted in this Nation’s history and tradition’ and ‘implicit in the concept of ordered liberty, such that neither liberty nor justice would exist if they were sacrificed.’” 2021 WL 4145746, at *5 (indirectly quoting Washington v. Glucksberg, 521 U.S. 702, 720–21 (1997)). If the asserted liberty interest meets that standard, then the government may not infringe it “‘unless the infringement is narrowly tailored to serve a compelling state interest.’” Id. (quoting Glucksberg, 521 U.S. at 721). If, by contrast, the legislative enactment or executive action “does not implicate a fundamental right,” the action is permissible if it “bear[s] a rational relationship to a legitimate government interest.” Id. (quotation marks omitted).
The court found that the plaintiffs did “not explain how the rights allegedly violated by the [public health order] are fundamental.” 2021 WL 4145746, at *5. “[I]ndeed nowhere,” said the court, did the plaintiffs “address how the right to work in a hospital or attend the State Fair, unvaccinated and during a pandemic, is ‘deeply rooted in this Nation’s history and tradition.’” Id.
In their request for preliminary relief, the plaintiffs relied on “the right to ‘engage in their chosen profession.’” 2021 WL 4145746, at *5. That, however, was no help to them, the court held, because “the Tenth Circuit”—the circuit within which the court sits—”has unequivocally held that the ‘right to practice in [one’s] chosen profession … does not invoke heightened scrutiny.’” Id. (quoting Guttman v. Khalsa, 669 F.3d 1101, 1118 (10th Cir. 2012)). Thus, said the court, “while Plaintiffs may ‘have a right to engage in their chosen professions,’ governmental infringement on this right will be “‘presumed to be valid’” so long as it is “‘rationally related to a legitimate state interest.”’” Id. (quoting Klaassen v. Trustees of Indiana Univ., 2021 WL 3073926, at *17 (N.D. Ind. 2021), in turn quoting City of Cleburne v. Cleburne Living Ctr., 473 U.S. 432, 440 (1985)).
Moreover, said the court, “federal courts have consistently held that vaccine mandates do not implicate a fundamental right and that rational basis review therefore applies in determining the constitutionality of such mandates.” 2021 WL 4145746, at *5. Applying that standard, the court rejected the plaintiffs’ substantive due-process claim, concluding that “[t]he vaccination requirements set forth in the [New Mexico public health order], … grounded in medicine and science, are rationally related to [the state’s] legitimate purpose of protecting our community ‘against an epidemic of disease [that] threatens the safety of its members.’” Id. at *8 (quoting Jacobson v. Massachusetts, 197 U.S. 11, 27 (1905)).
As Bexis did last month, the Valdez court explained that “[w]ith its decision in Jacobson”—which upheld “a Cambridge, Massachusetts regulation that required all adult inhabitants of that city, without exception, to be vaccinated against smallpox”—“the Supreme Court ‘settled that it is within the police power of a state to provide for compulsory vaccination.’” 2021 WL 4145746, at *6–7 (quoting Zucht v. King, 260 U.S. 174, 176 (1922)).
All that is necessary for state action to survive the “rational basis test” is that it bear “a rational relationship to a legitimate government interest.” Glucksberg, 521 U.S. at 721. The Valdez court found that New Mexico’s vaccination requirements did more than that, concluding that “[t]he governmental purpose of stemming the spread of COVID-19, especially in the wake of the Delta variant, is not only legitimate, but is unquestionably a compelling interest.” 2021 WL 4145746, at *7 (quotation marks omitted).
Having rejected plaintiffs’ substantive-due-process claim on the ground that that the New Mexico public health order requiring certain people to be vaccinated against SARS-CoV-2 “meets the rational basis test” (2021 WL 4145746, at *8), the Valdez court quickly disposed of the plaintiffs’ remaining constitutional claims. It concluded that the plaintiffs’ equal-protection, procedural-due-process, and impairment-of-contract claims were also subject to rational-basis review and that they therefore failed for the same reasons as the plaintiffs’ substantive-due-process claim. Id. at *9–11.
Finding that plaintiffs were unlikely to prevail on the merits of their claims, and that the remaining equitable factors likewise cut squarely against them, the court denied the preliminary injunction that the plaintiffs requested.
Onward to full vaccination.
This article was written by Andrew Tauber of Winston & Strawn LLP.