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Fate of Anthrax Vaccine Lawsuits Uncertain

November 1, 2001

Although critics claim that BioPort Corporation's anthrax vaccine has injured many people and killed others, experts say that lawsuits against the company are unlikely to succeed. BioPort is the United States' sole supplier of anthrax vaccine. In light of recent anthrax hysteria, the military has deemed the vaccine an essential tool of national security, making its producer essentially immune to suit.

Lawsuits previously filed against BioPort claim that the vaccine is ineffective and unsafe. Military and National Guard officers filed lawsuits and administrative petitions claiming they were court-martialed or forced to resign when they refused to take the anthrax vaccine. Another lawsuit blames the manufacturer for an Army sergeant's death.

All these lawsuits face a potential problem. In order to sue for military-related injuries, plaintiffs must deal with a judicially created prohibition on suits against the government for military related injuries. Also standing in the way are several other cases filed in recent years in which plaintiffs were unsuccessful in suing for anthrax-vaccine related injuries.

BioPort Corp. is well insulated from lawsuits stemming from its anthrax vaccine. As a government contractor, the company can claim it simply carried out the government's orders and specifications. However, to fully insulate itself using this defense, the company must show that it followed the government's specifications exactly. Any deviation from government standards may allow plaintiffs enough room to sue.

Additionally, the U.S. government agreed to indemnify the company against any lawsuits claiming vaccine related illnesses and injuries. In the event BioPort is held liable, the government will likely pay the judgment amount.

The military has vaccinated more than 500,000 soldiers with BioPort's anthrax vaccine. The Food and Drug Administration received reports of more than 1,500 adverse reactions, including some cases of anaphylactic shock.

The FDA did receive reports that six deaths were linked to the vaccine. However, BioPort claims there is no actual evidence linking the deaths to the administration of the vaccine.

One pending federal lawsuit filed under the False Claims Act asserts that BioPort made numerous misleading statements to government officials in attempts to secure and keep the exclusive vaccine contract. The contract is, in fact, extremely lucrative for BioPort. To date, estimates indicate the Department of Defense has paid the company approximately $150 million.

BioPort's anthrax vaccine received FDA approval in 1970 for use in preventing the skin form of the disease. The FDA has not specifically approved its use to prevent inhaled anthrax.

Another lawsuit filed by two Air Force soldiers is seeking a declaration that the anthrax vaccine is a new drug under investigation. If this happens, the military will be unable to use the vaccine because a 2000 law prohibits military use of experimental drugs on soldiers without their informed consent. Both soldiers in this suit refused the vaccine and were docked a substantial amount of pay or forced to resign.

-- Article Courtesy of InjuryBoard.com

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