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Doe v. Rumsfeld

December 22, 2003


The opinion of the court was delivered by: Signed: Emmet G. Sullivan United States District Judge


Plaintiffs, members of the active duty and selected National Guardsmen components of the Armed Forces as well as civilian contract employees of the Department of Defense ("DoD") who have submitted or have been instructed to submit to anthrax vaccinations without their consent pursuant to the Anthrax Vaccine Immunization Program ("AVIP"), commenced this action against the Secretary of Defense (Donald Rumsfeld), the Secretary of Health and Human Services (Tommy Thompson), and the Commissioner of the Food and Drug Administration (Mark McClellan).

Because plaintiffs maintain that Anthrax Vaccine Adsorbed ("AVA") is an experimental drug unlicensed for its present use and that the AVIP violates federal law (10 U.S.C. § 1107), a Presidential Executive Order (Executive Order 13139), and the DoD's own regulations (DoD Directive 6200.2), plaintiffs ask that in the absence of a presidential waiver the Court enjoin the DoD from inoculating them without their informed consent. Plaintiffs allege three causes of action against defendants: (1) violation of the Administrative Procedure Act ("APA") by defendant DoD based on the DoD's failure to follow federal law, a presidential executive order, and DoD directive with respect to its AVIP; (2) violation of the APA by defendant DoD for its intent to inoculate plaintiffs with an unlicensed drug that is unapproved for its intended use; and (3) violation of the APA by the defendants' alteration of the licensed Federal Drug Administration ("FDA") approved schedule of vaccination which rendered AVA a drug unapproved for its intended use.*fn1

Defendants DoD and FDA maintain that the issues plaintiffs present are non-justiciable and that plaintiffs fail to present an evidentiary basis sufficient to support standing at the preliminary injunction stage. With respect to the merits, they allege that, in seeking to prevent the DoD from inoculating them, plaintiffs seek to undermine a key component of military readiness and defense against battlefield use of biological weapons.

Pending before this Court is a Motion for a Preliminary Injunction. The central question before this Court is whether AVA is an"investigational" drug or a drug unapproved for its use against inhalation anthrax. Upon consideration of plaintiffs' motion for a preliminary injunction, the opposition, the reply, and oral arguments, as well as the statutory and case law governing the issues, and for the following reasons, it is, by the Court, hereby ORDERED that the Motion for a Preliminary Injunction is GRANTED. In the absence of a presidential waiver, defendants are enjoined from inoculating service members without their consent.

I. Background

A. Factual Background

In 1970, the National Institutes of Health ("NIH"), the agency then charged with licensing biologic drugs, see 37 Fed. Reg. 4004, 4004-04 (Feb. 25, 1972), licensed AVA for use against anthrax. See 36 Fed. Reg. 8704, 8705 (May 11, 1971). Two years later, authority to approve biologic drugs was delegated to the FDA. 37 Fed. Reg. 4004, 4004-05 (Feb. 25, 1972).

After the authority to license biologic drugs was delegated to the FDA, the agency initiated a review of the safety, effectiveness, and labeling of all licensed biologics. 21 C.F.R. 601.25. The Federal Register published a proposed rule containing the results of AVA's review on December 13, 1985. In that product review, the independent Biologics Review Panel recommended that the vaccine be classified as safe, effective, and not misbranded. In their recommendations the panel discussed the Brachman study*fn2 and stated that the vaccine's"efficacy against inhalation anthrax is not well meaningful assessment of its value against inhalation anthrax is possible due to its low incidence." Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Reviews, 50 Fed Reg. 51,002 (Dec. 13, 1985)(to be codified at 21 C.F.R. pt. 610). To date the AVA label does not specify which method of anthrax exposure it protects against. The Proposed Rule published in the December 13, 1985, Federal Register has never been finalized.

On October 5, 1995, the U.S. Army Medical Research and Material Command wrote the Michigan Department of Public Health ("MDPH"), the vaccine's manufacturer, that they were enclosing a plan"to expand the indication for use to include projections from aerosol exposure to B. anthraces spores." Pls.' Compl. Ex. G, Letter from Anna Johnson-Winegar to Robert Myers of October 5, 1995. The plan specifically asserts that"[t]his vaccine is not licensed for aerosol exposure expected in a biological warfare environment." Pls.' Compl. Ex. G, Attachment to Letter from Anna Johnson-Winegar to Robert Myers of October 5, 1995. The plan proposed was to amend the anthrax vaccine license through an Investigational New Drug ("IND") application submission.

On October 20, 1995 (as reflected in a November 13, 1995, memorandum from the Department of the Army Joint Program Office for Biological Defense) a meeting was held to discuss modifying the anthrax vaccine license"to expand the indication to include protection against an aerosol challenge of spores."*fn3 Pls.' Compl. Ex. H, Mem. Regarding: Minutes of the Meeting on Changing the Food and Drug Administration License for the Michigan Department of Public Health (MDPH) Anthrax Vaccine to Meet Military Requirements from David L. Danley to Distribution List on November 13, 1995.

On July 2, 1996, the FDA held a meeting to consult with and provide guidance to the DoD and MDPH officials who were formulating the forthcoming September 1996 IND application. The Army"presented a plan in progress to develop correlates in immunity in animals and then in humans vaccinated with MAVA in order to obtain a specific indication for inhalation anthrax." Pls. Reply Ex. 1, Summary of the Michigan Anthrax Vaccine Adsorbed (MAVA) Pre-IND Meeting with the FDA: Specific Indication for Inhalation Anthrax; Change in Schedule and Route at ¶ 5.

In September 1996, AVA's manufacturer submitted an IND application to the FDA in an attempt to get FDA approval for a modification of the AVA license to demonstrate the drug's effectiveness against inhalation anthrax. The IND application is still pending and, to date, there is no indication for inhalation anthrax on the label or in the product insert.

In 1997, the Assistant Secretary of Defense"took...steps to confirm that AVA is approved for use against inhalation anthrax." Defs.' Opp'n at 10. For instance, the Assistant Secretary of Defense (Health Affairs) wrote to the FDA's Lead Deputy Commissioner, stating that the"DoD has long interpreted the scope of the license to include inhalation exposure, including that which would occur in a biological warfare context" and inquiring"whether the FDA has any objection to our interpretation of the scope of the licensure for the anthrax vaccine." Defs. Opp'n. Ex. 3, Letter from Stephen Joseph to Mark Friedman of March 4, 1997. The Lead Deputy Commissioner responded"I believe your interpretation is not inconsistent with the current label." Defs. Opp'n. Ex. 2 Attach. 3, Letter from Mark Friedman to Stephen Joseph of March 13, 1997.

In a response to a citizen petition dated August 2002, the FDA's Associate Commissioner of Policy noted that the FDA still has yet to finalize the rule proposed in the December 13, 1985, Federal Register. But here, contradicting the panel's position regarding the Brachman study in the 1985 Federal Register, the FDA stated that the Brachman study included inhalation anthrax. Thus, the FDA concluded that"[t]he indication section of the labeling does not specify the route of exposure and thus includes both cutaneous and inhalation exposure." Pls.' Compl. Ex. D, Resp. to Citizen Pet. Dated October 12, 2001 from Margaret Dotzel to Russell Dingle on August 28, 2002.

The AVA product insert, which originally stated that the adverse reaction rate to the vaccine was 0.2 percent, was recently revised to reflect an adverse reaction rate between 5.0 percent and 35.0 percent. At least six deaths have been linked to the vaccine and the vaccine's pregnancy use risk has been upgraded from a Category C risk (risk cannot be ruled out) to a Category D risk (positive evidence of risk.)

B. Legal Background

In 1998, in response to concerns about the use of investigational new drugs during the 1991 Gulf War that may have led to unexplained illnesses among veterans, Congress signed into law 10 U.S.C. § 1107. This provision prohibts the administration of investigational new drugs, or drugs unapproved for their intended use, to service members without their informed consent. The consent requirement may be waived only by the President. In 1999, the President signed Executive Order 13139, pursuant to which the DoD must obtain informed consent from each individual member of the armed forces before administering investigational drugs and under which waivers of informed consent are granted only"when absolutely necessary." Exec. Order No. 13139, 64 Fed. Reg. 54,175 (September 30, 1999). In August, 2000, the DoD formally adopted these requirements in DoD Directive 6200.2.

In 1998, the DoD began a mass inoculation program using AVA as a preventative measure against inhalation anthrax for service members and civilian employees. The program was administered without informed consent or a presidential waiver. Plaintiffs contend that because AVA is not licensed for inhalation anthrax, its use by the DoD is not only investigational but it is also a drug unapproved for its intended use in violation of 10 U.S.C. § 1107, Executive Order 13139, and DoD Directive 6200.2. Tr. at 7-8. Defendants maintain that they are not in violation of any law because AVA is not an investigational new drug and it is licensed for inhalation anthrax.

II. Standard of Review

When seeking a preliminary injunction, the movant must demonstrate to the Court that: (1) there is a substantial likelihood that plaintiff will succeed on the merits; (2) plaintiff will be irreparably injured if an injunction is not granted; (3) an injunction will not substantially injure the other party; and (4) the public interest will be furthered by an injunction. Davenport v. Int'l Bhd. of Teamsters, 166 F.3d 356, 361 (D.C. Cir. 1999).

III. Discussion

A. Justiciability

1. Jurisdiction in an Article ...

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