UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
May 30, 2002
SONNIE BATES, ET AL. PLAINTIFFS,
DONALD RUMSFELD, ET AL. DEFENDANTS.
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.
I. Background *fn1
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, 19.) (4) Finally, regarding their challenge to the modified vaccination schedule, plaintiffs argue that the defendants' illegal change in the vaccination schedule should not be permitted to escape judicial review. (Id. at 22.
While each side has presented interesting substantive arguments, the Court will not need to ultimately reach them because it finds that the constraints placed on it by Article III of the Constitution preclude the issuance of a declaratory judgment in this matter. Therefore, plaintiffs' claims must be dismissed because this court lacks subject matter jurisdiction over their claims. *fn13
1. Plaintiff Bates' claims
Article III, § 2 of the United States Constitution provides that courts have jurisdiction over all "cases and controversies." As part of this requirement, litigants must demonstrate that they have standing to assert their claims. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992). To establish standing, plaintiffs must satisfy the following three-part test:
First, the plaintiff must have suffered an 'injury in fact' -- an invasion of a legally protected interest which is (a) concrete and particularized . . . and (b) 'actual or imminent, not 'conjectural or hypothetical[.]' Second, there must be a causal connection between the injury and the conduct complained of -- the injury has to be 'fairly trace[able] to the challenged action of the defendant, and not . . . th[e] result [of] the independent action of some third party not before the court.
. . . Third, it must be 'likely' as opposed to merely 'speculative' that the injury will be 'redressed by a favorable decision.' Id. at 560-61 (citations omitted).
It is the burden of the party seeking to invoke federal jurisdiction to establish the existence of these elements. Id. at 561 (citation omitted).
At the outset, the nature of the injury necessary for a party to have standing must be concrete. See City of Los Angeles v. Lyons, 461 U.S. 95, 101 (1983) ("[p]laintiffs must demonstrate a 'personal stake in the outcome' in order to 'assure that concrete adverseness which sharpens the presentation of issues' necessary for the proper resolution of constitutional questions."). In this regard, a plaintiff must be able to demonstrate that "he 'has sustained or is immediately in danger of sustaining some direct injury' as the result of the challenged official conduct and the injury or threat of injury must be both 'real and immediate' . . ." Id. at 102 (citations omitted).
Plaintiff Bates has failed to establish that he has sustained, or will sustain in the immediate future, injury flowing from the defendants' use of AVA. As stated previously, Bates voluntarily resigned from the Air Force on March 10, 2000, before a hearing could be held regarding his potential administrative discharge. At oral argument, plaintiffs' counsel stated that Bates is currently a member of the Air Force's Individual Ready Reserve, *fn14 and in that status counsel candidly acknowledged that the likelihood that Bates will be called to duty and would have to submit to the administration of AVA is uncertain at best. In addition, currently the military is vaccinating only selected special units. *fn15 Whether in fact the policy of immunizing all military personnel will resume is not definite, and in any event, whether Bates would be subject to that policy if it does resume considering his inactive status is pure speculation. See Lyons, 461 U.S. at 109 (plaintiff's lack of standing did not "rest on the termination of the police practice [of utilizing chokeholds] but on the speculative nature of his claim that he will again experience injury as a result of that practice even if continued.").
Plaintiffs nevertheless argue that by "declaring whether AVA is an IND vaccine for inhalation anthrax, this Court will clarify the primary legal question upon which the parties differ." (Pls.' Opp. at 7.) *fn16 Despite this appeal, a declaratory judgment can not be issued "when the possibility of the injury's occurring is remote and uncertain." Lampkin v. Connor, 360 F.2d 505, 509 (D.C. Cir. 1966); Atlas Air, Inc. v. Air Line Pilots Assoc., 232 F.3d 218, 227 (D.C. Cir. 2000) ("[u]nder the Declaratory Judgment Act, a dispute 'must not be nebulous or contingent but must have taken on fixed and final shape.") (citations omitted). Whether in fact the military will reinstate its policy requiring the vaccination of all military personnel is, at this point, contingent on unsettled future events and is therefore speculative. Because the likelihood that Bates will be subjected to the administration of AVA is remote, as is the situation for the other similarly situated plaintiffs who are no longer on active duty, they cannot satisfy Lujan's first prong.
Even assuming that plaintiff Bates and other similarly situated plaintiffs could demonstrate that they were forced to voluntarily resign from the military as a result of the AVA policy, as discussed more fully below, they have not shown that the injury they suffered is "'likely . . . to be redressed by a favorable decision'" by this Court. Lujan, 504 U.S. at 561; McCollum v. Smith, 596 F. Supp. 165, 167 (D.D.C. 1984) (when determining standing, the relevant inquiry, 'assuming justiciability of the claim, [is whether] the plaintiff has shown an injury to himself that is likely to be redressed by a favorable decision.'") (citing Simon v. Eastern Kentucky Welfare Rights Organization, 426 U.S. 26, 41 (1976)). Thus, as discussed in greater detail below, plaintiffs have failed to establish the redressability prong of standing. This deficiency dooms not only Bates' case but also all of the other plaintiffs' actions.
2. Plaintiff Buck's claims
Plaintiff Buck's case suffers from the same constitutional impediment as do all of the plaintiffs' cases - redressability. Although Captain Buck has suffered a direct injury as a result of the military's immunization program, i.e, his court martial conviction, it is unpredictable whether a declaration by this Court concerning AVA's status as an investigational drug will redress the injury he has suffered. Plaintiffs' counsel argues that a favorable declaration on this issue will be used by Buck, and similarly situated plaintiffs, to demonstrate to the military that its actions were contrary to law. However, a favorable declaration will not have the force to require the military to reverse its decisions. In fact, plaintiffs have not presented anything that even vaguely suggests that the declaration will have any impact at all in any subsequent proceedings before the military. See Lujan, 504 U.S. at 572 ("it is entirely conjectural whether the non-agency activity that affects respondents will be altered or affected by the agency activity they seek to achieve."); University Medical Center of Southern Nevada v. Shalala, 173 F.3d 438 (D.C. Cir. 1999).
In University Medical Center, the appellant sought a declaratory judgment that the Department of Health and Human Services ("HHS") had acted arbitrarily and capriciously in failing to include plaintiff on a list that would have entitled plaintiff to discounts from drug manufacturers on certain pharmeceutical drugs. 173 F.3d at 440. In affirming the dismissal of the case on the ground that the appellant's injury was not redressable, the District of Columbia Circuit held that "[e]ven if appellant had a declaratory judgment that the government unlawfully delayed in placing [appellant] on the list, it has never explained how, or under what legal theory, it would be entitled to recover against the manufacturers [for the higher prices it had to pay]." Id. at 442. The Court noted that the appellant's argument, that "it should be allowed to seek redress in two steps, first getting a declaratory judgment and then suing the manufacturers" was "essentially a concession that the redressability requirement cannot currently be met. Redressability must be satisfied now to establish jurisdiction." Id. (emphasis in original).
Similar to the appellant in University Medical Center, Captain Buck and other similarly situated plaintiffs have failed to establish that a favorable decision by this Court will immediately provide them with the relief they are seeking. Like the appellant in University Medical Center, plaintiffs seek redress in two steps - a favorable declaration from the Court and then a challenge to the military concerning its decisions to sanction them. In other words, Captain Buck can not demonstrate that the ultimate relief he is seeking, namely, reversal of the court martial decision, will be redressed by a declaration by this Court that AVA was in IND status at the time he refused to be vaccinated. McCollum, 596 F. Supp. at 169 (granting defendant's motion to dismiss plaintiffs' complaint for declaratory relief where the plaintiffs failed to demonstrate the declaratory relief requested would redress the injuries plaintiffs had sustained). And this reality is fatal to Caption Buck's case. See US Ecology, Inc. v. United States Dep't of the Interior, 231 F.3d 20, 25 (D.C. Cir. 2000) (when redressability is dependent on the actions of a third party, it is the plaintiff's burden to "'adduce facts showing that those choices have been or will be made in such manner as to . . . permit redressability of injury.'") (quoting Lujan, 504 U.S. at 562). Whether the military will even give deference to the Court's declaration is totally uncertain because this will depend upon "'the unfettered choices made by independent actors not before the court and whose exercise of broad and legitimate discretion the court cannot presume either to control or to predict.'" Id. at 24 (quoting ASARCO Inc. v. Kadish, 490 U.S. 605, 615 (1989)). Therefore, Captain Buck's claims and the claims of those plaintiffs who have actually suffered an injury still fall short of the mark because they have not demonstrated that a declaration entered in their favor by this Court will redress now (or in the future even though this consideration is irrelevant) the injuries they have sustained.
For the reasons stated above, defendants' motions to dismiss the complaint are granted due to plaintiffs' inability to establish standing. *fn17
SO ORDERED on this 29th day of May, 2002.
For the reasons set forth in the Memorandum Opinion that accompanies this Order, it is hereby ORDERED that the federal defendants' motion to dismiss plaintiffs' complaint is granted. It is further
ORDERED that Bioport Corporation's motion to dismiss plaintiffs' complaint is granted. SO ORDERED on this 29th day of May, 2002.