Serious adverse events (serious AEs) following the therapeutic use of Botulinum Toxin Type A (BoNT-A) are infrequent. Children with pediatric spasticity often have comorbidities that can cloud causation around an adverse event (AE). If a serious AE occurs, clear documentation of information sharing and informed consent as well as the provider-patient relationship are critical to minimizing litigation risks. Reviewing the litigation that has occurred following BoNT-A for pediatric spasticity can offer insight into how providers' perspectives regarding this intervention may differ from those of the public who might serve as jurists. This article offers suggestions for content sharing during the consent process to optimize patient understanding about potential adverse events.
Keywords: Black Box Warning; Botulinum Toxin Type A; Cerebral Palsy; FDA label; causation; consent; idiosyncratic reactions; indication; information sharing; medication guide; off label drug use; pediatric spasticity; serious adverse events.