Published 10/20/2001
BioPort faces lawsuit over vaccine

By Robert L. Jackson
Los Angeles Times

WASHINGTON - The sole U.S. producer of the anthrax vaccine, already facing trouble from government regulators, was hit Friday with a private multimillion dollar lawsuit alleging negligence in its manufacturing procedures.

The suit against BioPort Corp. of Lansing was filed in federal district court here and is believed to be the first action on behalf of soldiers allegedly harmed by vaccine shots they were required to take.

Company spokeswoman Kim Brennen Root said officials could not comment because they have not seen the complaint. Root acknowledged the company has had deficiencies noted by inspectors for the Food and Drug Administration, but she said the company expects a positive report on its procedures from federal regulators within the next six months.

The lawsuit, filed on behalf of one deceased and one injured soldier, notes that most of the vaccine produced by BioPort was administered to about 150,000 U.S. military personnel. The military began vaccinations in the early 1990s, sparked by concerns about the potential use of anthrax as a biological weapon by the Iraqi government.

Unlike antibiotics such as Cipro that are prescribed for people who have been exposed to anthrax, the vaccine is taken as a preventive measure.

The legal complaint alleges that the efficacy of the vaccine in the mass immunization program for the military was never sufficiently tested, nor were adverse reactions by soldiers accurately assessed.

"There was insufficient data to demonstrate protection against inhalation anthrax," the lawsuit says.

The plaintiffs are the heirs of Army Spc. Sandra Larson of Spokane, Wash., who died on June 12, 2000, and Ronda Wilson, of Savannah, Ga., a former soldier whose chronic ill health allegedly resulted from the vaccine.

According to the lawsuit, Larson began receiving her six injections in late 1998 and "almost immediately ... began having adverse reactions to the vaccine, including exhaustion and fatigue, skin rashes and numbness and pain in her hands."

When these symptoms did not dissipate, she was admitted to a military hospital, where she later lapsed into a coma and died, the complaint said.

Wilson, a helicopter pilot, also began having adverse reactions "almost immediately" after receiving her inoculations in late 1998, including rapid weight loss and an inability to eat solid foods, the lawsuit alleged.

"We're not trying to stop production of the vaccine," said plaintiffs' attorney Alan Milstein of Pennsauken, N.J. "But we want to compensate soldiers who were given the vaccine involuntarily and, as a result, were hurt or died while trying to serve their country."

Milstein added, "We would also like to guarantee that others who are vaccinated in the future obtain a product that is safe and effective."

Plaintiffs charge that the inoculations of Larson and Wilson have been traced to batches of vaccine that in one case were improperly stored for a period at room temperatures instead of being refrigerated or, in another case, from a lot that was contaminated with micro-organisms.

Some independent authorities noted that no proof has surfaced that BioPort's vaccine is defective or harmful.

In a study two years ago in the Journal of the American Medical Association, 14 experts in civilian biodefense reported that 590,000 doses of anthrax vaccine had been administered to members of the armed forces and, "no serious adverse events have been causally related."

The company has been unable to release any of its product since 1998 while awaiting approval by the Food and Drug Administration, officials said.