GARCIA v. SECRETARY OF HEALTH AND HUMAN SERVICES
1:19-vv-01927
Fed. Cl.May 19, 2025Background
- Ana Bruno Garcia sought compensation under the National Vaccine Injury Compensation Program, alleging that a December 2017 flu vaccine caused her to develop meningoencephalitis.
- Petitioner filed her claim in December 2019 and submitted extensive medical and expert evidence supporting an autoimmune/vaccine-related injury theory.
- Medical records indicated Garcia developed acute neurological symptoms (confusion, fever, seizure) seven days post-vaccination, was hospitalized, treated with antivirals/antibiotics, and recovered with no identified infectious etiology.
- Competing experts for petitioner (Drs. Schenk & Ramos) and respondent (Drs. Wilson & Tompkins) gave conflicting opinions regarding causation—vaccine-induced versus undiagnosed infectious process.
- The case was submitted for a ruling on the record (without a hearing); the special master weighed expert testimony under the standards of the Vaccine Act and Daubert.
- Ultimately, the special master found insufficient reliable medical theory or evidence directly linking the flu vaccine to petitioner’s illness by preponderance of evidence.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Causal Connection (Medical Theory) | Flu vaccine caused/triggered meningoencephalitis via molecular mimicry or autoimmunity | Flu vaccine not shown scientifically to cause such effect; more likely undiagnosed infection | Petitioner failed to show sound, reliable medical theory |
| Actual Causation (Specific Case) | Garcia's acute illness temporally tied to vaccination, nothing else identified | Symptoms and labs consistent with infectious process, exposure to sick contacts | Not proven, experts equivocated, general possibility insufficient |
| Proximate Temporal Relationship | Onset within 7 days is consistent with vaccine causation | Timing is possible for both infection and vaccine reaction | Court found timing plausible, but not independently sufficient |
| Standard of Proof/Eligibility | Sufficient evidence for preponderance via exclusion of other causes, strong temporal link | General and specific causation both lacking; only possibility shown | Denied: Preponderant evidence absent, petition dismissed |
Key Cases Cited
- Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishes three-pronged test for causation in Vaccine Act cases)
- Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315 (Fed. Cir. 2010) (petitioner must show vaccine was 'but-for' and substantial factor)
- Lombardi v. Sec’y of Health & Hum. Servs., 656 F.3d 1343 (Fed. Cir. 2011) (petitioner must establish they suffer from the injury alleged)
- Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317 (Fed. Cir. 2006) (contemporaneous medical records and treating physician opinions are favored)
- Daubert v. Merrell Dow Pharms. Inc., 509 U.S. 579 (1993) (establishes reliability standards for expert testimony)