V.H. v. HHS - Influenza, narcolepsy with cataplexy (2022)

Deidre and Alex Henkel, parents of V.H., a minor, filed a petition on September 21, 2015, alleging that the intranasal seasonal influenza vaccine (FluMist) V.H. received on September 24, 2012, caused him to develop narcolepsy with cataplexy. V.H. was five years old at the time of vaccination.

Petitioners first noticed increased fatigue and sleepiness in late October and November 2012, approximately one to two months after the vaccination. Medical records documented V.H.'s progressive sleepiness, leading to a diagnosis of narcolepsy with cataplexy by Stanford Sleep Medicine Center in September 2013, with a genetic marker associated with narcolepsy (DQB1*0602) identified.

Petitioners' expert, Dr. Lawrence Steinman, proposed a theory of molecular mimicry, suggesting that components of the FluMist vaccine, specifically nucleoprotein, shared similarities with orexin or its receptor, potentially triggering an autoimmune response leading to narcolepsy.

Respondent's experts, Drs. Andrew MacGinnitie and David Raizen, contested this theory.

Dr. MacGinnitie argued that the homology identified by Dr.

Steinman was not statistically significant and that the studies relied upon by Dr. Steinman were flawed.

Dr. Raizen stated that there was no evidence linking influenza B vaccination to narcolepsy and that the epidemiological studies did not support a link between FluMist and narcolepsy.

Special Master Herbrina Sanders denied the petition, finding that petitioners failed to establish by a preponderance of the evidence that the flu vaccine was the cause-in-fact of V.H.'s narcolepsy. The Special Master concluded that Dr.

Steinman's theory relied on temporal proximity alone and lacked sufficient support in the medical records to demonstrate a logical sequence of cause and effect. The Special Master also found that the medical records did not contain evidence of an autoimmune reaction in V.H. and that the temporal relationship between the vaccination and the onset of symptoms was not sufficiently established.

On review, Senior Judge Loren A. Smith upheld the Special Master's decision, finding no arbitrary or capricious action, and denied the motion for review.

The case was therefore denied compensation.