Thrombolysis (tissue plasminogen activator) in stroke: a medicolegal quagmire

Abstract

Background and purpose: Despite the success of the 1995 National Institutes of Neurological Disorders and Stroke (NINDS) study using IV recombinant tissue plasminogen activator (tPA) within 3 hours in acute stroke and its subsequent FDA approval, there has been a reluctance to use tPA because of safety and efficacy issues with high incidence of intracerebral hemorrhage, and protocol violations.

Summary of review: The following cases will illustrate the increased number of malpractice lawsuits generated by the controversy of "standard of care" and illustrate and educate clinicians regarding specific issues and how to avoid: (A) Failure to use tPA (loss of chance) or to transfer, Reed versus Granbury Hospital (Texas): acute stroke victim taken to local hospital with tPA available only for cardiology. Wife subsequently transferred patient to nearby stroke center but no tPA given. Defendant verdict; (B) Stroke misdiagnosis (failure to diagnose, loss of chance), Mei versus Kaiser Permanente South (San Francisco, CA): acute stroke while driving with ambulance taking to local hospital. Symptoms were misdiagnosed and neurologist did not see her for 6 hours. Plaintiff verdict; (C) Bleeding complications of therapy/failure of informed consent, Harris versus Oak Valley Hospital (California): acute stroke and hypertension treated with tPA with subsequent development of intracerebral hemorrhage. Patient alleged that tPA should not have been given. Defense verdict; (D) Expert witness testimony, Wojcicki versus Caragher (Massachusetts): a prominent neurologist gave "false and misleading testimony" and the Court found that the neurologist perpetrated a "fraud on the Court" intentionally and deliberately misleading the Court and jury. Court sanctioned the neurologist 88,685 dollars; Ensink versus Mecosta County General Hospital (Michigan): neurological testimony (plaintiff expert) regarding potential benefit of using tPA during last available 1 hour of window was felt to be "speculative". Defendant verdict.

Conclusions: Neurologists, emergency room physicians and hospitals are at increased liability risk if they use or do not use tPA. Detailed documentation, informed consent or timely transfer should reduce threat of legal action.