Giannetta v. Secretary of Health and Human Services
13-215
Fed. Cl.Sep 26, 2017Background
- Petitioner Alessandra Giannetta (then 14) received Menactra on June 8, 2011 and later was diagnosed with relapsing‑remitting multiple sclerosis (MS) in early 2012 (MRI with numerous lesions; CSF oligoclonal bands).
- Petitioner and family testified she experienced ascending right‑leg numbness in July 2011 that resolved after ~1 month; additional neurologic episodes (hand/face numbness, blurred vision, slurred speech) occurred in late 2011–Jan 2012.
- Treating evaluations (University of Chicago, Mayo Clinic) documented demyelinating lesions and noted the summer 2011 episode as possibly demyelinating; definitive diagnosis established by MRI/CSF in Jan–Feb 2012.
- Petitioner’s expert (Dr. Lawrence Steinman) advanced a molecular‑mimicry theory: Menactra polysaccharide–diphtheria‑toxoid conjugate triggered adaptive and innate immune responses culminating in CNS demyelination; timing 42–47 days post‑vaccine was asserted as plausible.
- Respondent’s experts (Drs. Mar and Halsey) disputed causation, emphasizing absence of epidemiologic evidence linking Menactra/diphtheria toxoid to MS and alternative explanations (mechanical/orthopedic dermatomal symptoms, possible intercurrent infection/allergies).
- Special Master found onset occurred in July 2011 (42–47 days after vaccination), accepted Dr. Steinman’s molecular‑mimicry/antigen‑memory theory as biologically plausible, rejected respondent’s alternative‑cause proof, and ruled petitioner entitled to compensation; case proceeded to damages.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Onset date of first MS symptoms | July 2011 (ascending right‑leg numbness ~42–47 days post‑vaccine) | Onset in Jan 2012; earlier complaints attributable to musculoskeletal/peripheral causes | Onset found to be July 2011 (42–47 days after vaccination) |
| Causation — biologic mechanism (Althen prong 1) | Menactra’s meningococcal glycans + diphtheria toxoid → molecular mimicry and memory B/T cell activation causing CNS demyelination | No reliable mechanistic link; cited literature does not support Menactra/diphtheria toxoid → MS; glycans poorly immunogenic | Court found Dr. Steinman’s molecular‑mimicry/antigen‑memory theory biologically plausible and reliable enough for Althen prong 1 |
| Causation — logical sequence and alternative causes (Althen prong 2 & burden shifting) | Vaccine triggered aberrant immune response in a predisposed patient producing MS; no competing environmental cause shown | Respondent pointed to possible viral/allergic illness and peripheral/dermatomal causes; emphasized lack of epidemiology | Court found the vaccine more likely than not to have triggered petitioner’s MS and held respondent failed to prove an alternative cause by preponderance |
| Timing (Althen prong 3) | 42–47 days is a medically reasonable risk interval for vaccine‑triggered demyelination (analogy to GBS influenza literature) | Timing analogies to GBS are inapt; no epidemiologic signal for Menactra→MS | Court accepted 42–47 day interval as medically appropriate and consistent with record |
Key Cases Cited
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (three‑part test for off‑table vaccine causation)
- Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (expert proof need not include epidemiologic studies; special master may weigh literature)
- Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (causation proof is case‑by‑case; no rigid scientific rules)
- Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (special master may require indicia of reliability for expert testimony)
- Whitecotton v. Sec’y of Health & Human Servs., 17 F.3d 374 (Fed. Cir. 1994) (burden‑shifting to respondent once petitioner establishes prima facie case)
- Walther v. Sec’y of Health & Human Servs., 485 F.3d 1146 (Fed. Cir. 2007) (respondent must show alternative cause by preponderance after prima facie case)
- Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344 (Fed. Cir. 1999) (vaccination need only be a substantial factor; but‑for causation standard explained)