Standiford Helm MD1 and Raymond McMahon JD2 Pain management is founded upon three principles: efficacy, access and, safety. In accordance with the dictate, First of All, Do No Harm, safety is the most important of these three. If this is so, how is it that pain management physicians can and frequently do find themselves facing medicolegal problems? There are many events that lead to the final common pathway of medicolegal concerns. The most common sources of problems for physicians come from adverse outcomes from procedures or prescriptions and from interactions or reviews by regulatory agencies, such as Medical Boards or the Drug Enforcement Agency (DEA). This chapter discusses the medicolegal issues faced by pain physicians, with the hope that these issues can be avoided or at least minimized. Pain management procedures are generally safe. As so many procedures take place around the central nervous system (CNS), adverse events can lead to significant morbidity. Despite this fact, the incidence of adverse events from pain management procedures remains low [1]. Interlaminar epidural steroid injections have a malpractice claim rate of less than one per million procedures. In contrast, regional anesthesia procedures have a 4 in 10 000 risk of neurologic complications and anywhere from a 0.4% to 5.2% risk of respiratory depression with intravenous (IV) patient-controlled analgesia [2]. Pain management physicians are generally concerned with litigation and lawsuits. In order to be sued, the plaintiff must show that four hurdles have been cleared: Duty starts when the doctor–patient relationship is established. The doctor–patient relationship is established when the physician examines, diagnoses, or treats the patient [4]. For the pain management physician, duty generally begins at the time of the first consultation, but not at the time when a patient has been scheduled but not seen. A special issue for pain management physicians is the scenario where another physician has examined the patient and determined that the pain management physician should perform a specific injection. For cost reasons, the initial consult at which the pain management physician might confirm the need for that injection might be waived, so that the first encounter occurs at the facility where the procedure is performed. By meeting the patient at the facility, duty is established. As a part of duty, physicians have an obligation to provide informed consent, discussing treatment options and risks associated with each of these options [5]. While informed consent can be provided during an initial meeting in the preoperative area, this limited ability to establish rapport, rather than duty, puts the physician at risk in that a patient’s decision to sue is often associated with a perceived lack of caring or collaboration [6]. The second issue necessary to proceed with a lawsuit is negligence, which is an act or omission that represents a departure from the standard of care. The standard of care varies by jurisdiction, but a reasonable definition for pain management physicians is “use the level of skill, knowledge, and care in diagnosis and treatment that other reasonably careful pain management physicians would use in the same or under similar circumstances” [7]. It is important to differentiate between the standard of care and best practice or guidelines. Guidelines, according to the Institute of Medicine, are recommendations intended to optimize patient care based upon systematic reviews of the evidence [8]. Best practice is optimal care. While best practice would be within the standard of care, the Institute of Medicine recognizes that care in the community lacks best practice, meaning care below best practice can still be compliant with the standard of care. It is common to see experts alleging non-existent departures from the standard of care based upon best-practice arguments, either drawn from guidelines or created de novo by the opposing expert. The third issue of a lawsuit is that the patient suffered injury or damage. If patient were to feel transient pain during the transforaminal injection of an inflamed nerve root, there would be no damage, as that is a component of the procedure. However, excessive pain or other complications can be compensatable damages. The fourth issue is that of causation: did a departure from the standard of care lead to the injury? Causation can be difficult to prove despite what some might see as a clear case of medical malpractice. First is that the patient can suffer harm with no departure from the standard of care. It appears that the cause of fulminant hematomas following cervical interlaminar epidural steroid injections is related to venous anatomy [9]. This information has not yet been widely disseminated. A patient could suffer catastrophic neurologic injury from an epidural injection without a departure from standard of care. The second area where experts can become confused with causation is that of irrelevant criticisms. The absence of naloxone in the office may be alleged to be a departure from the standard of care; if there is no issue of opioid overdose, that absence is irrelevant to the malpractice claim. Occasionally, treating physicians can confuse the issue of causation by publishing articles about a case before it is resolved. The conclusions of the treating physicians may be incorrect, with the court reaching a different conclusion. Articles about cases in litigation should be deferred until the case is resolved. Sometimes, a physician needs to terminate the doctor–patient relationship. The doctor–patient relationship is based not only upon acceptance of the patient into the practice, but mutual trust and acceptance between the patient and the physician. This is exemplified by the concept of shared decision-making, in which the physician and patient combine to apply evidence, clinical judgment and patient preference to come up with a treatment plan [10].
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Medical Legal Issues in Pain Management
Introduction
What Is a Malpractice Lawsuit?
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