Pope v. Secretary of Health and Human Services
14-78
| Fed. Cl. | Jun 7, 2017Background
- Petitioner Christina Pope filed a Vaccine Program petition alleging that her son B.P.’s May 11, 2011 DTaP and PCV vaccinations produced an encephalopathic developmental regression into autism and caused/exacerbated immunologic and mitochondrial dysfunction.
- Contemporaneous pediatric records show normal development through late 2011; first medical developmental concerns appear in January–June 2012 and formal CDSA diagnosis of autism in July 2012.
- Treaters disagreed: Dr. Harum diagnosed encephalopathic regression, IgG deficiency, and mitochondrial dysfunction and treated B.P. (including IV/subcutaneous immunoglobulin); other specialists (Dr. Roberts, Dr. Koeberl, Dr. Taravath, Dr. Cohen) found testing largely normal and declined mitochondrial disease/IVIG conclusions.
- Genetic and metabolic testing (karyotype, CMA, Fragile X, mtDNA sequencing, whole-exome, metabolic panels) were essentially normal; a buccal swab research assay suggested a modest Complex I finding but lacked clinical corroboration.
- Petitioner submitted two expert reports (Dr. Harum — treater, limited analysis; Dr. Kinsbourne — proposed vaccine-triggered oxidative stress aggravating subclinical mitochondrial dysfunction). Respondent submitted Dr. Cohen, a mitochondrial specialist, who rebutted mitochondrial disease and causation.
- Special Master Corcoran granted Respondent’s motion to decide on the record and dismissed the petition for failure to prove (1) preexisting mitochondrial disease/dysfunction, (2) an acute post-vaccination encephalopathic regression temporally linked to the vaccines, and (3) a reliable causation theory meeting Althen/Loving standards.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Existence of pre-vaccination mitochondrial disease/dysfunction | B.P. had an asymptomatic/subclinical mitochondrial deficiency later revealed by testing and expert assessment (Harum/Kinsbourne) | Medical/genetic/metabolic testing and clinical criteria do not support mitochondrial disease; abnormal findings are transient or non-diagnostic (Roberts/Cohen) | No preponderant evidence of mitochondrial disease or clinically significant dysfunction; petition fails Loving/Althen prerequisite |
| Occurrence of an acute post-vaccination encephalopathy/regression | B.P. regressed shortly after May 2011 vaccinations (parent affidavit, later treater notes) | Contemporaneous records show normal development for months after vaccination; first concerns recorded in early-mid 2012 | Contemporaneous medical records control; no reliable evidence B.P. experienced immediate post-vaccination encephalopathy or regression |
| Causation theory (vaccines aggravated mitochondria → autism) | Vaccination induced immune activation/oxidative stress that tipped mitochondrial function into clinical encephalopathy and regression (Kinsbourne) | Theory is speculative, unsupported by reliable evidence or literature for this case; experts’ opinions rest on faulty factual premises; precedent rejects similar theories | Petitioner failed Althen prongs: no reliable mechanism, no persuasive factual sequence tying vaccines to injury, and no medically-acceptable temporal link |
| Need for a hearing | Petitioner requested opportunity to present live testimony/expert evidence | Respondent moved to decide on the record; court found written record and expert reports sufficient to resolve material disputes | Hearing denied as unnecessary; record adequate and hearing would not change outcome |
Key Cases Cited
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (three-part test for proving causation-in-fact in Vaccine Program cases)
- Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (preponderance standard and substantial-factor causation discussion)
- Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (treatment of medical theory evidence in Vaccine Program)
- Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373 (Fed. Cir. 2015) (affirming remand where stronger factual record showed immediate post-vaccination encephalopathy and established mitochondrial disease)
- Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328 (Fed. Cir. 2010) (weight to be given to scientific evidence and treating expert testimony in autism cases)
- W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352 (Fed. Cir. 2013) (application of Loving framework to significant-aggravation claims)
- Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir. 2010) (credibility and relative persuasiveness of competing experts)
- Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525 (Fed. Cir. 1993) (contemporaneous medical records entitled to substantial weight over later testimony)