Doe v. Rumsfeld

District Court, District of Columbia
297 F. Supp. 2d 119, 2003 WL 22994225, 2003 U.S. Dist. LEXIS 22990 (2003)

ELI5:

Sections

Rule of Law:

Under 10 U.S.C. § 1107 and Executive Order 13139, the Department of Defense is prohibited from administering investigational new drugs or drugs unapproved for their intended use to service members without their informed consent, unless the President grants a specific waiver.

Facts:

In 1970, the National Institutes of Health (NIH) licensed the Anthrax Vaccine Adsorbed (AVA), but the license did not specify the method of exposure (cutaneous vs. inhalation) it protected against.
In 1985, an expert review panel found that AVA's efficacy against inhalation anthrax was not well documented due to insufficient data.
In 1996, the vaccine's manufacturer submitted an Investigational New Drug (IND) application to the FDA specifically to expand the license to include protection against inhalation anthrax; this application remains pending.
In 1998, the Department of Defense (DoD) initiated the Anthrax Vaccine Immunization Program (AVIP) to inoculate all service members against inhalation anthrax.
The DoD ordered the plaintiffs, including active duty members and civilian employees, to submit to the vaccination.
The plaintiffs did not provide informed consent to be vaccinated.
The President of the United States did not issue a waiver regarding the informed consent requirement for this vaccine.
The FDA has not issued a final rule or formal opinion declaring the vaccine to be safe and effective specifically for inhalation anthrax.

Procedural Posture:

Plaintiffs filed a complaint against the Secretary of Defense and others in the U.S. District Court for the District of Columbia.
Plaintiffs filed a Motion for a Preliminary Injunction to stop the mandatory vaccinations.
Defendants (DoD and FDA) filed an opposition to the motion, arguing the case was non-justiciable and the plaintiffs lacked standing.

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Issue:

Is the Anthrax Vaccine Adsorbed (AVA) considered an investigational drug or unapproved for its intended use against inhalation anthrax, thereby legally preventing the Department of Defense from mandating its administration to service members without informed consent or a Presidential waiver?

Opinions:

Majority - Sullivan

Yes, because the FDA has not formally approved the vaccine for use against inhalation anthrax, it remains an investigational drug for that purpose, requiring informed consent or a Presidential waiver. The Court first determined that the case is justiciable because it involves a broad policy decision rather than a battlefield command, and it does not interfere with pending court-martial proceedings against most plaintiffs. Regarding the merits, the Court found that the 1970 license was based on data insufficient to prove efficacy against inhalation anthrax. The Court relied on the fact that the manufacturer filed an Investigational New Drug (IND) application in 1996 specifically to secure approval for inhalation use, an admission that the current license was inadequate for that purpose. Furthermore, DoD's own internal documents had previously described the vaccine as not licensed for aerosol exposure. Since the drug is investigational for this specific use, the DoD's mandatory inoculation program violates 10 U.S.C. § 1107. The Court granted the injunction because the plaintiffs faced irreparable harm to their bodily integrity, and the public interest favors strict adherence to laws protecting service members from being used as experimental subjects.

Analysis:

This decision reinforces the principle that military deference has limits, particularly when statutory protections for service members' bodily integrity are at stake. It clarifies that a drug approved for one purpose (cutaneous anthrax) is considered 'investigational' or 'unapproved' if used for a different purpose (inhalation anthrax) that lacks substantial evidence of effectiveness, specifically triggering the informed consent protections of 10 U.S.C. § 1107. The ruling establishes that the Department of Defense cannot bypass statutory informed consent requirements for experimental treatments merely by asserting a broad interpretation of an old license; absent FDA formal approval or a Presidential waiver, soldiers cannot be forced to take experimental drugs.

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