Deborah Sue Hardiman v. HHS - Influenza, significant aggravation of NMOSD/transverse myelitis (2024)

Deborah Sue Hardiman filed a petition alleging that an influenza vaccine administered on October 27, 2014, significantly aggravated her pre-existing transverse myelitis, later amended to neuromyelitis optica spectrum disorder (NMOSD). Ms.

Hardiman had a long history of transverse myelitis flares dating back to 1994, which she managed with medications like Imuran. She received the flu vaccine on October 27, 2014, and her condition began to worsen in late November or early December 2014, approximately five weeks later, after she had stopped taking Imuran.

This flare resulted in significant disability, including paralysis, weakness, pain, and bladder/bowel issues, leading to extensive treatment and rehabilitation. The case proceeded as an off-Table claim, requiring proof of causation-in-fact.

Petitioner's expert, Dr. Marcel Kinsbourne, opined that the flu vaccine triggered a relapse of NMOSD, citing studies suggesting vaccinations can elicit autoimmune responses.

Respondent's expert, Dr. Michael Wilson, argued that Ms.

Hardiman's condition was more likely due to the cumulative effects of her long-standing disease and her discontinuation of immunosuppressive medication, rather than the vaccine. The Special Master found that while Ms.

Hardiman's condition significantly worsened after vaccination, she failed to establish a medical theory of causation linking the flu vaccine to her specific diagnosis of aquaporin-4 seronegative NMOSD, as the available literature primarily focused on aquaporin-4 positive NMOSD or lacked strong evidence for vaccine causation in seronegative cases. Furthermore, the Special Master found that the logical sequence of cause and effect was not sufficiently proven, noting that her treating physicians did not attribute the flare to the vaccine and that her discontinuation of immunosuppressants was a more likely cause.

Ultimately, the court determined that Ms. Hardiman had not met her burden of proof for vaccine causation and dismissed her petition.