HH v. HHS - DTaP, neurodevelopmental disorder (2015)

On February 25, 2008, Harold Hardy III and Tiffany Ann Hardy-Bell, as legal representatives of their minor daughter HH, filed a petition seeking compensation under the National Vaccine Injury Compensation Program. They alleged that vaccinations administered to HH on August 26, 2005, contributed to the causation of her severe neurodevelopmental disorder, diagnosed as an Autism Spectrum Disorder (ASD).

The petition initially alleged that the DTaP and Prevnar vaccines caused HH's condition, either directly or by significantly aggravating a pre-existing condition. The case was initially part of the Omnibus Autism Proceeding (OAP).

After the OAP test cases were decided unfavorably in 2010, the petitioners filed an amended petition on July 29, 2011, adding an allegation that HH had a mitochondrial disorder making her vulnerable to vaccine-induced injury, and also alleging a Table Injury Encephalopathy. An evidentiary hearing was held on February 7, 2014.

Petitioners were represented by Michael L. Cave, and Respondent was represented by Darryl R.

Wishard. Special Master George L.

Hastings presided over the case. HH was born on February 23, 2005.

She received a Hepatitis B vaccine on February 24, 2005. Subsequent vaccinations occurred at her two-month and four-month well visits.

On August 26, 2005, at her six-month well-child visit, HH received four vaccines: DTaP, Hepatitis B, IPV, and Prevnar. Twelve days later, on September 7, 2005, HH's parents reported congestion, a runny nose, and fever, along with increased sleeping and decreased appetite.

Her pediatrician diagnosed an ear infection and an upper respiratory infection; no neurological concerns were noted. The first documented developmental concern arose on December 21, 2005, when HH was noted not to be scooting or crawling.

By January 2006, concerns about lethargy, slow response to stimuli, and eyes 'dazing off' were noted. An MRI and chromosomal tests were normal.

A genetics specialist, Dr. Duane Superneau, evaluated HH on January 26, 2006, diagnosing neurodevelopmental delay and relative microcephaly, noting that her parents recognized developmental delay by nine months of age.

HH was evaluated by Dr. Stephanie Cave, a family physician specializing in developmental disorders, in February 2006.

Dr. Cave later became HH's treating physician and petitioners' expert witness.

Pediatric neurologist Dr. Robert Cruse evaluated HH on June 22, 2006, noting her head circumference was below the second percentile and had been declining since approximately three months of age, suggesting a pre-vaccination origin for her neurological problems.

Dr. Superneau reiterated in March 2007 that HH's microcephaly predated the August 2005 vaccinations and suggested her problems existed from birth.

On February 18, 2008, an educational psychologist administered the Autism Diagnostic Observation Schedule, concluding HH fell within the autism category. Petitioners' primary theory involved mitochondrial dysfunction making HH vulnerable to vaccine adjuvants, specifically aluminum.

Petitioners' expert, Dr. Stephanie Cave, alleged HH suffered seizures two hours after the August 26, 2005 vaccinations and experienced regression thereafter.

She also claimed HH had mitochondrial dysfunction, supported by her interpretation of laboratory results and application of the Morava criteria. However, Special Master Hastings found Dr.

Cave's application of the Morava criteria to be mathematically impossible and flawed, assigning HH a score indicating mitochondrial disorder was unlikely, contrasting with Dr. Cave's higher scores.

Dr. Wiznitzer, Respondent's expert, a pediatric neurologist, was found by Special Master Hastings to be far more persuasive.

Dr. Wiznitzer testified that HH's head circumference deceleration predated the August 2005 vaccinations, indicating a pre-existing neurological disorder.

He also refuted the claim of mitochondrial disorder based on the Morava criteria and noted that aluminum is not a heavy metal, contrary to Dr. Cave's assertion.

Regarding the Table Encephalopathy claim, Special Master Hastings rejected the parents' affidavits alleging convulsions two hours post-vaccination, finding them inconsistent with the medical records from September 7, 2005, which documented only upper respiratory symptoms and increased sleep, not a severe neurological event. The Special Master noted that the Table Encephalopathy definition requires a significantly decreased level of consciousness for at least 24 hours, which was not met.

Dr. Cave herself conceded that a Table Encephalopathy finding could not be supported without relying solely on parental statements.

On the causation-in-fact claim, Special Master Hastings found that two of HH's treating physicians, Dr. Cruse and Dr.

Superneau, concluded her microcephaly and neurological disorder predated the August 2005 vaccinations. Dr.

Cave's attempt to rebut this by excluding earlier head measurements was rejected, as standard growth charts showed a deceleration in head growth consistent with Dr. Cruse's findings.

The Special Master also found Dr. Cave's theory of mitochondrial dysfunction to be unconvincing due to her misapplication of the Morava criteria and her failure to establish a clear mechanism by which aluminum adjuvant would cause autism in the context of such dysfunction.

Dr. Wiznitzer's expert opinion, which found no causal link between the vaccinations and HH's condition, was deemed more credible.

Special Master Hastings issued his decision on November 3, 2015, denying compensation. He noted Dr.

Cave's history of offering opinions based on parental recollections without documentary support, warning that such approaches would likely not be compensated in future cases. The Special Master found that Petitioners failed to demonstrate, by a preponderance of the evidence, that HH suffered a Table Injury Encephalopathy or that the August 26, 2005 vaccinations caused or aggravated her neurodevelopmental disorder.