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On March 12, 2010, the Special Masters of the United States Court of Federal Claims issued decisions on the second round of test cases in the Autism Omnibus Proceeding.  The Special Masters found that the petitioners did not meet their burden of proving that thimerosal-containing vaccines contributed to the development of autism.

The Omnibus Autism Proceeding consists of over 5,500 cases alleging that certain childhood vaccinations caused or contributed to the child’s diagnosis of autism or autism spectrum disorder.  As part of the proceeding, three test cases were selected and tried under two general causation theories:  (1) that the MMR vaccine and vaccines that contained thimerosal (a compound consisting of 49.6% mercury used a preservative in certain vaccines) combined to cause autism; and (2) that thimerosal-containing vaccines alone caused the childrens’ autism.  The decisions on these two general causation theories will then be applied to the over 5,500 individual cases.

In February 2009, the Special Masters decided the first general causation theory against the families and on Friday rejected the second causation theory.

In the second causation theory decided on March 12, 2010, the petitioners asserted that the thimerosal in the vaccines substantially contributed to the causation of autism in genetically susceptible individuals.  The petitioners contended that the mercury contained in thimerosal, known as “ethylmercury,” made its way into the brain, converted into inorganic mercury and that the inorganic mercury then triggered a process of “neuroinflammation,” including “oxidative stress,” in the childrens’ brains.  Petitioners contended that the neuroinflammation impaired and disrupted brain function, resulting in autistic symptoms.

The Special Masters found that Petitioners did not meet their burden of proving that thimerosal-containing vaccines can contribute to the cause of autism.  The lengthy decisions may be found on the United States Court of Federal Claims website. www.uscfc.uscourts.gov.

Motions for review of the February 2009 Special Master decisions on the first general causation theory were filed with the Court of Federal Claims and denied in July and August 2009.  Two of the three February 2009 Special Master decisions on the first general causation theory were then appealed to the Court of Appeals of the Federal Circuit and are still pending.  It is likely that the Special Masters’ decisions on the second general causation theory decided on March 12, 2010 will also be appealed.

The Special Masters of the United States Court of Federal Claims issued its highly anticipated decisions today on the first three test cases in the Autism Omnibus Proceeding. In all three cases, the court found insufficient evidence of a causal link between the vaccines and autism.

The Omnibus Autism Proceeding consists of over 5,000 cases alleging that certain childhood vaccinations caused or contributed to the child’s diagnosis of autism or autism spectrum disorder. As part of the proceeding, three test cases were selected and tried under two general causation theories: (1) that the MMR vaccine and vaccines that contained thimerosal (a compound consisting of 49.6% mercury used as a preservative in certain vaccines) combined to cause autism; and (2) that thimerosal-containing vaccines alone caused the childrens’ autism. The decisions on these two general causation theories will then be applied to the over 5,000 individual cases.

The three test cases decided today pertained to the first general causation theory. The Special Masters issued separate decisions on each of the three test cases. The lengthy decisions may be found on the United States Court of Federal Claims website.

Hearings on the three test cases on the second general causation theory, that thimerosal-containing vaccines alone can cause autism, were completed in July of 2008. Decisions on the second general causation theory are not expected for a few months.

The National Vaccine Injury Compensation Program, or Vaccine Court as it is commonly called, was established as part of the National Childhood Vaccine Injury Act of 1986. The National Childhood Vaccine Injury Act was enacted to provide a prompt, efficient and fair system for compensation of those who suffer vaccine-related injuries and to reduce private tort litigation in state and federal court against vaccine manufacturers.

The Vaccine Court is a Federal “no-fault” system designed to compensate individuals thought to be injured by childhood vaccines.  A claimant must first pursue a claim in the Vaccine Court before suing a vaccine manufacturer for a vaccine-related injury or death.

There are a number of claims pending in the Vaccine Court asserting that one or more vaccinations caused the claimant to develop autism.  In July 2002, when there were over 400 such claims, the Vaccine Court established a procedure to handle the large number of autism claims filed and the large number expected to be filed in the future.

The Vaccine Court adopted a two phase procedure.  First, the Vaccine Court would inquire into the general causation issues involved in all of the autism cases – i.e., whether the vaccinations in question can cause autism and/or similar disorders, and if so, in what circumstances.  Second, the Vaccine Court would then apply the conclusions reached in the general causation phase, referred to as the “Omnibus Autism Proceeding,” to the individual autism cases.  Individual claimants were given the choice to either opt into the Omnibus Autism Proceeding, which would also then stay a case specific finding on their individual claim until after the Vaccine Court decides the general causation issue, or proceed with their individual claim.

The Omnibus Autism Proceeding is still in progress to determine the fate of the now 4,900 autism claims pending before the Vaccine Court and those that continue to be filed.

There are three separate theories being presented in the Omnibus Autism Proceeding:  (1) that the MMR (Measles, Mumps, Rebella) vaccine and vaccines containing an ethyl-mercury containing preservative, thimerosal, can combine to cause autism; (2) that thimerosal-containing vaccines alone can cause autism; and (3) that the MMR Vaccine alone can cause autism.   Three tests cases for each of these three theories have been selected to be tried before the Vaccine Court.

Between June and November 2007, the Vaccine Court heard the three test cases as to the first general causation theory.  The parties have filed post-hearing briefs as to these three test cases analyzing the evidence presented in those cases.  Additional briefing is due to be filed, after which the Vaccine Court is expected to issue written decisions.

Hearings on the three test cases selected for the second general causation theory, that thimerosal-containing vaccines alone can cause autism, are scheduled to be heard by the Vaccine Court in May 2008.