Leonora Bantugan v. HHS - Influenza, acute fulminant lymphocytic myocarditis and death (2019)
Case summary [AI summaries can sometimes make mistakes]
On July 13, 2015, Leonora Bantugan, as Representative of the Estate of Manuel Bolotaolo, Deceased, filed a petition under the National Vaccine Injury Compensation Program. The petition alleged that Mr.
Bolotaolo, aged 68, received a Fluzone influenza vaccine on September 18, 2014, and that this vaccination caused him to suffer acute fulminant lymphocytic myocarditis and die three days later, on September 21, 2014. Mr.
Bolotaolo had a history of hypertensive heart disease. The autopsy confirmed lymphocytic myocarditis as the cause of death.
Petitioner's theory of causation was that the influenza vaccine triggered an inflammatory process involving cytokines, leading to immune dysregulation that caused Mr. Bolotaolo's myocarditis and death.
Respondent argued against compensation, stating that the petitioner failed to prove by a preponderance of the evidence that the vaccine caused the injury. An entitlement hearing was held, during which petitioner's expert, Dr.
Alan S. Levin, and respondent's experts, Dr.
Lindsay Whitton, Dr. Brent T.
Harris, and Dr. Shane J.
LaRue, testified. Following the hearing, parties submitted additional expert reports, medical literature, and post-hearing briefs.
Special Master Nora Beth Dorsey presided over the case. The Special Master found that the petitioner failed to establish a sound and reliable medical theory or a logical sequence of cause and effect linking the vaccine to the injury.
While a temporal relationship existed between the vaccination and death, it was insufficient on its own to establish causation. The public decision does not describe the specific onset of symptoms, diagnostic tests performed beyond autopsy findings, or treatments administered.
Therefore, the petition for entitlement to compensation was denied. Petitioner was represented by Richard Gage of Richard Gage, P.C., and respondent was represented by Colleen Clemons Hartley of the United States Department of Justice.
Theory of causation
Petitioner alleged that a Fluzone influenza vaccine administered on September 18, 2014, to 68-year-old Manuel Bolotaolo caused acute fulminant lymphocytic myocarditis and death on September 21, 2014. Petitioner's expert, Dr. Alan S. Levin, opined that the vaccine's viral antigens activated T cells, leading to a massive infiltration of CD3 positive T cells and subsequent myocarditis and death, primarily through an innate immune system response involving cytokines. Respondent's experts, Dr. James Lindsay Whitton, Dr. Brent T. Harris, and Dr. Shane J. LaRue, disagreed, stating there was no evidence linking the influenza vaccine to lymphocytic myocarditis and that viral infection was a more likely cause. They argued that the influenza vaccine is a killed virus vaccine and does not replicate, unlike a live virus infection which can directly damage heart muscle and trigger an immune response. The autopsy confirmed lymphocytic myocarditis with T cell involvement and early myocardial necrosis, but found no viral inclusions or organisms. The Special Master found that Dr. Levin's theory was not sound or reliable, noting inconsistencies in his testimony and a lack of support in the medical literature for the vaccine causing lymphocytic myocarditis in the manner described. The Special Master also found that the petitioner failed to establish a logical sequence of cause and effect. While a temporal association of three days between vaccination and death was found to be medically acceptable, it was insufficient without a reliable theory of causation and a logical sequence of cause and effect. The petition was denied. Petitioner was represented by Richard Gage, P.C., and respondent by Colleen Clemons Hartley. Special Master Nora Beth Dorsey issued the decision on December 20, 2019.
Source PDFs
USCOURTS-cofc-1_15-vv-00721