Cozart v. HHS, (Fed. Cl. Spec. Mstr. Oct. 15, 2015) (Dorsey, SM)*
Petitioners had advanced the Triple-Risk Model for causation – vulnerable infant, critical development period, and exogenous stressor(s). The autopsy revealed that the infant had a susceptibility factor for SIDS, arcuate nucleus hypoplasia, which causes a malfunction in the 5HT system which regulates ventilation and arousal. The critical development period of 1-6 months was satisfied. Vaccines were proposed as the extrinsic risk factor. Although there was a fact issue as to the child’s position at death, the court determined that the child had been side-sleeping, which is an independent risk factor.
The court held that petitioners failed to prove that vaccines could be an extrinsic risk factor, for purposes of the Triple-Risk Model. The underlying theory had been that cytokines released in response to vaccines provoke an abnormal brainstem serotonin response, resulting in the suppression of arousal, i.e., in the face of elevated CO2 levels. Moreover, there was no evidence that the proffered mechanism was actually at play in the infant, i.e. no evidence that cytokines played a role.
Finally, the Court agreed with Respondent’s expert that the infant met the criteria for the Triple Risk Model of SIDS without the need to consider a speculative risk factor (vaccines): hypoplasia of the arcuate nucleus and several known risk factors for SIDS, male gender, the peak age for SIDS death (2-4 months) and prone position.
[*] This decision was initially filed months earlier, prior to Special Master Dorsey’s elevation to Chief. A motion for reconsideration was filed, and a motion to vacate the decision, based on its pendency, was granted. The motion for reconsideration was ultimately denied, and the original decision re-issued.