Cozart v. HHS, (Fed. Cl. Mar. 25, 2016) (Smith, SJ)

In the trial court, Petitioner failed to prove that vaccines could be an extrinsic risk factor, for purposes of the Triple-Risk Model of SIDS: vulnerable infant, critical development period and exogenous stressor(s).  The underlying theory had been that cytokines released in response to vaccines provoke an abnormal brainstem serotonin response, resulting in the suppression of arousal in the face of elevated CO2 levels.  The Special Master also held that there was no need to consider a speculative risk factor (vaccines) where the baby had many other risk factors for SIDS: male gender, peak age for SIDS death (2-4 months) and prone position.

On appeal, the court found that the Special Master’s determination that Respondent’s expert was more persuasive on the medical theory was not wholly implausible.  The Court also affirmed a finding that, in essence, required the Petitioner to prove the Daubert element that looks for objective evidence, e.g. brain findings, that the medical theory advanced actually played out in the case.  Other fact findings were affirmed as not arbitrary or capricious.  Finally, the court disagreed that the Special Masters elevated the burden of proof.

Vaccine Case Reviews Failure of Proof of Vaccine Causing SIDS