Frist bill further safeguards doctors from vaccine lawsuits

The legislation also would enhance the rights of children injured by vaccines.

By Joel B. Finkelstein, AMNews staff. April 28, 2003.

Washington -- Proposed reforms to the Vaccine Injury Compensation Program would close a loophole in what was supposed to be a no-fault law to protect physicians and vaccine manufacturers from lawsuits.

Physician groups credit the VICP with helping to turn around national immunization efforts that were beleaguered by vaccine shortages. Before the compensation program began, vaccine manufacturers complained that unfounded lawsuits were too costly, and physicians were worried about getting sued for administering mandated vaccines.

The 1986 law that created the program mandated that families of children with potentially vaccine-related disorders apply for compensation before filing a lawsuit. As a result, the number of vaccine-related lawsuits dropped dramatically.

"The program has been outstanding," said E. Stephen Edwards, MD, American Assn. of Pediatrics president. "It made a huge difference, having these liability protections."

But lawyers eventually found a loophole in the law that enabled them to sue when vaccines containing thimerasol were involved. They argued that it was not the vaccine that caused the problem, but the mercury-containing preservative, which was not explicitly covered under the law.

Senate Majority Leader Bill Frist, MD (R, Tenn.), has introduced a bill that, as part of overall reform of the compensation program, addresses this issue by clarifying that the law applies to the individual ingredients of vaccines.

Similar provisions in the 2003 budget package were ultimately repealed under pressure from Democrats who complained that it would interfere with pending class-action lawsuits. Dr. Frist is working to forge a compromise with Democrats.

"Vaccine shortages threaten our children and the health of our nation, yet unnecessary litigation continues to destabilize our vaccine supply by causing fewer vaccines to be developed and produced," he said.

Preserving children's rights

The bill also addresses issues raised by parents who say the program does not cover enough children. For example, it would extend the statute of limitations for vaccine injuries from three to six years.

"This will preserve the right of as many children as possible to participate in the program," said Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, a parent-led organization that advocates for reforming the mass vaccination system.

The bill would make congressional oversight more active, with reports due to Congress every six months. The center has called for this measure because it believes some Health and Human Services decisions attack the intent of the original law.

During the 1990s, HHS made substantial changes to the list of illnesses that could be presumed to be related to vaccination if no other cause was determined. Among these changes, HHS removed seizure disorders from the table and redefined encephalopathy in such a way as to also remove it from included disorders.

"We were promised it wouldn't be like this," Fisher said. The center hopes that better follow-up by Congress would help the program more closely follow the intent of the law.

Before the program was created, parents were faced with the choice of pursuing expensive court battles or settling out of court for what were often small amounts, Fisher said. In contrast, the program compensates families on average $800,000 to $900,000. But Fisher said HHS rejects three out of four compensation requests.

Policy vs. science

According to Fisher, the program was developed as a political solution to a scientific problem.

In the absence of convincing research on the causal relationship between vaccines and certain disorders that may develop during childhood, the no-fault program would ensure that a family would have quick and easy access to the compensation that it needed to care for a sick child.

The parents of children injured by vaccines, who were involved in negotiating the terms of the original law, were told that the program was meant to provide an alternative to going to court.

Congress recognized that this would mean making a presumption of causation in the families' favor, even if this resulted in some children being compensated who were not, in fact, injured by a vaccine.

The AAP's Dr. Edwards said that the compensation should be based on science.

He pointed to the lawsuits based on thimerasol, which has only anecdotally been linked to the development of autism.

Now that most vaccine manufacturers have eliminated the preservative from their vaccine products, "we're going to have the biggest natural experiment ever conducted," Dr. Edwards said.

Dr. Frist's bill provides for HHS-administered grants to study the associations between vaccines and childhood disorders.

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