Doe v. Rumsfeld

In 1988, the Department of Defense (DOD) began a mass inoculation program using an Anthrax Vaccine Absorbed (AVA), an anthrax vaccine, as a preventative measure against inhalation anthrax for service members and civilian employees. The program was administered without informed consent or a presidential waiver, in apparent contravention to 10 U.S.C. § 1107, which prohibited administering investigational drugs or drugs unapproved for their intended use, to service members without their informed consent or a presidential waiver. The vaccine had been linked to adverse reactions and pregnancy risks, but it had never been officially approved for use against inhalation anthrax despite attempts to clarify that by the manufacturer, the DOD, and the personal opinions of Food and Drug Administration (FDA) employees. During the licensing process, a review panel discussed a study that the vaccine’s efficacy against inhalation anthrax was not well documented, but the AVA label never specified whether it protected against cutaneous or inhalation exposure. A 1996 Investigational New Drug (IND) application to get FDA approval for inhalation anthrax remained pending at the time of the program. A group of service members and civilian employees sued the DOD, challenging the AVA program, and argued that because AVA had only been licensed to protect against cutaneous exposure, its use to protect against inhalation was investigational and therefore required informed consent or a presidential waiver. The DOD argued that judicial review of its program was not authorized, that the current license for AVA covered use against inhalation anthrax, that the FDA made a final decision on the investigational status of AVA for inhalation purposes, and requiring the DOD to get informed consent before administering AVA would be inconvenient and burdensome and significantly interfere with military function.