Thursday, November 11, 2004
For further info contact:
Mark S. Zaid, Esq.
John Michels, Jr., Esq.
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 service
members courts-martialed for refusing the anthrax vaccine and has
testified before Congress regarding the vaccine in 1999.
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