1:17-vv-00708
Fed. Cl.May 28, 2021Background:
- Petitioner (C.C.) received a Hepatitis B vaccine on March 23, 2016 and alleges it caused a right-shoulder SIRVA; petition filed May 30, 2017.
- Multiple medical and chiropractic visits occurred between March and October 2016; the first contemporaneous medical record mentioning shoulder pain is May 28, 2016.
- Petitioner was in a motor vehicle accident (MVA) on May 6, 2016 and sought chiropractic care for neck/back/knee pain thereafter; Respondent argued the MVA is an alternative cause.
- Petitioner submitted later declarations and witness statements (family, friend, husband) asserting shoulder pain began within days of vaccination; contemporaneous records are largely silent before May 28.
- Special Master found Petitioner proved the six-month duration requirement but concluded the evidence did not show onset within 48 hours (Table SIRVA), and that causation-in-fact failed (only Althen prong one satisfied).
- Result: petition denied and dismissed for failure to prove a Table injury or causation-in-fact by a preponderance of the evidence.
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Petitioner meets Table SIRVA onset (≤48 hours) | Pain began immediately or within days of vaccination (witnesses, petitioner statements) | Contemporaneous records show first shoulder complaint on May 28, 2016 (≈2 months later); many visits in between without shoulder complaints | Not met — onset within 48 hours not proven |
| Six‑month durational requirement | Petitioner experienced shoulder pain through October 2016 (witnesses, records of ongoing treatment) | Respondent did not meaningfully dispute duration given witness evidence | Met — preponderance shows ≥6 months of shoulder pain |
| Causation‑in‑fact (Althen 3‑prong test) | Improper administration can cause SIRVA; petitioner argues sequence and timing support causation | No expert opinion; records and alternative MVA cause undercut logical causal sequence and timing | Prong 1 satisfied (theoretical mechanism); Prongs 2 and 3 not satisfied — overall causation-in-fact not proven |
| Weight of contemporaneous medical records vs later testimony | Gaps explained by petitioner’s mental‑health, fragmented care, closed urgent‑care records; witness statements corroborate immediate onset | Contemporaneous records are presumptively reliable; later testimony insufficient to overcome absence of early records | Contemporaneous records favored; later declarations insufficiently consistent/compelling to rebut them |
Key Cases Cited
- Althen v. Sec'y of Dep't of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishes three‑prong test for vaccine causation)
- Moberly v. Sec'y of Health & Hum. Servs., 592 F.3d 1315 (Fed. Cir. 2010) (discusses proof standards for off‑Table causation)
- Capizzano v. Sec'y of Health & Hum. Servs., 440 F.3d 1317 (Fed. Cir. 2006) (addresses evidentiary sufficiency when alternative causes exist)
- Knudsen v. Sec'y of Health & Hum. Servs., 35 F.3d 543 (Fed. Cir. 1994) (requires vaccine to be a substantial factor in causing injury)
- de Bazan v. Sec'y of Health & Hum. Servs., 539 F.3d 1347 (Fed. Cir. 2008) (temporal relationship must fit medical understanding of etiology)
- LaLonde v. Sec'y of Health & Hum. Servs., 746 F.3d 1334 (Fed. Cir. 2014) (a plausible theory alone is insufficient; theory must be reputable and case‑specific)
- Cucuras v. Sec'y of Health & Hum. Servs., 993 F.2d 1525 (Fed. Cir. 1993) (contemporaneous medical records are generally trustworthy and can outweigh later testimony)