U.S. Defense Department Employees Discount Bush Administration Claims of Safety of Anthrax Vaccine
Global Security Newswire
Six anonymous U.S. Defense Department employees have claimed the Bush administration is trying to "manipulate" a U.S. Appeals Court in the ongoing legal case over the safety of the anthrax vaccine, Inside the Pentagon reported yesterday (see GSN, Dec. 2, 2005).
A U.S. District Court in October 2004 ruled that the mandatory anthrax vaccination program for military personnel was illegal. Justice Department lawyers have appealed that decision, while the Pentagon has gone ahead with a voluntary anthrax vaccination effort.
The Food and Drug Administration last month said the vaccine worked against anthrax contracted through the air and through the skin. After this determination was made, lawyers for the government filed a brief with the appeals court arguing the FDA decision justifies reinstating the mandatory program.
However, lawyers for the Defense Department employees have argued that the Bush administration is "attempting to orchestrate the course of litigation through their ability to act as government regulators," according to a brief filed last week in response to the government's December motion. As the recent FDA decision is not a part of the government's original appeal, "the court should reject this attempt by the government to put inadmissible material before the court in an effort to bolster its unsustainable case."
The Defense Department employees filed the lawsuit in March 2003 that later stopped the mandatory vaccination program. They argued that the vaccine was "investigational" and had not received FDA certification. Military law does not allow investigational vaccines to be administered to personnel without their informed consent or a presidential waiver.
Service members who refused to take the vaccine have faced administrative discipline and court-martials, Inside the Pentagon reported. Experts said that if the district court's ruling is upheld, the cases of the service members will be strengthened, as they would have been disobeying an illegal order.
"FDA's actions, which were specifically directed by the district court's order and judgment, cannot retroactively alter the status of the vaccine as determined by the district court in December 2003 and October 2004," lawyers for the employees argued.
However, the government argues that the program was legal since its inception and that the recent FDA action on the vaccine was needed only to show the court that the agency approved the vaccine.
"If the Court of Appeals doesn't reach the merits of the case due to the injunction having become moot, vacatur of [District] Judge [Emmet] Sullivan's judgment and injunction would be highly appropriate, [or] else a fundamentally flawed ruling . would evade review and remain on the books," said Brian Boyle, a former Justice Department attorney who worked on the case. "Mere dismissal of the appeal would be improper, since there is still a live dispute as to whether DOD was lawfully using the vaccine prior to the most recent FDA approval" (Elaine Grossman, Inside the Pentagon, Jan. 19).
Six anonymous U.S. Defense Department employees have claimed the Bush administration is trying to "manipulate" a U.S. Appeals Court in the ongoing legal case over the safety of the anthrax vaccine, Inside the Pentagon reported yesterday (see GSN, Dec. 2, 2005).
A U.S. District Court in October 2004 ruled that the mandatory anthrax vaccination program for military personnel was illegal. Justice Department lawyers have appealed that decision, while the Pentagon has gone ahead with a voluntary anthrax vaccination effort.
The Food and Drug Administration last month said the vaccine worked against anthrax contracted through the air and through the skin. After this determination was made, lawyers for the government filed a brief with the appeals court arguing the FDA decision justifies reinstating the mandatory program.
However, lawyers for the Defense Department employees have argued that the Bush administration is "attempting to orchestrate the course of litigation through their ability to act as government regulators," according to a brief filed last week in response to the government's December motion. As the recent FDA decision is not a part of the government's original appeal, "the court should reject this attempt by the government to put inadmissible material before the court in an effort to bolster its unsustainable case."
The Defense Department employees filed the lawsuit in March 2003 that later stopped the mandatory vaccination program. They argued that the vaccine was "investigational" and had not received FDA certification. Military law does not allow investigational vaccines to be administered to personnel without their informed consent or a presidential waiver.
Service members who refused to take the vaccine have faced administrative discipline and court-martials, Inside the Pentagon reported. Experts said that if the district court's ruling is upheld, the cases of the service members will be strengthened, as they would have been disobeying an illegal order.
"FDA's actions, which were specifically directed by the district court's order and judgment, cannot retroactively alter the status of the vaccine as determined by the district court in December 2003 and October 2004," lawyers for the employees argued.
However, the government argues that the program was legal since its inception and that the recent FDA action on the vaccine was needed only to show the court that the agency approved the vaccine.
"If the Court of Appeals doesn't reach the merits of the case due to the injunction having become moot, vacatur of [District] Judge [Emmet] Sullivan's judgment and injunction would be highly appropriate, [or] else a fundamentally flawed ruling . would evade review and remain on the books," said Brian Boyle, a former Justice Department attorney who worked on the case. "Mere dismissal of the appeal would be improper, since there is still a live dispute as to whether DOD was lawfully using the vaccine prior to the most recent FDA approval" (Elaine Grossman, Inside the Pentagon, Jan. 19).
