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James C. Martin v. Michael B. Donley

August 21, 2012

JAMES C. MARTIN, PLAINTIFF,
v.
MICHAEL B. DONLEY, SECRETARY OF THE AIR FORCE DEFENDANT.



The opinion of the court was delivered by: Reggie B. Walton United States District Judge

MEMORANDUM OPINION

This case arises from claims that the defendant, in his official capacity as the head of the Department of the Air Force with "final authority over [the] correction of records," unjustifiably denied the plaintiff's request for various record corrections pertaining to his resignation from the Air Force Reserve. Complaint ("Compl.") ¶¶ 3, 7, 9. Currently before the Court is the Defendant's Motion to Dismiss ("Def.'s Mot.").*fn1 For the reasons explained below, the Court will grant the defendant's motions.

I. BACKGROUND

A. The Anthrax Vaccination Immunization Program

According to the Center for Disease Control ("CDC") "[a]nthrax is an acute infectious disease caused by [a] spore-forming bacterium." CDC, Questions and Answers About Anthrax, EMERGENCY PREPAREDNESS & RESPONSE (Aug. 20, 2008) http://www.bt.cdc.gov/agent/anthrax/faq/ (last updated Aug. 20, 2008). "Anthrax spores can be used as a bioterrorist weapon," with infections occurring in three forms: "cutaneous (skin), inhalation, and gastrointestinal." Id.

In 1970, the National Institutes of Health ("NIH"), the agency then responsible for licensing biological drugs, licensed Anthrax Vaccine Absorbed ("AVA") "for use against anthrax." Def.'s Mem. at 3; see also Pl.'s Opp'n at 1. The NIH's AVA license did not "differentiat[e] among possible uses or limit[] the license to particular routes of exposure."

Def.'s Mem. at 21 (internal citation omitted). Subsequently, licensing authority was delegated to the Federal Drug Administration ["FDA"] and the FDA began a "review process to determine whether previously licensed products, including AVA, were safe, effective, and not misbranded." Def.'s Mem. at 3 (internal quotations and citations omitted). In 1985, an FDA panel noted that "AVA was not licensed against inhalation anthrax." Pl.'s Opp'n at 29. In 1996, the maker of AVA submitted an Investigational New Drug Application to the FDA, for the "purpose of obtaining a specific indication for inhalation anthrax," which remained pending for several decades. Id. (internal quotations omitted). As a result, in December 2003, the AVA label still "did not specify which method of anthrax exposure the [v]accine protected against." Id.

In 1997, the Department of Defense ("DoD") initiated the Anthrax Vaccination Immunization Program (the "vaccination program"), "which required members of the Armed Forces at risk of anthrax exposure to submit to mandatory vaccination." Def.'s Mem. at 3; see also Compl. ¶ 12. The following year, 1998, the vaccination program took effect and AVA inoculations began "as a preventative measure against inhalation anthrax." Compl. ¶¶ 12, 14. That same year, Congress enacted 10 U.S.C. § 1107, which proscribes the "administration of 'investigational' new drugs, or drugs unapproved for their intended use, to service members without their informed consent." Id. ¶ 13 (internal citations omitted). The requirement that the member provide consent to receive the investigational drug may be waived only by the President. Id. In 1999, President Clinton issued Executive Order 13139, which implemented the informed consent requirement and declared that presidential waiver would only be granted "when absolutely necessary." Id. ¶ 16 (internal quotation omitted).

The vaccination program was implemented without complications until July 17, 2000 when the DoD "dramatically reduce[d] the number of [AVA] inoculations due to an unexpected delay in the availability of vaccine supplies approved by the [FDA] as safe and effective." Id. ¶ 17. The DoD thus maintained the vaccination program only for personnel in areas of "highest threat." Id. In August 2000, the DoD "formally adopted the informed consent requirement" mandated by 10 U.S.C. § 1107. Id. ¶ 18. Nevertheless, on June 28, 2002, the DoD resumed the vaccination program with "mandatory inoculation[s] for military personnel . . . at higher risk whose performance is essential for certain mission critical capabilities." Id. ¶ 19.

Since the 1997 initiation of the vaccination program, there have been several "challenges to the legality of orders requiring military personnel to take [AVA]." Def's Mem. at 3. Notably, in 2003, Judge Emmet Sullivan of this Court ruled that, with regard to inhalation anthrax, "AVA is an investigational drug . . . [that was] being used for an unapproved purpose" in violation of 10 U.S.C § 1107. Id. ¶ 35 (citing Doe v. Rumsfeld, 297 F. Supp. 2d 119, 135 (D.D.C. 2003)). He then granted the plaintiffs' request for a preliminary injunction and enjoined inoculation under the vaccination program. Id.

Shortly after the Doe ruling, the FDA issued a final rule and order "[finding] that AVA was safe and effective 'independent of the route of exposure.'" Id. ¶ 36 (quoting 69 Fed. Reg. 255, 260 (Jan. 5, 2004)). Judge Sullivan, nonetheless, vacated the FDA's rule and order because "the FDA failed to follow [required] notice and comment procedures." Id. ¶ 37 (citing Doe v. Rumsfeld, 341 F. Supp. 2d 1, 16 (D.D.C. 2004). Finding a clear statutory prohibition on inoculation with investigational drugs, "Judge Sullivan issued a permanent injunction" on the vaccination program until the FDA certified AVA through the proper procedures. Id. ¶ 38 (citing Doe, 341 F. Supp. 2d at 16).

Finally, in December 2005, the FDA issued a new final order "explicitly finding AVA efficacious against inhalation anthrax," id. ¶ 39 (citing Doe v. Rumsfeld, 501 F. Supp. 2d 186, 188 (D.D.C. 2007) (internal citation omitted)), causing the District of Columbia Circuit to subsequently conclude that the injunction against the vaccination program had "dissolved on its own terms." The program was thus reinstated. Id. ¶ 39 (citing Doe v. Rumsfeld, 172 F. App'x, 327, 327 (D.C. Cir. 2006).

Following the Doe rulings, Judge James Robertson, a former member of this Court, declared that "prior to the FDA's December 2005 rulemaking, it was a violation of federal law for military personnel to be subjected to involuntary AVA inoculation because the vaccine was neither the subject of a presidential waiver nor licensed for use against inhalation anthrax." Id. ¶ 40 (quoting Rempfer v. U.S. Dep't of Air Force Bd. for Corr. of Military Records, 548 F. Supp. 2d 200, 210 (D.D.C. 2008)).

Notwithstanding the prior litigation in this Court, other courts have found that AVA has been properly licensed since 1970 and, therefore "the vaccination program [is] . . . a 'lawful response by [the military] to the dangers with which the military personnel of the United States may be confronted in the future." Def's Mem. at 3 (quoting O'Neil v. Secretary of the Navy, 76 F. Supp. 2d 641, 645 (W.D. Pa. 1999)). And the Court of Appeals for the Armed Forces concluded in 2006 that AVA was properly licensed since 1970 and held "that the Doe court decisions did not affect the legality of the [v]accination order." Id. at 6-7 (referencing United States v. Kisala, 64 M.J. 50, 54 (C.A.A.F. 2006).

B. The Plaintiff's Factual Assertions

Drawing all justifiable inferences in favor of the plaintiff, as the Court must, the factual allegations underlying this lawsuit are as follows. In 1992, the plaintiff enlisted in the United States Marine Corps Reserve and was later discharged in 1995. Compl. ¶ 8. Subsequently, the plaintiff joined the Air Force Reserve and was gradually promoted until he reached the rank of First Lieutenant in 1999. Id. ¶¶ 8, 10. Throughout his military career, the plaintiff "amassed an exemplary military record" demonstrating that he was a ...


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