M.V. v. HHS - Tdap, Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (2025)

Joseph Virissimo, on behalf of his minor child M.V., filed a petition on July 31, 2024, alleging that the meningococcal conjugate (MCV4) and tetanus, diphtheria, and acellular pertussis (Tdap) vaccines M.V. received on August 4, 2021, caused her to suffer from Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Petitioner submitted medical records and an expert report from immunologist Dr.

Jeffrey Davidson. Dr.

Davidson opined that the vaccines caused M.V.'s SJS/TEN, citing case reports, case series, systemic reviews, and a VAERS analysis. He noted M.V. had no other vaccines, drugs, or infections in the months prior to symptom onset, which occurred on August 17, 2021, thirteen days post-vaccination.

Dr. Davidson addressed potential confounding factors, stating M.V.'s positive antinuclear antibody was not indicative of autoimmune disease given other negative rheumatology panel results, and that a note of M.V. being "slightly sick 1-2 weeks before" vaccination was after her vaccination and no symptoms were reported on the day of vaccination.

Respondent argued that Dr. Davidson failed to present a reliable medical theory causally linking the vaccinations to the SJS/TEN or establish a logical sequence of cause and effect.

Respondent noted that much of Dr. Davidson's literature involved unrelated vaccines and argued he had not presented reliable scientific or medical evidence for an appropriate timeframe.

Respondent also highlighted references in the medical records to M.V. experiencing a viral illness prior to SJS/TEN onset and multiple positive tests during hospitalization, which Dr. Davidson did not discuss.

Respondent further contended that temporal relationship or elimination of other causes alone was insufficient. Respondent submitted an expert report from immunologist Dr.

Emanual Maverakis, who opined that the vaccinations were not connected to M.V.'s SJS/TEN. Dr.

Maverakis explained that SJS/TEN is mediated by cytotoxic CD8+ T cells, and that there is no mechanistic link between SJS/TEN pathophysiology and the immune response induced by vaccination. He disputed any association between SJS/TEN and vaccination, citing studies suggesting antigen quantity is critical and arguing M.V.'s antigenic dose was insufficient.

Dr. Maverakis opined M.V.'s condition was idiopathic or caused by a pre-vaccination infection.

After respondent filed his expert report, petitioner moved to dismiss his own petition. Special Master Christian J.

Moran construed this as a motion for involuntary dismissal. The Special Master found that petitioner had not presented a medical theory to explain how the MCV4 and/or Tdap vaccines could cause SJS/TEN.

The Special Master noted that case reports and VAERS analyses, as presented by Dr. Davidson, often have limited usefulness in litigation for establishing causation.

Therefore, the Special Master concluded that petitioner had not met the burden of proof under Althen v. Sec’y of Health & Hum.

Servs. The case was dismissed with prejudice for insufficient proof.