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U.S. Limits Anthrax Vaccine Legal Liability
Elaine M. Grossman
Global Security Newswire
WASHINGTON — The U.S. Health and Human Services Department early this month moved to shield government, industry and business officials from lawsuits filed by those who have received the anthrax vaccine (see GSN, Sept. 5, 2007).
Health and Human Services Secretary Michael Leavitt established legal immunity for public and private officials who oversee the production or distribution of the anthrax vaccine by declaring a public health emergency due to the risk of a bioterrorism attack. He said the emergency began on Oct. 1 and would run through Dec. 31, 2015.
U.S. law provides protection from lawsuits to individuals responsible for selected countermeasures, including antibiotics, during a declared emergency.
Under the Public Readiness and Emergency Preparedness Act, which President George W. Bush signed into law in December 2005, a health and human services secretarys emergency declaration can limit financial risk for government program planners and the manufacturers or distributors of pharmaceutical countermeasures. One exception to this immunity would be willful misconduct on the part of covered individuals.
The ramifications, in this instance, could be to prevent individuals who have received one or more anthrax inoculations from taking grievances to court, based on claims that the vaccine caused severe adverse reactions or did not work.
The anthrax vaccine has proven particularly controversial following reports of serious adverse events, including some deaths, among U.S. recipients (see GSN, Nov. 21, 2005). In addition, there are some doubts about the vaccines efficacy in protecting people from developing anthrax after breathing in spores during a biological attack.
A 2003 lawsuit — based on lapses in the Food and Drug Administrations drug-approval process for the vaccine — temporarily shut down the Defense Departments compulsory anthrax shots program. Mandatory inoculations resumed in 2006 for personnel whose assignments are judged to put them at heightened risk of exposure to anthrax (see GSN, Dec. 16, 2005).
Leavitts declaration was published in the Federal Register and quietly heralded at the end of a two-page news release devoted largely to another anthrax-related initiative (see GSN, Oct. 2).
Among the activities now afforded liability protection are those related to developing, manufacturing, distributing, prescribing, dispensing, administering and using anthrax countermeasures in preparation for, and in response to, a potential anthrax attack, the HHS news release states. This includes entities, such as large big-box retail stores, retail pharmacies, and other private sector businesses, that help to deliver and distribute medicines.
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