M. v. Secretary of Health and Human Services
133 Fed. Cl. 78
| Fed. Cl. | 2017Background
- Child A.P.M. received DTaP-Hib and MMR vaccines on July 14, 2006; parents allege post-vaccination regression to ASD and apraxia of speech.
- Parents reported loss of language and social withdrawal between about 15–20 months; autism diagnosis recorded in November 2007.
- Treating neurologist Dr. Frye (2010–2011) found elevated folate receptor blocking autoantibodies; CSF 5‑MTHF level from 2011 lumbar puncture was within lab reference range (low‑normal).
- Petitioners’ theory: DTaP triggered molecular mimicry → generation of folate‑receptor blocking autoantibodies → cerebral folate deficiency (or a milder variant) → autistic regression.
- Respondent’s expert disputed molecular mimicry plausibility, reliability of late antibody testing, and relevance of low‑normal CSF folate; also noted stronger homology with bovine milk proteins.
- Special Master denied entitlement: found no cerebral folate deficiency, petitioners’ theory not persuasive under Althen, inconsistent medical records on timing, and cow’s‑milk exposure an alternative explanation. Court sustained the Special Master’s decision.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether A.P.M. suffered a cerebral folate deficiency or related syndrome | Elevated blocking antibodies and low‑normal CSF folate show (mild) cerebral folate disorder caused symptoms | CSF folate was normal; clinical picture lacks classic deficiency; late antibody test unreliable | Special Master and court: no proven cerebral folate deficiency or delineated milder syndrome |
| Whether DTaP can cause blocking folate‑receptor autoantibodies via molecular mimicry | A five‑amino‑acid homology between pertussis protein and folate receptor plausibly induces antibodies | Five‑aa match insufficient for mimicry; greater exposure and homology to bovine milk better explains antibodies | Court: theory not persuasive; milk exposure undermines vaccine‑trigger theory |
| Althen prong 1 — medical theory linking vaccine and injury | Dr. Shafrir’s expert testimony supplies a plausible causal mechanism | Expert and literature do not show a reliable, vaccine‑specific link; petitioner’s expert lacks relevant CFDS experience | Court: petitioners failed to meet Althen prong 1 |
| Althen prongs 2–3 — logical sequence and temporal relationship | Parent testimony places regression within weeks of vaccination; sequence plausible | Contemporaneous records inconsistent; expert cannot specify a medically acceptable latency; alternative causes exist | Court: petitioners failed to prove logical sequence or a medically acceptable temporal window; decision affirmed |
Key Cases Cited
- Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (sets three‑part test for causation‑in‑fact in Vaccine Program cases)
- Pafford v. Sec'y of Health & Human Servs., 451 F.3d 1352 (Fed. Cir. 2006) (explains off‑table causation and relation of Althen to Shyface standards)
- Shyface v. Sec'y of Health & Human Servs., 165 F.3d 1344 (Fed. Cir. 1999) (but‑for and substantial‑factor causation principles)
- Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (courts may discount expert testimony lacking foundation or relevant experience)
- Hines ex rel. Sevier v. Sec'y of Health & Human Servs., 940 F.2d 1518 (Fed. Cir. 1991) (standard for upholding special master factual findings under arbitrary and capricious review)
- Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (temporal proximity and overall logic required; temporal coincidence alone insufficient)