Donna Osso v. HHS - Hepatitis B, Guillain-Barré Syndrome (“GBS”) (2023)

Donna Osso, a 59-year-old adult, received a hepatitis B vaccination on April 23, 2015, as a requirement for employment. Within approximately ten days, she began experiencing progressive weakness in her hands and legs, leading to difficulty walking and using her hands.

She presented to the emergency department multiple times, and after neurological consultations and an EMG, she was diagnosed with Guillain-Barré Syndrome (GBS). Petitioner alleged that the hepatitis B vaccine caused her GBS.

Respondent argued against compensation, stating the vaccine was not causally linked to GBS. The case proceeded as an off-Table claim, requiring Petitioner to prove causation-in-fact under the Althen standard.

Petitioner presented expert testimony from Dr. Marcel Kinsbourne, who opined that molecular mimicry is a sound medical theory linking the hepatitis B vaccine to GBS, supported by various studies and case reports.

Dr. Kinsbourne also concluded that Petitioner's GBS was more likely than not caused by the vaccine, citing the temporal proximity and the absence of other viable causes.

Respondent presented expert testimony from Dr. Lawrence Moulton, a biostatistician, who argued the epidemiological evidence was insufficient, and from Dr.

Thomas Leist, a neurologist, who opined that the hepatitis B vaccine is not causally associated with GBS and that Petitioner's GBS was not caused by the vaccine, suggesting possible alternative causes like an upper respiratory infection, though this was not strongly supported by medical records. The Special Master found that Petitioner established a sound medical theory (molecular mimicry), a logical sequence of cause and effect, and a proximate temporal relationship between the vaccination and her GBS.

The court found that Respondent failed to prove an alternative cause for Petitioner's injury. Therefore, the Special Master ruled that Donna Osso is entitled to compensation for her vaccine-related GBS, with a separate order to follow for damages.