The opinion of the court was delivered by: Reggie B. Walton, United States District Judge.
This lawsuit concerns an issue that recent events have made of particular relevance to our nation's security: biological warfare. Plaintiffs, Sonnie Bates and Captain John Buck, bring this action on behalf of themselves and all other similarly situated individuals, for a declaration, pursuant to the Declaratory Judgment Act, 28 U.S.C. § 2201 (2000), that Anthrax Vaccine Adsorbed ("AVA"), which is currently being administered only to selected units of the United States Armed Forces, is an investigational new drug ("IND") as defined by 21 U.S.C. § 355 (2000), or a drug unapproved for its intended use under 10 U.S.C. § 1107 (2000) and Presidential Executive Order 13139. The defendants include Donald H. Rumsfeld, Secretary of Defense for the Department of Defense ("DOD" or "Department"), Tommy Thompson, Secretary of Health and Human Services for the Department of Health and Human Services, Bernard A. Schwetz, Acting Principal Deputy Commissioner of the Food and Drug Administration ("FDA") (hereafter collectively referred to as the "federal defendants"), and Bioport Corporation ("Bioport"), a Michigan company with its sole place of business in Michigan, who is the current owner of the license to manufacture AVA.
This matter is currently before the Court on the federal defendants' motion to dismiss the complaint pursuant to Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6) and defendant Bioport's motion to dismiss the complaint pursuant to Federal Rules of Civil Procedure 12(b)(1) and 12(b)(2). For the reasons stated below, the Court concludes that the defendants' motions must be granted.
Taking the facts as stated in the complaint as true, Leatherman v. Tarrant County Narcotics Intelligence & Coordination Unit, 507 U.S. 163, 164 (1993), the facts pertinent to this action are as follows: AVA was licensed as a vaccine for use against anthrax *fn2 on November 2, 1970, by the United States Public Health Service. (Compl.¶ 8.) Plaintiff Bates is a former active-duty Air Force pilot who, following disciplinary action for his refusal to take AVA, voluntarily resigned and was then honorably discharged from active military service. *fn3 (Compl. ¶ 1.) Plaintiff Buck is a currently an active Air Force physician who faced court-martial charges for his failure to take AVA. *fn4 (Id.) The similarly situated individuals who are also designated as plaintiffs include "some 500 current and former members of the Armed Forces who have been disciplined or forced to resign for failure to take the AVA after being ordered to do so, and all active duty military members who may subsequently be ordered to take the vaccination." (Id.
The plaintiffs' actions stem from an announcement made in December 1997 *fn5 by the Department of Defense that indicated its intention to implement a "multi-service vaccination program for all active duty, Reserve and National Guard service members using the AVA as a preventative for inhalation anthrax." (Id. ¶ 28.) As a result of this program, plaintiffs and others similarly situated to them, were ordered to submit to involuntary anthrax vaccinations. (Id. ¶ 29.) Plaintiffs object to the administration of AVA because they argue the drug is an IND for which the Army must obtain their consent or a waiver by the President of the United States prior to administering the vaccine to them. *fn6 Plaintiffs argue that AVA is an investigational drug because (1) it is not licensed as a vaccine for inhalation anthrax, the purpose for which the military instituted its use *fn7 and because (2) the DOD has deviated from the licensed application's schedule for administering AVA. *fn8 (Id. ¶ 41.) Those persons refusing to submit to the AVA vaccination have been subjected to "military disciplinary actions, including courts-martial convictions, forfeitures of pay and allowances, incarceration, and administrative separation from the Armed Forces." (Id. ¶ 30.
Plaintiffs seek judicial declarations that AVA is an investigational new drug within the meaning of 10 U.S.C. § 1107 and Presidential Executive Order 13139; that AVA has been an investigational new drug since the original investigational new drug application was filed on September 20, 1996; that AVA has also been in investigational status as a result of the DOD's June 2000 modified vaccination schedule; and that, as of December 1997, AVA is a drug unapproved for its intended use within the meaning of 10 U.S.C. § 1107 and Presidential Executive Order 13139. Plaintiffs also seek to recover their litigation related costs and attorney's fees.
In June, 2001, the DOD ceased the administration of AVA for all but special mission units and research use, and there is no current plan to resume the vaccination of the remainder of the armed forces unless and until the shortage of AVA is resoloved. (Fed. Defs.' Mot. at 31.) *fn9
A. Standard for Deciding a Motion to Dismiss
When reviewing a motion to dismiss, the court must accept as true all the factual allegations contained in the complaint. Leatherman, 507 U.S. at 164. Pursuant to Federal Rule of Civil Procedure 12(b)(1), the plaintiff has the burden of establishing jurisdiction. Grand Lodge of the Fraternal Order of Police v. Ashcroft, 185 F. Supp.2d 9, 13 (D.D.C. 2001) (citation omitted). "A motion to dismiss under 12(b)(1) for lack of standing . . . involves an examination of the face of the complaint . . ." Haase v. Sessions, 835 F.2d 902, 908 (D.C. Cir. 1987). As a result, the "'plaintiff's factual allegations in the complaint . . . will bear closer scrutiny in resolving a 12(b)(1) motion' than in resolving a 12(b)(6) motion for failure to state a claim." Grand Lodge, 185 F. Supp.2d at 13-14 (citations omitted). However, in deciding a 12(b)(1) motion, the court is not limited to the allegations in the complaint but may consider "'such materials outside the pleadings as it deems appropriate to resolve the question whether it has jurisdiction in the case.'" Grand Lodge, 185 F. Supp.2d at 14 (citations omitted). The Court should only consider such additional evidence "to assure itself of the existence of standing." Haase, 835 F.2d at 907.
B. The Federal Defendants' Motion to Dismiss *fn10
The federal defendants make several arguments in support of their motion to dismiss the plaintiffs' complaint: (1) that this case is barred by the doctrine of sovereign immunity because the United States cannot be sued without its consent, and such consent is a prerequisite for the Court to acquire jurisdiction and (2) that this case should be dismissed because it does not present a justiciable controversy because plaintiff Bates' claims are moot as a result of his voluntary resignation from the Air Force. Both defendants also argue that (3) the declaratory judgment sought by both Bates and Buck *fn11 is incapable of redressing their injuries and that the Court should therefore exercise its discretion under the Declaratory Judgment Act to dismiss this case *fn12 and (4) plaintiffs' challenge to the now suspended modified vaccination schedule policy is moot because the modified schedule was adopted subsequent to Bates' resignation from the military and plaintiff Buck has not been subjected to this schedule.
Plaintiffs, in opposition to defendants' motions to dismiss, argue the following: (1) Bates has standing to challenge defendants' actions because he was forced to resign from the armed forces and this resignation stems from the defendant's "illegal vaccination program." (Pls.' Opp. at 17.) In addition, Captain Buck is currently facing a realistic prospect of being ordered to take AVA because he remains on active duty in the Air Force. (Id. at 20.) (2) Defendants are not shielded from suit as a result of sovereign immunity because they are acting contrary to federal law. (3) The investigational new drug status of AVA is a perfect issue to be resolved by declaratory judgment because a declaration by this Court as to AVA's IND status will allow the military courts and civilian administrative boards to determine the proper disposition of plaintiffs' administrative appeals. (Id. at 7, ...