Anthrax vaccine opponents file new lawsuit
By Gayle S. Putrich
Staff writer
Dec. 13, 2006
http://www.marinecorpstimes.com/story.php?f=1-292925-2421027.php
The legal battle over the military’s mandatory anthrax immunization program has
been revived, with six unnamed plaintiffs filing a class-action lawsuit against
the government Wednesday.
According to court documents, the basic premise of the lawsuit is the
plaintiffs’ claim that the vaccine is “unapproved for its applied/intended use.”
The lawsuit says that “plaintiffs will suffer substantial and irreparable injury
if they are forced to take the vaccine,” which the suit says has not been
properly approved by the government, despite the Food and Drug Administration
issuing its “final rule” on the vaccine a year ago.
The suit also says the Defense Department has failed to follow presidential
orders and federal laws that require the government to obtain informed consent
before giving an unapproved and experimental vaccine to anyone.
“FDA’s certification of the vaccine, which is based on slipshod statistical
analysis and 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 Chicago lawyer John J. Michels, Jr.,
co-counsel in the lawsuit. “Under these circumstances, the vaccine may not be
administered to service members without their informed consent. It is patently
illegal.”
The new lawsuit is just the latest chapter in the long and turbulent history of
the Pentagon’s anthrax vaccination program. Since December 2004, the six-shot
anthrax vaccine has been optional for all troops following the decision of a
federal judge for the U.S District Court for the District of Columbia to halt
the mandatory program with an injunction.
In December 2005, the FDA finalized its approval of the vaccine and a federal
appeals court dissolved the injunction, clearing the way for the Pentagon to
resume mandatory shots.
The Pentagon announced in October that mandatory inoculations would resume, but
defense officials are still formulating some parts of the vaccination plan,
which is now expected to begin early next year. The policy announced in October
directs mandatory anthrax shots for troops, emergency-essential civilians and
Defense Department contractors carrying out mission-essential services in the
Central Command area or South Korea for 15 consecutive days or more. Others
assigned to special mission units, such as biodefense units, are also expected
to be vaccinated as needed under the new policy.
As in the first anthrax vaccine lawsuit, the five male and one female plaintiffs
are unnamed — out of “fear of retaliation by the government,” their lawyers say.
Court documents claim they run the gamut of those who will be required to take
the vaccine after the new year: active-duty service members, reservists,
National Guardsmen, civilian Defense Department employees and contractors.
Robert Gates, who will be sworn in as defense secretary Monday, replacing Donald
Rumsfeld, is named in the lawsuit, along with Heath and Human Services Secretary
Mike Leavitt and Andrew C. Von Eschnebach, commissioner of the Food and Drug
Administration.
The Defense Department had no immediate comment on the lawsuit Wednesday
morning.
Pentagon officials have long maintained that the anthrax vaccine is safe, and
say that the 2005 FDA ruling grants them the legal authority to administer the
vaccine as they see fit. Only about half of the troops offered the vaccine
during the voluntary phase of the program have taken the shots, and officials
say it is a preventive-medicine and military-readiness concern for half of the
force to be vaccinated and half not to be, officials have said.
“This rate of vaccination not only put service members at risk but also
jeopardized unit effectiveness and degraded our medical readiness,” said Dr.
William Winkenwerder Jr., assistant secretary of defense for health affairs, in
announcing the resumption of mandatory shots in October.