Exum v. Secretary of Health and Human Services
21-1513V
Fed. Cl.Mar 20, 2025Background
- Petitioner Portia Exum received MMR and Tdap vaccines on August 20, 2018 and was later diagnosed with autoimmune hepatitis (AIH); abnormal liver enzymes first recorded Oct. 26, 2018 and liver biopsy performed Jan. 3, 2019.
- Petitioner alleged the vaccines caused AIH (off‑table claim). She submitted expert reports (Dr. Robert Gish) and medical literature; Respondent submitted rebuttal experts (Drs. Jeffrey Crippin and Andrew MacGinnitie).
- Chief Special Master denied compensation, finding Petitioner failed Althen prongs 1 and 2: (1) inadequate, unreliable immunologic theory and weak case‑report support; (2) temporal proximity alone insufficient and multiple plausible alternative causes existed.
- Petitioner moved for review, arguing the Special Master applied an incorrect/overly stringent prong‑one standard, erred on prong two, and omitted prong three analysis.
- The Court of Federal Claims granted the motion in part, vacated the Decision and remanded for the Chief Special Master to (a) more fully articulate the legal standard and reasoning for Althen prong one and two, (b) explain the weight given to literature, case reports, and expert testimony, and (c) reconsider prong two as necessary; remand decision due within 90 days.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Special Master applied correct legal standard for Althen prong one (can vaccine cause injury) | Exum: SM applied too stringent/credibility‑style test and required more than preponderant evidence of a "reputable, sound, reliable" theory | HHS: SM applied correct standard and findings are not arbitrary or capricious | Court: Standard articulated correctly, but SM failed to sufficiently explain application; remand for clearer rationale and engagement with literature/case reports |
| Whether petitioner proved Althen prong two (logical sequence/actual causation) | Exum: Medical theory, literature, and records establish a logical causal chain; alternatives not shown to be principally responsible | HHS: Timing alone is insufficient; multiple plausible alternative causes exist (travel, anti‑malarial, supplements, prior infections, IUD) | Court: SM's prong‑two findings are unclear as to whether petitioner was improperly required to exclude alternatives; remand to clarify analysis and correct legal framing if needed |
| Whether SM erred by not deciding Althen prong three (timing) | Exum: Failure to analyze prong three was error | HHS: No error—failure on any prong is dispositive; no need to reach prong three | Held: No reversible error in omitting prong three now; SM must address prong three only if prongs one and two are found satisfied on remand |
| Remedy — vacate, remand, or affirm | Exum: Decision should be set aside and entitlement awarded or remanded for correct standard application | HHS: Decision should be affirmed as not arbitrary or legally incorrect | Court: Granted in part — vacated Decision and remanded for fuller, reasoned findings and citation of record; remand decision due within 90 days |
Key Cases Cited
- Althen v. Sec'y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005) (three‑prong test for causation in vaccine cases)
- Andreu v. Sec'y of Health & Hum. Servs., 569 F.3d 1367 (Fed. Cir. 2009) (medical literature need not be conclusive; plausibility and preponderance standards explained)
- Boatmon v. Sec'y of Health & Hum. Servs., 941 F.3d 1351 (Fed. Cir. 2019) (prong‑one requires a reputable, sound, reliable theory)
- Grant v. Sec'y of Health & Hum. Servs., 956 F.2d 1144 (Fed. Cir. 1992) (temporal proximity alone cannot establish causation)
- Knudsen v. Sec'y of Health & Hum. Servs., 35 F.3d 543 (Fed. Cir. 1994) (Althen prong‑one need not be medically certain)
- Cedillo v. Sec'y of Health & Hum. Servs., 617 F.3d 1328 (Fed. Cir. 2010) (deference to special master factfinding and evaluation of literature)
- Doe v. Sec'y of Health & Hum. Servs., 601 F.3d 1349 (Fed. Cir. 2010) (burden‑shift rules and role of alternative‑cause evidence)
- Pafford v. Sec'y of Health & Hum. Servs., 451 F.3d 1352 (Fed. Cir. 2006) (vaccine must be a substantial factor; temporal relationship supports but does not prove causation)