U.S. DOJ States that Emergency Use Authorization Does Not Preclude Vaccine Mandates
By Fiona W. Ong - Shawe Rosenthal LLP
July 27, 2021
The U.S. Department of Justice (DOJ) has released an opinion (originally prepared on July 6, 2021 for the Deputy Counsel to the President) definitively stating that the Emergency Use Authorization (EUA) statute, under which current COVID-19 vaccines were approved by the Food and Drug Administration (FDA), “does not prohibit entities from imposing vaccination requirements” including “to return to work or be hired into a new job.” Although good news for employers wishing to impose such mandates (particularly in light of the Equal Employment Opportunity Commission’s approval of such mandates under federal anti-discrimination laws), they should keep in mind that such guidance is not necessarily determinative. And they should also consider any state vaccine restrictions.
The EUA statute requires “that individuals to whom the product is administered are informed . . . of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.” (Emphasis added). This language has given rise to an argument that vaccine mandates are in violation of public policy, as set forth in the EUA statute. And consequently, employees who are terminated because they exercise the option to refuse the COVID-19 vaccine could bring a claim of wrongful or abusive discharge in violation of public policy.
As noted by the DOJ, however, the assertion that vaccine mandates violate the EUA’s right to refuse the vaccine was already summarily rejected by a federal court in the case of Bridges v. Houston Methodist Hospital. The DOJ states that individuals “continue to have the ‘option’ of refusing the vaccine in the sense that there is no direct legal requirement that they receive it.” It further quoted the federal court in Bridges that an employee “can freely choose to accept or refuse a COVID-19 vaccine; however, if she refuses, she will simply need to work somewhere else.”
The DOJ further rejected the argument that Congress intended to restrict entities from imposing vaccination requirements through this language, as that would be a “strangely oblique” way to do so. Quoting the U.S. Supreme Court that “Congress does not hide elephants in mouseholes,” it noted that Congress simply could have stated that entities may not require individuals to use an EUA product.
According to the DOJ, the EUA language regarding the right to refuse is only informational in nature and does not prohibit public and private entities, including employers, from imposing vaccine mandates. Moreover, the DOJ further notes that the Food and Drug Administration has the discretion to modify or even omit the “the option to accept or refuse” notification; the requirement is not absolute.
Thus, while employees have the right to refuse the vaccine, the EUA does not govern any secondary consequences – such as the loss of employment – that arise from their exercise of that right. And while the FDA could require that entities notify individuals of such consequences, per the EUA statute, it need not do so.
Although this opinion demonstrates that the federal government believes that the EUA does not prohibit vaccine mandates, we caution employers that courts may not necessarily agree. The DOJ’s guidance is not necessarily determinative, and courts may choose to reject it. And while the federal court decision in the Bridges case is certainly helpful, it was a single decision that is not binding on courts in other jurisdictions. It is possible that another court could come to a different holding and find that an employee who was terminated for refusing the COVID-19 vaccine could, in fact, sustain a wrongful discharge in violation of public policy claim.
Moreover, separately from the EUA issue, many states have enacted or are considering restrictions on a company’s right to require proof of vaccination (e.g. bans on so-called “vaccine passports”). These bans come in many different forms. Some are limited to governmental or public entities. Others (including Alabama, Florida, North Dakota, and Texas) prohibit private entities from requiring vaccine passports in providing goods, services, or access to the public, but do not govern employers’ ability to impose a vaccine mandate on their employees. Montana prohibits employers from requiring proof of vaccination, and many other states have similar legislation pending before their state legislatures. It is critically important for employers seeking to impose vaccine mandates to stay on top of any changes in state law on this issue.
This is obviously a fast-moving and ever-changing situation, and we will continue to send out E-lerts on any significant developments. You may also wish to check our continually-updated FAQs frequently.
The 2022 World Cup is underway in Qatar - Some guidance on World Cup issues in the workplace https://t.co/QeBPc4qT6v
Massachusetts Department of Family and Medical Leave Releases New Model Notices and Poster https://t.co/E003ZYvn1n
A Divided Congress: Implications for Employers https://t.co/iJAv61UCvT