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For the past year, proposed legislation over an allegedly harmful vaccine additive has vexed Congress, vaccine makers and thousands of parents who claim that their children’s autism is linked to childhood vaccinations. And though lawmakers of both parties took the unusual step of seeking advice from the U.S. Court of Federal Claims’ chief judge, there is no clear resolution in the offing. While legal ethics experts say the consultation does not raise red flags, it illustrates the complexity of the debate over the additive, thimerosal. In late 2002, Congress passed a rider that would have effectively exempted Eli Lilly and Co. from liability for thimerosal, only to repeal it two months later because of opposition from a coterie of Senate moderates. This year, the fight is likely to return in earnest. Senate Majority Leader Bill Frist, R-Tenn., is still set on dealing with the thimerosal cases and revamping the Vaccine Injury Compensation Program (VICP), a 15-year-old program administered by the claims court. The VICP was set up by Congress in 1988 to protect vaccine manufacturers from consumer lawsuits that were thought to be potentially ruinous, while still providing compensation to people who were harmed by childhood vaccines. It funnels vaccine cases into an administrative process overseen by the Department of Health and Human Services and by special masters at the Court of Federal Claims. The program caps noneconomic damages at $250,000 for each claim, and carries a three-year statute of limitations. Payments come from federal funds, and special masters’ decisions can be appealed to a judge of the claims court and then to the U.S. Court of Appeals for the Federal Circuit. Parents who believe that their children’s autism was caused by thimerosal have filed more than 1,800 lawsuits — some in the VICP and some in state and federal trial courts around the nation. Scientists have not yet found a link between the mercury-based chemical and the rapidly rising rate of childhood autism, though they are studying the question intensively. Parent activist groups and plaintiffs lawyers say the VICP, which was designed in the 1980s to deal with rare side effects of childhood vaccines such as DPT or rubella, is a poor venue for the thimerosal disputes. One key issue, they say, is that the program’s three-year statute of limitations would effectively knock out most thimerosal claims, since autism can take five years or more to manifest itself. The thimerosal provision that appeared in the homeland security bill would have routed all thimerosal claims from the courts to the VICP. There, parents would have found that the program’s statute of limitations had already passed. “We’re far beyond the statute once we find out that there was injury,” says Lyn Redwood, an Atlanta parent activist and president of Safe Minds, a group dedicated to eliminating mercury compounds from the environment. Eli Lilly argues that as a component of a vaccine, thimerosal clearly ought to be included in the existing vaccine program. The company says plaintiffs lawyers are taking advantage of a loophole unintended by Congress when they file tort suits around the country that claim that thimerosal, as an additive rather than an actual vaccine, is not covered by the VICP. CASES AND CONTROVERSIES Frist and other members of the Senate Committee on Health, Education, Labor and Pensions were wrestling with these issues last year when they reached out to the judicial branch. Last December, staffers for Frist and Sen. Edward Kennedy, D-Mass., sought advice from Chief Judge Edward Damich of the claims court and from Gary Golkiewicz, the court’s chief special master. Damich, a former aide to Sen. Orrin Hatch, R-Utah, says he and Golkiewicz met with the aides to explain the workings of the VICP. “We were asked about three issues — causation, the statute of limitations and the impact on the workload of the special masters,” says Damich, who is careful to note that he and Golkiewicz limited their comments to describing the potential effects on the vaccine program of proposed changes in the law. “We didn’t make any recommendations either way,” Damich says. Golkiewicz, who as chief special master has day-to-day involvement with the VICP, says Senate aides “would contact me and ask a technical question: If you change a certain provision, what impact will it have? If you change the statute of limitations from three to six years, what’s the impact on the court in terms of its caseload?” Golkiewicz says he plays “a balancing role in terms of helping the parties have all the information they need to make a policy call. The questions [the staffers] asked were very appropriate. We provided factual information about what we do.” Golkiewicz recalls a meeting late last year on Capitol Hill that included staffers for Sen. Judd Gregg, R-N.H., the chairman of the health committee, as well as aides to committee members Frist, Kennedy and Hillary Rodham Clinton, D-N.Y. Spokespersons for Gregg, Frist and Kennedy confirmed that the senators take considerable interest in the thimerosal issue, but the spokespersons were unaware of meetings with claims court officials. A Clinton spokeswoman did not return a call. Although it is unusual for judges to consult with members of Congress, the contacts appear to raise no ethics issue. The canons of judicial ethics permit a judge to consult with a legislative official “on matters concerning the law, the legal system, and the administration of justice to the extent that it would generally be perceived that a judge’s judicial experience provides special expertise in the area.” Stephen Gillers, an ethics expert and professor at the New York University School of Law, says it’s fine for judges to discuss how a program such as the VICP has worked in the past, and that judges can even explain how it might work prospectively, as long as they refrain from talking with Hill staffers about the outcomes in pending cases. Barbara Loe Fisher, co-founder and president of the Vienna, Va.-based National Vaccine Information Center, says that as an anti-thimerosal activist, she is not troubled by the contacts. “I can see the utility of asking those in the trenches about the flaws in the system,” Fisher says. A POLITICAL WHODUNIT It remains to be seen whether the advice of the judge and the special master will help produce a workable piece of legislation. The language, which was slipped into the homeland security bill before lawmakers consulted Damich and Golkiewicz, antagonized Democrats and three moderate Republicans — Susan Collins and Olympia Snowe of Maine and Lincoln Chafee of Rhode Island. It caused a tempest that required the Senate GOP leadership to fashion a bizarre compromise: If lawmakers opposed to the vaccine reforms promised to vote for the homeland security bill as it then stood, the leadership would make sure the vaccine provision would be removed in the next Congress. The bill also created a political whodunit that has not been fully resolved. Frist, who had sponsored a broad vaccine reform bill that failed to pass the Senate in 2002, has said that he did not place the thimerosal language in the bill. Then-House Majority Leader Richard Armey, R-Texas, at one time said he added it at the request of the White House, but then later said he simply did it on his own. Lobbyists for Lilly and other vaccine makers acknowledge that they supported the language when it was part of the separate bill sponsored by Frist, but say they were as surprised as anyone when it showed up in the homeland security bill. In any case, congressional leaders made good on their promise last month and removed the provision. But it will be back again, and the old fight between vaccine makers and the families of alleged victims will be renewed. Frist spokesman Nick Smith says the senator is planning to introduce a measure that will closely track the proposal Frist wrote a year ago, but Smith says Frist remains undecided about what to do on the statute of limitations issue. Whatever he decides may not be good enough for the parent activists who are trying to keep their claims out of the VICP. “There is an epidemic of children with autism and learning disabilities,” says Redwood, the Atlanta parent activist. “The existing vaccine program is simply not set up to handle them.”

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