Medical Malpractice in Endourology: Analysis of Closed Cases From the State of New York

Medical Malpractice in Endourology: Analysis of Closed Cases From the State of New York Brian Duty,* Zhamshid Okhunov, Zeph Okeke and Arthur Smith From the Department of Urology, North Shore-Long Island Jewish Health System, New Hyde Park, New York Abbreviations and Acronyms MLMIC Medical Liability Mutual Insurance Company SWL extracorporeal shock wave lithotripsy Submitted for publication June 1, 2011. * Correspondence: The Smith Institute for Urology, North Shore-LIJ Health System, 450 Lakeville Rd., New Hyde Park, New York 11040 (telephone: 503-702-3920; FAX: 516-734-8537; e- mail: dutybd@me.com). Purpose: Medical malpractice indemnity payments continue to rise, resulting in increased insurance premiums. We reviewed closed malpractice claims pertaining to endourological procedures with the goal of helping urologists mitigate their risk of lawsuit. Materials and Methods: All closed malpractice claims from 2005 to 2010 pertaining to endourological procedures filed against urologists insured by the Medical Liability Mutual Insurance Company of New York were examined. Claims were reviewed for plaintiff demographics, medical history, operative details, alleged complication, clinical outcome and lawsuit disposition. Results: A total of 25 closed claims involved endourological operations and of these cases 10 were closed with an indemnity payment. The average payout was $346,722 (range $25,000 to $995,000). Of the plaintiffs 16 were women and mean plaintiff age was 51.4 years. Cystoscopy with ureteral stent placement/exchange resulted in 13 lawsuits, ureteroscopic lithotripsy 8, percutaneous stone extraction 2 and shock wave lithotripsy 2. There were 17 malpractice suits brought for alleged operative complications. Failure to arrange adequate followup was implicated in 4 cases. Error in diagnosis and delay in treatment was alleged in 3 claims. Conclusions: Urologists are not immune to the current medical malpractice crisis. Endourology and urological oncology generate the greatest number of lawsuits against urologists. Most malpractice claims involving endourological procedures result from urolithiasis and alleged technical errors. Therefore, careful attention to surgical technique is essential during stone procedures to reduce the risk of malpractice litigation. Key Words: urology, endoscopy, malpractice, insurance, risk management THE last decade has seen the emergence of the third major medical malpractice crisis, stemming from decreased insurance availability and increased premiums. 1 In response, more than 90% of physicians report practicing some degree of defensive medicine characterized by ordering tests, performing diagnostic procedures and referring patients for consultation with the intention of minimizing medical liability. 2 In all, 42% of physicians have restricted their practice by eliminating complex therapeutic procedures and avoiding patients with multiple medical comorbidities. These reactionary practices have led to increased health care costs and decreased access to medical specialists. Urologists are not immune. Their malpractice premiums have increased up to 57%. 3 Additionally, the average urologist can expect to be sued twice 528 www.jurology.com 0022-5347/12/1872-0528/0 Vol. 187, 528-532, February 2012 THE JOURNAL OF UROLOGY Printed in U.S.A. 2012 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH, INC. DOI:10.1016/j.juro.2011.10.045

MEDICAL MALPRACTICE IN ENDOUROLOGY 529 during his or her career. 4 Of the urological subspecialties endourology was found to generate the most malpractice claims. 5 Another study reported that stone related operations resulted in the greatest number of unsolicited complaints against urologists. 6 In this study we reviewed cases brought against urologists after endourological procedures to identify trends in decision making, surgical technique and patient interactions that increase litigation risk. The ultimate goal of this study was to help urologists mitigate malpractice exposure. MATERIALS AND METHODS The Medical Liability Mutual Insurance Company of New York State is the largest provider of professional liability insurance to physicians in New York. The company insures 69 hospitals, more than 18,000 physicians and more than 4,200 dentists. A little more than 300 urologists are covered by the MLMIC. All MLMIC closed cases between 2005 and 2010 involving endourological procedures were reviewed. The MLMIC claims database was searched by CPT code for lawsuits involving the endoscopic management of renal and ureteral stones, upper tract transitional cell carcinoma and upper tract obstruction. Extracorporeal shock wave lithotripsy was also included in the analysis. Depositions, narrative summaries, expert opinions and, when available, primary medical records were analyzed. Each claim was reviewed for plaintiff demographics, medical history, operative details, alleged complication, clinical outcome and claim disposition. RESULTS Of the 23 medical specialties insured by the MLMIC urology ranks 11th in total indemnity payments. From 2005 to 2010 a total of 585 claims against urologists were closed. Of these claims 23% (137) were closed with an indemnity payment. The total payout was $60,140,184, with an average of $438,979 per claim. The average indemnity payment for all MLMIC physicians was $424,439. Only 25 (4.3%) of the 585 closed claims involved endourological procedures. Of these 25 cases 10 (40%) were closed with an indemnity payment. Payouts ranged from $25,000 to $995,000, with an average of $346,722. Of the plaintiffs 16 were women and 9 were men. Age at case closure ranged from 28.0 to 89.0 years (mean 51.4). The Appendix summarizes the preoperative diagnosis, procedure, alleged complication, clinical outcome and claim disposition for the 25 closed cases. A total of 22 (88%) plaintiffs were treated for stone disease. The remaining 3 (12%) patients had ureteral obstruction, 2 from extrinsic compression and 1 from a ureteroneocystostomy anastomotic stricture. Cystoscopy with ureteral stent placement was performed in 13 plaintiffs (52%), ureteroscopic lithotripsy in 8 (32%), SWL in 2 (8%) and percutaneous stone extraction in 2 (8%). Plaintiffs alleged improper surgical technique (17 claims), failure to arrange followup (4), delay in treatment (2), failure to diagnose a preexisting medical condition (1) and improper patient contact (1). Cited complications were ureteral injury (6 cases), retained foreign body (6), sepsis (5), stent migration (2), placement of a defective stent (1), inability to place a ureteral stent (1), retroperitoneal hematoma (1), splenic laceration (1), operation on incorrect surgical site (1) and emotional trauma (1). There were 16 (64%) plaintiffs, none of whom died, who required further procedures after their alleged complications. Six (24%) patients died, all of sepsis, and 3 of these plaintiffs underwent no further treatment. Lastly 1 patient claimed emotional trauma due to inappropriate contact while under general anesthesia. Of these lawsuits 80% and 73% involved ureteral stones in cases with indemnity payments and dismissed claims, respectively. Ureteroscopic lithotripsy was performed in 50% of suits resulting in payment and in 20% of dismissed cases. Of the dismissed suits 73% involved cystoscopy with stent placement. Of the paid claims 20% pertained to stent placement procedures. Improper surgical technique was alleged in 90% of the cases resulting in an indemnity payment and in 53% of dismissed claims. Failure to arrange proper followup resulting in a retained ureteral stent was alleged in 27% of dismissed cases and in none of the claims with payment. The most common alleged complication in the indemnity payment group was ureteral injury (50%). Retained foreign body (32%) was the most common alleged complication in dismissed cases. Sepsis was present in 20% of both groups. DISCUSSION The threat of being named in a malpractice suit pervades medicine, and increases medical costs and limits access to care. Kaplan sent an anonymous survey to 110 urologists listed in The Best Doctors in America publication (group A) and to 246 American Board of Urology recertification candidates (group B). 7 The 2 groups did not differ in average number of lawsuits (group A 2.36, group B 1.9). Thus, most urologists can expect to be sued twice during their career regardless of professional reputation. Kahan et al reviewed 259 consecutive malpractice claims against urologists between 1996 and 1998. 5 The distribution of malpractice suits by American Urological Association section and urological subspecialty was assessed. The Southeastern section had the most claims filed, followed by the North

530 MEDICAL MALPRACTICE IN ENDOUROLOGY Central, South Central, Mid-Atlantic, New England, Western and New York sections. Endourological procedures resulted in the greatest number of lawsuits. Sobel et al found endourology malpractice claims were surpassed only by urological oncology suits. 4 Similarly Stimson et al noted that the management of urinary calculi and urological cancers generated the greatest number of unsolicited patient complaints. 6 Benson and Coogan analyzed 5,577 claims against urologists from the Physician Insurers Association of America between 1985 and 2007. 8 Although the number of claims did not increase over time, the mean indemnity payment did ($176,213 in 1997, $190,182 in 2002 and $227,838 in 2007). Operative complications followed by diagnostic errors and failure to properly monitor procedures resulted in the greatest number of lawsuits. Badger et al examined lawsuits with indemnity payment resulting from missed or delayed diagnoses. 9 Of the missed diagnoses 77% were urological and the remaining were nonurological (eg appendicitis). Of the missed urological conditions 71% were oncologic. The indemnity payment for a missed diagnosis was 92% greater than the average payment for all other claims (eg operative complications). In this study we focused on closed claims involving endourological procedures. Cystoscopy with ureteral stent placement/exchange generated 13 (52%) claims while ureteroscopic lithotripsy resulted in 8 (32%). Percutaneous stone extraction and SWL each resulted in 2 lawsuits. There were 17 malpractice suits for alleged operative complications. Failure to arrange adequate followup was implicated in 4 cases. Error in diagnosis and delay in treatment were alleged in 3 suits. Of the 25 closed claims only 10 (40%) generated an indemnity payment. Payments ranged in size from $25,000 to $995,000 with an average of $346,722. An informal analysis was performed by separating the closed claims into cases with and those without an indemnity payment. Ureteral stones were the most common presenting complaint in both groups. However, claims resulting in an indemnity payment were more likely to involve ureteroscopic lithotripsy (50% vs 20%), while cystoscopy with stent placement was the most common procedure in dismissed cases (73% vs 20%). Cases with payments were more likely to involve alleged errors in surgical technique (90% vs 53%). Alleged failure to arrange for ureteral stent removal was more common among dismissed cases (27% vs 0%). The ultimate goal of the study was not simply to catalog endourological lawsuits, but rather to learn how to prevent them. Retained stent material generated 6 claims. In 2 patients the stents fractured during removal resulting in an unsuspected retained foreign body. One case involved a double-j ureteral stent that had been placed after routine ureteroscopic lithotripsy. The other plaintiff had a nephroureteral stent placed by interventional radiology in preparation for percutaneous stone extraction. A portion of the nephroureteral stent fractured while being removed during the initial portion of the nephrolithotomy. Both lawsuits highlight the importance of inspecting all prosthetics to ensure they are intact on removal. Four claims were due to retained ureteral stents. All 4 patients were lost to followup and presented in a delayed fashion with flank pain. Each case was dismissed because the defense was able to show that the plaintiffs had been discharged home with instructions specifically detailing the presence of the ureteral stent and its need for removal. Ather et al noted their rate of forgotten double-j stents decreased from 12.5% to 1.2% after instituting a computerized system to track patients with indwelling ureteral stents. 10 Stent migration occurred in 2 plaintiffs. One patient presented with a ureteral stone and the other had long-standing retroperitoneal fibrosis. The incidence of stent migration varies in the literature from 3.7% to 8% in patients with long-term indwelling stents. 11 It is imperative to use a stent that is sufficiently long to ensure a complete curl in the kidney and bladder. A retrograde urogram with dilute contrast material should be obtained to ensure proper proximal position in nonseptic cases with complicated upper tract anatomy. Both cases had fluoroscopic images saved in the medical record demonstrating proper placement (full stent curl in the kidney and bladder) at the conclusion of the case, which resulted in dismissal. Ureteral injury (avulsion, laceration and perforation) occurred in 6 plaintiffs who underwent ureteroscopic lithotripsy. Each patient presented with a single stone in the ureter. Stone size ranged from 5 to 11 mm (mean 7.6). Five cases involved attempted basket stone extraction without prior lithotripsy. One plaintiff had previously undergone stent placement. Ureteral laceration after balloon dilation occurred in the remaining case. Rates of ureteral avulsion and perforation vary in the literature from 0.04% to 0.8% and 0.3% to 5.8%, respectively. 12 Avulsion most commonly occurs when attempting to basket too large a stone. This is particularly true when the stone is located in the proximal ureter or is impacted. Stone basketing in the proximal ureter should always be approached with caution. Attempting to remove intact stones larger than 4 to 5 mm is not advisable. In addition, the stone and ureteral mucosa should be visible at all times. Basketing should be aborted if the ureteral mucosa be-

MEDICAL MALPRACTICE IN ENDOUROLOGY 531 APPENDIX Summary of Closed Endourology Malpractice Claims gins to bunch adjacent to the stone. A safety wire should be used at all times. Mild ureteral perforation is usually of no clinical consequence. However, larger perforations mandate stopping the case and leaving a ureteral stent for 3 to 6 weeks. It is important to ensure that the lithotripter is touching the stone at all times to prevent ureteral injury. Any stone fragments trapped in the wall of the ureter at the perforation site must be removed, otherwise a ureteral stricture will invariably develop. The largest indemnity payment in the current study was $995,000. The case involved a patient who underwent SWL for a renal calculus despite the presence of an obstructive stone in the distal ureter. The preoperative abdominal x-ray report did not comment on the distal calculus even though it was visible. The treating urologist did not review the film before surgery. Urosepsis developed in the patient postoperatively and the patient died. This case highlights the 2 important points that SWL should never be performed in the presence of distal obstruction, and that radiology reports should never be relied upon solely. The treating physician should review all radiological studies before any procedure. This is supported by another lawsuit in our series. The urologist did not review the plaintiff s preoperative computerized tomography scan and performed ureteroscopy on the incorrect ureter because of an incorrect radiology report. Overall 6 plaintiffs died, all of urosepsis. Three presented with sepsis and underwent stent placement, and these 3 suits were dismissed. Sepsis developed in the remaining 3 patients after surgery. Of these cases 2 resulted in an indemnity payment ($650,000 and $995,000). One patient had no preoperative urine culture and did not receive perioperative or postoperative antibiotics. The remaining patient was diagnosed with an Escherichia coli urinary tract infection before surgery and was treated with ciprofloxacin. However, a test of cure was never performed. All patients undergoing stone surgery, including those undergoing shock wave lithotripsy, should be administered antimicrobial prophylaxis as outlined in the American Urological Association Best Practice Policy Statement. 13 In addition, repeat urine culture should be considered after treatment for high risk patients diagnosed with a preoperative urinary tract infection. The current study has several limitations. Data on lawsuits were acquired by searching the MLMIC malpractice claim database by CPT code. In multiple instances the search resulted in suits pertaining to open surgery, indicating errors in CPT code association in the database. Therefore, it is possible that suits pertaining to endourological cases were not captured. In addition, the primary medical records were not present in many of the files. In these instances medical details were acquired via the expert opinion of urologists hired by the MLMIC and narrative summaries that were drafted by attorneys, not urologists. Lastly the MLMIC only insures urologists in the state of New York so our findings may not reflect national trends. CONCLUSIONS Endourological procedures are a common source of medical malpractice suits brought against urologists. Most lawsuits arise from alleged technical errors in the operating room. Fortunately the majority of claims do not result in an indemnity payment. Nonetheless, comprehensive preoperative patient counseling and strict attention to surgical technique are the best means of reducing the risk of being sued. Primary/Secondary Diagnosis Procedure Nature of Allegation Alleged Complication Clinical Outcome Indemnity Ureteral stone Ureteral stent placement Improper surgical technique Incorrect surgical site Further endoscopic surgery $112,500 Ureteral stone Ureteral stent placement Improper surgical technique Placement of defective Further endoscopic surgery Dismissed stent Ureteral stone Ureteral stent placement Improper surgical technique Stent migration Further endoscopic surgery Dismissed Ureteral stone/urosepsis Ureteral stent placement Improper surgical technique Inability to place stent Death Dismissed Ureteral stone/renal failure Ureteral stent placement Improper surgical technique Sepsis Death $650,000 Ureteral stone/urosepsis Ureteral stent placement Delay in treatment Sepsis Death Dismissed Ureteral stone Ureteral stent placement Miscellaneous Improper patient contact Emotional trauma Dismissed Ureteral stone Ureteroscopic lithotripsy Improper surgical technique Ureteral avulsion Prolonged nephrostomy $200,000 tube Ureteral stone Ureteroscopic lithotripsy Improper surgical technique Ureteral avulsion Nephrectomy $325,000 Ureteral stone Ureteroscopic lithotripsy Improper surgical technique Ureteral laceration Open repair Dismissed (appendix continued)

532 MEDICAL MALPRACTICE IN ENDOUROLOGY APPENDIX (continued) Primary/Secondary Diagnosis Procedure Nature of Allegation Alleged Complication Clinical Outcome Indemnity Ureteral stone Ureteroscopic lithotripsy Improper surgical technique Ureteral perforation Further endoscopic surgery $500,000 Ureteral stone Ureteroscopic lithotripsy Improper surgical technique Ureteral perforation Ureteral stricture $375,000 Ureteral stone Ureteroscopic lithotripsy Improper surgical technique Ureteral perforation Loss of kidney $250,000 Ureteral stone Ureteroscopic lithotripsy Improper surgical technique Retained foreign body Further endoscopic surgery Dismissed Ureteral stone Ureteroscopic lithotripsy Failure to arrange followup Retained stent Further endoscopic surgery Dismissed Ureteral stone Extracorporeal shock wave lithotripsy Improper surgical technique Sepsis Death $995,000 Kidney stone Percutaneous stone extraction Improper surgical technique Retained foreign body Further endoscopic surgery $225,000 Kidney stone Percutaneous stone extraction Improper surgical technique Retroperitoneal hematoma Embolization Dismissed Kidney stone/polycythemia vera Extracorporeal shock wave lithotripsy Error in diagnosis Splenic laceration Splenectomy $25,000 Ureteral obstruction/cervical cancer Ureteral stent exchange Improper surgical technique Sepsis Death Dismissed Ureteral obstruction/retroperitoneal Ureteral stent placement Improper surgical technique Stent migration Further endoscopic surgery Dismissed fibrosis Ureteral obstruction/urosepsis Ureteral stent placement Delay in treatment Sepsis Death Dismissed REFERENCES 1. Mello MM, Studdert DM and Brennan TA: The new medical malpractice crisis. N Engl J Med 2003; 348: 2281. 2. Studdert DM, Mello MM, Sage WM et al: Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. JAMA 2005; 293: 2609. 3. Sherman C: Urologists hit by malpractice crisis. Renal Urol News 2005; 42. 4. Sobel DL, Loughlin KR and Coogan CL: Medical malpractice liability in clinical urology: a survey of practicing urologists. J Urol 2006; 175: 1847. 5. Kahan SE, Goldman HB, Marengo S et al: Urological medical malpractice. J Urol 2001; 165: 1638. 6. Stimson CJ, Pichert JW, Moore IN et al: Medical malpractice claims risk in urology: an empirical analysis of patient complaint data. J Urol 2010; 183: 1971. 7. Kaplan GW: Malpractice risks for urologists. Urology 1998; 51: 183. 8. Benson JS and Coogan CL: Urological malpractice: analysis of indemnity and claim data from 1985 to 2007. J Urol 2010; 184: 1086. 9. Badger WJ, Moran ME, Abraham C et al: Missed diagnoses by urologists resulting in malpractice payment. J Urol 2007; 178: 2537. 10. Ather MH, Talati J and Biyabani R: Physician responsibility for removal of implants: the case for a computerized program for tracking overdue double-j stents. Tech Urol 2000; 6: 189. 11. Richter S, Ringel A, Shalev M et al: The indwelling ureteric stent: a friendly procedure with an unfriendly high morbidity. BJU Int 2000; 85: 408. 12. de la Rosette JJ, Skrekas T and Segura JW: Handling and prevention of complications in stone basketing. Eur Urol 2006; 50: 991. 13. Wolf JS, Bennett CJ, Dmochowski RR et al: Urologic surgery antimicrobial prophylaxis. Linthicum, Maryland: American Urological Association Education and Research, Inc. 2008.