Stone v. Secretary of Health and Human Services
676 F.3d 1373
| Fed. Cir. | 2012Background
- Amelia Stone, born 2001, received DTaP on Aug 27, 2001 and had febrile seizures afterward; SMEI diagnosed and linked to SCN1A de novo mutation; mutation associated with severe phenotype.
- Rachel Hammitt, born 2003, received multiple vaccines on Mar 15, 2004 and had febrile seizures; SMEI diagnosed; SCN1A mutation, de novo, linked to SMEI.
- Petitioners filed under the Vaccine Act seeking compensation for SMEI as caused by vaccines; the SCN1A mutation was argued as the sole causative factor.
- Special Master found SCN1A mutation was the sole cause in both children, vaccines played no role; Court of Federal Claims affirmed.
- On remand, the special master reiterated the sole-cause finding; Federal Circuit affirmed the judgments in both appeals.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Causation standard off-Table in Vaccine Act cases | Petitioners claim vaccines were substantial factor; mutation not sole cause | Government shows mutation solely caused SMEI; vaccine not a factor | Causation standards applied per Walther/Shyface; vaccine not a substantial factor in either case |
| Superseding cause doctrine applicability | DTaP plus SCN1A mutation could be superseding cause | Mutation alone caused SMEI; superseding analysis inapplicable | Superseding-cause analysis not required where mutation found to be sole cause; no superseding analysis used |
| Burden of proof and evidentiary standards | Petitioners argue lower evidentiary burden | Government bore burden on factors unrelated; petitioners must show vaccine causation | Court upheld proper burden and found no error in weighing evidence; petitioners failed to prove vaccine-related brain injury |
| Admission of new evidence on remand | Motion to supplement with article and expert input should be allowed | Record should not be reopened; evidence would require further expert testimony | Special Master did not abuse discretion in denying supplementation on remand |
Key Cases Cited
- Walther v. Sec'y of Health & Human Servs., 485 F.3d 1146 (Fed. Cir. 2007) (causation in off-Table Vaccine Act cases; evidence to show substantial factor)
- Shyface v. Sec'y of Health & Human Servs., 165 F.3d 1344 (Fed. Cir. 1999) (vaccine causation standard; but-for and substantial factor)
- de Bazan v. Sec'y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir. 2008) (record may include alternative causes; not require elimination of all others)
- Doe v. Sec'y of Health & Human Servs., 601 F.3d 1349 (Fed. Cir. 2010) (consideration of the record as a whole; no embargo of relevant evidence)
- Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (off-Table causation framework; Althen principles)
- Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (test for vaccine-causation showing a logical sequence of cause)
- Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (absence of required proof of specific biological mechanism)
- Kinsbourne? (reference within opinion), (not a separate reporter case) () (expert testimony discussion; cited for causation reasoning)