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About the Omnibus Autism Proceeding

Beginning in 2001, parents began filing petitions for compensation with the Secretary of Health and Human Services (HHS) under the Vaccine Injury Compensation Program (VICP), alleging that certain childhood vaccinations might be causing or contributing to a neurodevelopmental disorder known as “autism spectrum disorder (ASD)” or “autism” for short. Specifically, it has been alleged that cases of autism or neurodevelopmental disorders similar to autism, may be caused by the measles-mumps-rubella (MMR) vaccine or thimerosal-containing vaccines, or from both.

In 2002, the Office of Special Masters (OSM) held a series of meetings with an informal advisory committee to address the task of dealing with these claims. The OSM issued Autism General Order #1 in July 2002, in which it established the procedure for addressing the Omnibus Autism Proceeding (OAP). The OAP was created to adjudicate the thousands of claims that were expected. As of August 2010, over 5,600 cases have been filed, and over 5,000 pending cases are being divided among the three presiding special masters. Some Petitioners have withdrawn, as is their statutory right, and may be pursuing claims against vaccine manufacturers in civil court, and some petitions have been dismissed because they were filed after the statute of limitations had expired.

Until the first autism hearing in June 2007, the Court did not require medical reviews of autism claims because it permitted them to be filed without medical records. After the first autism hearing, the Court began ordering newly filed claims to include medical records, and began requiring medical reviews by HRSA, as is standard in non-autism claims.

MMR and Thimerosal-Containing Vaccines (Theory 1)
On February 12, 2009, the U.S. Court of Federal Claims issued opinions in three test cases in favor of respondent (HHS) for Theory 1 (MMR vaccine and thimerosal-containing vaccines), ruling that the MMR, whether administered alone or in conjunction with thimerosal-containing vaccines, is not a causal factor in the development of autism or autism spectrum disorders. These decisions are the result of the 2007 hearings on general causation, and the question of causation in each of three test cases. All three test cases were appealed by petitioners to a judge of the U.S. Court of Federal Claims, and all three were decided in favor of respondent. Notices of appeal to the U.S. Court of Appeals for the Federal Circuit were then filed in two of the three test cases. On May 13, 2010, the Circuit issued an opinion in favor of respondent (HHS) in the first test case heard on appeal.  On August 27, 2010, the Circuit issued an opinion in favor of respondent (HHS) in the second test case heard on appeal. Only decisions by the Federal Circuit, and if appealed further, the Supreme Court, are binding on other VICP cases.

Thimerosal-Containing Vaccines (Theory 2)
On March 12, 2010, the Court issued opinions in three test cases in favor of respondent (HHS) for Theory 2 (thimerosal-containing vaccines only). These decisions are the result of the 2008 hearings on general causation and individual causation in three other test cases. None of the test cases was appealed by the petitioners.

Theory 3 Hearing
A general causation hearing for the third theory (i.e., MMR vaccine alone causes autism or ASD), originally scheduled for September 2008, was cancelled. Petitioners indicated in a letter to the Court that they did not plan to introduce new evidence, and would rely on the MMR vaccine evidence presented in the Theory 1 proceedings. Both sides agreed there was no need for test cases or a general causation hearing.

The special master’s decisions and decisions on appeal can be accessed at Autism Decisions and Background Information.

This information reflects the current thinking of the United States Department of Health and Human Services on the topics addressed. This information is not legal advice and 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.

last updated: August 19, 2010