Emily Tarsell v. HHS - HPV, cardiac arrhythmia resulting in her death (2018)

Emily Tarsell, as executrix of the estate of her daughter Christina Tarsell, filed a petition on April 19, 2010, alleging that Christina's HPV Gardasil vaccine caused an autoimmune reaction in the nervous tissue of her heart, resulting in cardiac arrhythmia and her sudden death. Christina was born in 1986 and received three doses of the HPV quadrivalent vaccine: August 22, 2007 (dose 1), November 20, 2007 (dose 2), and June 3, 2008 (dose 3).

She died on June 21, 2008, eighteen days after dose 3. The key temporal facts were as follows: approximately three weeks after dose 1, on September 12, 2007, Christina had a pre-participation physical at Bard College that recorded her pulse at 72 and showed her cardiovascular system to be normal, with no racing or skipping heartbeat.

However, on the same day she received dose 2 (November 20, 2007), her internist Dr. Lafferman detected an irregular pulse.

An EKG showed premature ventricular contractions. A subsequent echocardiogram on February 12, 2008, found normal heart structure.

Following dose 3 on June 3, 2008, Christina experienced dizziness and faintness from June 7-12, 2008, and died on June 21, 2008. Medical examiner Dr.

Kari Reiber determined that both the cause and manner of death were undetermined. Heart tissue sent to the CDC showed no conspicuous inflammatory cell infiltrates on microscopic examination.

Petitioner's theory was that the HPV vaccine caused an autoimmune reaction targeting the beta adrenergic receptors and/or L1 calcium channels of the heart, triggering fatal arrhythmia. Petitioner's experts were Dr.

Yehuda Shoenfeld, an immunologist, and Dr. Michael Eldar, a cardiologist.

Respondent's experts were Dr. Scott Yeager, a cardiologist, and Dr.

S. Michael Phillips, an immunologist.

An entitlement hearing was held on November 13-14, 2014. Special Master Moran denied compensation on February 16, 2016, finding that Ms.

Tarsell had not established by preponderant evidence that Christina's arrhythmia arose after the first HPV dose; that even if it had, the proposed mechanism contained too many leaps and unsupported assumptions; and that the CDC's finding of no inflammatory infiltrates in the heart tissue contradicted what the autoimmune theory would have predicted. The Court of Federal Claims, Judge Williams, vacated the decision and remanded on June 30, 2017 (133 Fed.

Cl. 782), directing the special master to apply different legal standards in analyzing the challenge-rechallenge evidence. On remand, Special Master Moran issued a ruling on September 25, 2017, finding entitlement under the Court-directed standards.

The normal cardiac findings on September 12, 2007 (three weeks after dose 1) followed by the arrhythmia detected on November 20, 2007 (three months after dose 1) constituted challenge-rechallenge evidence that was sufficiently probative to carry petitioner's burden of proof on the logical sequence prong, despite Dr. Phillips's contrary evidence.

On February 26, 2018, respondent filed a proffer for damages to which petitioner agreed: $250,000.00 for vaccine-related death, $60,000.00 for past pain and suffering, and $130.00 for past unreimbursable expenses, for a total of $310,130.00. Respondent reserved the right to seek review of the September 25, 2017 entitlement ruling.

Interim attorneys' fees of $173,107.70 had been awarded on May 13, 2015.