Koehn v. Secretary of Health & Human Services
2014 U.S. App. LEXIS 22780
| Fed. Cir. | 2014Background
- Koehn's daughter Vanessia received Gardasil in Feb and Apr 2008, with a third dose in Aug 2008.
- June 2008: she developed a body-wide rash treated with Benadryl and prednisone, which resolved in days.
- July 2008: she was diagnosed with presumptive juvenile idiopathic arthritis (SJIA) by hospital physicians.
- Aug 2008: a rheumatologist noted SJIA as likely; Vanessia began etanercept and later experienced SJIA flare with fever and pain.
- Koehn filed an off-Table Vaccine Act claim seeking causation-in-fact for SJIA; the Special Master denied relief.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| First Althen prong adequacy | Dr. McCabe's theory links Gardasil to SJIA via a cytokine trigger in predisposed individuals. | Scientific community did not accept the theory; it lacked peer review and widespread support. | Not dispositive; court found errors but affirmed denial. |
| Second Althen prong logical sequence | There is a logical cause-and-effect from Gardasil to Vanessia's SJIA. | Dr. Rose's treat-patient perspective more persuasive and the causal link weak. | Not dispositive; court affirmed the Special Master's weighting. |
| Third Althen prong proximate temporal relationship | SJIA onset within seven months of vaccination is plausible given immune response timing. | Cytokine release is typically immediate after antigen exposure; seven months is not supported. | Denied; absence of a medically acceptable seven-month window. |
| Overall causation under Althen test | The Pinto article showed cytokine upregulation after vaccination with no stimulus control reduces reliability. | The Special Master properly weighed evidence and found no adequate causal chain. | Affirmed denial of compensation. |
Key Cases Cited
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishes three-prong Althen causation standard)
- Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir. 2009) (causation-in-fact requires three showings by preponderance)
- de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir. 2008) (onset must occur within a medically acceptable timeframe)
- Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (standard of review for Vaccine Act determinations)
- Griglock v. Sec’y of Health & Human Servs., 687 F.3d 1371 (Fed. Cir. 2012) (arbitrary-and-capricious review of factual findings)