A.K. v. HHS - Influenza, narcolepsy and associated symptoms (2022)

On June 13, 2017, Laura and Bojan Kalajdzic filed a petition on behalf of their minor son, A.K., alleging that two doses of the FluMist influenza vaccine, received on October 30, 2014, and December 2, 2014, caused him to develop narcolepsy with cataplexy. A.K. was eight years old at the time of vaccination.

His initial symptoms of fatigue, poor sleep, and irritability began approximately one month after the second dose, with a formal diagnosis of narcolepsy and cataplexy occurring in June 2016. Petitioners presented expert testimony from Dr.

Benjamin Hughes and Dr. S.

Sohail Ahmed, who opined that the FluMist vaccine could cause narcolepsy, particularly in a genetically susceptible individual like A.K., and likely did so in this case. Dr.

Hughes reviewed literature on narcolepsy pathogenesis and the biologic plausibility of causation, noting numerous cases of narcolepsy onset following H1N1 influenza infection or immunization, and inferred a causative role for H1N1 infection or immunization in narcolepsy pathogenesis due to FluMist containing H1N1 antigens. Dr.

Ahmed theorized that an autoimmunological response to FluMist could mirror an influenza infection, and that the dual administration of the vaccine increased A.K.'s risk, especially given his genetic predisposition. Respondent presented expert testimony from Dr.

Thomas J. Dye, who argued that the FluMist vaccine was not reliably linked to narcolepsy, citing that no cases of narcolepsy had been linked to FluMist and that the specific FluMist batches used were likely ineffective.

Dr. Dye also noted that A.K.'s symptom onset timeline was more consistent with the natural history of the condition than a vaccine-induced reaction, and that studies like Duffy and Sarkanen found no association between narcolepsy and non-adjuvanted flu vaccines like FluMist.

The Chief Special Master denied entitlement, finding that Petitioners failed to establish by a preponderance of the evidence that FluMist can cause narcolepsy (Althen prong 1) or that there was a logical sequence of cause and effect between the vaccination and A.K.'s condition (Althen prong 2). The third prong, proximate temporal relationship, was conceded by Respondent.

The decision was affirmed on review by the Court of Federal Claims, which found no legal error in the Chief Special Master's application of the law and weighing of the evidence. The case was ultimately denied.