Vaccine victims forced to wait

'No fault' settlement system may change as claimants get sick of delay in compensation.

By Maureen Groppe

mgroppe@gns.gannett.com

January 31, 2003

WASHINGTON -- Betty Fluck is still waiting to find out if the federal government will compensate her for a hepatitis B vaccine that she believes is responsible for her persistent pain.

The government set up a program in the mid-1980s to help the small percentage of people who have a serious reaction to a vaccine, but Fluck and others like her have been complaining for years that the program is too slow and too adversarial.

It is increasingly likely that Congress will change the program this year, but not necessarily in the ways families want.

That's because drug companies, including Indianapolis-based Eli Lilly and Co., have been complaining, too. The industry is worried that victims and their families have found a way around the federal program, which was meant to resolve claims against vaccine manufacturers without costly court battles.

Fluck, a registered nurse from Kokomo, said that 12 hours after getting vaccinated as a work requirement in 1997, she awoke in the middle of the night screaming in pain with swollen joints and a 104-degree temperature.

Her fever subsided, but Fluck couldn't move her legs. After years in leg braces, she now walks with a cane and can't work.

"Before I was injured, I could kick a 6-foot-tall man in the head," the former karate enthusiast said. "Now I can't even lift my leg off the ground 6 inches."

And, like many other claimants, she has been waiting for compensation that is slow in coming.

More than $1.4 billion has been distributed since the federal compensation program began making payments in 1988, with an average payment of around $800,000.

So far, about 1,700 families nationwide have received payments. There is no specific payment figure for Indiana.

The program is sitting on a balance of $1.8 billion collected from a 75-cent tax on each dose of vaccine purchased. Some of that money has been loaned to other federal programs.

Claimants are supposed to apply to the fund first and sue only if they are unhappy with the outcome. But some families who believe the vaccine preservative thimerosal has caused autism or other neurological injuries have gone straight to court, arguing that vaccine additives are not the same as the vaccine itself.

At least 100 lawsuits have been filed that allege injuries were caused by thimerosal, which contains mercury. Lilly, once the largest manufacturer of thimerosal, no longer makes the product.

Republicans slipped language into a homeland security bill last November making vaccine preservative and additive claims part of the compensation program. That would have invalidated the lawsuits against drug companies, including Lilly.

But a public outcry forced lawmakers to announce this month that they will repeal the provision in the big spending bill Congress must pass to finish up last year's budget work. That could happen as early as next month.

Lilly officials have said they hope any effort by lawmakers to revamp the federal program will include language clarifying that vaccine-preservative injury claims should be handled by the government's vaccine court.

"The lawsuits that have been filed against Lilly and other manufacturers are not supported by science," the company said in a statement.

Senators agree that the entire vaccine program should be examined.

"If we allow out-of-control lawsuits to drive people out of the business of making these vaccines," Senate Majority Leader Bill Frist, a surgeon, said, "we will not be able to make vaccines which are critically important."

The program was supposed to be a nonadversarial, "no fault" system that compensated families without their having to meet higher levels of medical proof required in civil courts.

Instead, most claims take twice as long as the one year that was anticipated. Some have dragged on for a decade. Families say it is difficult to find lawyers to file their claims because settlements can take so long.

Some lawmakers are pushing to increase the payment for a vaccine-related death to at least $300,000 from $250,000, increase the time a family has to file a complaint to six years from three, and allow attorneys to get some payment while the claim is being processed.

The Bush administration supports some of those changes but is against a proposal by Rep. Dan Burton, R-Ind., to give families who have missed filing deadlines a two-year window to make a claim.

Burton's proposal primarily would help families who believe thimerosal injured their children but who received the vaccine years before there was speculation about a connection.

"It would do so much to help families who just didn't know much about the program," Burton said.

Burton, who believes the vaccine is responsible for his 4-year-old grandson's autism, has become the biggest advocate on Capitol Hill for the families of those injured by vaccines. He says his grandson's family has applied to the federal vaccine fund and is facing frustrations common among many claimants.

"They're just jerking him around," Burton said.

The government is trying to figure out what to do with thimerosal claims, which have more than tripled the number of petitions filed. Those filings increased from 214 in 2001 to at least 790 in 2002. So far, no payments have been made on thimerosal-related claims.

Thimerosal has not been proven to cause autism or other neurological conditions and is not one of the injuries for which compensation is easy to obtain. For that and other reasons, many families have chosen to sue vaccine makers instead. Litigation is also difficult, but the payout is probably bigger.

Fluck said she doesn't know if vaccine court petitioners would be better off taking their chances in civil court, because then they have to go up against the pharmaceutical industry's lawyers.

"Basically, we just want them to admit there's a problem and help the victims," Fluck said. "They need to fix this fund."

Call Maureen Groppe at 1-202-906-8118.