Garcia v. Secretary of Health and Human Services
21-1601V
Fed. Cl.Jun 27, 2025Background
- Cristian Garcia filed a claim under the National Childhood Vaccine Injury Act, alleging he developed anti-NMDAR encephalitis following a Tdap vaccination in October 2020.
- Garcia was diagnosed with anti-NMDAR encephalitis 18 days post-vaccination after experiencing seizures and related neuroinflammatory symptoms.
- Petitioner’s expert, Dr. Babinski, provided multiple theories linking the vaccine to Garcia’s disorder, referencing medical literature and adverse event reports, but conceded mechanisms were unclear.
- The Secretary’s expert, Dr. Hedrick, found no credible statistical or biological evidence linking Tdap vaccination to anti-NMDAR encephalitis and argued the events were coincidental.
- Chief Special Master denied compensation, concluding Garcia failed to present a sound medical theory (Althen prong 1) or show a logical sequence of cause and effect (prong 2); unrebutted by later expert responses.
- Garcia moved for review, arguing the Chief Special Master failed to consider two supplemental expert reports; the motion was denied by the Court.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Did the Tdap vaccine cause anti-NMDAR encephalitis? | Cited case reports, VAERS data, and proposed biological mechanisms. | No credible scientific or epidemiologic evidence. | No sound and reliable scientific evidence supports causation; claim denied. |
| Did the Chief Special Master fail to consider all evidence? | Special Master ignored supplemental expert reports (Exs. 45 and 50). | Presumed all evidence was considered; no express omission. | No evidence Special Master excluded relevant reports; presumption not rebutted. |
| Would any failure to consider expert supplements be harmful error? | Exclusion prejudiced petitioner’s presentation of theories. | Any error was harmless; did not affect the outcome. | Even if not considered, error was harmless as reports did not alter underlying deficiencies in proof. |
| Was the finding on causation arbitrary/capricious or contrary to law? | Causation improperly weighed; standard misapplied. | Standard properly applied; findings well-supported. | Decision was rational and within discretion; no reversible error found. |
Key Cases Cited
- Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005) (articulates three-prong test for causation in vaccine cases)
- Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352 (Fed. Cir. 2006) (approves the necessity for reliable scientific evidence of causation)
- Milik v. Sec’y of Health & Hum. Servs., 822 F.3d 1367 (Fed. Cir. 2016) (sets deferential standard for review of special master’s factual findings)
- Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322 (Fed. Cir. 2016) (special masters are presumed to consider all record evidence)
