Justin Zivin, MD, PhD, University of California, San Diego, CA, presented data demonstrating how legal issues influence the treatment of stroke. Recombinant tissue plasminogen activator (rt-PA) is a well-known FDA-approved thrombolytic treatment. It is estimated that only 4%–8% of acute ischemic stroke patients receive rt-PA, when up to 40%–50% of patients could derive benefit from the drug. In Dr. Zivin's opinion, fear of malpractice lawsuits depresses the use of this drug. The literature and regulatory approvals support the idea that rt-PA is a valid therapy for acute ischemic stroke. In a recent re-analysis of the NINDS rt-PA trial, “none of the bad outcomes was increased by rt-PA,” said Dr. Zivin (Figure 1). Demaerschalk (Stroke 2007) estimated the likelihood of being helped to being harmed (LHH) by rt-PA to be approximately 10. In other words, rt-PA therapy would be 10 times more likely to help a patient with acute ischemic stroke than to harm them.

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Figure 1.

NINDS rt-PA Trial.

These findings have not always translated into clinical practice. A survey conducted by the American College of Emergency Physicians indicated that 40% of emergency room doctors were unlikely to use rt-PA under ideal conditions (Brown et al. Ann Emerg Med 2005). When asked why, 65% cited concerns about intracerebral hemorrhage, 23% said due to lack of efficacy, and 12% replied that both reasons contributed to their decision. Ironically, the decision not to use rt-PA has resulted in more lawsuits than lawsuits that have been filed due to harm caused by using the drug (Bambauer et al. Ann Neurol 2006). “Many physicians believe that ‘to do no harm’ is a good strategy to avoid malpractice suits. What they fail to realize under those circumstances is that to fail to treat, to decide not to do something, is a decision. Failure to treat with rt-PA is more likely to result in adverse legal decisions,” said Dr. Zivin.

What can physicians do in this increasingly litigious environment? According to Michael Weintraub, MD, New York Medical College, Valhalla, NY, detailed documentation is absolutely critical. Legibly documenting time of symptom onset, time of diagnosis, time of workup completion, and rationale for using or not using rt-PA is particularly important. “Poor medical records can suggest negligence to the jury,” noted Dr. Weintraub. John P. Conomy, MD, JD, Case Western Reserve University, Cleveland, OH, offered additional advice. Because patients often turn to the internet to educate themselves, physicians need to be aware of this and step up their efforts to educate patients. Physicians should also educate themselves about the legal issues they face. “Attorneys know a great deal about a great many things. Physicians as a group know very little about law, because they've been taught very little about law. I think it belongs in the curricula of medical schools, at least in an introductory way,” summarized Dr. Conomy.