Nathaniel Ladue v. HHS - HPV, seizure disorder (2018)
Case summary [AI summaries can sometimes make mistakes]
On August 30, 2012, Nathaniel Ladue filed a petition for compensation on behalf of his minor son, B.L., alleging that the human papillomavirus (HPV) vaccine administered on November 24, 2010, caused B.L. to develop a seizure disorder. B.L., who was eleven years old at the time of vaccination, had a pre-existing diagnosis of severe autism, was nonverbal, and functioned at a preschool level with intellectual disabilities.
The parties agreed that the sole issue was whether the HPV vaccine caused B.L.'s seizure disorder. The Special Master found that the petitioner failed to meet the burden of proving by a preponderance of the evidence that the HPV vaccine caused B.L.'s seizure disorder.
The decision noted that B.L. had a high susceptibility to seizures due to his autism and intellectual disability, and that the medical literature did not support a causal link between the HPV vaccine and seizures. Experts agreed that B.L. was at a critical age for seizure onset due to his autism and intellectual disability, and that the seizures were likely unprovoked.
The Special Master concluded that B.L.'s underlying condition was the more probable cause of his seizures, and therefore denied entitlement to compensation. The decision was issued by Special Master Mindy Michaels Roth on August 6, 2018.
Petitioner was represented by Mark Sadaka, Esq., and respondent was represented by Darryl Wishard, Esq. The public decision does not describe the specific onset of symptoms, diagnostic tests performed beyond EEG and CT scans, or specific treatments beyond seizure medications like phenobarbital, Trileptal, and Topamax.
The medical records indicate B.L. received multiple vaccines prior to the HPV vaccine without event. His first witnessed seizure occurred five days after the HPV vaccination.
The medical records also detail B.L.'s ongoing struggles with autism, intellectual disability, and increasingly severe seizure activity, including status epilepticus and the need for intubation on multiple occasions. The decision does not specify any award amount as entitlement was denied.
Theory of causation
Petitioner alleged that the HPV vaccine administered on November 24, 2010, caused B.L., an 11-year-old with severe autism and intellectual disability, to develop a seizure disorder. Petitioner's expert, Dr. Marcel Kinsbourne, theorized that the autistic brain is primed for neuroinflammation and that the HPV vaccine acted as a secondary stimulus, triggering an exaggerated cytokine response and lowering the seizure threshold, leading to seizures. Dr. Kinsbourne relied on the Pinto study for cytokine response and the Riazi study for toxin-induced seizure susceptibility, but conceded limitations in both regarding adverse reactions and long-term effects. Respondent's expert, Dr. Shlomo Shinnar, contended that B.L.'s autism and intellectual disability, indicative of chronic encephalopathy, were the underlying causes of his increased seizure risk, particularly at his age. Dr. Shinnar stated there is no established association between the HPV vaccine and seizures, citing large population studies showing no increased risk. He argued that B.L.'s seizures were consistent with the known high incidence of epilepsy in individuals with autism and intellectual disability, and that the timing was not medically acceptable for causation. Special Master Mindy Michaels Roth found that petitioner failed to establish a reputable medical theory (Althen Prong I) connecting the HPV vaccine to seizures, as Dr. Kinsbourne's theory lacked sufficient empirical support and relied on studies not demonstrating adverse reactions. Petitioner also failed to establish a logical sequence of cause and effect (Althen Prong II), as B.L.'s underlying conditions were a more probable cause, and the vaccine's role was speculative. Finally, the proximate temporal relationship (Althen Prong III) was not met, as the five-day interval was not medically acceptable given B.L.'s susceptibility and lack of other adverse reactions. Entitlement was denied.
Source PDFs
USCOURTS-cofc-1_12-vv-00553