Judge Decides Pentagon Can Resume Anthrax Vaccinations

FROM THE NEW YORK TIMES

January 8, 2004
Judge Decides Pentagon Can Resume Anthrax Vaccinations

By THOM SHANKER

WASHINGTON, Jan. 7 — A federal judge on Wednesday lifted his injunction halting the military's mandatory anthrax vaccination program, and the Pentagon swiftly ordered the resumption of shots for all its personnel except the six anonymous people who brought the suit.

The judge, Emmet G. Sullivan of the United States District Court for the District of Columbia, ordered lawyers for the government and the plaintiffs to return in a week for a "status hearing" to discuss the next steps in what promises to be a protracted legal fight.

"We are disappointed, but not surprised that the injunction has been stayed for all but the six plaintiffs," said Mark S. Zaid, a lawyer for the six
"John Doe" military or Pentagon personnel who brought the suit.

Mr. Zaid pledged further legal action to challenge the effectiveness of the vaccine, the way it is administered and the scientific basis cited by the Bush administration for its approval. "The government's victory today may
only be fleeting," he said.

David S. C. Chu, the under secretary of defense for personnel and readiness, signed a memorandum late Wednesday ordering the resumption of the vaccination program.

Bryan Whitman, the Pentagon's deputy spokesman, said after the court action that "the Department of Defense believes this is a safe and effective vaccine" and that "it is an important force-protection measure for our troops" who may be faced with such an unconventional threat.

"It would be irresponsible not to provide the maximum amount of protective measures available to keep our service members safe," Mr. Whitman added.

Though Judge Sullivan was swayed by arguments put forth by government lawyers in staying his injunction, he wrote that the timing of a new Food and Drug Administration rule declaring that the anthrax vaccine was effective against the greatest potential danger raised suspicions.

In issuing his preliminary injunction on Dec. 22, Judge Sullivan accepted the plaintiffs' arguments that the vaccine used in the Pentagon's mandatory program had been approved by the F.D.A. to protect against skin exposure to anthrax — but not against anthrax that is inhaled, the far greater battlefield threat. Thus, the judge said, the vaccine was an "investigational" drug being forced on the troops for an unapproved purpose.

The Pentagon halted the program the next day, pending clarification of the legal issues, and the day after that the Justice Department filed a motion asking the judge to withdraw the injunction — or at least limit his ruling solely to the six plaintiffs whose suit prompted it.

On Dec. 30, the F.D.A. announced a new "final rule and order," which officially declared the anthrax vaccine effective against the inhaled form of the bacteria.

The Justice Department immediately moved to capitalize on the new rule, filing an emergency motion later that day asking Judge Sullivan to vacate the injunction, writing, "There can be no doubt that the F.D.A. order removes the legal basis upon which relief was sought and granted."

In his two-page order issued on Wednesday, Judge Sullivan wrote, "Although the timing of the issuance of the rule is arguably highly suspicious, nevertheless, the rule has been issued and the principle reason for the issuance of the injunction has been addressed by the government."

Mr. Zaid, a plaintiffs' lawyer, said after the court action that the agency's rule should be interpreted as an admission that the vaccine "was being used illegally by the Department of Defense before that time." He said any military personnel or Pentagon civilians penalized for refusing the mandatory vaccine "were unjustly punished."

The plaintiffs' lawyers challenged the rule as "primarily based on animal studies that have no proven correlation to human efficacy." They also filed documents on Tuesday asking the court to consider the anthrax case as a class action, to include all military personnel and Pentagon civilians.

Original Article

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