D'Tiole v. Secretary of Health & Human Services
132 Fed. Cl. 421
| Fed. Cl. | 2017Background
- Petitioner (received FluMist LAIV on Dec. 13, 2011 as a minor) alleges the vaccine caused narcolepsy with cataplexy; diagnosis confirmed by sleep clinic and HLA DQB1*06:02 testing by 2014.
- Initial sleep complaints appear in medical records beginning Feb.–Mar. 2012 with progressively worse daytime sleepiness and later neurologic/sleep evaluations; treatment with modafinil began after Aug. 2013 evaluation.
- Petitioner filed a Vaccine Act petition (non‑Table claim) in Jan. 2015; Respondent contested causation under Althen; experts submitted competing reports (Petitioner’s expert Dr. Steinman; Respondent’s Drs. Kohrman and MacGinnitie).
- Dr. Steinman advanced a molecular‑mimicry theory linking H1N1 (and studies about Pandemrix) to narcolepsy; Respondent’s experts argued FluMist’s LAIV formulation, manufacturing, and immunologic profile differ materially from Pandemrix and pointed to epidemiology showing no association for FluMist/LAIV.
- Special Master denied compensation on the ground Petitioner failed to satisfy Althen (theories relied on evidence tied to a different vaccine form and did not persuasively connect FluMist to narcolepsy); decision issued on the papers without an evidentiary hearing.
- Court of Federal Claims denied review, holding the Special Master’s factual assessments and weighing of evidence (including epidemiology and expert credibility) were not arbitrary or contrary to law and that declining a hearing was within discretion.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Special Master impermissibly required epidemiologic evidence to satisfy Althen prong 1 | D’Tiole: Special Master demanded epidemiology and thus raised claimant's burden beyond Althen | Gov: Special Master considered epidemiology among other evidence and found it unpersuasive for FluMist | Held: No error — Special Master permissibly weighed epidemiology; did not impose a heightened rule but found petitioner’s theory unreliable in this vaccine context |
| Whether Special Master required proof of a specific biological mechanism in violation of Knudsen | D’Tiole: Demanded mechanistic proof (e.g., nucleoprotein antibodies) contrary to Knudsen/Althen | Gov: Petitioner's own evidence tied mechanism to a different vaccine form (Pandemrix), so mechanistic gaps were probative | Held: No error — Special Master did not demand impossible proof but found petitioner failed to show his theory applied to FluMist |
| Whether petitioner met Althen prongs (causation, logical sequence, temporal relationship) | D’Tiole: Molecular mimicry theory and clinical timeline suffice to satisfy Althen | Gov: Formulation differences, weak epidemiology for LAIV, inconsistent onset records, and lack of evidence of an autoimmune process rebut causation/timing | Held: No — Petitioner failed to satisfy Althen prongs; Special Master’s findings upheld |
| Whether Special Master abused discretion by deciding without an evidentiary hearing | D’Tiole: Hearing needed to clarify novel application of Pandemrix‑based theory to FluMist and permit live expert testimony | Gov: Record was fully developed; experts had opportunity to respond; a hearing was discretionary and unnecessary | Held: No abuse — deciding on the papers was within Special Master's discretion given the record |
Key Cases Cited
- Althen v. Sec’y of HHS, 418 F.3d 1274 (Fed. Cir.) (establishes three‑part test for causation in off‑Table Vaccine Act claims)
- Capizzano v. Sec’y of HHS, 440 F.3d 1317 (Fed. Cir.) (court may not require epidemiologic studies as universal proof)
- Knudsen v. Sec’y of HHS, 35 F.3d 543 (Fed. Cir.) (cautions against requiring proof of specific biological mechanism)
- Hodges v. Sec’y of HHS, 9 F.3d 958 (Fed. Cir.) (deferential review of Special Masters’ fact‑intensive findings)
- Hines v. Sec’y of HHS, 940 F.2d 1518 (Fed. Cir.) (upholds deference where Special Master considered relevant evidence and articulated basis for decision)
- Porter v. Sec’y of HHS, 663 F.3d 1242 (Fed. Cir.) (credibility determinations of experts by Special Masters are virtually unreviewable)
- Lampe v. Sec’y of HHS, 219 F.3d 1357 (Fed. Cir.) (epidemiological studies may be probative and weighed by the Special Master)
- Cedillo v. Sec’y of HHS, 617 F.3d 1328 (Fed. Cir.) (Special Master must consider all record evidence; epidemiology can be weighed alongside other evidence)
- W.C. v. Sec’y of HHS, 704 F.3d 1352 (Fed. Cir.) (molecular mimicry has been litigated previously and may be overbroad in some applications)
- Moberly v. Sec’y of HHS, 592 F.3d 1315 (Fed. Cir.) (discusses off‑Table causation burdens under Vaccine Act)