G.T. v. HHS - Pneumococcal, Tourette syndrome (2024)

Filed 2020-04-24Decided 2024-05-29Vaccine Pneumococcal
denied

Case summary [AI summaries can sometimes make mistakes]

On December 1, 2020, A.T., as natural mother and guardian for G.T., a minor, filed a petition for compensation under the National Vaccine Injury Compensation Program. The petition alleged that G.T., who was three years old, suffered neurological harm from a pneumococcal vaccine administered on January 28, 2019.

G.T. had previously received three doses of the pneumococcal vaccine without complication. His pre-vaccination medical history included torticollis and plagiocephaly, but was otherwise normal.

Approximately seven days after the vaccination, on February 4, 2019, G.T. was seen by a pediatrician with complaints of "jerking body," twitching, eye twitching, and diarrhea, which his mother believed began the day after vaccination with symptoms such as excessive eye blinking, full body twitching, and difficulty walking. The pediatrician diagnosed a tic disorder.

Subsequent evaluations by other specialists, including a pediatric neurologist and an infectious disease specialist, considered diagnoses such as tic disorder, PANDAS, and seizures. An EEG performed in February 2019 showed "sharp wave activity" without clinical correlation.

By November 2019, G.T. was diagnosed with tics and static encephalopathy. In June 2020, a neurologist suspected an underlying genetic condition and referenced Tourette syndrome.

Genetic testing in September 2020 revealed a heterozygous variant of uncertain significance in the histidine decarboxylase gene, indicating a possible genetic diagnosis of autosomal dominant Tourette syndrome. The parties ultimately focused on Tourette syndrome as the alleged injury.

Petitioner alleged that the pneumococcal vaccine caused G.T.'s condition through cytokine-induced brain inflammation or molecular mimicry. Respondent argued that there was no scientific support for a causal link between the pneumococcal vaccine and Tourette syndrome, citing the lack of epidemiological studies and the speculative nature of Petitioner's expert theories.

Respondent also highlighted G.T.'s family history of neuropsychiatric disorders and a genetic variant as more likely contributors. Petitioner's experts, Dr.

Mahbubul Huq and Dr. M.

Eric Gershwin, proposed theories of cytokine-induced brain inflammation and molecular mimicry. Respondent's experts, Dr.

Lawrence Brown and Dr. Andrew MacGinnitie, opined that Petitioner failed to establish a reputable medical theory connecting the vaccine to Tourette syndrome, criticizing the Petitioner's expert theories as unsubstantiated and not supported by reliable evidence specific to the pneumococcal vaccine and Tourette syndrome.

They also noted G.T.'s lack of clear signs of systemic inflammation post-vaccination and that treater opinions did not strongly support a vaccine causal relationship. The Special Master found that Petitioner failed to establish a reputable medical theory connecting the vaccine to Tourette syndrome, as required by the first prong of the Althen test.

The Special Master found Dr. Huq's theories of cytokine-induced inflammation and molecular mimicry to be unsubstantiated and not supported by reliable evidence.

The Special Master also noted that G.T. did not exhibit clear signs of systemic inflammation post-vaccination, and treater opinions did not strongly support a vaccine causal relationship. Therefore, entitlement to compensation was denied.

Petitioner's counsel was Carol Gallagher. Respondent's counsel was Lauren Kells and later, U.S.

Department of Justice. The decision was issued by Chief Special Master Brian H.

Corcoran.

Theory of causation

Petitioner alleged that G.T., a three-year-old boy, suffered neurological harm from a pneumococcal vaccine administered on January 28, 2019, resulting in Tourette syndrome. Petitioner's expert, Dr. Mahbubul Huq, proposed two theories: 1) cytokine-induced brain inflammation, where polysaccharides in the vaccine trigger inflammatory cytokine release, which then affects the brain and leads to tics; and 2) molecular mimicry, suggesting cross-reactivity between vaccine components and brain tissue. Dr. Huq cited studies on cytokine effects and inflammation in neurological disorders, and studies on molecular mimicry in other contexts. Petitioner's other expert, Dr. M. Eric Gershwin, largely deferred to Dr. Huq's theories. Respondent's experts, Dr. Lawrence Brown and Dr. Andrew MacGinnitie, argued that Dr. Huq's theories lacked scientific support, were based on speculative connections, and were not corroborated by G.T.'s medical history, which showed no signs of systemic inflammation. They noted the absence of epidemiological studies linking the pneumococcal vaccine to Tourette syndrome and highlighted G.T.'s family history and genetic variant as potential causes. The Special Master found that Petitioner failed to establish a reputable medical theory under the first prong of the Althen test, deeming Dr. Huq's theories unsubstantiated and lacking specific evidence connecting the pneumococcal vaccine to Tourette syndrome. The Special Master also found that the rapid onset of G.T.'s symptoms was inconsistent with molecular mimicry and that there was no evidence of systemic inflammation. Consequently, entitlement to compensation was denied. The theory of causation was determined to be Off-Table.

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