Tuyet Mai v. HHS - Tdap, severe cutaneous adverse reaction (SCAR) (2022)
Case summary [AI summaries can sometimes make mistakes]
On December 28, 2017, Hoang-Hoa Nguyen, as Special Administrator for the Estate of Tuyet Mai, filed a petition for compensation under the National Vaccine Injury Compensation Program. The petition alleged that Ms.
Mai, who received a Tdap vaccine on August 11, 2015, subsequently developed Toxic Epidermal Necrolysis (TEN), serum sickness-like illness, toxic shock syndrome, Stevens-Johnson Syndrome (SJS), allergic exfoliative dermatitis, and died on January 2, 2016, as a result of the vaccine. The respondent argued against compensation, stating the case was not appropriate for compensation under the Vaccine Act.
Special Master Nora Beth Dorsey presided over the case. The parties disputed both the diagnosis and causation.
Petitioner's expert, Dr. M.
Eric Gershwin, opined that Ms. Mai's diagnosis was SJS/TEN, while Respondent's expert, Dr.
Markus Boos, opined that the correct diagnosis was drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome. Petitioner alleged the Tdap vaccine caused Ms.
Mai's condition and subsequent death. Respondent asserted that allopurinol, a medication Ms.
Mai was taking for gout, was the likely cause of her condition or that the vaccine was not the cause. The Special Master noted that while Ms.
Mai suffered a severe cutaneous adverse reaction (SCAR), Petitioner failed to prove by a preponderance of the evidence that the Tdap vaccine caused her condition or death, failing to satisfy the Althen criteria. The petition was dismissed.
Petitioner was represented by Howard Scott Gold of Gold Law Firm, and Respondent was represented by Naseem Kourosh of the U.S. Department of Justice.
The decision was issued on September 23, 2022.
Theory of causation
Petitioner alleged that the Tdap vaccine administered on August 11, 2015, caused Ms. Mai to develop a severe cutaneous adverse reaction (SCAR), specifically Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN), leading to her death. Petitioner's expert, Dr. M. Eric Gershwin, opined that Ms. Mai suffered from TEN secondary to the vaccination, citing a delayed hypersensitivity reaction mechanism and case reports of SJS/TEN following vaccinations. Respondent's expert, Dr. Markus Boos, opined that Ms. Mai suffered from DRESS syndrome, likely caused by allopurinol, and that the Tdap vaccine was not a recognized cause of SCARs. Respondent's expert Dr. You-Wen He also concluded that allopurinol was the likely cause and that there was scant evidence linking the Tdap vaccine to SCARs. The Special Master found that while Ms. Mai suffered a SCAR, Petitioner failed to prove by a preponderance of the evidence that the Tdap vaccine caused her condition or death, specifically failing to establish Althen Prong One (medical theory connecting vaccine to injury) and Althen Prong Two (logical sequence of cause and effect). The Special Master found Petitioner did prove Althen Prong Three (proximate temporal relationship). Ultimately, the petition was denied because Petitioner failed to meet her burden of proof on causation. Petitioner was represented by Howard Scott Gold, and Respondent by Naseem Kourosh. Special Master Nora Beth Dorsey issued the decision on September 23, 2022.
Source PDFs
USCOURTS-cofc-1_17-vv-02051