Mandating COVID-19 Vaccination Too Early Could Prompt Lawsuits 

As contractors start to think about COVID-19 vaccination policies, including whether to mandate that all employees receive the vaccine as a condition of employment, a recent lawsuit by an employee in New Mexico serves as a reminder that it may be prudent to wait until the COVID-19 vaccines receive full approval (or licensure) from the Food and Drug Administration (FDA) (for U.S. employers) and Health Canada (for Canadian employers).

Per the lawsuit, a government detention center in New Mexico announced on Jan. 29 that it was implementing a mandatory COVID-19 vaccination policy. The policy required all employees to receive the COVID-19 vaccine as “requirement and a condition of on-going employment.” Rather than receive this vaccine, an employee filed the federal lawsuit on Feb. 28 arguing that the employer’s policy violated the Food, Drug and Cosmetic Act (FD&C Act).  

Remember, at this time, no COVID-19 vaccine has been approved (or licensed) by the FDA; the Pfizer, Moderna, and Johnson & Johnson COVID-19 vaccines have received “Emergency Use Authorization” (EUA) from the FDA. The FD&C Act expressly provides that, in setting forth the conditions for EUA, the Secretary of HHS will “establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including…the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternative to the product that are available and of their benefit risks.” 21 U.S.C. § 360bbb–3(e)(1)(A)(ii)(III). 

The detention center employee’s lawsuit claims that, by mandating the vaccine as a condition of employment, the employer’s policy violates federal law (specifically 21 U.S.C. § 360bbb–3(e)(1)(A)(ii)(III)).  The employee is seeking a temporary restraining order that prevents the employer from enforcing its mandatory vaccination policy.

It’s too early to tell whether there is any merit to the employee’s claim under the FD&C Act. The suit is unique too because it involves a governmental employer and not a private company.  It is not entirely clear whether the “option to accept or refuse” would apply to a private employer’s vaccination mandate (as opposed to a government employer’s mandate). But, the lawsuit serves as a reminder that mandating COVID-19 vaccines prior to the vaccines receiving full FDA approval comes with legal risks.

Bottom Line

To avoid potential claims (under the FD&C Act in the U.S.), contractors should consider waiting to implement any mandatory vaccination policies until after the FDA (U.S. contractors) and Health Canada (Canadian contractors) have issued a final approval or licensure of the COVID-19 vaccine offered to employees. The FCA International legal team will continue monitoring this situation as it develops.