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Vaccine liability coverage expanded. (Homeland Security Law Covers All Vaccines).

ROCKVILLE, MD. -- A provision of the new homeland security law affords greater protections for physicians and vaccine manufacturers against liability for possible side effects.

The new law expands the National Vaccine Injury Compensation Program (VICP) to cover manufacturers of vaccine components or ingredients. Previously, the law covered vaccine manufacturers and vaccine administrators only.

Although this provision was included in the homeland security law (P.L. 107-296) in the interest of stockpiling new and powerful vaccines to protect against bioterrorism, it applies to other approved vaccines, such as those on the childhood immunization schedule.

The expansion of VICP applies to "any pending civil action, regardless of what stage it's in," Emily Marcus Levine, an attorney with the Department of Health and Human Services' Office of General Counsel, said at a meeting of the Advisory Commission on Childhood Vaccines.

VICP isn't a total remedy for liability protection. Injured parties still have the right to reject compensation and file suit. That rarely happens, however, since the VICP tends to pay out awards averaging $1 million, said Luke Sobota, an attorney from Washington, D.C.

"People tend to sue only if they didn't get anything from the [VICP's vaccine] court," he said.

The American Academy of Pediatrics has long maintained that all vaccine-related injuries should go through the VICP program. However, the academy has yet to take a specific position on the homeland security provision, a spokeswoman for the academy told this newspaper.

This extended coverage will have an impact on the thimerosal controversy, experts predict.

Reports linking thimerosal--a vaccine preservative--to autism in very young children, has spawned numerous lawsuits over the past few years, with parents seeking compensation for injuries that were allegedly incurred by their children. Other suits demand that vaccine manufacturers pay for the medical monitoring of children who have received vaccines containing thimerosal.

Plaintiff attorneys in particular have argued that thimerosal is an adulterant or contaminant to the vaccine, and therefore is not covered under VICP. The new law specifies that thimerisol is covered.

The threat of these lawsuits could end vaccine production, said Sen. Phil Gramm, who addressed the thimerosal issue during debate on the Senate floor. Plaintiff attorneys "have now reached around the arbitration process and have filed suits that total 10 times the aggregate value of all the vaccine sales in the world combined."

More than 1,000 thimerosal cases to date have been filed with the VICP program, in addition to 190 cases in federal and state courts, Mr. Sobota said. No awards on thimerosal claims have ever been made, although the defendants have spent tens of millions of dollars in litigation costs.

The VICP's vaccine court plans to examine whether there's any basis to these 1,000 claims over the next year or so, and issue a decision in July 2004, he added.

Not everyone in Congress thought the provision belonged in the bill. "This is not a homeland security issue. This is a fairness issue," Rep. Dan Burton (R-Ind.) asserted in mid-November. The number of autism cases in the United States has increased dramatically: 1 in every 250 children, as opposed to 1 in every 10,000 children 15 years ago. A growing number of parents believe that a vaccine caused the autism affecting their children, he said.

At the Advisory Commission on Childhood Vaccines meeting, Ms. Levine indicated that some members of Congress may seek to modify the vaccine liability provisions at some point.

Thimerosal has voluntarily been removed from childhood vaccines, although the traditional flu vaccine continues to have trace amounts of the derivative. A thimerosal-free influenza vaccine has been approved for children aged 6-35 months, but only limited quantities will be available for this flu season. The Food and Drug Administration approved a thimerosal-free formulation of the Fluzone influenza vaccine for this age group in September (PEDIATRIC NEWS, November 2002, p. 18).

An Institute of Medicine report issued several years ago found insufficient evidence to establish a causal relationship between exposure to thimerosal from vaccines and autism. However, the report did state that such a relationship was biologically plausible and required further research (PEDIATRIC NEWS, November 2001, p. 1).

A more recent study seems to further disprove the link. In examining 40 full-term infants aged 6 months or younger who were given vaccines with thimerosal, researchers from the University of Rochester (N.Y.) found that the vaccines did not seem to raise blood concentrations of mercury above safe values in the infants (Lancet 360[9347]:1737-39, 2002).
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Author:Silverman, Jennifer
Publication:Pediatric News
Geographic Code:1USA
Date:Jan 1, 2003
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