Eric And Kimberly Monte, As Natural Parents And Legal Guardians Of D.M., A Minor v. HHS - Influenza, autoimmune encephalitis, encephalopathy, and/or some unspecified autoimmune-mediated neurologic disorder (2024)

Filed 2021-10-04Decided 2024-01-31Vaccine Influenza
dismissedcognitive/developmental

Case summary [AI summaries can sometimes make mistakes]

On October 4, 2021, Eric and Kimberly Monte, as the natural parents and legal guardians of D.M., a minor, filed a petition for compensation under the National Vaccine Injury Compensation Program. They alleged that their son, D.M., developed autoimmune encephalitis, encephalopathy, and/or an unspecified autoimmune-mediated neurologic disorder after receiving an influenza vaccine on October 8, 2018.

D.M. was thirteen years old at the time of vaccination. The respondent, the Secretary of Health and Human Services, moved to dismiss the claim, arguing that the alleged injuries were not established by the record and that the flu vaccine could not have caused them.

Three days after the vaccination, on October 11, 2018, D.M. was taken to an emergency department after experiencing a headache following a football game the previous night where he was reportedly punched in the chin. He was described as "dazed and breathing heavily" at the end of the game and later "wandering around the house dazed and confused." An initial CT scan was normal, and he was diagnosed with a concussion.

A subsequent visit to his primary care provider noted the injury as a "hard hit" and that D.M. seemed "out of it" with short-term memory loss and uncharacteristic behaviors. He was again diagnosed with a concussion and advised to avoid sports.

Further evaluations included a visit to a neurologist who noted confusion and memory loss, assessing D.M. with "encephalopathy, unspecified." An EEG was normal. A neuropsychological evaluation noted an atypical gait and severe cognitive impairment, with the evaluator suggesting a significant "somatization" component and recommending further neurological assessment.

D.M. was hospitalized from November 12 to November 21, 2018. During this hospitalization, psychiatric evaluations were performed, and while infectious or autoimmune illness was considered, treaters proposed conversion disorder or a somatization-associated functional neurologic disorder as the most likely diagnoses.

A rheumatologic consultation noted improvement with intravenous steroid therapy, speculating on encephalopathy of unknown origin, but also stating the condition was "not caused by the flu vaccination." Subsequent evaluations by other neurologists and treaters continued to lean towards conversion disorder or functional neurologic disorder, with extensive testing for infectious or autoimmune causes yielding negative results. Some treaters noted that D.M.'s response to steroids and Ativan was more consistent with a psychosomatic illness or conversion disorder rather than true autoimmune disease.

Repeated testing for autoimmune encephalitis or associated diseases produced negative results. Petitioners presented expert testimony from Dr.

Justin Willer, a neurologist, who opined that D.M. suffered from vaccine-induced autoimmune encephalitis, arguing that the football injury was not the primary cause and that D.M.'s symptoms were consistent with this diagnosis. Dr.

Willer referenced studies involving the Hepatitis B vaccine and autoimmune encephalitis and suggested that D.M.'s responsiveness to steroids supported his autoimmune encephalitis diagnosis. He also downplayed the significance of the football injury, stating D.M. did not likely have a concussion because symptoms were not noted until after the game, he did not lose consciousness, and no adults observed strange behavior.

He also suggested that any conversion disorder was a secondary consequence of the encephalitis. Petitioners also submitted a neuropsychological evaluation by Kit W.

Harrison, Ph.D., which diagnosed "unspecified neurocognitive disorder; adjustment disorder with mixed anxiety and depressed mood." This evaluation did not address vaccine causation, the relationship to the football injury, or opine on conversion disorder. Respondent argued that the weight of evidence supported conversion disorder over autoimmune encephalitis, and that Dr.

Willer's opinion was not well-rooted in the record, particularly regarding the steroid response and the dismissal of the football injury. Respondent also contended that Petitioners failed to establish the three prongs of the Althen test for causation-in-fact.

Chief Special Master Brian H. Corcoran granted Respondent's motion to dismiss.

The Special Master found that the evidence did not preponderantly support an autoimmune encephalitis diagnosis. He noted that no testing confirmed such an injury, and no treating physicians settled on that diagnosis.

The Special Master found Dr. Willer's opinion unpersuasive, stating it was not sufficiently rooted in record proof and appeared to be "post hoc ergo propter hoc" reasoning.

The Special Master gave greater weight to the contemporaneous views of treating physicians who rejected the association with steroids and noted D.M.'s response to Ativan was more indicative of conversion disorder. The Special Master found the evidence of D.M.'s football injury to be a credible explanation for his symptoms, and Dr.

Willer's efforts to dismiss it unconvincing. The Special Master concluded that the medical record better supported explanations of concussion from the football game or conversion disorder, and that Petitioners failed to meet their burden of proof to establish a vaccine-related injury.

The claim was dismissed.

Theory of causation

Petitioners alleged that D.M., age 13, developed autoimmune encephalitis and/or encephalopathy after receiving an influenza vaccine on October 8, 2018. Petitioners' expert, Dr. Justin Willer, opined that the flu vaccine caused autoimmune encephalitis, which subsequently led to conversion disorder. Dr. Willer cited D.M.'s response to steroids and a temporal association between vaccination and symptom onset (three days) as support, while downplaying a reported football injury sustained shortly before symptom onset. Respondent argued that the weight of medical records and treating physician opinions pointed to concussion or conversion disorder, not vaccine-induced autoimmune encephalitis. Chief Special Master Brian H. Corcoran dismissed the claim, finding Dr. Willer's opinion unpersuasive and not sufficiently rooted in the record. The Special Master concluded that the evidence preponderantly supported a concussion from the football injury or conversion disorder as explanations for D.M.'s symptoms, rather than a vaccine-related autoimmune injury. The claim was dismissed for failure to meet the burden of proof under the Althen standard, specifically failing to establish a logical sequence of cause and effect and a medically acceptable temporal relationship for autoimmune encephalitis. The theory of causation was deemed "Off-Table."

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