Houston v. Secretary of Health and Human Services
18-420
| Fed. Cl. | Sep 17, 2021Background
- Petitioner (Joy Houston) received Tdap on Oct. 6, 2016 and MMR on Oct. 17, 2016 and later was diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP).
- She had longstanding, poorly controlled type 2 diabetes with prior neuropathic symptoms predating vaccination.
- New/worsening bilateral lower-extremity numbness and weakness presented in late October 2016, followed by neurology evaluation, EMG/NCS consistent with demyelinating polyneuropathy, and treatment with IVIG and steroids.
- Petitioner’s treating neurologist, Dr. Cornel Rogers, opined the Tdap (tetanus toxoid) likely triggered CIDP via molecular mimicry; Respondent’s expert, Dr. Brian Callaghan, rebutted, citing literature that CIDP is not consistently linked to antecedent infection/vaccination and mechanistically differs from GBS.
- Parties agreed to resolution on the written record; the Special Master found Petitioner failed to meet the Vaccine Act causation-in-fact requirements and dismissed the claim.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Tdap can cause CIDP (Althen prong 1) | Rogers: biologic plausibility via molecular mimicry and case reports implicating tetanus toxoid | Callaghan: CIDP pathogenesis differs from GBS; no evidence molecular mimicry or vaccines consistently trigger CIDP; case reports are weak | Petitioner failed to show Tdap can cause CIDP (Althen prong 1 not met) |
| Whether Tdap did cause Ms. Houston’s CIDP (Althen prong 2) | Temporal sequence after vaccination, treating neurologist supports causation, partial treatment response consistent with immune-mediated disease | Preexisting diabetic neuropathy and neuropathic complaints predate vaccination; no other treaters linked vaccine except Rogers; record shows possible pre-vaccination disease course | Petitioner failed to demonstrate vaccine was the likely cause (Althen prong 2 not met) |
| Temporal relationship (Althen prong 3) | Rogers: onset ~19 days post-Tdap, consistent with reported cases | Callaghan: onset estimates vary; Respondent did not dispute timeframe’s medical plausibility but argued other prongs fail; record may show earlier symptoms | Court: proposed timeframe could be medically acceptable, but prongs 1–2 fail and onset may have predated vaccination, so prong 3 is not dispositive |
| Weight of expert evidence and medical literature | Rogers (treating): supports causation though relies on analogy to GBS and case reports | Callaghan (academic/researcher): more persuasive; literature reviews show no consistent infectious/vaccine trigger for CIDP; case reports insufficient | Court favored Respondent’s expert; Rogers’ opinion deemed insufficiently grounded and case reports given little weight |
Key Cases Cited
- Althen v. Sec'y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishes the three‑prong test for causation‑in‑fact in vaccine cases)
- Moberly v. Sec'y of Health & Hum. Servs., 592 F.3d 1315 (Fed. Cir. 2010) (discusses burden of proof and preponderance standard in Vaccine Program)
- Boatmon v. Sec'y of Health & Hum. Servs., 941 F.3d 1351 (Fed. Cir. 2019) (rejects reliance on a merely "likely caused" standard)
- Lampe v. Sec'y of Health & Hum. Servs., 219 F.3d 1357 (Fed. Cir. 2000) (addresses role and weight of expert testimony)
- Knudsen v. Sec'y of Health & Hum. Servs., 35 F.3d 543 (Fed. Cir. 1994) (requires a sound and reliable medical theory under Althen prong one)
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (1993) (factors for evaluating reliability of expert scientific testimony)