S.R. v. HHS - Influenza, Guillain-Barré Syndrome (2025)

On June 10, 2019, Sanela Nicocevic filed a petition on behalf of her minor child, S.R., for compensation under the National Vaccine Injury Compensation Program, alleging that S.R. developed Guillain-Barré Syndrome (GBS) as a result of an influenza vaccine received on January 29, 2018. Sanela Redzepagic was later substituted as petitioner upon reaching the age of majority.

Initially, the respondent argued that S.R. had not established a Table GBS claim due to the onset occurring 46 days after vaccination, which is outside the typical 3-42 day window. However, the respondent later amended their position, stating they would not continue to defend the case and requested a ruling on the record.

The petitioner filed a motion for a ruling on the record, and the respondent responded. Special Master Mindy Michaels Roth reviewed the medical records, affidavits, and the expert report of Dr.

David Simpson. S.R. was a healthy 15-year-old at the time of vaccination.

Approximately 46 days after receiving the influenza vaccine, she began experiencing generalized body aches and weakness, progressing to an inability to walk. She presented to emergency rooms and clinics multiple times with worsening symptoms.

On March 25, 2018, she was transferred to Yale New Haven Children’s Hospital, where a lumbar puncture revealed albuminocytologic dissociation, and imaging showed enhancement of the cauda equina nerve root, findings consistent with GBS. She was diagnosed with GBS and treated with IVIG, showing significant improvement.

Petitioner’s expert, Dr. David Simpson, a neurologist, opined that the flu vaccine caused S.R.'s GBS through molecular mimicry, a theory supported by medical literature.

He noted that while the Table specifies 3-42 days for GBS onset after an influenza vaccine, studies, including one by Schonberger, suggest the attributable risk period can extend up to ten weeks. Dr.

Simpson also addressed the respondent's suggestion of an intervening upper respiratory infection, arguing that evidence supports an increased risk of upper respiratory infections following flu vaccination, suggesting both the respiratory symptoms and GBS could be causally related to the vaccine. The respondent did not present an expert to rebut Dr.

Simpson's findings or offer evidence of an alternative cause. Special Master Roth found that S.R. met the three prongs of the Althen test for causation-in-fact: a reputable medical theory connecting the flu vaccine to GBS (molecular mimicry), a logical sequence of cause and effect, and a proximate temporal relationship (46 days, supported by expert opinion and case law extending beyond the Table's 42-day window).

The Special Master concluded that the petitioner had met her burden of proof and that the flu vaccine was a substantial factor in S.R.'s development of GBS. Entitlement to compensation was granted, and the case was to proceed to damages.

Petitioner was represented by Maximillian Muller, Esq., and respondent was represented by Catherine Stolar, Esq. The decision was issued by Special Master Mindy Michaels Roth on April 15, 2025.