Chapter 12 Medicolegal Issues in ERCP

Medicine is an imprecise science, influenced by the vagaries and unpredictable nature of biologic systems and the art of interpersonal relationships. Human illnesses are, from the outset, adverse outcomes of life, and it is often difficult for physicians to correct or mitigate these illnesses. Furthermore, the techniques, tools, and technology available to aid in this task often have associated inadequacies or risks. Therefore restoring biologic function to its former healthy state is oftentimes incomplete, sometimes unsuccessful, and occasionally complicated by iatrogenic injury. Negative or adverse outcomes may include cognitive or technical failures, ineffective therapies, adverse events of therapy, high costs and extended hospitalizations, and missed work and life activities. Any or all of these may lead to patient dissatisfaction and a desire to assign blame and seek compensation.

It is in this environment of personal illness and fear, limited medical art and science, patient dissatisfaction, and legal avenues for redress that medicolegal issues arise. Especially in the United States, there was earlier a steady increase in the number of lawsuits filed for medical malpractice and in the size of awards granted for damages.¹ However, a recent analysis of paid claims for all medical lawsuits showed that the number and size of awards had leveled off.² Physicians and insurance companies generally blame unrealistic patient expectations, avaricious trial lawyers, and inappropriately high jury awards for the increased number of lawsuits, which in turn lead to high malpractice insurance rates, diminished access to certain types of medical care, and the costly practice of defensive medicine. Alternatively, attorneys and some patients blame true medical negligence, high medical costs, inadequate policing of incompetent physicians, and poor financial management by insurance companies for the worsening medicolegal climate.

It is therefore appropriate for physicians to study medicolegal issues, especially in their specialty areas of practice, to optimize patient outcomes, limit patient harm and dissatisfaction, and minimize the risk of malpractice litigation.

How Often Are Gastroenterologists and Endoscopists Sued?

Gastroenterologists, like all physicians, have reason to be concerned about malpractice litigation. Specialties vary in their exposure. Analysis of the Physician Insurers Association of America (PIAA) database from 1985 to 2005 showed that only 1.8% of claims concerned gastroenterologists ³ and that they ranked low in the scale of risk among specialties, 21st of 28.⁴ However, a recent comprehensive review of claims and outcomes from a large liability insurer over 24 years showed that gastroenterologists ranked much higher (5th out of 25).⁵ No fewer than 12% faced a claim every year; this was less than most surgical specialties but ahead of obstetrics and gynecology, surprisingly, and the authors calculate that by the age of 65 no fewer than 75% of physicians in the lowest risk specialties (and 99% in the highest) had faced a claim. It is reassuring that only 20% of claims result in a payment, and that, contrary to popular belief, the risk for all specialties has reduced somewhat in the last decade.

It might be thought that the unfortunate rise in the risk rankings for gastroenterologists is due to the increasing invasiveness of their practice. Paradoxically, while an analysis published 20 years ago ⁶ found that errors in procedural performance were more common reasons for claims than cognitive errors, the reverse now appears to be the case.³ Thus gastroenterologists not only need to take care to do their procedures well, for appropriate indications, but also must be mindful every day of the legal risk in diagnostic interviews, evaluations, medication prescriptions, injections, vaccinations, as well as other forms of patient interactions involving themselves and their staff.

How Common Are Lawsuits Involving ERCP?

Because endoscopic retrograde cholangiopancreatography (ERCP) is one of the most technically difficult procedures performed by gastrointestinal (GI) endoscopists and because adverse events, sometimes severe, are more common than with other endoscopic procedures, ERCP might be expected to account for a disproportionate number of claims against gastroenterologists. However, the relative risk of litigation arising from ERCP was actually substantially less than for other procedure types in the United States, at least when reported in 1995.⁶ In a Canadian study, ERCP-related events accounted for only about 6% of GI-related legal actions from 1990 to 1997.⁷ This apparent discrepancy is probably due mainly to the huge difference in the relative number of procedures involved. By contrast, ERCP is the most common type of endoscopic procedure associated with lawsuits in Japan.⁸ A simple Google search for “ERCP lawsuits” provides plenty of interesting reading.

What Are The Key Legal Principles?

Elements of a Malpractice Case: The Principles of Tort Law

The most common form of a medical malpractice action falls under the principles of tort law, a “civil wrong” rather than a criminal action. Such civil wrongs are generally compensated by monetary redress. To succeed in a medical malpractice action, the plaintiff must prove four basic legal elements by a preponderance of evidence (the fact at issue is more probable than not) rather than proving beyond a reasonable doubt as in criminal actions.^6,⁹ The four basic elements that must be proven are:

1. The physician owed a duty of care to the patient.

2. The physician breached that duty by violating the applicable standard of care.

3. The breach of duty caused an injury.

4. The patient’s injury is compensable (damages).

Standards of Care and Guidelines

The standard of care is a legal concept describing the duty that physicians must fulfill in their care of patients.^6,⁹ A failure to practice within the standard of care is a breach of that duty, one of the four central elements of a malpractice case. The standard of care is usually established through expert testimony, published data, and accepted practice guidelines. Of these, the most important in court is expert testimony. Expert testimony seeks to establish a standard of care reflecting the practice that is customary among competent gastroenterologists in good professional standing who are practicing with reasonable diligence, and should reflect the current practice at the time of the injury. Simply stated, the standard of care is “good patient care.” It is not defined as optimal or best medical practice exhibited by only a few noted experts in the field but rather as what would be expected from a reasonable peer under the same circumstances. Defendants’ lawyers sometimes suggest that the standard of care is somehow different, or less onerous, in their local community, as opposed to the situation in the ivory towers in which many experts live. This is a slippery slope, best avoided. The standard of care is national, not local.

However, because there are often many ways to manage a clinical problem, more than one standard of care may be applicable for evaluating or treating a condition. Practicing the “majority” standard, or the approach most commonly taken by most peers, is usually the most defensible method of practice. A less common approach, the “minority” standard, may be acceptable but should be explained in terms of why a strategy differing from the usual was employed.

Guidelines

Guidelines, or so-called practice parameters, developed by specialty societies, federal agencies, or panels of experts may be useful in establishing standards of care. These professional guidelines are often widely available and provide consensus statements codifying professional custom that may then form the actual basis for a legal standard of care. The validity of such guidelines stems from the sponsoring organization’s expertise and prestige, the nature and purpose of the guideline, conflicting views held by other authorities, and the direct applicability of the guideline to the case under consideration.

It might be tempting to assume that clinical guidelines would reduce malpractice risk by helping physicians understand a consensus of “good care,” but in reality they are more likely to be used in malpractice litigation by the plaintiff as evidence that the physician failed to meet the standard of care.⁹ However, the American Society for Gastrointestinal Endoscopy (ASGE) guideline on the use of ERCP is not restrictive.¹⁰

Who May Be Liable?

While most medical malpractice actions are taken against an individual directly involved with an alleged wrongdoing, there is also a legal concept that allows liability to be extended beyond someone who directly caused an injury to persons on whose behalf that person may have acted. There are several circumstances in which vicarious liability may be invoked.¹¹ Respondeat superior is the legal principle that holds a master responsible for the wrongdoings of his servants. These “master–servant” definitions have evolved to include employer–employee relationships, corporate agent relationships, and teacher–student relationships.^9,^12,¹³ These relationships may apply to preceptors, proctors, administrators, and employers. Such a concept allows blame to be shared among doctors, trainees, nurses, institutions, etc. and may provide additional financially responsible defendants, some with potentially greater resources than the original defendant, to share the liability for an injury.

Employer Liability

A physician may be held responsible for an adverse outcome attributable to substandard service by office staff such as violations in patient confidentiality, violations in sterile technique, or failure to provide appropriate training and supervision to ensure the proper functioning of office staff. This issue has become even more important recently with the increasing use of nonphysician providers in gastroenterology practices and ambulatory surgical centers.¹⁴

Preceptor

The concept of a preceptor as a teacher or instructor in the area of GI endoscopy is central to the training of young physicians new to the specialty and to practicing physicians acquiring new skills. Such a preceptor endoscopist might be found vicariously liable for current or future acts of his or her trainee. More to the point of ERCP, a supervising endoscopist might be held liable for part of the damages arising from a trainee learning the procedure, an experienced colleague acquiring new skills, or either in future misadventures. The degree of liability attributable to each of the principals would depend on many factors, including knowledge on the part of the patient that the procedure would be performed by a trainee, the experience of the trainee, and whether the trainee was performing the procedure within an appropriate standard of care such that the procedure was done for reasonable indications and with appropriate skill. With regard to future injuries after completion of training, liability would hinge on the appropriateness of training and the veracity of credentials.

The expert endoscopist should not train the unprepared novice endoscopist to take on complex difficult tasks before that trainee has the necessary training and experience to safely acquire these skills. Furthermore, training less-than-expert ERCP endoscopists for a technically difficult and seldom needed procedure exposes patients, endoscopists, and trainers to lawsuits, including lawsuits involving vicarious liability. These procedures should probably be conducted at advanced centers for complex or high-risk cases, and ERCP, particularly with advanced techniques, should be concentrated among fewer endoscopists who would thereby perform these procedures more frequently.

Proctor

A physician who observes and monitors another physician, particularly one seeking privileges, is known as a proctor. Proctors have no duty to the patient and therefore no liability since their role is simply to assess the capabilities of the physician being monitored. If the proctor becomes involved in the care of the patient, however, this could change. To avoid such entanglement, the proctor should not interfere with the proctored physician; should have a thorough understanding of proctoring and hospital endoscopy privileges; should not offer advice or interact with the patient; should report only to the hospital or regulatory committee; and in the event that he or she witnesses substandard medical care that is harmful to the patient, should consider contacting an appropriate superior, asking the proctored physician to discontinue the questionable actions, or, as a last resort, intervening with careful appropriate documentation.

Administrator

If a physician acts in an administrative capacity in an endoscopy unit or gastroenterology division, he or she has a duty to patients receiving care in that unit. Failure to develop policies and procedures that ensure a safe environment and comply with state and federal regulations may constitute vicarious liability. Such responsibilities may include the acquisition and maintenance of endoscopic equipment, privileging, infection control, and workplace safety. Further, if the responsible director knew or should have known that an unskilled physician was practicing in the unit and did not take appropriate corrective actions, vicarious liability could exist.

Hospital Liability

Hospitals may be held responsible for the mistakes of a hospital-based physician employed by that institution or for inadequate oversight provided by endoscopy unit or gastroenterology division directors. They may also incur vicarious liability for improperly privileging physicians who are inadequately trained to perform a certain service.^12,¹⁵

Summary

In summary, the gastroenterologist or endoscopist may incur liability for the mistakes of individuals whom they supervised even if they themselves were unaware of the improper actions and even after their immediate supervisory role had ended. All of the aforementioned roles of preceptor, proctor, employer, and administrator should be approached with care and forethought. An understanding of potential vicarious liability may allow better risk management strategies to minimize exposure to liability.

Informed Consent

Medical malpractice actions most commonly involve the “tort of negligence,” wherein a physician is felt to have practiced below the standard of care (“breach of duty”). There is, however, a common and independent cause of malpractice action involving the failure to obtain informed consent.^9,¹⁶^–¹⁸ This is often a secondary allegation filed along with an allegation of practicing below the standard of care.

Theory of Informed Consent

The ethical and legal requirement to obtain informed consent prior to a procedure comes from the concept of personal patient autonomy and is rooted in the theory of patient self-determination. Against such a backdrop, the courts have found that a person’s right to self-determination warrants that a physician obtain informed consent. The competent patient, after receiving appropriate disclosure of material risks of the procedure in question and understanding the risks, benefits, and alternative approaches, then makes a voluntary and uncoerced informed decision of whether to proceed.

Early on, the consent process operated under a provider-based standard (professional standard of disclosure) whereby the physician was expected to disclose information about the treatment that reasonable physicians believed relevant and that reasonable physicians generally disclosed to their patients in similar circumstances. More recently, however, courts have been moving toward a patient-based standard, which mandates that a treating physician disclose as much information as a reasonable patient would wish to know.

The essential elements of informed consent include the following:

1. The nature and character of the proposed procedure, preferably in nontechnical terms.

2. The reason or indication for the procedure.

3. The likely benefits of the procedure.

4. The material risks and adverse events of the procedure, including their relative incidences and severities.

5. The alternatives to the procedure, including those that may be more or less hazardous than the one proposed, and the alternative of no treatment.

The consent process should also include an assessment of the individual’s competence to understand the information presented and the opportunity for patients to ask questions.

Obtaining informed consent is a process that includes more than placing a signature on a standardized consent form. It involves mutual communication and decision making and can advance the physician–patient relationship. It can also be a risk management tool, transferring responsibility for risk to the patient who has understood and accepted that even competently performed procedures can have adverse outcomes.