L.K. v. HHS - MMR, autistic disorder (2017)

Chad King and Christel King filed a petition on behalf of their minor child, L.K., alleging that the MMR, hepatitis A, and varicella vaccines caused autistic disorder. The petition was filed on January 4, 2002.

On June 22, 2015, the petitioners agreed to be bound by the ruling in the lead case of a mini-omnibus proceeding, J.M. et al. (02-10V). Chief Special Master Nora Beth Dorsey issued a decision in the lead case on August 31, 2017, finding that the petitioners had not met the first prong of the Althen test for causation-in-fact.

This decision was attached to L.K.'s case, and the petition was dismissed on August 31, 2017. The public decision was refiled in redacted form on February 7, 2018.

No compensation was awarded. The petitioners' theory of causation, advanced by their expert Dr.

Theresa Deisher, posited that residual human DNA and/or retroviral fragments in the MMR, hepatitis A, and varicella vaccines could cause autistic disorder through mechanisms such as insertional mutagenesis or autoimmunity. Dr.

Deisher's research involved a "change point" analysis of autism prevalence data, which she correlated with the introduction or increased dosage of vaccines manufactured using human cell lines. She identified change points in the United States for 1980.9, 1988.4, and 1996, linking them to the introduction of MMR II, a second MMR dose recommendation, and the varicella vaccine, respectively.

She also linked the hepatitis A vaccine to continued increases in autism rates after 1998. Respondent's experts, including Dr.

M. Daniele Fallin (epidemiology), Dr.

Dan Arking (genetics), and Dr. Neal Halsey (vaccine safety), disputed Dr.

Deisher's findings. They criticized her ecological study design, highlighting the risk of ecological fallacy and the inability to infer causation from population-level data.

They also pointed to numerous limitations in the data used, including changes in diagnostic criteria for autism over time, variations in reporting practices, potential confounding factors like paternal age and increased awareness, and the inappropriate use of statistical software. Furthermore, the experts argued that Dr.

Deisher's theories regarding insertional mutagenesis, retrograde transport, microvesicle transport, and autoimmunity lacked sufficient scientific support and were not biologically plausible in the context of vaccine administration and autism development. Specifically, they noted that the proposed mechanisms for DNA fragments to reach the brain and cause mutations were speculative and not supported by the cited literature.

The experts also highlighted that the majority of current research suggests autism is a neurodevelopmental disorder with prenatal origins, contradicting Dr. Deisher's focus on postnatal vaccine exposure.

Chief Special Master Dorsey found that Dr. Deisher's change point study did not provide reliable evidence of causation.

She noted that the study's ecological design could not establish causation, and that the data had numerous limitations, including potential inaccuracies in prevalence data and the inappropriate use of statistical software. The Special Master also found that Dr.

Deisher's theories lacked an evidentiary foundation, with many hypotheses being taken out of context from medical articles and lacking sufficient scientific support. The Special Master concluded that the gaps between the science and Dr.

Deisher's opinions were too large. The decision emphasized that while the Program does not require absolute certainty, the proposed mechanisms were too speculative to meet the preponderance of the evidence standard.

The Special Master also rejected the argument for an adverse inference due to the denial of access to the Vaccine Safety Datalink, finding no evidence of bad faith or negligence by the respondent. Ultimately, the petition was dismissed for insufficient proof.