Anderson Ex Rel. R.A. v. Secretary of Health & Human Services
131 Fed. Cl. 735
| Fed. Cl. | 2017Background
- R.A. received MMR and varicella vaccines on December 13, 1999; within a week he had a high fever and was treated for a viral illness; developmental concerns first documented around 15–21 months and became pronounced by 2 years.
- Petitioners alleged MMR triggered or aggravated an underlying secondary mitochondrial dysfunction, producing an inflammatory cascade that caused autism-spectrum disorder.
- Treating and later specialist evaluations (2001–2008) produced mixed metabolic and mitochondrial test results; a 2008 evaluation by Dr. Shoffner diagnosed a probable mitochondrial disorder; earlier records did not show clear regression.
- Petitioners litigated initially in the Omnibus Autism Proceeding and later pursued the claim individually; experts testified at a December 2015 hearing (Dr. Huq for petitioners; Dr. Cohen for respondent).
- Special Master Corcoran denied compensation (Nov. 1, 2016), finding petitioners failed to prove mitochondrial dysfunction and failed all three Althen causation prongs; petitioners sought review by the Court of Federal Claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether R.A. had mitochondrial dysfunction (threshold factual issue) | Expert Huq: abnormal biochemical markers and multisystem findings show secondary mitochondrial dysfunction | Expert Cohen: test results unreliable/inconsistent; clinical history not typical of mitochondrial disease | Court upheld Special Master: credible weighing favored Cohen; petitioners failed to prove mitochondrial dysfunction |
| Althen prong 1 — reliable medical theory linking MMR to autism via mitochondrial injury | MMR-induced fever/immunosuppression triggered inflammation worsening mitochondrial function leading to autism | Govt: petitioners offered no persuasive, reliable literature or mechanism for this theory; prior Omnibus findings reject immunosuppression theory | Court: Special Master reasonably found theory unsupported and not novelly established |
| Althen prong 2 — logical sequence of cause-and-effect (onset/regression) | Petitioners: fever within week of vaccination initiated a gradual cascade; compensatory mechanisms delayed outward regression | Govt: contemporaneous records show no neurological change until months later; fever likely viral not vaccine reaction | Court: Special Master reasonably concluded record does not show the required sequence; petitioners failed this prong |
| Althen prong 3 — medically-acceptable temporal relationship | Petitioners: delay of months can be explained by two-phase pathophysiology (citing Paluck) | Govt: petitioners offer no specific evidence why months passed with no demonstrable change; temporal gap unexplained | Court: Special Master reasonably found timing insufficient to establish causation; Paluck distinguishable |
Key Cases Cited
- Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir.) (adopts Althen three-part test for off-Table vaccine causation)
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.) (sets three-prong causation-in-fact test)
- Saunders v. Sec’y of Health & Human Servs., 25 F.3d 1031 (Fed. Cir.) (standards of review for special masters)
- Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518 (Fed. Cir.) (arbitrary and capricious standard explained)
- Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357 (Fed. Cir.) (deference to special master credibility findings)
- Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373 (Fed. Cir.) (two-phase neurodegeneration theory and temporal analysis)
- Hazlehurst v. Sec’y of Health & Human Servs., 604 F.3d 1343 (Fed. Cir.) (Omnibus Autism Proceeding procedures and deference to special master)
- Munn v. Sec’y of Health & Human Servs., 970 F.2d 863 (Fed. Cir.) (standards for reviewing discretionary and factual rulings)
- Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352 (Fed. Cir.) (importance of temporal evidence under Althen)