Marlo Mayle v. HHS - Influenza, right sensorineural hearing loss (2018)

Filed 2017-09-08Decided 2018-11-15Vaccine Influenza
dismissed

Case summary [AI summaries can sometimes make mistakes]

Marlo Mayle, an adult, filed a petition on September 8, 2017, alleging that an influenza vaccine administered on November 16, 2014, caused her right sensorineural hearing loss. Petitioner submitted her medical records and affidavit but did not provide an expert report to support her claim.

The respondent filed a report on July 18, 2018, recommending against entitlement, noting that petitioner's treating physicians did not support her allegations, although they acknowledged anecdotal reports of hearing loss following flu vaccination. The respondent also pointed to petitioner's history of mitral valve prolapse, which has been associated with sudden sensorineural hearing loss.

On November 15, 2018, petitioner informed the court that she had been unable to find a credible expert and requested a ruling based on the existing record. The Special Master, Laura D.

Millman, noted that the case was a causation in fact matter. The medical records did not substantiate the allegations, and no medical opinion from an expert was provided.

Petitioner saw Dr. John J.

Hiestand on January 6, 2015, complaining of ringing and fullness in her right ear, which began approximately seven weeks after vaccination. Dr.

Hiestand's impression was serous otitis media and he stated, "I don't think flu shot had any connection to this." Petitioner later saw Dr. Ellen Baxter, an ENT specialist, on February 16, 2015, reporting symptoms that began the day after vaccination.

An audio test showed a moderately severe sensorineural hearing loss in her right ear. Dr.

Baxter's assessment included sudden right hearing loss, unilateral sensorineural hearing loss, and tinnitus, and she wrote, "I'm unsure if her flu shot caused this as there is no diagnostic test that can prove that. However, anecdotally, I have seen this frequently in my career, post flu shot." Dr.

Hiestand, in a letter dated November 25, 2017, reiterated his initial thought that the symptoms were not connected to the flu shot, while acknowledging that sensorineural hearing loss has been associated with flu shots in some patients, though this remains an area of uncertainty. Petitioner also submitted a case report by Kolarov et al. discussing bilateral deafness after influenza vaccination, noting that while the cause of SSNHL is often idiopathic, inflammation of the eighth cranial nerve can be due to hypersensitivity responses to vaccines.

The authors speculated that thimerosal might play a role, but then conceded this was unlikely given the low concentration. The Special Master found that petitioner failed to establish a prima facie case of causation in fact, as her medical records did not support her allegations and she did not provide a supporting medical expert opinion.

Consequently, the petition was dismissed. Petitioner was represented by Kevin A.

Mack, and respondent was represented by Robert P. Coleman, III.

The decision was issued by Special Master Laura D. Millman on November 15, 2018.

Theory of causation

Petitioner Marlo Mayle, age 79, received an influenza vaccine on November 16, 2014, and subsequently developed right sensorineural hearing loss. Petitioner alleged the vaccine caused her injury. The Special Master's decision does not describe the specific mechanism of injury or the theory of causation presented by the petitioner, other than a general allegation of causation. Petitioner's treating physicians, Dr. John J. Hiestand and Dr. Ellen Baxter, expressed uncertainty about a causal link, noting anecdotal reports but also potential alternative causes like mitral valve prolapse. Petitioner was unable to obtain an expert report to support her claim. A submitted case report by Kolarov et al. speculated on a potential link between influenza vaccination and sensorineural hearing loss via hypersensitivity or thimerosal, but the authors acknowledged the speculative nature and low likelihood of the latter. The Special Master found that petitioner failed to establish a prima facie case of causation in fact, as the medical records did not substantiate the allegations and no supporting medical expert opinion was provided, thus dismissing the petition. The theory of causation was determined to be 'Off-Table'. The decision was issued by Special Master Laura D. Millman on November 15, 2018. Petitioner was represented by Kevin A. Mack, and respondent was represented by Robert P. Coleman, III.

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