RWC v. HHS - MMR, autism spectrum disorder (2014)

On November 17, 2008, Richard and Viletta Coombs, as natural parents and guardians of their son RWC, filed a petition for compensation under the National Vaccine Injury Compensation Program. They alleged that RWC's autism spectrum disorder (ASD) was caused by or aggravated by the measles, mumps, and rubella (MMR) and Varivax vaccinations administered on November 14, 2005.

The petition was initially filed pro se, with attorney Lawrence Gene Michel later substituting as counsel. Petitioners amended their petition on September 17, 2010, alleging that the vaccines aggravated RWC's underlying mitochondrial disorder, specifically Complex I and III deficiencies, leading to chronic illness, fevers, developmental delay, and features consistent with ASD.

Respondent, the Secretary of Health and Human Services, contended that there was insufficient evidence to confirm a mitochondrial disorder and a lack of temporal connection between the immunizations and the onset of developmental issues. Special Master George L.

Hastings presided over an evidentiary hearing on November 19, 2012. Petitioners presented expert testimony from Dr.

J. Ivan Lopez, a pediatric neurologist.

Respondent presented expert testimony from Dr. Mark Sheldon Korson, a specialist in metabolic and mitochondrial disorders, and Dr.

Max Wiznitzer, a pediatric neurologist with expertise in ASD. Special Master Hastings found Respondent's experts to be far more persuasive.

He noted that Dr. Lopez's testimony was self-contradictory regarding the timing of fevers post-vaccination, and that Dr.

Wiznitzer testified it was biologically impossible for an attenuated MMR virus to cause a fever within one day. Dr.

Lopez also could not identify when any alleged autistic regression occurred or point to medical records showing it, while Dr. Wiznitzer concluded RWC's clinical course was consistent with the trajectory of ASD presentation.

Furthermore, the Special Master found that Petitioners failed to establish that RWC had a mitochondrial disorder. Dr.

Shoffner, the treating specialist, was not convinced RWC had a mitochondrial disease, scoring him low on the Nijmegen scale. Dr.

Korson supported this assessment, explaining that Complex I and III enzymology findings alone are insufficient for diagnosis without genetic confirmation, and RWC's genetic tests were negative. Dr.

Lopez's attempt to re-score RWC under the Nijmegen criteria was found unpersuasive and speculative. Special Master Hastings denied the petition on April 8, 2014, finding that Petitioners failed to establish a medical theory connecting the vaccines to the injury, a logical sequence of cause and effect, or a proximate temporal relationship, thus failing all prongs of the Althen test.

He noted that the case was "not a close case." On April 24, 2014, the parties filed a stipulation regarding attorneys' fees and costs. On April 30, 2014, Special Master Hastings issued a decision awarding $10,848.00 in attorneys' fees and costs to Petitioners' counsel, Lawrence Gene Michel, as the underlying entitlement petition was denied.