Dean v. Secretary of Health and Human Services
13-808
| Fed. Cl. | Jul 10, 2017Background
- Petitioners Jessica and Ryan Dean filed on behalf of their minor child I.D., alleging that DTaP and Hib vaccines administered on Feb 24, 2011 caused significant neurological/developmental injury.
- Contemporaneous pediatric and neurology records (spring–summer 2011) describe abnormal hand movements but document normal neurological exams and a normal EEG; pediatric neurologist Dr. Ronald Davis diagnosed benign motor stereotypies and cleared further immunizations.
- Petitioners later (2013–2014) supplied expanded recollections that I.D. had an immediate post‑vaccine reaction (fever, vomiting, screaming, lethargy) and obtained a treater declaration (Dr. Cornelia Franz) and VAERS report asserting a vaccine‑related encephalopathic event and permanent disability.
- Petitioners’ experts: immunologist Dr. David Axelrod (theory: vaccine‑induced cytokine upregulation breaches the blood‑brain barrier and tetanus toxoid/immune responses damage CNS via epitope spreading) and pediatric neurologist Dr. Harvey Cantor (supporting literature). Respondent’s expert: pediatric neurologist Dr. Lawrence Brown (rebutting causation and emphasizing record consistency with benign stereotypies).
- Special Master resolved the case on the written record (no hearing). After reviewing records, expert reports, and argument under Althen, the Special Master found Petitioners failed to prove causation and dismissed the claim.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Adequacy of causation theory (Althen prong 1) | Axelrod: vaccines upregulate proinflammatory cytokines → BBB permeability → CNS injury; tetanus toxoid binds gangliosides causing epitope spreading | Brown: literature does not support pathologic, sustained cytokine effects or toxoid CNS action after acellular DTaP; Axelrod lacks specific, relevant expertise; cited studies are inapposite | Held: Theory not reliable or persuasive; literature relied on is weak, in vitro, or inapplicable; expert experience insufficient to bridge gaps. |
| Actual causation / logical sequence (Althen prong 2) | Post‑vaccine temporal sequence and treater opinion (Dr. Franz) support that vaccines caused I.D.’s developmental problems | Contemporaneous records (EEG, Dr. Davis exam) show normal neuro findings; treater declaration largely repeats parents’ later recollection and is not corroborative | Held: Petitioners failed to show the vaccines did cause the injury; contemporaneous treater/neurology evidence favors benign stereotypies. |
| Temporal relationship (Althen prong 3) | Timing of reported immediate reaction and onset of abnormal movements fits the proposed cytokine/autoimmune timeline | Records do not corroborate immediate post‑vaccine encephalopathy; cytokine literature shows short‑lived changes (≈24 hrs) and not the prolonged course alleged | Held: Petitioners did not establish a medically‑acceptable timeframe connecting vaccination to the claimed developmental injury. |
| Weight of contemporaneous records vs later testimony | Parents and treating pediatrician later provided history and treater declaration supporting vaccine causation | Contemporaneous medical records and specialist evaluation are more reliable; later testimony/inconsistent histories are less persuasive | Held: Greater weight given to contemporaneous records and Dr. Davis’s evaluation; later, uncorroborated accounts and after‑the‑fact treater opinion are insufficient. |
Key Cases Cited
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (three‑part test for causation in Vaccine Program cases)
- Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (preponderance standard and but‑for/substantial factor causation)
- Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (weight of treating physicians’ opinions in causation analysis)
- Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir. 2009) (petitioners need not rely on extensive literature to satisfy Althen prong 1, but overall burden remains preponderance)
- Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (requirement that Althen theory be a sound and reliable medical explanation)