J.H.R. and H.R.K. v. HHS - MMR, autistic disorder; pervasive developmental disorder, not otherwise specified (2018)

On January 4, 2002, J.H.R. and H.R.K. filed a petition on behalf of their son, J.J.K., alleging that the MMR vaccine administered on January 19, 1999, at age one, caused his autistic disorder and pervasive developmental disorder, not otherwise specified. The case was part of the Omnibus Autism Proceeding (OAP) and later consolidated into a "mini-omnibus" proceeding led by V.J.M. v.

Secretary (No. 02-10V), with petitioners agreeing to be bound by the lead decision. The theory of causation proposed by petitioners was that residual human DNA fragments and/or human endogenous retrovirus (HERV-K) fragments in the rubella component of the MMR vaccine triggered autism through insertional mutagenesis or autoimmunity.

On February 7, 2018, Chief Special Master Nora Beth Dorsey issued a decision in the lead case, V.J.M., denying entitlement and dismissing the petition. The decision found significant methodological limitations in petitioners' principal expert, Dr.

Theresa Deisher's, "autism change point" study. The proposed mechanisms of insertional mutagenesis, retrograde transport of DNA fragments, microvesicle transport, and hematopoietic stem cell uptake were deemed either undeveloped or contradicted by a lack of supporting experiments.

Dr. Deisher conceded that the role of HERV-K retroviruses in disease was "observational" and unknown.

The decision noted that numerous epidemiological studies overwhelmingly rejected a causal association between the MMR vaccine and autism. Petitioners failed Prong One of the Althen test, which requires establishing a medical theory causally connecting a vaccine and an injury by a preponderance of the evidence.

The court found that Dr. Deisher's theories lacked an evidentiary foundation, with many hypotheses being taken out of context from medical articles.

The proposed mechanisms for DNA fragments to reach the brain, such as retrograde transport, microvesicle transport, and uptake by hematopoietic stem cells, were found to be speculative and unsupported by evidence. Furthermore, the court found no evidence that residual DNA in vaccines causes genetic mutations or triggers an autoimmune process leading to autism.

The court also noted that Dr. Deisher's own concessions about the speculative nature of her theories, using terms like "possible" and "possibility," highlighted the lack of a scientifically plausible explanation.

The numerous criticisms of Dr. Deisher's change point study, including its ecological design, data accuracy issues, and inappropriate use of statistical software, further undermined its reliability.

The decision concluded that the petitioners had not met their burden of proof, and therefore, J.J.K.'s petition was dismissed along with the other cases in the mini-omnibus proceeding.