K.L v. Secretary of Health and Human Services
12-312
| Fed. Cl. | May 3, 2017Background
- Petitioner K.L., born 1993, received three doses of the HPV (Gardasil) vaccine; the third dose was administered February 9, 2010. Two days later she experienced a generalized tonic‑clonic seizure and was hospitalized and evaluated with CT, MRI, EEG, and lumbar puncture; imaging and CSF were normal.
- Treating clinicians considered multiple possible contributors (recent URI, OTC antihistamine/decongestant use, and recent HPV vaccination) but subsequent pediatric epilepsy specialists (notably Dr. Poduri) diagnosed juvenile‑onset idiopathic partial‑onset epilepsy after an excellent MRI and normal CSF/EEG findings.
- Petitioner alleged the HPV vaccine caused epilepsy/seizures, headaches, cognitive problems, and other sequelae via an immune/cytokine‑mediated mechanism (initially invoking IL‑1β), supported by treating notes, expert testimony (Dr. Engstrand), and several epidemiologic and case‑series articles.
- Respondent rebutted with a board‑certified pediatric epileptologist (Dr. Shinnar) who concluded K.L.’s presentation was idiopathic epilepsy, emphasized lack of objective evidence of autoimmune encephalitis/inflammation, and cited large epidemiological studies finding no HPV‑epilepsy link.
- Special Master considered the parties’ experts, medical records, and literature, found petitioner’s causation theory scientifically weak and insufficiently supported by the record, and denied compensation for a non‑Table vaccine injury claim.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether HPV vaccine can causally explain K.L.’s new‑onset epilepsy | Gardasil triggered an immune response (cytokine upregulation) causing brain hyperexcitability and afebrile seizure; close temporal onset (2 days) supports causation | No reliable mechanism or epidemiologic support; K.L. shows features of idiopathic epilepsy and lacks biomarkers of autoimmune encephalitis | Denied — petitioner failed to establish a reliable medical theory linking HPV vaccine to her epilepsy |
| Whether medical records and treating opinions support vaccine causation | Early treating notes listed vaccine as possible contributor; petitioner stresses temporal proximity and some treater speculation | Specialists with epilepsy expertise reviewed records and concluded idiopathic epilepsy; objective testing (MRI, CSF, EEG) was normal | Denied — contemporaneous records and specialist opinions favored idiopathic epilepsy over vaccine causation |
| Temporal relationship: Is 2‑day onset medically acceptable for alleged cytokine mechanism? | Two‑day interval is consistent with some report(s) and with petitioner’s proposed cytokine mechanism | Temporal proximity alone insufficient; literature relied upon is weak or not HPV‑specific; IL‑1β is associated with febrile seizures (not afebrile) | Not persuasive — timing alone did not satisfy causation given weak theory and lack of corroboration |
| Reliability and persuasiveness of experts and literature | Dr. Engstrand: neurologist supporting immune/cytokine theory and citing passive surveillance studies and some literature | Dr. Shinnar: pediatric epileptologist with specialty expertise; large cohort studies show no HPV‑neurologic link; criticizes passive VAERS‑style reports | Court found respondent’s expert and epidemiologic studies more persuasive; petitioner’s expert lacked requisite immunologic support and her literature was unconvincing |
Key Cases Cited
- Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315 (Fed. Cir. 2010) (preponderance standard for Vaccine Act claims and burden explanations)
- Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317 (Fed. Cir. 2006) (standards for establishing causation under the Vaccine Act)
- Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005) (three‑part test for causation in non‑Table vaccine claims)
- Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543 (Fed. Cir. 1994) (requirements for a reliable medical theory under Althen prong one)
- Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367 (Fed. Cir. 2009) (permissive evidentiary approaches to Althen prong one)
- de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347 (Fed. Cir. 2008) (timing must align with proposed biological mechanism)
- Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339 (Fed. Cir. 2010) (weighing competing expert credibility)
- Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357 (Fed. Cir. 2000) (need for expert testimony on medical causation)
- Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328 (Fed. Cir. 2010) (use of Daubert factors in evaluating expert reliability in Vaccine Program cases)