Depena v. Secretary of Health and Human Services
13-675
| Fed. Cl. | Mar 22, 2017Background
- Child (Rhone DePena) received MMR vaccine at age 7 and developed severe pneumococcal pneumonia within weeks, requiring a prolonged hospitalization; pneumococcus was identified as the cause.
- Petitioners alleged the MMR vaccine transiently suppressed T-cell immunity, permitting invasive pneumococcal disease; they relied on testimony from Dr. Boris Lokshin (pediatric pulmonologist).
- Respondent argued MMR does not impair the immune components critical to pneumococcal defense and submitted Dr. Neil Romberg (pediatric immunologist) as rebuttal; respondent conceded timing was medically acceptable for causation inference.
- Core scientific dispute: whether human defenses against pneumococcus depend materially on T cells (petitioners) or primarily on innate immunity and B‑cell–derived antibodies (respondent); petitioners relied in part on mouse studies and emerging human research.
- Special master found Dr. Romberg more qualified and persuasive, rejected extrapolation from murine data to humans without adequate justification, and concluded petitioners failed to satisfy Althen prongs (especially prong 1 and 2).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Causation theory (Althen prong 1) | MMR-induced T‑cell suppression caused vulnerability to pneumococcus | Human defense against pneumococcus is T‑cell independent; protection relies on innate immunity and antibodies | Theory not persuasive; prong 1 not met |
| Logical sequence / mechanism (Althen prong 2) | Vaccine-induced T‑cell impairment led to inability to prevent progression from colonization to invasive disease | No reliable causal chain shown; other factors and innate/antibody defenses explain outcome | Petitioners failed to prove causation sequence; prong 2 not met |
| Temporal relationship (Althen prong 3) | Onset occurred within a medically acceptable timeframe after vaccination | Respondent conceded timing was acceptable | Timing conceded; prong 3 met but insufficient alone |
| Reliance on animal and emerging human studies | Mouse Th17/IL‑17 data and some human studies support T‑cell role | Murine immune responses differ from humans; extrapolation unjustified; human data inconclusive | Murine evidence insufficiently translatable; petitioners’ human data do not overcome established immunologic principles |
Key Cases Cited
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (sets three‑part test for vaccine causation)
- Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (explains preponderance standard and finder‑of‑fact role)
- Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir. 2009) (warning against imposing medical‑certainty standard)
- Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir. 2008) (discusses timing requirement under Althen prong 3)
- Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (treating‑physician opinions are important in prong‑2 analysis)
- Hibbard v. Sec’y of Health & Human Servs., 698 F.3d 1355 (Fed. Cir. 2012) (temporal association insufficient alone; must satisfy other Althen prongs)
- Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302 (Fed. Cir. 1999) (endorses use of Daubert‑style analysis in Vaccine Program)