For vaccines covered under the VICP, individuals alleging that the thimerosal in a vaccine caused an injury or death must first file a claim with the VICP before any civil litigation can be pursued. According to section 2133 of the Public Health Service Act (42 U.S.C. 300aa-33(5)), a “vaccine-related injury or death” eligible for compensation under the VICP does not include an injury or death associated with an adulterant or contaminant intentionally added to a vaccine.

Components, such as thimerosal, that are added to microorganisms to create vaccines cannot and should not be considered adulterants or contaminants. Instead, preservatives and components, such as thimerosal, should be considered one of several elements that comprise vaccines. Because thimerosal is not an adulterant to or a contaminant in vaccines, individuals who have claims relating to thimerosal in vaccines covered under the VICP are not statutorily barred from filing claims with the VICP. As such, the Department of Health and Human Services (HHS) believes individuals interested in filing such a claim must first file the claim with the VICP before pursuing any other civil litigation.

On October 11, 2002, the U.S. Court of Federal Claims (the Court) ruled that thimerosal-related injury claims are subject to the Court’s jurisdiction pursuant to the National Childhood Vaccine Injury Act of 1986, as amended. Plaintiffs had filed a petition for compensation in the Court, but then filed a motion to challenge the jurisdiction of the Court for thimerosal-related injuries. The Court found the plaintiff’s arguments to be without merit. As such, the Court’s Chief Special Master accepted HHS’s arguments and found that the Court’s jurisdiction was mandated on all fronts. Leroy v. Secretary of HHS is the first definitive statement by the Court that thimerosal-related vaccine injury claims are subject to its jurisdiction. For further information on the “Omnibus Autism Proceeding”, visit the Court’s website at http://www.uscfc.uscourts.gov/osmPage.htm.

This answer reflects the current thinking of the United States Department of Health and Human Services on the topics addressed. This answer does not create or confer any rights for or on any person and does not operate to bind the Department or the public. The ultimate decision about the scope of the statutes authorizing the VICP is within the authority of the United States Court of Federal Claims, which is responsible for resolving claims for compensation under the VICP.