Vega v. Secretary of Health and Human Services
13-183
Fed. Cl.May 26, 2017Background
- Infant D.V.M. (born Jan 12, 2010) received routine 2‑month vaccinations including DTaP on March 12, 2010; pediatric exam that day was normal.
- Within ~24 hours parents observed sleepiness, decreased feeding, then at ~9:00 p.m. abnormal rightward gaze/head posture; by early March 13 he was unresponsive and seizing.
- Imaging on March 13, 2010 showed a ~1.5 cm hemorrhage at the left ambient cistern/brainstem with intraparenchymal, intraventricular, and subarachnoid blood; serial MRIs thereafter showed interval improvement and no definitive vascular malformation.
- Treating teams considered nonaccidental trauma and structural/vascular lesion in differential; ophthalmology found no retinal hemorrhages; serial imaging and later MRIs did not identify a residual lesion or malformation.
- Petitioners filed a Vaccine Program claim alleging a Table encephalopathy within 72 hours of DTaP; respondent conceded encephalopathy met Table criteria but argued an exception applied because a structural vascular lesion caused the hemorrhage.
- Experts: respondent’s Dr. Wiznitzer opined an occult vascular malformation ruptured (destroying itself) prior to vaccination; petitioner’s Dr. Kinsbourne found no evidence of structural lesion and argued timing was consistent with vaccine encephalopathy.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether D.V.M. suffered a Table encephalopathy within the required time | D.V.M. had significantly decreased consciousness and hospitalization within 72 hours of DTaP, satisfying Table criteria | Respondent conceded the encephalopathy met Table criteria | Held for petitioners — encephalopathy met Table criteria |
| Whether respondent proved an alternative cause (structural/vascular lesion) by preponderance | No imaging or follow‑up record demonstrated a persistent vascular malformation; clinical onset after vaccination supports vaccine causation | An acute bleed from an occult vascular malformation destroyed the lesion, explaining absence on later imaging; hemorrhage preceded vaccination or was unrelated to it | Held for petitioners — respondent failed to show preponderant evidence of structural lesion as cause |
| Timing/causation relationship between vaccination and neurological onset | Onset of neurological signs (gaze/head turn, unresponsiveness) began hours after vaccination — consistent with vaccine encephalopathy timing | Hemorrhage was evolving before or independent of vaccination; temporal association not causal | Held for petitioners — record supports onset after vaccination and no evidence hemorrhage predated vaccine |
| Burden allocation and close‑calls rule in Vaccine Program | Close calls resolved for petitioners; if cause not proven by preponderance, Table presumption stands | Respondent must show factors unrelated to vaccine by preponderance to rebut presumption | Held for petitioners — close‑calls rule and lack of preponderant contrary evidence leave Table presumption intact |
Key Cases Cited
- Rooks v. Sec’y of Health & Human Servs., 35 Fed. Cl. 1 (1996) (describing the Vaccine Program’s remedial purpose to compensate vaccine‑injured persons fairly and expeditiously)
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (close calls in Vaccine Program resolved in favor of petitioner)