Harris v. Secretary of Health & Human Services
102 Fed. Cl. 282
| Fed. Cl. | 2011Background
- Jordan Harris, born March 6, 2004, developed seizures beginning May 2004 soon after the first DTaP vaccination.
- Medical records document multiple seizures through 2007 with various neurologic evaluations; initial seizure temporally associated with vaccination.
- Genetic testing revealed a SCN1A splice-site mutation, with later assessments describing a GEFS+ phenotype and potential SMEI spectrum involvement.
- Petitioner’s expert Dr. Kinsbourne posited a gene-environment interaction: the DTaP vaccine can trigger seizures in a genetically susceptible child.
- Government experts Drs. Wiznitzer and Raymond countered that SCN1A mutation alone explains the epilepsy and that vaccination did not alter outcome.
- Special Master Moran denied compensation, finding SCN1A mutation sole cause; petition for review was granted by the Court of Federal Claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Causation-in-fact under Althen | Harris argues DTaP was a substantial factor. | Government contends mutation alone caused GEFS+; vaccine not substantial factor. | Petition granted; vaccine can be substantial factor under Althen. |
| Was SCN1A mutation the sole cause or an alternate cause? | Mutation is not sole cause; environmental trigger may contribute. | Mutation alone explains GEFS+; no environmental causation. | SCN1A mutation not proven as sole cause; reverse decision; vaccine found causally relevant. |
| Burden of proving alternative causation under 42 U.S.C. § 300aa-13(a)(1)(B) | Government must prove no alternative cause predominates. | Record supports alternative causation via SCN1A mutation. | Government failed to prove sole alternative cause; petitioner entitled to compensation. |
Key Cases Cited
- Althen v. Sec’y of HHS, 418 F.3d 1274 (Fed. Cir. 2005) (establishes three-element causation standard)
- Capizzano v. Sec’y of HHS, 440 F.3d 1317 (Fed. Cir. 2006) (preponderance standard; evidence may satisfy multiple elements)
- Shyface v. Sec’y of HHS, 165 F.3d 1344 (Fed. Cir. 1999) (preponderance of evidence standard; not requiring scientific certainty)
- Knudsen ex rel. Knudsen v. Sec’y of HHS, 35 F.3d 543 (Fed. Cir. 1994) (alternate causation burden; circumstantial evidence permissible)
- Andreu v. Sec’y of HHS, 569 F.3d 1367 (Fed. Cir. 2009) (credibility and weight of medical opinion; epidemiology not sole arbiter)
- Loving v. Sec’y of HHS, 86 Fed.Cl. 135 (Fed. Cl. 2009) (combines Whitecotton framework with Althen elements for significant aggravation context)