Empirical characteristics of litigation involving tissue plasminogen activator and ischemic stroke.

STUDY OBJECTIVE The use of tissue plasminogen activator (tPA) in potential stroke victims by emergency physicians is controversial. One factor that may represent a barrier to use is medicolegal concerns resulting from adverse outcomes. The jury verdicts, settlements, and other adjudications associated with tPA and stroke care are assessed to determine the characteristics of these cases, including whether cases arose from adverse consequences associated with tPA or failure to provide tPA. METHODS Using 7 primary jury verdict, settlement, and other adjudication legal databases, lawsuits involving tPA and stroke were collected for analysis of the clinical circumstances of the litigation, the causes of action against providers, the basis for liability, and the presence of emergency physicians and neurologist consultation in the litigation. RESULTS Thirty-three cases were found involving tPA ischemic stroke therapy. In 29 (88%) of these cases, patient injury was claimed to have resulted from failure to treat with tPA. Emergency physicians were the most common physician defendants. Defendants prevailed in 21 (64%) cases, and among the 12 with results favorable to the plaintiff, 10 (83%) involved failure to treat and 2 (17%) claimed injury from treatment with tPA. CONCLUSION The available evidence concerning litigation involving stroke therapy with tPA indicates liability is predominantly associated with failure to provide tPA, rather than adverse events associated with its use.