Faoro v. HHS, (Fed. Cl. Spec. Mstr. Jan. 29, 2016) (Dorsey, CSM)
This case differed from all of the prior SCN1A cases, in which compensation was denied because the child, in this case, did not have a de novo mutation. Rather, the mutation was shared by the mother, who was healthy. The mutation involved a stop codon and was predicted to be disease-causing. Petitioners argued that the mutation was a susceptibility factor, and vaccines were the environmental trigger that caused Dravet’s in the child. Respondent argued that mosaicism explained why the mother was asymptomatic, i.e., only some of her cells contained the mutation.
The Court reached the same conclusion as the prior SCN1A cases – vaccination does not affect the prognosis or severity of Dravet syndrome. The Court also found that mosaicism was the best explanation for the asymptomatic parent. Interestingly the Court held that it was not proven that the vaccine caused the initial seizure.
In analyzing whether a significant aggravation case had been proven, the Court held that Loving prong 3, asks not whether the petitioner was worse after the vaccines than before, but whether the petitioner’s clinical course and the outcome were any different than it would have been without the vaccination. Because the child’s clinical course was consistent with Dravet, there was no significant aggravation. The Court observed that, since there was no way to predict what might have been had the vaccine not been given, it was impossible to show that the vaccine resulted in a worse outcome.
Finally, the court held that Respondent had proven that a factor unrelated, the mutation, was the sole cause of the child’s Dravet.