## Facts

- Anonymous active-duty service members, National Guard personnel, and Department of Defense (DoD) civilian contractors challenged the DoD’s Anthrax Vaccine Immunization Program (AVIP), which required Anthrax Vaccine Adsorbed (AVA) inoculations.
- Plaintiffs alleged AVA was being used to protect against inhalation anthrax in a way that rendered it an investigational product or a drug unapproved for its intended use, triggering informed-consent requirements.
- Plaintiffs asserted the DoD’s compulsory vaccination policy violated 10 U.S.C. § 1107, Executive Order 13139, and DoD Directive 6200.2 because vaccinations were ordered without informed consent and without any presidential waiver.
- Plaintiffs brought Administrative Procedure Act (APA) claims seeking to halt involuntary inoculations and moved for a temporary restraining order and preliminary injunction.
- The government opposed, arguing the dispute was non-justiciable, plaintiffs lacked standing, and AVA was licensed for the relevant purpose; it also asserted that stopping AVIP would harm military readiness.
- Plaintiffs pleaded a third APA theory based on alleged alteration of the FDA-approved dosing schedule, but the court declined to reach it because no plaintiff alleged an altered schedule as to them.

## Issues

1. Whether the dispute over mandatory anthrax vaccination presents a justiciable controversy and whether plaintiffs had standing to seek preliminary injunctive relief.
2. Whether AVA, as administered under AVIP for protection against inhalation anthrax, was an investigational new drug or a drug unapproved for its intended use under 10 U.S.C. § 1107 and related authorities.
3. Whether the preliminary injunction factors favored enjoining the DoD from administering AVA without informed consent or a presidential waiver.

## Decision

- The court held the claims were justiciable and that plaintiffs had standing because they faced imminent, concrete injury from orders to vaccinate backed by adverse consequences.
- The court found plaintiffs showed a likelihood of success that AVA, as used for inhalation anthrax under AVIP, fell within 10 U.S.C. § 1107 as either investigational or unapproved for its intended use.
- The court concluded the DoD could not compel AVA inoculations without informed consent absent a presidential waiver under § 1107.
- Applying the preliminary injunction factors, the court found irreparable harm from compelled vaccination under threat of discipline, and held the balance of equities and public interest favored enforcing statutory and executive informed-consent protections.
- The court granted the preliminary injunction and enjoined the DoD from administering AVA without informed consent unless and until a presidential waiver issued.

## Legal Principles

- Federal courts may review military-administered medical programs under the APA when plaintiffs assert violations of statutory and regulatory constraints, notwithstanding general deference to military judgment.
- Under 10 U.S.C. § 1107 and Executive Order 13139, the military must obtain informed consent before administering an investigational new drug or a drug unapproved for its intended use, unless the President grants a waiver.
- A preliminary injunction may issue where plaintiffs show likely success on the merits, irreparable harm, favorable balance of equities, and consistency with the public interest, including the public interest in executive compliance with congressionally mandated protections.

## Conclusion

The court preliminarily enjoined mandatory AVA inoculations under AVIP because plaintiffs showed that, for inhalation anthrax protection, the vaccine was investigational or unapproved for its intended use and therefore could not be compelled without informed consent absent a presidential waiver.


Doe v. Rumsfeld, 297 F. Supp. 2d 119 (D.D.C. 2003)