Basem Alsaadeh v. HHS - Influenza, hearing loss (2024)

On July 30, 2019, Basem Alsaadeh filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that he suffered hearing loss as a result of receiving an influenza vaccine and a Prevnar 13 vaccine on October 22, 2016. Respondent argued against compensation.

The parties did not dispute that Petitioner suffered hearing loss, but they disputed whether the diagnosis was autoimmune inner ear disease (AIED) and whether the hearing loss was caused by the vaccinations. Petitioner contended he met the criteria under Althen v.

Secretary of Health & Human Services, 418 F.3d 1274 (Fed. Cir. 2005), while Respondent argued Petitioner failed to prove causation.

Petitioner, a 58-year-old physician, received the influenza and Prevnar 13 vaccines on October 22, 2016. Approximately one week later, he developed symptoms consistent with an upper respiratory infection (URI) and subsequently noticed hearing problems.

Initially, treating physicians diagnosed him with conductive hearing loss due to otitis media with effusion, which improved after tympanostomy tube placement. Later audiograms showed sensorineural hearing loss (SNHL).

Petitioner's expert, Dr. Richard Beck, opined that Petitioner had AIED, attributing it to the vaccinations.

Dr. Beck proposed a theory that the vaccines caused an abnormal immune response or immunodeficiency, leading to AIED.

He also cited medical literature regarding immune-mediated hearing loss and suggested that Petitioner's low pneumococcal antibody titers indicated an abnormal immune response. Respondent presented expert reports from Dr.

Douglas C. Bigelow and Dr.

J. Lindsay Whitton.

Dr. Bigelow disagreed with the AIED diagnosis, stating Petitioner's initial hearing loss was predominantly conductive and that the subsequent SNHL likely developed progressively, not suddenly or fluctuatingly as expected with AIED.

He attributed the conductive hearing loss to otitis media with effusion, potentially exacerbated by Petitioner's smoking, URI symptoms, and underlying medical conditions. He opined that the SNHL, particularly in the left ear, was likely progressive and its etiology was unknown, but that it occurred too long after vaccination to be causally related.

Dr. Whitton, an immunologist, deferred to Dr.

Bigelow on diagnosis but opined there was no evidence of immunodeficiency, citing Petitioner's normal immunoglobulin levels and appropriate response to the Prevnar 13 vaccine based on pneumococcal antibody titers. He also highlighted Petitioner's poorly controlled diabetes and cardiovascular disease as significant risk factors for SNHL, independent of vaccination.

Special Master Nora Beth Dorsey found that Petitioner failed to prove by a preponderance of the evidence that he had AIED. She noted that Petitioner's treating physicians did not diagnose AIED, and his initial hearing loss was diagnosed as conductive, not sensorineural.

Furthermore, Petitioner did not respond favorably to steroid treatment, which is often characteristic of AIED. The Special Master also found that Petitioner failed to establish a sound and reliable medical theory connecting the vaccines to his hearing loss.

Dr. Beck's theories were found to be underdeveloped, speculative, and lacking sufficient support in the medical literature, particularly concerning the proposed mechanisms of immune-mediated hearing loss and immunodeficiency following vaccination.

The Special Master also found that the temporal relationship between the vaccinations and the onset of SNHL was not medically acceptable, as the SNHL did not manifest until over two years after the vaccinations, while the initial issues were conductive hearing loss. Ultimately, the Special Master concluded that Petitioner failed to satisfy the three prongs of the Althen test for causation: a sound medical theory, a logical sequence of cause and effect, and a proximate temporal relationship.

Therefore, the petition was dismissed.