Faoro v. Secretary of Health & Human Services
128 Fed. Cl. 61
Fed. Cl.2016Background
- H.E.F., born August 28, 2007, received routine pediatric vaccinations at two and four months (including DTaP-containing Pediarix, Hib, Prevnar, RotaTeq). Shortly after her four‑month vaccines she had focal seizures and thereafter recurrent, prolonged febrile and afebrile seizures beginning December 28–29, 2007.
- Genetic testing (2008) identified a novel truncating SCN1A mutation; 70–80% of Dravet syndrome cases are linked to SCN1A mutations. H.E.F.’s mother tested positive for the mutation but is asymptomatic; respondent attributed this to parental mosaicism.
- H.E.F. developed the clinical phenotype of Dravet syndrome (temperature‑sensitive prolonged seizures, later developmental delay and ataxia) and was formally diagnosed in 2013.
- Petitioners filed a Vaccine Act claim alleging vaccines either caused or significantly aggravated H.E.F.’s seizures/Dravet syndrome; respondent argued the SCN1A mutation was the sole substantial cause unrelated to vaccination.
- Chief Special Master Dorsey denied compensation (finding the SCN1A mutation caused the condition and vaccines did not alter prognosis); petitioners sought review and the Court denied their motion.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether petitioner met Althen causation-in-fact showing vaccines caused H.E.F.’s Dravet syndrome | Vaccines (via fever/immune response) provided a "second hit" triggering seizures and earlier onset; petitioners relied on possibility vaccines could trigger first seizure | Respondent conceded vaccines can trigger fever/seizures but maintained SCN1A truncation mutation explains onset/prognosis and vaccines do not change disease course | Court upheld Special Master's finding that petitioners did not meet Althen; SCN1A mutation was more persuasive cause; petitioners’ burden was not increased |
| Whether respondent proved an alternative sole substantial cause (Knudsen/De Bazan framework) | Petitioners argued once they propose a causal theory, respondent cannot meet alternative‑cause burden and petitioners need only a plausible theory | Respondent offered SCN1A mutation (inherited from mother with mosaicism) as the sole substantial factor causing Dravet syndrome | Court agreed with Special Master that respondent met alternative‑cause framework; mosaicism plausibly explains maternal asymptomatic status and mutation is sole substantial cause |
| Whether vaccines significantly aggravated a preexisting condition (Loving test) | Petitioners urged treating the preexisting SCN1A condition as benign and showing vaccine altered its course | Respondent and Special Master relied on clinical course of Dravet and expert testimony showing truncating SCN1A mutations predict severe course irrespective of vaccines | Court affirmed Special Master’s Loving analysis: vaccines did not significantly aggravate Dravet syndrome in this case |
| Admissibility/consideration of post‑hearing supplemental genetic evidence | Petitioners objected to untimely respondent evidence and argued it altered burden | Respondent obtained additional SCN1A literature and a database; parties agreed to redact argumentative portions and file the material | Court noted outcome would be same even without supplemental report; admission did not change result |
Key Cases Cited
- Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishing three‑prong test for causation‑in‑fact in Vaccine Act cases)
- Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (government's alternative causation proof held to same standards as petitioner's causation proof)
- De Bazan v. Sec'y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir. 2008) (Vaccine Act sole‑substantial‑factor analysis explained)
- Deribeaux v. Sec'y of Health & Human Servs., 717 F.3d 1363 (Fed. Cir. 2013) (affirming denial of compensation where SCN1A mutation was found to be disease cause unrelated to vaccination)
- Munn v. Sec'y of Health & Human Servs., 970 F.2d 863 (Fed. Cir. 1992) (standards of review for special master findings)
- Loving v. Sec'y of Health & Human Servs., 86 Fed. Cl. 135 (Fed. Cl. 2009) (framework for determining significant aggravation under the Vaccine Act)