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.
Posts: 259 | From: Humble, Tx. | Registered: Jul 2005
| IP: Logged |
Keep hearing that the anthrax vaccine is a experimental vaccine.But in truth the anthrax vaccine has been around for a long time now and been in use outside of the military.What I believe makes this experimental vaccine is what they are using to in the vaccine to speed our immune system responce.Whatever they are using is what I believe is what has screwed up my system and mybe alot of others as well. Mark A USN
[ December 14, 2006, 09:21 AM: Message edited by: Mark Azofeifa ]
Posts: 145 | From: Detroit ,Mi | Registered: Jul 2005
| IP: Logged |
IF the government honored its commitment instead of making up lies and half-truths this issue wouldn't be as bad as it is now. They screw people up, then cover it up for years, and wonder of wonders the program is plauged with lawsuit after lawsuit. Who wants to take a protective measure that has long term health risks down the road that will be denied at every corner? VAERS is a joke every adverse reaction should be required by law even if it's just swelling and observers should be used, that are not ringers, put in place by the Government to ensure mandatory adverse reaction reporting is in place.
Posts: 269 | From: Fla | Registered: Oct 2006
| IP: Logged |
(c) 1999-2005. INDIVIDUAL MEMBERS RESERVE ALL RIGHTS TO THEIR POSTINGS ON THIS BULLETIN BOARD WHERE COPYRIGHT IS NOT EXPLICITLY DISCLAIMED. (KANSAS CITY, MO.) *** Junior members, members, moderators, and administrators reserve common-law copyright privileges and rights to their own individual postings, unless expressly disclaimed. By using this bulletin board and in consideration for the privileges of such use, all guests, junior members, members, moderators, and administrators irrevocably agree to grant AGWVA permission and consent to use, store, retrieve, copy, distribute, and edit such message postings without limitation or exception, and irrevocably appoints AGWVA as agent for the purpose of execting any document or instrument necessary to effectuate this agreement. Furthermore, by using this bulletin board and in consideration therefor, all authorized or unauthorized guests, junior members, members, moderators, and administrators agree that the controlling jurisdiction over any dispute or controversy arising from the use or access of this bulletin board shall be governed under the laws of the State of Missouri and jurisdiction of the Circuit Court of Clay County, Missouri. *** While we encourage private messages to be posted in private forums requiring special authorization to enter, some messages on this bulletin board are protected by attorney-client privilege, doctor-patient privilege, and/or priest-penitent privilege, and such messages are intended solely for the use of those posting those messages, the intended recipient of that message, and AGWVA Bulletin Board's management - any disclosure beyond these parties is unintentional. The voluntary provision of medical, regulatory services/VA-representation, or religious services to members of the AGWVA Bulletin Board shall be limited by the case-by-case circumstances of each situation and shall be provided or not provided at the sole discretion of the person providing such services with the understanding that such services may stop or be limited at any time. Voluntary provision of any such service does not guarantee or assure any person a future or further right to such services. *** For posting messages to or from this bulletin board, AGWVA's management (moderators and administrators) are not compensated, directly or indirectly. *** Unauthorized use, copying, or distribution of material posted to this bulletin board is prohibited. Unauthorized access to this bulletin board is illegal and AGWVA reserves the right to prosecute anyone attempting to illegally access this bulletin board. AGWVA has stated explicit rules of conduct for its members posting on this bulletin board and all such rules are incorporated herein by reference as if fully set out hereinbelow. ***