Medicolegal Sidebar: Clinical Practice Guidelines—Do They Reduce Professional Liability Risk?

Clinical practice guidelines represent prima facie authority (meaning, that which is presumed correct unless proven otherwise) such that diligent adherence to practice guidelines should reduce the risk of malpractice litigation. In practice, however, this is not always the case. While guidelines can sometimes be introduced as a defense by an accused physician, injured patients can just as well use them to allege a breach of the standard of care. Given the limitations and shortcomings associated with clinical practice guidelines—including obsolescence, conflicts of interest, and inconsistencies with the standard of care—we believe that clinical practice guidelines should not be admissible as evidence in medical malpractice litigation. Clinical Practice Guidelines as the Legal Standard? Practice guidelines are treatment recommendations issued by professional medical societies to improve patient care. But standard of care is different; it is a legal yardstick that measures physician conduct against that of other reasonably prudent peers in the same specialty, and under similar circumstances. The Institute of Medicine (IOM) has described practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” [1]. Case law suggests that courts have sometimes elevated practice guidelines to the status of a legal standard. One example where a court was reluctant to allow practice guidelines into evidence was the 1992 case of Quigley v Jobe, in which a woman with a breast lump was told to self-monitor, and come back in 6 months [9]. She returned a year later with breast cancer. Before treating this patient, as a condition of insurability, the physician had been required by his insurance company to sign a statement stipulating that, “I have read and understand the [risk management] guidelines ... on ... Delayed Diagnosis of Breast Carcinoma.” By signing acceptance of this guideline, the physician had acknowledged the possible consequences associated with non-compliance, such as the non-renewal of his professional liability policy. The defendant sought to exclude the guideline from the lawsuit because it would be prejudicial to his case, and the court agreed. Agreeing to practice according to a guideline did not mean that the defendant adopted that guideline as a legal standard, according to the court. The court found that, “Clinical practice guidelines are written statements of the best clinical practices … the law does not oblige any physician to provide ‘optimal medical care,’ much less ‘the best clinical’ care. A test that holds the physician to any higher a standard of care is prohibited” [9]. In contrast to Quigley, other court rulings have allowed clinical practice guidelines to serve as evidence of the standard of care. In the 1997 ruling Frakes v Cardiology Consultants [2], a cardiologist sent a patient home after a normal chest radiograph and resting electrocardiogram (EKG). A treadmill EKG could not be done because of chest pain. The patient was told to return for a thallium stress test the next day, but he died just 3 hours after discharge. In his defense, the cardiologist cited a consensus statement issued by the American College of Cardiology and American Heart Association that supported his decision-making. The court agreed that these guidelines were sufficiently accepted by cardiologists as the standard of care. These case examples are relevant to orthopaedic surgery. For example, practice guidelines direct orthopaedic surgeons to avoid unnecessary advanced imaging studies when treating the acute onset of low back pain, absent other clinical findings. If a patient being treated for this condition fails to improve with non-surgical care, and upon seeking a second opinion, a spine tumor is discovered on an MRI scan, the guideline recommending no imaging at the outset, if admissible under the rules of evidence, would serve as a defensive shield against an allegation of undue delay in cancer diagnosis. Clinical Practice Guidelines: Limitations in Malpractice Litigation The role of clinical practice guidelines in malpractice reform is also uncertain [3]. In the 1990s, Maine statutorily recognized 20 practice guidelines in four specialties (anesthesia, obstetrics-gynecology, radiology, and emergency medicine) [7], such that defendant physicians could use adherence as a defense, but plaintiffs could not use non-adherence to prove breach. Data showed no impact on medical malpractice claims filed, settlement costs, malpractice premiums, or reduction in defensive medicine practices, leading to repeal of the statute [12]. Yet, a survey of plaintiffs’ lawyers showed that half the respondents considered practice guidelines before taking on malpractice cases, with exculpatory guidelines discouraging the filing of lawsuits, and affecting settlement decisions [4]. Since settlements are often confidential, the impact of practice guidelines on pre-litigation negotiations may not show up in the reported data. Our view is that a majority of lawyers today are probably aware of practice guidelines when evaluating the merits of a potential medical malpractice lawsuit. One reason why practice guidelines do not have a clear impact on malpractice litigation may relate to their shortcomings. In one study, none of the 114 randomly selected clinical practice guidelines met the IOM’s definition of trustworthiness [10]. Another study examined 279 practice guidelines published from 1986 to 1997 and found that fewer than 20% specified how the supporting evidence was identified, and fewer than 25% cited references [11]. While more recent treatment recommendations may be improved, the limitations of earlier practice guidelines can undercut their utility as evidence in medical malpractice cases. Financial conflicts can erode the credibility of practice guidelines as well. For example, among the physicians who helped develop cardiovascular guidelines, over half had financial ties to the companies whose products they were commenting on [8]. Another study showed that 71% of chairs of clinical policy committees and 90.5% of co-chairs reported relevant financial conflicts [5]. The use of high-dose steroids for spinal injury was advocated by a Cochrane review; the sole reviewer had financial ties to the steroid manufacturers. A later survey of 1,000 neurosurgeons showed only 11% believed that the guideline was safe and effective, and yet 60% prescribed corticosteroids to acute spinal injury patients to reduce malpractice risk [6]. These inconsistencies support our view that clinical practice guidelines should not be admissible as evidence in medical malpractice litigation. Conclusions Clinical practice guidelines can provide physicians and medical extenders with recommendations that are based on professional consensus. And such guidelines can promote good and cost-efficient care based on the best available evidence. Clinical practice guidelines, however, are designed to improve care, not to define standard care. They can also limit physician autonomy, impose rules that are adopted mainly to avoid litigation risk, and may be developed by physicians with relevant financial conflicts. In our view, courts should exclude clinical practice guidelines from evidence of the standard of care or of its breach.