Class Action Suit Targets Anthrax Vaccine
The Connecticut Law Tribune
By THOMAS D. WILLIAMS
http://www.ctlawtribune.com/getarticle.aspx?ID=24652
Two years after an earlier lawsuit temporarily halted mandatory anthrax vaccinations for all 2.4 million U.S. military service members and some military contractors, another group of military service members and Pentagon civilian contractors are going to federal court to block the vaccine's forced use.
Six complainants, remaining unidentified to protect them from retaliatory military discipline, filed suit against federal military and health officials Dec. 13 in U.S. District Court for the District of Columbia. They're asking a judge once again to declare the controversial vaccine an unapproved drug and unlawful for use without informed consent.
Connecticut's U.S. Rep. Christopher Shays, R-Stamford, state Attorney General Richard Blumenthal and two well-known Connecticut U.S. Air Force officers, Thomas Rempfer and Russ Dingle, were leading opponents of the inoculation program when it began in 1997. For seven years, in vain, they pressured Congress, two presidents and high-ranking Pentagon officials to halt the program. Lt. Col. Dingle, of East Hartford, died in September 2005.
A federal court order in late 2004 halted mandatory vaccinations based on a finding that the Food and Drug Administration failed to follow licensing regulations. But soon after the FDA issued a final order approving the vaccine's safety and effectiveness in December 2005, the Department of Defense announced it was reinstituting the mandatory inoculation program for those serving in Korea and the Middle East.
Critics charge the FDA failed to provide evidence the vaccine was effective against inhalation (weaponized) anthrax, and failed to address reports of adverse health consequences from the vaccine.
Reached last week, Blumenthal said he hasn't yet reviewed the class action. But he seemed to place little confidence in the FDA final rule. "My belief has been consistently that the vaccine should be voluntary unless and until a new vaccine is developed that is safe and effective," he said.
Shays agreed. Military personnel "volunteer to put on the uniform to defend us. They should not be required to put untested vaccines into their bodies," he said.
Each of the plaintiffs faces either termination from employment or criminal prosecution if they refuse inoculation.
Adverse Reactions
The U.S. Government Accountability Office reported that the vaccine's systemic adverse reaction rate was 100 times higher than the 0.2 percent rate reported on the product's label. Adverse vaccine reactions were said by users to include immune disorders, muscle and joint pains, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least half a dozen deaths and a number of birth defects have been attributed to use of the vaccine, but they have not been definitively proven as linked.
Chicago attorney John J. Michels Jr., co-counsel in the litigation with D.C. attorney Mark S. Zaid, charged, "FDA's certification of the vaccine … is based on slipshod statistical analysis, and an improper use of testing data. [That], as well as the defense department's alteration of the vaccine dosing schedule, renders [it] a drug unapproved for its applied use under current federal law."
Defense department and FDA spokespersons declined to comment on the pending litigation, but maintained the safety and effectiveness of the vaccine. "We believe, in issuing its final order last December, the FDA affirmed once and for all the safety and efficacy of our vaccine," said Kim Brennen Root, a spokeswoman for BioPort Corp., the vaccine's manufacturer.
Nearly 500 active-duty service members have refused the vaccine, and more than 100 have been court-martialed. Additionally, approximately 500 to 1,000 pilots and flight crew members have quit, resigned or transferred from the Air National Guard or Reserves rather than take the vaccine. The vaccine is voluntary in the Australian, British and Canadian militaries, as well as for U.S. Department of State employees, even though they serve in the same geographical region as that of U.S. military service members.
By THOMAS D. WILLIAMS
http://www.ctlawtribune.com/getarticle.aspx?ID=24652
Two years after an earlier lawsuit temporarily halted mandatory anthrax vaccinations for all 2.4 million U.S. military service members and some military contractors, another group of military service members and Pentagon civilian contractors are going to federal court to block the vaccine's forced use.
Six complainants, remaining unidentified to protect them from retaliatory military discipline, filed suit against federal military and health officials Dec. 13 in U.S. District Court for the District of Columbia. They're asking a judge once again to declare the controversial vaccine an unapproved drug and unlawful for use without informed consent.
Connecticut's U.S. Rep. Christopher Shays, R-Stamford, state Attorney General Richard Blumenthal and two well-known Connecticut U.S. Air Force officers, Thomas Rempfer and Russ Dingle, were leading opponents of the inoculation program when it began in 1997. For seven years, in vain, they pressured Congress, two presidents and high-ranking Pentagon officials to halt the program. Lt. Col. Dingle, of East Hartford, died in September 2005.
A federal court order in late 2004 halted mandatory vaccinations based on a finding that the Food and Drug Administration failed to follow licensing regulations. But soon after the FDA issued a final order approving the vaccine's safety and effectiveness in December 2005, the Department of Defense announced it was reinstituting the mandatory inoculation program for those serving in Korea and the Middle East.
Critics charge the FDA failed to provide evidence the vaccine was effective against inhalation (weaponized) anthrax, and failed to address reports of adverse health consequences from the vaccine.
Reached last week, Blumenthal said he hasn't yet reviewed the class action. But he seemed to place little confidence in the FDA final rule. "My belief has been consistently that the vaccine should be voluntary unless and until a new vaccine is developed that is safe and effective," he said.
Shays agreed. Military personnel "volunteer to put on the uniform to defend us. They should not be required to put untested vaccines into their bodies," he said.
Each of the plaintiffs faces either termination from employment or criminal prosecution if they refuse inoculation.
Adverse Reactions
The U.S. Government Accountability Office reported that the vaccine's systemic adverse reaction rate was 100 times higher than the 0.2 percent rate reported on the product's label. Adverse vaccine reactions were said by users to include immune disorders, muscle and joint pains, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least half a dozen deaths and a number of birth defects have been attributed to use of the vaccine, but they have not been definitively proven as linked.
Chicago attorney John J. Michels Jr., co-counsel in the litigation with D.C. attorney Mark S. Zaid, charged, "FDA's certification of the vaccine … is based on slipshod statistical analysis, and an improper use of testing data. [That], as well as the defense department's alteration of the vaccine dosing schedule, renders [it] a drug unapproved for its applied use under current federal law."
Defense department and FDA spokespersons declined to comment on the pending litigation, but maintained the safety and effectiveness of the vaccine. "We believe, in issuing its final order last December, the FDA affirmed once and for all the safety and efficacy of our vaccine," said Kim Brennen Root, a spokeswoman for BioPort Corp., the vaccine's manufacturer.
Nearly 500 active-duty service members have refused the vaccine, and more than 100 have been court-martialed. Additionally, approximately 500 to 1,000 pilots and flight crew members have quit, resigned or transferred from the Air National Guard or Reserves rather than take the vaccine. The vaccine is voluntary in the Australian, British and Canadian militaries, as well as for U.S. Department of State employees, even though they serve in the same geographical region as that of U.S. military service members.
