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 the Jericho woman grew irate when Republicans in Congress denied her one more thing, the chance to hold someone immediately 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 proven – 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 like 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.
“It’s one small item plucked out in the most crude possible way,” Gostin said.
Democrats called it payback to the pharmaceutical industry, which has given Republicans $14 million 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 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 Minority Leader Trent Lott (R-Miss.) conceded.
“The speaker agreed to work on these issues,” said an aide to House Speaker Dennis Hastert (R-Ill.). “I don’t know that there was really any specific agreement made.” That comment seems to undermine moderate Republican senators, who said party leaders promised to modify the liability protection so it doesn’t nullify pending lawsuits.
The liability protection was added as many people have blamed thimerosal for the tripling of autism cases in the last 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, a developmental disability that usually appears within the first three years of life, but “the hypothesis is biologically plausible.”
The possible connection opened new avenues for lawsuits over thimerosal. Since 1988, vaccine manufacturers had been protected from liability when Congress started the federal compensation fund to compensate people claiming vaccine-related injuries.
But the fund, financed with a vaccine-sales tax, proved slow and difficult. A 1999 government audit found that claims typically took more than two years, and that the government was fighting them with unexpected vigor: 68 percent of the 5,566 resolved claims have been rejected to date, leaving the fund with a $1.8 billion balance.
Thimerosal seemed to provide a way to sue its manufacturers and vaccine makers who used it directly because as an additive, it was not protected by the fund.
Mike Hugo, a Boston lawyer working on 1,000 thimerosal cases, said vaccine manufacturers knew of risks in the 1970s but “continued to use thimerosal, even though scientists were telling them other things may be safer.”
Industry officials denied the charge.
Republicans also noted that the liability protections were recommended by the American Academy of Pediatrics and the compensation fund’s advisory commission to help stabilize the vaccine industry.
Other advocates had sought to make the fund more friendly to victims and had competing legislation. “But,” said Rep. Henry Waxman (D-Calif.), who helped create the vaccine fund, “the administration and the Republican leadership have chosen to ignore those and move only on some industry protections.”