Judge advances anthrax vaccine refusal case
Judge advances anthrax vaccine refusal case
By Elaine M. Grossman
Global Security Newswire
http://www.govexec.com/dailyfed/0308/032408gsn1.htm
WASHINGTON - A U.S. federal judge has ruled that the Defense Department must again consider exonerating two military pilots whose Connecticut Air National Guard careers ended after they refused to take compulsory anthrax vaccine shots.
The plaintiffs were among hundreds of service members compelled to leave the military after resisting the inoculations during the late 1990s and early 2000s. Many cited qualms about the vaccine's safety and efficacy in protecting against inhaled anthrax, the form of exposure that Pentagon officials anticipated in the event of a biological weapons attack.
The federal courts have since found that the military's mandatory vaccine program was being conducted illegally for more than six years, beginning with its March 1998 inception. Pending Food and Drug Administration approval for using the drug specifically against inhaled anthrax, the Defense Department could not administer the six-shot series without an individual's informed consent, a federal judge said in an October 2004 decision.
The following year, the drug agency issued its long-awaited approval. The question has remained, though, as to whether those service members who refused the vaccine during the previous six-year period might yet be vindicated.
In the latest judgment, U.S. District Judge James Robertson said the two Connecticut pilots might have a basis to demand redress. This potentially could open the door to hundreds more military personnel seeking absolution - and perhaps reinstatement or compensation - for similarly being forced out of the service after refusing orders to take the drug, according to issue experts.
The March 14 court finding said an Air Force board must revisit the plaintiffs' years-old requests to have their military records corrected. Both of the officers, Thomas Rempfer and the late Russell Dingle, also sought compensatory relief for back pay and lost promotions. Rempfer additionally requested reinstatement as a Connecticut Air National Guard pilot.
The case began when the two resisted taking the shots in the late 1990s and left their unit under threat of disciplinary action. The two avoided court martial or administrative discipline by seeking reassignment to the Air Force Reserve. Both were honorably discharged from the Guard in 1999.
Arguing that they had been improperly forced out, the two officers petitioned the Air Force to correct their military records and grant relief. In making their cases to the Air Force Board for Correction of Military Records, the pilots contended that the anthrax vaccine program was illegal at the time and thus they had a right to refuse the shots.
However, the Air Force board rejected both officers' applications, claiming that federal plaintiffs in a separate case called Doe v. Rumsfeld had failed to prove that the Pentagon vaccination effort was illegal.
The Doe plaintiffs - six anonymous defense personnel subject to taking the anthrax vaccine - "did not in fact prevail against the secretary of defense," the Air Force review board stated in March 2007 in denying the Rempfer and Dingle claims. Dingle died in September 2005 but his estate represents him in the case.
The two officers challenged the military board's decision with a lawsuit, initially filed in federal court in December 2005 and later amended as the Doe case moved through the justice system.
Imposing a permanent injunction on the Pentagon's compulsory anthrax vaccine effort in October 2004, U.S. District Judge Emmet Sullivan said the Food and Drug Administration had never approved the vaccine as safe and effective for preventing inhalational anthrax. The vaccine was initially developed and tested to protect laboratory workers and animal pelt handlers against anthrax contracted through the skin.
Lacking a presidential waiver, the Pentagon could not give anthrax shots without an individual's informed consent, Sullivan wrote in his landmark decision. Sixteen months later, a federal appeals court effectively concluded the case, determining that the FDA certification, issued in December 2005, newly permitted the drug to be administered involuntarily to military personnel.
The outcome of the Doe case gave the "plaintiffs the exact result they sought: revised action by the FDA," Sullivan later wrote.
In this month's decision, Robertson supported Rempfer and Dingle's argument that the Air Force review board had wrongly based its denial of their petitions on a fundamental mischaracterization of the Doe case.
The service board did "not accurately describe the outcome of the Doe litigation," Robertson stated. "Contrary to the board's conclusion, the plaintiffs in the Doe litigation clearly prevailed. To base denial of Rempfer's constructive discharge and compensatory relief claims on the fiction that the Doe plaintiffs lost would be arbitrary and capricious."
The judge advanced the same argument in supporting Dingle's parallel claim.
"Taken as a whole, Judge Sullivan's decisions in Doe v. Rumsfeld conclude that, prior to the FDA's December 2005 rulemaking, it was a violation of federal law for military personnel to be subjected to involuntary [anthrax] inoculation because the vaccine was neither the subject of a presidential waiver nor licensed for use against inhalation anthrax," Robertson wrote.
In what is shaping up to be a split among U.S. judges, Robertson noted that some courts have differed over the question of whether military orders to take the shots prior to FDA approval were illegal. He added that military records-correction boards are not legally bound to grant relief to applicants on the basis of a court case like Doe.
However, Robertson signaled that the courts would not tolerate a military board's misrepresentation of Doe as a win for the Defense Department in denying service personnel claims; rather, any denial would have to be based on other grounds.
The Air Force review board decision, in particular, was so flawed that it must now be reconsidered, the judge said.
Remanding the Rempfer and Dingle cases back to the military panel for another look, Robertson warned the board against substituting its own views about vaccine legality for those of the federal court.
"This is a big opinion," said John Michels, co-counsel on the Doe case. "This opens the door to a bunch of people coming back for relief."
However, a statute of limitations might prevent military personnel from filing lawsuits more than six years after an alleged wrong has occurred. Absent new legislation on Capitol Hill, the passage of time since the Pentagon launched its anthrax vaccine program in 1998 could bar many of those affected from obtaining corrective action today, Michels said in a March 14 interview.
"For a lot of people, it's too late to go to court," he said. "This is a situation that cries out for congressional intervention."
By Elaine M. Grossman
Global Security Newswire
http://www.govexec.com/dailyfed/0308/032408gsn1.htm
WASHINGTON - A U.S. federal judge has ruled that the Defense Department must again consider exonerating two military pilots whose Connecticut Air National Guard careers ended after they refused to take compulsory anthrax vaccine shots.
The plaintiffs were among hundreds of service members compelled to leave the military after resisting the inoculations during the late 1990s and early 2000s. Many cited qualms about the vaccine's safety and efficacy in protecting against inhaled anthrax, the form of exposure that Pentagon officials anticipated in the event of a biological weapons attack.
The federal courts have since found that the military's mandatory vaccine program was being conducted illegally for more than six years, beginning with its March 1998 inception. Pending Food and Drug Administration approval for using the drug specifically against inhaled anthrax, the Defense Department could not administer the six-shot series without an individual's informed consent, a federal judge said in an October 2004 decision.
The following year, the drug agency issued its long-awaited approval. The question has remained, though, as to whether those service members who refused the vaccine during the previous six-year period might yet be vindicated.
In the latest judgment, U.S. District Judge James Robertson said the two Connecticut pilots might have a basis to demand redress. This potentially could open the door to hundreds more military personnel seeking absolution - and perhaps reinstatement or compensation - for similarly being forced out of the service after refusing orders to take the drug, according to issue experts.
The March 14 court finding said an Air Force board must revisit the plaintiffs' years-old requests to have their military records corrected. Both of the officers, Thomas Rempfer and the late Russell Dingle, also sought compensatory relief for back pay and lost promotions. Rempfer additionally requested reinstatement as a Connecticut Air National Guard pilot.
The case began when the two resisted taking the shots in the late 1990s and left their unit under threat of disciplinary action. The two avoided court martial or administrative discipline by seeking reassignment to the Air Force Reserve. Both were honorably discharged from the Guard in 1999.
Arguing that they had been improperly forced out, the two officers petitioned the Air Force to correct their military records and grant relief. In making their cases to the Air Force Board for Correction of Military Records, the pilots contended that the anthrax vaccine program was illegal at the time and thus they had a right to refuse the shots.
However, the Air Force board rejected both officers' applications, claiming that federal plaintiffs in a separate case called Doe v. Rumsfeld had failed to prove that the Pentagon vaccination effort was illegal.
The Doe plaintiffs - six anonymous defense personnel subject to taking the anthrax vaccine - "did not in fact prevail against the secretary of defense," the Air Force review board stated in March 2007 in denying the Rempfer and Dingle claims. Dingle died in September 2005 but his estate represents him in the case.
The two officers challenged the military board's decision with a lawsuit, initially filed in federal court in December 2005 and later amended as the Doe case moved through the justice system.
Imposing a permanent injunction on the Pentagon's compulsory anthrax vaccine effort in October 2004, U.S. District Judge Emmet Sullivan said the Food and Drug Administration had never approved the vaccine as safe and effective for preventing inhalational anthrax. The vaccine was initially developed and tested to protect laboratory workers and animal pelt handlers against anthrax contracted through the skin.
Lacking a presidential waiver, the Pentagon could not give anthrax shots without an individual's informed consent, Sullivan wrote in his landmark decision. Sixteen months later, a federal appeals court effectively concluded the case, determining that the FDA certification, issued in December 2005, newly permitted the drug to be administered involuntarily to military personnel.
The outcome of the Doe case gave the "plaintiffs the exact result they sought: revised action by the FDA," Sullivan later wrote.
In this month's decision, Robertson supported Rempfer and Dingle's argument that the Air Force review board had wrongly based its denial of their petitions on a fundamental mischaracterization of the Doe case.
The service board did "not accurately describe the outcome of the Doe litigation," Robertson stated. "Contrary to the board's conclusion, the plaintiffs in the Doe litigation clearly prevailed. To base denial of Rempfer's constructive discharge and compensatory relief claims on the fiction that the Doe plaintiffs lost would be arbitrary and capricious."
The judge advanced the same argument in supporting Dingle's parallel claim.
"Taken as a whole, Judge Sullivan's decisions in Doe v. Rumsfeld conclude that, prior to the FDA's December 2005 rulemaking, it was a violation of federal law for military personnel to be subjected to involuntary [anthrax] inoculation because the vaccine was neither the subject of a presidential waiver nor licensed for use against inhalation anthrax," Robertson wrote.
In what is shaping up to be a split among U.S. judges, Robertson noted that some courts have differed over the question of whether military orders to take the shots prior to FDA approval were illegal. He added that military records-correction boards are not legally bound to grant relief to applicants on the basis of a court case like Doe.
However, Robertson signaled that the courts would not tolerate a military board's misrepresentation of Doe as a win for the Defense Department in denying service personnel claims; rather, any denial would have to be based on other grounds.
The Air Force review board decision, in particular, was so flawed that it must now be reconsidered, the judge said.
Remanding the Rempfer and Dingle cases back to the military panel for another look, Robertson warned the board against substituting its own views about vaccine legality for those of the federal court.
"This is a big opinion," said John Michels, co-counsel on the Doe case. "This opens the door to a bunch of people coming back for relief."
However, a statute of limitations might prevent military personnel from filing lawsuits more than six years after an alleged wrong has occurred. Absent new legislation on Capitol Hill, the passage of time since the Pentagon launched its anthrax vaccine program in 1998 could bar many of those affected from obtaining corrective action today, Michels said in a March 14 interview.
"For a lot of people, it's too late to go to court," he said. "This is a situation that cries out for congressional intervention."
