Jodilyn Druery v. HHS - Influenza, acute cardiovascular event, likely myocardial infarction, resulting in ventricular fibrillation (2023)

Filed 2017-09-07Decided 2023-07-11Vaccine Influenza
denied

Case summary [AI summaries can sometimes make mistakes]

On September 7, 2017, Jodilyn Druery filed a petition under the National Vaccine Injury Compensation Program alleging that an influenza vaccine administered on October 26, 2016, caused her to suffer an acute cardiovascular event, likely a myocardial infarction, resulting in ventricular fibrillation and the subsequent implantation of a defibrillator. The case proceeded as an off-Table claim, requiring Ms.

Druery to prove causation-in-fact. Petitioner presented expert opinions from cardiologist Robert Stark, M.D., and immunologist David Axelrod, M.D., who theorized that an exaggerated inflammatory response to the vaccine caused endothelial dysfunction and myocardial infarction.

Petitioner also presented expert cardiologist Athol Winston Morgan, M.D., who responded to specific questions posed by the Special Master. Respondent, the Secretary of Health and Human Services, presented expert opinions from cardiologist Shane LaRue, M.D., and immunologist Noel Rose, M.D., Ph.D., later supplemented by immunologist Arnold Levinson, M.D.

Respondent's experts argued that there was no scientific evidence linking the influenza vaccine to myocardial infarction and that Ms. Druery's condition was likely due to underlying risk factors such as atherosclerosis and hypertension, or potentially Takotsubo syndrome.

Special Master Daniel T. Horner issued a decision on July 11, 2023, finding that Ms.

Druery failed to meet her burden of proof under the three prongs of the Althen standard. Specifically, the Special Master concluded that Ms.

Druery had not established a reliable medical theory connecting the vaccine to her injury (Althen prong one), nor a logical sequence of cause and effect (Althen prong two). The Special Master also noted that while the temporal relationship (Althen prong three) might be met, it was insufficient without meeting the other prongs.

The Special Master found that the studies cited by petitioner's experts were inadequate to support their theories and that the evidence of underlying risk factors and alternative explanations presented by respondent's experts was more persuasive. The public decision does not describe the specific onset of symptoms, diagnostic tests beyond those related to the cardiac event, or treatments other than the defibrillator implantation and general medical advice.

Petitioner filed a Motion for Review, which was denied by Judge Marian Blank Horn on February 29, 2024. The court affirmed the Special Master's decision, finding it was not arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.

Therefore, Ms. Druery's petition was denied.

Theory of causation

Petitioner Jodilyn Druery, a 45-year-old female, received an influenza vaccine on October 26, 2016. She alleged an off-Table injury, claiming the vaccine caused an acute cardiovascular event, likely myocardial infarction, leading to ventricular fibrillation and defibrillator implantation. Petitioner's experts, cardiologist Robert Stark, M.D., and immunologist David Axelrod, M.D., proposed a theory that an exaggerated inflammatory response to the vaccine caused systemic inflammation, endothelial dysfunction, and subsequent myocardial infarction, citing studies on cytokine elevation and vasospasm post-vaccination. Respondent's experts, cardiologist Shane LaRue, M.D., and immunologists Noel Rose, M.D., Ph.D., and Arnold Levinson, M.D., countered that no scientific evidence links the influenza vaccine to myocardial infarction, highlighting epidemiological studies showing a cardioprotective effect of the vaccine and suggesting alternative causes like atherosclerosis, hypertension, or Takotsubo syndrome. Special Master Daniel T. Horner denied the petition, finding petitioner failed to establish a reliable medical theory (Althen prong 1) or a logical sequence of cause and effect (Althen prong 2). The court affirmed, finding the Special Master's decision was not arbitrary or capricious, upholding the denial of compensation.

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