Flores v. Secretary of Health and Human Services
115 Fed. Cl. 157
Fed. Cl.2014Background
- Petitioner (Valeria Flores) received first and second HPV vaccinations in April and June 2008; severe neurologic collapse began the day after the second dose, ultimately diagnosed as a spinal cord stroke.
- Extensive workup at Rush and rehabilitation records showed permanent injury and ventilator dependence; clinicians documented rapid onset and lack of inflammatory markers.
- Petitioner alleged the second HPV shot caused a blood clot (spinal cord stroke) via an immune response supercharged by genetic susceptibility.
- Petitioner’s expert (Dr. Kerr) proposed a multi-gene clotting predisposition, priming by the first vaccine, and clot formation after the second vaccine via inflammation or platelet aggregation.
- Respondent’s experts (Drs. Bingham and Gill) countered: clinical data showed no systemic or localized inflammation, D-dimer results made venous thrombosis unlikely, and the timing/biology did not support vaccine-caused clotting.
- The special master denied compensation (finding petitioner failed to prove genetic predisposition and the vaccine–inflammation/platelet aggregation link), and the Court of Federal Claims affirmed, sustaining the special master’s decision.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether special master required petitioner to identify specific genes for genetic susceptibility | Flores: Special master impermissibly demanded identification of specific genes or gene cluster | HHS: Lack of identified genetic cluster undermines petitioner’s causation theory; expert speculation insufficient | Court: Requiring specific gene IDs was error, but harmless because other fatal deficiencies remained |
| Whether special master improperly relied on medical literature to reject causation | Flores: Special master used literature to raise petitioner’s burden contrary to Althen/Capizzano | HHS: Special master may consider literature submitted by parties to evaluate a theory’s reputation and support | Court: No error — special master properly considered submitted literature to assess the theory’s supportability |
| Whether lack of identified alternative cause improperly weighed against petitioner | Flores: Unknown etiology should not detract from petitioner’s theory; lack of alternative cause is respondent’s burden | HHS: Absence of known cause can be considered when assessing petitioner’s prima facie case | Held: Special master permissibly considered lack of alternative cause and concluded idiopathic nature did not bolster petitioner’s theory |
| Whether special master abused discretion rejecting vaccine→inflammation/platelet aggregation link | Flores: Dr. Kerr’s testimony on localized inflammation/platelet aggregation was credible and timing/priming explained rapid reaction | HHS: Clinical tests (CSF, systemic labs, D-dimer) show no inflammation or platelet aggregation; timing inconsistent with proposed mechanism | Court: No abuse of discretion — record lacked evidence that inflammation or platelet aggregation occurred, a required link in the causation chain |
Key Cases Cited
- Althen v. Sec'y of HHS, 418 F.3d 1274 (Fed. Cir.) (articulating three-part test for causation-in-fact under Vaccine Act)
- Capizzano v. Sec'y of HHS, 440 F.3d 1317 (Fed. Cir.) (circumstantial proof of predisposition permitted; petitioner not required to produce medical literature)
- Stone v. Sec'y of HHS, 676 F.3d 1373 (Fed. Cir.) (special master may require evidence that a key component of expert theory actually occurred)
- Moberly v. Sec'y of HHS, 592 F.3d 1315 (Fed. Cir.) (special master entitled to require indicia of reliability for expert assertions)
- Andreu v. Sec'y of HHS, 569 F.3d 1367 (Fed. Cir.) (special master may consider submitted scientific literature to evaluate the reputability of a causation theory)
- Whitecotton v. Sec'y of HHS, 81 F.3d 1099 (Fed. Cir.) (when Table recovery not alleged, causation-in-fact requires preponderant proof under statutory elements)