Tuesday, March 31, 2009

U.S. COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS -- Autism Proceedings

Since its inception in 1986, 5,535 autism cases have been filed with the U.S. Court of Claims under the Vaccine Injury Compensation Program. Last month, the U.S. Court of Claims ruled against the parents of three autistic children claiming a right to compensation under the Program. The Program was created under the National Childhood Vaccine Injury Act of 1986 as a no-fault system to compensate victims harmed by the side effects of certain government-recommended vaccines. It is administered by the Health Resources and Services Administration of the Department of Health and Human Services. Claims are paid out of a trust fund financed through an excise tax on vaccine doses.

Several known side effects of vaccines are listed on a Vaccine Injury Table created by the HRSA. If table listed, an injury occurring within a specified period after a vaccination is presumed to have been caused by the vaccine. Claimants with timely table listed injuries are automatically covered under the Program if their injury lasted for greater than six months or resulted in a hospital stay, surgery or death. When a victim claims an injury that is not table listed, he or she must prove by a preponderance of the evidence that the vaccine caused the injury.

Since autism is not table listed, the petitioners in the recent cases had the burden of proving by a preponderance of the evidence that vaccines were the cause-in-fact of the autism. In the recent cases, the Special Masters of the Claims Court relied upon the standard of proof created in a 2005 federal circuit court case, Althen v. Secretary of HHS and found that the petitioners did not meet their burden. The Althen standard allows a petitioner to meet the burden of proof through medical theory, a logical sequence of cause and effect and a showing of a proximate temporal relationship between vaccination and injury.

The Special Masters found the Petitioners’ evidence failed all three prongs of the Althen standard. Petitioners argued that mercury in thimerosal-containing vaccines led to immune dysfunction allowing the measles virus in the MMR to persist in the victims’ brains causing autism. However, the Special Masters found the medical study and expert testimony supporting their medical theory unreliable. First, the medical study had not been replicated. Also, the laboratory that completed the study failed to publish any sequencing data to confirm the validity of its testing. The Petitioners’ expert testimony and published articles were deemed less credible than countering evidence given by governments’ experts. The Special Masters preferred the credentials of the governments’ experts and felt the published articles on the Petitioners’ theory relied on the laboratory study they already rejected. The Special Masters also found no logical sequence of cause and effect because the Petitioners’ experts testified that the persistence of the measles virus caused the autism, while also claiming that the symptoms of autism showed within 7 days of the MMR vaccine. Finally, the Petitioners’ experts were unable to specify a post- vaccination time frame for the first symptoms of autism that could be deemed consistent with causation.