Bile Duct Injury and Litigation in Laparoscopic Cholecystectomy: A Global Review of Current and Future Preventative Initiatives

Abstract

Objective:

This narrative review examined factors contributing to the initiation and outcome of litigation of bile duct injury (BDI) in laparoscopic cholecystectomy (LC), with reference to case studies and legal precedents in Australasian and international jurisdictions. It also explored potential strategies to prevent BDI and subsequent malpractice litigation.

Background:

Despite the advantages of minimally invasive surgery, the reported iatrogenic BDI rate in LC remains higher than that in some open cholecystectomy series. The resulting BDIs are also more complex and severe. BDI is a serious complication, and medicolegal costs are a substantial burden for healthcare and insurance systems. BDI persists as one of the most common reasons for malpractice lawsuits against general surgeons in the United States and United Kingdom.

Methods:

PubMed, Ovid (Medline), Embase, Google Scholar, and Westlaw databases were searched for studies related to BDI in LC and its litigation.

Results:

Reasons for initiation of claims after LC include inadequate informed consent and unexpected postoperative course, severe physical disability or death after BDI, belief of medical negligence, and plaintiff loss of income. Identifiable perioperative risk factors for BDI and its litigation should be addressed to minimize BDI, malpractice complaints, and medicolegal costs.

Conclusions:

The narrative review of international literature suggested that BDI during the performance of LC and its associated litigation remains preventable. Implementation of heuristics training, navigation paradigms, and a universal culture of safety in the performance of LC is required to improve rates of BDI and medicolegal ramifications.

INTRODUCTION

Bile duct injury (BDI) is a devastating complication of laparoscopic cholecystectomy (LC), causing substantial morbidity, mortality, and healthcare and medicolegal costs.^1–9 Reported iatrogenic BDI rates in LC (0.1%–0.7%) remain higher than the series of open cholecystectomy (OC) (0.1%–0.2%), and resulting injuries are more complex and severe (Strasberg-type E1–E5) (Table 1).^1–9

TABLE 1.

Strasberg and Bismuth Classifications of Biliary Injuries⁵

Biliary Injury	Strasberg Type	Bismuth Type
Bile leak from cystic duct or liver bed	A	—
Occluded aberrant RHD	B	—
Bile Leak from aberrant RHD	C	—
Lateral injury <50% diameter of major extrahepatic BD	D	—
Low CHD stricture with >2 cm CHD stump	E1	Type I
Low CHD stricture with <2 cm CHD stump	E2	Type II
Hilar stricture, preserved hepatic biliary confluence, no CHD	E3	Type III
Hilar stricture, loss of hepatic biliary confluence	E4	Type IV
Stricture of CHD and aberrant RHD	E5	Type V

“—” indicates not applicable; BD, bile duct; CHD, common hepatic duct; RHD, right hepatic duct.

BDI remains a leading cause of malpractice lawsuits against general surgeons in the USA, UK, and Canada.^1,9,10 Our narrative review aims to provide a global perspective on contributing factors and preventative initiatives in BDI and litigation. This includes heuristics education, culture of safety in cholecystectomy (COSIC), and incorporation of Societal recommendations and emerging technologies.¹ A Westlaw search was performed of US LC litigation (2019–2024) and amalgamated with previous data (2000–2018).^3,4,10

LC Learning Curve

The early learning curve suggested a doubling of all complications compared with OC following the 1991 introduction of LC.¹¹ Complications included bowel or vascular injuries, hemorrhage, BDIs, and bile leaks requiring intervention.¹¹ BDI incidence peaked at 0.35% in 1994 and subsequently declined; however, rates of other injuries (0.41%) and bile leaks requiring intervention (0.57%) stabilized. BDI risk was greatest for surgeons performing 1 to 50 LC [odds ratio (OR) = 2.40; 95% confidence interval (CI), 1.09–5.29; P = 0.029] compared with surgeons performing >300 LCs in the preceding 5 years.¹¹ Surgical complexity and inexperience were significant independent risk factors for intraoperative complications.¹¹

Despite decades of LC training, BDI remains its most frequently litigated complication.^3,4,10 A 2022 prospective study of 21,706 LCs in 57 countries reported an 8% 30-day morbidity rate and 0.4% mortality.² There were 278 (1.3%) bile leaks and 48 (0.2%) severe BDIs documented. Advanced age, American Society of Anesthesiologists (ASA) grade, and Nassar operative difficulty grades were associated with increased complications, and emergent or delayed LCs with increased bile leak rates and higher Strasberg BDI severity. The study reported international variance in LC performance and resource availability, emphasizing a global approach to quality assurance and ongoing collaboration.²

BDI Malpractice Claims

When medical negligence is suspected, patients may complain to the hospital grievance board, Medical Disciplinary Board, or Health Care Complaints Commission. Validated complaints increase the likelihood of out-of-court settlement. Patients infrequently sue due to a single adverse outcome. Litigation is more likely when care deficiencies coincide with poor outcomes and breakdowns in patient-surgeon relationships.^10,12 Fear of lawsuits and exorbitant malpractice premiums contribute to defensive medicine, as reflected by avoidance of performing certain procedures or high-risk patients.¹ However, underestimation of both BDI risk and consequences may hinder universal uptake of preventative initiatives.⁶

BDI Morbidity and Mortality

BDI markedly decreases quality of life (QOL) and long-term survival [hazard ratio (HR) = 2.79; 95% CI: 2.71–2.88] compared with uneventful LC.¹³ This was found in older patients (>65 years) and younger patients in a retrospective nationwide analysis (1992–1999) of USA Medicare patients involving 1,570,361 cholecystectomies and 7911 CBD injuries (0.5%).¹³ A study of 769,782 privately insured US patients undergoing cholecystectomy (2003–2020) reported 0.1% overall BDI incidence.¹³ All-cause mortality was increased after BDI (HR = 3.02; 95% CI: 2.48–3.68), and after adjustment for surgical indications and patient comorbidity (HR = 1.57; 95% CI: 1.38–1.79).¹³ Patients who litigate after BDI have significantly lower QOL scores than those with BDI who do not sue.^11,14

Litigation Outcomes

Iatrogenic BDI during LC is a leading cause of litigation in general surgery in the USA and UK.^1,9,10,15,16 A retrospective analysis of cholecystectomy-related US claims (Verdictsearch 2004–2017) reported 60% of malpractice litigation cases involving main BD laceration resulted in plaintiff verdicts, unchanged from preceding (1999–2004) cases.¹⁰ Despite tort reform in some US states capping non-economic damages and contingency fees and limiting collateral-source rule,¹⁷ 745 LC-related malpractice claims (including 397 BDIs) cost a total of US$128M (1995–2015).^13,16 In 2019, average plaintiff payment in US BDI litigation was US$723,844 ± $1,119,457, with average settlement US$1,350,000 ± $563,471.¹⁰ These outcomes affect indemnity insurance premiums and practice viability for US surgeons.¹⁸ For example, between 2013 and 2023, mean malpractice premiums in Illinois increased by 46%, and inflation-adjusted premiums by 10% for general surgeons. This followed Illinois State’s 2010 removal of caps on awards for economic and non-economic losses in malpractice cases. Between 2000 and 2018, nationwide inflation-adjusted average Medicare reimbursement for 20 common general surgical procedures (including LC) decreased by 24%, while surgical practice costs rose by 60%. In high-premium US states such as Florida, Rhode Island, New York, Illinois, and Connecticut, general surgeons would have needed to perform between 140 and 181 LCs/annum just to cover malpractice insurance.¹⁸

Patterns of expenditure associated with litigation involving general surgery in Canada, the UK, and the USA have increased over the last decade, despite claim numbers remaining broadly static.^9,10,19 Respective damages awarded, UK National health service (NHS) legal costs, paid claimant legal costs and overall costs (2013–2014) in 25 closed BDI claims were £2,184,186, £178,979, £1,195,187, £3,558,352, compared with 27 closed claims (2020–2021) with costs of £4,838,955, £553,797, £2,034,200, and £7,426,953.¹⁹ Across 400 successful closed BDI claims in the UK NHS between 1994/1995 and 2020/2021, costs were overall (£61,998,571), damages paid (£39,127,583), NHS legal costs (£4,243,830) and claimants’ legal costs (£18,627,158) (Fig. 1). This highlights the advantages of no-fault compensation for injured patients in civil law systems, as up to 60% of the awards in common law systems are consumed by legal and administrative costs.^18,19 Figure 2 summarizes primary reasons for successful BDI claims in 400 cases closed or settled in the NHS (1994/1995–2020/2021).¹⁹ An independent systematic search of the Westlaw USA database identified 32 cholecystectomy-related litigation cases (2019–2024). Tables 2 and 3 incorporate data from Farooq et al⁴ to summarize 263 US-litigated cases (2000–2024).

FIGURE 1.

Number of closed claims involving BDI, costs of litigation, and damages paid in the UK NHS per fiscal year from 2001 to 2021.¹⁹

FIGURE 2.

Primary reason for litigation in 400 closed claims involving BDI in the UK NHS from 1994 to 2021.¹⁹

TABLE 2.

Westlaw Data 2000–2018⁴ Combined with Data from 2019–2024 of US Litigation Involving LC

Characteristics	Total (N = 263)
Primary defendant
Surgeon	162
Other physician	28
Nonphysician	73
Sex of patient-plaintiff
Female	164
Male	99
US regions
Northeast	63
Midwest	60
South	108
West	30
Other	2
Emergency cases	26
Primary reason for litigation
Failure to diagnose	8
Misinterpretation of tests	5
Procedural error	128
Failure to treat	30
Medication error	6
Failure to refer/order appropriate tests	9
Failure to obtain consent	13
Unnecessary surgery	8
Wrongful death	43
Other	13
Allegation phase of care
Preoperative assessment	46
Intraoperative error	117
Postoperative care	26
≥2	72
Trial outcome
Plaintiff verdict	47
Defendant verdict	130
Settlement	30
Other	39
Plaintiff verdict award amount (median)	$500,842 USD
Laparoscopic surgery performed	196
Appealed	175
Follow-up surgery required	154
Biliary tract repair	91
Exploratory laparotomy	15
Bowel repair	16
Removal of foreign body	5
Other/multiple	27
Death	61

TABLE 3.

Westlaw Data 2019–2024 of US Litigation Involving LC

Characteristics	Total (n = 32)	Characteristics	Total (n = 32)
Defendant(s)		Allegation phase of care
Surgeon	20	Preoperative assessment	6
Physician	5	Intraoperative error	11
Nonphysician	7	Postoperative care	2
Sex of patient-plaintiff		≥2	13
Female	18	Plaintiff verdict award amount (range)	$465,000–10,100,000 USD
Male	14	Type of cholecystectomy
States represented	21	Laparoscopic	27 (84.4%)
US regions		Open	2
Northeast	13	Unspecified	3
Midwest	8	Conversion to Open	3
South	5	Trial outcome
West	4	Plaintiff verdict	2
Other	2	Defendant verdict	8
Planned cholecystectomy	13	Settlement	3
			1 case had a settlement of $850,000 USD
			2 cases had undisclosed settlements
Emergency cholecystectomy	9	Dismissal	2
Incidental cholecystectomy	1	Ongoing	17
Unspecified cholecystectomy	9	Appealed	22
Primary reason for litigation		Follow-up surgery required	20
Failure to diagnose	2	BDI Repair	9
Misinterpretation of tests	1	Exploratory Laparotomy	2
Spilled gallstones	2	Multiple	8
Surgical clips	2	Other	1
Biliary injury	9	Deaths	4 (12.5%)
	N.B. 4 cases are ongoing
	3 cases resulted in defendant verdict
	2 cases resulted in plaintiff verdict
Vascular injury	2
Failure to treat	1
Failure to convert to open surgery	1
Failure to recognize/disclose surgical complication	2
Failure to refer	1
Infection	1
Informed consent	1
Unnecessary surgery	4
Wrongful death	1
Other	2

Westlaw Search: ‘cholecystectomy’ AND ‘malpractice’ between January 1, 2019, and January 1, 2025, in all state and federal records produced 39 overall cases. The final total was 32 cases (n = 4 nonrelevant to cholecystectomy removed, n = 3 duplicates removed).

As in European and some Organization for Economic Co-operation and Development (OECD) countries, the Dutch arbitration system for medical liability is based on Codex Iustinianeum or civil law.¹⁴ This contrasts to Anglo-Saxon common law, involving adversarial litigation in the USA, UK, Australia, and Canada.¹ Incidence of BDI-related claims in the Netherlands has remained consistent (mean = 0.08%) since 1999, with shorter resolution times (mean = 2.4 years) and increasing rejection rates.¹⁴ Median compensation in accepted/settled cases was €9,826.07 (range: €1588–€55,301.06), with liability admitted in 18% and rejected in 69% of cases (2004–2006).¹⁴ Compensation increased with delayed diagnostic imaging (>5 days), delayed BDI diagnosis (>7 days), or primary-center relaparotomy with BDI repair.¹⁴ Lower rates of litigation and smaller compensation amounts reflect Dutch universal healthcare, arbitration emphasis, and lack of legal contingency fees.¹⁴

In Sweden, indemnity for avoidable injuries requiring causal proof is covered by insurance under the Patient Injury Act.²⁰ This includes diagnostic-, treatment-, or infection-related injuries, irrespective of injury severity or rarity. While general tort law still applies in cases of inadequate consent or medical negligence, failure to inform patients of complications occurring in <2% of cases is not considered culpa.²⁰ The Swedish Medical Responsibility Board provides disciplinary oversight for “incorrect” or negligent treatment. The Nordic (and New Zealand) legal model has faced criticism for offering improved patient access for reparation without impetus for prevention reform.^20,21

Iatrogenic BDI is a severe complication and challenging to defend in common law systems, where litigation is time-consuming and expensive.^1,9,10,16,22 This may explain the paucity of litigated cases in Australia.¹ In a search of Australian legal databases (1995–2021), all 3 BDI-related cases resulted in plaintiff verdicts.¹ Although Farooq et al⁴ found only 20% of 231 injury claims from LC (2000–2018) resulted in a plaintiff verdict in the USA, plaintiffs requiring BD repair as a second operation after LC (82/134, 61%) were more likely to successfully litigate.^4,10,15

Litigation Sources

Major BDI is the most frequent source for litigation following LC.^4,10,15 However, minor injuries or bile leaks from the cystic duct, right posterior sectoral ducts, or duct of Luschka may lead to litigation if not well managed.^4,10,15 A 2021 international scoping review by Cirocchi et al¹⁵ reported 89.8% of 1185 litigated LC cases were BDI related, with 25.5% ± 29% CBD, 15.2% hepatic bile duct, 7.5% ± 7.1% cystic duct injuries, and 30% unspecified bile leaks. Other serious injuries included vascular (5%) and bowel injuries (7%) related to trocar or Veress needle insertion, or during dissection.^10,15

Cirocchi et al¹⁵ analyzed 14 pooled studies (1991–2021) from the USA, UK, Netherlands, and Turkey involving 2406 LC-related claims. Major BDIs included complete BD transection (29.6%–56.8%), resection (40.5%–61.1%), clipping (9.3%), or diathermy burns (8.1%).¹⁵ BDI severity (Strasberg-type E) and more proximal injury were associated with greater litigation and costs, and less defensible.¹⁵ Higher grade BDIs often require multiple remedial bilioenteric surgeries, liver resection, or endoscopic retrograde cholangiopancreatography (ERCP)/radiological procedures, with lower success rates and higher long-term complications.^3,5,8,10,15

A survey completed by 278/500 Dutch patients who sustained BDI during LC (1990–2005), found complete CBD transection was the only independent predictive factor for claim initiation (OR = 7.5; 95% CI: 1.9–30.6).¹⁴ Of these patients, 19% submitted an injury claim.¹⁴ Complete CBD transection has a 100% restricture rate if repaired with end-to-end suturing over T-tube by primary surgeons.⁸ Stricture formation in proximal CHD or biliary confluence injuries is also related to ischemia and fibrosis from concomitant thermal or hepatic arterial injuries. Failed BDI repair leads to recurrent cholangitis, liver abscess, chronic sepsis, multiple revisional surgeries, secondary biliary cirrhosis, or liver transplantation for end-stage liver disease.^8,23 A defense verdict was less likely in major common BDI (10%), compared with hepatic duct (42%) or cystic duct (100%) injuries.¹⁵

In an Italian tertiary center series of 210 patients referred with BDI (1994–2016), 70.4% had Strasberg-type E injuries.¹² Of these, 36.7% initiated claims, with plaintiff verdict in 86.7% of cases (median payment = €90,500; range €10,000–600,000).¹² Successful litigation factors included:

• Intraoperative surgical repair attempts before referral (OR = 29.60; P = 0.004),

• BDI severity grade 2 (OR = 14.33; P = 0.02).

• associated vascular injury (OR = 10.40; P = 0.002),

• BDI surgical repair at tertiary center (OR = 5.09; P = 0.001),

• male plaintiff (OR = 4.34; P = 0.003),

• endoscopic repair attempts before referral (OR = 3.32; P = 0.007),

• interval time between cholecystectomy and referral (OR = 1.006; P = 0.006).¹²

Technical, Perceptual, and Judgement Errors

Phases of care associated with LC litigation include improper intraoperative surgical performance (47.6%) and postoperative injury management (29.3%).¹⁵ Less common are preoperative care errors, including incorrect assessment (6.2%) and unnecessary surgery (3.6%).¹⁵ Further analysis of intraoperative surgical performance identified “problematic visualization” as the most common intraoperative error (42.8%), followed by improper response to damage (25.2%), inadvertent visceral injury (17%), and failure to convert to OC (14%).¹⁵ Improper response to damage included “ill-judged attempts to control bleeding” and “immediate repair performed by referring surgeon instead of Hepatopancreaticobiliary (HPB) outreach team”.¹⁵

Lack of stereoscopic depth perception and haptic feedback in LC leads to spatial disorientation, visual misperception, and duct misidentification.^8,10,15,24 Cognitive fixation and failure to apply stopping rules are additional sources of error.²⁴ This also applies to robotic-assisted cholecystectomy, associated with increased risk of definitive operative BDI repair versus LC (0.7% vs 0.2%; relative risk (RR) = 3.16; 95% CI: 2.57–3.75).²⁵

In 97% of LC BDI cases, the primary cause of error is “visual perceptual illusion”, related to disorientation, cue ambiguity, excessive physical traction, scarring, inflammation, or anatomical variations.⁸ This is reported with less experienced surgeons and cases with cholecystitis or aberrant/distorted biliary anatomy, although the highest number of BDIs occur during elective or “technically easy” LC.¹² Misidentification of biliary anatomy may reflect insufficient safety measures and risk underestimation.²⁴

Significant preoperative factors predictive of open conversion are summarized in Table 4.^26–28 Intraoperative factors which contribute to a “difficult LC” (Table 5) or conversion to OC (Table 6) include biliary anatomical variations, dense adhesions or fibrosis of the gallbladder/Calot’s triangle, bile/pus outside the gallbladder, a completely buried, distended, sclero-atrophic, or gangrenous gallbladder, pericholecystic abscess, cholecysto-enteric fistula, Mirizzi syndrome, or ongoing bleeding.^26,28–36 Many are detectable with careful preoperative assessment and imaging, allowing appropriate precautions.^2,15 Intraoperative scoring to direct management includes Nassar Grades 3 to 4, conversion from laparoscopic to OC score >6, or Sugrue 10-point gallbladder scoring system (G10) score ≥3 (Table 6).^26,29,31,32

TABLE 4.

Preoperative Risk Factors for Conversion to Open Cholecystectomy^26,28

Preoperative Risk Factors for Open Conversion	Reference	P
Male patient	Rothman et al28	0.002
	Chin et al26	0.053, 0.042, 0.012, 0.005, 0.003, <0.001, 0.0000
Age >65 years	Rothman et al28	0.0009
	Chin et al26	0.036, 0.02, 0.016, <0.001
BMI > 30 kg/m²	Chin et al26	0.04, 0.00011, 0.0001
Diabetes	Chin et al26	0.053, 0.051, 0.045, 0.021, 0.019
Temperature >37.5 °C	Chin et al26	0.008
Late presentation (>72 hours)	Chin et al26	0.0004, <0.05
Acute cholecystitis	Chin et al26	0.0028, 0.001, <0.001
Elevated WCC (no specific cutoff)	Chin et al26	0.0001
Prolonged prothrombin time	Chin et al26	0.03
CRP >76 mg/L	Chin et al26	0.0001
Elevated ALT	Chin et al26	0.002
ALP >80 IU/L	Chin et al26	0.026
Elevated total bilirubin level	Chin et al26	0.045
Hypoalbuminemia (<32 g/L)	Chin et al26	0.043
Emergency surgery	Chin et al26	0.05, 0.007, <0.001
Previous ERCP	Chin et al26	<0.001
Previous abdominal surgery	Chin et al26	0.03, 0.011, 0.001
GB wall >4–5 mm thick on U/S	Rothman et al28	<0.000001
>3 mm thick on U/S	Chin et al26	0.0073
CBD > 6 mm diameter on U/S	Chin et al26	0.001
Impacted gallbladder neck calculus on U/S	Chin et al26	0.0053

ALT indicates alanine aminotransferase; ALP, alkaline phosphatase; BMI, body mass index; CBD, common bile duct; CRP, C reactive protein; ERCP, endoscopic retrograde cholangiopancreatography; GB, gallbladder; U/S, ultrasound; WCC, white cell count .

TABLE 5.

Risk Factors for Difficult Cholecystectomy^33–36

Risk Factors for Difficult LC	Reference	P
Male patient	Bhandari et al33	0.001
	Atta et al34	0.038
Age >65 years	Atta et al34	1.000
Diabetes	Atta et al34	0.330
Smoking	Bhandari et al33	0.275
	Atta et al34	0.179
History of acute cholecystitis	Bhandari et al33	0.001
WCC > 10.0 × 109/L	Chen et al35	0.006
Previous abdominal surgery	Atta et al34	0.681
Maximum gallstone diameter >2cm	Chen et al35	<0.001
Palpable gallbladder	Atta et al34	0.552
Gallbladder neck calculus	Chen et al35	<0.05
Aberrant biliary/vascular anatomy	Sarmiento et al36	<0.05
Liver cirrhosis	Atta et al34	0.33
	Sarmiento et al36	<0.05
Adhesions in Calot’s triangle	Atta et al34	0.000
Fibrotic gallbladder	Bhandari et al33	0.005

TABLE 6.

Intraoperative Risk Factors for Conversion to Open Cholecystectomy^26,29–32

Intraoperative Risk Factors for Conversion	Reference	P	Open Conversion Rate (Mean ± SD)
Unclear anatomy at Calot’s triangle	Khakimov et al30	<0.001	29.2 ± 23.0%
Dense adhesions/fibrosis of GB and Calot’s triangle	Khakimov et al30	<0.001	37.5 ± 22.5%
Bile/pus outside gallbladder	Sugrue et al29	0.0046	36.4%
Completely buried gallbladder	Sugrue et al29	0.018	33.3%
Distended/shrunken GB	Sugrue et al29	0.1508	19.7%
Gangrenous gallbladder	Chin et al26	<0.001	22.5%
Gallbladder abscess	Khakimov et al30	0.26	6.35%
	Chin et al26	<0.001	22.50%
Cholecysto-enteric fistula	Sugrue et al29	0.0066	62.5%
	Khakimov et al30	0.008	3.7 ± 3.4%
Mirizzi syndrome	Khakimov et al30	0.376	3.7 ± 3.5%
Uncontrollable bleeding	Khakimov et al30	<0.001	10.1 ± 8.4%
Nassar scale (grades 4–5)	Griffiths et al31	<0.001	28%
CLOC score >6	Sutcliffe et al32	<0.001	7.1%
G10 score ≥3 G10 score ≥5	Sugrue et al29	<0.0001	Range: 12.4%–66.7% 33%

CLOC indicates conversion from laparoscopic to open cholecystectomy.

Historically, there was a higher risk of BDI during an individual surgeon’s first 1 to 50 LCs, with 60% occurring in their first 5 years of practice.³⁷ However, after the initial “learning curve” of technical proficiency, a second peak of BDI occurs by surgeons with experience of 100 to 1000 LC cases or >10 years of independent surgical practice. Consistent reporting of this phenomenon across the USA, Canada, Netherlands, Belgium, Spain, India, Taiwan, China, and Japan emphasizes the requirement for constant vigilance, and ongoing training in surgical heuristics and nontechnical skills, even for experienced surgeons.^{6,12,22,25,27}

A Swedish national study of 154,934 cholecystectomies performed (2006–2019) found the major BDI rate was 0.3% in elective and 0.4% in acute procedures.³⁸ Low-volume surgeons (<20 LC/year) were significantly more likely to cause BDI during elective surgery and to convert to OC in both elective and acute LCs, compared with high-volume surgeons (>33 LC/year).³⁸

In a Dutch series of 800 referred patients with BDI after LC (1990–2012), preventative safety measures were infrequently utilized, including complete dissection of Calot’s triangle (16.5%), Strasberg critical view of safety (CVS) (6.3%), and fluoroscopic intraoperative cholangiography (IOC) (11.2%).^6,11 In 2007, the Dutch Society of Surgery introduced LC guidelines, which required CVS documentation and recommended open conversion if CVS could not be obtained.^6,11 CVS reporting improved from 4% (16/425) to 17% (17/103; P < 0.001), consultation with HPB colleagues from 3% (14/425) to 8% (8/103; P < 0.01), and median tertiary referral times for patients with BDI decreased from 25 to 13 days (P < 0.01). However, no significant decrease occurred in attempted primary BDI repair by referring surgeons (21% vs 18.5% after 2007; P = 0.54).¹¹

In a separate analysis of CVS documentation involving 1108 consecutive LCs (2009–2011) in a Dutch teaching hospital, there were 19 (1.17%) overall biliary injuries (Strasberg A–E) and 0.6% major BDIs.³⁹ Although 80% of operation notes stated CVS attainment, a retrospective video analysis concurred in only 10.8%. In BDI cases with operative video, 73% had CVS documentation. However, on video review, none satisfied all 3 CVS requirements, including 360° cystic duct view following clearance of fibrofatty tissue in the hepatocystic triangle, lower 1/3 of gallbladder dissected from the liver bed, and only 2 structures entering the gall bladder.³⁹ A 2018 Dutch national survey completed by 410 surgeons and 200 residents in surgical training also suggested major discrepancies in the definition of a CVS and its attainment during LC.⁴⁰ Inadequate description and implementation of obligatory CVS requirements have also been reported in India, China, Mexico, and the USA.⁴¹

Furthermore, up to 80% of BDIs may occur when surgeons attempt the establishment of a CVS, emphasizing the importance of proper navigation before and during dissection.²⁴ A potential injury source is the initial anterior infundibular approach in the hepatocystic triangle, without first opening the posterior peritoneal reflection. This may expose the right hepatic duct, common hepatic duct, or right hepatic artery to misidentification or injury (Fig. 3).⁴² Using initial gallbladder posterior mobilization and avoidance of cystic artery skeletonization in the hepatocystic triangle in 1402 consecutive LCs, Iskandar et al⁴² reported zero BDIs and 4 cystic duct bile leaks (managed by ERCP).

FIGURE 3.

Lymph node of Calot (Lund) as a navigational paradigm. Do not operate within the trapezoidal, shaded area bounded medially by the common hepatic duct, inferiorly by the sentinel lymph node of Lund, laterally by the anterior cystic artery after it emerges from behind the node of Lund and superiorly by the inferior margin of the liver. The Trapezoid of no dissection = the hepatocystic triangle minus Calot’s triangle. A posterior window should first be obtained between the posterior wall of the gallbladder and the posterior cystic artery (1), prior to further proximal dissection of the gallbladder infundibulum (2), with control of the cystic artery as it emerges from behind the node of Lund (Calot), avoiding cystic artery skeletonization in the hepatocystic triangle. Diagram reproduced from Iskandar et al.⁴²

IOC

Intraoperative errors contributing to BDI may derive from a lack of IOC, but also ductal cannulation errors or IOC misinterpretation. Flum suggested BDI could potentially be reduced by 40% with routine IOC.⁸ However, there are marked international variations in IOC use (mean rate: 38.8%, range: 1.6%–96.4%), and the true effect of IOC in the prevention of BDI remains controversial.⁴³ A recent SRMA of 62 published studies (2003–2018) found no significant difference in BDI rate between cholecystectomy with IOC (0.39%) versus without (0.43%) (OR = 0.88, CI: 0.65–1.19, P = 0.41).⁴³ Other preventative initiatives include the use of navigational paradigms, video-based learning, CVS documentation, repetitive VR simulation/competency-based education, fluorescent/intravital cholangiography, heuristics module training, intraoperative assessment of difficulty scoring, artificial intelligence (AI) navigation and CVS guidance, AI-powered mobile gaming app, and SAGES Safe Cholecystectomy Taskforce (SAFE CHOLE) (Fig. 3).^{6,8,24,29,44–49}

Whether IOC can prevent BDI and its litigation is debatable as anatomical navigation, dissection, incision, and clipping occurs before IOC.²⁴ However, IOC has benefit in excluding choledocholithiasis, maintaining theater team skills, confirming biliary anatomy, and potential BDI recognition, allowing early referral to HPB specialists.²⁴ IOC is also considered a cost and time-effective strategy to negate severe patient harm, as per legal precedent in Australia.¹ However, IOC was misinterpreted as “normal” in >50% of BDI-related cases.^8,24 Failure to perform, or correctly interpret IOC as per Le Quesne’s criteria,^8,45 may delay management of BDI and be perceived as a breach of duty of care to adequately prevent or investigate complications.

Open Conversion

The decision to convert to OC is a source of medical liability, particularly as medicolegal expert witnesses often conjecture that early conversion may prevent BDI.^15,22,24 However, open conversion does not necessarily make a difficult LC any easier.²⁴ Strasberg⁷ opined that inexperienced surgeons would be uncomfortable converting to laparotomy in difficult cases. Such scenarios include severe contractive inflammation, gallbladder dome only being visible at laparoscopy, or inability to obtain CVS.⁷ Open conversion alone should not be considered a “bailout procedure”, and the decision to abandon a total LC represents an inflection point, an intraoperative timeout, or a stopping rule. Options include bailout subtotal cholecystectomy (fenestrated or reconstituted), laparoscopic stone removal/surgical cholecystostomy, or prudent procedure cessation and HPB referral.⁷ Fundus-first cholecystectomy is another “bailout” option, but dissection can extend behind the foreshortened cystic plate onto the right portal pedicle, risking extreme vasculobiliary injuries.⁵ Open conversion is an independent risk factor for complications, including BDI, wound infection and intra-abdominal abscess, and most subtotal cholecystectomies can be laparoscopically completed.^2,5,50

Sirinek et al⁵¹ reviewed mean OCs performed by each chief general surgery resident during 5 years of residency in 2 Texas teaching hospitals. Completed OCs diminished from 70.4 in the prelaparoscopic era (1981–1990) to 22.4 in the first decade of LC (1991–2001), and 3.6 in the second decade (2004–2013).⁵¹ Importantly, major BDIs still occur after open conversion, and thus, safe conversion must be learned as per Dutch safety recommendations.^11,24 Open conversion is not the sole solution in difficult LC for inexperienced surgeons, as it is associated with higher complex biliary injury rates [Bismuth III–V injury 34% (24/64) vs 65% (46/116); P = 0.013] (Table 1).⁶

Delayed Recognition

Immediate BDI recognition during LC is crucial, as it allows for prompt treatment, preventing complications such as sepsis, jaundice, bile peritonitis, and organ failure.^2,12,13,50 From litigated cases, 80%–86% of BDIs were not detected during LC, with an average 10-day diagnostic delay.^10,22 Delays in BDI diagnosis and HPB referral are strong predictors for malpractice litigation.^9,22 Delayed BDI recognition and definitive management impose a great financial burden on patients and healthcare systems due to additional remedial operations, extended length of stay (LOS), and medicolegal claims.^12,13,15 It may exacerbate morbidity due to untreated complications, such as peritonitis and sepsis.¹³ However, delayed diagnosis is not the sole predictor of indemnity payment. Successful malpractice claims are a product of cumulative events, with plaintiff verdicts hinging not only on delays but also on failure to adequately treat the injury.⁹

Repair by Primary Surgeon

Incorrect postoperative management (delayed referral, attempted primary repair before referral) is an important contributing factor to litigation.¹² While Strasberg-type A and some-type D biliary injuries may be managed with re-laparoscopy/washout/drainage and ERCP/endoscopic sphincterotomy/biliary stenting, loss of biliary tract continuity (Strasberg-type B/C/E BDI) typically requires Roux-en-Y hepaticojejunostomy. Attempted repair by primary surgeons often leads to suboptimal outcomes, with immediate and early repairs by nonspecialist surgeons being independent respective risk factors for recurrent cholangitis (50% and 27%), restricture (75% and 61%) and revisional reconstructions (31% and 61%).¹⁴ In contrast, repairs performed by HPB specialists are associated with improved long-term patency (76%–83% vs 53%–58%), decreased LOS (mean 9.3 ± 4.3 vs 11.7 ± 8.4 days), and improved morbidity and mortality.^8,14,15,52

Even when successfully repaired, BDIs are still associated with impaired QOL, loss of productivity, and utilization of disability benefits.⁵³ In tort law, plaintiff compensation may include direct economic and non-economic losses, punitive damages, and medicolegal costs.¹⁷

Informed Consent

In 2016, the Canadian Medical Association found 65% of all medicolegal cases involved inadequate consent for surgical procedures, and of these, 79% had unfavorable outcomes.⁵⁴ The Canadian Medical Protective Association defines informed consent “a voluntary process where important elements include details of the procedure, complications, and proposed alternatives”.⁵⁵ It is expected that “along with a signed consent form, there should be supplemental documentation of details of the consent discussion in the patient chart or on the physical consent form itself”.⁵⁴ LC was the most common laparoscopic procedure in 423 cases handled by the Canadian Medical Protective Association (CMPA) in 2017. Of these, 29% involved deficient informed consent.⁵⁴

A Canadian retrospective review of 270 medical records of LC (2015–2017) revealed that only 2% contained all elements of informed consent.⁵⁴ Documented discussion of possible OC was found in 96% of cases. However, potential complications including BDI, bleeding, infection, bowel injury, or subtotal cholecystectomy were documented in only 15.6%, 13%, 11.9%, 6.3%, and 0% of files, respectively.⁵⁴ Procedural details (10%) and alternative therapies (9%) were also infrequently documented. A digital education platform (DEP) adjunct to standard verbal consent was then evaluated in an RCT involving 79 patients with acute biliary pathology requiring LC (2021–2023).⁵⁵ DEP significantly improved patients’ immediate understanding of LC risks and benefits, and retention of this acquired knowledge.⁵⁵

Insufficient information provided to the patient/relatives prior to LC is considered medical malpractice in Germany.²² Similarly, failure to obtain adequate consent was the primary cause in 2.3% of 400 successful BDI claims in the UK NHS (1994–2021), and 5.1% of 231 US LC malpractice claims (2000–2018) (Fig. 2).^4,19 Poor documentation of informed consent can predispose to medicolegal vulnerability, as it becomes challenging to prove the patient was adequately informed. Yet, in a questionnaire completed by 200 patients post-LC in Austria, 30% of patients could not recall associated procedural risks despite having signed consent.⁵⁶ In Australia, in 481 cases (2002–2008) of alleged inadequate consent involving conciliated complaints or medical negligence, 92% (442/481) involved surgical procedures, 2% of which comprised LCs.⁵⁷

Legal ramifications of inadequate informed consent are profound, particularly from legal precedents such as Rogers v. Whitaker (1992) in Australia.¹ This landmark case involved failure to warn of sympathetic ophthalmia, a rare complication (rate 1/14,000) of ophthalmic surgery. In rejecting the Bolam test and dismissing the defendant surgeon’s appeal, Australia’s High Court ruled doctors have a duty to warn patients of any material risk involved in a proposed treatment, where a material risk is “one that a reasonable person in similar circumstances would consider significant”. Failure to adequately inform patients about LC BDI risk can be interpreted as a breach of this duty of care, thereby forming the basis for a negligence claim.^1,4,7,58 Procedure-specific consent forms facilitate documentation.⁷ However, no single strategy protects clinicians against claims of medical negligence.⁵⁴ Written documentation provides evidence that surgical procedures and risks are discussed, but may not guarantee patient comprehension or retention of information.^56,58 Nevertheless, risk management encompasses comprehensive discussions about proposed procedures with detailed documentation.^7,54

Medical Negligence

Medical negligence is defined as “absence of reasonable care and skill of a medical practitioner in the treatment of a patient, which causes loss or injury to the patient”.¹ Whether BDI constitutes medical negligence depends on the absence of reasonable care and skill, resulting injury or death; and accepted medical practice and unavoidable risks.¹ However, the interpretation of medical negligence varies between countries, medical experts, and legal jurisprudences.

BDI: Inherent Risk?

The continued BDI prevalence after the learning curve suggests it remains an inherent or unavoidable risk of LC.^6,13,24 This was supported by anonymized surveys of practicing Canadian and UK surgeons, where surgeons felt BDIs still occurred despite high procedural volume and experience.^13,59 In Australia, the legal view on BDI being an inherent risk relies on the definition of “reasonable care and skill” provided by the Civil Liability Act (CLA) 2002.⁶⁰ Inherent risk is an outcome that cannot be avoided by the exercise of reasonable care and skill. The importance of this lies in CLA Section 5I(1), which states that there will be “no liability for materialization of inherent risk”. If BDI was indeed an inherent risk of LC, there could be no negligence arising from its materialization. However, the difficulty with CLA citation in BDI defense lies in the ambiguity of “reasonable care and skill”. As such, the court can call on surgical peer opinion to define competent professional practice, which is often not clearly defined.¹ Even so, rejection of expert opinion may occur if the court considers it irrational.¹

COSIC

Despite LC being the standard treatment for symptomatic cholelithiasis, no single guideline for its safe practice has been universally adopted.^5,11,61,62 In addition, lack of systematized teaching of surgical technique and heuristics, and unequal access to resources, leads to heterogeneous LC performance.^2,63 Intraoperative bleeding, unclear anatomy, or unanticipated complexity may add extra cognitive load on surgeons during LC. Together with difficult port access, unexpected interruptions or equipment problems, this may lead to errors in intraoperative navigation, decision making, and biliary or visceral injuries.^8,24 Cognitive strategies include mnemonics, visualization, navigation aids, critical thinking, surgical team communication, stopping rules, or surgical pauses.⁶⁴ Early consultation with senior surgical colleagues, practicing reflective surgery, and fostering COSIC is also recommended (Table 7).^6,64

TABLE 7.

Recommendations for Safe LC and Levels of Evidence^{5,6,11,12,24,26,35,37,40,42,48,55,58,61,62,65,66}

Operative Phase	Error	Recommendation	Reference	Level of Evidence
Preoperative	Failure to recognize risk factors for difficult or high-risk LC	Exhaustive preoperative work-up for high-risk patients	De’Angelis et al5	2a
	Imaging of the biliary tree	Preoperative MRCP	Wakabayashi et al61	3a
	Informed consent	Digital education platforms	Alqaydi et al55	1b
		Procedure-specific consent forms	Crozier et al58	1b
Intraoperative	Surgical navigation of the biliary tree	Use of multiple anatomical landmarks	Pesce et al37	2c
		Rouviere’s sulcus	Connor et al24	4
		Calot’s lymph node	Iskandar et al42	4
		B-SAFE method	Chen et al35	2c
	Imaging of the biliary tree	IOC	Brunt et al11	2a
			De’Angelis et al5	2b
			Van de Graaf et al40	1b
		IOUS	Van de Graaf et al40	2b
		ICG	De’Angelis et al5	2b
			Van de Graaf et al40	2b
	Failure to recognize IO risk factors for difficult LC	Intraoperative scoring and identification of risk factors for conversion	Chin et al26	2a
	Improper or inadequate dissection	Avoidance of infundibular approach	Brunt et al11	2a
		CVS criteria before division of structures	De’Angelis et al5	3a
			Wakabayashi et al61	2b
			Weis et al6	1b
			Van de Graaf et al40	3a
		Use of real-time AI to obtain CVS	Fernicola et al48	5
			Leifman et al66	4
			Wu et al70	1b
			Corallino et al71	3a
		D-line approach when CVS cannot be achieved	Badawy et al65	4
	Documentation	CVS video-documentation	De’Angelis et al5	2b
	Failure to perform open or stepdown procedure	Open conversion	Wakabayashi et al61	3a
		Subtotal cholecystectomy	Wakabayashi et al61	3a
			De’Angelis et al5	3a
		Fundus-first (dome-down)	Brunt et al11	2a
			Chen et al35	2c
	BDI repair by primary surgeon	HPB specialist referral/assistance	Ardito et al12	2b
			Brunt et al11	2a
Postoperative	Failure to investigate for BDI or complication	ERAS pathway for safe discharge and readmission	Nair et al62	1a
		Prompt investigation of inadequate patient recovery	De’Angelis et al5	3a

ERAS indicates Enhanced recovery after surgery; HPB, Hepatopancreaticobiliary.

Adherence to preventative strategies across all perioperative phases decreases the incidence of BDI and enhances both patient and surgeon safety (Table 7).^{5,6,11,12,24,26,35,37,40,42,48,55,58,61,62,65,66} Such strategies may provide some medicolegal defense if BDI occurs. However, this is dependent on local jurisprudence and case specifics.^11,22 National guidelines and standardized training based on SAGES SAFE CHOLE program would define “reasonable care and skill” expected of general surgeons, promote COSIC, and guide appropriate intraoperative decision making.^6,7 BDI often stems from “illusions of shape and form” due to lack of depth perception and tactile feedback, improper exposure, and spatial disorientation.^8,13 This emphasizes the importance of using multiple anatomical landmarks for navigation during LC,⁶³ including the B-SAFE mnemonic: bile duct, Sulcus of Rouviere, left hepatic artery pulsation, umbilical fissure, Enteric (duodenum)³⁵; Trapezoid of no dissection⁴²; and Rouviere’s sulcus,²⁴ hepatic segment 4 and umbilical fissure to identify the hilar plane (R4U)⁴¹ or the D-line.^11,63,65,67 Multisociety guidelines uniformly recommend the CVS technique to prevent misidentification injuries.^11,13,46,61 Proper CVS implementation during LC can decrease BDI rates from 0.32% to 0.09% or lower.⁴¹

Combining AI simulation, near-infrared indocyanine green (NIR-ICG) imaging and 3D visualization to obtain a CVS may prevent BDI by improving visuospatial orientation, surgical heuristics, and navigation.^{10,24,46,61,67,68} Through deep learning algorithms, image classification, object detection,⁶⁹ machine learning, and real-time integration, AI can identify anatomical structures (72%–92% accuracy),^48,66 validate CVS achievement (100% specificity and 97% sensitivity),⁶⁶ and alert both novice and experienced surgeons to safe and unsafe dissection zones during LC.⁴⁸ AI-based LC coaching also significantly improved CVS attainment (11%–78%, P = 0.021) and surgical performance compared to standard education, in an RCT involving 10 hospitals in China.⁷⁰ A recent SRMA of 25 studies published since 2020 reported AI in LC being more effective in identifying “No-Go” zones of dissection and CVS rather than “Go” zones or individual anatomical structures, although balanced accuracy of CBD identification was 95%.⁷¹ AI may motivate CVS attainment due to the Hawthorne effect, as surgeons are aware of their performance being monitored. The authors concluded that although AI could not replace the opinion of an expert surgeon during a difficult LC, it was a valid adjunct, especially for less experienced surgeons.⁷¹ Current limitations of AI platforms include small annotation datasets and intersurgeon variability in supervised machine learning (data pipeline), variability in anatomical recognition with image magnification, obesity or severe cholecystitis (workflow and usability), integration with laparoscopic equipment (interface), adoption and diffusion (infrastructure), and lack of direct evidence of BDI prevention.⁴⁸

Adjunctive approaches may also convince the court of a surgeon’s due diligence. If a CVS cannot be achieved, a bailout or stepdown procedure is recommended.^11,61 A retrospective comparative study found open conversion and total cholecystectomy was complicated by 3.5% BDIs, compared with zero incidence for bailout subtotal LC.⁶¹ Subtotal LC is, however, associated with increased intra-abdominal collections, retained gallstones, bile leaks, ERCP intervention, and reoperation.^2,61 Although there is no consensus that IOC prevents BDI, it may have utility in intraoperative BDI recognition and avoidance of litigation. Appropriate training in the use and interpretation of fluoroscopic IOC or alternative forms of real-time imaging such as IO ultrasound and NIR-ICG fluorescent cholangiography may improve BDI risk and litigation.^5,8,40,72 NIR-ICG imaging is comparable to IOC in biliary visualization (82% vs 85%), and allows a dynamic, convenient, and repeatable guide for safe dissection.^8,40,72 Current drawbacks of these alternative forms of imaging are the learning curve in their performance and interpretation, and equipment availability and underpowered research.⁴⁰

Streamlined referral systems to facilities with HPB specialists based on known risk factors for difficult LC may avoid high-risk operations by inexperienced surgeons and ensure primary BDI repair by specialists.¹² Risk factor awareness may guide surgical triaging of patients (Table 4), planning and approach to cholecystectomy (Table 5), inform early open conversion or stepdown strategy (eg, subtotal cholecystectomy), and ensure senior surgeons are available for advice or immediate BDI repair (Table 6).^2,13,26,28 The identification and proactive management of high-risk patients may assist in preventing negligence claims, by demonstrating a surgeon’s commitment to COSIC.¹³ If BDI is recognized intraoperatively, it is strongly recommended that the surgeon cease dissection, place drains to create a controlled biliary fistula, and transfer the patient to an HPB tertiary referral center.¹¹ A laparotomy for diagnosis or injury staging is strongly discouraged.⁵ In addition to BDI prevention strategies, informed consent training through DEPs and procedure-specific consent forms may help protect against litigation.^54,55 Video or photographic documentation of CVS is also desirable. However, operative video debriefing with CVS annotation and validated assessment (OSATS and GOALS scores) for structured feedback during LC training is required for successful implementation.^39,73,74

Progress is required in surgical education, mentoring, cognitive and perceptual heuristics, imaging, and technique.^{5,6,11,12,24,26,35,37,40,42,48,55,58,61,62,65,66} This facilitates safe navigation, dissection above the hilar plane, and satisfactory CVS, with a zero BDI goal.^11,24 The short-term effectiveness of SAFE CHOLE digital education modules in changing surgical practice versus standard CME has been confirmed in a US RCT.⁶ The French Federation of Visceral and Digestive Surgery recently incorporated SAFE CHOLE into its e-learning CME platform.⁷⁵ Postimplementation, 56% of participants reported changing their cholecystectomy practice, 46% routinely began obtaining a CVS, 12% used time-out before vital structure transection, 11% adopted routine IOC, and 67% performed subtotal LC when CVS was unobtainable. When faced with BDI, 45% would transfer to tertiary centers, 33% would seek colleague assistance, and 10% would proceed with attempted BD repair.⁷⁵

CONCLUSION

The continued prevalence of BDI and its devastating consequences make COSIC an important part of surgical practice. Lawsuits after LC stem from inadequate informed consent, BDI severity, intraoperative judgement errors, failed repair by the primary surgeon, delayed BDI diagnosis, and lack of early involvement of HPB specialists. Legal precedents necessitate improved informed consent, BDI-preventative measures, and standardized LC technique. Barriers to COSIC such as risk underestimation, learning curves, under-adopted navigation paradigms, and IOC performance and interpretation should be addressed to improve safety and minimize BDI during LC and subsequent litigation.

ACKNOWLEDGMENTS

R.B.W., D.A.H., D.K., Y.L., and O.P. contributed to the concept, design, and implementation of the research, R.B.W. and D.A.H. to the data search, analysis of the results, and the writing of the draft and revised manuscript. D.A.H., D.K., Y.L., O.P., and R.B.W. reviewed the final manuscript. D.K. and R.B.W. supervised the project.