Genarina Decastro v. HHS - Hepatitis B, Bell's palsy and/or off-Table injuries, including but not limited to idiopathic facial paralysis, [Ménière]’s disease, vertigo, inner ear pain, and intraocular pressure (2024)

Genarina Decastro, an adult, received the first dose of her Hepatitis B vaccine on January 2, 2015. She alleged that this vaccine caused her to suffer Bell's palsy and other related off-Table injuries, including facial paralysis, Ménière's disease, vertigo, inner ear pain, and intraocular pressure.

Because her alleged injuries were not listed on the Vaccine Injury Table for the Hepatitis B vaccine, Ms. Decastro had the burden to prove causation-in-fact under the Althen standard.

She submitted medical records detailing her extensive treatment history for Bell's palsy, which began with symptoms of ear pain and facial droop shortly after her second Hepatitis B vaccination on February 10, 2015. Her treating physicians diagnosed her with Bell's palsy, and she underwent various treatments including steroids, antivirals, physical therapy, acupuncture, Botox injections, and surgery.

Petitioner's expert, a pharmacist, opined that the Hepatitis B vaccine could cause Bell's palsy through viral reactivation and cited post-marketing data. Respondent's expert, a neurologist, countered that the petitioner's symptoms were more consistent with Ramsay Hunt syndrome, caused by varicella-zoster virus reactivation, and that there was no reliable scientific evidence linking the Hepatitis B vaccine to Bell's palsy or viral reactivation.

The Special Master found that the petitioner failed to establish a reputable medical theory that the Hepatitis B vaccine can cause Bell's palsy (Althen prong one), noting that her expert's theory was largely unsupported and that the cited case reports were weak evidence. Furthermore, the Special Master found that the timing of onset was not proximate to the vaccination, as the earliest symptoms appeared the day before the second dose, and that the petitioner's condition was more likely Ramsay Hunt syndrome, pointing to a viral cause unrelated to the vaccine (Althen prongs two and three).

Consequently, the petition was denied.