Michelle Cedillo v. HHS - MMR, severe autism and gastrointestinal injuries (2009)

On December 9, 1998, Theresa and Michael Cedillo filed a petition for compensation under the National Childhood Vaccine Injury Act of 1986 on behalf of their daughter, Michelle Cedillo. They alleged that Michelle suffered severe autism and gastrointestinal injuries as a result of vaccinations containing thimerosal and the measles, mumps, and rubella (MMR) vaccine.

Michelle Cedillo was born on August 30, 1994. She received several vaccinations containing thimerosal, including DTP, hepatitis B, and hemophilus influenza vaccines, prior to her MMR vaccination on December 20, 1995, at 15 months of age.

Following the MMR vaccination, Michelle developed a fever and rash, and her mother reported a decrease in her verbalizations. By 18 months of age, developmental delay was suspected, and by 21 months, she was diagnosed with severe autism and profound mental retardation.

The petition was initially filed as a "Table Injury" claim but was later amended to a "causation-in-fact" claim, alleging that thimerosal-containing vaccines in combination with the MMR vaccine caused autism. This case was one of three test cases in the Omnibus Autism Proceeding established to address approximately 5,000 autism-related claims.

Special Master George Hastings presided over the case. Petitioners presented testimony from six expert witnesses: H.

Vasken Aposhian, Ph.D.; Vera Byers, M.D., Ph.D.; Karin Hepner, Ph.D.; Ronald Kennedy, Ph.D.; Marcel Kinsbourne, M.D.; and Arthur Krigsman, M.D. Respondent presented testimony from nine expert witnesses: Jeffrey Brent, M.D., Ph.D.; Stephen Bustin, Ph.D.; Edwin Cook, M.D.; Eric Fombonne, M.D., FRCPsych; Diane Griffin, M.D., Ph.D.; Stephen Hanauer, M.D.; Christine McCusker, M.D.

M.Sc., FRCP; Brian Ward, M.D., M.Sc.; and Max Wiznitzer, M.D. In a 174-page decision issued on February 12, 2009, Special Master Hastings denied the Cedillos' claim.

He found that the evidence was overwhelmingly contrary to the petitioners' claims and that they failed to demonstrate that the vaccinations played any role in causing Michelle's problems. The Special Master specifically found the Unigenetics Laboratory test results, which petitioners relied upon to show the presence of measles virus, to be unreliable due to numerous procedural flaws and lack of replication.

He also found that the petitioners failed to establish a persuasive medical theory, a logical sequence of cause and effect, or a proximate temporal relationship between the vaccinations and Michelle's injuries, thus failing to meet the Althen causation standard. The Court of Federal Claims, in an opinion by Judge Wheeler on July 7, 2009, affirmed the Special Master's decision.

The court agreed that the Unigenetics testing was unreliable and that the petitioners failed to meet the Althen causation standard. The court found the Special Master's decision to be rational, reasonable, and in accordance with the law.

The claim was denied.