Tarsell v. Secretary of Health and Human Services
10-251
| Fed. Cl. | Oct 13, 2017Background
- Christina Tarsell (born 1986) received HPV vaccine doses on Aug 22, 2007; Nov 20, 2007; and Jun 3, 2008 and died June 21, 2008; autopsy listed cause and manner of death as "undetermined."
- After the first dose, an irregular pulse/ventricular premature contractions (VPCs) were first documented by physician Lafferman on Nov 20, 2007 (EKG abnormal); two EKGs and an echocardiogram showed no structural heart defect.
- Christina had intermittent dizziness/faintness and a transient rash in June 2008 (after third dose) and died 18 days after the third HPV dose; CDC pathology of heart tissue showed no conspicuous inflammatory infiltrates.
- Petitioner retained immunologist Dr. Shoenfeld and cardiologist Dr. Eldar advancing a molecular‑mimicry/autoantibody theory causing L‑type calcium channel dysfunction leading to arrhythmia; respondent’s experts (Drs. Phillips and Yeager) disputed causation and timing and emphasized absence of histologic cardiac injury.
- Special master initially denied entitlement (2016); the Court of Federal Claims vacated and remanded for reconsideration under clarified legal standards (2017); on remand the special master found petitioner met Althen prongs and awarded entitlement, deferring damages.
Issues
| Issue | Tarsell's Argument | HHS's Argument | Held |
|---|---|---|---|
| Prong 1 — Biological plausibility (Althen prong 1) | HPV vaccine can trigger molecular mimicry producing autoantibodies to cardiac L‑type calcium channels causing arrhythmia (theory described as "plausible"). | Theory unlikely/probable? Respondent conceded plausibility of molecular mimicry broadly but argued the mechanism and causation here were unlikely and lacked support. | Court of Federal Claims standard: petitioner need only present a "plausible" theory; special master found petitioner met this lower plausibility standard. |
| Prong 3 — Timing (temporal relationship) | Arrhythmia onset occurred after first dose (detected Nov 20, 2007) and death occurred within a medically appropriate interval after third dose (18 days). | Respondent argued arrhythmia likely pre‑existing (adolescents commonly have asymptomatic VPCs) and absence of earlier abnormal pulses undermines temporal link. | Special master (on remand) concluded it was not more likely than not that arrhythmia predated vaccination; medically appropriate interval for molecular mimicry set at ~7 days to 3 months; findings support onset within that window and death within window after third dose. |
| Prong 2 — Logical sequence / challenge‑rechallenge | Challenge after first dose (newly detected arrhythmia) and re‑challenge after third dose (symptoms June 7–12 and death June 21) create a logical causal sequence consistent with the experts’ mechanism. | Respondent emphasized lack of expected pathological findings (no inflammatory infiltrates), absence of treating‑physician attribution, and that red dots/rash do not indicate autoimmune reaction. | Special master credited challenge‑rechallenge pattern plus symptom timeline; although respondent’s points weakened the claim, overall preponderant evidence satisfied prong 2. |
| Treating‑physician evidence and other background (hypothyroidism, rash) | Prior brief references to possible hypothyroidism and post‑vaccine rash supported predisposition/immune response. | Respondent noted lack of treating‑physician diagnosis of autoimmune disease, normal subsequent thyroid labs, and that rash likely not autoimmune; pathologist and CDC tests showed no myocarditis. | Special master found thyroid history and rash had little probative value; lack of treating‑physician causation statements did not defeat entitlement given challenge‑rechallenge and timing findings. |
Key Cases Cited
- Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.) (establishes three‑part test for vaccine causation)
- Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir.) (discusses standard for pleading/plausibility in Vaccine Act context)
- Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir.) (courts defer to special masters’ credibility and weighing of expert testimony)
- Bazan v. Sec'y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir.) (temporal relationship requires preponderant proof of medically acceptable onset interval)
- W.C. v. Sec'y of Health & Human Servs., 704 F.3d 1352 (Fed. Cir.) (addresses temporal proof issues and burden allocation)
- Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir.) (prong two has substantive meaning; challenge‑rechallenge may support causation)
- Cloer v. Sec'y of Health & Human Servs., 654 F.3d 1320 (Fed. Cir.) (Althen described as pleading framework; ultimate burden remains preponderance)
- Hibbard v. Sec'y of Health & Human Servs., 698 F.3d 1355 (Fed. Cir.) (discusses plausibility and ultimate burden of proof)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (Supreme Court discussion of the plausibility standard in pleadings)