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Medical Malpractice Primer for Practicing Interventional Radiologists
Canadian Association of Radiologists Journal 70 (2019) 292e299 www.carjonline.org
Vascular and Interventional Radiology / Radiologie vasculaire et radiologie d’intervention
Medical Malpractice Primer for Practicing Interventional Radiologists Osman Ahmed, MD*, Brian Funaki, MD Department of Radiology, Section of Vascular and Interventional Radiology, University of Chicago Medicine, Chicago, Illinois, USA
Abstract Medical professional liability (MPL), also commonly referred to as medical malpractice, is a costly issue in health care today, accounting for roughly 2.4% of total health care expenditure in the United States. Almost all physicians currently in clinical practice will either be subject to a lawsuit themselves or work with someone who has. Given a lack of formal structured education about MPL in medicine for trainees, this review aims to define and discuss the relevant concepts in MPL as a reference for early career interventionalists to understand the current medicolegal environment and learn best practices to avoid litigation. Resume La responsabilite professionnelle des medecins (RPM), appelee egalement faute professionnelle medicale, est un probleme co^uteux du systeme de sante actuel et represente environ 2,4 % des depenses totales des soins de sante aux Etats-Unis. Presque tous les medecins actuellement en pratique clinique feront l’objet d’une poursuite judiciaire, ou collaboreront avec un confrere ayant ete la cible d’une telle action. En raison du manque de formation formelle et structuree sur la responsabilite professionnelle en medecine, cette synthese vise a definir et a discuter des notions pertinentes relatives a la responsabilite professionnelle des medecins afin de servir de reference aux praticiens en medecine interventionnelle en debut de carriere et leur permettre ainsi de comprendre le milieu medicolegal actuel et d’acquerir les pratiques necessaires pour eviter les litiges. Ó 2019 Canadian Association of Radiologists. All rights reserved.
Medical professional liability (MPL), also commonly referred to as medical malpractice, is a pervasive and costly issue in health care today. In 2008, the systemic costs associated with MPL were estimated to be $55.6 billion, or roughly 2.4% of total health care expenditure in the United States [1]. While the incidence of MPL across specialties may vary, almost all physicians currently in clinical practice will either be subject to a lawsuit themselves or work with someone who has [2]. Furthermore, 7% of all physicians are sued annually with annual rates reaching up to 20% for those in surgical subspecialties [3]. Despite an alarming risk of MPL for physicians, there is little structured education offered to trainees or early graduates entering practice to mitigate or prevent MPL suits from occurring. Although recent trends have indicated that the number of claims filed against doctors has been decreasing (likely as a result of tort reform and/or limits on non* Address for correspondence: Osman Ahmed, MD, 58040 S. Maryland Ave, MC 2026, Chicago, Illinois 60637, USA. E-mail address: [email protected] (O. Ahmed).
economic awards), it remains imperative that future medical professionals be taught strategies to minimize risk [3]. This initiative is particularly relevant in interventional radiology where the risks of MPL for interventional radiologists are more congruent with surgical subspecialties when compared to their diagnostic counterparts given a higher active clinical role in patient management [4,5]. This review aims to define and discuss the relevant concepts in MPL as a reference for early career interventionalists to understand the current medicolegal environment and learn best practices to avoid litigation. Defining Medical Professional Liability Patients and their families pursue MPL for a variety of reasons. Studies have demonstrated that following an adverse event, patients are more prone to pursue litigation if they were already unsatisfied with their doctor [6,7]. This may stem from poor communication, being dismissive of patient/ family concerns, a perceived lack of caring, poor delivery of information, as well as an unwillingness of the physician to
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Medical malpractice primer / Canadian Association of Radiologists Journal 70 (2019) 292e299
talk frankly with their patient [8]. Furthermore, insensitive handling of adverse outcomes, attempting to cover up a mistake, or refusing to issue an apology increases the likelihood of a lawsuit [8e10]. Although some patients seek monetary compensation as a primary reason to take legal action, others are also motivated by nonmonetary goals, such as learning the truth of what occurred, seeking an apology, protecting others from harm, or attempting to correct a perceived flaw in the health care system 8,9]. It is important to define what constitutes malpractice. In short, MPL is defined as ‘‘a breach of the physician’s duty that causes injury to the patient’’ [11]. To legally prove malpractice, 4 conditions must be met: duty, breach, injury, and causation [2]. Duty, also referred to as ‘‘duty of care’’ or ‘‘standard of care,’’ is defined by what a reasonable physician would do under similar circumstances. Recent trials have upheld the idea that standard of care is constituted by what a ‘‘minimally competent physician’’ would do under the same circumstances with the same set of resources [12]. Breach refers to a negligent act or omission that that initiates malpractice [13]. Most states require that the breach caused injury with a greater than 50% likelihood of medical certainty [2]. This burden of proof is important to recognize and generally the same in all civil lawsuits; if something is ‘‘more likely than not,’’ it is considered to be true. The proof is not required to meet the standard of a criminal trial, which is typically characterized as ‘‘beyond a reasonable doubt.’’ To confer breach as negligence, it is compared to the standard of care and decided by a jury with the aid of testimony provided by expert medical witnesses [14]. Without negligence, an adverse outcome in the care of a patient is not considered MPL [2]. An elderly man underwent attempted gastrostomy tube placement that was aborted due to perforation of a t-tac fastener causing a 1 cm rent in the stomach. The patient was subsequently managed by open surgical closure and gastrostomy tube placement. He recovered, returned home, and died of his underlying disease 18 months later. A lawsuit was filed alleging that the complication led to his untimely demise. Experts agreed that the complication could occur in the absence of negligence and that management of the complication was both timely and appropriate. The case was dropped by plaintiff’s attorney as it did not constitute malpractice [15]. Once breach is established, injury and causation must also be shown. Injury in the setting of MPL refers to the damage that occurred during course of treatment and resulted from the breach. In most instances, the injury sustained must be persistent and severe to be considered for litigation [11,16]. A 76-year-old woman with renal insufficiency and hypertension was found to have a significant right renal artery stenosis. She was seen in clinic and elected to undergo renal artery angioplasty and stent insertion. The procedure went uneventfully, but in retrospect, intraprocedural images demonstrate probable guidewire perforation of the renal capsule (Figure 1A). Four hours after the procedure, the patient became hypotensive and tachycardic. She underwent
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computed tomography, which demonstrated a large perinephric hematoma (Figure 1BeD). A vascular surgeon was consulted and documented that he would be unable to treat the underlying problem. The patient remained hypotensive despite blood transfusions and expired later that night. Litigation was settled out of court in favor of the plaintiff. Experts noted that while the complication that caused bleeding could occur without negligence, the interventional radiologist deviated from standard of care by not attempting further treatment such as embolization after perinephric hematoma was discovered given the patients worsening condition. This case clearly met 4 conditions of malpractice. There was duty, breach (failure to treat complication), injury (death), and causation (hemorrhage). Finally, MPL is confirmed when breach and injury are linked by causation. Causation is divided into 2 components that must both be proven: causation-in-fact and proximate cause. Causation-in-fact means the breach caused the injury. Proximate cause means the injuries were foreseeable. In MPL, proximate cause can be shown by proving that a reasonable physician would have predicted the injury to occur following the breach of duty. A 68-year-old man with hepatocellular carcinoma underwent a planning angiogram prior to radio-embolization treatment. The procedure was uneventful but the patient developed swelling at the site of arterial access 1 day following the procedure. The arteriotomy was closed with a collagen-based plug closure device. The patient then experienced chest pain and was taken by ambulance to his local emergency room. He suffered a myocardial infarct, and computed tomography scan of the pelvis revealed a right groin hematoma (Figure 2). A lawsuit was initiated contending that the interventional radiologist was negligent in obtaining hemostasis and the groin hematoma resulted in his myocardial infarct. After expert witness consultation, the case was withdrawn by plaintiff’s attorney. In this example, establishing proximate cause ultimately proved unsuccessful. The injury (myocardial infarct) was not clearly caused by injury (small groin hematoma) nor does the hematoma, in and of itself, indicate a deviation from the standard of care as it is a known complication of angiography. Malpractice in interventional radiology can occur in almost any procedure or referral. A 46-year-old woman with a history of large uterine fibroids was seen at her local emergency room at 10 PM on a Friday night with a 2-day history of right leg swelling and severe vaginal bleeding. She worked as a truck driver and was unable to drive. An emergency room physician ordered an extremity ultrasound exam, which revealed deep venous thrombosis from the calf to the common femoral vein. Given her ongoing vaginal bleeding and history of fibroids, the physician considered anticoagulation contraindicated and instead urgently consulted the interventional radiologist on call. After discussion, the plan was for an inferior vena cava filter and uterine artery embolization, which were to be performed Saturday morning. At 2 AM, the patient became unresponsive and expired. An autopsy deemed a large
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Figure 1. (A) Right renal angiogram prior to placement demonstrates probable inadvertent perforation of the renal capsule by the distal end of the guidewire. (B) Four-hour post procedure computed tomography angiogram demonstrating large right perinephric hematoma displacing the right kidney anteriorly. (C) Four-hour post procedure computed tomography angiogram demonstrating large right perinephric hematoma displacing the right kidney anteriorly. (D) Fourhour post procedure computed tomography angiogram demonstrating large right perinephric hematoma displacing the right kidney anteriorly.
pulmonary embolus as the cause of death. A malpractice suit was filed. Experts noted that local university hospitals placed inferior vena cava filters routinely on-call when consulted. As such, the local community standard required the interventional radiologist to place the filter on call. There was some question regarding the establishment of ‘‘duty’’ since the interventional radiologist had not yet seen the patient, although experts considered urgent consultation and agreement of a plan to be adequate. The case was settled for an undisclosed sum out of court. In summary, the radiologist held a relationship with the patient in which he had a duty to care for him and breached that duty by not placing an inferior
vena cava filter that night. This breach subsequently led to the direct injury of fatal pulmonary embolism that was persistent and substantial (ie, death) and would have been foreseeable to any reasonable physician in the same circumstance (proximate cause). Role of the Plaintiff Attorney In MPL, plaintiff’s attorneys utilize contingency fees as payment for their services. These fees, which can constitute up to 40% of awards, are only collected when a verdict is reached in the plaintiff’s favor. In some respects, this helps
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responses [15]. All depositions follow a question and answer format with the entire process being recorded by a stenographer [18]. Following discovery and its accompanying depositions, motions along with interrogatories are submitted and trial prep is performed. Motions are applications filed to the court by either the prosecutor or defense attorney. The purpose of the motion is to rule on a certain topic or issue prior to a trial commencing. Similarly, interrogatories are a set of written questions submitted by either side to clarify any matters of fact and determine what facts are to be presented at trial. A settlement can be reached or the suit dropped at any time but often, this occurs after depositions are taken. If no settlement is reached prior to the above sequence of events, the case proceeds to trial. Figure 2. Sequential images from a non-contrast abdominopelvic computed tomography at the level of the femoral head demonstrate a small- to moderate-sized hematoma in the right groin region at the site of previous arterial access. A left femoral central venous catheter is also noted.
to limit frivolous lawsuits since plaintiff’s attorneys are not incentivized to accept cases that lack merit. The plaintiff’s costs of litigation are paid by plaintiff’s attorney. This arrangement is offset by the fact that the monetary amount of contingency awards is unlimited in many states [2]. In the majority of cases, when a suit is filed, plaintiff’s attorneys offer immediate settlement terms as this limits their own investment in the suit (ie, they want their award without having to use their own resources to obtain it). It is rarely beneficial for either side to go to court given the additional expenses incurred and as such, many cases are either settled or dropped. It is not uncommon for parties to reach a settlement immediately prior to the court date. In most cases, plaintiff’s attorneys rely on the testimony of expert medical witnesses to prove the 4 tenets of MPL as discussed above [15]. Litigation Timeline The timeline of litigation in MPL suits can be lengthy. On average, it takes about 3.5 years for claims to be resolved [17]. Out of court resolution can take months or years, but if a suit is taken to trial, the outcome usually takes longer and can last up to 5-10 years to reach verdict. For this reason, many claims are settled out of court due to preference to avoid such delays and reach a timely resolution [15]. After a suit is filed, the process begins with a period known as discovery. During discovery, hospital records are subpoenaed and information is shared between both parties involved in the claim. This is generally the lengthiest part of the litigation. It is during discovery that expert witnesses are disclosed and depositions are taken under oath of those that may testify in the case. Depositions are critical elements of a trial, as they allow the physician a formal opportunity to explain their side of events and justify their actions [18]. During this time the plaintiff attorney will attempt to commit the physician to a set of facts and assess the possibility of calling them to the witness stand based on the strength or weakness of their
Preparing for Deposition and Trial Anyone who has provided care or been affected by it may be deposed. When a physician is faced with an MPL, properly preparing for the deposition may be one of the best ways to defend the care provided and potentially avoid trial [15,18]. To begin, it is advisable for the physician to set aside dedicated time to practice with their defense attorney. A mock deposition with one’s attorney can allow the involved physician to face the difficult questions that inevitably will be asked by the plaintiff’s attorney. This will also allow the physician the opportunity to determine the optimal method to present the facts of the case in an organized and coherent manner [18]. Such an exercise is also protected by attorneyclient privilege [15]. Second, thorough review of the medical record is recommended as it is critical for the physician involved to be fully aware of the aspects of care provided and documented in the chart [18]. As mentioned previously, trials can take up to years to begin and, therefore, adequate record keeping and review of them prior to any deposition or testimony can allow the physician to present a knowledgeable recount of events and rationale about decisions made during the course of medical care [18]. Several tips can be applied on deposition day to accurately defend oneself [15]. Prior to answering any question, the deponent should take time to carefully think about their response before speaking and strive to answer questions in layman’s terms. Unless asked by your own attorney, one should avoid answering questions with a simple ‘‘yes’’ or ‘‘no’’ response, as well as avoiding qualifies such as ‘‘I guess’’ or ‘‘I think.’’ Instead, it is advisable to answer leading questions from plaintiff’s attorney with ‘‘not exactly’’ followed by an explanation to clarify a response. Alternatively, one can also say ‘‘That question cannot be answered with a simple yes or no answer. Would you like for me to explain?’’ In addition, when questioned outside one’s scope of specialty or induced to assign blame to another physician, it is better to respond with ‘‘This is outside my area of expertise and I have no opinion on it’’ [15]. Finally, it is important for the physician to remember their role in litigation as the defendant and not the expert witness. The physician must testify or disclose only the facts (referred
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to as a ‘‘witness of fact’’) surrounding the case upon which the defense’s expert witness can defend the physician’s actions [19]. When questioned, responses should be concise, confidently spoken, and limited to the question asked. Responses explaining the adverse outcome should be sincere, easy to understand, and compatible with the testimony of the expert witness [18]. If the question is vague or the answer is unclear, ask the attorney to rephrase it. References to literature should indicate that information provided is informative but not authoritative [15]. Additionally, it is better to admit when you are not sure or cannot recall the answer to a question rather than guessing or providing a response that is not grounded by the facts of the case [18]. Finally, although most depositions only last a few hours, it is imperative that the physician remain calm and non-combative to avoid demonstrating a lack of professionalism [18]. As a physician, we are taught to seek the truth. It is important to recognize that a plaintiff’s attorney seeks information that will strengthen their case, irrespective of veracity. Anything you say can and will be used against you in court. Role of the Medical Expert Medical experts are critical to both sides of a lawsuit [20]. In some states, expert medical witnesses are required to render an opinion at trial [18]. The specific role of the expert is to define the standard of care and determine whether or not a breach of that standard occurred and resulted in injury [20]. Given these expectations, the medical expert is typically a member of the same profession as the accused physician and careful consideration should be given to how experts are chosen [4,20]. For example, in a lawsuit involving a pediatric interventional radiologist, an ideal expert would be one with extensive clinical experience and teaching in the field of pediatric interventions [4]. While the physician is limited only to the facts of a case, the expert witness can provide their subjective opinion as to whether the standard of care was met based on the merit of their credentials. It is this testimony that then allows juries to decide if an adverse event secondary to negligence occurred [21]. Expert medical testimony is critical as most juries are comprised of lay people who would otherwise be unable to judge whether or not the alleged actions of a physician are negligent. To qualify as an expert witness in MPL, a person must meet the modern Federal Rules of Evidence Rule 702 (FRE 702). FRE 702 states, ‘‘If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education may testify thereto in the form of an opinion or otherwise’’ [22]. Given that medical facts are often needed to be explained in MPL, medical expert witnesses are almost always needed. The few instances in which medical experts are not required include those instances in which negligence was so obvious that common knowledge can be applied by the judge and jury, so-called never events, such as an air embolism, retained foreign body (eg, retained
sponge during port placement) or performing an intervention on the wrong extremity or body part (eg, accidentally performing kyphoplasty at L1 for a compression fracture at T12) [20]. This is often termed ‘‘res ips loquitur’’ or ‘‘the thing speaks for itself.’’ In our experience, experts are used even in these cases. Methods to Prevent or Avoid MPL The main reason people sue is that that they are pissed off because no one talked to them. If all doctors just talked to patients, we’d be out of business. dPlaintiff’s Malpractice Attorney Prevention is the best strategy to avoid malpractice. Professional competency (ie, staying up to date on current guidelines of practice), clear and effective communication, and thorough documentation represent major elements of avoiding litigation [18]. Importantly, these are also all critical in simply providing excellent medical care. In the face of medical errors or adverse outcomes, honest and open dialogue is suggested. A negative outcome may not constitute malpractice, but when compounded by poor communication, it can serve as the basis of litigation [23]. Furthermore, patients tend to be more forgiving when they feel that practitioners have their best interests in mind [23]. Advice on ‘‘admission of guilt’’ is varied. While apologies can be misconstrued as admissions of guilt, many states have enacted apology laws that allow physicians to express sympathy without having this gesture be misinterpreted as an admission of liability [24]. Irrespective of culpability though, it is always advisable to speak directly with patient and family and express the fact that you are sorry that any complication occurred. Simply state the obvious, ‘‘We are very sorry that this occurred despite our best efforts and (if possible) we will do everything we can to help rectify the situation.’’ Using this approach, physicians can be sympathetic about an adverse event without admitting liability that can be misinterpreted as negligence and avoid appearing apathetic at the same time. In interventional radiology, it is essential to verbally communicate the risks prior to any planned intervention as part of informed consent [23]. Informed consent must contain a written copy of these risks, the stated purpose of the procedure planned, any alternative options, as well as the overall prognosis with potential harms and benefits not undergoing the intervention [25]. Studies have suggested that a proper consent should be patient-centered and allow for shared decision-making [26,27]. Additionally, incorporation of a checklist into the consent allows for standardization of the process and ensures that all elements of the process are implemented [26]. Furthermore, consent can only be obtained from the patient when he/she has the decision-making capacity to do so. If a patient cannot provide consent, it should be obtained from a surrogate or designated alternative decision maker [28]. In the event of an emergency with a
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non-consentable patient where delay of treatment would present a risk of death or severe harm, the intervention can be undertaken without written consent provided that this emergency is documented by the physician in the medical record [28]. As interventional radiology is a rapidly evolving field, new, unestablished procedures or novel alternatives to conventional surgery are ubiquitous. Additional efforts are required to properly obtain patient consent for these innovative therapies. One method is to emulate the consent process of clinical trials. Informed consent for a clinical trial typically includes more information and comparisons than the consent for standard treatment. This specifically implies informing patients about the expected benefits, what is known and not known about the new procedure, any possible known risks, and any alternative treatments in plain language. Doing so helps patients understand the differences between the new procedure compared to the standard therapy and with additional information provided, they can ideally make a more informed decision [29]. For outpatients, this can be done at the time of the initial clinic visit. Consent for interventional procedures are also unique in that many procedures in interventional radiology involve the usage of devices in an ‘‘off-label’’ fashion. Using a medical device off-label means utilizing it in a manner not originally intended. In the United States, industry is not allowed by the Food and Drug Administration (FDA) to advertise or market a product for an off-label use; however, the FDA does not have the authority to regulate how a device is used by a physician in clinical practice [30]. Presently, the Society of Interventional Radiology supports the lawful use by a physician of an FDA-approved medical device or drug product for an unlabeled indication when such use is based upon sound scientific evidence and/or sound medical opinion [31]. With respect to consent, it is important to disclose that many day-to-day procedures in interventional radiology utilize devices in an off-label manner and that these practices have been shown in the medical literature to be safe and efficacious for these indications. Additionally, during any intervention, it is important to follow joint commission guidelines and perform a ‘‘time out’’ to prevent never events such as wrong site or wrong procedure [25]. Given the evolving nature of the specialty, it is also important that interventionalists also be aware of new techniques or revisions to old ones. Following a negative outcome, it is helpful to remember that extra attention and empathy towards the patient helps show that the physician is not abandoning them. Conversely, avoidance behavior following an adverse event dehumanizes the physician and increases the likelihood of litigation [23]. For interventional radiologists, this point is especially critical as the day-to-day workflow in most practices makes daily clinical follow-up of some interventions more difficult. For outpatients, this is also important and documentation of follow-up or failure to follow up is very important in the event the outcome leads to MPL [4]. And again, this constitutes good health care.
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Every interventional radiologist will have complications. The vast majority are unavoidable and could occur in any reasonable physician’s care. Most complications in and of themselves do not constitute malpractice. However, once a complication occurs, from a medicolegal perspective, the management of said complication is often more important than the complication itself. We call this the ‘‘two strikes and you’re out’’ rule. There are a number of important steps to follow once a complication occurs. First and foremost, the complication should be treated by whomever can provide the best and most expeditious care. And this should be documented accordingly. Second, when appropriate, liberal consultation of other specialists is recommended. If in doubt, consult. When there is broad agreement between specialists, the best care is usually delivered and such care is more difficult to mischaracterize. Third, discuss what occurred with the patient and/or family, at least in general terms, and what is being done to ameliorate the problem. The most common complications should have already been discussed (and documented) during the informed consent process. It is important to also remember that any electronic communication between physician and patient before or after an intervention can be admissible in court. Fourth, contact your risk management department in the hospital so that they can further document care and help in management. In general, reviewing and organizing a timeline of facts (along with supporting documents) surrounding the event can be very helpful to your lawyer. Ask yourself, ‘‘What would a reasonable physician do under these circumstances?’’ and document as such. Finally, initiation of a root cause analysis and documentation of the process to prevent a similar event in the future can be considered when appropriate. This process highlights the ‘‘just culture’’ of medicine and can also be relayed to the patient and/or family members to highlight the initiatives taken by their health care providers to focus on improvement and preventing such errors from occurring in the future. Psychological Impact of MPL on Physicians The emotional toll on a physician when a lawsuit is filed is high [23]. The process can have negative effects on the confidence of a physician to practice medicine effectively. The range of emotions experienced is varied and includes anxiety, fear, anger, remorse, shame, and betrayal. Exacerbated by advice from legal counsel to avoid talking about the details of a lawsuit, a feeling of isolation can set in for physicians, which can also lead to self-doubt and a decrease in confidence [32]. Moreover, the protracted nature of malpractice litigation precludes closure. Most physicians often feel guilty or responsible regardless of the causation of the adverse outcome [33]. Driven by a code of professional ethics and/or personal integrity, physicians are compelled to offer an apology regardless of whether their actions were the cause of the injury sustained by the patient. As mentioned above, while apologies can be misconstrued as admissions of guilt, many states have
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enacted apology laws that allow physicians to express sympathy without having this gesture be misinterpreted as an admission of liability [24]. Despite the outcome of any litigation, it is important for physicians to maintain a sense of resiliency to avoid future errors and workplace burnout [32]. Malpractice Insurance MPL insurance is required in almost all states as a prerequisite to practice. As current employment structures are evolving towards large group practices or hospital employeebased contracts, many MPL insurance decisions, such as coverage terms and limits of liability, are handled by the executive committees or hospital administrative staff [34]. Nonetheless, it is important for physicians to be aware of coverage provided and options given when available. Malpractice insurance is typically offered by traditional insurance carriers, medical risk retention groups (ie, organization of medical professionals), or even ‘‘self-insured’’ in the case of large medical systems that set up medical liability trust funds to pay for MPL defense. In the United States, 2 basic types of MPL insurance exist: ‘‘claims-made’’ and ‘‘occurrence’’ based. A claims-made policy is one in which the policy holder must actively be carrying the insurance when both the incident occurred and when the claim against the physician was filed [17]. As such, physicians who hold a claims-made policy who leave their practice may need to purchase added protection to prevent claims that may be filed under the statute of limitations (if not already written into the policy). This protection, referred to as ‘‘tail coverage,’’ provides protection to the policy holder after their insurance is discontinued upon leaving their practice. Tail coverage can be very costly, often reaching up to 3 times the price of an annual malpractice insurance premium and typically must be paid as a one-time assessment. In some instances, the liability coverage after leaving a practice with a claims-made policy can be absorbed by the insurance carrier of the physician’s new practice, with this alternative to tail coverage colloquially referred to as ‘‘nose coverage’’ [17]. As opposed to claims-made, occurrencebased policies cover any claim that occurred during the period of coverage, regardless if the claim was filed after the policy expired. For this reason, occurrence-based policies do not require tail (or nose) coverage after policy expiration. Given the benefits of an occurrence-based policy, these options are typically more expensive and less likely to be offered by employers when compared with claims-made policies. Most insurance policies offer limits of coverages that are in the range of $1 million for the maximum amount paid for all injuries caused by patient care and treatment to one patient (ie, single claim) during the policy period (ie, generally 1 year) [17]. The maximum amount paid per policy period for all claims filed can typically range around $3 million and is known as the aggregate amount. This implies that any individual or collection of suits greater than the individual or aggregate limits collectively can leave the physician
responsible for the remainder balance of settlement if these values are exceeded. It is advisable to review what incidents are covered under one’s insurance policy and to ensure that the full range of clinical procedures performed are covered [17]. For interventional radiologists, this is especially relevant, as the risk from interventions performed and the coverage amounts required are higher when compared to diagnostic radiologists [4]. Furthermore, when faced with litigation, policies typically will cover a range of expenses associated with settling suits, such as attorney costs, court fees, expert witness fees, and compensatory/punitive damages. However, some policies do not pay defense costs or will put a limit on the amount paid. If so, it is incumbent on the policy holder to ensure that the overall policy limits are set high enough to be able to cover defense costs in addition to any amount that results from a verdict for the plaintiff [17]. It is also critical to recognize that in some states, awards that exceed malpractice coverage could put the individual physician’s assets at risk. As such, a frank discussion with a financial planner or attorney who specializes in these matters is advised. Conclusion Medical professional liability is a prevalent topic in health care that will affect most physicians in clinical practice and can exert a great deal of negative psychological stress. Understanding the reasons why patients pursue litigation and the 4 elements of duty, breach, injury, and causation needed to prove MPL are important concepts for early career interventional radiologists to learn in order to reduce the risk of being sued. Effective patient communication and compassionate care are effective methods to avoid litigation in the face of a negative or adverse event and more importantly, constitute good medical practice. In the event malpractice is alleged, providing a clear and organized deposition is critical to mitigate its outcome. Finally, reviewing one’s insurance policy when entering practice is key to understanding what is and what is not covered when faced with MPL. Acknowledgement We would like to acknowledge Dr Mehran Midia for his contribution to this manuscript. References [1] Mello MM, Chandra A, Gawande AA, Studdert DM. National costs of the medical liability system. Health Aff 2010;29:1569e77. [2] Austin C, Kusumoto F. Updates in medical professional liability: a primer for electrophysiologists. [Epub ahead of print]. J Interv Card Electrophysiol 2018. https://doi.org/10.1007/s10840-0180453-9. [3] Jena AB, Seabury S, Lakdawalla D, Chandra A. Malpractice risk according to physician specialty. N Engl J Med 2011;365:629e36.
Medical malpractice primer / Canadian Association of Radiologists Journal 70 (2019) 292e299 [4] Hill GQ, Smouse HB. Lessons learned on how to protect an interventional radiologist against malpractice claims. Semin Intervent Radiol 2006;23:315e8. [5] Berlin L. Medicolegal-malpractice and ethical issues in radiology. AJR Am J Roentgenol 2017;209. W333e4. [6] Hickson GB, Entman SS. Physician practice behavior and litigation risk: evidence and opportunity. Clin Obstet Gynecol 2008;51:688e 99. [7] Duclos CW, Eichler M, Taylor L, et al. Patient perspectives of patiente provider communication after adverse events. Int J Qual Health Care 2005;17:479e86. [8] Chiu YC. What drives patients to sue doctors? The role of cultural factors in the pursuit of malpractice claims in Taiwan. Soc Sci Med 2010;71:702e7. [9] Bismark M, Dauer E, Paterson R, Studdert D. Accountability sought by patients following adverse events from medical care: the New Zealand experience. CMAJ 2006;175:889e94. [10] Vincent C, Young M, Phillips A. Why do people sue doctors? A study of patients and relatives taking legal action. Lancet 1994;343:1609e13. [11] Fisher M, Schneider P. Stroke and the law: principles and practice. Stroke 2014;45:3141e6. [12] Moffett P, Moore G. The standard of care: legal history and definitions: the bad and good news. West J Emerg Med 2011;12:109e12. [13] Sanbar S, Warner J. Medical malpractice overview. In: Sanbar S, Firestone M, Fiscina S, LeBlang T, Wecht C, Zaremski M, editors. Legal Medicine. 7th ed. Philadelphia: Mosby Elsevier; 2007. p. 253e64. [14] Kessler DP. Evaluating the medical malpractice system and options for reform. J Econ Perspect 2011;25:93e110. [15] Funaki B. Medical malpractice issues related to interventional radiology complications. Semin Intervent Radiol 2015;32:61e4. [16] Oetgen WJ, Parikh PD, Cacchione JG, et al. Characteristics of medical professional liability claims in patients with cardiovascular diseases. Am J Cardiol 2010;105:745e52. [17] Malpractice insurance: what you need to know. J Oncol Pract 2007;3: 274e7. [18] Teichman PG, Bunch NE. Depositions: defending your care. Fam Pract Manag 2001;8:34e6. [19] Guidelines for expert witness testimony in medical malpractice litigation. Committee on Medical Liability. American Academy of Pediatrics. Pediatrics 2002;109:974e9.
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[20] Bal BS. The expert witness in medical malpractice litigation. Clin Orthop Relat Res 2009;467:383e91. [21] Localio AR, Lawthers AG, Brennan TA, et al. Relation between malpractice claims and adverse events due to negligence. Results of the Harvard Medical Practice Study III. N Engl J Med 1991;325:245e51. [22] United States Code Service. Federal Rules of Evidence. Article VII. Opinions and Expert Testimony.. New York, NY: Matthew Bender; 2008. [23] Kreimer S. Managing risk: how to prevent patient injury and avoid lawsuits. Med Econ 2013;90:46e9. [24] Saitta N, Hodge SD. Efficacy of a physician’s words of empathy: an overview of state apology laws. J Am Osteopath Assoc 2012;112: 302e6. [25] Carrafiello G, Floridi C, Pellegrino C, et al. Errors and malpractice in interventional radiology. Semin Ultrasound CT MR 2012;33:371e5. [26] Ripley BA, Tiffany D, Lehmann LS, et al. Improving the informed consent conversation: a standardized checklist that is patient centered, quality driven, and legally sound. J Vasc Interv Radiol 2015;26: 1639e46. [27] Requarth JA. Informed consent challenges in frail, delirious, demented, and do-not-resuscitate adult patients. J Vasc Interv Radiol 2015;26: 1647e51. [28] Abaunza H, Romer K. Elements for adequate informed consent in the surgical context. World J Surg 2014;38:1594e604. [29] How is informed consent for a clinical trial or research study different from consent for standard treatment? American Cancer Society. Available at: https://www.cancer.org/treatment/finding-and-paying-fortreatment/understanding-financial-and-legal-matters/informed-consent/ clinical-trial-consent.html. Accessed January 1, 2019. [30] Cannavale A, Santoni M, Mancarella P, et al. Malpractice in radiology: what should you worry about? Radiol Res Pract 2013;2013:219259. [31] Society of Interventional Radiology Position Statement on Off-Label Use. Available at: https://www.sirweb.org/globalassets/aasociety-ofinterventional-radiology-home-page/practice-resources/standards_pdfs/ sir_off-label_position_statement_approved_11-2-15.pdf. Accessed January 15, 2019. [32] Rehm SJ, Borden BL. The emotional impact of a malpractice suit on physicians: maintaining resilience. Cleve Clin J Med 2016;83:177e8. [33] Sattia N, Hodge S. Physician apologies. Pract Lawyer 2011. Fall:35e43. [34] Smith JE, Stearns TH, Musgrove J. Malpractice insurance considerations for employed physicians. Med Econ 2015;92:48e50.
Vascular and Interventional Radiology / Radiologie vasculaire et radiologie d’intervention
Medical Malpractice Primer for Practicing Interventional Radiologists Osman Ahmed, MD*, Brian Funaki, MD Department of Radiology, Section of Vascular and Interventional Radiology, University of Chicago Medicine, Chicago, Illinois, USA
Abstract Medical professional liability (MPL), also commonly referred to as medical malpractice, is a costly issue in health care today, accounting for roughly 2.4% of total health care expenditure in the United States. Almost all physicians currently in clinical practice will either be subject to a lawsuit themselves or work with someone who has. Given a lack of formal structured education about MPL in medicine for trainees, this review aims to define and discuss the relevant concepts in MPL as a reference for early career interventionalists to understand the current medicolegal environment and learn best practices to avoid litigation. Resume La responsabilite professionnelle des medecins (RPM), appelee egalement faute professionnelle medicale, est un probleme co^uteux du systeme de sante actuel et represente environ 2,4 % des depenses totales des soins de sante aux Etats-Unis. Presque tous les medecins actuellement en pratique clinique feront l’objet d’une poursuite judiciaire, ou collaboreront avec un confrere ayant ete la cible d’une telle action. En raison du manque de formation formelle et structuree sur la responsabilite professionnelle en medecine, cette synthese vise a definir et a discuter des notions pertinentes relatives a la responsabilite professionnelle des medecins afin de servir de reference aux praticiens en medecine interventionnelle en debut de carriere et leur permettre ainsi de comprendre le milieu medicolegal actuel et d’acquerir les pratiques necessaires pour eviter les litiges. Ó 2019 Canadian Association of Radiologists. All rights reserved.
Medical professional liability (MPL), also commonly referred to as medical malpractice, is a pervasive and costly issue in health care today. In 2008, the systemic costs associated with MPL were estimated to be $55.6 billion, or roughly 2.4% of total health care expenditure in the United States [1]. While the incidence of MPL across specialties may vary, almost all physicians currently in clinical practice will either be subject to a lawsuit themselves or work with someone who has [2]. Furthermore, 7% of all physicians are sued annually with annual rates reaching up to 20% for those in surgical subspecialties [3]. Despite an alarming risk of MPL for physicians, there is little structured education offered to trainees or early graduates entering practice to mitigate or prevent MPL suits from occurring. Although recent trends have indicated that the number of claims filed against doctors has been decreasing (likely as a result of tort reform and/or limits on non* Address for correspondence: Osman Ahmed, MD, 58040 S. Maryland Ave, MC 2026, Chicago, Illinois 60637, USA. E-mail address: [email protected] (O. Ahmed).
economic awards), it remains imperative that future medical professionals be taught strategies to minimize risk [3]. This initiative is particularly relevant in interventional radiology where the risks of MPL for interventional radiologists are more congruent with surgical subspecialties when compared to their diagnostic counterparts given a higher active clinical role in patient management [4,5]. This review aims to define and discuss the relevant concepts in MPL as a reference for early career interventionalists to understand the current medicolegal environment and learn best practices to avoid litigation. Defining Medical Professional Liability Patients and their families pursue MPL for a variety of reasons. Studies have demonstrated that following an adverse event, patients are more prone to pursue litigation if they were already unsatisfied with their doctor [6,7]. This may stem from poor communication, being dismissive of patient/ family concerns, a perceived lack of caring, poor delivery of information, as well as an unwillingness of the physician to
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talk frankly with their patient [8]. Furthermore, insensitive handling of adverse outcomes, attempting to cover up a mistake, or refusing to issue an apology increases the likelihood of a lawsuit [8e10]. Although some patients seek monetary compensation as a primary reason to take legal action, others are also motivated by nonmonetary goals, such as learning the truth of what occurred, seeking an apology, protecting others from harm, or attempting to correct a perceived flaw in the health care system 8,9]. It is important to define what constitutes malpractice. In short, MPL is defined as ‘‘a breach of the physician’s duty that causes injury to the patient’’ [11]. To legally prove malpractice, 4 conditions must be met: duty, breach, injury, and causation [2]. Duty, also referred to as ‘‘duty of care’’ or ‘‘standard of care,’’ is defined by what a reasonable physician would do under similar circumstances. Recent trials have upheld the idea that standard of care is constituted by what a ‘‘minimally competent physician’’ would do under the same circumstances with the same set of resources [12]. Breach refers to a negligent act or omission that that initiates malpractice [13]. Most states require that the breach caused injury with a greater than 50% likelihood of medical certainty [2]. This burden of proof is important to recognize and generally the same in all civil lawsuits; if something is ‘‘more likely than not,’’ it is considered to be true. The proof is not required to meet the standard of a criminal trial, which is typically characterized as ‘‘beyond a reasonable doubt.’’ To confer breach as negligence, it is compared to the standard of care and decided by a jury with the aid of testimony provided by expert medical witnesses [14]. Without negligence, an adverse outcome in the care of a patient is not considered MPL [2]. An elderly man underwent attempted gastrostomy tube placement that was aborted due to perforation of a t-tac fastener causing a 1 cm rent in the stomach. The patient was subsequently managed by open surgical closure and gastrostomy tube placement. He recovered, returned home, and died of his underlying disease 18 months later. A lawsuit was filed alleging that the complication led to his untimely demise. Experts agreed that the complication could occur in the absence of negligence and that management of the complication was both timely and appropriate. The case was dropped by plaintiff’s attorney as it did not constitute malpractice [15]. Once breach is established, injury and causation must also be shown. Injury in the setting of MPL refers to the damage that occurred during course of treatment and resulted from the breach. In most instances, the injury sustained must be persistent and severe to be considered for litigation [11,16]. A 76-year-old woman with renal insufficiency and hypertension was found to have a significant right renal artery stenosis. She was seen in clinic and elected to undergo renal artery angioplasty and stent insertion. The procedure went uneventfully, but in retrospect, intraprocedural images demonstrate probable guidewire perforation of the renal capsule (Figure 1A). Four hours after the procedure, the patient became hypotensive and tachycardic. She underwent
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computed tomography, which demonstrated a large perinephric hematoma (Figure 1BeD). A vascular surgeon was consulted and documented that he would be unable to treat the underlying problem. The patient remained hypotensive despite blood transfusions and expired later that night. Litigation was settled out of court in favor of the plaintiff. Experts noted that while the complication that caused bleeding could occur without negligence, the interventional radiologist deviated from standard of care by not attempting further treatment such as embolization after perinephric hematoma was discovered given the patients worsening condition. This case clearly met 4 conditions of malpractice. There was duty, breach (failure to treat complication), injury (death), and causation (hemorrhage). Finally, MPL is confirmed when breach and injury are linked by causation. Causation is divided into 2 components that must both be proven: causation-in-fact and proximate cause. Causation-in-fact means the breach caused the injury. Proximate cause means the injuries were foreseeable. In MPL, proximate cause can be shown by proving that a reasonable physician would have predicted the injury to occur following the breach of duty. A 68-year-old man with hepatocellular carcinoma underwent a planning angiogram prior to radio-embolization treatment. The procedure was uneventful but the patient developed swelling at the site of arterial access 1 day following the procedure. The arteriotomy was closed with a collagen-based plug closure device. The patient then experienced chest pain and was taken by ambulance to his local emergency room. He suffered a myocardial infarct, and computed tomography scan of the pelvis revealed a right groin hematoma (Figure 2). A lawsuit was initiated contending that the interventional radiologist was negligent in obtaining hemostasis and the groin hematoma resulted in his myocardial infarct. After expert witness consultation, the case was withdrawn by plaintiff’s attorney. In this example, establishing proximate cause ultimately proved unsuccessful. The injury (myocardial infarct) was not clearly caused by injury (small groin hematoma) nor does the hematoma, in and of itself, indicate a deviation from the standard of care as it is a known complication of angiography. Malpractice in interventional radiology can occur in almost any procedure or referral. A 46-year-old woman with a history of large uterine fibroids was seen at her local emergency room at 10 PM on a Friday night with a 2-day history of right leg swelling and severe vaginal bleeding. She worked as a truck driver and was unable to drive. An emergency room physician ordered an extremity ultrasound exam, which revealed deep venous thrombosis from the calf to the common femoral vein. Given her ongoing vaginal bleeding and history of fibroids, the physician considered anticoagulation contraindicated and instead urgently consulted the interventional radiologist on call. After discussion, the plan was for an inferior vena cava filter and uterine artery embolization, which were to be performed Saturday morning. At 2 AM, the patient became unresponsive and expired. An autopsy deemed a large
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Figure 1. (A) Right renal angiogram prior to placement demonstrates probable inadvertent perforation of the renal capsule by the distal end of the guidewire. (B) Four-hour post procedure computed tomography angiogram demonstrating large right perinephric hematoma displacing the right kidney anteriorly. (C) Four-hour post procedure computed tomography angiogram demonstrating large right perinephric hematoma displacing the right kidney anteriorly. (D) Fourhour post procedure computed tomography angiogram demonstrating large right perinephric hematoma displacing the right kidney anteriorly.
pulmonary embolus as the cause of death. A malpractice suit was filed. Experts noted that local university hospitals placed inferior vena cava filters routinely on-call when consulted. As such, the local community standard required the interventional radiologist to place the filter on call. There was some question regarding the establishment of ‘‘duty’’ since the interventional radiologist had not yet seen the patient, although experts considered urgent consultation and agreement of a plan to be adequate. The case was settled for an undisclosed sum out of court. In summary, the radiologist held a relationship with the patient in which he had a duty to care for him and breached that duty by not placing an inferior
vena cava filter that night. This breach subsequently led to the direct injury of fatal pulmonary embolism that was persistent and substantial (ie, death) and would have been foreseeable to any reasonable physician in the same circumstance (proximate cause). Role of the Plaintiff Attorney In MPL, plaintiff’s attorneys utilize contingency fees as payment for their services. These fees, which can constitute up to 40% of awards, are only collected when a verdict is reached in the plaintiff’s favor. In some respects, this helps
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responses [15]. All depositions follow a question and answer format with the entire process being recorded by a stenographer [18]. Following discovery and its accompanying depositions, motions along with interrogatories are submitted and trial prep is performed. Motions are applications filed to the court by either the prosecutor or defense attorney. The purpose of the motion is to rule on a certain topic or issue prior to a trial commencing. Similarly, interrogatories are a set of written questions submitted by either side to clarify any matters of fact and determine what facts are to be presented at trial. A settlement can be reached or the suit dropped at any time but often, this occurs after depositions are taken. If no settlement is reached prior to the above sequence of events, the case proceeds to trial. Figure 2. Sequential images from a non-contrast abdominopelvic computed tomography at the level of the femoral head demonstrate a small- to moderate-sized hematoma in the right groin region at the site of previous arterial access. A left femoral central venous catheter is also noted.
to limit frivolous lawsuits since plaintiff’s attorneys are not incentivized to accept cases that lack merit. The plaintiff’s costs of litigation are paid by plaintiff’s attorney. This arrangement is offset by the fact that the monetary amount of contingency awards is unlimited in many states [2]. In the majority of cases, when a suit is filed, plaintiff’s attorneys offer immediate settlement terms as this limits their own investment in the suit (ie, they want their award without having to use their own resources to obtain it). It is rarely beneficial for either side to go to court given the additional expenses incurred and as such, many cases are either settled or dropped. It is not uncommon for parties to reach a settlement immediately prior to the court date. In most cases, plaintiff’s attorneys rely on the testimony of expert medical witnesses to prove the 4 tenets of MPL as discussed above [15]. Litigation Timeline The timeline of litigation in MPL suits can be lengthy. On average, it takes about 3.5 years for claims to be resolved [17]. Out of court resolution can take months or years, but if a suit is taken to trial, the outcome usually takes longer and can last up to 5-10 years to reach verdict. For this reason, many claims are settled out of court due to preference to avoid such delays and reach a timely resolution [15]. After a suit is filed, the process begins with a period known as discovery. During discovery, hospital records are subpoenaed and information is shared between both parties involved in the claim. This is generally the lengthiest part of the litigation. It is during discovery that expert witnesses are disclosed and depositions are taken under oath of those that may testify in the case. Depositions are critical elements of a trial, as they allow the physician a formal opportunity to explain their side of events and justify their actions [18]. During this time the plaintiff attorney will attempt to commit the physician to a set of facts and assess the possibility of calling them to the witness stand based on the strength or weakness of their
Preparing for Deposition and Trial Anyone who has provided care or been affected by it may be deposed. When a physician is faced with an MPL, properly preparing for the deposition may be one of the best ways to defend the care provided and potentially avoid trial [15,18]. To begin, it is advisable for the physician to set aside dedicated time to practice with their defense attorney. A mock deposition with one’s attorney can allow the involved physician to face the difficult questions that inevitably will be asked by the plaintiff’s attorney. This will also allow the physician the opportunity to determine the optimal method to present the facts of the case in an organized and coherent manner [18]. Such an exercise is also protected by attorneyclient privilege [15]. Second, thorough review of the medical record is recommended as it is critical for the physician involved to be fully aware of the aspects of care provided and documented in the chart [18]. As mentioned previously, trials can take up to years to begin and, therefore, adequate record keeping and review of them prior to any deposition or testimony can allow the physician to present a knowledgeable recount of events and rationale about decisions made during the course of medical care [18]. Several tips can be applied on deposition day to accurately defend oneself [15]. Prior to answering any question, the deponent should take time to carefully think about their response before speaking and strive to answer questions in layman’s terms. Unless asked by your own attorney, one should avoid answering questions with a simple ‘‘yes’’ or ‘‘no’’ response, as well as avoiding qualifies such as ‘‘I guess’’ or ‘‘I think.’’ Instead, it is advisable to answer leading questions from plaintiff’s attorney with ‘‘not exactly’’ followed by an explanation to clarify a response. Alternatively, one can also say ‘‘That question cannot be answered with a simple yes or no answer. Would you like for me to explain?’’ In addition, when questioned outside one’s scope of specialty or induced to assign blame to another physician, it is better to respond with ‘‘This is outside my area of expertise and I have no opinion on it’’ [15]. Finally, it is important for the physician to remember their role in litigation as the defendant and not the expert witness. The physician must testify or disclose only the facts (referred
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to as a ‘‘witness of fact’’) surrounding the case upon which the defense’s expert witness can defend the physician’s actions [19]. When questioned, responses should be concise, confidently spoken, and limited to the question asked. Responses explaining the adverse outcome should be sincere, easy to understand, and compatible with the testimony of the expert witness [18]. If the question is vague or the answer is unclear, ask the attorney to rephrase it. References to literature should indicate that information provided is informative but not authoritative [15]. Additionally, it is better to admit when you are not sure or cannot recall the answer to a question rather than guessing or providing a response that is not grounded by the facts of the case [18]. Finally, although most depositions only last a few hours, it is imperative that the physician remain calm and non-combative to avoid demonstrating a lack of professionalism [18]. As a physician, we are taught to seek the truth. It is important to recognize that a plaintiff’s attorney seeks information that will strengthen their case, irrespective of veracity. Anything you say can and will be used against you in court. Role of the Medical Expert Medical experts are critical to both sides of a lawsuit [20]. In some states, expert medical witnesses are required to render an opinion at trial [18]. The specific role of the expert is to define the standard of care and determine whether or not a breach of that standard occurred and resulted in injury [20]. Given these expectations, the medical expert is typically a member of the same profession as the accused physician and careful consideration should be given to how experts are chosen [4,20]. For example, in a lawsuit involving a pediatric interventional radiologist, an ideal expert would be one with extensive clinical experience and teaching in the field of pediatric interventions [4]. While the physician is limited only to the facts of a case, the expert witness can provide their subjective opinion as to whether the standard of care was met based on the merit of their credentials. It is this testimony that then allows juries to decide if an adverse event secondary to negligence occurred [21]. Expert medical testimony is critical as most juries are comprised of lay people who would otherwise be unable to judge whether or not the alleged actions of a physician are negligent. To qualify as an expert witness in MPL, a person must meet the modern Federal Rules of Evidence Rule 702 (FRE 702). FRE 702 states, ‘‘If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education may testify thereto in the form of an opinion or otherwise’’ [22]. Given that medical facts are often needed to be explained in MPL, medical expert witnesses are almost always needed. The few instances in which medical experts are not required include those instances in which negligence was so obvious that common knowledge can be applied by the judge and jury, so-called never events, such as an air embolism, retained foreign body (eg, retained
sponge during port placement) or performing an intervention on the wrong extremity or body part (eg, accidentally performing kyphoplasty at L1 for a compression fracture at T12) [20]. This is often termed ‘‘res ips loquitur’’ or ‘‘the thing speaks for itself.’’ In our experience, experts are used even in these cases. Methods to Prevent or Avoid MPL The main reason people sue is that that they are pissed off because no one talked to them. If all doctors just talked to patients, we’d be out of business. dPlaintiff’s Malpractice Attorney Prevention is the best strategy to avoid malpractice. Professional competency (ie, staying up to date on current guidelines of practice), clear and effective communication, and thorough documentation represent major elements of avoiding litigation [18]. Importantly, these are also all critical in simply providing excellent medical care. In the face of medical errors or adverse outcomes, honest and open dialogue is suggested. A negative outcome may not constitute malpractice, but when compounded by poor communication, it can serve as the basis of litigation [23]. Furthermore, patients tend to be more forgiving when they feel that practitioners have their best interests in mind [23]. Advice on ‘‘admission of guilt’’ is varied. While apologies can be misconstrued as admissions of guilt, many states have enacted apology laws that allow physicians to express sympathy without having this gesture be misinterpreted as an admission of liability [24]. Irrespective of culpability though, it is always advisable to speak directly with patient and family and express the fact that you are sorry that any complication occurred. Simply state the obvious, ‘‘We are very sorry that this occurred despite our best efforts and (if possible) we will do everything we can to help rectify the situation.’’ Using this approach, physicians can be sympathetic about an adverse event without admitting liability that can be misinterpreted as negligence and avoid appearing apathetic at the same time. In interventional radiology, it is essential to verbally communicate the risks prior to any planned intervention as part of informed consent [23]. Informed consent must contain a written copy of these risks, the stated purpose of the procedure planned, any alternative options, as well as the overall prognosis with potential harms and benefits not undergoing the intervention [25]. Studies have suggested that a proper consent should be patient-centered and allow for shared decision-making [26,27]. Additionally, incorporation of a checklist into the consent allows for standardization of the process and ensures that all elements of the process are implemented [26]. Furthermore, consent can only be obtained from the patient when he/she has the decision-making capacity to do so. If a patient cannot provide consent, it should be obtained from a surrogate or designated alternative decision maker [28]. In the event of an emergency with a
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non-consentable patient where delay of treatment would present a risk of death or severe harm, the intervention can be undertaken without written consent provided that this emergency is documented by the physician in the medical record [28]. As interventional radiology is a rapidly evolving field, new, unestablished procedures or novel alternatives to conventional surgery are ubiquitous. Additional efforts are required to properly obtain patient consent for these innovative therapies. One method is to emulate the consent process of clinical trials. Informed consent for a clinical trial typically includes more information and comparisons than the consent for standard treatment. This specifically implies informing patients about the expected benefits, what is known and not known about the new procedure, any possible known risks, and any alternative treatments in plain language. Doing so helps patients understand the differences between the new procedure compared to the standard therapy and with additional information provided, they can ideally make a more informed decision [29]. For outpatients, this can be done at the time of the initial clinic visit. Consent for interventional procedures are also unique in that many procedures in interventional radiology involve the usage of devices in an ‘‘off-label’’ fashion. Using a medical device off-label means utilizing it in a manner not originally intended. In the United States, industry is not allowed by the Food and Drug Administration (FDA) to advertise or market a product for an off-label use; however, the FDA does not have the authority to regulate how a device is used by a physician in clinical practice [30]. Presently, the Society of Interventional Radiology supports the lawful use by a physician of an FDA-approved medical device or drug product for an unlabeled indication when such use is based upon sound scientific evidence and/or sound medical opinion [31]. With respect to consent, it is important to disclose that many day-to-day procedures in interventional radiology utilize devices in an off-label manner and that these practices have been shown in the medical literature to be safe and efficacious for these indications. Additionally, during any intervention, it is important to follow joint commission guidelines and perform a ‘‘time out’’ to prevent never events such as wrong site or wrong procedure [25]. Given the evolving nature of the specialty, it is also important that interventionalists also be aware of new techniques or revisions to old ones. Following a negative outcome, it is helpful to remember that extra attention and empathy towards the patient helps show that the physician is not abandoning them. Conversely, avoidance behavior following an adverse event dehumanizes the physician and increases the likelihood of litigation [23]. For interventional radiologists, this point is especially critical as the day-to-day workflow in most practices makes daily clinical follow-up of some interventions more difficult. For outpatients, this is also important and documentation of follow-up or failure to follow up is very important in the event the outcome leads to MPL [4]. And again, this constitutes good health care.
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Every interventional radiologist will have complications. The vast majority are unavoidable and could occur in any reasonable physician’s care. Most complications in and of themselves do not constitute malpractice. However, once a complication occurs, from a medicolegal perspective, the management of said complication is often more important than the complication itself. We call this the ‘‘two strikes and you’re out’’ rule. There are a number of important steps to follow once a complication occurs. First and foremost, the complication should be treated by whomever can provide the best and most expeditious care. And this should be documented accordingly. Second, when appropriate, liberal consultation of other specialists is recommended. If in doubt, consult. When there is broad agreement between specialists, the best care is usually delivered and such care is more difficult to mischaracterize. Third, discuss what occurred with the patient and/or family, at least in general terms, and what is being done to ameliorate the problem. The most common complications should have already been discussed (and documented) during the informed consent process. It is important to also remember that any electronic communication between physician and patient before or after an intervention can be admissible in court. Fourth, contact your risk management department in the hospital so that they can further document care and help in management. In general, reviewing and organizing a timeline of facts (along with supporting documents) surrounding the event can be very helpful to your lawyer. Ask yourself, ‘‘What would a reasonable physician do under these circumstances?’’ and document as such. Finally, initiation of a root cause analysis and documentation of the process to prevent a similar event in the future can be considered when appropriate. This process highlights the ‘‘just culture’’ of medicine and can also be relayed to the patient and/or family members to highlight the initiatives taken by their health care providers to focus on improvement and preventing such errors from occurring in the future. Psychological Impact of MPL on Physicians The emotional toll on a physician when a lawsuit is filed is high [23]. The process can have negative effects on the confidence of a physician to practice medicine effectively. The range of emotions experienced is varied and includes anxiety, fear, anger, remorse, shame, and betrayal. Exacerbated by advice from legal counsel to avoid talking about the details of a lawsuit, a feeling of isolation can set in for physicians, which can also lead to self-doubt and a decrease in confidence [32]. Moreover, the protracted nature of malpractice litigation precludes closure. Most physicians often feel guilty or responsible regardless of the causation of the adverse outcome [33]. Driven by a code of professional ethics and/or personal integrity, physicians are compelled to offer an apology regardless of whether their actions were the cause of the injury sustained by the patient. As mentioned above, while apologies can be misconstrued as admissions of guilt, many states have
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enacted apology laws that allow physicians to express sympathy without having this gesture be misinterpreted as an admission of liability [24]. Despite the outcome of any litigation, it is important for physicians to maintain a sense of resiliency to avoid future errors and workplace burnout [32]. Malpractice Insurance MPL insurance is required in almost all states as a prerequisite to practice. As current employment structures are evolving towards large group practices or hospital employeebased contracts, many MPL insurance decisions, such as coverage terms and limits of liability, are handled by the executive committees or hospital administrative staff [34]. Nonetheless, it is important for physicians to be aware of coverage provided and options given when available. Malpractice insurance is typically offered by traditional insurance carriers, medical risk retention groups (ie, organization of medical professionals), or even ‘‘self-insured’’ in the case of large medical systems that set up medical liability trust funds to pay for MPL defense. In the United States, 2 basic types of MPL insurance exist: ‘‘claims-made’’ and ‘‘occurrence’’ based. A claims-made policy is one in which the policy holder must actively be carrying the insurance when both the incident occurred and when the claim against the physician was filed [17]. As such, physicians who hold a claims-made policy who leave their practice may need to purchase added protection to prevent claims that may be filed under the statute of limitations (if not already written into the policy). This protection, referred to as ‘‘tail coverage,’’ provides protection to the policy holder after their insurance is discontinued upon leaving their practice. Tail coverage can be very costly, often reaching up to 3 times the price of an annual malpractice insurance premium and typically must be paid as a one-time assessment. In some instances, the liability coverage after leaving a practice with a claims-made policy can be absorbed by the insurance carrier of the physician’s new practice, with this alternative to tail coverage colloquially referred to as ‘‘nose coverage’’ [17]. As opposed to claims-made, occurrencebased policies cover any claim that occurred during the period of coverage, regardless if the claim was filed after the policy expired. For this reason, occurrence-based policies do not require tail (or nose) coverage after policy expiration. Given the benefits of an occurrence-based policy, these options are typically more expensive and less likely to be offered by employers when compared with claims-made policies. Most insurance policies offer limits of coverages that are in the range of $1 million for the maximum amount paid for all injuries caused by patient care and treatment to one patient (ie, single claim) during the policy period (ie, generally 1 year) [17]. The maximum amount paid per policy period for all claims filed can typically range around $3 million and is known as the aggregate amount. This implies that any individual or collection of suits greater than the individual or aggregate limits collectively can leave the physician
responsible for the remainder balance of settlement if these values are exceeded. It is advisable to review what incidents are covered under one’s insurance policy and to ensure that the full range of clinical procedures performed are covered [17]. For interventional radiologists, this is especially relevant, as the risk from interventions performed and the coverage amounts required are higher when compared to diagnostic radiologists [4]. Furthermore, when faced with litigation, policies typically will cover a range of expenses associated with settling suits, such as attorney costs, court fees, expert witness fees, and compensatory/punitive damages. However, some policies do not pay defense costs or will put a limit on the amount paid. If so, it is incumbent on the policy holder to ensure that the overall policy limits are set high enough to be able to cover defense costs in addition to any amount that results from a verdict for the plaintiff [17]. It is also critical to recognize that in some states, awards that exceed malpractice coverage could put the individual physician’s assets at risk. As such, a frank discussion with a financial planner or attorney who specializes in these matters is advised. Conclusion Medical professional liability is a prevalent topic in health care that will affect most physicians in clinical practice and can exert a great deal of negative psychological stress. Understanding the reasons why patients pursue litigation and the 4 elements of duty, breach, injury, and causation needed to prove MPL are important concepts for early career interventional radiologists to learn in order to reduce the risk of being sued. Effective patient communication and compassionate care are effective methods to avoid litigation in the face of a negative or adverse event and more importantly, constitute good medical practice. In the event malpractice is alleged, providing a clear and organized deposition is critical to mitigate its outcome. Finally, reviewing one’s insurance policy when entering practice is key to understanding what is and what is not covered when faced with MPL. Acknowledgement We would like to acknowledge Dr Mehran Midia for his contribution to this manuscript. References [1] Mello MM, Chandra A, Gawande AA, Studdert DM. National costs of the medical liability system. Health Aff 2010;29:1569e77. [2] Austin C, Kusumoto F. Updates in medical professional liability: a primer for electrophysiologists. [Epub ahead of print]. J Interv Card Electrophysiol 2018. https://doi.org/10.1007/s10840-0180453-9. [3] Jena AB, Seabury S, Lakdawalla D, Chandra A. Malpractice risk according to physician specialty. N Engl J Med 2011;365:629e36.
Medical malpractice primer / Canadian Association of Radiologists Journal 70 (2019) 292e299 [4] Hill GQ, Smouse HB. Lessons learned on how to protect an interventional radiologist against malpractice claims. Semin Intervent Radiol 2006;23:315e8. [5] Berlin L. Medicolegal-malpractice and ethical issues in radiology. AJR Am J Roentgenol 2017;209. W333e4. [6] Hickson GB, Entman SS. Physician practice behavior and litigation risk: evidence and opportunity. Clin Obstet Gynecol 2008;51:688e 99. [7] Duclos CW, Eichler M, Taylor L, et al. Patient perspectives of patiente provider communication after adverse events. Int J Qual Health Care 2005;17:479e86. [8] Chiu YC. What drives patients to sue doctors? The role of cultural factors in the pursuit of malpractice claims in Taiwan. Soc Sci Med 2010;71:702e7. [9] Bismark M, Dauer E, Paterson R, Studdert D. Accountability sought by patients following adverse events from medical care: the New Zealand experience. CMAJ 2006;175:889e94. [10] Vincent C, Young M, Phillips A. Why do people sue doctors? A study of patients and relatives taking legal action. Lancet 1994;343:1609e13. [11] Fisher M, Schneider P. Stroke and the law: principles and practice. Stroke 2014;45:3141e6. [12] Moffett P, Moore G. The standard of care: legal history and definitions: the bad and good news. West J Emerg Med 2011;12:109e12. [13] Sanbar S, Warner J. Medical malpractice overview. In: Sanbar S, Firestone M, Fiscina S, LeBlang T, Wecht C, Zaremski M, editors. Legal Medicine. 7th ed. Philadelphia: Mosby Elsevier; 2007. p. 253e64. [14] Kessler DP. Evaluating the medical malpractice system and options for reform. J Econ Perspect 2011;25:93e110. [15] Funaki B. Medical malpractice issues related to interventional radiology complications. Semin Intervent Radiol 2015;32:61e4. [16] Oetgen WJ, Parikh PD, Cacchione JG, et al. Characteristics of medical professional liability claims in patients with cardiovascular diseases. Am J Cardiol 2010;105:745e52. [17] Malpractice insurance: what you need to know. J Oncol Pract 2007;3: 274e7. [18] Teichman PG, Bunch NE. Depositions: defending your care. Fam Pract Manag 2001;8:34e6. [19] Guidelines for expert witness testimony in medical malpractice litigation. Committee on Medical Liability. American Academy of Pediatrics. Pediatrics 2002;109:974e9.
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[20] Bal BS. The expert witness in medical malpractice litigation. Clin Orthop Relat Res 2009;467:383e91. [21] Localio AR, Lawthers AG, Brennan TA, et al. Relation between malpractice claims and adverse events due to negligence. Results of the Harvard Medical Practice Study III. N Engl J Med 1991;325:245e51. [22] United States Code Service. Federal Rules of Evidence. Article VII. Opinions and Expert Testimony.. New York, NY: Matthew Bender; 2008. [23] Kreimer S. Managing risk: how to prevent patient injury and avoid lawsuits. Med Econ 2013;90:46e9. [24] Saitta N, Hodge SD. Efficacy of a physician’s words of empathy: an overview of state apology laws. J Am Osteopath Assoc 2012;112: 302e6. [25] Carrafiello G, Floridi C, Pellegrino C, et al. Errors and malpractice in interventional radiology. Semin Ultrasound CT MR 2012;33:371e5. [26] Ripley BA, Tiffany D, Lehmann LS, et al. Improving the informed consent conversation: a standardized checklist that is patient centered, quality driven, and legally sound. J Vasc Interv Radiol 2015;26: 1639e46. [27] Requarth JA. Informed consent challenges in frail, delirious, demented, and do-not-resuscitate adult patients. J Vasc Interv Radiol 2015;26: 1647e51. [28] Abaunza H, Romer K. Elements for adequate informed consent in the surgical context. World J Surg 2014;38:1594e604. [29] How is informed consent for a clinical trial or research study different from consent for standard treatment? American Cancer Society. Available at: https://www.cancer.org/treatment/finding-and-paying-fortreatment/understanding-financial-and-legal-matters/informed-consent/ clinical-trial-consent.html. Accessed January 1, 2019. [30] Cannavale A, Santoni M, Mancarella P, et al. Malpractice in radiology: what should you worry about? Radiol Res Pract 2013;2013:219259. [31] Society of Interventional Radiology Position Statement on Off-Label Use. Available at: https://www.sirweb.org/globalassets/aasociety-ofinterventional-radiology-home-page/practice-resources/standards_pdfs/ sir_off-label_position_statement_approved_11-2-15.pdf. Accessed January 15, 2019. [32] Rehm SJ, Borden BL. The emotional impact of a malpractice suit on physicians: maintaining resilience. Cleve Clin J Med 2016;83:177e8. [33] Sattia N, Hodge S. Physician apologies. Pract Lawyer 2011. Fall:35e43. [34] Smith JE, Stearns TH, Musgrove J. Malpractice insurance considerations for employed physicians. Med Econ 2015;92:48e50.