HL v HHS, (Fed. Cl. Spec. Mstr. Mar. 17, 2016) (Hastings, SM)

The petitioner unsuccessfully argued that a vaccination significantly aggravated her child’s pre-existing Leigh Disease, resulting in the child’s death. Experts for both sides agreed that the child had Leigh disease, that metabolic decompensation can be caused by a fever or infectious illness, and that such an illness likely contributed to the metabolic decompensation which ultimately led to her death. The only significant disagreement was whether the FluMist vaccine administered played any causal role in triggering that metabolic decompensation. Respondent’s expert argued that metabolic decompensation can occur without any apparent trigger, and the most likely trigger, if any, was an upper respiratory infection prior to the FluMist vaccination. Petitioner’s expert argued that the vaccine likely played a causal role because the child had previously recovered from prior infections without incident.

The court found petitioner’s expert unpersuasive, thus petitioner failed to establish by preponderant evidence that FluMist vaccination contributed to triggering the metabolic decompensation that led to death, or in any other way significantly aggravated the metabolic condition (Leigh Disease) which was present from her birth.

First, the court agreed with Respondent’s expert that the prior infection was a more likely trigger than the vaccine, because the first neurological symptoms allegedly occurred the very same day as the vaccine, which would be too soon to implicate the vaccine. Moreover, petitioner’s expert conceded that a trigger doesn’t always precede decompensation, and that not all infections cause decompensation. Petitioner’s expert also agreed that, since there was no way to measure the amount of oxidative stress caused by the infection, there was no way to know whether the additional impact of the vaccine was even necessary for the decompensation to occur.

Several points were made by the court which could arise in any type of vaccine case: 1) package inserts fall well short of constituting either a warning or a contraindication, and are not good evidence of causation; 2) medical literature pertaining to wild viruses is not relevant to the vaccinations for the same disease, even a live attenuated vaccine.

Vaccine Case Reviews Denial – Aggravation of Leigh Disease/Death by Flumist