Mandatory anthrax vaccine for troops challenged in court

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Attorneys for six military officers and Defense Department personnel argued in a U.S. District Court yesterday that the Department of Defense must stop inoculating soldiers as a remedy for inhalation anthrax because the vaccine is in "investigational" stages and is being used without approval.

Appearing before Judge Emmet G. Sullivan in John Doe, et. al. v. Rumsfeld, et. al., plaintiffs were seeking a preliminary injunction that would prevent the government from vaccinating military personnel unless the recipients heard an explanation of potential side-effects and gave consent, or the president issued a waiver. They said that under a federal statute such regulations are necessary for drugs under investigation.

"In some cases, they're not even told it's going to be an anthrax vaccination," said John Michels Jr., the plaintiffs' attorney.

Mr. Michels brought up the case of a woman who said she told the person administering the shot that she was pregnant and was fearful of the effects of the vaccination, yet was told that didn't exempt her.

When soldiers who reject the shot are court-martialed and punished, that is "irreparable damage," one requirement needed for a judge to issue an injunction, the defense has said.

But attorneys for the defendants -- the Defense Department, and the Food and Drug Administration -- said the treatment has been accepted for years for all forms of anthrax, including the inhalation variety. Although plaintiffs' attorneys maintained that it is still to be determined whether the vaccine is an acceptable treatment for inhalation anthrax, the defense attorneys said it is settled.

"There are risks with all vaccines, your honor," said Ronald Wiltsie, a Department of Justice trial lawyer, who is representing the defendants. "The risks here are no greater than a tetanus shot or MMR," measles, mumps and rubella shots.

Mr. Wiltsie also disputed the plaintiffs' claim of irreparable damage, saying punishing personnel by court-martialing them does not warrant such a description.

In the first day of oral arguments, yesterday, the lawyer also detailed a different and more informative process that soldiers go through if they are reluctant to receive the vaccination. He said they are informed about the type of inoculation they will receive and are counseled by a medical professional if they refuse. They are then give an order, and if they still refuse, are subject to discipline.

The plaintiffs "seek to undermine a key component of military readiness and defense against battlefield use of biological weapons," attorneys for the defense wrote in a brief to the court.

The Pentagon has said the anthrax vaccine is safe but acknowledged that severe harmful reactions develop in about one in 100,000 vaccinations. When inhaled, dry anthrax spores can be deadly to humans.

At least 600,000 employees in the Defense Department have received the vaccination, and officials say they plan to immunize each of the 2.4 million members of the military.

Also at issue is whether the case, which involves military parties, belonged in a federal court instead of a military one. Defense attorneys denied that the federal court should be the decision-maker in the case.

"This goes to the core of the military's ability to structure its forces and control them," Mr. Wiltsie said.

But Mr. Michels said military courts have a pattern of following rules set by the heads of the armed forces branches. "I don't believe there is a military judge anywhere ... that would step up and say, 'I'm going to stand against the secretary of defense, the secretary of the Air Force," he said.

There have been several cases of U.S. soldiers refusing to take the anthrax vaccine, whether for religious reasons or for fear of breast-feeding infants or the long-term effects it could have on children they might bear.

Two Air Force officers filed a lawsuit against the Pentagon in 2002, challenging the mandatory anthrax vaccines for soldiers. One complainant received 60 days of base restriction and was fined $21,000 for refusing the anthrax vaccine, and the other was forced to end his 14-year military career.