Anthrax Vaccine Military Lawsuit: Injunction, Refusals, and VA Claims

The military’s mandatory anthrax vaccine triggered a wave of lawsuits in the early 2000s, and the most important of them — Doe v. Rumsfeld — produced a 2004 federal court injunction holding that the Pentagon had been forcing troops to take the shot illegally for years. The anthrax vaccine military lawsuit record, taken together, established that the vaccine was being used for a purpose the FDA had never formally approved, that service members were entitled to informed consent, and that hundreds of troops had been disciplined or discharged under an order a federal judge later called unlawful. The FDA eventually reclassified the vaccine in late 2005, which dissolved the injunction and allowed mandatory vaccinations to resume. For veterans still dealing with the aftermath, two avenues remain open: records-correction petitions for those punished, and VA disability claims for those who believe the vaccine injured them.

Why the Vaccine Was Challenged

Anthrax Vaccine Adsorbed (AVA) was licensed by the National Institutes of Health in 1970 for a narrow group — industrial workers, veterinarians, and lab scientists who risked skin exposure to anthrax.¹ When Secretary of Defense William Cohen announced in 1997 that the entire force would be vaccinated, the concern wasn’t cutaneous anthrax. It was inhalation anthrax, the form a biological weapon would deliver.

No human clinical studies had demonstrated the vaccine’s effectiveness against inhaled anthrax. The manufacturer had filed an Investigational New Drug application in 1996 seeking approval for that use, and it was still pending when the suits were filed.² That gap mattered because of 10 U.S.C. § 1107, enacted in 1998, which bars the military from administering investigational drugs or drugs unapproved for their applied use without written notice and informed consent. The one escape hatch is a presidential waiver on national security grounds.³ Neither President Clinton nor President George W. Bush ever signed one for anthrax.⁴

By late 2001, more than 522,000 service members had received roughly 2.1 million doses under the Anthrax Vaccine Immunization Program.¹ The regimen called for six doses over 18 months plus annual boosters.

Doe v. Rumsfeld and the 2004 Injunction

In 2003, six plaintiffs — active duty troops, National Guardsmen, and civilian DoD contract employees — sued under pseudonyms in the U.S. District Court for the District of Columbia. The case went to Judge Emmet G. Sullivan. They were represented by Mark S. Zaid of Krieger & Zaid and John J. Michels Jr. of McGuireWoods.⁵

On December 22, 2003, Judge Sullivan granted a preliminary injunction, finding the plaintiffs had shown a substantial likelihood of success. He noted that FDA had issued no formal opinion on the vaccine’s status for inhalation anthrax and that the 1996 IND application remained pending.²

On October 27, 2004, he went further. In a permanent injunction covering all U.S. military personnel, not just the six plaintiffs, Sullivan ruled that the FDA had failed to follow its own procedures and had never sought the required public comment on the vaccine’s safety and effectiveness. “Unless and until FDA follows the correct procedures to certify AVA as a safe and effective drug for its intended use,” he wrote, “defendant DoD may no longer subject military personnel to involuntary anthrax vaccinations absent informed consent or a Presidential waiver.”⁶ Zaid called the ruling a vindication of what he and his co-counsel had argued for six years: that the program was illegal from day one.⁷

The FDA Order and the Appeals That Followed

The injunction’s effect was temporary. On December 19, 2005, the FDA issued a final order (70 Fed. Reg. 75,180) declaring AVA safe and effective against all forms of anthrax regardless of exposure route. The agency conceded that the primary clinical study, a 1950s look at industrial workers, had too few inhalation cases to be statistically meaningful, and relied on primate studies instead.⁸

On February 9, 2006, the D.C. Circuit ruled the government’s appeal moot. Because Sullivan’s injunction had been conditioned on the FDA’s failure to classify the vaccine, the December 2005 order dissolved it by its own terms. The court declined to vacate Sullivan’s underlying opinion, sending that question back to the district court.⁹ On October 16, 2006, the Pentagon announced that mandatory vaccinations would resume. During the voluntary interval, participation had fallen to around 50%.⁸

One more challenge followed. In Rempfer v. Sharfstein, eight service members argued the FDA’s 2005 order was arbitrary and capricious because the underlying evidence was too weak. The D.C. Circuit rejected the challenge in September 2009, citing considerable deference to the FDA’s scientific judgment that the exposure route was irrelevant to efficacy and that manufacturing changes to the vaccine had been adequately validated.¹⁰

What Happened to Service Members Who Refused

While the civil suit worked its way through federal court, troops who refused the vaccine were being disciplined. More than 500 members of the armed forces were disciplined or court-martialed for refusal.¹¹ Attorney Michels estimated roughly 600 personnel were discharged between 1998 and 2004.⁵ One soldier received a seven-month prison sentence.¹²

Airman Basic Christopher B. Washington’s case was typical. Stationed in Saudi Arabia in 1999, he took five of his six required shots and refused the sixth. After nonjudicial punishment reduced him from E-4 to E-1 with a suspended forfeiture of pay, he refused a direct order in January 2000. A special court-martial sentenced him to a bad-conduct discharge and two months’ confinement. In the Air Force alone, more than 150 anthrax-refusal cases led to discipline.¹³

Military appellate courts, unlike the federal district court, upheld vaccination orders as lawful. In United States v. Kisala (2006), the Court of Appeals for the Armed Forces affirmed the conviction of a specialist who refused, holding that because AVA was a licensed product, the informed consent requirements of 10 U.S.C. § 1107 were not implicated. The court gave considerable deference to FDA administrative determinations and set a particularly high burden on service members trying to challenge the lawfulness of such orders.¹⁴

Reinstatement and Clearing a Military Record

Service members who were discharged or disciplined for refusing the vaccine can petition their service’s Board for Correction of Military Records seeking cleared records, back pay, and reinstatement. The outcomes have been mixed, and the standard is tough.

Two Connecticut Air National Guard pilots, Captain Thomas Rempfer and Major Russell Dingle, became well-known examples. Their commander had asked them to research AVIP; their report recommended halting the vaccinations. Both refused the vaccine and left the Connecticut Guard in January 1999.¹⁵ The Air Force Board for Correction of Military Records denied their applications, relying on a characterization that the Doe plaintiffs had not actually prevailed.

On March 14, 2008, U.S. District Judge James Robertson called that reasoning a “fiction.” He ruled the board’s denial arbitrary and capricious, holding that the Doe plaintiffs had clearly prevailed in establishing that mandatory inoculation violated federal law for more than six years, from the program’s inception until the FDA’s December 2005 approval. Robertson remanded the cases and warned the board not to substitute its own views on the vaccine’s legality for those of the federal court.¹⁶ Even so, the broader record shows that among the many service members who sought to clear their records, only a few succeeded.¹⁵

VA Disability Claims for Anthrax Vaccine Injuries

Veterans who believe the vaccine caused lasting health problems can file disability claims with the Department of Veterans Affairs. The VA treats administration of the anthrax vaccine as an “injury” for compensation purposes, on the theory that it introduces a foreign substance capable of causing adverse effects on body tissue. That classification applies even when the shot was given during Inactive Duty for Training.¹⁷

A successful claim needs three things: a current diagnosed disability, evidence the vaccination happened during military service, and a medical opinion linking the disability to the vaccine. Board of Veterans’ Appeals decisions show the bar is high. Claims are routinely denied when service treatment records show no reaction at the time of vaccination, when symptoms surfaced years later, or when a VA examiner attributes the condition to other causes. A veteran’s own description of symptoms is not enough to establish diagnosis or causation. That requires a professional medical opinion.¹⁸ Claims have been denied for sleep apnea, chronic fatigue, joint pain, and hand numbness where examiners concluded the connection to the vaccine was “less likely than not.”

The research record on long-term effects is itself divided. A 1996 Presidential Advisory Committee found it unlikely that the vaccine, alone or combined with other vaccines, caused the health problems reported by Gulf War veterans.¹⁹ A 2024 study of 111 Gulf War veterans by the Minneapolis VA Health Care System’s Brain Sciences Center reported that 47.1% of vaccinated veterans developed Gulf War Illness, compared with 17.2% of unvaccinated veterans, and hypothesized that the vaccine’s antigen can persist in individuals lacking specific immune markers needed to clear it.²⁰ A veteran pursuing a claim will generally need a medical opinion that engages with this record for the specific condition at issue.

Where the Program Stands Now

No class action settlement or compensation fund came out of the anthrax vaccine litigation. The lawsuits produced a federal court ruling that the mandatory program was illegal for the years it operated without informed consent or a presidential waiver, and that ruling has been the legal foundation for individual records-correction petitions ever since. It did not create a payment mechanism for troops who were disciplined, discharged, or injured. Those remedies run through the correction boards and the VA claims process, case by case.

The vaccination program itself continues in narrower form. Under current DoD policy, anthrax immunizations as a force health protection measure are limited to personnel or groups specifically identified by the Office of the Secretary of Defense in consultation with the Chairman of the Joint Chiefs of Staff and the geographic combatant commanders.²¹ Emergent BioSolutions remains the manufacturer, under a DoD contract awarded in January 2024 worth up to $235.8 million over five years, with an option to extend through 2033.²²

1
National Center for Biotechnology Information. The Anthrax Vaccine: Is It Safe? Does It Work? – History
2
LSU Law Center. Doe v. Rumsfeld, Memorandum Opinion
3
Office of the Law Revision Counsel. 10 U.S.C. § 1107 – Notice of Use of an Investigational New Drug
4
Just Security. Should the COVID-19 Vaccine Be Required for the Military
5
Government Executive. Military Personnel Punished for Refusing Anthrax Vaccine Seek Compensation
6
American Medical Association Journal of Ethics. Informed Consent and the Military: The Anthrax Vaccination Case
7
The New York Times. Judge Halts Forcing of Anthrax Shots
8
National Center for Biotechnology Information. US Military Reintroduces Mandatory Anthrax Vaccinations
9
D.C. Circuit Court of Appeals. Doe v. Rumsfeld, No. 04-5440
10
FindLaw. Rempfer v. Sharfstein
11
National Center for Biotechnology Information. US Court Rules Mandatory Anthrax Vaccination Illegal
12
National Center for Biotechnology Information. The Anthrax Vaccine: Is It Safe? Does It Work? – Production
13
LSU Law Center. United States v. Washington
14
U.S. Court of Appeals for the Armed Forces. United States v. Kisala, No. 04-0246
15
Army Times. The Shadow of Anthrax
16
Government Executive. Judge Advances Anthrax Vaccine Refusal Case
17
Department of Veterans Affairs. Board of Veterans’ Appeals Decision, Citation Nr: 1111676
18
Department of Veterans Affairs. Board of Veterans’ Appeals Decision, Citation Nr: 1622783
19
PBS. Gulf War Syndrome – Analysis: Vaccines
20
Department of Veterans Affairs. Gulf War Illness Research Presentation
21
Department of Defense. DoD Instruction 6205.02 – DoD Immunization Program
22
Fierce Pharma. Emergent Snares $235.8M US Contract to Provide Anthrax Vaccine