Influencing Factors Leading to Malpractice Litigation in Radical Prostatectomy

Transcription

1 Influencing Factors Leading to Malpractice Litigation in Radical Prostatectomy Marc Colaco,*, Jason Sandberg and Gopal Badlani From the Department of Urology, Wake Forest School of Medicine, Winston-Salem, North Carolina Abbreviations and Acronyms LARP ¼ laparoscopic assisted radical prostatectomy MIP ¼ minimally invasive prostatectomy RALP ¼ robotic assisted laparoscopic prostatectomy RRP ¼ radical retropubic prostatectomy Accepted for publication December 3, * Correspondence: Department of Urology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, North Carolina (telephone: ; FAX: ; mcolaco@wakehealth.edu). Nothing to disclose. Financial interest and/or other relationship with Piedmont Stone Center, Society of University Urologists and NIDDK. See Editorial on page Editor s Note: This article is the fourth of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 1940 and Purpose: The litigious nature of the medical-legal environment is a major concern for American physicians with an estimated cost of $10 billion. In this study we identify the causes of litigation in cases of radical prostatectomy as well as the factors that contribute to verdicts or settlements resulting in indemnity payments. Materials and Methods: Publicly available verdict reports were recorded using the WestlawÒ legal database. To identify pertinent cases we used the search terms medical malpractice and prostate or prostatectomy with dates ranging from 2000 to Cases were evaluated for alleged cause of malpractice, resulting injury, findings and indemnity payment (if any). Results: The database search yielded 222 cases, with 25 being relevant to radical prostatectomy. Of these cases 24.0% were settled out of court and the remaining 76.0% went to trial. Of those cases that went to trial 20.8% saw patients awarded damages. There was no significant difference in awards between verdict and settlement. Overall 36.0% of patients claimed that they did not receive proper informed consent and 16.0% claimed that the surgery was not the proper standard of care. Thirteen of the cases claimed negligence in the performance of the surgery with the bulk of these claims being the result of rectal perforation. Conclusions: The main issues that arise in radical prostatectomy malpractice litigation are those of informed consent and clinical performance. Comprehensive preoperative counseling, when combined with proper surgical technique, may minimize the impact of litigation. Key Words: prostatectomy, malpractice, jurisprudence, informed consent IT has been estimated that medical errors contribute nearly $30 billion in avoidable cost each year in the United States. 1 Malpractice litigation resulting from these errors costs an additional $10 billion in legal and settlement fees for health care providers. 2,3 These figures are of particular concern to surgeons as postoperative complications have proved to be the most costly type of error and may constitute up to 39% of the costs for medical errors. 4 The litigious nature of the United States medical-legal environment is of particular concern for urologists. A 2011 survey reported that median annual malpractice insurance premiums are highest for surgical and procedural practitioners, with urologists dedicating a median of $22,500 annually (vs a median of $14,700 for all medical specialties). 5 It has been estimated that the average urologist will be sued approximately twice in a career, with one study 1770 j /14/ /0 THE JOURNAL OF UROLOGY 2014 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH,INC. Vol. 191, , June 2014 Printed in U.S.A.

2 RADICAL PROSTATECTOMY MALPRACTICE 1771 suggesting that lawsuit rates may be as high as once every 11 years regardless of experience level. 6 Independent of trial outcome, being sued has financial implications, and is stressful, distracting and time-consuming. 3 Previous studies have assessed malpractice cases across all urological procedures, reporting an average indemnity paid claim of $174, This number may be considerably higher when limited to a specific subspecialty. For example, endourology cases, including ureteral stenting, ureteroscopic lithotripsy, shock wave lithotripsy and percutaneous stone extraction, produced a mean indemnity paid claim of $346,722 from 2005 to 2010 in one region of the country. 8 However, the largest review to our knowledge of jury verdict cases against urologists showed that the majority of men s health diagnosis related claims were related to prostate cancer (24%), while the majority of men s health treatment related claims were related to prostate surgery (13%). 9 Thus, in this study we identify the causes of litigation and the factors that contribute to malpractice litigation with regard to radical prostatectomy. Our goals are to cultivate strategies that limit malpractice exposure for urologists who routinely perform radical prostatectomy, and to encourage the best possible patient outcomes and expectation management. MATERIALS AND METHODS Data Collection Publicly available federal and jury verdict reports were recorded using the Westlaw legal database. This database is composed of public records collected via numerous vendors from many jurisdictions, and has previously been validated in the analysis of several other medical-legal issues in a variety of other specialties including otolaryngology, 10,11 infectious disease 12 and genetics. 13 As the database does not contain any protected patient information, it does not require institutional review board review. To identify pertinent cases we used the search terms medical malpractice and prostate or prostatectomy with dates ranging from 2000 to Jury verdicts, depositions and narrative summaries were evaluated for their relevance to prostatectomy. Cases that were not directly related to prostatectomy or that were repeats were excluded from analysis. Each relevant case was then reviewed for legal and medical outcome. Various factors including patient demographics, alleged cause of malpractice and resulting injury were also recorded for analysis. All data were collected in April Statistical Analysis Nonparametric statistical analysis using the Mann- Whitney U test was used for comparison of continuous variables (MicrosoftÒ Excel). Statistical significance was set at p <0.05. RESULTS The initial search using the identified terms yielded a total of 222 cases. Of those cases 177 were excluded as not being related to prostatectomy and 21 were excluded as being repeat entries. Thus, a total of 25 cases were available for analysis, including 2 involving LARP, 5 involving RALP and 18 involving open RRP. Of the reviewed cases 24.0% were settled out of court and the remaining 76.0% went to trial. Of those cases that went to trial 79.2% were found in the physician s favor while 20.8% saw patients awarded damages (fig. 1, A). Verdict Figure 1. A, case outcomes for litigation related to prostatectomy. B, mean payments in cases resolved via out of court settlements vs verdict. Error bars represent standard error of means.

3 1772 RADICAL PROSTATECTOMY MALPRACTICE awards were larger than settlement awards, although the results were not significant (Mann- Whitney U p >0.05, fig. 1, B). The table outlines the cases in which indemnity payments were awarded. The breach of duty involved in claiming negligence fell into the 3 categories of negligence in providing informed consent, negligence in surgical decision making and negligence in the performance of clinical duties. Overall 36.0% of patients claimed that they did not receive proper informed consent. In 4 cases (16.0%) they claimed that the surgery was unnecessary. In 2 of these instances the patient did not actually have prostate cancer, yet underwent prostatectomy due to sample mislabeling. In the other 2 the plaintiff argued that radical prostatectomy was not the best treatment option. Thirteen of the cases claimed negligence in the performance of the surgery with the bulk of these claims being the result of rectal perforation (representing 40.0% of all cases). The remaining cases involved postoperative events (20.0%) and a single case of an intraoperative cardiac event. Figure 2, A shows the breakdown of alleged contributing factors to the malpractice, and figure 2, B shows the breakdown of forms of negligence in clinical performance. For cases involving negligent clinical performance, the plaintiff claimed that the error was not properly recognized in 32.0% of cases. Except for tissue mislabeling there was no correlation between the nature of the alleged negligence or the number of alleged causes of negligence and the verdict decision or size of indemnity. Financial losses were the most commonly cited injury and were listed in all cases. The most commonly alleged medical injury was the need for additional medical treatment, which was cited in 56.0% of cases. Other commonly cited clinical injuries include sexual dysfunction, severe medical issues (including sepsis and cardiac events) and incontinence seen in 40.0%, 24.0% and 20.0% of cases, respectively. Figure 3 shows the most commonly alleged clinical injuries. DISCUSSION Although urologists are among the least sued in the surgical fields, 14 the likelihood of complications and the complexity of urological surgery still make them potential targets for litigation. Given that more than 230,000 cases of prostate cancer are diagnosed annually, and nearly 50% of these cases result in radical prostatectomy as initial therapy, 15,16 it is important that urologists who perform this surgery are informed of the potential legal risks and the best means to protect themselves. Simply making a medical error is not sufficient cause for an indemnity award. To win a malpractice suit the plaintiff must prove all 4 elements of negligence by the preponderance of evidence, which are 1) the defendant had a duty to act, 2) the defendant breached of that duty, 3) the plaintiff suffered damages and 4) the damages suffered were directly caused by the breach in duty. 17 For medical malpractice, duty is a given. All physicians have a duty to best treat their patients. Thus, in this study we focused on the remaining 3 factors of breach of duty, damages and causation. Our results show that breach of duty came in the 3 major forms of lack of adequate informed consent, performance of unnecessary surgery and inadequate surgical technique. Claims of informed consent hinge on the 2 principles of 1) the physician did not adequately explain the risks of the proposed treatment and alternative treatments, and 2) the patient would have declined the treatment if he had this information. 18 This claim was made in 36% of cases, and speaks to the importance of patient understanding. Note that it is not enough to simply tell a patient about a procedure. Plaintiffs can claim that they did not understand the information as it was presented to them and, thus, that they received inadequate informed consent. Although it may be difficult to assess a patient s understanding, it is part of the physician s duty to make information as accessible as possible. Documentation is equally as important as evidence should legal claims arise. 18 Although cases involving claims of unnecessary surgery resulting from mislabeling were rare (8% of reported cases), they represent a clear breach in duty and a serious issue. In these 2 cases, patients underwent prostatectomy due to the mislabeling of biopsy samples in the clinic. Neither patient actually had prostate cancer. Both of these men experienced erectile dysfunction and incontinence, while Alleged cause of malpractice in cases with payments Outcome (No. cases) Payment ($) Rectal tear during surgery Settlement (2), verdict (2) 500K (settlement), 1.25M (settlement), 1.1M (verdict), 1.5M (verdict) Tissue mislabeled leading to unnecessary surgery Settlement (2) 650K, 1.05M Failure to remove all portions of the prostate Settlement (1) 625K Failure to diagnose preop þ postop ureteral complications Verdict (1) 1.5M Failure to monitor intraoperatively Verdict (1) 750K Postop pneumonia leading to death Settlement (1) 1.5M

4 RADICAL PROSTATECTOMY MALPRACTICE 1773 Figure 2. A, general types of alleged breaches of duty. B, alleged types of negligence in clinical performance. PE, pulmonary embolism. one of them also sustained a bladder injury as a result of surgery. Some authors have suggested implementing strategies to reduce the incidence of specimen mislabeling, including a paperless requisition process, and confirmation of the correct site and correct patient by 2 health care providers with or without radio frequency identification technology, although we acknowledge that radio frequency identification may be cost prohibitive in many settings. 19 For cases in which the plaintiff alleged that surgery should not have been the chosen treatment option and that alternative options were warranted, the situation is less clearly defined. There are Figure 3. Most commonly alleged injuries several recognized modalities for the treatment of prostate cancer, and radical prostatectomy may not be the best option for all patients. This issue actually falls under informed consent. Urologists need to discuss all treatment modalities with their patients and share the decision making process. Only 2 cases of the 25 were noted to be laparoscopic assisted radical prostatectomy (8%) in contrast with 5 RALP (20%) and 18 RRP (72%). Given our analysis of only 25 cases, it is difficult to identify any emerging trends in the penetration of LARP vs RRP. However, a recent report from the SEER (Surveillance, Epidemiology, and End Results) database demonstrated that the use of minimally invasive prostatectomy, including RALP and LARP, increased from 9% to 43% from 2003 to In 2013 Hofer et al used the National Inpatient Sample and put national estimates at 117,245 MIP (RALP and LARP) vs 578,973 RRP (16.8% MIP overall). 20 They also noted a lower complication rate for MIP vs RRP which, if one assumes a complication is more likely to stimulate litigation, may support the inference that RRP makes the surgeon more likely to be sued. Further supporting this inference is the fact that among rectal injury cases 7 were RRP while only 3 were MIP (2 RALP, 1 LARP). Avoiding rectal injury should be one of the primary concerns for any urologist performing prostatectomy as this error constituted 10 of 13 cases (77%) claiming negligence in performing the surgery. Our findings highlight the importance of understanding that many malpractice claims do not involve

5 1774 RADICAL PROSTATECTOMY MALPRACTICE medical errors in the traditional sense. In every case proper communications not only between surgeon and patient, but also between surgeon and staff, are vital in eliminating avoidable errors. The surgeon should make a habit of explicitly asking patients to confirm and repeat back their understanding of the risks, benefits and alternatives to a procedure, and document the conversation accordingly. The surgeon should also be diligent in confirming proper specimen labeling with staff through a ritualized, memorable set of procedures that are performed at each collection, no matter how routine. The importance of demanding excellence in communication through repetition and explicit 2-way conversation cannot be overstated. These findings are not unique to the treatment of prostate cancer. Good communication and informed consent should be pervasive throughout all practices and specialties. Claims of inadequate surgical technique were the most common and difficult to assess as radical prostatectomy is a complex surgery requiring intense knowledge and dexterity. Even the best surgeons may occasionally make technical errors. Rectal perforation was the most commonly cited technical error, accounting for more than half the claims involving technique. The management of these errors again begins in the preoperative informed consent phase (in explaining that such complications are possible). If such a complication does happen, timely recognition and diagnosis are of the utmost importance. Injury claims ranged from the common issues (incontinence and sexual dysfunction) to the more severe, including sepsis and death. While all these potential complications should be discussed with patients before surgery, urologists must also consider the management of expectations. Studies have quoted incontinence rates of almost 7% at high volume centers, 21 and sexual dysfunction rates anywhere between 25% and 90%. 22,23 Expectation management is especially important in the discussion of surgery modality. Studies have shown that patients who undergo robotic surgery are more likely to be regretful and dissatisfied than those who undergo an open procedure, even when the outcomes are similar. This dissatisfaction is the result of unrealistic expectations 24,25 and, as such, accurate pretreatment counseling is vital to generating realistic expectations and subsequent patient satisfaction. To grant adequate informed consent, patients must be aware of these risks and their relative frequency, regardless of the treatment strategy. Finally, although the purpose of this study was to examine the ways that urologists may avoid malpractice litigation, if litigation is to happen, urologists are often fortunate to be successful in their defense. Of cases that went to trial the decision was in the physician s favor 79.2% of the time. While this finding does not remedy the many associated costs with going to trial, it does somewhat vindicate surgeons in the performance of their duties. For those physicians deciding between settlement and trial, it is important to note that although the indemnities awarded at trial were greater than the settlements, this difference was not significant. However, this does not take into account the increased time and costs associated with going to trial, so such a decision should not be taken lightly. This study does have several limitations, mainly due to the nature of the Westlaw database itself. Westlaw is comprised of records purchased from several vendors in many different jurisdictions. As such, Westlaw contains voluntarily attorney submitted cases from all jurisdictions as well as nonvoluntarily submitted cases from several jurisdictions. 26 In cases that occurred in jurisdictions that have involuntary reporting plaintiffs and defendants are recorded as John Doe or Anonymous. This was seen in 5 of our cases, all of which were settled in the pretrial phase. Also, some cases may not have progressed long enough before parties reached an out of court settlement and these cases would not be included in public records. Thus, Westlaw is not a complete record of litigation. Still, the resource has been demonstrated to be a valid and valuable tool for litigation analysis in many other medical and nonmedical studies. 10e13,26e28 Furthermore, the extrapolation of national databases that collect a subset of data to the general population is a common and validated practice for many clinical investigations as demonstrated by SEER and Centers for Medicare and Medicaid Services database based studies. 29,30 Currently the only major data source that encompasses all malpractice litigation is the National Practitioner Data Bank, but this database has unfortunately been closed to the public since Should public access to the database ever be restored, it would be a boon to public health research and the understanding of malpractice litigation. CONCLUSIONS Radical prostatectomy is a complex procedure and can result in malpractice litigation. Fortunately the majority of cases that do actually go to trial are found in favor of the physician. The main issues that arise in malpractice litigation are those of informed consent and clinical performance. Thus, it is important that physicians manage expectations, and fully explain all likely outcomes and possibilities before surgery with proper attention paid to documentation. Comprehensive preoperative counseling, when combined with proper surgical technique, is a urologist s best defense against litigation.

6 RADICAL PROSTATECTOMY MALPRACTICE 1775 REFERENCES 1. Kohn LT, Corrigan JM and Donaldson MS: To Err is Human: Building a Safer Health System. Washington, DC: The National Academies Press Anderson GF, Hussey PS, Frogner BK et al: Health spending in the United States and the rest of the industrialized world. Health Aff (Millwood) 2005; 24: Exclusive Survey. Malpractice premiums: dropping, but still high. Med Econ 2008; 85: Thomas EJ, Studdert DM, Newhouse JP et al: Costs of medical injuries in Utah and Colorado. Inquiry 1999; 36: Hertz BT and Arthurs J: Malpractice rates plateauing. The only thing to fear may be fear itself. Med Econ 2011; 88: Kaplan GW: Malpractice risks for urologists. Urology 1998; 51: Benson JS and Coogan CL: Urological malpractice: analysis of indemnity and claim data from 1985 to J Urol 2010; 184: Duty B, Okhunov Z, Okeke Z et al: Medical malpractice in endourology: analysis of closed cases from the State of New York. J Urol 2012; 187: Hsieh MH, Tan AG and Meng MV: Medical malpractice in American urology: 22-year national review of the impact of caps and implications for contemporary practice. J Urol 2008; 179: Blake DM, Svider PF, Carniol ET et al: Malpractice in otology. Otolaryngol Head Neck Surg 2013; 149: Svider PF, Kovalerchik O, Mauro AC et al: Legal liability in iatrogenic orbital injury. Laryngoscope 2013; 123: Cramer R, Leichliter JS, Stenger MR et al: The legal aspects of expedited partner therapy practice: do state laws and policies really matter? Sex Transm Dis 2013; 40: Clayton EW, Haga S, Kuszler P et al: Managing incidental genomic findings: legal obligations of clinicians. Genet Med 2013; 15: Jena AB, Seabury S, Lakdawalla D et al: Malpractice risk according to physician specialty. N Engl J Med 2011; 365: Siegel R, Naishadham D and Jemal A: Cancer statistics, CA Cancer J Clin 2013; 63: Cooperberg MR, Broering JM and Carroll PR: Time trends and local variation in primary treatment of localized prostate cancer. J Clin Oncol 2010; 28: Moffett P and Moore G: The standard of care: legal history and definitions: the bad and good news. West J Emerg Med 2011; 12: Raab EL: The parameters of informed consent. Trans Am Ophthalmol Soc 2004; 102: Francis DL, Prabhakar S and Sanderson SO: A quality initiative to decrease pathology specimen-labeling errors using radiofrequency identification in a high-volume endoscopy center. Am J Gastroenterol 2009; 104: Hofer MD, Meeks JJ, Cashy J et al: Impact of increasing prevalence of minimally invasive prostatectomy on open prostatectomy observed in the National Inpatient Sample and National Surgical Quality Improvement Program. J Endourol 2013; 27: Bianco FJ Jr, Riedel ER, Begg CB et al: Variations among high volume surgeons in the rate of complications after radical prostatectomy: further evidence that technique matters. J Urol 2005; 173: Tutolo M, Briganti A, Suardi N et al: Optimizing postoperative sexual function after radical prostatectomy. Ther Adv Urol 2012; 4: Walsh PC, Marschke P, Ricker D et al: Patientreported urinary continence and sexual function after anatomic radical prostatectomy. Urology 2000; 55: Sivarajan G, Prabhu V, Taksler GB et al: Ten-year outcomes of sexual function after radical prostatectomy: results of a prospective longitudinal study. Eur Urol 2014; 65: Schroeck FR, Krupski TL, Sun L et al: Satisfaction and regret after open retropubic or robotassisted laparoscopic radical prostatectomy. Eur Urol 2008; 54: Kovalerchik O, Mady LJ, Svider PF et al: Physician accountability in iatrogenic cerebrospinal fluid leak litigation. Int Forum Allergy Rhinol 2013; 3: Svider PF, Pashkova AA, Husain Q et al: Determination of legal responsibility in iatrogenic tracheal and laryngeal stenosis. Laryngoscope 2013; 123: Nau ML, McNiel DE and Binder RL: Postpartum psychosis and the courts. J Am Acad Psychiatry Law 2012; 40: Hollingsworth JM, Saigal CS, Lai JC et al: Surgical quality among Medicare beneficiaries undergoing outpatient urological surgery. J Urol 2012; 188: Watanabe JH, Campbell JD, Ravelo A et al: Cost analysis of interventions for antimuscarinic refractory patients with overactive bladder. Urology 2010; 76: 835. EDITORIAL COMMENTS The finding that most litigated cases (79.2%) result in verdicts favoring the defendant physician is consistent with previously published data. 1 Furthermore, the litigation reduction strategies highlighted in the discussion (eg comprehensive consent and expectation management) are sound and likely well-known to the practicing urological surgeon. Regarding the study methodology and data interpretation, I offer a few notes of caution. The limitations of the Westlaw legal database must be underscored. Designed to capture cases that inform evolving case law rather than observational research, this database introduces selection bias. Evidence of such bias is seen in the percentage of cohort cases that proceed to trial (76.0%), a figure exceeding the 5% to 10% seen in legal practice. 2 In addition, applying the descriptive findings to the broader urological community is difficult given the small cohort size (25). Finally, any association between legal outcomes and explanatory variables is confounded by not accounting for state tort reform statutes. C. J. Stimson, MD, JD Department of Urologic Surgery Vanderbilt University Medical Center Nashville, Tennessee

7 1776 RADICAL PROSTATECTOMY MALPRACTICE REFERENCES 1. Jena AB, Chandra A, Lakdawalla D et al: Outcomes of medical malpractice litigation against US physicians. Arch Intern Med 2012; 172: Annual Report of the Tennessee Judiciary, Fiscal Year ; 2013, p 327. Colaco et al provide an informative first look at characteristics of malpractice litigation involving radical prostatectomy. Although the cases are few, the frequency of settlement and the frequency with which cases going to trial result in payment are remarkably close to national data (reference 14 in article). What is impossible to assess in their analysis is how often malpractice cases related to prostatectomy do not make it to litigation (ie lawsuit). Nationally approximately 50% of surgical malpractice cases filed against insurers do not result in litigation, 1 but still comprise significant monetary and nonmonetary costs to physicians. Perhaps the most striking finding of the study is that a third of cases involved alleged failures of informed consent. This is consistent with communication failures being recognized as an important source of malpractice litigation. It also reinforces how efforts by physicians to communicate the need for and risks of surgery can not only improve quality of care but also reduce liability. Anupam B. Jena Department of Health Care Policy Harvard Medical School Boston, Massachusetts REFERENCE 1. Jena AB, Chandra A, Lakdawalla D et al: Outcomes of medical malpractice litigation against US physicians. Arch Intern Med 2012; 172: 892. REPLY BY AUTHORS To the best of our knowledge this is the first medicolegal analysis of malpractice litigation regarding radical prostatectomy. Despite its value, the authors agree that there are several inherent limitations to our study. As we mentioned, although the Westlaw database has been used for many other medicolegal analyses (references 10, 12, 13, 27 and 28 in article), it is comprised of cases progressing far enough to be included in public record. Furthermore, the requirement for case reporting varies by jurisdiction, making our analysis more valuable in raising awareness of factors involved in litigation and associated outcomes rather than as an estimator of the prevalence of litigation itself. While we agree with the point that tort law differs from state to state, there are some factors that are universal to the understanding of malpractice. As such, we believe that an understanding of the 4 components of tort (duty, breach of duty, damages and causation) and the factors that may influence these components are valuable to American urologists regardless of their location.