Mykelle Jivon D’Tiole v. HHS - Influenza, narcolepsy with cataplexy (2017)

On January 27, 2015, the parents of Mykelle Jivon D’Tiole, a minor at the time, filed a petition seeking compensation under the National Vaccine Injury Compensation Program. They alleged that the FluMist influenza vaccine administered to Mr.

D’Tiole on December 13, 2011, caused him to develop narcolepsy with cataplexy. Mr.

D’Tiole was 14 years old at the time of vaccination. His parents did not provide consent for the vaccination and were unaware it had occurred until 2014.

The case proceeded as an off-Table claim. Petitioner’s expert, Dr.

Lawrence Steinman, proposed a theory of molecular mimicry, suggesting that components of the H1N1 strain in FluMist could cross-react with hypocretin receptors in the brain, leading to an autoimmune attack and narcolepsy. Dr.

Steinman based this theory on research related to the Pandemrix vaccine, an inactivated influenza vaccine previously associated with narcolepsy in Europe. Respondent’s experts, Dr.

Michael Kohrman and Dr. Andrew MacGinnitie, argued that the scientific literature and epidemiological studies, particularly the Duffy study, did not support a link between FluMist and narcolepsy.

They emphasized the differences in vaccine formulation and manufacturing between FluMist (a live attenuated influenza vaccine, LAIV) and Pandemrix (an inactivated, adjuvanted vaccine), and contended that Dr. Steinman's research, while potentially applicable to Pandemrix, did not extend to FluMist.

The Special Master, Brian H. Corcoran, issued a decision without a hearing, granting Respondent’s motion to dismiss.

The Special Master found that Petitioner failed to establish a reliable causation theory under the Althen standard, concluding that Dr. Steinman's theory, while potentially applicable to Pandemrix, was not sufficiently supported for the specific FluMist vaccine administered.

The Special Master also found that the other Althen prongs, regarding a logical sequence of cause and effect and a proximate temporal relationship, were not met due to inconsistencies in the medical records regarding symptom onset and progression, and a lack of evidence of an autoimmune process. Petitioner appealed this decision.

On March 28, 2017, Senior Judge Edward J. Damich of the U.S.

Court of Federal Claims affirmed the Special Master's decision, finding it was not arbitrary or capricious and that the Special Master properly weighed the evidence and did not abuse his discretion by deciding the case without a hearing. The court agreed that Petitioner failed to establish a reliable causation theory and that the evidence presented did not sufficiently link FluMist to narcolepsy.

The petition for compensation was denied.