Alicia Leann Bohn v. HHS - DTaP, death; alleged cytokine-mediated endothelial damage/capillary leak; official probable asphyxia due to co-sleeping (2021)

On February 25, 2016, Alicia Leann Bohn filed a petition under the National Childhood Vaccine Injury Program on behalf of her deceased minor child, G.B. She alleged that routine childhood vaccinations administered on March 12, 2014, including Haemophilus influenzae type b (Hib), pneumococcal conjugate (Prevnar), rotavirus (RotaTeq), and Pediarix (a combination vaccine including diphtheria, tetanus, acellular pertussis, hepatitis B, and inactivated poliovirus), caused G.B.'s death on March 13, 2014.

G.B. was born on January 14, 2014, and received a hepatitis B vaccine at birth. He had a two-month well-child visit on March 12, 2014, where Dr.

Edward Legako administered the routine vaccines after assessing him as normal. Petitioner stated that G.B. cried hysterically and passed out at the pediatrician's office after vaccination.

Later that day, he was miserable, cried, and slept for about four hours. Overnight, he woke twice crying and nursed minimally.

After the second awakening, between 4:30 and 5:00 a.m., petitioner placed him in her bed. She awoke at 8:45 a.m. and found him lifeless.

Emergency responders were called, and CPR was administered for approximately 20 to 25 minutes. The official cause of death listed on the autopsy report by Dr.

Ruth Kohlmeier was accidental death due to probable asphyxia from co-sleeping. The autopsy revealed no traumatic injury, negative toxicology, fixed livor mortis, heavy organs for age, pulmonary petechiae, and marked atelectasis and congestion in the lungs.

Petitioner requested a review of the autopsy slides by Dr. Steven Rostad, who found vascular congestion, acute hemorrhages, atelectasis, and granular ependymitis, but concluded these findings were nonspecific and could be explained by asphyxia.

Petitioner's experts were pediatric pathologist Dr. Laurel Waters and neuropathologist Dr.

Douglas C. Miller.

Dr. Waters questioned the asphyxia conclusion, suggesting that the multiple vaccines stimulated the immune system, potentially causing a lethal cytokine storm or increased capillary permeability, and that a prior hepatitis B exposure might have contributed.

Dr. Miller disagreed with both asphyxia and classic SIDS, interpreting the autopsy findings as an acute visceral microvascular bleeding disorder, likely cytokine-mediated and similar to systemic capillary leak syndrome, despite the presence of SIDS risk factors.

Respondent's experts were pediatric immunologist Dr. Christine McCusker and pathologist Dr.

Sara Vargas. Dr.

McCusker opined that ordinary post-vaccination cytokine levels are far below those seen in a cytokine storm and that G.B. did not exhibit expected signs of excessive cytokine activation. She also rejected hypersensitivity mechanisms and noted epidemiological literature finding no causal link between vaccines and SIDS.

Dr. Vargas supported the medical examiner's asphyxia conclusion, citing co-sleeping, loose bedding, and likely prone positioning, and also noted the absence of findings consistent with vaccine-mediated capillary leak.

She also raised the possibility of congenital pancreatic islet cell hyperplasia with hyperinsulinemic hypoglycemia. Special Master Daniel T.

Horner dismissed the petition on August 23, 2021. He found that petitioner had not shown the medical examiner's conclusion of probable asphyxia due to co-sleeping was incorrect.

Furthermore, he ruled that petitioner failed all three prongs of the Althen test for causation-in-fact. Specifically, the Special Master found that the cytokine/capillary-leak theory was not supported by reliable evidence that vaccines can trigger systemic capillary leak or cytokine storm, the clinical record did not show progressive excessive cytokine reaction, the autopsy findings did not establish the proposed condition, and the short timing between vaccination and death was insufficient without a persuasive mechanism and logical sequence.

He also found that SIDS itself did not support vaccine causation under the Triple Risk Model, referencing prior case law. No compensation was awarded.

Petitioner was represented by Patricia Ann Finn of Patricia Finn, P.C. Respondent was represented by Laurie Wiesner of the U.S.

Department of Justice.