Tim A. Zikeli v. HHS - Influenza, sudden sensorineural hearing loss (2025)

Tim A. Zikeli, a 62-year-old adult, received an influenza vaccine on October 23, 2018.

He alleged that he developed sudden sensorineural hearing loss (SSNHL) in his right ear two days later, on October 25, 2018. Mr.

Zikeli sought compensation under the National Vaccine Injury Compensation Program, claiming the flu vaccine caused his hearing loss. The respondent, the Secretary of Health and Human Services, argued against compensation, stating the case was not appropriate for it under the Vaccine Act.

The court analyzed the case under the Althen standard for off-Table claims, requiring proof of a medical theory connecting the vaccine to the injury, a logical sequence of cause and effect, and a proximate temporal relationship. Mr.

Zikeli presented expert testimony from Dr. Edwin Monsell, who proposed a seven-step mechanism involving inflammation and microvascular changes triggered by the vaccine.

However, the court found Dr. Monsell's theory to be unreliable and unsupported by foundational evidence, noting that many of the cited studies involved different conditions or methodologies than vaccination.

The respondent's experts, Dr. Herman F.

Staats and Dr. Yu-Lan Mary Ying, argued that the scientific literature does not support the proposed mechanism and that alternative causes, such as Petitioner's hyperlipidemia and potential asymptomatic viral infections, could explain the hearing loss.

The court found the respondent's experts' opinions more persuasive. The court also noted that Mr.

Zikeli's treating physician, Dr. Anders Holm, had advised that the flu shot would not cause his symptoms, and that while Mr.

Zikeli's primary care physician later noted the hearing loss might be related to the vaccine, his records also indicated that no doctors attributed the hearing loss to the shot. Although the temporal relationship of two days between vaccination and onset was met, the court concluded that Mr.

Zikeli failed to prove by a preponderance of the evidence that the flu vaccine caused his SSNHL. Therefore, the petition was dismissed.