Robert Madigan v. HHS - Influenza, unilateral sudden sensorineural hearing loss ("SSNHL") in his left ear (2022)
Case summary [AI summaries can sometimes make mistakes]
Robert Madigan filed a petition on December 10, 2014, alleging that the influenza vaccine he received on December 9, 2011, caused him to suffer unilateral sudden sensorineural hearing loss (SSNHL) in his left ear. The case proceeded as an off-Table claim, requiring Mr.
Madigan to prove causation-in-fact. Petitioner's counsel was Andrew Downing of Van Cott & Talamante PLLC, and respondent's counsel was Christine Mary Becer of the U.S.
Department of Justice. Special Master Daniel T.
Horner presided over the case. Mr.
Madigan initially alleged cognitive impairment as well, but later withdrew that claim. The case involved extensive medical record review and expert testimony.
Petitioner presented expert testimony from otolaryngologist George W. Hicks, M.D., and his treating physicians, Barry S.
Erner, D.O., and Christopher Nicora, M.D. Respondent presented expert testimony from infectious disease specialist Kenneth H.
Fife, M.D., Ph.D. Dr.
Hicks proposed that the flu vaccine could cause SSNHL through a "stress response theory," involving increased circulating cytokines and activation of NF-kB, leading to inflammation and damage in the inner ear, potentially in combination with reactivation of a latent HSV-1 infection. Respondent's expert, Dr.
Fife, questioned the plausibility of this mechanism, arguing that vaccine components would not reach the inner ear in sufficient concentration and that the blood-labyrinthine barrier would prevent such an effect. Dr.
Fife also noted the lack of established association between the flu vaccine and SSNHL in medical literature and suggested that Mr. Madigan's condition was idiopathic and occurred by chance.
Special Master Horner found that petitioner had established a logical sequence of cause and effect between the vaccination and his SSNHL, supported by the stress response theory and the opinions of his experts, and that respondent had not proposed an alternative etiology. On June 25, 2021, Special Master Horner issued a ruling on entitlement, finding Mr.
Madigan entitled to compensation. A subsequent joint stipulation on damages was filed.
On December 30, 2022, Special Master Horner awarded Mr. Madigan a lump sum of $635,545.39, payable to the petitioner.
Theory of causation
Petitioner Robert Madigan, age 76, received an influenza vaccine on December 9, 2011, and subsequently developed unilateral sudden sensorineural hearing loss (SSNHL) in his left ear. The claim was pursued as an off-Table, causation-in-fact claim. Petitioner's expert, Dr. George W. Hicks, proposed the "stress response theory," suggesting that the influenza vaccine acted as a systemic stressor, increasing circulating cytokines and activating NF-kB, leading to inflammation and damage in the inner ear's cochlear lateral wall. This could potentially be exacerbated by reactivation of a latent HSV-1 infection. Petitioner's treating physicians, Dr. Barry S. Erner and Dr. Christopher Nicora, also opined that the vaccine was the probable cause. Respondent's expert, Dr. Kenneth H. Fife, argued against a plausible mechanism, citing the localized nature of vaccine response, the blood-labyrinthine barrier, and a lack of established association between influenza vaccines and SSNHL in medical literature, suggesting the condition was idiopathic and coincidental. Special Master Daniel T. Horner found that Dr. Hicks's stress response theory provided a sound and reliable medical explanation for SSNHL following vaccination. The Special Master determined that a logical sequence of cause and effect was established, supported by medical records and expert testimony, and that the temporal relationship between the vaccination and the onset of SSNHL (within four days) was medically acceptable. Respondent did not propose an alternative etiology. Petitioner was found entitled to compensation. On December 30, 2022, a joint stipulation on damages resulted in an award of $635,545.39 to petitioner. Attorneys for petitioner were Andrew Downing and Christine Mary Becer for respondent.
Source PDFs
USCOURTS-cofc-1_14-vv-01187