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Action Against Pentagon, HHS And FDA Seeks To Again Stop Government’s Illegal Vaccination Program

Two years after an earlier lawsuit shut down the Department of Defense’s (“DoD”) Anthrax Vaccination Immunization Program, another six military servicemembers and Defense Department civilian contractors filed suit today in the United States District Court for the District of Columbia to request that a federal judge once again declare that the anthrax vaccine is an unapproved drug and unlawful without informed consent. The identities of the plaintiffs are being withheld for fear of retaliation by the government.

Each of the plaintiffs faces either termination from employment or criminal prosecution if they refuse inoculation with the vaccine. The lawsuit is being filed as part of a class action effort on behalf of all military servicemembers and civilians facing inoculation purportedly to prevent aerosolized exposure from anthrax.

This past October 2006, the DoD announced it was reinstituting a mandatory inoculation program (applicable to those serving in the Korean and Middle East theatres) after having administered it on a voluntary basis for two years in the aftermath of a court order to do so. The DoD’s action follows the Food and Drug Administration’s (“FDA”) pronouncement of December 19, 2005 of a Final Rule and Order declaring the vaccine to be safe, effective, and not misbranded as protection against all forms of anthrax. The FDA is also a defendant in the current case.

"FDA’s certification of the vaccine, which is based on slipshod statistical analysis, and an improper use of testing data, as well as DoD’s alteration of the vaccine dosing schedule, render the vaccine a drug unapproved for its applied use under current federal law," said John J. Michels, Jr., co-counsel in the litigation and a partner in the Chicago law office of McGuire Woods LLP. "Under these circumstances, the vaccine may not be administered to service members without their informed consent. It is patently illegal", he added.

Internal government documents, many of which are described in the lawsuit, reveal a history of regulatory violations and scientific concerns regarding the DoD's Anthrax Vaccination Immunization Program (“AVIP”). A 1994 report by the Senate Veterans Affairs Committee concluded that the vaccine could not be expected to protect troops against airborne anthrax and should be considered experimental. In February 2000, the House of Representative's Committee on Government Reform recommended the termination of the mandatory AVIP. In December 2003 and again in October 2004, a federal judge declared the vaccination program illegal until the FDA acted.

“The AVIP is a public relations program fueled by bureaucratic concerns rather than science that flouts FDA precedent to such a degree that all logic has been thrown out the window. The FDA has disgraced its reputation by statistically manufacturing
supporting evidence in order to support an unlawful military policy,” said Mark S. Zaid, Esq., a Washington, D.C. lawyer serving as co-counsel in the litigation. Zaid added that all available threat information indicates the residents of the Washington, D.C. area are likely at far greater risk of exposure to anthrax than
members of the military serving in Korea or Iraq.

In December 1997, the DoD ordered the inoculation of all 2.5 million active duty
personnel, regardless of duty station or responsibilities. The immunization series calls for six injections of the vaccine over a period of 18 months, followed by annual booster shots. Vaccinations began in March 1998, but in July 2000 the scope
of the mandatory vaccination program was reduced due to the continuing inability of
the vaccine manufacturer, BioPort, to comply with federal manufacturing standards. After a four-year hiatus, the FDA allowed BioPort to resume production in January 2002. Inoculations were temporarily halted by a federal judge in December 2003, and the mandatory program was permanently stopped in October 2004. Since that time approximately 50% of those offered the vaccination declined.

Nearly 500 active-duty service-members have refused the vaccine, and more than 100 have been court-martialed. Additionally, approximately 500-1000 pilots and flight crew members have quit, resigned or transferred from the Air National Guard or Reserves rather than take the vaccine. The vaccine is voluntary in the Australian, British and Canadian militaries, as well as for U.S. Department of State employees even though they serve in the same geographical region as that of U.S. military servicemembers.

John J. Michels, Jr., is a partner in the Chicago office of McGuire Woods LLP
(www.mcguirewoods.com), and previously represented Major Sonnie Bates and Captain John Buck, the highest military officers to refuse the anthrax vaccine, and was the author of a high-profile legal memorandum analyzing the illegality of the AVIP; the subject matter of which he testified on before Congress in October 2000. Mr. Michels served as co-counsel in Doe#1 et al. v. Rumsfeld et al, which declared the mandatory vaccination program unlawful in 2004.

Mark S. Zaid is a Washington, D.C. lawyer who specializes in representing individuals employed within the United States Intelligence and Military communities. He also serves as the Executive Director of The James Madison Project (www.jamesmadisonproject.org), a non-profit organization that educates the public on national security issues including the anthrax vaccine controversy. Mr. Zaid has represented dozens of anthrax refusers, including service as senior defense counsel in nearly one dozen courts-martials. He testified before the House of Representatives regarding the AVIP in March 1999, and was co-counsel in Doe#1 et al. v. Rumsfeld et al, which declared the mandatory vaccination program unlawful in 2004.