Patton v. Secretary of Health and Human Services
15-1553
| Fed. Cl. | Jun 11, 2021Background:
- Petitioner (then 15) received an influenza vaccine on Jan 11, 2013 and developed acute bilateral upper‑extremity weakness and pain six days later; he was admitted to All Children’s Hospital.
- Initial workup (CT, brain and spine MRIs, EMG/NCS, labs) was largely normal except for a small C5–C6 disc bulge; treating neurologist concluded resolving brachial neuritis (Parsonage‑Turner syndrome).
- Petitioner later amended his claim to assert radiculomyelitis; experts for petitioner (Dr. Morgan, then Dr. Napoli) advanced radiculomyelitis and/or concurrent brachial neuritis caused by the vaccine via molecular mimicry.
- Respondent’s expert (Dr. Chaudhry) disputed both diagnoses and emphasized normal MRIs, normal EMG/NCS, inconsistent exam findings, and lack of CSF or MRI evidence of myelitis or radiculitis.
- Special Master held petitioner proved brachial neuritis (treating physicians’ views, clinical picture, literature) but did not prove radiculomyelitis; petitioner failed Althen prong one (sound theory) and prong two (logical sequence), though prong three (timing) was satisfied. Case dismissed.
Issues:
| Issue | Patton's Argument | HHS's Argument | Held |
|---|---|---|---|
| Whether petitioner suffered radiculomyelitis | Experts (Morgan/Napoli) say clinical signs (T4 sensory level, Babinski, band‑like chest pain) support radiculomyelitis | Normal MRIs, normal EMG/NCS, lack of CSF or objective evidence; treating docs did not diagnose it | Not proven by preponderant evidence; radiculomyelitis rejected |
| Whether petitioner suffered brachial neuritis (PTS) | Treating physicians diagnosed PTS; petitioner’s expert (Napoli) supports it and literature shows variable presentations | Respondent argues atypical features (bilateral, rapid improvement, negative EMG/MRI) undermine diagnosis | Proven by preponderant evidence (treating‑physician weight + literature) |
| Althen prong 1 — Is there a reliable theory that flu vaccine can cause brachial neuritis? | Napoli: autoimmune mechanism (molecular mimicry) analogized from flu→GBS literature and case reports | Molecular mimicry invoked without mechanistic or epidemiologic support specific to flu→axonal brachial neuritis; IOM found no causal epidemiology | Prong 1 not met — theory insufficiently supported for flu→brachial neuritis |
| Althen prong 2 — Logical sequence that vaccine caused this petitioner’s brachial neuritis | Temporal proximity, lack of alternative trigger, treating physicians’ nexus | Lack of mechanistic link, inconsistent/atypical clinical course, no objective corroboration beyond timing | Prong 2 not met — causal sequence not demonstrated (timing alone insufficient) |
Key Cases Cited
- Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (sets three‑prong causation‑in‑fact test used in Vaccine Program)
- Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir. 2010) (diagnosis identification is prerequisite to Althen analysis)
- Lombardi v. Sec'y of Health & Human Servs., 656 F.3d 1343 (Fed. Cir. 2011) (petitioner must prove at least one recognized injury before Althen)
- Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (treating‑physician opinions are highly probative on diagnosis and causation)
- Boatmon v. Sec'y of Health & Human Servs., 941 F.3d 1351 (Fed. Cir. 2019) (Althen prong one requires a "sound and reliable" medical theory)
- Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (petitioners need not prove scientific certainty; preponderance standard)
- LaLonde v. Sec'y of Health & Human Servs., 746 F.3d 1334 (Fed. Cir. 2014) (plausible theory alone is insufficient; must be reputable and case‑specific)
- Hibbard v. Sec'y of Health & Human Servs., 698 F.3d 1355 (Fed. Cir. 2012) (failure on any Althen prong is dispositive)