Kottenstette v. Secretary of Health and Human Services
15-1016
| Fed. Cl. | Dec 27, 2017Background
- Infant CK (born June 1, 2012) received DTaP, HiB, IPV, and Prevnar at four months (Oct 2, 2012); within hours she had abrupt clusters of afebrile spasms. EEG showed hypsarrhythmia/abnormal background and diagnosis of infantile spasms; treated promptly with ACTH but remained drug‑resistant with persistent spasms and profound developmental disability.
- Petitioners allege vaccines (particularly the pertussis component) triggered cryptogenic infantile spasms and substantially aggravated a chronic encephalopathy; they offered expert Dr. Marcel Kinsbourne.
- Respondent disputed causation and offered Dr. John Zempel, who argued literature does not support vaccine causation for (acellular) DTaP, mechanisms are unproven, and temporal coincidence is expected given the age window for infantile spasms.
- Petitioners relied on older studies (Bellman 1983, Melchior 1977) and mechanistic literature linking immune/stress responses to seizure triggers; Dr. Kinsbourne advanced a ‘‘two‑hit’’ trigger theory and emphasized the abrupt, explosive onset shortly after vaccination.
- Special Master found petitioners met the Althen factors: accepted that pertussis vaccine can trigger infantile spasms in a small subset, that vaccination plausibly precipitated CK’s abrupt onset within hours, and that earlier onset materially worsened her outcome; ruled entitlement to compensation and moved case to damages.
Issues
| Issue | Plaintiff's Argument (Kottenstette) | Defendant's Argument (HHS) | Held |
|---|---|---|---|
| Did CK’s Oct 2, 2012 vaccinations trigger her cryptogenic infantile spasms? | Vaccines (DTaP pertussis component) triggered spasms within hours via innate immune/stress response; abrupt onset supports a trigger. | No reliable epidemiologic or mechanistic proof; temporal proximity is coincidental given age window for spasms. | Held for petitioners: vaccinations (DTaP) triggered onset. |
| Did vaccines substantially worsen CK’s long‑term neurologic outcome (chronic encephalopathy)? | Early, vaccine‑triggered onset produced refractory spasms that destroyed brain development; earlier onset produced worse outcome. | Outcome attributable to underlying (cryptogenic) brain abnormality; uncertain that timing materially altered long‑term prognosis. | Held for petitioners: vaccination‑triggered early onset caused/disproportionately worsened outcome. |
| Are older epidemiologic studies (Bellman, Melchior) and circumstantial evidence sufficient without modern RCTs/animal models? | Yes; those studies support perturbation/triggering in a small number, and clinical facts of CK’s case supply circumstantial proof. | No; studies are old, small, concern whole‑cell DTP not acellular DTaP, and do not establish causation for this case. | Held for petitioners: court accepted Bellman/Melchior as supportive combined with clinical picture. |
| Temporal plausibility: is a-hours interval medically reasonable for causation? | Innate immune activation and cytokine/stress pathways can act rapidly; hours is plausible. | No established mechanism showing vaccines produce spasms within hours; coincidence more likely. | Held for petitioners: an onset within hours is consistent with a triggering effect. |
Key Cases Cited
- Althen v. Sec’y of HHS, 418 F.3d 1274 (Fed. Cir. 2005) (sets three‑part test for causation in vaccine cases)
- Knudsen v. Sec’y of HHS, 35 F.3d 543 (Fed. Cir. 1994) (allows causation findings despite lack of full scientific proof; circumstantial evidence permitted)
- Capizzano v. Sec’y of HHS, 440 F.3d 1317 (Fed. Cir. 2006) (rejects rigid prerequisites—epidemiology, rechallenge, markers—for proving causation)
- Grant v. Sec’y of HHS, 956 F.2d 1144 (Fed. Cir. 1992) (medical theory and logical sequence requirement for causation)
- Shyface v. Sec’y of HHS, 165 F.3d 1344 (Fed. Cir. 1999) (substantial‑factor test for vaccine causation)