Warren v. Secretary of Health and Human Services
13-919
| Fed. Cl. | Oct 30, 2017Background
- Petitioner Kiona Warren filed a Vaccine Act petition alleging HPV vaccine (administered Sept. 17, 2010) caused thrombotic thrombocytopenic purpura (TTP); an initial claim of vaccine-caused SLE was later withdrawn.
- Medical records show onset of severe cytopenias (platelets 14,000; hemoglobin 7) in December 2010, approximately 10–11 weeks after vaccination.
- Petitioner filed an amended petition in 2015 narrowing the claim to TTP only.
- In October 2017 petitioner moved to voluntarily dismiss, stating she could not prove entitlement and planned to pursue civil litigation after judgment of dismissal.
- The Special Master granted the motion, dismissing the petition and directing entry of judgment absent a motion for review.
Issues
| Issue | Warren's Argument | Secretary's Argument | Held |
|---|---|---|---|
| Whether petitioner can prove causation-in-fact that HPV vaccine caused TTP | Warren alleged temporal onset and medical records linking TTP onset after HPV vaccination | Respondent defended on the merits (implicitly requiring Althen proof); no explicit affirmative defense presented in dismissal order | Dismissal granted after petitioner conceded inability to prove entitlement; petition dismissed |
| Whether temporal association alone suffices for causation | Warren relied on temporal proximity (10–11 weeks) and clinical onset | Secretary relied on legal standards requiring medical theory, logical sequence, and proximate timing | Court reiterated temporal association alone is insufficient under precedent |
| Whether petitioner met the Althen three-prong test | Warren could not establish the required proof elements to satisfy Althen | Secretary required full Althen proof; absence of supporting expert/scientific evidence fatal | Court dismissed petition for failure to meet burden (petitioner conceded inability to prove entitlement) |
| Procedural effect of voluntary dismissal motion | Warren requested dismissal to conserve resources and pursue civil action | Secretary did not oppose dismissal motion | Special Master granted motion and directed entry of judgment unless review sought |
Key Cases Cited
- Althen v. Sec'y of HHS, 418 F.3d 1274 (Fed. Cir. 2005) (articulates three-prong causation-in-fact test for Vaccine Program claims)
- Grant v. Sec'y of HHS, 956 F.2d 1144 (Fed. Cir. 1992) (temporal association alone insufficient; petitioner must provide a reputable medical/scientific explanation)
- Shyface v. Sec'y of HHS, 165 F.3d 1344 (Fed. Cir. 1999) (petitioner must show vaccine was a substantial factor and "but for" cause)