Omnibus Autism Proceeding


U.S. Court of Federal Claims Issues Ruling on Final Theory of Causation

The National Vaccine Injury Compensation Program (VICP) was enacted in 1986. The VICP was designed in response to the perceived crisis in vaccine tort liability claims. Under the VICP, lawsuits alleging a correlation between vaccinations and injuries must first be filed with the United States Court of Federal Claims. The Court established the Office of Special Masters (OSM) to serve in a capacity similar to trial judges in the vaccine cases.

In 2002, the OSM issued Autism General Order No. 1, in response to the large number of cases being filed under the VICP alleging a relationship between vaccinations and autism spectrum disorder (“autism”). The OSM first took an in depth look into the general causation issues involved in the autism cases. The Petitioners Steering Committee (PSC) developed three theories of general causation to be litigated. Later, this number was reduced to two, as the third theory was covered by the first. The proceedings became known as the Omnibus Autism Proceeding.

The first theory of causation designated by the PSC is that MMR vaccines and thimerosal-containing vaccines can combine to cause autism. Three test cases was selected to represent this theory: Cedillo v. HHS, No. 98-916V, wherein the petitioner received DTP, hepatitis B and hemophilus influenza vaccines, along with the MMR vaccination; Hazlehurst v. HHS, No. 03-654V, wherein the petitioner received up to 11 vaccines possibly contained thimerosal and the MMR vaccination; and Snyder v. HHS, No. 01-162V, wherein the petition received hepatitis B and hemophilus influenza type b, along with the MMR vaccination. The Special Masters’ decisions in the first three cases were issued on February 12, 2009. The Court found that the evidence failed to demonstrate that the vaccinations at issue played a role in causing autism. All three cases were appealed to United States Federal Court of Claims where they were affirmed. Cedillo v. HHS, 89 Fed. Cl. 158 (2009); Hazlehurst v. HHS, 88 Fed. Cl. 473 (2009); Snyder v. HHS, 88 Fed. Cl. 706 (2009). Currently, Cedillo and Hazlehurst are pending appeal to the Federal Circuit Court of Appeals.

The second theory of causation is that thimerosal-containing vaccines can alone cause autism. The three test cases selected as representatives of this theory were King v. HHS, No. 03-589V; Mead v. HHS, No. 03-215V; and Dwyer v. HHS, No. 03-1202V. The Special Masters’ decisions were issued on March 12, 2010. Once again it was determined that there was no casual connection between the vaccines at issue and autism. The petitioners in these cases now have the option to seek review of the Special Masters decisions in the Court of Federal Claims.

As of March 2010, 13,330 cases have been filed under the VICP, of which 5,617 are autism cases. To date, the Court has held that there is no correlation between vaccinations and autism.


1 The information contained herein can be found at the U.S. Court of Federal Claims website (, along with additional information concerning the Omnibus Autism Proceeding.