M.D.P. v. HHS - DTaP, Sudden Infant Death Syndrome (SIDS) (2020)
Case summary [AI summaries can sometimes make mistakes]
On September 17, 2015, Crystal Downing-Powers and Zachary Powers filed a petition on behalf of their infant son, M.D.P., alleging that routine childhood vaccinations administered on October 7, 2013, caused or contributed to his death from Sudden Infant Death Syndrome (SIDS) on October 9, 2013. M.D.P. was approximately 5.5 months old at the time of vaccination.
The vaccines administered included Haemophilus influenzae type B (Hib), pneumococcal conjugate (PCV), and Pediarix, which is a combination vaccine for diphtheria-tetanus-acellular pertussis, hepatitis b, and inactivated polio. Petitioners' experts, Dr.
Douglas Miller and Dr. Lawrence Steinman, proposed theories that vaccines could act as an exogenous stressor within the Triple Risk Model of SIDS, or that pertussis toxin in the DTaP vaccine could cause ADP-ribosylation leading to neuronal death.
Respondent's experts, Dr. Christine McCusker and Dr.
Brent Harris, argued that there is no evidence linking vaccination to SIDS and that M.D.P.'s death was likely due to other factors or was unexplained. The Special Master reviewed extensive expert reports and case law, particularly the Federal Circuit's decision in Boatmon v.
Secretary of Health & Human Services, which held that theories linking vaccines to SIDS via cytokine activity were not sound and reliable. The Special Master found that the petitioners' experts failed to establish a sound and reliable medical theory causally connecting the vaccinations to M.D.P.'s death, as required under the Althen test for off-Table claims.
Specifically, the court found that the proposed link between vaccines and SIDS through the Triple Risk Model was not supported by current scientific literature and that the ADP-ribosylation theory was inapposite and lacked sufficient evidence. Therefore, the petition was denied and dismissed for insufficient proof.
The Special Master expressed sympathy to the family for their loss.
Theory of causation
Petitioners alleged that routine childhood vaccinations administered on October 7, 2013, to M.D.P., a 5.5-month-old infant, caused or contributed to his death from Sudden Infant Death Syndrome (SIDS) on October 9, 2013. SIDS is not a "Table Injury." Petitioners' experts, Dr. Douglas Miller and Dr. Lawrence Steinman, proposed two main theories: 1) Vaccines act as an exogenous stressor within the Triple Risk Model of SIDS, potentially by increasing cytokines (IL-1β, IL-2) that suppress the medullary serotoninergic network responsible for arousal from apnea or hypercarbia. 2) Pertussis toxin in the DTaP vaccine can cause ADP-ribosylation, which is associated with seizures and neuronal death. Respondent's experts, Dr. Christine McCusker and Dr. Brent Harris, contended that no scientific evidence links vaccines to SIDS and that the proposed mechanisms are not sound or reliable. The Special Master, Daniel T. Horner, found that the petitioners failed to establish a sound and reliable medical theory under the Althen test. The court found that the extension of the Triple Risk Model to include vaccines as an exogenous stressor was not supported by scientific literature and was based on the ipse dixit of Dr. Miller, with insufficient evidence that vaccine-induced cytokines affect the 5-HT system in vivo at relevant levels. The ADP-ribosylation theory was found to be inapposite as M.D.P. did not have a seizure disorder, and the supporting literature was largely outdated or inconclusive regarding DTaP vaccines and SIDS. The petition was denied. Attorneys for petitioners were Andrew Downing, Esq. Attorneys for respondent were Julia Marter Collison, Esq. The decision date was July 1, 2020.
Source PDFs
USCOURTS-cofc-1_15-vv-01043