U.S. Judge Lifts Ban on Pentagon Anthrax Shots

[senorpepr]

WASHINGTON (Reuters) - A federal judge on Wednesday lifted his earlier court order and allowed the Pentagon to resume its policy of compelling U.S. troops to get vaccinated against the deadly germ warfare agent anthrax.

U.S. District Judge Emmet Sullivan, granting a request by the Bush administration, issued a stay of his Dec. 22 order that had prohibited the mandatory anthrax inoculations until a trial could be held on a lawsuit filed by six unidentified troops and Pentagon civilian workers who challenged the policy.

Sullivan's ruling came eight days after the Food and Drug Administration declared the vaccine safe and effective against the form of anthrax in which airborne bacterial spores are inhaled into the lungs -- the most likely way U.S. troops may face the disease on a battlefield.

In a two-page order, the judge called the timing of the FDA's action so soon after his earlier ruling "arguably highly suspicious," while plaintiffs' lawyers accused the FDA of acting hastily due to political pressure by the Pentagon.

Sullivan said that regardless of the timing, the FDA's action addressed his earlier concern the agency had never categorized the vaccine as safe and effective against inhalation anthrax.

Sullivan left in place a prohibition on the Pentagon requiring the six plaintiffs to get the shots.

Worried about possible dangerous side effects, hundreds of U.S. service members have refused to get the shots since the inoculation program began in 1998. Many have faced punishment, including being thrown out of the military.

Sullivan, in his Dec. 22 ruling, accepted the plaintiffs' contention the vaccine was an experimental drug being employed by the Pentagon for an unapproved use: protecting against inhalation anthrax as well as less-hazardous exposure through the skin.

The judge wrote at the time that without informed consent or a presidential order, the Pentagon could not require that troops "serve as guinea pigs for experimental drugs."

But the FDA on Dec. 30 endorsed the drug for use against inhaled exposure to anthrax, moving quickly after 18 years of inaction on the matter. The FDA move prompted the Justice Department to file a motion asking the court to lift the ban on mandatory anthrax vaccines. The Pentagon had halted the inoculations following the Dec. 22 order.

'UNDUE PRESSURE'

Mark Zaid, a lawyer for the plaintiffs, expressed disappointment in the judge's decision but said he did not plan to appeal.

"We will be exploring the extent to which the Defense Department put undue pressure on the FDA," Zaid said.

The plaintiffs shortly before midnight on Tuesday filed an amended lawsuit, calling the FDA's action "so arbitrary and capricious as to amount to bad faith."

Zaid said the FDA ruling only served to confirm the vaccine had previously been used illegally by the Pentagon and that any troops or civilian contractors disciplined for refusing the shots were unjustly punished.

The plaintiffs also notified the judge they may seek class-action status, which could allow more than 2.5 million active-duty, National Guard and Reserve troops and contractors to join the case.

A Pentagon spokesman said he did not know whether the Defense Department would immediately resume giving the inoculations on a mandatory basis.

Defense officials have said about 1 million troops have been given the shots since the vaccination program began.