Medical Malpractice: Are You Covered?

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Many factors have contributed to radiology’s increasingly important role in our health-care system and to the specialty’s contributions to medicine. Demographics suggest that radiology will continue to be demanded by the physicians who will care for an aging and expanding population. Likewise, new indications for existing technology have accelerated the utilization of diagnostic-imaging procedures in both elective and emergency situations. For example, physicians’ reliance on imaging to arrive at a prompt diagnosis can be seen in the unprecedented rise in the use of CT in US emergency departments—from 2.7 million exams in 1995 to more than 16 million in 2007, representing an average growth rate of 16% per year.1 Other factors contributing to increased utilization of imaging include patient expectations, the use of diagnostic-imaging procedures (including mammography) in screening programs, defensive medicine, the financially motivated ordering of unnecessary or noncontributory diagnostic tests, and the recommendation by radiologists of follow-up studies (of which the value is frequently questioned by referring physicians). In a 2008 report,2 America’s Health Insurance Plans estimated that 20% to 50% of diagnostic-imaging procedures fail to provide information that improves the patient’s diagnosis. While much has been written about the financial burden of unnecessary imaging exams, less attention has been focused on the increasing exposure to the risk of litigation for radiologists. They can be exposed either directly (for example, through failure to diagnose or incorrect diagnosis) or as defendants in cases that seem tangential to the performance and/or interpretation of radiological exams (in circumstances where counsel for the plaintiff sues all who were involved in the medical care delivered, even where their performance was not the proximate cause of the injury). Medical Malpractice Medical malpractice is professional negligence, by act or omission, by a health-care provider, in which care provided deviates from accepted standards of practice in the medical community and causes injury or death to the patient, with many cases involving medical error. Standards and regulations for medical malpractice vary by country and by jurisdiction within countries. The plaintiff must establish all four elements of the tort of negligence for a successful medical-malpractice claim: First, a duty was owed. A legal duty exists whenever a hospital or health-care provider undertakes care or treatment of a patient. Second, a duty was breached. The provider failed to conform to the relevant standard of care. The standard of care is proved by expert testimony or by obvious errors (the doctrine of res ipsa loquitur, or the thing speaks for itself). Third, the breach caused an injury. The breach of duty was a proximate cause of the injury. Fourth, there are damages. Without damages (losses that might be pecuniary or emotional), there is no basis for a claim, regardless of whether the medical provider was negligent. Likewise, damages can occur without negligence—for example, when someone dies of a fatal disease. Most settled malpractice claims (73%) involve medical error, according to a 2006 study.3 The authors discovered that claims without evidence of error are not uncommon, but most plaintiffs in such cases (72%) are denied compensation. The vast majority of expenditures (54%) go toward litigation over errors and payment for them. An examination of records of 1,452 closed malpractice claims revealed that an overwhelming majority (97%) were associated with injury; in those cases, 73% of plaintiffs received compensation. Just 3% of the claims were not associated with injuries; in those cases, 16% of plaintiffs received compensation. Well over half of the claims (63%) were associated with errors; in those cases, 73% of plaintiffs received compensation (with an average payment of $521,560). The other 37% of claims were not associated with errors; in those cases, 28% of plaintiffs got compensation (with an average payment of $313,205). Claims not associated with errors accounted for 13% to 16% percent of the total costs. For every dollar spent on compensation, $0.54 went to administrative expenses (including lawyers, experts, and courts). Claims involving errors accounted for 78% of administrative costs.2 ,3Separating Myth From Reality Until recently, little information was available regarding the direct and indirect costs assumed at the level of the practice or individual health-care practitioner—including loss of productivity for medical personnel, as defendants in litigation, related to communication and meetings with lawyers, trial preparation, and lost income—when cases go to trial. The Physician Insurers Association of America (PIAA), Rockville, Maryland, is a leading insurers’ trade association that represents domestic and international medical professional liability insurance companies owned and/or operated by physicians, hospitals, dentists, and other health-care providers. PIAA domestic member companies include large national insurance companies, midsized regional writers, single-state insurers, and specialty companies that serve specific niche markets in health-care provision. Collectively, these companies provide insurance protection to more than 60% of US private-practice physicians, and they write approximately 46% (or $5.2 billion) of the total annual industry premium.4 In a long-term analysis5 of radiology data from 1985 through 2008 provided by the PIAA, the most common condition for which claims were filed against radiologists was female breast cancer, resulting in an indemnity payment almost 39.2% of the time and representing 33.7% of the total paid for all radiology claims. The second most prevalent condition was cancer of the bronchus and lung, which resulted in a payment 36.3% of the time and accounted for 12.6% of total indemnity payments (Table 1).
Table 1. Most Prevalent Conditions in Radiology Claims, 1985–2008
In 2008 (the last year for which reportable data are complete), the average indemnity payment for radiology ($358,349) is comparable to the overall average indemnity of $345,498. These figures represent the portion of the radiology contribution to total judgments or settlements, many of which involve multiple defendants. Radiology ranks sixth among the 28 specialties in the number of claims paid and monies paid for cases that closed between 1985 and 2008 (Table 2) and sixth in number of claims closed (Table 3). Radiology did not, however, rank in the top 10 specialties for average size of indemnity: It ranked 13th (Table 4).
Table 2. Paid Claims, 1985–2008
Table 3.Closed Claims, 1985–2008
The percentage of claims that result in payment has remained remarkably stable over time and is not much higher than the average across specialties: 31.2% of the radiology claims that closed in 2008 resulted in an indemnity payment, compared with 31.7% a decade ago and 28.4% for all physician specialty groups.5 Both the number of claims against radiology and their severity, however, have increased over time. In 1985, closed claims amounted to 419, with a total indemnity of just more than $5.5 million and an average indemnity of $45,268. By 2008, the number of closed claims had increased to 559, with a total indemnity of $60.4 million and an average indemnity of $350,000. Remedies That Limit Exposure By paying close attention to the following commonly made errors, radiologists can diminish their exposure to medical-malpractice claims. Errors in perception are the most common reason that a radiologist is sued. These are often referred to as misses or missed diagnoses. Failure to diagnose has been determined to be the number-one reason that radiologists get sued; 75% of radiology lawsuits allege failure to diagnose or failure to communicate in a timely manner.6 Interpretation errors are cognitive errors in which an abnormality is perceived, but is incorrectly identified. For example, a normal structure might be called abnormal. Radiologists win many of the lawsuits that allege only interpretation errors.7 Perceptual and interpretive errors can be addressed through a variety of mechanisms, including peer review and departmental and multidisciplinary case-review conferences. Peer-review programs should be comprehensive and should include assessment of all modalities interpreted by each radiologist. A predetermined methodology should include a defined schedule of studies (by modality) to be reviewed, usually expressed as a percentage of total studies. For example, employing peer-review programs with blind interpretation of mammography results using ACR® BI-RADS® categories is an objective method for assessing performance for a widely used, high-risk procedure. Another tactic is to incorporate radiology into multidisciplinary conferences to address errors that contribute to adverse outcomes and increased risk of litigation; these are commonly referred to as morbidity and mortality conferences. They present a multidisciplinary forum for the retrospective analysis of cases in which errors contribute to significant adverse outcomes for patients. Case review also can be incorporated into regularly scheduled department meetings. Follow-up Intervals and Procedures Follow-up or additional studies to clarify or confirm an impression should be suggested when appropriate. There is a continuum, however, between absolute recommendations and the absence of any recommendation at all. Compounding this dilemma is the fact that radiologists possess varying thresholds for assigning significance to common observations. When uncertainty and doubt arise, reliance on experience and familiarity with appropriate follow-up care can be supplemented by a strategy culled from a variety of reference material. This material includes appropriateness guidelines established by the ACR,8 decision-support mechanisms,9 multidisciplinary guidelines or guidelines established by specialties in which imaging is central to diagnosis and evaluation, and evidence-based criteria usually found in peer-reviewed medical literature. The acceptance/penetration of these standards into common practice varies. In many instances, these standards form the basis of an established, accepted standard of care. Evidence-based medicine and standards also can inform recommendation of the appropriate follow-up procedure, as well as the recommended interval before follow-up care, if immediate intervention is not deemed necessary or indicated. Three examples highlight the complexity and controversial nature of follow-up intervals. Pulmonary nodules and increasing sensitivity: With the increasing sensitivity and resolution of multidetector CT scanning techniques, previously undetected or poorly visualized findings have created an entire subset of risk in the evaluation and management of small pulmonary nodules. Guidelines promulgated by the Fleischner Society10 are beneficial in the evaluation of small pulmonary nodules and in their proper follow-up care and management. Assessment of simple and complex renal cysts: Most incidental renal masses can be diagnosed with confidence and either ignored or treated without further testing. Some renal masses, however, particularly small ones, remain indeterminate and require a management strategy that is both medically appropriate and practical. The Bosniak classification is a practical and useful guide to the diagnosis and management of cystic renal masses.11 The evaluation of thyroid nodules when observation yields to fine-needle aspiration: The Society of Radiologists in Ultrasound12 convened a panel of specialists from a variety of medical disciplines to come to a consensus on the management of thyroid nodules identified using thyroid ultrasonography, with a particular focus on which nodules should and should not be subjected to ultrasound-guided fine-needle aspiration. Failure to Communicate The failure to communicate significant abnormal findings in a timely manner is one of the greatest problems facing radiologists today. It is a causal factor in 80% of all lawsuits, although not the primary factor.13 There are various strategies designed to improve communication between referring physicians and the radiology facilities that perform exams, and many of these can be found in recent literature and on the ACR’s website. Adherence to four recommendations from the ACR practice guideline14 should serve as a roadmap for practices and institutions. First, communicate directly when immediate treatment or surgical intervention is needed or when there is a significant change between the preliminary and final reports. Second, handle nonroutine communication in a manner that gets the information to the referring physician. If there is any doubt concerning whether to use routine communication, use nonroutine communication. Third, be aware of potential communication obligations for self-referred patients and for those referred on a third-party basis. Fourth, document all nonroutine communications, including the date, the time, who spoke, and what was said. Communicating significant abnormal findings in a timely manner is the one area in which one can make a significant change to reduce personal risk and liability. Practices and departments should institute reasonable policies and procedures to define (and establish standards for) communicating critical results within a radiology practice, regardless of imaging location. Common examples of critical results include pneumothorax, pneumoperitoneum, pulmonary embolism, acute intracranial hemorrhage, and ectopic pregnancy.
Table 4. Average Indemnity, 1985–2008
It is important to refine practice guidelines to reflect the particular circumstances in which one practices. Look beyond the traditional means of communicating. For example, is there a methodology in place that conforms to the guidelines for patient notification of the Mammography Quality Standards Act? Are there safeguards in place for situations when existing procedures are insufficient? Litigation can be the result of failure to communicate results effectively to screening participants when those participants move or change physicians. Another common vulnerability is failure to establish policy for appropriate communication of results when self-referral is the portal of entry into the health-care system, and there is no physician of record. Establishing standards of communication is becoming increasingly complicated in circumstances where preliminary interpretation by one radiologist is followed by final interpretation provided by another radiologist. As technology continues to provide alternative venues (usually remote) for interpretations of studies, the standard of care mandates that adherence to guidelines must be uniform, regardless of where the interpretation of the procedure occurs. Policies that establish a standard require a mechanism for compliance with that standard. In addition to peer-review programs, routine audits of the effectiveness of communications guidelines should be adopted—and should incorporate rigorous assessment of the effectiveness of the policy, as well as the quantitative level of compliance with the established standard. Effective communication in acute-care settings requires using a multidisciplinary approach to determine both the efficacy of the program and the uniformity of the standard, as it relates to similar policies across the entire medical milieu. Coordination with risk management is also key in ensuring that standards and policies are applicable beyond the scope of the institution and are compliant with new or established guidelines promulgated by state and federal regulatory agencies. Be Prepared Radiologists will continue to be defendants in both meritorious and frivolous malpractice suits. Society is becoming more litigious, resulting in an increase in the frequency of medical-malpractice lawsuits. Understanding the basis for medical malpractice in radiology is a good place to start. Enterprise-wide commitment to risk management is the most effective and efficient mechanism for the development of successful strategies to improve risk and deliver high-quality care. While many cling to the holy grail of tort reform with limits on awards, this approach is not likely to be realized at the national level, nor is there a mandate for comprehensive tort reform at the state level. While there are examples where legislation at the state level mitigates the magnitude of damages, these examples fail to address why radiology is fertile ground for medical-malpractice claims. Understanding why radiologists are sued is vital in planning an effective risk-management program. Knowledge about the most likely areas where litigation occurs can direct efforts, at a practice or institutional level, to apply risk-management techniques. Comprehensive assessment of policies and procedures is a good starting point for addressing matters such as communication of results. Addressing the other areas where risk can be improved is less concrete and is more related to individual performance in interpretation and in making follow-up recommendations. Nonetheless, there is great potential in pursuing a methodical approach to lowering risk and improving the quality of care provided. This requires integration of many disciplines within the radiology milieu. In the past, little attention was focused on the educational value that the lawyers who defend these cases and the companies that provide medical-malpractice insurance can offer. Integrating this information with that provided through risk-management resources will be limited by the willingness of the targets of malpractice suits to embrace the notion that managing risk benefits everyone in the health-care system. Radiologists can lower their risk primarily through communication, education, and constructive feedback from others involved in the delivery of health care. Howard B. Kessler, MD, is medical director, Radiology Solutions, New Jersey and Pennsylvania divisions, Philadelphia, Pennsylvania. D. Scott Jones, CHC, LHRM, is vice president, corporate compliance and risk management, Healthcare Providers Insurance Exchange and American Healthcare Providers Insurance Services, Philadelphia.