Legal Concepts for Gastroenterologists

This chapter is written for educational purposes, and should not be construed to provide specific legal advice; for that the reader will need to consult his/her own health care attorney.

Endoscopic evaluation has become an indispensable and powerful tool for prevention, diagnosis, and therapy for digestive disorders. Performance of endoscopic procedures is not without risk, however. In the event of a bad outcome, physicians may face legal liability. It is therefore important that gastroenterologists understand the types of legal risk they may face and best practices for managing those risks.

This chapter briefly addresses legal aspects of gastrointestinal endoscopy. Part I of this chapter describes the types of malpractice lawsuits faced by gastroenterologists. Part II describes the anatomy of a malpractice suit, including the role of adherence to the applicable standard of care. Part III describes the basic elements and importance of obtaining and documenting informed consent. Part IV briefly summarizes legal obligations regarding protected health information. Finally, part V concludes with a discussion of risk management approaches, including good documentation practices, use of clinical practice guidelines (CPGs), and best practices for managing complications and errors once they have occurred.

Types of Lawsuits Faced by Gastroenterologists

Malpractice lawsuits are a fact of practice for physicians in the United States. Beginning in the 1990s, several large studies, including the landmark Harvard Medical Malpractice Study, revealed surprising levels of medical errors and malpractice suits and provided an important impetus for the safety movement.

More recently, a published study of claims data from 1991 through 2005 for all physicians covered by a large, national professional liability insurer revealed that each year 7.4% of physicians had a malpractice claim, with 1.6% having a claim leading to payment. The study identified a large degree of variation by specialty in physicians' risk of facing a malpractice lawsuit. Gastroenterologists during the study period faced a higher degree of malpractice risk than US physicians overall, with over 10% of gastroenterologists facing a malpractice claim annually. Because gastroenterology involves the performance of invasive procedures, such as colonoscopies, this slightly elevated malpractice risk is not surprising.

To avoid potential lawsuits, it is important for gastroenterologists practicing in the United States to be familiar with the types of malpractice claims gastroenterologists most often face. One common type of malpractice claim gastroenterologists face is a claim of missed or delayed diagnosis. These claims often stem from a delayed diagnosis of colorectal cancer (CRC) due to missteps such as failure to conduct an initial CRC screening with the appropriate level of care, failure to notify patients of abnormal test results, and failure to ensure that patients complete follow-up appointments. Other types of malpractice claims gastroenterologists face include claims related to improper performance of a procedure (e.g., a perforated bowel resulting from poor colonoscopy technique) or failure to monitor a patient's case. In addition to claims arising from medical error, malpractice liability may also result from “nonmedical” conduct, such as failure to obtain informed consent or breach of patient confidentiality and privacy protections.

Data on the relative frequency of different types of malpractice claims against gastroenterologists is limited. However, a review of gastroenterology claims data compiled by the Physician Insurers Association of America (PIAA) from 1985 through 2005 revealed that the most common reasons gastroenterologists face malpractice lawsuits are “error in diagnosis” (28% of claims), “improper performance” of a procedure (25% of claims), “failure to supervise or monitor case” (9% of claims), and performance of a procedure “when not indicated or contraindicated” (2.3% of claims). There was no “medical misadventure” identified in 19% of claims.

Legal Principles in Medical Practice

Medical malpractice actions are typically based on the legal theory of negligence. A claim of negligence requires the plaintiff's attorney to prove four elements:

1.
Duty: The physician owed an obligation of care to the plaintiff;
2.
Breach of Duty: The physician violated that duty by practice below the applicable standard of care;
3.
Causation: The physician's substandard practice caused harm to that individual; and
4.
Damages: The plaintiff suffered cognizable and compensable harm.

Duty

To prove the element of duty, it generally suffices to establish the existence of a physician-patient relationship. Although a physician has no legal duty to accept a person as a patient or to provide care to a person with whom the physician does not have a physician-patient relationship, once the physician establishes a physician-patient relationship with an individual, the physician has a duty to provide competent care to that person and could be held liable for failure to do so.

It is generally evident when such duty has been established. For example, a physician-patient relationship may be established by the patient entering the hospital or clinic and the physician accepting to or beginning to treat the patient. The duty of care may also be established in less obvious situations, however, such as when advising an emergency room physician about a patient while on call or providing a “curbside consult” to a patient while not on call.

As less formal methods of medical communication, such as medical web platforms or emails that allow patients to interact with physicians, become more prevalent, it is important for physicians to remain cognizant of the potential for such venues to lead to the establishment of a physician-patient relationship and the corresponding duty of care.

Breach of Duty

To prove the element of breach, the plaintiff must show that the physician did not provide the level of care that a reasonable and prudent member of the medical profession would undertake under the same or similar circumstances. Breach may be established by showing that the treatment itself was substandard or that the physician failed to obtain informed consent to the procedure from the patient. With respect to substandard treatment, whether a physician has breached his or her duty to the patient and provided inadequate care is determined in reference to the standard of care that the physician was expected to provide. The standard of care is based on prevailing practice and may be established by the testimony of an expert in the field as to whether the physician's care was adequate or, with increasing frequency, reference to CPGs or quality measures. Importantly, it is not the negative result that determines whether the physician breached his or her duty to the patient, but whether the physician acted with the degree of skill and care of a reasonable physician in the circumstances. One must distinguish a “bad outcome” from negligence.

The current standard of care and whether the physician's conduct fell short of this standard has traditionally been established through expert witness testimony, but courts are increasingly relying on respected national guidelines as well. CPGs are treatment standards developed by practitioners (typically medical associations) and are informed by a systematic review of evidence and assessment of the benefits and harms of alternative care options. While a court will regard such guidelines as relevant evidence, it generally will not allow them, standing alone, to establish the standard of care in any given situation. Nevertheless, CPGs and quality measures may be cited by experts and become important determinants of the standard of care.

While in many cases breach must be established by reference to expert testimony or medical guidelines, in certain cases the breach falls within the “common knowledge” or “obvious occurrence” exception, wherein the wrong committed is within the realm of a layperson's comprehension (e.g., a sponge retained in the abdomen at surgery, or amputation of the wrong limb). Expert witnesses are also unnecessary under a similar but technically separate doctrine called res ipsa loquitur (the thing speaks for itself), a legal term applying to a narrow category of malpractice cases in which the jury may infer negligence from the mere fact of an accident's occurrence. Whereas some jurisdictions openly disfavor application of res ipsa loquitur in medical malpractice cases, other jurisdictions apply it in common knowledge or obvious occurrence cases.

Causation

The third element, causation, may be established by showing that the physician's substandard medical care directly led to the harm experienced by the plaintiff. Causation is frequently the most complicated and difficult element for plaintiffs to prove in medical malpractice cases. Because patients commonly have preexisting conditions, it is often difficult to determine whether the physician's substandard practice “caused” the patient's bad outcome or whether the patient's harm would have happened anyway.

Although the causation analysis varies from state to state, a 2014 case involving a gastroenterologist in Pennsylvania provides a good illustration of how courts have handled complex causation analysis in malpractice cases. The plaintiff in this case suffered from chronic constipation for which her gastroenterologist prescribed Visicol. Visicol is approved for cleansing the colon for a colonoscopy; use of Visicol for long-term treatment of chronic constipation was an off-label use. The plaintiff was on Visicol for five years before her nephrologist took her off the medication after diagnosing her with permanent, progressive kidney disease. At trial, the plaintiff presented evidence that her kidney failure was caused by long-term ingestion of Visicol as prescribed by her gastroenterologist. The defendant gastroenterologist responded by raising the patient's history of bulimia, hypertension, and nonsteroidal antiinflammatory drug (NSAID) use as alternative explanations for the kidney disease.

Following the trial, a jury determined that the gastroenterologist was negligent, but denied recovery to the plaintiff, finding that she had failed to prove causation. As interpreted by the lower court, causation required a showing that but for the Visicol prescription, the plaintiff would not have experienced the injury of progressive kidney disease. Given the plaintiff's preexisting conditions, this could not be established. The case did not end there, however. The patient appealed the case, and the appellate court remanded the case for a new trial with an instruction to apply an alternative theory of causation, the increased risk theory. Under the increased risk theory, a plaintiff may prove causation based on a showing that the defendant's conduct increased the risk that the harm sustained by the plaintiff would occur. Thus, even though Visicol may not have caused the plaintiff's kidney disease, the plaintiff could recover by demonstrating that chronic use of Visicol caused an increased risk of developing kidney disease.

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