Tarsell v. Secretary of Health and Human Services
133 Fed. Cl. 782
| Fed. Cl. | 2017Background
- Petitioner (Emily Tarsell, executrix) alleged Gardasil vaccinations (three doses in 2007–2008) caused her daughter Christina to develop an RVOT‑VPC cardiac arrhythmia that worsened with each dose and culminated in Christina’s death in June 2008.
- Christina’s medical records across ~12 years show multiple pre‑vaccine pulse checks (the court counts ~30) with no documented arrhythmia; first physician detection was on November 20, 2007 (EKG confirmed).
- Timeline: Dose 1 — Aug 22, 2007; first documented arrhythmia — Nov 20, 2007; Dose 2 — Nov 20, 2007; Dose 3 — June 3, 2008; symptomatic decline within days after dose 3; death discovered June 23, 2008.
- Autopsy reported cardiac arrest of unknown cause; histology by CDC reported no conspicuous myocardial inflammatory infiltrates; no post‑mortem testing for autoantibodies was performed.
- Special Master denied compensation, finding petitioner failed to prove causation (timing/onset, biological theory, and logical sequence), and petitioner sought review.
- Court of Federal Claims granted review, concluded the Special Master applied overly stringent standards on Althen prongs, vacated and remanded for reconsideration consistent with Vaccine Act evidentiary rules.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Temporal relationship (Althen prong 3) | Christina had no documented arrhythmia before vaccines; onset is after dose 1 and temporally compatible with immune response timing | Onset is "unknown"; absence of continuous monitoring means pre‑existing arrhythmia cannot be ruled out | Court: Special Master raised petitioner’s burden impermissibly; must weigh medical records and expert opinion to determine if it is "more likely than not" arrhythmia began after vaccination or within a medically appropriate timeframe |
| Medical theory (Althen prong 1) | Molecular mimicry → autoantibodies to L‑type calcium channel → arrhythmia; biologically plausible per experts and literature | Theory speculative; Special Master argued petitioner needed to show the theory was "more likely than not" to occur | Court: Prong 1 requires biological plausibility, not proof that the mechanism is more likely than not; Special Master applied too demanding a standard |
| Cause‑in‑fact/logical sequence (Althen prong 2) | Challenge‑rechallenge, symptom worsening after subsequent doses, predisposition to autoimmunity, expert opinions and some epidemiologic/case report support causation | CDC histology shows no inflammatory infiltrates; epidemiologic studies argued against link for general population | Court: Special Master failed to consider the totality of evidence (treating‑physician records, challenge‑rechallenge, predisposition, expert testimony); remand required to reassess all evidence under correct standards |
| Use and weight of treating physicians and autopsy findings | Treating records and timing of symptoms are probative; lack of autoantibody testing is understandable given postmortem constraints | Autopsy/CDC tissue findings undermine the proposed autoimmune mechanism | Held: Treating records must be considered; absence of inflammatory infiltrates does not conclusively disprove petitioner’s autoimmune mechanism (experts testified infiltrates are not required); Special Master must reassess on remand |
Key Cases Cited
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.) (establishing the three‑prong test for causation‑in‑fact in Vaccine Act cases)
- Knudsen by Knudsen v. Sec’y of Dep’t of Health & Human Servs., 35 F.3d 543 (Fed. Cir.) (Vaccine Act causation decided case‑by‑case; epidemiology not always required)
- Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir.) (permissibility of circumstantial evidence including challenge‑rechallenge)
- Moberly ex rel. Moberly v. Sec’y of Dep’t of Health & Human Servs., 592 F.3d 1315 (Fed. Cir.) (preponderance standard and discussion of burden on Althen prongs)
- de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir.) (temporal relationship must be medically acceptable given disorder’s etiology)
- Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344 (Fed. Cir.) (adopting Restatement substantial‑factor/"but‑for" principles for vaccine causation)
- Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir.) (treating physician evidence and biologic plausibility can satisfy Prong 1)
- W.C. v. Sec’y of Dep’t of Health & Human Servs., 704 F.3d 1352 (Fed. Cir.) (affirming special master’s timing/onset analysis when record supports finding lesions predated vaccine)
- Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357 (Fed. Cir.) (appellate limits on reweighing factual evidence of special master)
- Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373 (Fed. Cir.) (court’s duty to ensure special master applied Vaccine Act evidentiary standards and articulated a rational basis)