J. v. SECRETARY OF HEALTH AND HUMAN SERVICES
1:17-vv-00059-UNJ
Fed. Cl.Feb 9, 2022Background
- Petitioner (L.J.) received an influenza vaccination in the right deltoid on October 20, 2014 and immediately experienced severe local pain; she sought care beginning October 29, 2014 for right shoulder/arm pain with numbness and paresthesias.
- Extensive contemporaneous treatment included multiple courses of physical therapy (≈100 sessions across providers), acupuncture, orthopedic and neurology evaluations, EMG/NCS showing carpal/cubital tunnel findings, and improvement to ~75–85% within ~1 year.
- Petitioner filed a Vaccine Program petition on January 13, 2017 (pre-dating SIRVA’s addition to the Vaccine Injury Table), proceeding on a causation‑in‑fact (Althen) theory.
- Petitioner’s expert, Dr. Marko Bodor, opined vaccination high in the deltoid can penetrate bursa/tendons and cause immune‑mediated shoulder inflammation (SIRVA) with secondary/centrally‑mediated symptoms; Respondent’s expert, Dr. Robert Lightfoot, argued a central sensitivity syndrome (CSS)/fibromyalgia‑type disorder better explains the diffuse, largely objective‑test‑normal presentation.
- The Special Master resolved the case on the papers, finding by preponderance that the flu vaccine caused Petitioner’s right SIRVA (entitlement granted), but rejecting preponderant proof that TMJ and carpal/cubital tunnel syndromes were vaccine‑caused (those were preexisting or unrelated); damages to be determined separately.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does the vaccine have a reliable medical theory to cause SIRVA (Althen prong 1)? | Bodor: injection placed too high can enter subdeltoid/subacromial bursa and trigger immune‑mediated inflammation; literature and his publications support mechanism. | Lightfoot: does not deny SIRVA can occur generally but disputes it here; emphasizes lack of objective inflammatory markers and normal imaging. | Held: Preponderant evidence supports that influenza vaccine can cause SIRVA; prong 1 satisfied. |
| Did the vaccine cause Petitioner’s shoulder injury (Althen prong 2)? | Temporal proximity, immediate severe pain at injection, contemporaneous treating records (PTs, orthopedist, neurologist) documenting shoulder pain, reduced ROM and provider opinions linking injury to vaccination. | Lightfoot: diffuse symptoms, normal inflammatory labs and imaging, and findings of preexisting neuropathies point to CSS or preexisting conditions rather than vaccine causation. | Held: Preponderant evidence shows the vaccine more likely than not caused Petitioner’s right shoulder SIRVA; prong 2 satisfied. |
| Was onset timeframe medically acceptable (Althen prong 3)? | Onset immediate/within hours; first clinic visit nine days later but records describe immediate pain/ burning at time of injection. | Lightfoot stresses lack of abundant contemporaneous documentation of immediate onset beyond patient report. | Held: Onset within medically acceptable timeframe (immediate/within 48 hours); prong 3 satisfied. |
| Are petitioner’s other complaints (TMJ, carpal/cubital tunnel, systemic CSS) vaccine‑related? | Petitioner: secondary effects (e.g., TMJ via compensatory clenching; distal numbness via central down‑regulation) stem from SIRVA. | Respondent: TMJ history predates vaccination; EMG shows preexisting carpal/cubital tunnel; CSS better explains diffuse symptoms. | Held: Preponderant evidence does not support that TMJ or carpal/cubital tunnel syndromes were caused by vaccine; these are preexisting or unrelated. CSS diagnosis was not accepted. |
Key Cases Cited
- Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishes three‑prong test for causation‑in‑fact in Vaccine Program)
- Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (but‑for and substantial factor causation standard; preponderance requirement)
- Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir. 2009) (no single type of evidence required to satisfy Althen prong one)
- Boatmon v. Sec'y of Health & Human Servs., 941 F.3d 1351 (Fed. Cir. 2019) (first Althen prong requires a preponderant evidentiary showing)
- de Bazan v. Sec'y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir. 2008) (timing requirement: medically acceptable temporal relationship)
- Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (Althen prong one requires a legally probable medical theory)
- Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (weight afforded to medical records and treating physician evidence)