Bender v. Secretary of Health and Human Services, 11-693

Background

Petitioner Olivia Bender (age 14 at vaccination) received meningococcal (Menactra) and Hepatitis A vaccines on May 29, 2009 and developed acute transverse myelitis (TM) with symptom onset on July 10, 2009 (42 days post‑vaccination).
MRI studies in July 2009 showed evolving thoracic spinal cord lesions consistent with TM; initial mycoplasma IgM lab result was reported positive but later found to be an erroneous flag (IgM actually negative; IgG positive indicating remote prior exposure).
Petitioner was treated with IVIG and steroids; multiple specialists treated/rehabilitated her; treating records did not attribute TM to vaccination.
Petitioner offered two experts: an immunologist (Dr. Byers) asserting vaccine‑triggered autoimmunity via cytokine‑driven bystander activation/epitope spreading, and a neurologist (Dr. Chen); Respondent offered an immunologist (Dr. Forsthuber) and a neurologist (Dr. Lotze) who disputed the mechanisms and the 42‑day timeframe.
Key disputes: (1) whether a reputable biological mechanism links the vaccines to TM absent molecular mimicry, (2) whether the vaccines more likely than not caused Petitioner’s TM (process‑of‑elimination and temporal link), and (3) whether 42 days is a medically acceptable interval for causation in this case.

Issues

Issue	Bender's Argument	Secretary's Argument	Held
1. Can the Menactra/Hep A vaccines biologically cause TM (Althen prong 1)?	Vaccine‑induced cytokine responses (esp. IL‑6) can trigger autoimmunity via bystander activation or epitope spreading even absent molecular mimicry; vaccines are sufficiently immunogenic to do so in a susceptible host.	No reliable mechanism: petitioner conceded molecular mimicry not shown; bystander activation/epitope spreading require an initial antigen‑specific trigger and literature does not support cytokines alone initiating TM.	Held for Secretary: petitioner failed to prove a reliable, vaccine‑specific biological mechanism.
2. Did the vaccines actually cause Petitioner’s TM (Althen prong 2)?	Absence of an identified alternative cause, erroneous IgM aside, and case reports/VAERS and package insert references support causation by process of elimination.	Temporal association alone is insufficient; no corroborating medical evidence or treating‑physician attribution; idiopathic TM is plausible; epidemiology does not support association.	Held for Secretary: petitioner did not meet burden to show vaccine "did cause" TM.
3. Is 42 days a medically acceptable interval between vaccination and TM onset (Althen prong 3)?	Literature and case reports show variable intervals (up to weeks/months); expert testimony did not impose a strict upper bound.	Typical autoimmune timing is ~3–4 weeks; case reports relied on are unreliable or inapplicable; epidemiologic study found no increased TM risk in 0–42 days.	Held for Secretary: 42‑day interval not shown to be medically acceptable given petitioner’s theory and records.
4. Weight of epidemiology, VAERS, and package inserts	These sources support plausibility and should be considered.	VAERS and package inserts do not establish causation; recent epidemiologic study (Baxter) shows no association.	Held for Secretary: epidemiology weighs against causation; VAERS/inserts afforded little weight.

Key Cases Cited

Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.) (establishes three‑prong test for causation in Vaccine Program)
Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir.) (preponderance standard and but‑for/substantial‑factor causation in Vaccine Program)
Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir.) (discusses evidentiary standards for Althen prong one and role of special masters)
Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir.) (decision may rest on credibility and persuasiveness of competing experts)
de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir.) (Althen prong three requires medically acceptable temporal relationship)
Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir.) (medical records and physician opinion requirements in Vaccine Program)