Michael Trainer v. HHS - Hepatitis A, bilateral tinnitus and hearing loss (2013)
Case summary [AI summaries can sometimes make mistakes]
Michael Trainer filed a petition for compensation under the National Vaccine Injury Compensation Program on December 15, 2010, alleging that a hepatitis A vaccination he received on December 17, 2007, caused him to develop bilateral tinnitus and hearing loss. Petitioner, who was 55 years old at the time of vaccination, had a history of tinnitus dating back to 1995, which he attributed to neurofibromatosis.
His pre-vaccination medical records indicated intermittent tinnitus, sometimes worse in the left ear, and normal audiograms. He also had a history of neurofibromas, including one removed from his cervical spine in 1995.
Petitioner reported that his tinnitus began or worsened shortly after receiving the hepatitis A vaccine, describing it as high intensity in both ears, impacting his sleep, concentration, and ability to understand speech. He sought compensation for an off-Table injury, arguing that the neomycin sulfate content in the vaccine caused ototoxicity, or alternatively, that an autoimmune or direct neural mechanism was responsible.
The respondent was the Secretary of Health and Human Services. Special Master Hamilton-Fieldman issued a decision on the record on July 24, 2013, denying compensation.
The Special Master found that Petitioner failed to satisfy all three prongs of the Althen test for establishing causation. Regarding the first prong, the Special Master found Petitioner's theory that neomycin sulfate in the vaccine caused his injury to be fatally flawed due to significant errors in dosage calculations, overstating the neomycin content by approximately 1,000-fold, and that the actual dose was far below any established ototoxic threshold.
The proposed autoimmune mechanism was also unsupported by medical literature. For the second prong, the Special Master found no logical sequence of cause and effect, noting that Petitioner's pre-existing neurofibromatosis and suspected acoustic neuroma were more plausible causes for his bilateral tinnitus and hearing loss.
The Special Master also noted that no treating physician opined that the vaccine caused Petitioner's condition. The third prong, proximate temporal relationship, was met by Petitioner's reporting of tinnitus onset or worsening shortly after vaccination, but this alone was insufficient without a valid theory of causation.
The Special Master concluded that the weight of the evidence did not support Petitioner's assertion that the hepatitis A vaccine caused his tinnitus and hearing loss, and that Petitioner had not demonstrated either a Table Injury or that his condition was actually caused by the vaccination. Compensation was denied.
Theory of causation
Michael Trainer, age 55, received a hepatitis A vaccine on December 17, 2007, and subsequently alleged bilateral tinnitus and hearing loss. Petitioner's theory of causation posited that neomycin sulfate, an excipient in the hepatitis A vaccine, caused ototoxicity, or alternatively, an autoimmune or direct neural mechanism. Special Master Hamilton-Fieldman denied the claim on July 24, 2013, finding Petitioner failed all three Althen prongs. Prong I (medical theory) was not met because Petitioner's neomycin sulfate ototoxicity theory was based on a dosage calculation error that overstated the neomycin content by approximately 1,000-fold, placing it far below ototoxic thresholds; the autoimmune theory lacked support in medical literature. Prong II (logical sequence) was not met as Petitioner's pre-existing neurofibromatosis and suspected acoustic neuroma were more plausible causes for his symptoms, and no treating physician opined vaccine causation. Prong III (temporal relationship) was met by Petitioner's reported onset of symptoms after vaccination, but was insufficient without a valid theory of causation. Petitioner did not present expert testimony, relying instead on medical literature and VAERS reports, which were found insufficient. Petitioner's counsel was Diana Stadelnikas, and Respondent's counsel was Julia McInerny. Compensation was denied.
Source PDFs
USCOURTS-cofc-1_10-vv-00865