Bill rules out lawsuits against vaccine maker

By Thomas Frank
Newsday

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WASHINGTON — Kathy Kilpatrick knows her 6-year-old daughter, Mary Kate, will never experience a normal life, because autism makes her almost unable to express feelings and needs.

The privation has long saddened Kilpatrick, but last week she grew irate when Republicans in Congress denied her one more thing — the chance to hold someone accountable.

Republicans put a last-minute provision in the homeland-security bill that blocks efforts by Kilpatrick and thousands of parents of autistic children to sue manufacturers of a children's-vaccine additive that may cause autism.

The provision diverts a potential tidal wave of claims — none of them proved — that experts say could rival lawsuits filed over asbestos. Republicans say lawsuits might ruin companies whose capacity to produce vaccines is essential to fight the heightened threat of a biochemical terrorist attack.

But experts and critics call the provision a back-door gift to politically influential drug companies, particularly Eli Lilly and Co., whose chairman, Sidney Taurel, is on the White House Advisory Council on Homeland Security. The provision would extend the liability protection now given for vaccines to vaccine additives.

One additive faces serious medical questions and legal claims: thimerosal, invented by Lilly and used until recently in many common children's vaccines. An estimated 150 individual autism lawsuits and thousands more under preparation target Lilly.

But now families such as the Kilpatricks must file claims with a federal compensation fund that pays medical costs and up to $250,000 more for pain and suffering, but makes no finding of fault. Plaintiffs can reject settlement offers and sue in court, but face tougher legal standards for winning punitive damages.

It's the corporate protection — not the cash limit — that enrages Kilpatrick.

"They need to be held accountable. The thought that my daughter could be living a normal life — she could be on a soccer team, she could be going to birthday parties, she could fall in love some day — none of those things are going to happen. Ever," she said.

Experts were stunned at how the liability provision was rammed through Congress with little deliberation, circumventing the usual committee process.

Lawrence Gostin, director of the Center for Law and the Public's Health at Georgetown and Johns Hopkins universities, agreed the liability protection should help assure vaccine supplies. But, he added, "We could have also done it by just giving a trillion dollars to the vaccine industry.

"Liability is there for important and complex reasons," Gostin said, citing negligence prevention and victim compensation.

The real problem with the U.S. vaccine supply is not that lawsuits threaten manufacturers, Gostin said, but that there is no national strategy to ensure that important vaccines are produced.

"If the sole concern was the national interest, there would have been a full and open debate about the best way to ensure stable investment and procurement of vaccines," Gostin said.

But that wasn't done when Republicans took the one-page liability provision out of a stalled bill on vaccines and added it to the 484-page homeland-security bill charging toward approval.

Rep. Dan Burton, R-Ind., — in whose home state Eli Lilly is based — said he and many other House members voted for the bill not knowing about the vaccine provision.

Burton's grandson has autism, which Burton believes was caused by thimerosal.

"I didn't know what autism was. Then my grandson got nine shots in one day," Burton said. "He's ruined for life.

"The language that was put in the bill, that gets (vaccine makers) off scot-free."

Democrats called it payback to the pharmaceutical industry, which has given $14 million to Republicans since January 2001, and $5.2 million to Democrats, according to the nonpartisan Center for Responsive Politics.

They also questioned the influence of Mitch Daniels, Eli Lilly's former director of North American operations who is director of the White House Office of Management and Budget.

Management and Budget Office spokesman Trent Duffy dismissed the charge, noting that Daniels had divested himself of all Lilly holdings. And Republicans said Democrats were beholden to lawyers, who opposed the provision and have given Democrats $45 million since January 2001 versus $17.5 million to Republicans.

Still, Republican leaders have backed off their late additions to the homeland-security bill. "Some provisions went beyond what we needed to do," Senate GOP Leader Trent Lott of Mississippi conceded.

The liability protection was added as many people have blamed thimerosal for the tripling of autism cases in the past decade.

The Food and Drug Administration advanced speculation in 1999 when it said infants who get recommended immunizations receive excessive mercury. It asked vaccine makers to stop using mercury-based thimerosal, which was used to prevent contamination when doctors jabbed a needle into the same vial to vaccinate child after child.

Last year, the Institute of Medicine said evidence was inadequate to find or deny a link between thimerosal and autism, but "the hypothesis is biologically plausible."

Information from Gannett News Service is included in this report.

Copyright © 2002 The Seattle Times Company