Trey Cobb v. HHS - HPV, narcolepsy and cataplexy (type 1 narcolepsy) (2023)
Case summary [AI summaries can sometimes make mistakes]
On August 21, 2017, Jeffrey and Kimberly Cobb filed a petition for compensation on behalf of their minor son, Trey Cobb, alleging that he developed narcolepsy and cataplexy (type 1 narcolepsy) that was caused or significantly aggravated by his human papillomavirus (HPV) vaccinations on August 25, 2014, and August 18, 2015. The petition stated that Trey was 13 and 14 years old at the time of these vaccinations.
The case proceeded as an off-Table claim, requiring proof of causation under the Althen standard. Petitioner presented expert testimony from Dr.
Lawrence Steinman, who theorized that molecular mimicry between components of the HPV vaccine and hypocretin (orexin), a neuropeptide involved in wakefulness, could trigger an autoimmune response leading to the destruction of orexin-producing neurons and thus narcolepsy. This theory was supported by BLAST search results showing sequence homology and the Latorre study, which identified orexin-specific T cells in narcolepsy patients.
Respondent presented expert testimony from Dr. Lawrence Brown and Dr.
Robert Fujinami, who argued that there was no established link between the HPV vaccine and narcolepsy, that the molecular mimicry theory was not supported by the evidence, and that the HPV vaccine might even offer protection against autoimmune disease. The Special Master found Dr.
Steinman's theory persuasive, particularly with the addition of the Latorre paper, and determined that the onset of symptoms between one to three weeks after vaccination was a medically acceptable timeframe. The Special Master concluded that Petitioner had met his burden of proof for entitlement to compensation, and an order regarding damages would follow.
Petitioner counsel was Mark Sadaka of the Law Offices of Sadaka and Associates, LLC. Respondent counsel was Debra Begley of the U.S.
Department of Justice. Special Master Katherine E.
Oler issued the ruling on October 4, 2023.
Theory of causation
Petitioner, Trey Cobb, received his third HPV vaccine on August 17, 2015. He developed symptoms of excessive daytime sleepiness and cataplexy, leading to a diagnosis of narcolepsy type 1. Petitioner alleged the HPV vaccine caused his condition. This was an off-Table claim. Petitioner's expert, Dr. Lawrence Steinman, theorized that the HPV vaccine contains molecular mimics of hypocretin (orexin) and its receptors. Using BLAST searches, Dr. Steinman identified homology between orexin and the HPV 11 L1 protein, suggesting a potential for molecular mimicry. He further supported this theory with the Latorre study, which found orexin-specific T cells in patients with narcolepsy, arguing this provided evidence of an autoimmune attack on orexin neurons. Dr. Steinman opined that this autoimmune response, triggered by the vaccine, led to the destruction of orexin-producing neurons and caused Petitioner's narcolepsy. Respondent's experts, Dr. Lawrence Brown and Dr. Robert Fujinami, argued against this theory, stating there was no established link between the HPV vaccine and narcolepsy, that the molecular mimicry theory was unsupported by evidence, and that alum adjuvants, like those in the HPV vaccine, might offer protection against autoimmune disease. The Special Master found Dr. Steinman's theory, particularly bolstered by the Latorre paper, to be persuasive. The Special Master also found the onset of symptoms between one to three weeks post-vaccination to be a medically acceptable timeframe. Petitioner met the Althen standard for entitlement. Petitioner counsel: Mark Sadaka. Respondent counsel: Debra Begley. Special Master: Katherine E. Oler. Decision Date: October 4, 2023.
Source PDFs
USCOURTS-cofc-1_17-vv-01123