E.S. v. HHS - HPV, autonomic dysfunction, headaches, chronic fatigue syndrome (CFS), postural orthostatic tachycardia syndrome (POTS), small fiber neuropathy (SFN), cardiac condition, aggravation of preexisting diabetes mellitus (2021)

Filed 2017-04-07Decided 2021-06-14Vaccine HPV
denied

Case summary [AI summaries can sometimes make mistakes]

E.S. filed this action on April 4, 2017, seeking compensation under the National Vaccine Injury Compensation Program. She alleged that the human papillomavirus (HPV) and hepatitis A vaccines received on July 15, 2014, and the HPV and influenza vaccines received on August 19, 2015, aggravated her pre-existing type I diabetes (T1D) and caused other conditions, including headaches, narcolepsy, chronic fatigue syndrome (CFS), postural orthostatic tachycardia syndrome (POTS), small fiber neuropathy (SFN), and a cardiac condition.

E.S. had a history of T1D since age five, along with other medical issues. The Special Master denied her claim, finding that many of her alleged injuries were not preponderantly established and that her theories of causation were unreliable.

The Special Master noted that the medical record did not establish a causal connection between the vaccines and her alleged injuries, including POTS, narcolepsy, CFS, SFN, and aggravation of T1D. The Court reviewed the Special Master's decision and denied E.S.'s motion for review, sustaining the Special Master's denial of compensation.

The Court found that the Special Master appropriately considered the evidence and applied the relevant legal standards, concluding that E.S. failed to prove by a preponderance of the evidence that the vaccines caused her alleged injuries or significantly aggravated her T1D.

Theory of causation

Petitioner alleged that the HPV and Hepatitis A vaccines administered on July 15, 2014, and the HPV and Influenza vaccines administered on August 19, 2015, aggravated her pre-existing Type I Diabetes (T1D) and caused headaches, narcolepsy, CFS, POTS, SFN, and a cardiac condition. Petitioner's experts, Dr. Steinman and Dr. Lee, proposed theories linking the HPV vaccine to these conditions, primarily through molecular mimicry and autoimmune responses, and suggested that the vaccine could exacerbate T1D. Respondent's experts, including Dr. LaRue (cardiologist), Dr. MacGinnitie (pediatrician/immunologist), Dr. Raizen (neurologist/sleep specialist), and Dr. Gibbons (neurologist), opined that the evidence did not support a causal link between the vaccines and the alleged injuries. They challenged the Petitioner's diagnoses, the proposed mechanisms of causation, and the temporal relationship between vaccination and symptom onset. The Special Master denied the claim, finding that the alleged injuries were not preponderantly established and the causation theories were unreliable. The Court of Federal Claims affirmed the Special Master's decision, agreeing that the Petitioner failed to meet the burden of proof under the National Childhood Vaccine Injury Act, specifically the Althen criteria for causation, and that the medical evidence did not preponderantly support her claims. No award was granted.

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