Laura Holt v. HHS - Hepatitis B, mitochondrial disorder aggravated by vaccination, leading to encephalopathic event (2017)

Laura Holt filed a petition on behalf of her minor daughter, A.H.T., on January 21, 2005, alleging that the hepatitis B vaccine administered on April 4, 2002, caused A.H.T. to develop an autism spectrum disorder (ASD). Initially, the petition followed the standard for the Omnibus Autism Proceeding (OAP).

After the OAP test cases were decided against petitioners, Ms. Holt amended the petition on September 22, 2011, to allege that the hepatitis B vaccine aggravated an underlying mitochondrial disorder, causing an encephalopathic event and ASD-like symptoms.

Petitioner's experts, Dr. Levinson and Dr.

DeMio, opined that the vaccine aggravated a mitochondrial disorder. Respondent's experts, Dr.

Wiznitzer and Dr. McCandless, testified that A.H.T. did not suffer an encephalopathic event and that the evidence did not support vaccine-induced aggravation of a mitochondrial disorder.

Chief Special Master Denise Kathryn Vowell denied the petition on June 24, 2015. The Special Master found no reliable evidence of a post-vaccination fever or encephalopathy in the contemporaneous records, noting that the reported post-vaccination symptoms were unremarkable for a newborn.

She also found that A.H.T. had at best a "possible, but not probable" mitochondrial disorder and that the alleged developmental delays appeared around 18 months of age, which was outside any plausible vaccine-reaction window. The Special Master also noted that the video evidence did not support the parents' claims of significant lethargy or inconsolable crying.

The Special Master found that A.H.T. did not experience a fever after the vaccination, and that her gastrointestinal issues, crying, and sleep problems were consistent with colic. The Special Master also found that the evidence did not support the claims of exercise intolerance or hypotonia consistent with mitochondrial disease.

The Special Master concluded that A.H.T. did not have a mitochondrial disorder that was aggravated by the vaccine, nor did she suffer an encephalopathic event. Ms.

Holt filed a motion for review, which was reassigned to Judge Thomas C. Wheeler.

Judge Wheeler denied the motion for review on May 23, 2017. Judge Wheeler found that the Chief Special Master's factual findings were not arbitrary and capricious, particularly regarding the absence of fever and encephalopathy.

He agreed that the distinction between mitochondrial dysfunction and disorder was significant and that A.H.T. only had evidence of the former, not the latter, and that her diagnosis was at best "possible." Judge Wheeler also found that the Chief Special Master appropriately weighed the testimony of the treating physicians, Drs. Levinson and DeMio, giving them less deference due to their alternative medicine practices and the timing of their treatment relative to the vaccination.

The Court affirmed the Chief Special Master's conclusion that Ms. Holt failed to establish causation under the Althen prongs, as there was no biologically plausible medical theory, logical sequence of cause and effect, or proximate temporal relationship linking the vaccine to the alleged injury.