Archer v. Secretary of Health and Human Services
15-656
| Fed. Cl. | Jun 29, 2021Background
- Petitioner (age 55) received Tdap on August 7, 2012 and began abdominal/urinary complaints in late September–mid‑October 2012; gait problems noted by late October–November 2012.
- October–November 2012 MRIs showed a central T2 hyperintense lesion from C6–T3 and a small focal cystic area at C7–T1; LP (11/26/2012) showed mild CSF pleocytosis (8 WBC) and elevated protein.
- Mayo Clinic evaluation (March 2013) concluded a probable inflammatory myelopathy / monophasic transverse myelitis (TM); treating neurologists repeatedly diagnosed transverse myelitis and excluded AV fistula, sarcoid and tumor.
- Petitioner’s experts (Drs. Jani‑Acsadi, Imperioli) opined monophasic longitudinally extensive TM caused by Tdap via immune mechanisms (molecular mimicry, bystander activation); respondent’s expert (Dr. Donofrio) emphasized a syrinx/noncommunicating cavitation or other non‑vaccine causes and questioned CSF and timing.
- Special Master found the medical records and treating‑physician opinions preponderantly support a diagnosis of transverse myelitis, but concluded petitioner failed to prove the required temporal relationship to the vaccine (Althen prong 3) and therefore entitlement was denied.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Diagnosis: Did petitioner suffer transverse myelitis? | Treating physicians and petitioner experts: multi‑segment central cord lesion, positive CSF findings, Mayo Clinic diagnosis → TM | Respondent: imaging shows syrinx; CSF/enhancement not convincingly inflammatory; alternative causes plausible | Held: Diagnosis of TM established (preponderant evidence) |
| Althen prong 1 — Medical theory (can vaccine cause TM?) | Theory: vaccine can induce TM via molecular mimicry / epitope spreading / bystander activation | Respondent: theory is general; timing and specific mechanistic proof lacking | Held: Theory (molecular mimicry) accepted as medically plausible/reputable |
| Althen prong 2 — Logical sequence/causal link | Clinical course and imaging consistent with post‑vaccine monophasic inflammatory myelopathy | Respondent: alternative explanations (preexisting syrinx/insidious disease) and gaps in inflammatory markers undercut causal chain | Held: Evidence did not establish causation given failure on prong 3 (prong 2 not credited sufficiently in light of timing) |
| Althen prong 3 — Temporal relationship (did onset occur in medically acceptable window?) | Petitioner: onset 2–63 days (experts suggest 4–6 weeks acceptable); some literature allows up to 3 months in rare cases | Respondent: onset was too delayed (mid‑Oct ≈ 54–67 days after 8/7/12); immunologic response expected sooner; many post‑vaccine TM cases occur within weeks | Held: Onset as recorded (mid‑October) was outside a medically acceptable timeframe for Tdap→TM causation; Althen prong 3 not met → petition dismissed |
Key Cases Cited
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishes three‑prong test for causation‑in‑fact in vaccine cases)
- De Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir. 2008) (timing must be medically acceptable and consistent with theory)
- Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (preponderance standard; vaccine must be but‑for and a substantial factor)
- Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (government bears burden to prove an alternative, more likely cause once petitioner makes a prima facie case)
- Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir. 2010) (special master should determine the injury supported by the record before applying Althen)
- Lombardi v. Sec’y of Health & Human Servs., 656 F.3d 1343 (Fed. Cir. 2011) (weighing of medical evidence and treating‑physician opinions in vaccine claims)
- Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (favoring medical records and treating‑physician evidence in causation analysis)
- Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525 (Fed. Cir. 1993) (medical records are generally trustworthy and entitled to substantial weight)