FOR IMMEDIATE RELEASE: May 24, 2004
FOR FURTHER INFORMATION CONTACT
Mark S. Zaid, Esq.
(202) 454-2809
(202) 498-0011 (cell)
John J. Michels, Jr., Esq.
(312) 750-2770
(630) 561-2505 cell
TOPIC: Federal Court To Hold Oral Arguments Tomorrow To Determine Whether The Pentagon's Anthrax Vaccination Immunization Program Is Experimental And Requires Informed Consent
WHEN: Tuesday, May 25, 2004, at 10:00 A.M.
WHERE: Courtroom #1 (Judge Emmet Sullivan)
U.S. District Courthouse
3rd & Constitution Avenues, N.W.
BACKGROUND:
The lawsuit was filed on March 18, 2003, by six plaintiffs (and other similarly situated individuals) who are either members of the active duty and selected National Guardsmen components of the Armed Forces or civilian contract employees of the Defense Department. Each of the plaintiffs had been ordered to take the anthrax vaccine.
On December 22, 2003, Judge Sullivan granted a Preliminary Injunction prohibiting the government’s use of the anthrax vaccine for protection against inhalation exposure without informed consent. The Court ruled that the vaccine “is an investigational drug and a drug being used for an unapproved purpose…Absent an informed consent or presidential waiver, the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs.”
However, on December 30, 2003, the defendant Food & Drug Administration (FDA) issued a Final Rule and Order concerning the alleged safety and effectiveness of the vaccine. Relying upon a 1985 proposed rule, the FDA claimed that “the efficacy of the vaccine includes all cases of anthrax disease regardless of the route of exposure or manifestation of disease.”
On January 7, 2004, Judge Sullivan, on the sole basis of the FDA's new Final Rule, rescinded his order enjoining the Government from administering the anthrax vaccine without consent (except for the 6 plaintiffs who remain protected). He called the timing of FDA's issuance "highly suspicious".
Since that time the parties have filed their respective Cross-Motions for Summary Judgment. The plaintiffs have highlighted numerous procedural and substantive deficiencies in the actions of the Defense Department and FDA, as well as with the anthrax vaccine itself (copies of the plaintiffs' supporting memorandums of law are attached). The remedy sought is the invalidation of the FDA's Final Rule and the re-imposition of the injunction. The Government claims the vaccine is safe and effective and should be allowed to continue its program.
Tomorrow's oral arguments will decide which side prevails.
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Copies of additional court filings are available upon request.
Last revised: May 2004