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Plaintiffs In Anthrax Vaccine Lawsuit Are Named From Tuesday, August 21, 2007 issue.

Plaintiffs In Anthrax Vaccine Lawsuit Are Named

By Elaine M. Grossman
Global Security Newswire

WASHINGTON — Eight plaintiffs have publicly identified themselves for the first time in a lawsuit filed last December against the U.S. government for its alleged failure to properly certify the anthrax vaccine (GSN, July 6).

An amended complaint describes the eight as active-duty, reserve or National Guard service members, civilians or defense contractors subject to taking the vaccine.  Those in uniform include three individuals currently deployed to Iraq and range from low-ranking enlisted personnel to a lieutenant colonel.

Each has “been ordered, or will imminently be ordered, to take [anthrax vaccine] as part of the military duties or employment obligations, or have been administered [the vaccine] in violation of FDA’s mandated shot sequence protocol,” according to the document, filed Aug. 15 at the U.S. District Court in Washington.

The lawsuit claims the plaintiffs represent a “class” of “similarly situated” individuals subject to taking the anthrax vaccine throughout the defense community.

The Defense Department inoculates selected service members and defense personnel considered at risk of exposure to an adversary’s airborne delivery of anthrax spores.  The vaccine program began in 1998 during the Clinton administration.

The complainants initially filed the lawsuit anonymously, challenging the validity of a Food and Drug Administration ruling in 2005 that the Defense Department could use the existing vaccine to prevent inhaled anthrax.  They allege the vaccine has not been demonstrated safe, effective and appropriate for protecting humans against the inhaled form of the disease, and is now being used in violation of agency rules.

The suit is the second of two lodged since 2003 against the government’s anthrax program.  The first case, dubbed “Anthrax I,” resulted in a court injunction against the Pentagon’s mandatory program of shots for defense personnel deemed at risk for anthrax exposure because of their assignment or location (GSN, Oct. 28, 2004).

The ban was lifted in February 2006, shortly after the Food and Drug Administration issued a “final rule and order” certifying the vaccine for Pentagon use (GSN, Dec. 16, 2005).

As of early this year, the military services resumed administering anthrax shots on a mandatory basis for personnel deployed to designated high-threat areas, which include Iraq and other Persian Gulf nations, Afghanistan and South Korea.  Other individuals subject to involuntary inoculations include those whose position or assigned mission might increase their potential risk of exposure to a bio-weapon, such as key civilian officials or emergency response personnel.

Those declining the shots have risked punitive action or dishonorable discharge from the service.

However, critics allege the Pentagon’s widespread use of the vaccine is not based on sound science.

The second lawsuit, “Anthrax II,” alleges the FDA decision was invalid and the Defense Department is administering shots in a manner inconsistent with the approved drug license.

The plaintiffs seek to have the drug declared “unapproved for its applied use” under the federal law that governs the administration of vaccines to U.S. troops.  They want the court to issue another permanent injunction barring the Pentagon’s use of the vaccine until it is properly licensed.

To bolster their request for anonymity in Anthrax II, the litigants cited a concern that the government might retaliate against those who oppose the vaccine program.

However, U.S. District Judge Rosemary Collyer — in her first ruling on the case — in June supported the government’s insistence that the plaintiffs reveal their identities as a matter of “fairness” and “openness.”  She called complainants’ fears of government reprisal “vague and unsubstantiated.”

Collyer invited the plaintiffs appeal her decision to a higher court, drop the lawsuit, or proceed with the case by revealing their identities.

They opted to file an amended complaint with their names attached.  In last week’s filing, the litigants identified themselves as:

Air Force Lt. Col. Thomas Rempfer, an Air National Guard officer attached to the 214th Reconnaissance Group at Davis Monthan Air Force Base, Ariz.;

Navy Lt. Cmdr. Joshua Cohen, attached to Carrier Strike Group Three and stationed at Bremerton, Wash.;

Navy Reserve Lt. Cmdr. Gareth Harris, assigned to HSC-84 in Norfolk, Va.;

Army Staff Sgt. Kevin Ferrara, attached to the 38th Construction and Training Squadron at Ramstein Air Base, Germany, and currently deployed to Iraq;

Army Spc. Shameka Edwards, assigned to B Company, 299th FSB, Schweinfurt, Germany, and currently stationed in Iraq;

Army Pfc. Eric Gearhart, attached to the 86th Signal Battalion, 11th Signal Brigade, at Fort Huachuca, Ariz., and currently serving in Iraq;

Navy Airman Michael Palmer, attached to the USS Kitty Hawk currently in Atsugi, Japan; and

Merchant Marine Seaman James Hailstone, attached to the U.S.N.S. 1st Lt. Jack Lummus.

Through one of their attorneys, John Michels, the plaintiffs this week declined to provide additional comment about the case.


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