FROM THE INDIANAPOLIS STAR

http://www.indystar.com/print/articles/3/019358-1213-P.html

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."


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