Bates v. Rumsfeld

Citations: 271 F. Supp. 2d 54; 2002 U.S. Dist. LEXIS 26762; 2002 WL 32128718Docket: CIV.A. 01-0941(RBW)

Court: District Court, District of Columbia; May 30, 2002; Federal District Court

SummaryOriginalCytator Case TreatmentBackward CitatorAnalysis

EnglishEspañolSimplified EnglishEspañol Fácil

Bates v. Rumsfeld is a legal action concerning the use of Anthrax Vaccine Adsorbed (AVA) by the U.S. Armed Forces. Plaintiffs Sonnie Bates and Captain John Buck, representing themselves and approximately 500 similarly situated individuals—current and former military members disciplined for refusing AVA—seek a declaration that AVA is an investigational new drug (IND) under 21 U.S.C. 355 and unapproved for its intended use under 10 U.S.C. 1107 and Presidential Executive Order 13139. The defendants include high-ranking officials from the Department of Defense, the Department of Health and Human Services, the FDA, and Bioport Corporation, the manufacturer of AVA. The case is currently before the court on motions to dismiss from both the federal defendants and Bioport, citing Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6) for the former, and 12(b)(1) and 12(b)(2) for the latter.

The background indicates that AVA was licensed as a vaccine against anthrax in 1970. Bates, a former Air Force pilot, resigned after refusing the vaccine, while Buck, an active-duty physician, faced court-martial for the same reason. The complaints arose following a Department of Defense announcement in December 1997 about a vaccination program for all military personnel against inhalation anthrax, which led to involuntary vaccinations. Plaintiffs contend that AVA is not licensed for this use and that the Department of Defense has not adhered to the approved administration schedule, necessitating their consent or presidential waiver before vaccination. The court is set to evaluate the merits of the motions to dismiss based on these claims.

Individuals refusing the AVA vaccination have faced severe military disciplinary measures, including courts-martial, pay forfeitures, incarceration, and administrative separation. Plaintiffs are seeking court declarations that AVA qualifies as an investigational new drug under 10 U.S.C. 1107 and Executive Order 13139, asserting its investigational status since the application was filed on September 20, 1996, and due to changes made in June 2000. They claim AVA has been unapproved for its intended use since December 1997. Additionally, plaintiffs are requesting reimbursement for litigation costs and attorney's fees. The Department of Defense (DOD) halted the AVA vaccination in June 2001 for most personnel, continuing only for special mission units and research, with no plans to resume until the AVA shortage is resolved.

In analyzing a motion to dismiss, the court must accept the complaint's factual allegations as true. Under Federal Rule of Civil Procedure 12(b)(1), plaintiffs bear the burden of proving jurisdiction. A dismissal for lack of standing requires thorough examination of the complaint. The court can consider materials outside the pleadings to determine jurisdiction. 

Federal defendants argue for dismissal based on: 1) sovereign immunity, as the United States cannot be sued without consent; 2) lack of a justiciable controversy due to the mootness of plaintiff Bates' claims following his resignation; 3) the declaratory judgment sought by Bates and Buck is incapable of addressing their injuries; and 4) mootness of plaintiffs' challenge to the modified vaccination schedule since it was implemented after Bates' resignation, and Buck has not been subjected to it. In response, plaintiffs assert that Bates has standing due to his forced resignation linked to the defendants' actions, while Buck faces potential orders to receive the AVA vaccination while on active duty.

Defendants cannot claim sovereign immunity as a defense against the lawsuit since their actions conflict with federal law. The investigational new drug (IND) status of AVA is appropriate for resolution through declaratory judgment, as a court declaration would aid military and civilian boards in addressing plaintiffs' administrative appeals. Plaintiffs contend that the defendants' unauthorized alterations to the vaccination schedule warrant judicial review. However, the court determines it lacks subject matter jurisdiction under Article III of the Constitution, leading to the dismissal of the plaintiffs' claims.

To establish standing, plaintiffs must demonstrate an "injury in fact," linking their injury directly to the defendants' actions, and show that a favorable court ruling could remedy the injury. Bates, the plaintiff, has not shown a concrete injury related to the administration of AVA since he voluntarily resigned from the Air Force and is now in the Individual Ready Reserve. His potential return to active duty and exposure to AVA administration remains uncertain and speculative, failing to meet the standing requirements. The court cites precedent emphasizing the need for a "personal stake" in the outcome and "real and immediate" injuries for standing.

Plaintiffs assert that a court declaration regarding AVA's status as an IND vaccine for inhalation anthrax would clarify a key legal issue between the parties. However, the court emphasizes that a declaratory judgment is inappropriate when the likelihood of injury is remote and uncertain. The Declaratory Judgment Act requires disputes to be definite rather than speculative. The military's potential reinstatement of a vaccination policy is contingent on future events, making any injury to the plaintiffs, particularly Bates and others no longer active duty, unlikely. Consequently, they fail to meet the first prong of the standing requirement established in Lujan. Even if Bates could demonstrate injury due to the AVA policy, it is unclear whether a favorable ruling would remedy that injury.

Captain Buck's claims face similar challenges regarding redressability. While he has experienced a direct injury from the military’s immunization program, the potential impact of the court’s declaration on AVA's status remains uncertain. Plaintiffs' counsel argues that a favorable declaration could help Buck demonstrate the military's actions were unlawful; however, such a declaration would not compel the military to change its decisions. There is no evidence that this declaration would influence future military proceedings. The court cites a precedent where a plaintiff's injury was deemed non-redressable despite seeking a declaratory judgment, illustrating that plaintiffs cannot currently satisfy the redressability requirement.

Redressability is a critical requirement for establishing jurisdiction, and plaintiffs, including Captain Buck, have not demonstrated that a favorable court decision will provide the relief sought. Similar to the situation in *University Medical Center*, the plaintiffs' process for seeking redress involves two steps: obtaining a favorable court declaration and then challenging military sanctions. Captain Buck's claim that a court declaration regarding his vaccination status will lead to the reversal of his court martial decision is insufficient. Referencing *McCollum*, the court has previously dismissed cases where plaintiffs could not show that the requested declaratory relief would address their injuries. The burden is on the plaintiff to provide evidence that actions by third parties, such as the military, will allow for redressability. The uncertainty regarding whether the military will comply with the court's declaration complicates matters, as it relies on independent decisions not influenced by the court. Consequently, Captain Buck and other plaintiffs have not established that a favorable declaration will resolve their injuries. The court has granted motions to dismiss the complaint from both federal defendants and Bioport Corporation due to the plaintiffs' failure to demonstrate standing.

Bates was penalized via non-judicial proceedings, required to pay $1,600 monthly for two months, and received a reprimand. Following the initiation of administrative discharge proceedings by the Air Force on March 8, 2000, Bates voluntarily resigned on March 10, 2000, which was approved on March 18, 2000, leading to his discharge "under honorable conditions." Consequently, Bates is no longer an active member of the armed forces and is currently in inactive status.

Captain Buck, a commissioned Air Force officer and board-certified emergency medicine physician, was notified on October 18, 2000, of his imminent deployment to the Persian Gulf and the requirement to receive the anthrax vaccination. Buck refused the vaccine, demanded a court-martial, and was subsequently charged with willfully disobeying a lawful order. The military judge ruled that the anthrax vaccine (AVA) was not an investigational new drug and the order to be inoculated was lawful. On May 18, 2000, Buck was convicted by an 11-member court-martial panel and sentenced to a reprimand, forfeiture of $1,500 per month for 14 months, and a 60-day restriction to Keesler Air Force Base. At the time of the complaint, Buck had several levels of review pending, which were exhausted by March 22, 2002.

The announcement made by former Secretary of Defense William Cohen on May 18, 1998, approved the Anthrax Vaccine Immunization Program (AVIP) to protect service members from potential biological threats. Under 10 U.S.C. § 1107 and Presidential Executive Order 13139, investigational drugs or unapproved drugs cannot be administered to military members without prior consent, unless waived by the President. Initially, the Department of Defense sought proposals for an anthrax vaccine due to a lack of effective options, ultimately contracting with SAIC Corporation in 1995 to facilitate FDA approval for AVA.

On September 20, 1996, Michigan Biologic Products Incorporated (MBPI), a predecessor of Bioport, submitted an Investigational New Drug (IND) application to demonstrate that Anthrax Vaccine Adsorbed (AVA) is effective against inhalation anthrax. Bioport later supplemented this IND application to include inhalation anthrax in the AVA license, which is currently pending approval by the FDA. Plaintiffs claim this license modification indicates that the Department of Defense (DOD) is using AVA investigationally as a preventative measure against inhalation anthrax.

The AVA vaccination schedule consists of three initial injections followed by three additional doses over 18 months. However, in June 2000, the DOD suspended AVA vaccinations for most personnel due to a vaccine shortage, leading to a modified vaccination schedule for those who had begun the series. Plaintiffs argue this deviation constitutes a new investigational use of AVA, although no plaintiff has experienced this modified schedule.

There have been three vaccine supply shortages; during the first two, only those at highest risk received the vaccine. The most recent slowdown, which occurred after the complaint was filed, restricts AVA administration to specific personnel and research groups. The DOD plans to resume broader vaccination only if Bioport completes renovations, the FDA approves the application related to those renovations, and vaccine production issues are resolved.

Bioport adopted the federal defendants' arguments but additionally claimed it was not subject to personal jurisdiction in the District of Columbia, asserting a lack of minimum contacts required for due process. The Court determined that the complaint must be dismissed under Rule 12(b)(1), rendering the personal jurisdiction issue moot. All defendants argued that Captain Buck's case should be dismissed due to his failure to exhaust administrative remedies.

Captain Buck's court-martial concluded on March 22, 2002, leading to the exhaustion of all his administrative appeals, which the parties conceded during oral argument. Plaintiffs lack standing to assert their claims, rendering the court's assessment of the claims' merits unnecessary. The distinction between Federal Rule of Civil Procedure 12(b)(1) (jurisdiction) and 12(b)(6) (merits) is highlighted, affirming that standing issues fall under subject matter jurisdiction. The federal defendants confirmed that Bates has no military status in the Air Force reserves, and despite accepting all factual allegations as true at this stage, Bates’ lack of a current palpable threat of receiving the anthrax vaccine negates his standing to challenge the vaccine's investigational status. The ongoing nature of the military's vaccination program does not moot the case, as voluntary cessation of allegedly illegal conduct does not eliminate the possibility of its recurrence. However, the uncertainty regarding Bates' potential exposure to the vaccine leads to the conclusion that he lacks standing. A favorable ruling from the Court would not obligate the Air Force Board for Correction of Military Records to act in Bates' favor. An accompanying Order will reflect the Court's ruling.