Vaccine Injury Compensation

Although routine vaccinations have reduced by 95 percent the number of Americans who contract a number of infectious diseases, sometimes a vaccine can have severe side effects, including death and disabling conditions that require lifetime medical care. In the 1980s, lawsuits stemming from such incidents threatened to affect the availability and the cost of vaccines as well as the development of new ones. To address this problem, Congress created the Vaccine Injury Compensation Program, which requires people who believe they have been injured by a vaccine to file a claim with the program rather than sue the vaccine manufacturer or those who administered the vaccine. The program uses a vaccine injury table, which is intended to minimize the difficulties that petitioners have in proving that the injury resulted from a vaccine. By contrast, in a lawsuit, the injured party bears the burden of proving that the vaccine caused injury. GAO found that although the program appears to provide an easier process for obtaining compensation than the traditional civil tort system, the process has not been as quick or as easy as expected. Processing most claims under the program takes more than two years. In 1990, when a filing deadline neared for injury claims relating to vaccinations received before October 1988, the number of claims soared to more than 3,200. This influx created a large backlog of claims, which the Department of Health and Human Services (HHS) is still trying to resolve. Also, as the program received more funding for staff and experts to defend claims, the government increasingly challenged claims in which the cause of injury was in doubt. As a result, petitioners needed more information and time to prepare cases, which resulted in processing times that were much longer than envisioned when the program began. HHS' recent changes to the vaccine injury table will make the process easier for some people to obtain compensation, but it will make it harder for a larger number to do so. The program trust fund has grown to $1.3 billion, primarily because the income from vaccine excise taxes has been higher than payments for claims and associated administrative costs and because interest has been accruing on the fund's balance.

GAO noted: (1) overall, while the program appears to provide an easier process for obtaining compensation than the traditional civil tort system, the process has not been as quick or as easy as expected; (2) processing most VICP claims takes more than 2 years; (3) in 1998 and 1989, the program received about 200 claims and processed nearly all of them within 2 years; (4) but in 1990, when a filing deadline neared for injury claims relating to vaccinations received before October 1988, the number of claims filed jumped to over 3,200; (5) this influx created an immediate and large backlog of claims, which HHS is still working to resolve; (6) another factor significantly increasing processing times is that as the program received additional funding for staff and experts to defend claims, the government increasingly challenged claims in which the cause of injury was in doubt; (7) as a result, petitioners needed more information and time to prepare cases, which resulted in processing times that were much longer than envisioned when the program began; (8) HHS' recent changes to the vaccine injury table will make the process easier for some people to obtain compensation, but will make it more difficult for a larger number to do so; (9) this is because far more claims have historically been associated with injuries HHS removed from the table than for injuries HHS added to it; (10) removing these injuries shifts the burden of proof to the petitioner, making it more difficult to qualify for compensation under VICP; (11) HHS based its decisions to add or remove table injuries on various factors but did not have a clear and transparent methodology to demonstrate that these factors were consistently applied for each injury table change; (12) without such transparency, changes that make compensation more difficult for petitioners may continue to be questioned by some, regardless of their merit; (13) the VICP trust fund has grown to $1.3 billion, primarily because the income from vaccine excise taxes has been higher than payments for claims and associated administrative costs and interest has been accruing on the fund balance; (14) the excess tax revenue--$948 million as of 1998--has been loaned to the Treasury and used for other federal programs and activities; (15) vaccine manufacturers, federal agencies, and petitioner advocates have expressed concerns about the rising balance and have proposed options to decrease the vaccine excise tax or increase trust fund spending; and (16) exercising these options, however, would have implications for the overall federal budget.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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