Paluck v. Secretary of Health & Human Services
2015 U.S. App. LEXIS 8270
| Fed. Cir. | 2015Background
- K.P., born Jan 15, 2004, had early motor delays but normal cognitive scores; received MMR, pneumococcal, and varicella vaccines on Jan 19, 2005.
- Within 48 hours he developed fever, irritability, and feeding/sleeping changes; by Feb–July 2005 he experienced rapid neurodevelopmental regression (spasticity, loss of skills, seizures) and progressive MRI changes.
- Experts later diagnosed an underlying mitochondrial disorder present from birth; Petitioner (Palucks) alleged the vaccines significantly aggravated that disorder causing neurodegeneration.
- Special master initially denied entitlement, finding petitioner’s expert (Frye) lacked a plausible theory and that symptoms did not appear within the special master’s fixed 2–3 week window; Court of Federal Claims vacated and remanded.
- On remand the special master accepted the medical plausibility but again found the timing and pattern of deterioration inconsistent with Frye’s theory; the Court of Federal Claims set aside that finding and awarded entitlement.
- The Federal Circuit affirmed the Court of Federal Claims, holding the special master misapprehended the causation theory, misconstrued contemporaneous records (including chiropractic notes and MRIs), and improperly imposed a strict three-week onset rule.
Issues
| Issue | Paluck (Plaintiff) Argument | HHS (Defendant) Argument | Held |
|---|---|---|---|
| Whether petitioner established a medically plausible theory linking vaccination to K.P.’s decline | Frye: vaccines can trigger immune activation → oxidative stress in mitochondrial disease → progressive neurodegeneration | Theory conceded as medically plausible (no meaningful dispute) but evidence did not fit predicted timing/pattern | Court: theory plausible; special master erred in rejecting it as applied to the record |
| Whether factual record shows vaccine-caused significant aggravation (Althen prongs 2 & 3) | Contemporaneous fever, rapid post-vaccine clinical decline, spasticity by Feb 11, progressive MRI changes support causal sequence and proximate timing | Special master: deterioration wasn’t sufficiently rapid/linear and first clear sign appeared after special master’s 3-week cut-off | Court: record shows progressive decline within a medically acceptable interval; special master misread records; entitlement proper |
| Appropriateness of the special master’s temporal cutoff (three weeks) | No fixed onset period required; mitochondrial disorders vary; literature/cases show onset within days–weeks to months | Special master argued clinical symptoms must appear within three weeks to support causation | Court: setting a hard three-week rule was arbitrary and capricious; timing must be evaluated case-by-case under Althen preponderance standard |
| Deference to special master’s factual findings | Petitioner: special master misapprehended expert testimony and contemporaneous records; Court of Federal Claims may set aside arbitrary findings | HHS: special master had rational basis; appellate court should not reweigh credibility | Court: appellate court and CFC may set aside special master findings that are arbitrary, misconstrue evidence, or draw unsupported inferences; affirmed CFC’s vacatur of special master |
Key Cases Cited
- Andreu v. Sec’y of Dep’t of Health & Human Servs., 569 F.3d 1367 (Fed. Cir.) (treating physician evidence and review standards in Vaccine Act cases)
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.) (three-prong test for causation-in-fact under Vaccine Act)
- Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir.) (burden of proof and review standards)
- Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302 (Fed. Cir.) (recognizing vaccine risks and Vaccine Act purpose)
- Porter v. Sec’y of Health & Human Servs., 663 F.3d 1242 (Fed. Cir.) (deference to special masters but limits where findings are unsupported)
- Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir.) (improperly raising petitioner’s burden)
- de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir.) (petitioner need not rule out alternative causes once Althen satisfied)
- Walther v. Sec’y of Health & Human Servs., 485 F.3d 1146 (Fed. Cir.) (government’s burden to prove alternative causation)
- Hines ex rel. Sevier v. Sec’y of Dep’t of Health & Human Servs., 940 F.2d 1518 (Fed. Cir.) (special master must consider record as a whole and articulate rationale)
- Shalala v. Whitecotton, 514 U.S. 268 (U.S.) (purpose and design of Vaccine Act compensation scheme)