What constitutes the standard of care?

Introduction 

As the interplay between law and medicine has become more pronounced, certain legal concepts have gained prominence in medical discussions. One such concept is the “standard of care,” which is a recurrent theme in many controversial areas of emergency medicine, from the use of thrombolysis in ischemic stroke1., 2., 3. to steroid therapy in spinal cord injury.4., 5. In addition, standard of care is a central issue in many individual medical-legal proceedings. Despite its importance, many clinicians, and particularly physicians-in-training, likely possess a limited understanding of what standard of care means, and are unfamiliar with its specific definition in the legal literature. This article reviews the legal concept of standard of care, including a discussion of some difficulties inherent in its definition and how it might be established in a legal proceeding.

Defining standard of care 

Consider the following hypothetical scenario: a 67-year-old man presented to a community emergency department (ED) after family members discovered he had developed garbled speech and an inability to move his right arm. Family members stated that they had witnessed the patient ambulate “about 2 hours ago” but were uncertain of the precise time of symptom onset. Examination by the emergency physician on duty revealed a hypertensive man with systolic blood pressure of 195 mm Hg, dysarthric speech, and a right-sided motor deficit more pronounced in the arm than leg. An urgent head computed tomography scan was obtained, which the emergency physician interpreted as normal. The physician considered the use of thrombolysis in this patient, and elected to withhold this treatment because of concerns regarding time of onset, hypertension, and potential adverse effects. This decision was discussed with the patient's family members and recorded in the ED chart. The patient was admitted to the hospital with the diagnosis of acute ischemic stroke and was subsequently discharged to an extended care facility after experiencing mild improvement in his neurologic deficits. Six months later, the treating emergency physician was sued, alleging substandard emergency care in the case. The plaintiff's attorney argued that (1) there were no definite contraindications to thrombolysis in this case, (2) there is evidence in the medical literature supporting the use of thrombolysis in ischemic stroke, (3) the patient's long-term outcome might have been more favorable had this therapy been given, and (4) other emergency physicians would have treated this patient with thrombolysis. Two expert witnesses testified that they would have given a thrombolytic in the case, and the attorney played for the jury a television public service announcement that encouraged patients with signs of stroke to “get to the ED within 3 hours to receive this new life-saving treatment.” The defendant physician countered that (1) thrombolysis in this setting carries a significant risk of an adverse outcome, (2) some trials in the medical literature do not support its routine use, and (3) a significant number of practicing emergency physicians would not have used this treatment. What are some of the issues regarding the determination of the “standard of care” in a case such as this?

To most physicians, the term “standard of care” connotes an action or treatment that would be expected by a consensus of the medical community in a given situation, or how a physician's colleagues would act in a certain circumstance. Although this perception is not inaccurate, the legal definition is more complex and, at times, problematic in its practical application. Negligence theory is the subset of tort law that bears directly on most medical malpractice actions. In negligence cases, a defendant is accused of acting in a manner contrary to that expected of a “reasonably prudent” person, and thereby causing some harm to another person.6 Black's Law Dictionary defines standard of care as “that degree of care which a reasonably prudent person should exercise under same or similar circumstances. If a person's conduct falls below such a standard, he may be liable in damages for injuries or damages resulting from his conduct.”7 In professional negligence cases, a defendant physician may be liable for actions where there was a duty to provide care, a care standard was breached, and as a result of that breach, damage or injury was done to another.8 Each of these elements must be present and proven by a preponderance of evidence for a finding of medical liability.8 In addition, simply demonstrating that a mistake or an adverse event occurred is not sufficient for a finding of negligence.9 Thus, the outcome of medical malpractice cases depends on the definition of the relevant professional care standard or practice custom of the medical community. Clearly, in our scenario there was a duty to provide care, but was a care standard breached?

Issues in defining care standards 

Historically, courts have allowed for differing medical care standards depending on geography; specifically, practice differences in rural versus urban settings.6 The “locality rule” defined the medical standard of care as the “average degree of skill, care, and diligence exercised by members of the same profession, practicing in the same or a similar locality in light of the present state of medical and surgical science.”10 The locality distinction was made in deference to practitioners in areas where technical or communication barriers theoretically prevented access to newer practice modalities or information. However, many courts have abandoned the locality rule as medical education and practice have become more standardized, and specialization and board certifications have become more prominent.6 With these changes in medicine, “certain courts have disregarded geographical considerations holding that in the practice of a board-certified medical or surgical specialty, the standard should be that of a reasonable specialist practicing medicine or surgery in the same special field.”7 Now, physicians are more likely to be held to national or specialty standards rather than local custom or practice.

A second problem in defining the standard of care stems from the recognition that the practice of medicine is complex and ever-changing, and there may be multiple acceptable ways to approach a given patient or problem. The “respectable minority” doctrine may protect a practitioner from liability if it can be shown that a given action would be deemed acceptable by a reputable or respected minority of colleagues. The defendant physician in our hypothetical case may argue, for instance, that withholding thrombolysis in a stroke patient may fall within the standard of care if a certain number of physicians would have done the same under similar circumstances. The law recognizes that 2 different physicians may reasonably act differently in treating the same patient, and both approaches might be considered appropriate standard of care if it can be shown that they are considered acceptable by a significant contingent of practitioners within the same specialty.8

Another consequence of the complexity of medicine, and specifically the field of emergency medicine, is that many situations encountered in the course of daily practice are new or complicated. In these situations, established care standards may not apply or even exist. Therefore, the standard of care must often be viewed as “situation-specific,” with the recognition that in some cases a standard may not be definable.11 Moreover, some common diagnostic and therapeutic modalities in medicine lack robust scientific support, yet still may be considered standard as a result of their widespread clinical use.12

Establishing the standard of care in court 

In the course of a medical malpractice action, a plaintiff will attempt to demonstrate that a professional standard of care was breached. Because judges and juries are not sufficiently familiar with medical practice standards, expert witnesses are usually required to testify in such cases.13 The expert witness is called on specifically to establish the professional standard of care in the case. The witness is required to qualify personal opinion as such, and to “differentiate for the jury a widely accepted standard of care, as opposed to the ideal care that might be provided by the most astute clinician practicing under optimum circumstances.”13 If a witness is deemed by the court to be unqualified or unable to establish the standard of care, a plaintiff cannot demonstrate that a breach of care has occurred. The court may exclude expert witness testimony “if the expert is deemed not sufficiently qualified or if the testimony does not meet up to standards of the expert's profession.”6., 14. In the past, expert witnesses were often required to come from the defendant's same or similar geographic locality. More recently, experts have been allowed to testify on care standards as long as they can demonstrate sufficient familiarity with the acceptable practice custom of the defendant's specialty. This may or may not require that the expert witness be a member of the defendant's same specialty.6., 13.

In some medical malpractice cases, other modalities are used to corroborate expert testimony in establishing the standard of care.6 One such modality is the use of literature such as textbooks, journal articles, or pharmaceutical package inserts or manufacturer's instructions. The introduction of such evidence is sometimes problematic, however, because textbook information may be out of date or not reflective of current practice, and multiple journal articles may be produced arriving at contradictory conclusions or reporting results of methodologically flawed studies. That is, the latest journal article will not necessarily be indicative of the specialty care standard. In the case of the hypothetical scenario presented previously, for instance, both parties were able to cite evidence from the medical literature in support of their respective positions. From a practical legal perspective, the applicability of this “learned treatise” evidence is often diminished by the fact that it was not produced under oath and its authors are usually not available for cross-examination.8., 11.

Another method of proving the standard of care that has recently gained wider acceptance is through reference to published medical guidelines. There has been a proliferation of established guidelines on the part of medical societies, specialty and board organizations, and government agencies, with the goal of standardizing practice according to scientific evidence and public policy aims.15 Some courts and state statutes have provided for the use of such guidelines in establishing the standard of care, and conformity to established or published guidelines may help protect practitioners from liability.11 One problem with the use of guidelines in this manner is the fact that different groups may publish standards that are contradictory. A specific example of such a contradiction may be found in the substantive differences in published guidelines for the treatment of community-acquired pneumonia issued by the American Thoracic Society and the Infectious Diseases Society of America,16., 17. specifically with respect to admission criteria and the need for blood and sputum cultures.18 The evolution of clinical guidelines such as these underscores the need for continuous clinical research activity to clarify care standards, particularly in the field of emergency medicine, which incorporates practice from a wide spectrum of medical specialties. The issue of conflicting guidelines would be a prominent feature in the hypothetical scenario provided above regarding stroke thrombolysis. For instance, the American Heart Association classifies this therapy as a “Class I” intervention and “definitely recommended” in defined clinical settings.19 At least one emergency medicine specialty society has taken a more cautious view, stating that the evidence for thrombolysis in acute ischemic stroke “is insufficient to warrant its classification as standard of care.”20

Another problem with guidelines is their potential to be affected by the distinctive motivations of the groups that issue them.6 For example, concern has been raised regarding pharmaceutical industry influence on the content of certain clinical practice guidelines.21 Government agency guidelines may be politically motivated or focused excessively on cost-containment, and physician groups may issue guidelines with the specific intent of limiting member liability. Guidelines should theoretically be specific to most effectively define care standards, yet guidelines that are too specific might expose practitioners to liability when their actions may be proper or acceptable but fall outside of rigid protocols.

Finally, physicians should remember that even practice that conforms to published consensus guidelines or policy statements may not meet the legal definition of standard of care. For example, a guideline that reflects the latest evidence-based approach may not be considered standard if a large number of practitioners do not adhere to it. Plaintiffs' attorneys have successfully argued against practice that conformed to published national guidelines by demonstrating that many physicians do not follow them.22 Although clinical guidelines may be used as evidence of the standard, an expert witness is still usually required in an actual legal proceeding to declare them relevant and applicable to the case under consideration.23

An exception to the requirement for an expert witness to establish standard of care is in cases in which a defendant's conduct is so extreme or negligence so obvious that it may readily be ascertained by a lay jury. This is termed the “common knowledge” exception.24 A related exception is called res ipsa loquitur, meaning “the thing speaks for itself.”8 In this situation, a plaintiff makes a claim on the basis of circumstantial evidence, inferring that the adverse outcome could not have occurred in the absence of negligence on the part of the defendant. Negligence in cases employing res ipsa is generally apparent to the layperson, such as in the performance of a procedure on the wrong body part, and therefore an expert witness to establish a standard is not usually required. Despite the foregoing exceptions, the expert witness remains the most common way in which the standard of care is defined in medical-legal proceedings.

Learning more about the standard of care 

At some point before graduation, emergency medicine residents should become familiar with the concept of standard of care and how such a standard is established in a legal proceeding. Residents can learn more about standard of care by becoming familiar with the published clinical policies and position statements of their specialty professional organizations.25., 26., 27. Emergency medicine society Web sites such as those of the American College of Emergency Physicians and the American Academy of Emergency Medicine frequently post information on risk management and expert witness issues, and opportunities for formal instruction and continuing medical education in this area exist.28 Some medical schools have staged mock malpractice trials using actual lawyers and judges, helping to familiarize students with legal issues in medicine.29 Residents can also benefit from reviewing malpractice case reports; one particularly valuable resource is a recurring feature in the journal Pediatric Emergency Care entitled “Legal Briefs,” which reviews emergency medicine malpractice cases and provides accompanying commentary.30 Finally, residents should be aware of the timely legal issues relevant to emergency medicine practice, including liability reform and ethical expert witness testimony.31., 32.

In conclusion, the term standard of care frequently arises in medical discussions, and practice within the standard can protect physicians from legal liability. Nevertheless, precisely defining the medical standard of care is frequently difficult and controversial, and in many cases, no clear predetermined standard will exist. Furthermore, involvement in research activities will help advance the scientific foundation of emergency medicine, thereby helping to establish clearer practice standards in many currently controversial areas of the specialty. As the law affects emergency practice to an ever larger degree, physicians-in-training will benefit from a working knowledge of what the standard of care concept means in our specialty.