Republicans Press for Bill to Shield Vaccine Makers From Suits

NY Times, April 9, 2003

WASHINGTON, April 8 - The mysterious new respiratory ailment that has
terrified people around the globe has extended its reach to the
Capitol, where Senate Republicans are using the disease to press
their case that vaccine manufacturers should be shielded from

Led by Senate Majority Leader Bill Frist, Republicans are trying to
revive the long-stalled measure. Today, Dr. Frist linked his bill to
the epidemic of severe acute respiratory syndrome, or SARS, warning
that pharmaceutical companies would not produce vaccines against the
disease unless they were protected against "frivolous suits" that
could drive them out of business.

"If we need a vaccine for this potential global epidemic, are we
prepared?" Dr. Frist asked during a news conference to publicize the
bill. "The answer is no, absolutely not."

But whether that argument will hold sway in the Senate is unclear.
With the Committee on Health, Education, Labor and Pensions scheduled
to take up the legislation on Wednesday, Republicans and Democrats
spent the day deep in negotiations over a provision that would
dismiss thousands of lawsuits filed by parents who assert that a
mercury-based vaccine preservative, thimerosal, caused autism in
their children.

Democrats are pressing for language to permit the parents to seek
compensation through a government "vaccine court," even if their
claims fall outside the six-year statute of limitations Dr. Frist has
proposed. By late afternoon, an agreement seemed near.

"We're close," said Senator Christopher J. Dodd, Democrat of
Connecticut and a central participant in the negotiations. Asked
about the Republicans' SARS argument, Mr. Dodd shrugged. "We're
talking about childhood vaccines. It's another issue," he said.

But tonight, negotiations fell apart, people involved in them said.

The legislation would overhaul the 1986 Vaccine Injury Compensation
Act, which created the vaccine court. The law requires parents of
children injured by vaccines to file claims with the court before
suing manufacturers. It imposes a statute of limitations, three years
from the date of injury, and created a taxpayer-financed fund to pay
the awards.

But the 1986 law covers only vaccines, not vaccine ingredients or
additives - a loophole that has left manufacturers vulnerable to
lawsuits. Chief among them is Eli Lilly, the developer of thimerosal.
In recent years, thousands of parents of autistic children have sued
Lilly, creating what Dr. Frist describes as "an end run around" the
vaccine court.

His bill would dismiss those lawsuits, but it would give parents six
years instead of three to file claims with the vaccine court. The
bill would also increase the cap on awards for children's pain and
suffering to $350,000 from $250,000, and would permit parents to file
claims for their own pain and suffering.

Despite those concessions, the bill remains hugely controversial -
not so much because of its provisions, but because of the way
Republicans have handled it. Last year, Republicans quietly inserted
the thimerosal language into legislation creating the Department of
Homeland Security. The provision immediately became known as
the "Lilly rider." It was struck from the security bill at the
insistence of parents and several moderate Republican senators.

Among those parents are Laura and Scott Bono of Durham, N.C., whose
14-year-old son Jackson has mercury poisoning that they attribute to

The Bonos assert that they would stand a better chance against
manufacturers in civil court than in the vaccine court. Because there
is no science linking thimerosal to autism, the government fund has
paid no claims to parents who say their children were harmed by it.

Republicans say the bill is a fair alternative. The measure has the
support of the American Academy of Pediatrics and other doctors'
groups, and follows the recommendations of an independent advisory

It does not contain any provisions directly related to SARS vaccine
research. But in a climate where the latest news story can often
provide political advantage, the new disease has become entwined with
the vaccine legislation nonetheless.

That became evident on Monday, when Dr. Anthony S. Fauci, the leading
infectious disease expert at the National Institutes of Health,
testified about SARS before the Senate health committee. He said
vaccine research on the disease was in its infancy and the government
would like industry to get involved.

The committee chairman, Senator Judd Gregg, said the Senate needed to
pass the vaccine bill quickly. "We have this N.I.H., which is such an
extraordinary organization" in conducting vaccine research, Mr. Gregg
said later in an interview. "The question is, do you have an industry
that is willing to take the risk?"

At today's news conference, both Mr. Gregg and Dr. Frist hit hard on
the SARS theme. But Senator Debbie Stabenow, a Michigan Democrat and
a leading opponent of the vaccine bill, said she saw no connection.

"That's a very serious thing," she said of the new epidemic, "and we
certainly want to do everything we can to help people. But you don't
have to take away the rights of parents of autistic children to do