Suzanne Mulrenin v. HHS - Influenza, Mast Cell Activation Syndrome (MCAS) (2021)
Case summary [AI summaries can sometimes make mistakes]
On January 4, 2018, Suzanne Mulrenin filed a petition on behalf of her minor child, R.M., alleging that R.M. suffered from Mast Cell Activation Syndrome (MCAS) caused or significantly aggravated by an influenza vaccination received on November 16, 2015. R.M., born January 9, 2006, was nearly nine years old at the time of vaccination.
Prior to the vaccination, R.M. had a history of stomachaches, allergies, and constipation. Following the vaccination, R.M. experienced persistent abdominal pain, weakness, gait instability, flushing, nausea, headaches, and other symptoms.
The petitioner's expert, Dr. Jonathan Bernstein, opined that R.M. had MCAS and that it was vaccine-caused, hypothesizing that IgG autoantibodies generated by the influenza vaccine could induce mast cell activation and mediator release.
The respondent's expert, Dr. Andrew MacGinnitie, disagreed with the diagnosis of MCAS, citing concerns about overdiagnosis and R.M.'s symptoms not meeting diagnostic criteria, particularly the chronic nature of her abdominal pain and the lack of consistent biochemical markers.
Dr. MacGinnitie also disputed the existence of a reliable medical theory linking the influenza vaccine to MCAS.
The Special Master, Daniel T. Horner, reviewed the medical records and expert opinions.
He found that R.M. did not meet the diagnostic criteria for MCAS, as her abdominal pain was chronic rather than episodic, and there was insufficient evidence of validated mast cell activation markers. The Special Master also found no sound medical theory linking the influenza vaccine to MCAS, no logical sequence of cause and effect supported by treating physicians, and an inadequate temporal relationship.
Consequently, the petition was dismissed. Petitioner was represented by Andrew Donald Downing of Van Cott & Talamante, PLLC, and respondent was represented by Darryl R.
Wishard of the U.S. Department of Justice.
Theory of causation
Petitioner alleged that R.M., age 9, developed Mast Cell Activation Syndrome (MCAS) caused by a November 16, 2015 influenza vaccination. MCAS is not a "Table Injury." Petitioner's expert, Dr. Jonathan Bernstein, opined that R.M. met the diagnostic criteria for MCAS and that the influenza vaccine caused it, proposing a theory that vaccine-generated IgG autoantibodies could induce mast cell activation. Respondent's expert, Dr. Andrew MacGinnitie, disagreed with the MCAS diagnosis, citing R.M.'s chronic, non-episodic abdominal pain and lack of consistent biochemical markers, and disputed the vaccine causation theory. Special Master Daniel T. Horner found that R.M. did not meet the MCAS diagnostic criteria, specifically noting the chronic nature of her abdominal pain and insufficient evidence of validated mast cell activation markers. He also found no sound medical theory linking the vaccine to MCAS, no logical sequence of cause and effect supported by treating physicians, and an inadequate temporal relationship. The petition was dismissed. Petitioner was represented by Andrew Donald Downing, and respondent by Darryl R. Wishard.
Source PDFs
USCOURTS-cofc-1_18-vv-00022