HHS limits anthrax vaccine legal liability

The 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.

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 Bush signed into law in December 2005, a health and human services secretary's 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 inoculation 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. In addition, there are some doubts about the vaccine's 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 Administration's drug-approval process for the vaccine -- temporarily shut down the Defense Department's 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.

Leavitt's 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.

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."

Health and Human Services argued the legal shield is essential to guarantee that countermeasures are there if U.S. citizens need them.

"Providing liability protection to all involved in such efforts will help ensure their full participation and bolster response efforts," according to the news release.

"Preparedness is a shared responsibility that must involve all sectors of society, including the private sector, community groups, families and individuals," Leavitt stated in the release. "We are using the authorities available to us to do all we can to support preparedness at all levels."

The move comes as a pivotal advisory group convened by the Centers for Disease Control and Prevention prepares to decide whether state and local health officials should consider giving anthrax vaccines to as many as 3 million civilian first responders nationwide.

Millions of U.S. military personnel have already received the vaccines since the Pentagon's shots program began in 1997, but the law prohibits service members or their families from holding the government liable for injury or death.

Now that the population of vaccine recipients could expand to include millions of civilians -- who normally do have a right to take medical injury claims to court -- federal response planners and government contractors might be growing nervous about their potential legal vulnerability, according to vaccine critics.

"There are people still getting ill from side effects and from the vaccine," John Michels, an attorney in litigation targeting the Pentagon's inoculation program, told Global Security Newswire. "When they expand this vaccine from the military population to a civilian population, they're going to have people who sue."

Emergent BioSolutions of Rockville, Md. -- the nation's only manufacturer of an FDA-approved anthrax vaccine -- recently announced that Health and Human Services had ordered 14.5 million doses of its BioThrax vaccine, worth as much as $404 million. The company is already under a $448 million contract to produce 18.8 million doses of the vaccine.

The vaccine regimen calls for six shots over an 18 month period, plus annual boosters.

Michels said commercial interests appear to be playing a role in the legal immunity issue. He questioned whether there had been any bona fide escalation in the anthrax threat sufficient to justify the declaration of an emergency.

"We have no indications [now] ... that we're much more likely to be attacked by anthrax," Michels said. "But [government officials] see the writing on the wall. They see ... an erosion of [lawsuit] immunity for vaccine manufacturers as a result of widespread civilian use."

Meryl Nass, a bioterrorism expert who has been highly critical of federal handling of anthrax vaccine issues, accused Leavitt of taking more interest in protecting bureaucrats from legal action than in protecting the public from health threats.

"How do you decide there is an emergency when there is no evidence of one?" she asked in e-mailed comments.

Noting the HHS secretary's designation of "governmental program planners" as among those afforded legal immunity by the declaration, Nass asserted that the agency "designates an emergency as a means to protect itself."

Leavitt's declaration, though, states that "targeted liability protections for anthrax countermeasures" are "based on a credible risk that the threat of exposure to [anthrax] and the resulting disease constitutes a public health emergency." The document does not offer additional details on the nature or level of threat.

A request that Health and Human Services elaborate on the basis for the public health emergency declaration went unanswered at press time.

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