K.T. Ex Rel. Dudenhoeffer v. Secretary of Health & Human Services
132 Fed. Cl. 175
| Fed. Cl. | 2017Background
- Petition filed under the Vaccine Act alleging MMR vaccine (Aug 6, 2009) caused K.T., then ~1 year old, to develop myoclonic-astatic epilepsy (MAE) / epileptic encephalopathy (EE); petition brought by mother, Alisha Dudenhoeffer.
- Early medical records show a febrile seizure in April 2009, vaccination Aug 6, 2009, and cluster of new seizure-type events starting ~9 days after MMR; EEG abnormalities and normal MRI; multiple neurology visits and treatment changes.
- Petitioner’s expert (Dr. Yuval Shafrir) testified that molecular mimicry (autoimmune response, e.g., antibodies to Caspr2) plausibly links MMR to MAE/EE; cited several animal and small clinical studies.
- Respondent’s expert (Dr. Gregory Holmes) disputed causation, criticizing the relevance, methodology, and power of the cited studies (noting especially limitations of the Obregon mouse study).
- Special master found petitioner proved diagnoses of MAE and EE but denied compensation, concluding petitioner failed Althen prongs 1 and 2 (medical theory and logical sequence), though finding temporal proximity (prong 3).
- Court review: petitioner sought review, arguing the special master applied an impermissibly heightened standard; the Court of Federal Claims denied review and sustained the special master’s decision.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the special master applied a too‑rigorous standard for Althen prong 1 (medical theory) | Shafrir’s molecular mimicry theory need only be plausible/reliable under Althen; special master required more (confirmation/probability) | Special master properly evaluated reliability and plausibility against the record and literature; not bound to accept ipse dixit | Court: special master applied correct legal standard and reasonably found petitioner’s theory insufficient (prong 1 failed) |
| Whether the special master improperly required treating‑physician causation opinions for Althen prong 2 (logical sequence) | Special master demanded affirmative treating‑doctor causation rather than allowing expert opinion + records to suffice | Special master considered treating‑physicians’ statements but did not require them; expert’s second‑prong proof was inadequate | Court: special master did not err; petitioner failed to show a reliable logical sequence (prong 2 failed) |
| Whether temporal proximity alone suffices to prove causation | Temporal proximity (~9 days) + theory should be enough under Althen when timeframe fits | Temporal association is relevant but insufficient without a reliable mechanism and logical sequence | Court: temporal nexus (prong 3) existed but alone is inadequate to satisfy prong 2; special master’s separation of prongs correct |
| Whether the special master’s factual findings were arbitrary and capricious | Petitioner contends the special master misweighed evidence and ignored favorable literature | Respondent contends findings were supported by record, expert conflict, and literature limitations | Court: under deferential review, special master’s factfinding and inferences were plausible and not arbitrary; decision sustained |
Key Cases Cited
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishes three‑prong test for causation‑in‑fact in vaccine cases)
- Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344 (Fed. Cir. 1999) (vaccine must be a substantial factor; petitioner bears preponderance burden)
- Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (medical or scientific certainty not required but theory must be sound and reliable)
- Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357 (Fed. Cir. 2000) (articulation of arbitrary and capricious standard on review of special master findings)
- Munn v. Sec’y of Health & Human Servs., 970 F.2d 863 (Fed. Cir. 1992) (standard of review: fact findings arbitrary and capricious; court will not reweigh evidence)