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By Ori Twersky

WASHINGTON (Reuters Health) Dec 04 - The growing number of vaccine-related autism claims could threaten to overwhelm the US government's tax-based injury compensation program and force it into entering numerous costly settlements despite the lack of an established connection, according to federal officials.

Created by a congressional act in 1986, the National Vaccine Injury Compensation Program was designed to provide individuals injured by a vaccine with compensation while limiting litigation and keeping vaccines widely available. The rationale was that vaccines would always be easy targets for litigation because they have inherent side effects and almost everyone is vaccinated.

At question now is whether the program will be able to withstand a potential flood of new claims, alleging that the once commonly used vaccine preservative thimerosal caused hundreds of American children to develop autism, officials from the US Department of Justice (DOJ) told the HHS Advisory Commission on Childhood Vaccinations on Wednesday.

Thimerosal is no longer used in most childhood vaccinations, and its alleged connection to autism has not been established. But a recently passed federal law has now effectively ensured that virtually all such existing and future claims would be filed under the federal compensation program, the officials noted before a Department of Health and Human Service (HHS) advisory committee.

Passed as a provision of the Homeland Security Act, the November law extended the vaccine liability protection to manufacturers of vaccine components such as thimerosal. As in 1986, the rationale was that such liability protection is needed to ensure that the US will always have adequate access to needed vaccines.

Justice officials deny that the newly passed law actually served to change the landscape. "It was always our view that even under the old law, they (the litigants) had to come here first," Mark W. Rogers, assistant director of the DOJ's Torts Branch, told Reuters Health.

But the number of actual claims filed so far and the expected number of new claims filed because of the Homeland Security Act is raising some concern that such claims could overwhelm the system, he said. "We simply don't know," Rogers said. "It will all depend upon the number of claims filed."

Still, federal figures paint a potentially grim picture. Thanks in large part to the thimerosal controversy, the number of claims filed under the compensation program grew more than four-fold in fiscal 2002, according to the federal figures, and are on record pace for the fiscal 2003 year that began in October.

At present, the government is trying to establish whether such claims have any merit, making them eligible for out-of-court settlements.

"We cannot litigate thousands of cases," explained Gary Golkiewicz, a representative of the US court that adjudicates such claims, to the government advisory committee. "There have already been about 1,100 petitions filed and who knows how many more are coming."

Golkiewicz said until specific standards are established for judging these cases, the court was also likely to continue struggle, making the no-fault out-of-court settlements more likely.

"The present game plan is to try to isolate it," he said. "Keep the chaos in one corner."

Even if a connection is never established, the sheer number of claims could force such out-of-court settlements, Golkiewicz said. "These autism/thimerosal cases are going to test the program, stress the program," he said.

On the plus side, the program is solvent and has reserves amounting to about $1.8 billion, said Thomas E. Balbier, Jr., director of the of Vaccine Injury Compensation division at HHS. As of November, there were also only six outstanding claims dating from before 1988, suggesting that the government is moving faster to adjudicate these claims and get them resolved, he said.

Omitting controversial claims such as the autism cases, the average time to closing on such claims has been reduced to about 11 weeks, Golkiewicz said. "The vital signs are otherwise good," he said.

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