Every year, up to 1.2 million laparoscopic cholecystectomies (CCY) are performed in the United States (US) for gallstone disease.1 CCY is one of the most commonly performed operations in the US and is by and large considered a safe procedure with most patients discharged on the same day postoperatively. However, major morbidity still occurs in 5% of cases,2 with a serious complication being a bile duct injury (BDI) that can lead to long-term disability3–5 and reduced survival.6–9 The unexpected nature of these morbid complications likely explains the high medical malpractice claim rate associated with CCY-related injuries,10 and BDIs in particular.11,12
Despite moving along the laparoscopic CCY learning curve in the last 3 decades, the incidence of BDI-related malpractice claims following laparoscopic CCY has not decreased.11 These claims bear an incredible burden on patients; in addition to enduring the harm event associated with the claim, most patients are not ultimately compensated. When a claim does result in a payout to a patient, for every dollar spent on compensation, approximately 54 cents is spent on administrative costs and legal fees.13 For surgeons, involvement in a claim is strongly related to burnout, depression, and suicidal ideation.14 Additionally, the perceived threat of malpractice claims, highest for surgeons among all medical specialties,15 perpetuates the practice of defensive medicine and risk aversion which imposes a significant financial burden on the healthcare system.16
To mitigate the physical, emotional, and financial impact that these malpractice claims have on both patients and physicians, including trainees, we must better understand the nature of malpractice claims after CCY. Most large malpractice databases, including the National Practitioner Database, are limited by a lack of detailed clinical information and inclusion of only paid malpractice cases, therefore missing claims that are either denied, dropped, dismissed, or successfully defended in court. This study represents the largest review of both paid and unpaid cholecystectomy closed claims using a deeply-coded malpractice claims database, and aims to describe the costs and contributing factors of these claims as well as assess factors associated with patient payout.
Using the CRICO Strategies’ Comparative Benchmarking System (CBS) database, we performed a retrospective analysis of general surgery closed malpractice claims from 1995 to 2015. The CBS database is a private repository of over 350,000 open and closed malpractice claims involving >20 insurers, >165,000 physicians, and >400 hospitals, representing approximately 30% of paid and unpaid US malpractice claims. Each case is extensively reviewed and analyzed by physician experts as part of the defense. Nurse clinical taxonomy specialists then review all clinical and legal records associated with the cases and deeply code them based on a CBS proprietary clinical coding taxonomy. This taxonomy captures both system and clinical factors, including allegation, severity, responsible service, diagnoses, clinical setting of the event, and contributing factors.
From all claims in which general surgery was the primary responsible service, we isolated cases involving the surgical management of benign biliary disease. We did this by including cases with diagnosis and procedure keywords such as “biliary,” “cholecystitis,” “gallbladder,” and “cholecystectomy.” All cases were reviewed to isolate claims related to management of nonmalignant and nontraumatic biliary disease. While this study captures malpractice cases in which the surgeon is identified as the primary responsible party across the patient care timeline, from work-up and diagnosis to treatment and follow-up, regardless of whether or not the patient underwent an operation, “CCY claims” and “CCY cohort” are used in the paper for simplicity given that >98% of claims involved a cholecystectomy.
Case variables, including patient age and sex, open claim duration, clinical setting of the event, responsible service, allegation category, clinical severity, diagnoses, associated procedures and complications, and contributing factors, were reviewed for each claim. In addition to reviewing the coded variables, the free-text clinical vignettes for each case were individually reviewed by one of the authors (RMG) to confirm and more specifically characterize the referring diagnoses, procedures, associated complications, and clinical context of each case.
Clinical severity was coded according to the National Association of Insurance Commissioners Injury Severity Scale, in which the lower rankings are for less serious injuries from which people usually recover (burns, infections, scars, emotional harms) and the higher rankings are for permanent injuries which range from minor (loss of fingers or other nondisabling injuries) to grave (quadriplegia, severe brain damage, fatal prognosis, and death).17 Allegation category and contributing factors are coded by a clinical taxonomy specialist. Allegation category is coded based on the primary reason for which a plaintiff initiates a claim and contributing factors include features of the case that are deemed to have played a role in the reason for the malpractice claim. Any malpractice claim may have one or more contributing factors recorded. The coding undergoes a rigorous audit to ensure that the taxonomy is consistently applied across all cases, and is overseen by a governance committee with representation from legal, underwriting, analytics, risk, and patient safety experts.
In addition to these variables, the outcomes and costs associated with each claim were reviewed. Claims are cases where the healthcare provider is formally notified of the allegations and there is a demand for compensation. A claim becomes a suit when the claimant also files a summons and complaint with a court of law. Total indemnity was defined as the total dollar amount awarded to the plaintiff in any given malpractice case not including legal and administrative costs, whereas total incurred cost was defined as the combination of indemnity and all expenses including legal and administrative costs involved in a particular case. A case was considered to be unpaid if the total indemnity was zero, indicating the case was either dropped, dismissed, denied, or a defense verdict entered. Cases with nonzero total indemnity were considered paid, indicating the case was either settled or a plaintiff verdict was entered.
For descriptive analysis, categorical variables were reported as percent frequencies and continuous variables were reported as means ± standard deviation when the distribution was normal, and medians with interquartile ranges for non-normal distributions. Univariate analysis was performed to compare characteristics and costs between paid and unpaid claims. For each comparison, the chi-square test was used for categorical data, paired t test for normally distributed continuous variables, and Wilcoxon rank sum test for non-normally distributed continuous variables. A multivariable logistic regression model was then developed to determine factors associated with patient payout/indemnity. Statistical analysis was performed with Stata/SE 13 software (StataCorp LLC, College Station, TX) and significance was defined at P < 0.05.
From 4081 general surgery malpractice claims, 745 claims (18% of general surgery claims) were related to the surgical management of benign biliary disease and met inclusion and exclusion criteria. Claim characteristics are displayed in Table 1. For this cohort of claims, the mean patient age was 47 years and most patients were female (70%). The average time from event to filing a claim was approximately 1 year, and average time from event to case close was just over 3 years. Most events occurred in the inpatient setting, specifically in the operating room, and general surgery was the admitting service in 70% of cases. Most cases were of medium clinical severity and approximately 18% of cases were associated with a death. The referring diagnosis for most patients was cholecystitis and 98% of cases involved a cholecystectomy (Fig. 1). For most claims, patients alleged improper management or performance of surgery.
As shown in Table 1, approximately 40% of cases resulted in a payout to the patient. A resident or fellow was named in 14% of claims. The median expense per claim (including administrative fees and legal costs) was $17,710 and median indemnity payment was $230,000. The total costs of both paid and unpaid claims over the study period were $128,496,004.
Figure 2 demonstrates the top contributing factor categories for patient harm for the cholecystectomy cohort versus all general surgery claims. Most claims in the CCY cohort had at least 1 major contributing factor that was technical in nature (n = 572, 77% of claims), such as misidentification of an anatomical structure or improperly utilized equipment. Clinical judgment was the second most common contributing factor (n = 443, 60% of claims) and includes factors such as failure in ordering a diagnostic test, delay in selection of appropriate therapy, and failure or delay in obtaining a referral after a complication occurred. Communication was the third most common contributing factor (n = 177, 24% of claims) and includes factors such as inadequate informed consent process, poor patient/provider rapport including unsympathetic response to patients’ concerns, and poor communication between providers. Documentation contributing factors (n = 124, 17% of claims) include delayed, inconsistent, and/or lack of documentation. Behavior-related contributing factors (n = 75, 10% of claims) include patient factors such as noncompliance with clinical recommendations. As demonstrated in Figure 2, a significantly greater percentage of claims from the cholecystectomy subset had a “technical” issue as a contributor to patient harm compared with all general surgery claims, which had a significantly greater percentage of communication and behavior-related claims.
Table 2 demonstrates the main complications associated with the cholecystectomy claims. The number one complication was bile duct injury (BDI), occurring in 50% of claims. These injuries were recognized intraoperatively 19% of the time and required additional surgery in the form of biliary reconstruction 77% of the time. Other top associated complications included bowel perforation, hemorrhage from an adjacent structure (eg, liver, portal vessel(s), omentum), and major vascular injury on trocar insertion.
Detailed disposition data (Table 3) was available for 90 claims (12%). Eighty percent of unpaid claims were denied, dropped, or dismissed, while 20% of unpaid claims resulted in a defense verdict. These claims, even with no payout to the patient, had a median total cost of $15,054 per claim. For paid claims, 96% were settled versus resulted in a jury verdict, and the median total cost per claim for settled claims was $278,536. For claims with outcomes determined by jury verdict, 93% of cases (13/14) resulted in a verdict in favor of the defense.
On univariate analysis comparing cases that resulted in a payout versus not, there were significant differences in time from event to filing of the suit, main associated complication, and clinical severity (Table 4). On multivariable logistic regression analysis, longer time between the event and filing of a suit was less likely to result in a plaintiff payout, while high clinical severity, bile duct injury, and bowel perforation during cholecystectomy were associated with plaintiff payout (Table 5). On both univariate and multivariable analysis, a resident or fellow being named in a claim was negatively predictive of plaintiff payout. Subgroup analysis examining the claims in which a resident or fellow was named revealed that there was no seasonal increase in the harm events that led to the claim for the resident/fellow group versus the rest of the cohort (Supplemental Table 1, http://links.lww.com/SLA/B545). There were also no differences in clinical severity of the harm events between the 2 groups.
This study represents the largest recent analysis of both paid and unpaid malpractice claims related to the surgical management of benign biliary disease. Using a private medical professional liability repository, we found that CCY-related injuries rank among the leading sources of medical malpractice claims against general surgeons. The most common associated complication was a BDI that was not recognized intraoperatively, of which 77% required additional surgery in the form of biliary reconstruction. The time from event to case close for both paid and unpaid claims was over 3 years. Most unpaid claims were denied, dropped, or dismissed and most paid claims were settled out of court. Both BDI and bowel perforation were associated with plaintiff payout, while a resident or fellow being named in a claim was negatively predictive of plaintiff payout.
The most common contributing factor category associated with CCY claims was a technical problem during surgery, associated with a significantly higher percentage of the CCY claims subset versus all general surgery claims. BDI was the most commonly involved complication and was associated with plaintiff payout. Consistent with prior literature,18 BDI was missed intraoperatively 81% of the time and most often required biliary reconstructive surgery. Intraoperative cholangiography remains valuable for injury recognition when interpreted correctly,19,20 however, routine use is not generally practiced given that most BDIs occur when the common bile duct is confused with the cystic duct, and thus BDIs often occur before routine intraoperative cholangiography is performed.21 As such, promoting the safe performance of CCY through careful dissection and willingness to convert to an open procedure at an early stage remain important tenets for the prevention of BDIs.22,23 Recently, the Society for American Gastrointestinal Endoscopic Surgeons convened the Safe Cholecystectomy Task Force that administered a Delphi consensus survey and subsequently published 6 critical factors for safe surgical practice in laparoscopic CCY. These guidelines are now being used in training, assessment, and research efforts performed as part of the Safe Cholecystectomy Program.24
Similar to prior studies, a majority of claims also involved a gap in perioperative clinical judgment11,18,25 and highlight the importance of timely recognition and expert management of complications.20,26–29 Bowel perforation during CCY, most often in the setting of trocar or electrocautery injury, was also associated with patient payout. Similar to BDIs, these injuries emphasize not only the need for meticulous technique, but also the imperative to set appropriate expectations by presenting patients with a realistic understanding of the risks of even routine, minimally invasive procedures.10 Promoting a universal culture of safety for CCY involves both mitigating complications and improving perioperative care and communication, elements that will invariably decrease malpractice risk associated with the procedure.
On both univariate and multivariable analysis, having a resident or fellow named in a claim was negatively predictive of plaintiff payout. While this finding could be attributed to a number of factors, including tort law variation by state, fellow or resident involvement can be a surrogate for being at a teaching or tertiary referral hospital where there may be more control over outcomes after complications. Teaching hospitals often have more immediate access to advanced endoscopy, interventional radiology, and specialized surgery. They are thus able to handle more advanced cases that are easier to defend, and potentially garner a greater “forgiveness factor” for the physicians and trainees involved.
Building on prior studies that focus largely on paid claims,10,18,26,30 this study sheds light on the characteristics and costs of unpaid claims, which represent the majority of claims. For the 60% of cases that resulted in no payout to the patient, the median total incurred administrative and legal costs for surgeons still totaled over $15,000 per claim for denied, dropped, and dismissed claims and over $90,000 for claims that resulted in a defense verdict. For claims that resulted in a payout to the patient, almost all were ultimately settled out of court and both paid and unpaid claims lasted over 3 years. Considering the high administrative and legal costs for these claims and the years spent for both patients and providers, the question arises: are there opportunities for better communication and earlier resolution after bad outcomes, given that most claims are ultimately dropped or settled out of court anyway?
Despite adoption of traditional tort reforms such as damages caps, shorter statutes of limitation, and attorney fees limits, concerns persist over the US liability system's trifling prioritization of future error prevention combined with its detrimental effects on the patients and providers involved. There has thus been some effort to channel disputes away from the legal system, most prominently in the form of Communication Resolution Programs that guide hospitals and clinicians to discuss unanticipated outcomes with patients, while taking quick steps to learn from errors and compensate patients when substandard care causes harm. Several adopters of Communication Resolution Programs have reported substantially lower malpractice claims and costs, decreased time to resolution, and greater focus on patient safety improvements after adverse events.31–33 In the setting of CCY complications, increased transparency and engagement around unanticipated outcomes may help expedite resolution and enhance focus on improvement opportunities, without triggering the financial and emotional burden of the traditional claims process.
The biggest limitation of most malpractice claims research is the inclusion of only cases that result in a claim, thus speaking to only a small fraction of patient harm events.34 The evaluation of near-miss events in the local setting remains paramount in fostering a culture of safety and guiding improvement strategies. The present study is also limited by the quality of the available data. We cannot accurately trend the number of CCY claims over time since insurers and provider groups join and leave the database at different times, and information as to the denominator of total claims from these organizations at various time points is not available. This database also does not permit for state-based subanalysis. Given that this database includes insurers with different liability policy limits and involves claims from states with and without statuary caps on damages, median indemnity payment has limited applicability on a case-by-case basis. Lastly, the database lacks specific patient data (such as consistently coded comorbidities and patient costs), important provider data (such as experience and prior claim history), and does not account for the significant emotional costs associated with claims. Given that only 10% of physicians feel adequately supported by their employer health care organization after a serious medical error or near miss,35 organizations should optimize use of clinical peer support programs in these settings.36
Data from medical malpractice cases, though imperfect, can contribute information necessary to provide safer and higher quality medical care, help identify areas of current surgical practice that are most in need for improvement, and guide health care reform. This work builds on previous studies that emphasize the importance of strategies that reduce the risk and aid in recognition of CCY complications. In addition, this study demonstrates the enormous financial and physical burden of both paid and unpaid claims, warranting further work to develop better and earlier communication and resolution between patients and providers after adverse events.
The authors appreciate CRICO, and specifically Dr. Luke Sato, Carol Koehane, Dr. Jonathan Einbinder, and Winnie Yu for helping provide data. The authors also thank the Harvard Medical School Fellowship in Patient Safety and Quality for providing foundational context instrumental to completion of this work.
2. Giger UF, Michel JM, Opitz I, et al. Risk factors for perioperative complications in patients undergoing laparoscopic cholecystectomy
: analysis of 22,953 consecutive cases from the Swiss Association of Laparoscopic and Thoracoscopic Surgery
database. J Am Coll Surg
3. Melton GB, Lillemoe KD, Cameron JL, et al. Major bile duct injuries
associated with laparoscopic cholecystectomy
: effect of surgical repair on quality of life. Ann Surg
4. Savader SJ, Lillemoe KD, Prescott CA, et al. Laparoscopic cholecystectomy
-related bile duct injuries
: a health and financial disaster. Ann Surg
5. Sicklick JK, Camp MS, Lillemoe KD, et al. Surgical management of bile duct injuries
sustained during laparoscopic cholecystectomy
: perioperative results in 200 patients. Ann Surg
6. Flum DR, Cheadle A, Prela C, et al. Bile duct injury
and survival in medicare beneficiaries. JAMA
7. Fong ZV, Pitt HA, Strasberg SM, et al. Diminished survival in patients with bile leak and ductal injury: management strategy and outcomes. J Am Coll Surg
2018; 226: 568–576 e1.
8. Halbert C, Altieri MS, Yang J, et al. Long-term outcomes of patients with common bile duct injury
following laparoscopic cholecystectomy
. Surg Endosc
9. Tornqvist B, Stromberg C, Persson G, et al. Effect of intended intraoperative cholangiography and early detection of bile duct injury
on survival after cholecystectomy
: population based cohort study. BMJ
10. Kern KA. Malpractice
litigation involving laparoscopic cholecystectomy
. Cost, cause, and consequences. Arch Surg
11. Alkhaffaf B, Decadt B. 15 years of litigation following laparoscopic cholecystectomy
in England. Ann Surg
12. Strasberg SM. Biliary injury in laparoscopic surgery
: part 1. Processes used in determination of standard of care in misidentification injuries. J Am Coll Surg
13. Studdert DM, Mello MM, Gawande AA, et al. Claims, errors, and compensation payments in medical malpractice
litigation. N Engl J Med
14. Balch CM, Oreskovich MR, Dyrbye LN, et al. Personal consequences of malpractice
lawsuits on American surgeons. J Am Coll Surg
15. Deshpande SP, Deshpande SS. Factors impacting perceived threat of malpractice
lawsuits by various medical specialists. Health Care Manag (Frederick)
16. Mello MM, Chandra A, Gawande AA, et al. National costs of the medical liability system. Health Aff (Millwood)
17. National Association of Insurance Commissioners. Medical Malpractice
Closed Claims. 1980; 2:304.
18. McLean TR. Risk management observations from litigation involving laparoscopic cholecystectomy
. Arch Surg
19. Massarweh NN, Flum DR. Role of intraoperative cholangiography in avoiding bile duct injury
. J Am Coll Surg
20. Strasberg SM. Biliary injury in laparoscopic surgery
: part 2. Changing the culture of cholecystectomy
. J Am Coll Surg
21. Carlson MA, Ludwig KA, Frantzides CT, et al. Routine or selective intraoperative cholangiography in laparoscopic cholecystectomy
. J Laparoendosc Surg
22. Hunter JG. Avoidance of bile duct injury
during laparoscopic cholecystectomy
. Am J Surg
23. MacFadyen BV Jr, Vecchio R, Ricardo AE, et al. Bile duct injury
after laparoscopic cholecystectomy
. The United States experience. Surg Endosc
24. Pucher PH, Brunt LM, Fanelli RD, et al. SAGES expert Delphi consensus: critical factors for safe surgical practice in laparoscopic cholecystectomy
. Surg Endosc
25. Chandler JG, Voyles CR, Floore TL, et al. Litigious consequences of open and laparoscopic biliary surgical mishaps. J Gastrointest Surg
26. Carroll BJ, Birth M, Phillips EH. Common bile duct injuries
during laparoscopic cholecystectomy
that result in litigation. Surg Endosc
27. Connor S, Garden OJ. Bile duct injury
in the era of laparoscopic cholecystectomy
. Br J Surg
28. Lillemoe KD. Current management of bile duct injury
. Br J Surg
29. Schmidt SC, Langrehr JM, Hintze RE, et al. Long-term results and risk factors influencing outcome of major bile duct injuries
. Br J Surg
30. Kern KA. Medicolegal analysis of bile duct injury
during open cholecystectomy
and abdominal surgery
. Am J Surg
31. Kachalia A, Kaufman SR, Boothman R, et al. Liability claims and costs before and after implementation of a medical error disclosure program. Ann Intern Med
32. Mello MM, Boothman RC, McDonald T, et al. Communication-and-resolution programs: the challenges and lessons learned from six early adopters. Health Aff (Millwood)
33. Mello MM, Kachalia A, Roche S, et al. Outcomes in two Massachusetts hospital systems give reason for optimism about communication-and-resolution programs. Health Aff (Millwood)
34. 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
35. Waterman AD, Garbutt J, Hazel E, et al. The emotional impact of medical errors on practicing physicians in the United States and Canada. Jt Comm J Qual Patient Saf
36. Hu YY, Fix ML, Hevelone ND, et al. Physicians’ needs in coping with emotional stressors: the case for peer support. Arch Surg
bile duct injuries; bile duct injury; cholecystectomy; gallbladder; malpractice; patient safety; quality improvement; surgery
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