U.S. Judge Lifts Ban on Pentagon Anthrax Shots

WASHINGTON (Reuters) - A federal judge on Wednesday lifted his earlier court order and allowed the Pentagon (news - web sites) 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 (news - web sites) 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 (news - web sites) 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.

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.

Rank	Location	Receipts	Donors/Avg	Freepers/Avg	Monthlies
56	Turkey	10.00	1	10.00	10	1.00

U.S. Army Buys $30 Million in Anthrax Shots

By Jim Wolf

Fri Jan 2, 8:34 PM ET

WASHINGTON (Reuters) - The Defense Department announced on Friday a $29.7 million order for anthrax vaccine based on the assumption that a federal judge's ban on mandatory inoculations will be reversed.

Privately held BioPort Corp. of Lansing, Michigan, was awarded the Army order on Wednesday as part of a $245.6 million contract, the Pentagon (news - web sites) said.

The move demonstrates confidence "we will resume the anthrax vaccination program as it existed before the judge's order," said Bryan Whitman, a Defense Department spokesman.

On Dec. 22 U.S. District Judge Emmet Sullivan barred the Pentagon from "inoculating service members without their consent."

In a preliminary injunction, he ruled the vaccine used in the Pentagon's mandatory program was an "investigational drug" being used for what was an unapproved purpose.

The Pentagon said the next day it would administer the vaccine only on a voluntary basis until the legal issues were sorted out.

On Tuesday the U.S. Food and Drug Administration (news - web sites) said the anthrax vaccine was safe for use in protecting U.S. troops against inhaled exposure to the potentially deadly bacteria.

The Bush administration then asked the court to lift the ban on mandatory shots.

The administration also has asked for a stay of the order for all service members except the six plaintiffs while the court weighs the government's motion for a complete lifting of the ban.

Mark Zaid, an attorney for the plaintiffs, said the Army's order for the new vaccine doses could amount to a case of fraud, waste and abuse.

"If the judge's decision stands, the Pentagon may have just wasted millions of dollars," he said.

Defense officials say 1 million service members have been vaccinated since the program started in 1998. Only about 10 have refused to take the shots since the Sept. 11, 2001, attacks against Washington and New York.

Anthrax is considered the top biological weapon threat. It can be transmitted in three ways -- through inhalation of the spores, into a cut in the skin, or by eating contaminated meat.

Inhaled anthrax is by far the deadliest form. In 2001 five Americans died from anthrax inhaled from contaminated mail.

Class action suit to follow! And this is a good thing, because otherwise any and every new "biodefense" vaccine currently under development will be tried on soldiers, regardless of whether they consent, and with no previous track record.

InsideDefense.com
January 6, 2004

Anthrax Vaccine Litigants To File Class-action Complaint Against DOD Plaintiffs challenging the Pentagon's 5-year-old mass inoculation program against anthrax will amend their complaint within the next 24 hours to include a class-action certification, according to one of the lead attorneys. The move constitutes the latest salvo in a legal tit-for tat with the Bush administration following a federal judge's Dec. 22 injunction against mandatory anthrax inoculations, which the Defense Department gives military personnel serving abroad in regions where they may face a biological threat. U.S. District Judge Emmet Sullivan agreed with the plaintiffs -- six Defense Department personnel who have been ordered to take the inoculations -- that the vaccine must be considered experimental against inhaled anthrax. The vaccine was initially developed and tested to protect against skin exposure. The judge says the law allows the Pentagon to inoculate service members only with their informed consent, a prerequisite that could be bypassed if the president issues a waiver based on national security requirements. In response to the court action, the administration filed an emergency motion Dec. 24, seeking clarification about whether the injunction applied only to the six anonymous plaintiffs. Absent a class action, the Justice Department argues, the court should vacate the injunction or apply it solely to the six personnel who filed the suit. John Michels, a lead attorney in the complaint, says the plaintiffs believe a class-action certification is unnecessary to invalidate a policy or rule. But he told Inside the Pentagon that he and co-counsel Mark Zaid can demonstrate that every service member or DOD employee ordered to take the anthrax vaccine is similarly affected. "I don't think we need a class action to have the court enforce this properly across the military", he said in a Jan. 2 interview. There are several cases that say when you invalidate an agency's rule or policy, it is simply applied to those affected by the rule, without having to be parties to the litigation. Michels questions if it is in the government's best interests to effectively invite a court to certify that all deployable members of the armed services represent a class harmed by the mandatory anthrax vaccine program, given the potential implications for military morale. But if that's where the government wants to take us in this case, I guess that's where we'll end up, he told ITP. Michels is a retired Air Force judge advocate officer now in private practice. He has also represented Air Force Maj. Sonnie Bates and Capt. John Buck, the highest military officers to refuse the anthrax vaccine. More than 1 million troops have been inoculated with the anthrax vaccine. Sullivan's opinion notes that some of the government's own scientists have said there is insufficient human data to show the vaccine protects against inhaled anthrax. "The women and men of our armed forces put their lives on the line every day to preserve and safeguard the freedoms that all Americans cherish and enjoy", Sullivan writes in the opinion. "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". In response, the Food and Drug Administration on Dec. 30 unveiled a Final Rule stating that the efficacy of the vaccine includes all cases of anthrax disease regardless of the route of exposure. A Wall Street Journal editorial greeted the new rule as a welcome blow to pseudoscientific hysteria, adding Sullivan is notorious for his judicial activism. Michels responds that the new rule is dramatically inconsistent with previous FDA practice regarding anecdotal evidence of efficacy in humans. Research has been unable to demonstrate a critical correlation between animal and human resistance to anthrax in response to the vaccine, he says. Within the next day, the plaintiffs may also file an amended complaint challenging the sufficiency of the FDA Final Rule, Michels said. Meanwhile, Sullivan will hold a hearing tomorrow on the government's emergency motion to stay the injunction. Sullivan notes the product insert for the anthrax vaccine, 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 and 35.0 percent. At least six deaths have resulted from the vaccine and the estimated risk to pregnant women has been revised upward, he writes in the opinion. The judge says the administration alleges that plaintiffs' claims of injury are purely speculative because adverse personnel actions against them for refusing inoculations may or may not occur. However, the court agrees with plaintiffs that the defendants' argument ignores the fact that when challenging an investigational drug . . . an inoculation without informed consent or a presidential waiver is the injury."
-- Elaine M. Grossman

Some interesting quotes from the plaintiff's attorney, Mark Zaid, following the latest ruling:

"We are disappointed, but not surprised that the injunction has been stayed for all but the six plaintiffs. The FDA's belated issuance of its Final Rule 18 years late, and only after the Court had issued an injunction, confirms that the vaccine was being used illegally by DoD before that time. That means any military servicemembers and DoD contractors who were disciplined for refusing the vaccine were unjustly punished as the order to take the vaccine was unlawful.

THe FDA's Final Rule is primarily based on animal studies that have no proven correlation to human efficacy. However, a law passed in 2002 specifically requires that such proof exist, and it does not. In fact, the CDC is still conducting research on this very subject, which won't be completed until 2007.

In the absence of a proven correlate of immunity between humans and animals, specific to anthrax infection, the FDA's Final Rule's reliance on animal data is illegal, and reflects an arbitrary and capricious decision. Therefore, the government's victory today may only be fleeting.

We plan to seek to revive the program-wide injunction as well as challenge the substance of the FDA Final Rule. We anticipate further court proceedings will invalidate the FDA's Final Rule and therefore result in a determination that DoD's mandatory use of the anthrax vaccine is illegal."

Here's the actual judge's order from today (seems to foreshadow more litigation):

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
)
JOHN DOE #1, et al, )
)
Plaintiffs, )
)
v. ) Civil Action No. 03-707 (EGS)
)
DONALD H. RUMSFELD, et al )
)
Defendants.
ORDER
On December 22, 2003 the Court issued a Preliminary Injunction enjoining the defendants from inoculating service members without their consent. The Court was persuaded that the record evidence before the Court was devoid of an FDA final decision on the investigational status of Anthrax Vaccine Adsorbed ("AVA"). Within days of the Court's injunction, the Food and Drug Administration ("FDA") published a final rule categorizing AVA as safe and effective for use against inhalation anthrax. 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. Accordingly, upon consideration of the government's Motion to Stay the Injunction as Applied to Persons Other than the Named Parties, the Response and Reply, hereto, and pursuant to the proceedings held in open court on January 7, 2004, it is hereby ORDERED that the government is entitled to a stay of the Court's injunction pending further order of the Court and further challenges to the government's final rule; and it is FURTHER ORDERED that the Motions Hearing previously scheduled for January 14, 2004 at 10:00 a.m. in Courtroom One has been converted to a Status Hearing.
Signed:
Emmet G. Sullivan
United States District Judge
January 7, 2004

Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.