Lisa Mathis v. HHS - Influenza, multiple sclerosis (2023)

Lisa Mathis, born in 1968, filed a petition on April 14, 2020, alleging that an influenza vaccine administered on October 25, 2018, significantly aggravated her multiple sclerosis (MS). Ms.

Mathis, who was 50 years old at the time of vaccination, had sought chiropractic care for symptoms such as tightness and tingling in the years prior, and on June 7, 2017, reported intermittent numbing discomfort in her feet. Approximately 16 months before the vaccination, she reported intermittent neck and low back tightness.

No treating doctor had diagnosed her with MS before the vaccination, though experts agreed she likely had central nervous system lesions prior to receiving the vaccine. Following the vaccination, Ms.

Mathis experienced increased symptoms, and on November 15, 2018, informed a colleague of her primary care doctor about constant numbness and tingling on her left side starting after the flu vaccination. An MRI on December 4, 2018, revealed at least ten lesions in her brain, and a neurologist confirmed a diagnosis of relapsing-remitting MS after additional testing.

Ms. Mathis's amended petition, filed April 14, 2021, conformed to the opinion of her retained expert, Dr.

Bart Chwalisz, who opined that while Ms. Mathis may have had clinically silent MS plaques before the vaccine, the clinical onset of her symptoms clearly dated to the vaccination.

Dr. Chwalisz proposed several mechanisms by which a flu vaccine could cause or aggravate MS, including molecular mimicry, bystander activation, and complement instigation.

The Secretary of Health and Human Services contested these allegations, relying on the report of his expert, Dr. Thomas Leist.

Dr. Leist opined that Ms.

Mathis had experienced symptoms consistent with prodromal MS for at least 18 months prior to vaccination and that the flu vaccine is not known to cause or aggravate MS. He further stated that her pre- and post-vaccination symptoms were similar.

The parties submitted briefs, and the Special Master, Christian J. Moran, decided the case without an evidentiary hearing, noting that both experts had testified previously and that he was familiar with the issues.

The Special Master applied the six-prong test from Loving, focusing on the last three prongs, which correspond to the Althen factors for off-Table cases. Ms.

Mathis's claim failed on the fourth prong, which requires a petitioner to present a reliable medical theory connecting the vaccine to the injury. The Special Master found that Ms.

Mathis did not persuasively show that flu infections are similar enough to flu vaccinations to support her claim, as infections involve viral replication while vaccinations do not. The Special Master also reviewed several epidemiologic studies cited by both parties, including Langer-Gould, Mealy, and Karussis for the petitioner, and Mokhtarian, Miller, and Mailand for the respondent.

The Special Master concluded that the overall epidemiologic evidence weighed against a finding that the flu vaccine can cause or aggravate MS. Furthermore, the three specific theories proposed by Dr.

Chwalisz—molecular mimicry, bystander activation, and complement instigation—were found to be insufficiently developed and unpersuasive. The Special Master noted that while molecular mimicry is accepted in some contexts, it requires empirical evidence linking a specific vaccine to a specific disease, which Ms.

Mathis did not provide. Bystander activation was presented with minimal explanation, and the complement theory, though longer, was also found unpersuasive, referencing prior decisions where similar arguments were rejected.

Because Ms. Mathis failed to establish a reliable medical theory of causation, her petition was denied.

Petitioner counsel was Ronald C. Homer & Meredith Daniels of Conway Homer, P.C.

Respondent counsel was Nina Ren of the United States Department of Justice. Special Master Christian J.

Moran issued the decision on August 23, 2023.