Kristen Coons v. HHS - Td, small fiber neuropathy (2024)

Petitioner Kristen Coons, age 36, received a Td vaccine on June 23, 2019. She alleged developing small fiber neuropathy. Petitioner's experts, Dr. David Axelrod (immunologist) and Dr. Mitchell Miglis (neurologist), opined that the Td vaccine caused her small fiber neuropathy through molecular mimicry. They theorized that similarities between amino acid sequences in the tetanus and diphtheria toxoids and small nerve fiber receptors (such as TRPV1, CASPR2, sodium channels, and nicotinic receptors) triggered an autoimmune response targeting Petitioner's small nerve fibers. They cited literature suggesting small fiber neuropathy can be a variant of Guillain-Barré Syndrome (GBS), for which molecular mimicry is a known mechanism, and that Td vaccines have been associated with GBS. They also noted Petitioner had a prior Tdap vaccine in 2013, suggesting a secondary immune response to the 2019 Td vaccine, with symptom onset three days post-vaccination, which they deemed a medically acceptable timeframe for such a response. Respondent's expert, Dr. Thomas Leist (neurologist), argued against causation, stating there was no literature linking Td vaccine to small fiber neuropathy, that the three-day onset was too short, and that Petitioner had alternative causes such as vitamin B12 deficiency and rabies vaccinations. Special Master Nora Beth Dorsey found Petitioner established a sound and reliable medical theory of causation (molecular mimicry), a logical sequence of cause and effect, and a proximate temporal relationship (onset within three days), satisfying the Althen standard. The Special Master found the theory of molecular mimicry analogous to GBS and supported by the evidence of homology and literature. The Special Master determined the three-day onset was medically acceptable for a secondary immune response. Petitioner was awarded $144,627.10, including $130,000.00 for pain and suffering, $14,055.08 for lost earnings, and $572.02 for expenses.2 for expenses.2 for expenses.2 for expenses.2 for unreimbursable expenses.