Ruling on Record-Mitochondrial Disorder


Bushnell v. HHS, Case No. 02-1648V (Fed. Cl. Spec. Mstr. Jun. 12, 2015) (Hastings)

Former OAP case alleging that a mitochondrial disorder caused an “enzyme deficiency,” leading to an “accumulation of Thimerosal contained in the vaccines he was administered,” leading to ASD.

An expert report for Petitioner was filed by Dr. Donald Marks (microbiology, internal medicine, pharmaceutical research); for Respondent, reports were filed by Dr. Max Wiznitzer (pediatrics, neurology with special qualification in Child Neurology), and Dr. Edward Cetaruk (emergency medicine, toxicology).  A hearing was not held; Petitioner requested a ruling on the record.

Dr. Wiznitzer concluded that the onset of J.R.B.’s ASD “fits one of the identified development trajectories – acquisition of some words * * * followed by apparent expressive/stagnation/slowing of expressive language development with gradual appearance of impaired socialization.” He further argued that in fact there is “no history in the contemporaneous medical records of an autistic regression.” Dr. Wiznitzer also noted that “there is no documentation of any adverse event following immunization in his contemporaneous medical records,” and that there were “multiple febrile illnesses (8 in the first 2 years of life) that were not associated with or followed by neurologic regression.” Wiznitzer argued that this, among other factors, casts doubt on Dr. Marks’ suggestion that J.R.B.’s autism was caused by mitochondrial stress. He also stressed that Dr. Marks’ theory lacks a plausible biological basis, in that he has not provided sufficient data regarding the toxicity of either mercury or aluminum. He also argued there is insufficient evidence that J.R.B. experienced an “acute” encephalopathy. Dr. Cetaruk argued that vaccinations do not contain sufficient doses of either mercury or aluminum to be poisonous and that even if a poisoning occurred by those elements, such poisoning would not manifest as autism. He further noted that there is no evidence to suggest that mercury or aluminum in vaccines “sets off” or “triggers” regressive encephalopathy among mitochondrial patients or that such patients are vulnerable to those elements. Dr. Cetaruk also disputed Dr. Marks’ claim that the immune response from aluminum adjuvants contained in vaccines could have exacerbated J.R.B.’s mitochondrial disorder. He stressed the lack of reliable scientific data to support Dr. Marks’ theory.

In sum, the Court found that Dr. Marks’ report was entirely unsupported in that it failed to articulate sufficient support for his opinion in either the factual record of the case or in the relevant medical literature. Moreover, Dr. Marks’ report was far outweighed by the reports of Respondent’s experts who were more qualified, and “far more persuasive in that they were more detailed, more coherent, and better supported by the facts of J.R.B’s case and the relevant medical literature.”

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