Written by Jeremy Mittman and Shanda Lowe
As expected, the first batch of lawsuits challenging COVID-19 vaccine mandates are popping up across the country—a possibility that we noted in an earlier post on this subject. So far, at least two federal lawsuits have been filed based on the fact that the COVID-19 vaccines currently in use are only available under an Emergency Use Authorization (“EUA”) from the FDA, and thus cannot be required by employers.
First, in February 2021, a corrections officer at the Doña Ana County Detention Center in Las Cruces, New Mexico filed a lawsuit asking the Court to enjoin his employer from terminating his employment pursuant to its “Mandatory COVID-19 Vaccination Directive,” which required him to get a COVID-19 vaccine as a condition of ongoing employment. See Legarreta v. Macias et al., 2:2021cv00179 (D.N.M. filed 2/28/21). The plaintiff claims that his employer’s directive violates federal law—specifically section 564 of the Federal Food, Drug, and Cosmetic Act (the “Act”), which governs the emergency authorization of “unapproved” medical products. He also alleged state law claims for retaliation based on his termination for refusing to receive a vaccine.
The newest lawsuit, California Educators for Medical Freedom et al v. The Los Angeles Unified School District et al., 21-cv-02388 (C.D. Cal. filed 3/17/2021), seeks injunctive relief and damages on behalf of seven employees of the Los Angeles Unified School District, due to the District’s March 2021 vaccine mandate. The District allegedly instructed employees they could face “job detriment, up to and including termination from employment” if they were not vaccinated by April 2021. Like the New Mexico lawsuit, the District employees claim that this mandate violates federal and state laws including “the FDA’s regulations, protocols, and guidance thereunder” and California laws against medical experimentation without consent (California Health & Safety Code § 24170 et. seq.).
It is still early in both cases, but the Plaintiffs are certainly not assured an easy victory. The Act permits the FDA to authorize unapproved medical products when the Secretary of Health and Human Services declares that such emergency authorized use is appropriate, and may be read to require that a party directing use of the medical product, and not just the FDA, ensure that recipients are informed (to the extent practicable given the applicable circumstances):
- That FDA has authorized emergency use of the product;
- Of the significant known and potential benefits and risks associated with the emergency use of the product, and of the extent to which such benefits and risks are unknown;
- That they have the option to accept or refuse the EUA product and of any consequences of refusing administration of the product; and
- Of any available alternatives to the product and of the risks and benefits of available alternatives.
Arguably, the vaccine directives from both the Doña Ana County Detention Center and the Los Angeles Unified School District satisfied the obligations imputed to them under the Act. Moreover, the vaccine provider would have been required to present any recipient with the relevant Fact Sheet, further explaining the provisional authorization and their right to refuse. However, it is still unclear how the court’s will rule on these issues.
Of course, as we discussed previously, the relevant EEOC regulations and California laws do not seem to preclude employers from mandating vaccines (subject to compliance with other State and Federal laws regarding employment discrimination and reasonable accommodations). And, it is still unclear whether refusing a vaccine directive is a “protected activity” that would trigger a retaliatory discharge claim. Nevertheless, these cases highlight the importance of carefully crafting any vaccine policies employers choose to implement (while COVID-19 vaccines are still subject to EUAs) to reduce the risks of costly potential legal battles.