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Judge Affirms Win for Plaintiffs in ‘Anthrax I’ Case

http://www.nti.org/d_newswire/issues/2007_9_5.html#C0469347

Judge Affirms Win for Plaintiffs in ‘Anthrax I’ Case
By Elaine M. Grossman
Global Security Newswire

WASHINGTON — For the first time, a federal judge last month declared six U.S. defense personnel the definitive winners in a four-year court battle over the anthrax vaccine (see GSN, Aug. 21).

The Aug. 21 decision, which revolves around payment of attorneys’ fees, is the latest chapter in a protracted struggle over whether the Defense Department can require service members to take the anthrax vaccine. U.S. District Court Judge Emmet Sullivan decided the government defendants must pay the plaintiffs’ expenses because the plaintiffs won the case.

The litigants — defense personnel who were required to take anthrax vaccine shots in a Defense Department effort that began in 1998 — won the first round of litigation in October 2004, when Sullivan issued a permanent injunction banning mandatory inoculations. Based on a finding that the vaccine was never certified to protect against “weaponized” airborne anthrax spores, the judge declared the Pentagon’s mandatory vaccinations “illegal” (see GSN, Oct. 28, 2004).

However, the Food and Drug Administration 14 months later certified the drug for preventing inhaled anthrax. Citing the FDA move, an appellate court in February 2006 officially “dissolved” the injunction (see GSN, Dec. 16, 2005).

The Pentagon restarted its mandatory shots program early this year.

In the latest matter under dispute, Justice Department attorneys argued the so-called “Anthrax I” plaintiffs were ineligible for government reimbursement of attorneys’ fees and expenses because they had not prevailed on appeal. The government defendants insisted they had won at the appellate court, where a three-judge panel allowed the Pentagon to restart its vaccine program.

Sullivan concluded otherwise, declaring: “There is no question that plaintiffs have prevailed overall as they achieved the permanent injunctive relief that they sought.”

The judge noted that the appellate court sent the case back to the lower court only after the Food and Drug Administration issued a final ruling that certified the anthrax vaccine for use in preventing inhaled anthrax. That was “the exact result” the plaintiffs sought, according to Sullivan.

In the end, then, the government appeal was unnecessary, Sullivan said. He thus termed it “reasonable” for the government to reimburse the plaintiffs for their expenses, “as they ultimately prevailed.”

The decision might well strengthen the hand of the two plaintiff attorneys, Mark Zaid and John Michels, who filed a second legal challenge to the Pentagon’s anthrax vaccination program last December.

Known as “Anthrax II,” the latest lawsuit alleges that the December 2005 FDA certification was invalid and that the Pentagon has resumed administering treatments inconsistent with the approved drug license. Zaid and Michels are asking the federal judge hearing that case, Rosemary Collyer, to impose another ban on the defense effort until the vaccine is properly tested and licensed for Pentagon use.

In last month’s decision, Sullivan bolstered from the bench the arguments the new set of eight plaintiffs make in their lawsuit. The judge clearly rejected the government’s long-standing contention that the original drug license allowed the vaccine to be used for the prevention of anthrax regardless of the route of exposure, including disease contracted through the lungs. The license cited a more narrow use for the vaccine: to prevent disease in mill workers, veterinarians or laboratory personnel, who might contract anthrax through the skin by handling animals or pelts.

When the Food and Drug Administration issued its court-mandated certification in 2005, the license was updated to reflect the agency’s contention that the vaccine could be used more broadly to prevent disease from airborne spores.

Sullivan’s new decision reaffirms the plaintiffs’ view that the vaccine was proven safe and effective only in “limited circumstances” and that a “lack of data permitted no meaningful analysis of the [vaccine’s] effectiveness against inhalation anthrax.”

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