Thomas Anderson, et al. v. United Airlines, Inc., et al.

Section 564 of the Food, Drug, and Cosmetics Act (“FDCA”) provides that the Food and Drug Administration’s (“FDA”) standard process for approving drugs and biologics may be suspended in the case of emergency. In place of the FDA’s rigorous standard “approval” process, Section 564 provides that where a requisite emergency has been declared, drugs and biological products may be released into interstate commerce so long as they have proceeded through Section 564’s “authorization” process. The “authorization” process provided in Section 564 is largely within the discretion of the Secretary of the Department of Health and Human Services, allowing the Secretary to “authorize” a particular drug or biological product if its known and potential benefits outweigh its known and potential risks. Section 564 of the FDCA provides all recipients of “authorized” drugs or biological products the right to refuse receipt of such drug or biological product. Question 1: Is there a violation of Section 564’s guarantee of a right to refuse when an employer imposes adverse employment consequences on employees who refuse to accept a vaccine that has been authorized but not approved by the FDA, such that Petitioners’ claim in this case under the Illinois Whistleblower Act should have been permitted to proceed?