Oliver v. Sec'y of Health & Human Servs.
900 F.3d 1357
Fed. Cir.2018Background
- Infant E.O. received routine vaccinations (including DTaP) at six months on April 9, 2009 and had a febrile seizure that night; seizures recurred and progressed to a diagnosis of SCN1A-associated Dravet syndrome in 2010.
- Petitioners (Laura and Eddie Oliver) filed a Vaccine Act claim alleging vaccines caused E.O.'s Dravet syndrome; the Chief Special Master denied compensation for failure to prove causation under the Althen framework.
- The Court of Federal Claims affirmed the Special Master's decision; the Olivers appealed to the Federal Circuit, which affirmed the lower courts' rulings.
- The Special Master found the Government's expert and evidence more persuasive on all three Althen prongs (medical theory, logical sequence, temporal relationship) and concluded petitioners failed to show vaccines were a substantial factor.
- Petitioners argued the Special Master misapplied Daubert, improperly applied estoppel and denied a full hearing; the Federal Circuit rejected these arguments as either fact‑weighting challenges or unsupported.
- Judge Newman dissented, arguing that evolving science shows vaccination can trigger Dravet in genetically susceptible infants and that such cases fall squarely within the Vaccine Act's purpose.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Causation under the Vaccine Act (Althen prongs) | Vaccination triggered/severely altered E.O.'s clinical course in conjunction with SCN1A mutation | SCN1A mutation alone explains Dravet; petitioners failed to meet Althen burden | Affirmed: petitioners failed to prove any Althen prong by preponderant evidence |
| Use of Daubert to evaluate expert evidence | Special Master misapplied Daubert and applied an improper evidentiary standard | Special Master properly weighed expert evidence; Daubert inapposite where evidence was admitted and weighed | Affirmed: no Daubert error; credibility and weight determinations are for factfinder |
| Reference to prior similar denials / estoppel claim | Reference to other denials effectively estopped petitioners from full presentation | No equitable estoppel was applied; single reference to similar cases is not estoppel | Affirmed: no estoppel; Special Master considered evidence on the merits |
| Denial of an evidentiary hearing | Denial prevented full and fair adjudication; hearing was needed to resolve disputes | Record was fully developed; Special Master has discretion to deny hearing | Affirmed: denial of hearing within Special Master's discretion |
Key Cases Cited
- Milik v. Sec'y of Health & Human Servs., 822 F.3d 1367 (Fed. Cir.) (standard of review; deferential review of special master's factual findings)
- Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir.) (off‑Table causation requires vaccine as substantial factor)
- Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.) (three‑part causation test for Vaccine Act claims)
- Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (U.S.) (framework for assessing reliability of expert testimony)
- Whitecotton ex rel. Whitecotton v. Sec'y of Health & Human Servs., 81 F.3d 1099 (Fed. Cir.) (appellate courts generally may not consider extra‑record studies)
- de Bazan v. Sec'y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir.) (Daubert inapposite where special master admitted and weighed evidence)
- Terran ex rel. Terran v. Sec'y of Health & Human Servs., 195 F.3d 1302 (Fed. Cir.) (special master's use of Daubert factors permissible)
- Burns ex rel. Burns v. Sec'y of Dep't of Health & Human Servs., 3 F.3d 415 (Fed. Cir.) (special masters have wide discretion to decide whether to hold evidentiary hearings)