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In a landmark case that began on June 11, a federal court in Washington, D.C., is hearing the claims of a woman who believes that a vaccine, which contained the mercury-containing preservative thimerosal, caused her daughter, Michelle Cedillo, to develop autism. The case is the first of nine test cases that will be heard consecutively by the court over the next 12 months.
The outcome of these test cases will determine whether more than 4,800 parents will receive compensation from the National Vaccine Injury Compensation Program, which was set up to shield vaccine manufacturers from lawsuits. The parents, who believe their children developed autistic symptoms shortly after they received the measles, mumps, and rubella (MMR) vaccine, have filed suit against the government. The government requires that all children have this vaccine in order to attend public schools. The program caps specific damages awards at $1 million.
The Cedillo case is being followed closely by thousands of parents of autistic children. The public health community and vaccine manufacturers also are watching the proceedings with intense interest. They expect that a ruling in favor of the parents would have a disastrous effect on vaccine acceptance by other parents and would result in many more deaths from common childhood diseases.
"This is a test case about proving by a preponderance of the evidence that thimerosal, or the MMR vaccine, or a combination of the two, caused or was a substantial contributing cause for the serious injuries that these children have suffered," said Thomas B. Powers, a lawyer for the Cedillo family.
A number of large scientific studies haven't found convincing links between autism and vaccines or thimerosal. An Institute of Medicine report published in 2004 that examined the scientific literature on the subject concluded that there is no evidence of an association between autism and vaccines or thimerosal.
In 1999, the Centers for Disease Control & Prevention ordered that most vaccines for children, with the exception of the flu vaccine, be produced without thimerosal. Since that time, the number of diagnosed cases of autism and related disorders has continued rising. Now, according to CDC, 1 in 150 eight-year-old children has autism or a related disorder. Most vaccines produced for the developing world are still preserved with thimerosal.
Michelle Cedillo's mother, Theresa Cedillo, has testified that her 12-year-old daughter developed severe autism shortly after she received the MMR vaccine at 15 months of age. Her lawyers allege that thimerosal in earlier vaccines, beginning with the hepatitis B vaccine given shortly after birth, weakened Michelle's immune system. That enabled the MMR vaccine to cause a severe case of measles, they say, with consequent neurological damage.
Lawyers for the Cedillo family are offering testimony this week. Next week, the government will present its evidence. A panel of three so-called special masters will decide the case.
The standard of proof to be used in the Cedillo case and in the other test cases is not nearly as strict as it is in criminal proceedings. Plaintiff's lawyers must show only by a preponderance of evidence that a vaccine, or the preservative thimerosal, or a combination of the two, more likely than not triggered autism.
Transcripts and audiocasts of the Cedillo case are available at www.uscfc.uscourts.gov/OSM/OSMAutism.htm.
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