Garner v. Secretary of Health and Human Services
15-63
| Fed. Cl. | May 3, 2017Background
- Petitioner Finnettia Garner received Twinrix (Hep A+B) and typhoid vaccines on December 13, 2011 and later alleged she developed Parsonage-Turner Syndrome (PTS) and related injuries.
- Petitioner reports initial severe right-shoulder pain 45 days post-vaccination while in Angola, with subsequent left-shoulder pain beginning in June 2012; contemporaneous records are sparse and show no treatment for the January episode.
- An EMG/NCS performed June 26, 2012 was normal; orthopedist Dr. Shah recorded a tentative diagnosis of “possible” PTS in June–July 2012, but records also show left humeral subluxation and other plausible non-vaccine explanations.
- Petitioner relied on immunologist Dr. Yehuda Shoenfeld (molecular mimicry and ASIA/adjuvant theories); Respondent’s expert Dr. Eric Lancaster (neurologist) contested the PTS diagnosis and causation, emphasizing normal electrodiagnostic testing and typical rapid onset of PTS.
- Special Master Corcoran reviewed the written record and expert reports, declined a hearing, and evaluated the claim under the Vaccine Act and the Althen three-prong test for non‑Table causation.
- Ruling: the petition was dismissed for failure to prove by preponderant evidence that Twinrix caused PTS — petitioner failed Althen prongs (timing, logical sequence, and persuasive theory/evidence).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| 1) Diagnosis: whether petitioner had PTS | Garner contends clinical history and treating physician’s notes support PTS | Respondent notes lack of objective PTS signs (no atrophy, no persistent weakness/numbness) and a normal EMG/NCS | Court: PTS diagnosis not persuasively established; treating note weight limited by missing/contradictory objective data |
| 2) Causal theory reliability (ASIA / molecular mimicry) | Shoenfeld: vaccines can induce autoimmunity via molecular mimicry and adjuvant (ASIA) mechanisms | Lancaster: ASIA is unreliable; molecular mimicry not shown for PTS here; cited literature and mechanisms not persuasive | Court: Molecular mimicry could be a plausible mechanism in general, but ASIA was not persuasive and Shoenfeld’s showings were insufficient for this case |
| 3) Temporal relationship (Althen prong 3) | Petitioner: onset 45 days post-vaccination is medically appropriate for an autoimmune trigger | Respondent: 45 days is too long for PTS causation given typical rapid onset; literature shows shorter windows (days–6 weeks) | Court: 45-day (and the later waxing/waning course) was not shown to be a medically-acceptable timeframe for vaccine-caused PTS in this record |
| 4) Overall proof / logical sequence (Althen prong 2 and burden) | Petitioner: combining history, Shoenfeld’s theory, and some literature supports vaccine causation | Respondent: alternative explanations (subluxation, travel/flight, car accident), absent treating providers’ linkage to vaccine, and normal testing defeat logical causation | Court: Petitioner failed to present a preponderant logical sequence tying vaccine to injury; alternative explanations and missing corroboration dispositive |
Key Cases Cited
- Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (preponderance standard and burden explanation in Vaccine Program)
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (three‑prong test for non‑Table vaccine causation)
- Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (standards for vaccinerelated expert evidence)
- Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir. 2009) (treatment of expert theory and medical literature in Althen prong one)
- Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328 (Fed. Cir. 2010) (evaluation of scientific evidence and expert testimony in Vaccine Program)
- Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir. 2010) (weighing competing expert testimony)