Action Against Pentagon, FDA and Vaccine Manufacturer Seeks To Declare Vaccine Experimental And Illegal By Its Current Use

WASHINGTON, D.C. -- May 2, 2001

The highest ranking military officer and the first military physician to refuse the controversial anthrax vaccine filed a lawsuit today before the United States District Court for the District of Columbia. Sonnie Bates, a former Air Force Major, and Captain John Buck have sued to request that a federal judge declare the vaccine as it is being presently used by the U.S. military as an experimental drug. The vaccine is being utilized by the Department of Defense ("DoD") in order to allegedly protect servicemembers and civilian contractors from exposure to aerosolized anthrax. However, the Food and Drug Administration ("FDA") has never formally approved the vaccine for this use.

An Investigational New Drug ("IND") application was filed in 1996 by the DoD and the vaccine manufacturer requesting FDA approval for the vaccine for use against aerosol anthrax. The IND application still remains pending despite DoD's inoculation of more than 500,000 persons. Named as defendants, on behalf of their respective agencies, will be Secretary of Defense Donald Rumsfeld, Secretary of Health and Human Services, Tommy Thompson, and Bernard A. Schwetz, Acting Principal Deputy Commissioner, FDA, as well as BioPort, Inc., the vaccine's manufacturer.

While assigned to Dover Air Force Base in Delaware, Major Bates refused the anthrax vaccine in November 1999, and was forced to end his 14-year career as a result. Although he was not court-martialed, he was given a general discharge under honorable conditions in March 2000, and ordered to pay a fine. Captain Buck, however, is facing formal court-martial charges for his refusal in January 2001, and is scheduled to be prosecuted at Keesler Air Force Base, Mississippi, in September 2001.

"The substantive changes in the way the vaccine is used and the purpose for which it is used render the vaccine an IND under current federal law," said John J. Michels, Jr., one of the attorneys in the case. "As an IND, 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 within the lawsuit Complaint, revealed a history of health 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. "Unfortunately, when anthrax is used as a biological weapon, it is likely to be aerosolized and thus inhaled," the report said. "Therefore, the efficacy of the vaccine against biological warfare is unknown.…The vaccine should be considered investigational when used as a protection against biological warfare."

Executive Order 13139, which was signed by then-President Clinton in September 1999, does not allow the DoD to administer investigational new drugs to service members without their informed consent, except in times of national emergency. If the lawsuit results in the anthrax vaccine being classified as an investigational drug, federal law would require informed consent each time the vaccine is administered. The AVIP would essentially become a voluntary program. Earlier this year Defense Secretary Donald Rumsfeld reportedly asked for a review of the vaccination policy.

"As every day goes by the AVIP continues to ruin the lives of dedicated servicemembers and their families. It is time for this program to be terminated", said Mark S. Zaid, Esq., another attorney assisting with the lawsuit. "I hope this litigation will open the eyes of the right people at the Pentagon who will now conclude 'enough is enough, let it end'", he added.

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 December 1999 it was announced that Phase II and III of the program would be delayed for at least one year due to the continuing existence of FDA violations at the vaccine's manufacturing plant. The DoD now only has enough vaccine to last until September 2001. A report issued by the House of Representative's Committee on Government Reform in February 2000, recommended the termination of the AVIP. Nearly 500 active-duty service-members have refused the vaccine, and more than 60 have been court-martialed. Additionally, approximately 600-800 pilots and flight crew members have quit or resigned from the Air National Guard or Reserves rather than take the vaccine, thereby jeopardizing the United States' capabilities to conduct future air campaigns.

John J. Michels, Jr., is a partner in the Tyson's Corner office of McGuire Woods, and serves as a Lieutenant Colonel in the Air Force Reserve. Mr. Michels represented Major Bates 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. Mark S. Zaid is Of Counsel to the Washington, D.C. law firm of Lobel, Novins & Lamont, and also serves as the Executive Director of The James Madison Project (www.jamesmadisonproject.org), anon-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 court-martials. He testified before the House of Representatives against the AVIP in March 1999.

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Mark S. Zaid, Esq. Lobel, Novins & Lamont
1275 K Street, N.W. Suite 770
Washington, D.C. 20005
(202) 371-6626 (202) 371-6643 fax

Contents
Official Documents
Congressional Testimony
Position Papers
Troop Experiences
News Articles
Government Contact Information
Opinion
Informative WWW Sites
Benefit versus Risk

Final Complaint in Adobe Acrobat Format

Last revised: May 2001