Jimenez v. Secretary of Health and Human Services
17-1190
| Fed. Cl. | Jul 28, 2021Background
- In Sept. 2014 the petitioner (age 15) received first doses of HPV and Hepatitis A vaccines; about one week later he developed a salmon‑colored rash followed by fevers, migratory arthralgias, night sweats and systemic inflammatory markers.
- Extensive inpatient and outpatient workups (Dec 2014–2016) excluded infectious and malignant causes; treating rheumatologists ultimately diagnosed systemic juvenile idiopathic arthritis (sJIA) and treated him with corticosteroids and cytokine inhibitors (IL‑6 and IL‑1 agents).
- Petitioner’s expert (Dr. M. Eric Gershwin) proposed a causation theory: vaccination (especially HPV) induced innate immune cytokine release that, in a genetically susceptible host, triggered persistent macrophage/innate immune dysregulation leading to sJIA.
- Respondent’s experts (Drs. Rosé and Platt) disputed causation: they questioned the sJIA diagnosis versus CAPS/Muckle‑Wells, argued the proposed mechanism lacked precedent and that post‑vaccine cytokine responses are transient and epidemiology does not support vaccine‑caused sJIA.
- The special master found by preponderant evidence that petitioner suffers from sJIA and that the HPV and/or Hep A vaccines caused the sJIA, concluding petitioner satisfied all three Althen prongs and is entitled to compensation.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Diagnosis | sJIA: clinical picture, labs, biopsy, treating physicians’ diagnoses | CAPS/MWS or other autoinflammatory disorder should be considered; biopsies and rash features atypical for sJIA | Court found sJIA established by preponderance; CAPS not supported by clinical features or testing |
| Causation theory (Althen prong 1) | Vaccine (esp. HPV) induces cytokines → in genetically susceptible host causes persistent macrophage dysregulation → sJIA | Theory is speculative/overbroad; vaccines cause only transient cytokine increases; no consensus or epidemiologic support | Accepted: theory deemed medically plausible and sufficiently reliable for Program purposes |
| Logical sequence / but‑for causation (Althen prong 2) | Temporal onset of rash then systemic inflammation consistent with mechanistic model; extensive negative workup for alternate triggers | Coincidence plausible; absence of treating‑physician attribution to vaccine; other unexcluded triggers possible | Accepted: circumstantial course, labs, and response to cytokine inhibitors support vaccine as substantial factor |
| Temporal relationship (Althen prong 3) | Rash began ~1 week after vaccination; cited studies showing cytokine elevations up to 14 days post‑vaccination | Typical vaccine cytokine response resolves within 72 hours; one‑week onset inconsistent with proposed mechanism | Accepted: one‑week onset found medically acceptable given cited literature (Herrin/Hervé) |
Key Cases Cited
- Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishes three‑prong test for vaccine causation)
- Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir. 2009) (treating physicians’ opinions and contemporaneous records are given weight)
- Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (circumstantial evidence and reliable medical opinion can satisfy causation)
- Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir. 2010) (appropriate to resolve diagnosis before Althen analysis)
- Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (preponderance standard explained; vaccines must be a substantial factor)
- Pafford v. Sec'y of Health & Human Servs., 451 F.3d 1352 (Fed. Cir. 2006) (but‑for and substantial‑factor principles in vaccine causation)
- Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (medical theory need not be scientifically certain but must be reliable)
- Boatmon v. Sec'y of Health & Human Servs., 941 F.3d 1351 (Fed. Cir. 2019) (requiring a "sound and reliable" medical theory for Althen prong one)
- De Bazan v. Sec'y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir. 2008) (requires medically acceptable temporal relationship)
- Koehn v. Sec'y of Health & Human Servs., 773 F.3d 1239 (Fed. Cir. 2014) (same vaccine and illness; emphasized temporal association issues)
- Cucuras v. Sec'y of Health & Human Servs., 993 F.2d 1525 (Fed. Cir. 1993) (contemporaneous medical records are generally trustworthy)