H.C. v. HHS - Influenza, Ramsay Hunt syndrome (2022)

On January 4, 2016, H.C., a 38-year-old adult, filed a petition under the National Vaccine Injury Compensation Program alleging that an influenza vaccine received on January 4, 2013, caused her to suffer from Ramsay Hunt syndrome. Respondent, the Secretary of Health and Human Services, argued against compensation.

The parties agreed that H.C. received the flu vaccine on January 4, 2013, and was diagnosed with Ramsay Hunt syndrome, which results from reactivation of the varicella zoster virus (VZV). The disputed issues included the cause of H.C.'s Ramsay Hunt syndrome, the timeline of her eosinophilic granulomatosis with polyangiitis (EGPA) diagnosis, and the role of her clinical picture.

The core dispute centered on whether the flu vaccine caused H.C.'s Ramsay Hunt syndrome under the Althen standard. Petitioner was represented by Robert J.

Krakow, and respondent was represented by Colleen Hartley. Special Master Nora Beth Dorsey presided over the case.

After reviewing the evidence, Special Master Dorsey found that H.C. failed to prove by a preponderance of the evidence that the flu vaccine caused her Ramsay Hunt syndrome, and therefore, the petition was dismissed. The decision was originally filed on May 9, 2022, and refiled in redacted form on July 20, 2022.

H.C.'s medical history included childhood chickenpox, asthma, mitral valve prolapse, ear infections, an ACL tear, and a C-section. Her family history was significant for Bell's palsy and autoimmune illnesses.

Records from 2010-2011 indicated asthma, upper respiratory infections, and elevated eosinophils. On January 10, 2013, six days after vaccination, H.C. developed left-sided facial numbness and drooping, initially diagnosed as Bell's palsy.

On January 14, 2013, with the appearance of vesicles in her left ear, the diagnosis was changed to Ramsay Hunt syndrome. She experienced severe facial paralysis, hearing loss, vertigo, and eye complications, requiring multiple surgeries and ongoing pain.

In 2013, she also developed a nasal septal perforation and was later diagnosed with EGPA in 2017. Petitioner's expert, Dr.

Scott Zamvil, proposed three potential mechanisms by which the flu vaccine could cause Ramsay Hunt syndrome: molecular mimicry between vaccine antigens and VZV, amplification of immune responses by concomitant viral infections, and activation of the innate immune system. Dr.

Zamvil cited case reports of Ramsay Hunt syndrome following flu vaccination and other herpes virus reactivations after vaccinations. However, he conceded that there was no case report establishing a causal association between the flu vaccine and Ramsay Hunt syndrome and admitted he did not know why the January 2013 vaccine would have triggered the condition when prior vaccinations had not.

He also acknowledged that Ramsay Hunt syndrome is not an autoimmune disease, making molecular mimicry an unlikely mechanism. Petitioner's other expert, Dr.

M. Eric Gershwin, focused on H.C.'s EGPA diagnosis and opined that it was not relevant to the cause of her Ramsay Hunt syndrome, stating there were no reports of EGPA causing Ramsay Hunt syndrome.

He believed H.C. developed EGPA in 2017, four years after her vaccination. Respondent's experts, Dr.

Vinay Chaudhry and Dr. Arnold I.

Levinson, disagreed with petitioner's causation theories. Dr.

Chaudhry opined that H.C.'s Ramsay Hunt syndrome was caused by VZV reactivation due to her underlying EGPA, which reduced immune competence, and that the flu vaccine played no causative role. He believed H.C. had EGPA prior to her vaccination.

Dr. Levinson also analyzed Dr.

Zamvil's theories and found them unsupported by evidence, particularly the molecular mimicry and innate immune activation theories. He also addressed H.C.'s EGPA, suggesting it may have played a role in her Ramsay Hunt syndrome episodes.

Special Master Dorsey found that H.C. failed to establish a sound and reliable medical theory connecting the flu vaccine to her Ramsay Hunt syndrome (Althen Prong One). She noted that Ramsay Hunt syndrome is not an autoimmune disease, making molecular mimicry an inappropriate mechanism, and that the evidence did not support the proposed homologies or the innate immune activation theory.

The Special Master also found that H.C. failed to prove a logical sequence of cause and effect (Althen Prong Two). While acknowledging a temporal association between the vaccine and the onset of symptoms, she gave greater weight to the fact that none of H.C.'s treating physicians attributed her condition to the vaccine.

The Special Master also considered the possibility that H.C.'s EGPA illness was a contributing factor. Finally, while a temporal relationship existed (Althen Prong Three), it was insufficient on its own to prove causation.

Therefore, the petition was dismissed.