Bohn v. Secretary of Health and Human Services, 16-265

Background

Petitioner Alicia Bohn filed a Vaccine Act petition after her infant son G.B. died ~24 hours after receiving routine 2‑month vaccinations (DTaP, HepB, IPV, Hib, PCV13/Prevnar, rotavirus) on March 12–13, 2014.
Oklahoma City Chief Medical Examiner performed an autopsy and determined manner of death: accidental, cause: "probable asphyxia due to co‑sleeping;" autopsy showed heavy organs, pulmonary petechiae, and congestion.
Petitioner’s experts (Drs. Miller and Waters) proposed a vaccine‑triggered cytokine‑mediated endothelial injury (cytokine storm or systemic capillary leak syndrome leading to microvascular hemorrhage) as the cause of death.
Respondent’s experts (Drs. McCusker and Vargas) countered: post‑vaccine cytokine responses are mild compared to cytokine storms/SCLS; autopsy and scene photos (co‑sleeping on soft bedding, prone positioning, livor mortis) support accidental asphyxia; hemorrhages could reflect CPR/postmortem changes.
The case was decided on cross‑filed expert reports and a motion for ruling on the written record; the Special Master applied the Althen three‑prong causation test and dismissed the petition for insufficient proof of vaccine causation.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Proper cause of death: asphyxia vs SIDS vs vaccine injury	Vaccination triggered systemic cytokine response causing endothelial damage and fatal hemorrhage (not asphyxia).	Medical examiner’s autopsy + scene evidence support accidental asphyxia from co‑sleeping; SIDS/other causes more likely than vaccine injury.	Asphyxia due to co‑sleeping is the most likely cause; ME’s finding entitled to significant weight.
Althen prong 1 — Medical theory linking vaccine to injury	Vaccines elicit cytokines; in rare cases this could precipitate cytokine storm or SCLS‑like capillary leak causing hemorrhage.	Vaccine‑elicited cytokine levels are orders of magnitude lower than in documented cytokine storms/SCLS; literature does not implicate vaccines as triggers.	Petitioner failed to provide a sound, reliable medical theory connecting routine vaccines to catastrophic cytokine‑mediated endothelial injury.
Althen prong 2 — Logical sequence of cause and effect	Temporal proximity and autopsy findings (multi‑organ congestion/hemorrhage) support causation; maternal account of post‑vaccine lethargy adds corroboration.	Child’s clinical course lacked hallmark prodrome of cytokine storm/SCLS; autopsy findings explained by asphyxia/CPR; absence of medullary defect undermines SIDS‑based cytokine hypotheses.	Petitioner did not establish a persuasive, coherent causal chain from vaccination to death.
Althen prong 3 — Temporal relationship	Death within ~24 hours is consistent with cytokine peak (24–48 hrs) and thus temporally plausible.	Capillary leak/hemorrhagic manifestations in SCLS/cytokine storms typically follow a longer prodrome; timing alone is insufficient without a reliable mechanism.	Temporal proximity was insufficient to prove a medically‑acceptable causal timeframe given the weak mechanistic support.

Key Cases Cited

Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishes three‑prong test for causation‑in‑fact under Vaccine Act)
Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (medical theory need only be legally probable; must be reliable)
Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir. 2009) (role of evidence and expert proof under Althen)
Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (weight of treating physician records in causation analysis)
Shyface v. Sec'y of Health & Human Servs., 165 F.3d 1344 (Fed. Cir. 1999) (but‑for and substantial‑factor causation concepts)
de Bazan v. Sec'y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir. 2008) (medically‑acceptable temporal relationship requirement)
Boatmon v. Sec'y of Health & Human Servs., 941 F.3d 1351 (Fed. Cir. 2019) (affirming requirement that expert theories be sound and rejecting unsupported expansion of SIDS model to include vaccination as exogenous stressor)
Lombardi v. Sec'y of Health & Human Servs., 656 F.3d 1343 (Fed. Cir. 2011) (determine what injury is supported before applying Althen)
Walther v. Sec'y of Health & Human Servs., 485 F.3d 1146 (Fed. Cir. 2007) (burden‑shifting principles when petitioner meets Althen)
Doe/11 v. Sec'y of Health & Human Servs., 601 F.3d 1349 (Fed. Cir. 2010) (government may present alternative cause evidence such as SIDS)