Mandy Bangerter v. HHS - DTaP, infantile spasms (2022)

Petitioner Mandy Bangerter alleged that D.B., a minor born with Down syndrome, suffered infantile spasms following receipt of DTaP, Hepatitis B, IPV, Hib, Pneumococcal Conjugate 13-Valent, and Rotavirus vaccines on February 14, 2014. Petitioner's experts, Dr. Marcel Kinsbourne and Dr. Karen Harum, contended that the DTaP vaccine caused D.B.'s infantile spasms, either directly or indirectly through a vaccine-induced partial seizure that evolved into infantile spasms. Dr. Kinsbourne proposed a 'two-hit' theory where Down syndrome was the first hit (susceptibility) and the DTaP vaccination was the second hit, triggering infantile spasms via immune and stress responses affecting the HPA axis and releasing CRH, or by causing initial partial seizures that transformed into infantile spasms. Dr. Harum opined that D.B. suffered residual developmental effects for more than six months post-vaccination. Respondent's expert, Dr. Gregory Holmes, argued that the scientific literature does not support a causal link between DTaP vaccines and infantile spasms, and that D.B.'s developmental delays were consistent with his Down syndrome. Dr. Holmes also contended that the infantile spasms resolved within six months and D.B. did not suffer residual effects beyond that period. Special Master Daniel T. Horner found that petitioner failed to establish Althen prong one (medical theory) and prong two (logical sequence of cause and effect), citing the lack of persuasive evidence linking DTaP to infantile spasms and the misinterpretation of cited literature by petitioner's experts. The Special Master also found that petitioner failed to establish Althen prong three (proximate temporal relationship) and the six-month severity requirement, noting D.B.'s rapid recovery and return to baseline within six months. The petition was denied. Attorneys: Richard Gage for petitioner, Julia Marter Collison for respondent. Special Master: Daniel T. Horner. Decision Date: February 14, 2022.