BARRIOS v. SECRETARY OF HEALTH AND HUMAN SERVICES
23-230
Fed. Cl.Mar 11, 2025Background
- Jennifer and Michael Barrios filed a claim under the Vaccine Injury Compensation Program, alleging their child, B.H.B., developed type 1 narcolepsy after receiving non-adjuvanted influenza vaccines in 2020.
- B.H.B.'s symptoms began within a month of the second vaccine dose and culminated in a narcolepsy diagnosis by Dr. Emmanuel Mignot, who opined there was biological plausibility for causation.
- The Chief Special Master had previously rejected similar claims linking non-adjuvanted influenza vaccines to narcolepsy, finding insufficient evidence of causation, and advised Petitioners they needed new scientific or medical evidence to proceed.
- Petitioners consulted Dr. Michael Lacey, who disagreed with certain epidemiological studies relied on by the Chief Special Master, but offered no new scientific or medical findings.
- The Chief Special Master dismissed the claim on the grounds that no new evidence or studies supported causation, and Petitioners appealed, arguing they were denied the opportunity to file an expert report and thus a full opportunity to present their case.
- The Court of Federal Claims reviewed the dismissal under a deferential standard, considering whether the decision was arbitrary, capricious, an abuse of discretion, or not in accordance with law.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Reliance on prior decisions about vaccine-narcolepsy link | Prior cases should not preclude reconsideration | Reliance on prior, uncontradicted cases is proper | Use of prior decisions was not abuse of discretion |
| Dismissal without expert report | Not allowed to fully present Dr. Lacey’s expert opinion | Record was sufficient, and petitioners given opportunity | No abuse of discretion in deciding on the written record |
| Sufficiency of evidence under Althen prong one | Plausibility, not certainty, should suffice | Preponderance, not plausibility, is required standard | Preponderance of evidence standard applies |
| Directions regarding response to show cause order | Only permitted to discuss existing record | Clear instructions to present new scientific/medical evidence | Petitioners not limited; failure to present new evidence fatal |
Key Cases Cited
- Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishes three-prong causation test for non-table vaccine claims)
- Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352 (Fed. Cir. 2006) (first Althen prong requires reputable medical theory)
- Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351 (Fed. Cir. 2019) (sets deferential review standard for special master findings)
- Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543 (Fed. Cir. 1994) (causation theory must be legally probable, not scientifically certain)
- Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367 (Fed. Cir. 2009) (scientific evidence for causation viewed under preponderance standard)