J.M. and V.M. on behalf of V.J.M. v. HHS - MMR, pervasive developmental disorder (“PDD”), not otherwise specified, autism (2018)

On January 4, 2002, J.M. and V.M. filed a petition on behalf of their son, V.J.M., alleging that the MMR vaccine administered on January 19, 1999, caused his pervasive developmental disorder, not otherwise specified (PDD-NOS), also known as autism. V.J.M. was one year old at the time of vaccination.

The petitioners claimed that following the vaccination, V.J.M. failed to gain or maintain his verbal and social skills. This case was designated as the lead case for a mini-omnibus proceeding involving 23 other cases with similar allegations.

According to the mother's affidavit, V.J.M. received the MMR, Hib, and hepatitis B vaccines on January 19, 1999. On that day, he fell asleep in the car and was unusually difficult to wake.

Later, he exhibited cranky behavior and began spinning in circles. Two days later, V.J.M. was seen by his pediatrician for a sore throat, but the mother did not mention the spinning or staring, believing they were insignificant.

V.J.M. had a history of recurrent ear infections. His 18-month well-child visit on July 20, 1999, noted no developmental or behavioral concerns; he received DTaP and oral polio vaccines at this visit.

The first medical record mention of a developmental issue was on June 21, 2000, when he was referred for speech, hearing, and behavioral evaluations. A July 2000 psychological evaluation noted speech development delays, leading to intensive behavioral therapy, speech and language therapy, and occupational therapy starting in September 2000.

His progress plateaued, prompting a neurological evaluation. Pediatric neurologist Dr.

Arnold Gold evaluated V.J.M. on May 24, 2001, finding his behaviors consistent with autism spectrum disorder, including repetitive spinning, jumping, teeth grinding, scattering objects, rocking, and aversion to head touching. Dr.

Gold could not establish an etiology but questioned any relationship to the MMR vaccination and found no evidence of seizure disorder or progressive encephalopathy. V.J.M. was diagnosed with PDD-NOS/autistic disorder.

The petitioners' theory of causation centered on the assertion that residual human DNA fragments and HERV-K human endogenous retrovirus fragments contained in the rubella component of the MMR vaccine triggered autism through insertional mutagenesis and autoimmunity. Petitioners' primary expert, Dr.

Theresa Deisher, presented an epidemiological study purporting to show "autism change points" corresponding to vaccine reformulations using human-cell-line-cultured rubella. She also proposed mechanisms for DNA fragment transport to the brain.

Petitioners did not testify at the hearing. Respondent argued against compensation, stating that petitioners failed to provide adequate evidence that the MMR vaccination or any other vaccination caused V.J.M.'s autism.

After extensive litigation, Chief Special Master Nora Beth Dorsey issued a decision on August 31, 2017 (reissued in redacted form on February 7, 2018), denying entitlement. The decision found Dr.

Deisher's change-point study to have significant methodological limitations, including an ecological study design, data accuracy issues, and flawed statistical analysis. The proposed mechanisms of insertional mutagenesis and autoimmunity were found to be unsupported by evidence or undeveloped.

The decision also noted that numerous epidemiological studies "overwhelmingly rejected" a causal association between MMR and autism. Petitioners failed to meet Prong One of the Althen test, which requires demonstrating a medical theory causally connecting the vaccine and the injury.

Consequently, the petition was denied, and similar decisions followed for the other 22 cases in the mini-omnibus proceeding. The attorneys involved were John F.

McHugh for the petitioners and Ann Donohue Martin for the respondent. Chief Special Master Nora Beth Dorsey presided over the case.