Silverio v. Secretary of Health and Human Services
15-235
| Fed. Cl. | Dec 9, 2019Background
- Petitioner Kristen Silverio filed a Vaccine Program petition for her minor child G.L. after G.L. received varicella and pneumococcal conjugate vaccines on April 16, 2012.
- Within 24 hours G.L. developed fever and a prolonged, focal complex febrile seizure (status) and had multiple subsequent febrile and afebrile seizures; she was later diagnosed with intractable epilepsy.
- Petitioner’s expert (Dr. Siegler) opined vaccine‑induced fever triggered complex febrile status epilepticus that produced cortical/functional changes and ultimately frontal‑lobe epilepsy.
- Respondent’s expert (Dr. Holmes) agreed vaccines can cause fever and provoke febrile seizures but maintained febrile seizures do not cause chronic frontal‑lobe epilepsy and posited a preexisting lesion or infection as alternative causes.
- The special master credited treating‑physician contemporaneous notes, found petitioner met Althen’s three prongs, rejected respondent’s alternative‑cause showing, and awarded entitlement to compensation (case proceed to damages).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Causation of April 17, 2012 seizure by April 16 vaccinations | Vaccines caused fever within 24 hrs that triggered complex febrile (status) seizure | Vaccines unlikely; elevated WBC suggests infection caused fever/seizure | Held for petitioner: vaccines were a substantial factor causing the vaccine‑proximate febrile seizure; treating notes support vaccine link |
| Medical theory linking vaccine to epilepsy (Althen prong 1) | Vaccine → fever → prolonged/focal febrile seizures → seizure‑induced cortical/functional changes → epilepsy | Even if vaccines caused fever/seizure, literature supports causation only for temporal‑lobe injury; frontal‑lobe epilepsy requires preexisting focus | Held for petitioner: Dr. Siegler’s theory supported by literature and was sufficiently reputable and reliable |
| Logical sequence that vaccines caused this petitioner’s epilepsy (Althen prong 2) | First vaccine‑proximate complex focal/status events lowered threshold and produced cascading network changes, leading to intractable epilepsy | Complex febrile seizures reflect underlying brain disease that would have produced epilepsy regardless of fever | Held for petitioner: sequence accepted given normal pre‑seizure development, treating physicians’ contemporaneous opinions, and supportive literature |
| Temporal relationship (Althen prong 3) | Onset within 24 hours is medically appropriate to infer causation | Timing alone insufficient; even if proximate, it does not establish causation of later epilepsy | Held for petitioner: temporal proximity appropriate and satisfied prong three |
| Alternative causes (respondent burden after Althen) | N/A (petitioner not required to eliminate all alternatives) | Infection or preexisting frontal lesion caused seizures/epilepsy | Held for petitioner: respondent failed to prove alternative sole substantial cause; no preexisting lesion documented and WBC elevation was attributed to stress/seizure in records |
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 Vaccine Act cases)
- Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (discusses Table vs. off‑Table claims and evidentiary standards)
- Andreu ex rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir. 2009) (expert testimony must be supported by reputable medical/scientific explanation)
- Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352 (Fed. Cir. 2006) (Vaccine can be a substantial factor and need not be sole cause)
- Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344 (Fed. Cir. 1999) (discusses substantial‑factor and but‑for standards)
- de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir. 2008) (temporal relationship requirement under Althen)
- Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d 1363 (Fed. Cir. 2013) (burden shifts to respondent to prove alternative cause)
- Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (no per se scientific rules; causation resolved case‑by‑case)
- Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373 (Fed. Cir. 2012) (addresses application of Althen and evaluation of expert proof)
- LaLonde v. Sec’y of Health & Human Servs., 746 F.3d 1334 (Fed. Cir. 2014) (requires trustworthy expert testimony tied to supporting medical literature)