Federal Appeals Court Upholds Mandatory Anthrax Vaccinations

The Blog of Legal Times
Sep. 30, 2009

A federal appeals court in Washington today refused to stop mandatory anthrax vaccinations for servicemembers, finding that the vaccine was properly approved.

In an unanimous ruling, a panel of the U.S. Court of Appeals for the D.C. Circuit upheld the dismissal of a suit filed by eight servicemembers who were challenging a Food and Drug Administration order that found the vaccine effective. The plaintiffs also sought to block the Defense Department from administering the vaccine. The plaintiffs did not contest the safety of the vaccine.

A lawyer for the plaintiffs, John Michels Jr., who agued the case on appeal in April, said he was disappointed with the ruling. "We thought we'd put enough evidence in the record," said Michels, a partner in the Chicago office of Baker & McKenzie who worked on the case with Mark Zaid, a solo practitioner in Washington. "This is just one of these situations where it's a high bar to challenge a federal executive agency decision."

The Defense Department in 1998 implemented its Anthrax Vaccine Immunization Program, which required mandatory vaccination for servicemembers who were at risk of exposure to the disease. The program was temporarily suspended between 2000 and 2002 due to a shortage of the vaccine.

In 2004, servicemembers successfully sought a permanent injunction targeting the enforcement of the vaccination program. The FDA in 2005 issued a final order that declared the vaccine to be safe and effective. A D.C. Circuit panel found the final order caused the permanent injunction to dissolve. Additional servicemembers filed suit in 2006 in the U.S. District Court for the District of Columbia. Judge Rosemary Collyer in 2008 dismissed the suit.

At issue in the suit was whether the FDA properly found that the vaccine was effective. The plaintiffs' lawyers argue that the FDA's reliance on a particular study could not support a finding of effectiveness against anthrax that is contracted by inhalation. The lawyers for the plaintiffs also said the Defense Department is forcing servicemembers to undergo an unapproved schedule of inoculations.

Circuit Judge Merrick Garland, who wrote the opinion, supported the FDA's position that the vaccine responds to anthrax in the same way irrespective of how a person contracts the disease. Garland and panel Judges Karen LeCraft Henderson and David Tatel, gave the FDA a "high level" of deference in its scientific judgment. Click here for the court's opinion.

Justice Department attorney Melissa Patterson of the Civil Division appellate staff argued for the Food and Drug Administration.