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Judge neither vacates nor reiterates prior opinion - Anthrax Vaccine

Inside the Pentagon
By: Elaine M. Grossman
Page 1

Judge neither vacates nor reiterates prior opinion

Litigation over the Pentagon's anthrax immunization program fizzled toward an unexpected conclusion early this month when U.S. District Court Judge Emmet Sullivan opted to ignore an invitation from a three- judge appeals panel to consider vacating a decision he'd issued nearly two years ago. Instead, Sullivan said at a Sept. 7 hearing in Washington the only issue he sees remaining before his court is how much the U.S. government owes the plaintiffs in attorney's fees.

The case revolves around a Pentagon effort, begun in 1998, to inoculate more than a million defense personnel with the anthrax vaccine. Defense officials said the mandatory shots were necessary to ensure troops and civilians in high-risk regions or jobs do not fall victim to potentially lethal biological attacks. The Defense Department sought to use the vaccine to protect against "weaponized" anthrax spores an adversary might spread through the air.

Six anonymous defense personnel challenged the program with a lawsuit, filed in March 2003, saying the Pentagon could not legally administer the six-shot inoculation series involuntarily because the anthrax vaccine had never been properly licensed for wide-scale protection against inhaled transmission of the disease. Under the law, a U.S. president could invoke national security concerns and override a service member's right to decline inoculations, but neither President Clinton nor President Bush did so.

Rather, the government has defended the mandatory shots, insisting the vaccine was properly licensed.

In an October 2004 summary judgment on the case, Sullivan supported the plaintiffs, declaring the Pentagon's involuntary vaccination effort to be "illegal" (Inside the Pentagon, Oct. 28, 2004, p1). Sullivan issued a permanent injunction against giving mandatory shots until such time as the Food and Drug Administration carried out a proper process to certify the anthrax vaccine, or a presidential waiver is issued.

In response, the Defense Department temporarily suspended the shots. But in May 2005, the Pentagon resumed the effort on a voluntary basis, citing the authority of a relatively new law, the 2004 Project BioShield Act (ITP, May 5, 2005, p5).

Later that month, the government challenged Sullivan's decision at the U.S. Court of Appeals (ITP, May 19, 2005, p1). As the Justice Department's appeal was pending, FDA completed the formal process the lower court judge had said was necessary before the injunction against mandatory shots could be lifted. The agency issued a "final rule and order" last December confirming its view the anthrax vaccine is safe, effective and appropriate for the prevention of inhaled spores (ITP, Jan. 5, p1).

Based on FDA's long-awaited certification, the federal appeals panel decided in February that the government appeal before it had become moot. But in an interesting twist, the higher court remanded part of the case back to Sullivan. The appeals panel suggested Sullivan might rule on the government's pending request to vacate his 2004 finding that the Pentagon's anthrax inoculation program was illegal between its May 1998 inception and the FDA certification, issued in December 2005 (ITP, Feb. 16, p1).

"By its own terms . . . the injunction has dissolved, and this case no longer presents a live controversy on which we may pass judgment," the appeals court said in its five-paragraph decision.

"The government urges us to vacate the district court's opinion" that the Pentagon vaccination program was illegal until FDA issued its final rule and order in December 2005, the three judges stated. "We decline to do so, and instead remand with instructions to the district court to consider that request."

In court early this month, Sullivan said a joint proposal co-authored in July by the complainants and defendants essentially wraps up the case. In fact, the document summarizes different views the two sides have about how Sullivan should act on the case.

"Plaintiffs request that the court refuse the defendant's request for vacatur, and adopt the findings and holding expressed in its October 2004 order that the vaccine was not a drug approved for its applied use until the FDA properly completed its review of the vaccine and issued a final rule and order on Dec. 19, 2005," the joint proposal states. The government's repeated statements that the vaccine status was safe, effective and not misbranded all along "fly in the face of this court's specific factual determinations and rulings," the plaintiffs note.

However, in the same document, the government appears to concede that it could not reasonably expect Sullivan to vacate his own earlier judgment that the Pentagon's use of the vaccine was illegal prior to last year's FDA certification.

"In light of the Court of Appeals' finding of mootness, the government does not believe that any substantive issues remain in this case and that the case should be dismissed," the document reads.

The two parties agree that, because the government did not prevail at the Court of Appeals, it now owes the plaintiffs payment for attorney's fees.

This remains the only pending issue before Sullivan, the federal judge said with little explanation at the Sept. 7 hearing.

"Can the parties resolve the issue of attorney's fees?" he asked the litigants, offering to assign the case to a magistrate.

Ronald Wiltsie, representing the Justice Department, told Sullivan he anticipates the two parties could probably sort out the issue themselves, once the plaintiffs update a petition for fees initially submitted to the court in November 2004. The attorneys said they could probably agree on payment for plaintiff attorney fees by early next year.

After the hearing, Mark Zaid, who serves as plaintiff co-counsel, told ITP he would estimate their total fee request will top $312,000. In 2004, the plaintiffs also tallied expert fees of nearly $22,000.

Despite the seemingly ambiguous disposition of the case as remanded back to Sullivan's court, those opposed to the Pentagon's involuntary program are confident the judge's 2004 declaration that it was illegal will form a strong basis for further litigation.

"The appeal was mooted," says one attorney involved in the case, speaking on condition of not being named. "It doesn't affect Judge Sullivan's [2004] order at all."

Those following the issue anticipate hundreds of service members who received dishonorable discharges for refusing orders to take the anthrax vaccine will appeal to the Pentagon to correct their records. Members of the military are not required to obey illegal orders. In addition, these individuals may request back pay through the end of their enlistment period and possibly seek damages if the blemish on their records made it hard to find work in the civilian world. A small number of personnel may ask to be reinstated into the military, according to sources.

"Were the government to have to cover all associated expenses involving service members and civilians who were unlawfully disciplined due to the illegal vaccine program, the amount would likely be in the tens of millions [of dollars]," Zaid told ITP on Sept. 7.

Appeals to a service board for the correction of military or naval records are made on a case-by-case basis and cannot be done as a class, sources say.

Meanwhile, the Pentagon continues to give anthrax inoculations to defense personnel on a voluntary basis.