Barrett v. Secretary of Health and Human Services
14-137
| Fed. Cl. | Oct 2, 2017Background
- Petitioners (Kenneth and Tammy Barrett) filed under the Vaccine Injury Program after their preterm infant son J.H.B. (born at 33+2 weeks) received DTaP, Hep B, IPV, Hib, Prevnar, and rotavirus vaccines on Aug. 28, 2013 and died Aug. 31, 2013; autopsy listed cause of death as acute viral pneumonia with nasopharyngeal swab positive for rhino/entero virus.
- Petitioners alleged the alum adjuvant in several vaccines skewed the infant’s immune response (Th-2 bias) and, together with prematurity and an incipient viral infection, substantially contributed to fatal pneumonia.
- Petitioners’ expert Dr. M. Eric Gershwin (immunology/pediatrics) offered a theory that alum can rapidly skew innate immunity toward Th-2 in a premature infant, impairing Th-1 antiviral defenses within hours–days.
- Respondent’s expert Dr. Hamid Bassiri (pediatric infectious diseases) agreed alum can bias Th-2 but disputed dose/extrapolation from animal studies, argued the infection preexisted and elicited a Th-1 response that would not have been undone by alum, and pointed to epidemiology and dose considerations as undermining causation.
- The special master evaluated the record, the three Althen factors (medical theory, logical causation sequence, temporal relationship), and expert testimony, finding petitioners met the preponderance standard and awarding entitlement; damages to be determined separately.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| 1. Whether petitioners established a medical theory linking vaccines (alum) to fatal viral pneumonia (Althen prong 1) | Alum adjuvant can skew a premature infant’s immune system toward Th-2, impairing antiviral Th-1 responses and allowing a mild viral infection to become fatal (supported by animal studies and clinical observations in preterms). | Alum’s Th-2 effect is dose-dependent and animal results do not reliably extrapolate; background aluminum exposure and epidemiology do not show increased viral mortality post-vaccination. | Held for petitioners: theory found reasonable and supported sufficiently for Vaccine Act preponderance standard. |
| 2. Whether vaccines were a substantial factor in causing the death (logical sequence, Althen prong 2) | Vaccination with alum occurred while an incipient rhino/entero infection was present or incubating; alum-induced skewing of new naïve T cells reduced effective Th-1 response, allowing progression to fatal pneumonia. | Autopsy findings ("chronic inflammatory cells") indicate infection predated vaccination and elicited Th-1 response; once differentiated, Th-1 cells would not be reskewed; death could be explained by progression of preexisting infection in a preterm. | Held for petitioners: special master found petitioners’ sequence more likely and vaccines were a but-for and substantial factor along with prematurity and virus. |
| 3. Whether the temporal interval between vaccination and death is medically acceptable (Althen prong 3) | Innate/adjuvant effects can occur within hours; clinical studies in preterms show immune/CRP changes and cardiorespiratory events within 48–72 hours of vaccination, consistent with the ~63-hour interval here. | Recommended monitoring window (per cited study) is primarily 48 hours and most events occur within that window; petitioner’s death (~63 hours) falls outside the critical period cited. | Held for petitioners: timing found medically acceptable given literature showing early innate responses and some events up to ~66 hours. |
| 4. Whether respondent proved a more likely non-vaccine cause (e.g., natural progression of viral pneumonia) | Petitioners: no other convincing alternative cause identified; prematurity and alum together explain unexpected fatal outcome from ordinarily nonfatal virus. | Respondent: infection likely preexisting and sufficient to cause death in a susceptible preterm infant; epidemiology and literature do not support vaccine causation. | Held for petitioners: respondent did not carry burden to show a non-vaccine factor was principally responsible. |
Key Cases Cited
- Rooks v. Sec'y of Health & Human Servs., 35 Fed. Cl. 1 (1996) (describing Vaccine Program purpose and compensatory goals)
- Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (distinguishing Table and off-Table causation and Althen framework)
- Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (three-part test for causation-in-fact under Vaccine Act)
- Shyface v. Sec'y of Health & Human Servs., 165 F.3d 1344 (Fed. Cir. 1999) (vaccines may be a substantial factor alongside infection causing death)
- Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (burden shifts to respondent to show an alternative cause is more likely)