Hardy v. HHS, (Fed. CL. Spec. Mstr. Nov. 3, 2015) (Hastings, SM)
The Court held that Petitioners failed to demonstrate either that the child suffered a Table encephalopathy, or that the vaccines caused, or aggravated, her neurodevelopmental disorder. With regard to the table claim, the medical records offered no support whatsoever that the child suffered an “acute encephalopathy” as described in the QAI. An increase in sleep was the only post-vaccinal symptom recorded in the period just after the vaccinations in question.
The causation-in-fact claim failed for a number of reasons. First, Petitioner’s expert relied on a faulty factual premise that the child suffered seizures and a dramatic alteration in her development within 24 hours of vaccination, which the special master found not to be true. Second, two different treating physicians–one pediatric neurologist and one geneticist — opined that onset of the child’s microcephaly pre-dated her vaccinations and probably contributed to her subsequent neurodevelopmental problems. Moreover, Respondent’s expert pointed to other evidence in the record suggesting the child was developmentally delayed prior to the vaccines. For this reason, the claim failed on prong three.
Additionally, the Special Master found that the child did not have a mitochondrial “disorder” or “dysfunction” that predisposed her to injury by the vaccinations she received. Even assuming for the sake of argument, that the child did suffer from some kind of mitochondrial dysfunction or disorder, there was no explanation why that would show that vaccinations either initially caused or aggravated the child’s neurodevelopmental disorder. Petitioner’s expert did not present any explanation of her theory that the presence of “mitochondrial dysfunction” would make an infant more susceptible to the unspecified “toxins” in unspecified vaccines. For this reason, the claim failed under prong one.
In finding no significant aggravation occurred, the Court found that the child’s condition soon after the vaccinations was substantially unchanged from her pre-vaccination condition.
In closing, the special maser issued the following warning: “I hereby put Vaccine Act attorneys (and pro se litigants) on notice that if Dr. Cave’s opinion, relying on the same discredited theories and approaches, is offered in other Vaccine Act cases, I will not be likely to compensate such a petitioner for any work by Dr. Cave performed after the publication date of this Decision.”
With respect to mito/autism claims generally, the special master noted that in most cases, there has been insufficient proof the child actually suffers from a mitochondrial disorder. Moreover, there also has been a lack of persuasive evidence that even genuine mitochondrial disorders are of any relevance–i.e., can make a child more susceptible to the causation or aggravation of an ASD by vaccination. The special master distinguished Paluck, which did not involve autism. The special master then issued the additional warning:
“Therefore, I strongly advise counsel in Vaccine Act cases to carefully scrutinize, for credibility, any cases in which an expert witness asserts that the existence of a mitochondrial disorder caused the child to be susceptible to causation or aggravation of an ASD by vaccines. If, as in this case, and in the cases cited at Section 11(A) above, there is no credible evidence that the child even suffers from a mitochondrial disorder, I will be unlikely to find that the use of such expert was reasonable, and thus compensable. Further, even in the context of an actual mitochondrial disorder, the expert must be able to supply credible evidence that a mitochondrial disorder can make a child susceptible to causation or aggravation of an ASD by vaccines, or else I may, again, be disinclined to compensate the attorney for presenting such expert.”