911 F.3d 1381
Fed. Cir.2019Background
- Infant E.O. received routine six‑month DTaP vaccinations and within hours developed fever and seizures, followed by recurrent seizures, encephalopathies, and developmental disability.
- Post‑injury genetic testing identified an SCN1A gene mutation associated in some patients with Dravet syndrome.
- Petitioners (E.O.’s parents) sought compensation under the National Childhood Vaccine Injury Act (Vaccine Act); Special Master and courts concluded the mutation was the sole cause, disqualifying recovery.
- The government argued that the SCN1A mutation would have caused the injury regardless of vaccination, so the Vaccine Act does not apply.
- Judge Newman dissented from denial of rehearing en banc, arguing that evolving science (vaccinomics/adversomics) shows genetics often interact with vaccines and that removing cases where vaccination triggered injury but a mutation is present undermines the Act’s purpose.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Vaccine Act compensation is barred because the claimant has a genetic mutation that could cause the injury | Oliver: Vaccination triggered seizures and consequent injury; presence of a mutation should not bar compensation when vaccine initiated the harm | HHS: The SCN1A mutation was the sole cause; vaccination was irrelevant to legal entitlement to compensation | Court denied rehearing; lower rulings treating mutation as sole cause stand (dissent argues this is erroneous) |
| Whether preexisting genetic conditions constitute "significant aggravation" vs. exclusive causation | Oliver: Genetic findings may interact with vaccine exposure and do not establish sole causation | HHS: Mutation alone explains the injury; not a vaccine‑caused condition under the Act | Court and Special Master found mutation as sole cause, excluding Vaccine Act relief; dissent disputes this interpretation |
| Whether new scientific evidence (post‑decision) showing incomplete penetrance/variable phenotypes of SCN1A should alter causation analysis | Oliver: New science shows not all with SCN1A develop Dravet; vaccination can precipitate phenotype; merits reconsideration en banc | HHS: Earlier decisions stand; causation findings sufficient | Petition for rehearing en banc denied; dissent urges en banc to reassess in light of advancing science |
| Whether judicial precedent interpreting genetic causation in vaccine cases should be revisited given advances in genetics and "adversomics" | Oliver: Precedents oversimplify causation; court should adapt to scientific advances to preserve Vaccine Act purpose | HHS: Prior case law supports exclusion where mutation shown as sole cause | Court declined en banc rehearing; dissent argues precedent is inconsistent with current science |
Key Cases Cited
- Snyder v. Secretary of Health & Human Services, [citation="553 F. App'x 994"] (Fed. Cir.) (discussing SCN1A mutation as sole cause in a vaccine injury context)
- Deribeaux ex rel. Deribeaux v. Secretary of Health & Human Services, 717 F.3d 1363 (Fed. Cir. 2013) (affirming finding that SCN1A mutation was sole substantial cause of post‑vaccination seizures and delays)
- Stone v. Secretary of Health & Human Services, 676 F.3d 1373 (Fed. Cir. 2012) (holding a genetic mutation solely responsible for vaccine‑initiated seizures)