Emergency Use Authorization Vaccines – A Caution to Employers

Ruder Ware

Happy New Year!  As we move into 2021, we know that many of you are considering whether to require employees to get the COVID-19 vaccination.  The current COVID-19 vaccines have received Emergency Use Authorization (“EUA”) from the Food and Drug Administration.  The Federal Food, Drug and Cosmetic Act (“FDCA”) governs the conditions of emergency use authorization including the condition that:

“individuals to whom the product is administered are informed … of the option to accept or refuse administration of the product…” Section 546(e)(1)(A).

Both the Pfizer-BioNTech COVID-19 EUA Fact Sheet and the Moderna COVID-19 EUA Fact Sheet clearly specify that recipients or their caregivers must have the right to accept or refuse the vaccine.  Links to each fact sheet:

Pfizer Vaccine Fact Sheet

Moderna Vaccine Fact Sheet

So what does this mean for employers?

Employers who require employees to get these vaccines prior to full FDA approval run the risk of a “wrongful discharge” in violation of public policy. While Wisconsin and many other states recognize the “at-will doctrine” (employer may terminate employees at any time for any reason) there are exceptions.  One such exception is “when the discharge is contrary to a fundamental and well-defined public policy as evidenced by existing law.” (See Brockmeyer v. Dun & Bradstreet, 113 Wis.2d 561, 335 N.W.2d 834 (1983))

Accordingly, employees terminated for refusing the vaccine under the FDCA likely have a viable claim for wrongful discharge under the public policy doctrine.

Bottom line: Once the vaccine receives formal FDA approval (barring religious or accommodation issues as we reported in our previous e-alert: Breaking News! EEOC Issues Vaccine Guidance), you can take a stronger stance on requiring the vaccine.  Until then, we recommend you steer clear of a mandate.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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