Payne v. Secretary of Health and Human Services
12-475
| Fed. Cl. | Oct 30, 2017Background
- Petitioner (Thompson) received a trivalent seasonal influenza vaccine on Sept. 15, 2009 (covered by the Vaccine Act) and an H1N1 monovalent vaccine on Oct. 23, 2009 (not Table-covered for 2009–2010 season). She developed neurologic symptoms shortly after the H1N1 dose.
- Medical evaluations were mixed: some neurologists diagnosed or suspected GBS/AIDP/CIDP or post-vaccination polyneuropathy (notably Dr. Carlo Tornatore), while many other treating physicians found normal studies or suggested functional/conversion disorder. Multiple EMGs and one LP were largely normal; some later testing showed demyelinating-appearing lesions on brain MRI and some EMG abnormalities.
- Dr. Tornatore (treating expert) testified that the seasonal vaccine primed memory B cells (per exhibit 126), so the later H1N1 dose triggered an anamnestic/plasmablast response cross-reacting with nervous-system epitopes (molecular mimicry), producing an acute GBS-like syndrome that evolved to CIDP; he treats petitioner with IVIG and attributes persistent objective findings (e.g., Adie pupil, prior urinary retention) to autoimmune neurologic injury.
- Dr. Chaudhry (respondent’s expert) disputed the diagnosis of GBS/CIDP: petitioner’s course and objective testing do not meet Brighton criteria (monophasic course, absent/depressed reflexes, consistent EMG and CSF findings); most EMGs were normal; autonomic signs and Adie’s pupil are not convincingly linked to peripheral autonomic neuropathy; he also questioned the immunologic significance of the priming/recall theory for causing injury here.
- The special master found Dr. Tornatore persuasive, credited treating-physician weight and exhibit 126’s explanation for plasmablast recall, concluded both vaccines were substantial factors (seasonal priming + H1N1 trigger), and ruled in favor of petitioner on entitlement; the case proceeded to damages.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Causation in fact: Did vaccination cause petitioner’s neurologic injury? | Thompson: Seasonal vaccine primed immune response; H1N1 dose triggered an anamnestic, cross-reactive antibody response causing GBS/CIDP-spectrum injury. | HHS: Clinical course, testing, and many treating assessments do not show GBS/CIDP; timing and studies do not support vaccine causation. | Held for petitioner: vaccines were substantial factors and Althen prongs satisfied. |
| Medical theory (Althen prong 1) | Dr. Tornatore: recall/plasmablast activation and molecular mimicry (supported by PNAS article) can cause neuropathy. | Dr. Chaudhry: Article does not show exaggerated pathogenic recall; peak responses are short-lived and would not produce petitioner’s course. | Held that petitioner met prong 1; treating expert and article provided a credible theory. |
| Logical sequence (Althen prong 2) | Temporal sequence: priming (Sept vaccine) then trigger (Oct H1N1) explains rapid onset and subsequent neurologic findings. | Respondent: clinical findings, EMGs, CSF, and course are inconsistent with GBS/CIDP sequence. | Held that a logical cause–effect sequence was shown by preponderance of evidence. |
| Temporal relationship (Althen prong 3) | Thompson: onset within one day of H1N1 is appropriate given priming six weeks earlier. | HHS: onset too rapid and testing inconsistent; recall responses typically peak earlier and wane. | Held that timing was appropriate and satisfied proximate temporal relationship. |
Key Cases Cited
- Althen v. Sec’y of HHS, 418 F.3d 1274 (Fed. Cir. 2005) (sets three-part test for vaccine-causation proof)
- Grant v. Sec’y of HHS, 956 F.2d 1144 (Fed. Cir. 1992) (explains need for affirmative proof of causation beyond absence of other causes)
- Shyface v. Sec’y of HHS, 165 F.3d 1344 (Fed. Cir. 1999) (vaccine need only be a substantial factor, not predominant cause)
- Capizzano v. Sec’y of HHS, 440 F.3d 1317 (Fed. Cir. 2006) (treating-physician opinions merit careful consideration)
- Broekelschen v. Sec’y of HHS, 618 F.3d 1339 (Fed. Cir. 2010) (court’s guidance on evaluating evidence in vaccine cases)
- Andreu v. Sec’y of HHS, 569 F.3d 1367 (Fed. Cir. 2009) (treatment of expert and medical evidence in vaccine claims)