Auch v. Secretary of Health and Human Services
12-673
| Fed. Cl. | Mar 16, 2017Background
- Kathleen J. Auch received a Fluzone influenza vaccine on October 6, 2009 and sought compensation under the National Vaccine Injury Compensation Program alleging a generalized polyneuropathy.
- She reported immediate post-vaccination symptoms (dizziness, blurry vision, weakness), multiple ER visits and a five-day hospital admission in mid‑October 2009; contemporaneous neurology workup (including an October 15, 2009 EMG) was read as unremarkable for polyradiculoneuropathy and favored POTS or non‑specific causes.
- In August 2010 she was diagnosed with an axonal motor and sensory polyneuropathy by neurologist Dr. Raval; an EMG that month confirmed distal symmetrical polyneuropathy.
- Petitioner’s experts (Drs. Neumayr and Steinman) argued the flu vaccine triggered an autoimmune neuropathy via molecular mimicry; Respondent’s expert (Dr. Lancaster) disputed causation, emphasizing the negative 2009 EMG, clinical course, and the long gap before the 2010 diagnosis.
- Key factual disputes: whether October 2009 symptoms represented a vaccine‑caused neuropathy, whether the October 2009 EMG could have been masked by steroid(s), and whether the 2010 polyneuropathy is temporally and causally linked to the 2009 vaccination.
- Special Master Corcoran found Althen prong one (plausible biological theory) satisfied but concluded Petitioner failed to prove Althen prongs two and three (actual causation and medically‑acceptable timing) and dismissed the claim.
Issues
| Issue | Auch's Argument | Secretary's Argument | Held |
|---|---|---|---|
| Did the flu vaccine cause petitioner’s polyneuropathy (causation‑in‑fact)? | Vaccine triggered autoimmune neuropathy (molecular mimicry); October 2009 symptoms were onset and 2010 diagnosis is related. | Record does not support vaccine causation; alternative explanations and inconsistent clinical findings. | Denied — petitioner failed to prove vaccine more likely than not caused the 2010 polyneuropathy. |
| Were petitioner’s October 2009 symptoms neuropathic and vaccine‑related? | October 2009 spells were early manifestations of vaccine‑induced neuropathy. | Contemporaneous examinations/EMG did not show neuropathy; symptoms fluctuated and improved quickly, inconsistent with acute neuropathy. | Held against petitioner — 2009 symptoms not shown to be neuropathic or vaccine‑caused. |
| Could the October 15, 2009 EMG have been falsely negative due to steroid treatment? | Steroid (methylprednisolone) given before EMG could have masked abnormalities. | One short steroid dose would not normalize EMG within days; treating neurologist’s interpretation reliable. | Held against petitioner — steroid masking not persuasively demonstrated; negative 2009 EMG undermines proximate causation. |
| Was the ~10‑month interval between vaccination and formal polyneuropathy diagnosis medically acceptable under petitioner’s theory? | If onset began ~1 week post‑vaccination, an autoimmune course could account for later confirmed neuropathy. | Long asymptomatic interval and symptom remission in 2010 inconsistent with vaccine causation. | Held against petitioner — petitioner failed to show a medically‑acceptable temporal link given the record and clinical course. |
Key Cases Cited
- Althen v. Secretary of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.) (establishes three‑prong test for vaccine causation)
- Moberly v. Secretary of Health & Human Servs., 592 F.3d 1315 (Fed. Cir.) (preponderance standard and substantial‑factor but‑for causation explained)
- Capizzano v. Secretary of Health & Human Servs., 440 F.3d 1317 (Fed. Cir.) (treatment of medical theory and role of expert evidence in vaccine cases)
- Knudsen v. Secretary of Health & Human Servs., 35 F.3d 543 (Fed. Cir.) (discussion of required showing for Althen prong one)
- Cedillo v. Secretary of Health & Human Servs., 617 F.3d 1328 (Fed. Cir.) (use of Daubert factors and reliability of expert testimony in Vaccine Program disputes)