L.J. v. HHS - Hepatitis B, Sudden Infant Death Syndrome (SIDS) (2016)
Case summary [AI summaries can sometimes make mistakes]
David and Wanda Jewell, parents of L.J., filed a petition on March 7, 2011, alleging that the hepatitis B, inactivated polio, DTaP, Hib, PCV, and rotavirus vaccines administered on April 8, 2009, caused their infant daughter's death from Sudden Infant Death Syndrome (SIDS). L.J. was born on February 7, 2009.
She received her first hepatitis B vaccine the day after birth. On April 8, 2009, at her two-month well-child check-up, she received multiple vaccines.
Her parents reported she was fussy and ate less that night. The following morning, she was found deceased in her crib.
The autopsy attributed her death to SIDS, with no evidence of trauma or disease. The petitioners presented expert testimony from Dr.
Douglas Miller and Dr. James Oleske.
They theorized that vaccines could trigger an inflammatory response, releasing cytokines that could depress the brainstem's arousal and respiratory functions, particularly in infants with underlying vulnerabilities, consistent with the 'Triple Risk Model' of SIDS. They suggested L.J. may have had a defective 5-HT system and that the vaccines acted as an exogenous stressor.
The respondent presented expert testimony from Dr. Lucy Rorke-Adams and Dr.
Christine McCusker. They disagreed with the petitioners' experts, arguing there was no evidence of vaccine-induced changes in L.J.'s clinical presentation or postmortem examination, that the autopsy slides did not show a defect, and that L.J.'s death was more likely due to recognized SIDS risk factors like side-sleeping and overbundling.
The Special Master, Lisa Hamilton-Fieldman, found that the petitioners failed to establish a scientifically sound and reliable medical theory that vaccines can cause SIDS through the proposed mechanism. The Special Master also found that the petitioners did not prove L.J. had a brain defect or that vaccine-induced cytokine activity caused her death.
The Special Master noted the presence of other recognized SIDS risk factors. Ultimately, the petition was denied, finding the petitioners had not proven by a preponderance of the evidence that the vaccinations caused L.J.'s death.
Ronald Homer represented the petitioner, and Glenn MacLeod represented the respondent.
Theory of causation
Petitioners alleged that the hepatitis B, inactivated polio, DTaP, Hib, PCV, and rotavirus vaccines administered on April 8, 2009, to infant L.J. caused her death from Sudden Infant Death Syndrome (SIDS). Petitioners' experts, Dr. Douglas Miller and Dr. James Oleske, proposed a theory based on Dr. Hannah Kinney's 'Triple Risk Model' of SIDS. They theorized that vaccines act as an exogenous stressor by triggering systemic cytokine release, which can depress the brainstem's arousal and respiratory functions, particularly in infants with underlying vulnerabilities, such as a defective 5-HT system. Dr. Miller suggested L.J. may have had hypoplasia or aplasia of the arcuate nucleus, a brainstem abnormality associated with SIDS. Respondent's experts, Dr. Lucy Rorke-Adams and Dr. Christine McCusker, disagreed. They argued there was no evidence of vaccine-induced changes in L.J.'s presentation or autopsy, that the autopsy slides did not show a defect, and that recognized SIDS risk factors like side-sleeping and overbundling were more likely causes. The Special Master found that the petitioners failed to establish a scientifically sound and reliable medical theory connecting vaccines to SIDS via the proposed mechanism, did not prove L.J. had a brain defect, and did not prove vaccine-induced cytokine activity caused her death. The petition was denied. Petitioner counsel: Ronald Homer. Respondent counsel: Glenn MacLeod. Special Master: Lisa Hamilton-Fieldman. Decision Date: August 29, 2016.
Source PDFs
USCOURTS-cofc-1_11-vv-00138