Harmon v. Secretary of Health and Human Services
12-298
| Fed. Cl. | Jul 6, 2017Background
- Petitioner Shelaine Harmon received Gardasil (HPV vaccine) on June 4, 2009, and developed neurologic symptoms (hip/leg pain, tingling, numbness) beginning by mid‑July 2009 and more severe neurologic events in early August 2009.
- Hospital workup (Aug 2009) showed brain lesions on MRI and CSF oligoclonal bands; treating teams considered MS, ADEM, and CNS vasculitis.
- Petitioner experienced multiple relapses (Oct 2009, Mar 2010, 2015), progressive white‑matter disease on serial MRIs, an open brain biopsy (Mar 2010) not consistent with classic MS plaque, and varied expert/treating opinions but eventual treating neurologists favored an atypical relapsing demyelinating disorder most consistent with MS.
- Petitioner alleged the HPV vaccine caused a chronic autoimmune CNS demyelinating illness; expert for petitioner (Dr. Souayah) advanced molecular mimicry between HPV antigens and myelin as the mechanism and argued timing (onset ≈40 days post‑vaccine) was medically acceptable.
- Respondent disputed causation (expert Dr. Leist), arguing the epidemiologic literature shows no association, case reports/VAERS are insufficient, timing and pathology were atypical for vaccine causation, and a concurrent molluscum contagiosum infection or preexisting/longstanding disease could explain findings.
- Chief Special Master Nora Beth Dorsey found petitioner met the preponderance standard and awarded entitlement, concluding the vaccine likely caused petitioner’s CNS demyelinating condition under Althen.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether petitioner suffered a qualifying CNS inflammatory demyelinating injury | Harmon: records, MRI, CSF oligoclonal bands and treating opinions support an inflammatory demyelinating disorder (atypical MS) | HHS: presentation and biopsy atypical; various differential diagnoses (vasculitis, others) undermine clear diagnosis | Held: petitioner has a CNS inflammatory demyelinating condition, likely an atypical relapsing MS (precise label not required) |
| Onset timing of injury relative to vaccination | Harmon: sensory symptoms began by mid‑July 2009 (~40 days post‑vaccine), with MRI/CSF evidence in early Aug 2009 — compatible with molecular mimicry timing | HHS: onset and oligoclonal band timing outside preferred intervals for ADEM; later relapses remote from vaccine weaken causal link | Held: onset by July 14, 2009 (≤40 days), a medically acceptable temporal relationship for the asserted mechanism |
| Whether HPV vaccine can cause CNS demyelination (Althen Prong 1) | Harmon: molecular mimicry plausible; literature (including Wucherpfennig & Strominger) shows sequence homology between HPV peptides and myelin proteins; vaccines can be highly immunogenic | HHS: no epidemiologic proof of association; case reports/VAERS insufficient; non‑live vaccine less likely than infection to provoke chronic autoimmune CNS disease | Held: petitioner provided preponderant evidence that HPV vaccine can cause CNS demyelinating conditions via molecular mimicry; Prong 1 satisfied |
| Whether vaccination was actual cause of petitioner’s illness (Althen Prong 2 & 3) | Harmon: temporal sequence, MRI lesions consistent with symptoms, CSF oligoclonal bands, lack of alternative explanation, and expert opinion establish logical sequence and proximate timing | HHS: alternative explanations (concurrent molluscum infection, preexisting disease) and atypical pathology/timing argue against causation | Held: Petitioner met burden on Althen Prongs 2 and 3 — vaccine was a substantial factor and timing was medically acceptable; entitlement granted |
Key Cases Cited
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (sets three‑prong test for causation‑in‑fact in Vaccine Program cases)
- Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (discusses burden and weighing expert testimony)
- Cappizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (treating physicians’ records and opinions are favored evidence)
- Lombardi v. Sec’y of Health & Human Servs., 656 F.3d 1343 (Fed. Cir. 2011) (special master’s role is to decide causation based on whole record, not to render a novel clinical diagnosis)
- Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir. 2009) (expert opinion may suffice absent supporting literature)
- Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir. 2010) (credibility and persuasiveness of competing experts are central to Vaccine Program decisions)
- Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (no rigid scientific rules; flexible causation analysis permitted)