Thursday, November 11, 2004
For further info contact:
Mark S. Zaid, Esq.
ZaidMS@aol.com
John Michels, Jr., Esq.
jmichels@mcguirewoods.com
Defense Department Embarks On Dissinformation Campaign Concerning Anthrax Vaccination Program
Involuntary Vaccinations Must Stop For A Minimum Of Three To Four Months In Order For The Government To Comply With Court Order
WASHINGTON, D.C. --
On October 27, 2004, the Honorable Emmet Sullivan of the U.S. District Court for the District of Columbia vacated an Order issued by the Food & Drug Administration and imposed a permanent injunction prohibiting the Department of Defense from administering the anthrax vaccine without informed consent or a presidential waiver. This second injunction followed Judge Sullivan's earlier decision of December 22, 2003, that the anthrax vaccine was investigational and unlicensed for its intended purpose to protect against inhalational exposure.
Since the imposition of a permanent injunction the Department of Defense has led a disinformation campaign to downplay the significance of the Court's decision, particularly regarding the length of time the injunction will remain in place. These efforts, which are made amidst convenient FDA silence, do a great disservice to the loyal men and women who are attempting to protect the United States of American in military and civilian positions.
"DoD is trying to equate Judge Sullivan's granting a permanent injunction with his earlier decision granting a preliminary injunction, but that's simply wishful thinking," said Mark S. Zaid, Esq. of the Washington, D.C. Law Firm of Krieger & Zaid, PLLC, one of two lawyers who brought the lawsuit on behalf of the plaintiffs. "In fact, given the state of the medical and scientific evidence, it will be extremely difficult for FDA to make a proper case that the vaccine has any effectiveness against inhalation anthrax. That means the vaccine stays an investigational drug and it cannot be used by the military without informed consent or a presidential waiver," Zaid added.
The Court found that the FDA failed to allow for public comment when it decided to ignore the recommendations of its own expert panel and determined the vaccine was properly licensed for inhalation anthrax. In addition to the Court's new findings, Judge Sullivan also explicitly incorporated his earlier findings that the vaccine was never licensed for inhalation anthrax, and that the FDA and DoD authorized the use of an experimental drug on service members.
"The upshot of the court's ruling on October 27, 2004, is that the anthrax vaccination program violated federal law from 1998 forward, at a minimum. Any order to submit to anthrax vaccination during the entire existence of the program was illegal, said the plaintiffs' co-counsel John Michels, a partner in the Chicago office of McGuireWoods, LLP. "The soldiers that DoD discharged for refusing to take the shots are entitled to back pay and allowances from the date they were removed from paid status to the point where DoD properly decides what to do with them. In fairness to the hundreds of service members who were wrongfully separated from active duty, DoD should begin processing each one for compensation and reinstatement, particularly if it wants to avoid congressional involvement," added Michels.
Both lawyers noted that the stockpiling of anthrax vaccine currently in progress is being done with a product that is untested and unapproved as a preventative measure against inhalation anthrax, the most likely type of anthrax to be used in a terrorist attack. They also commented that the DoD's statements that Judge Sullivan's order does not challenge the "safety or efficacy" of the vaccine are deliberately misleading.
"Vaccines are licensed only when they are proved to be both safe and effective. The court's ruling that the vaccine is not licensed goes to the heart of the matters of safety and efficacy for this vaccine. In fact, the license for the vaccine and the original FDA expert panel both recommended against widespread inoculation with the product", said Michels.
In addition to those service members who were wrongfully discharged, the plaintiffs' attorneys said that they are aware of hundreds of other service members who left active duty or the active reserves to avoid the vaccine, and many others who developed serious and debilitating illnesses immediately after receiving the shots. Whether these individuals will be allowed back into their units or receive proper compensation for illnesses caused by an experimental drug is probably up to the Veterans Administration and the National Guard or Reserve leadership. Additional legal action on behalf of those who were disciplined and who have fallen ill from the vaccine is currently being prepared.
The lawsuit was filed under pseudonyms on March 18, 2003, by six plaintiffs (and other similarly situated individuals) who are either members of the active duty and selected National Guardsmen components of the Armed Forces or civilian contract employees of the Defense Department. Each of the plaintiffs had been ordered to take the anthrax vaccine. The government has indicated it will shortly seek to vacate the injunction based on the FDA’s Final Rule.
The plaintiffs were represented by John J. Michels, Jr., a partner in the Chicago office of McGuireWoods LLP (www.mcguirewoods.com), who previously represented Major Sonnie Bates and Captain John Buck, the highest military officers to refuse the anthrax vaccine, and Mark S. Zaid, Managing Partner of the Washington, D.C. law firm of Krieger & Zaid, PLLC, who has defended more than one dozen servicemembers courts-martialed for refusing the anthrax vaccine and has testified before Congress regarding the vaccine in 1999.
