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James-Cornelius v. Secretary of Health and Human Services

Court: US Court of Appeals for the Federal Circuit

Docket: 19-2404

Opinion Date: January 8, 2021

Judge: Jimmie V. Reyna

Areas of Law: Legal Ethics, Public Benefits

James-Cornelius sought compensation under the National Vaccine Injury Compensation Program, alleging that her 17-year-old son, E.J., had suffered dysautonomia, postural orthostatic tachycardia syndrome (POTS), and other symptoms as a result of receiving three shots of the HPV vaccine, Gardasil®. While there are no records of medical visits between his first and second vaccinations, the records document his medical visits, symptoms, and diagnoses after his third vaccination. The petition identified medical articles hypothesizing that HPV vaccines can cause dysautonomia and POTS and alleged that the increasing severity of his symptoms is “evidence of re-challenge” and that the pattern of worsening reactions is “strongly probative of a causal relationship” between the vaccine and E.J.’s symptoms, some of which were listed as potential Gardasil® side effects. James-Cornelius unsuccessfully attempted to obtain medical records relating to urgent care visits that she believed occurred before E.J.’s second vaccination. She eventually dismissed her petition, explaining that “she [would] likely be unable to prove" entitlement to compensation. James-Cornelius sought $17,111.12 in attorneys’ fees and costs under 42 U.S.C. 300aa-15(e)(1), asserting that she had filed her petition in good faith and with a reasonable basis. . The Federal Circuit vacated the denial of the petition. The Special Master failed to consider relevant objective evidence. E.J.’s medical records support for James-Cornelius’s reasonable basis claim even without an express medical opinion on causation. The Special Master erroneously concluded that petitioners’ affidavits are categorically “not 'objective" for evaluating reasonable basis.