Gertrude Smilo v. HHS - Influenza, myasthenia gravis (2023)

Gertrude Smilo, as Administratix of the estate of her deceased husband Joseph G. Smilo, filed a petition alleging that Mr.

Smilo developed myasthenia gravis, which was caused by or significantly aggravated by an influenza vaccine he received on October 17, 2016. Mr.

Smilo was 63 years old at the time of vaccination and passed away on April 6, 2017. The death certificate listed liver failure due to hepatocellular carcinoma (HCC) as the immediate cause of death, with myasthenia gravis, septic shock, and multiple organ failure as significant contributing conditions.

Petitioner argued that Mr. Smilo's myasthenia gravis met the Vaccine Act's severity requirement through inpatient hospitalization and surgical intervention (PEG tube placement) and that the vaccine was a substantial factor in his death.

Respondent argued against compensation, asserting that Mr. Smilo's myasthenia gravis symptoms predated the vaccination and that there was no reliable evidence that the flu vaccine causes or worsens myasthenia gravis.

The Special Master found that Mr. Smilo's symptoms of myasthenia gravis, specifically ptosis, began prior to his vaccination, based on contemporaneous medical records.

The court also found that Mr. Smilo underwent two PEG tube insertions, which qualified as surgical interventions resulting in inpatient hospitalizations, thus satisfying the severity requirement.

However, the court ultimately denied the petition, finding that Petitioner failed to prove by a preponderance of the evidence that the flu vaccine caused or significantly aggravated Mr. Smilo's myasthenia gravis.

The court found Petitioner's proposed causation theories, including molecular mimicry and haptenization, to be unsupported by reliable medical or scientific evidence and speculative. Furthermore, the court found that Mr.

Smilo's myasthenia gravis was not caused or significantly aggravated by the vaccine, as his symptoms predated vaccination and the medical literature did not support a causal link between the flu vaccine and myasthenia gravis, especially in light of studies showing no exacerbation in patients with pre-existing myasthenia gravis who received the flu vaccine. The court also found that Petitioner failed to establish a logical sequence of cause and effect, noting that treating physicians did not attribute causation to the vaccine.

Therefore, the petition was dismissed.