Santacroce v. Secretary of Health and Human Services
15-555
| Fed. Cl. | Dec 28, 2016Background
- Petitioner Sabrina Santacroce filed a Vaccine Program claim on behalf of her son J.R. alleging Varivax, Prevnar, and hepatitis A vaccines administered March 8, 2013 caused dystonia musculorum deformans.
- J.R. had earlier vaccinations in April 2012 and subsequent vaccinations in August 2013; petitioner reported onset of abnormal movements and other symptoms after the March 2013 and August 2013 shots.
- Medical records (neurologic exam and prolonged EEG) showed normal neurological findings, developmental milestones normal, and treating clinicians attributed episodes to behavioral/temper tantrum phenomena rather than seizures or a neurologic disorder.
- A VAERS report described seizure-like activity after August 2013 vaccinations, but treating physicians’ objective testing and notes contradicted that characterization.
- Petitioner acknowledged she likely could not meet the burden to prove medical/scientific causation and moved for dismissal; no expert report was submitted to support causation.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether vaccines caused J.R.’s dystonia (causation-in-fact) | Vaccines temporally associated with onset; vaccines caused abnormal movements | Medical records and testing do not support a vaccine-caused neurologic condition; behavioral explanation fits findings | Dismissed for failure to prove medical causation; temporal association insufficient |
| Whether petitioner provided a persuasive medical theory linking vaccine to injury | Implicitly argued vaccines explain symptoms; relied on temporal proximity | No expert or reputable medical explanation provided in record | Dismissed: petitioner failed to present a medical theory or expert support |
| Whether other evidence (VAERS, parental reports) can substitute for medical records/expert opinion | VAERS and parental observations show post-vaccination events supporting claim | VAERS and lay reports do not overcome objective normal testing and treating clinicians’ conclusions | Dismissed: unsubstantiated assertions cannot satisfy Vaccine Act burden |
| Timeliness/statute of limitations regarding 2012 vaccinations | If April 2012 vaccines caused onset within days, claim would be time-barred; petitioner instead alleged 2013 events | Respondent notes potential statute of limitations and problems alleging hereditary condition caused by vaccine | Court observed statute-of-limitations issue and genetic nature of dystonia as additional concerns; dismissal stands on causation failure |
Key Cases Cited
- Althen v. Sec’y of HHS, 418 F.3d 1274 (Fed. Cir.) (establishes three-part test for causation in Vaccine Program)
- Grant v. Sec’y of HHS, 956 F.2d 1144 (Fed. Cir.) (absence of other causes does not satisfy petitioner’s affirmative burden; need reputable medical/scientific explanation)
- Shyface v. Sec’y of HHS, 165 F.3d 1344 (Fed. Cir.) (petitioner must show vaccination was a substantial factor in causing injury)