Donna Baldwin v. HHS - Influenza, ventricular fibrillation and cardiac arrest (2020)

Donna Baldwin, a 54-year-old woman, filed a petition alleging that her October 13, 2011 influenza vaccination caused her to suffer ventricular fibrillation and cardiac arrest six days later. The case proceeded as an off-Table claim, meaning Ms.

Baldwin had to prove causation-in-fact under the Althen standard. She presented expert opinions from cardiologists Dr.

Robert Waugh and Dr. Robert Stark, who theorized that inflammation caused by the vaccine could lead to cardiac events, either through autonomic nervous system imbalance or a pro-thrombotic state.

Respondent, the Secretary of Health and Human Services, presented competing expert opinions from Dr. Laurence Sperling and Dr.

Shane LaRue, who argued that Ms. Baldwin's cardiac event was more likely caused by her pre-existing conditions, such as obesity, diabetes, and hypertension, combined with emotional distress and physical exertion.

The Special Master reviewed extensive medical records and expert reports. He found that Ms.

Baldwin failed to establish a legally plausible medical theory connecting the vaccine to her injury (Althen prong one), citing limitations in the studies relied upon by her experts and the fact that her specific vaccine brand was not studied. He also found that Ms.

Baldwin failed to demonstrate a logical sequence of cause and effect supported by her medical records (Althen prong two), noting that her treating physicians did not link the event to the vaccine and that her medical records supported alternative causes. The Court of Federal Claims affirmed the Special Master's decision, denying Ms.

Baldwin's motion for review and sustaining the denial of entitlement. The case was ultimately denied compensation.