Surgeons opinions of legal practice in bile duct injury following cholecystectomy.

INTRODUCTION: Litigation for bile duct injury following laparoscopic cholecystectomy places financial strain on the health service, causes significant patient morbidity and adversely affects the patient and surgeon. Claimants argue that the injury itself is evidence of negligence. METHODS: A questionnaire addressing views on BDI causation was sent to members of AUGIS working in the National Health Service, UK. Response themes and responses were compared between groups of surgeons. RESULTS: Of 117 respondents, 45% experienced BDI and 22% had medicolegal experience. 47% of respondents identified factors outside the surgeons control as being relevant to BDI. Those that had experienced BDI from their own surgery were less likely to identify surgeon/systems errors as the primary cause for BDI than those that had not (34% vs 74%, p < 0.001). Medicolegal expert surgeons were more likely to report that substandard technique should be presumed (50% vs 19%, p = 0.002), however, 25% of medicolegal experts indicated that not all BDIs caused by their own surgery could have been avoided. CONCLUSION: A significant number of experienced surgeons indicated that BDI following LC should not be assumed to result from surgeon negligence or institutional failure. This suggests that negligence should not be inferred from the act of BDI alone.

Quality of Life and Medico-Legal Implications Following Iatrogenic Bile Duct Injuries.

In this review we aimed to evaluate quality of life after bile duct injury and the consequent medico-legal implications. A comprehensive English language literature search was performed on MEDLINE, Embase, Science Citation Index and Google™ Scholar databases for articles published between January 2000 and April 2016. The last date of search was 11 April 2016. Key search words included bile duct injury, iatrogenic, cholecystectomy, prevention, risks, outcomes, quality of life, litigation and were used in combination with the Boolean operators AND, OR and NOT. Long-term survival after bile duct injury is significantly impaired (all-cause long-term mortality approximately 21 %) along with the quality of life (especially psychological/mental state remains affected). Bile duct injury is associated with high rates of litigation. Monetary compensation varied from £2500 to £216,000 in the UK, €9826-€55,301 in the Netherlands and $628,138-$2,891,421 in the USA. Bile duct injuries have profound implications for patients, medical personnel and healthcare providers as they cause significant morbidity and mortality, high rates of litigation and raised healthcare expenditure.

[Complicated course of a laparoscopic cholecystectomy]. / Komplizierter Verlauf einer laparoskopischen Cholezystektomie.

The case presented deals with the complicated course of a laparoscopic cholecystectomy in a 45-year-old female patient due to cholecystolithiasis. The patient complained that during the operation an injury to the small intestine occurred, which was only operatively treated at midday of the despite massive pain and insufficient pain treatment. The intervention was claimed to have resulted in mental and physical suffering. The case is assessed by two independent experts in the sense of a "scientifically founded comment" with respect to the decision of the arbitration board and taking the surgical standards into consideration.

Major common bile duct injury and risk of litigation: a surgeon's perspective.

Risk for a lawsuit for medical malpractice has unfortunately become part of physicians' daily professional activities, with a blowout in indemnity insurance premiums, especially in high-risk medical specialties. Common bile duct injury following laparoscopic cholecystectomy is a well-recognized and feared complication for surgeons because of its associated morbidity, and it also ranks among the leading sources of medical malpractice claims against surgeons in the world. The purpose of this article is to raise awareness within the medical community and in particular among specialist surgeons on the important threat they could be facing in terms of litigation in the event of an adverse surgical outcome following such a commonly performed procedure. There is a real need for open debate on this concerning topic, as the fear of lawsuits and exorbitant malpractice premiums are pushing a substantial number of medical professionals to practice defensive medicine, reflected by the avoidance of performing certain procedures or treating high-risk patients perceived to have higher litigation rates, or simply walking away from their current practices, creating a chronic shortage of specialized doctors in certain surgical areas.

[Liability of surgeons with respect to injuries to the bile duct during laparoscopic cholecystectomy : Analyses of malpractice litigations in the years 1996-2009]. / Arzthaftung bei Gallengangsverletzungen nach laparoskopischer Cholezystektomie : Analyse der gerichtlichen Urteile der Jahre 1996 bis 2009.

BACKGROUND: Injuries to the bile duct during laparoscopic cholecystectomy are often a cause of malpractice litigations. METHODS: A total of 13 legal verdicts as a result of bile duct injury from 1996 to 2009 were reviewed. Comments on the verdicts and the opinions of expert witnesses were analyzed. RESULTS: Out of 13 claims, 7 were upheld and 6 were rejected. Most expert witnesses from 1996 to 2002 stated that not carrying out a cholangiography and insufficient preparation of the cystic duct constituted a performance below the standard of care expected. Expert witness testimonies from 2004 to 2009, however, regarded injury to the bile duct as predominantly inherent to treatment. CONCLUSION: With the expansion and acceptance of laparoscopic interventions, changes in the results of malpractice litigation have become evident. In contrast to the phase during establishment of the technology, an injury to the bile duct is nowadays judged predominantly as inherent to treatment.

Prevalence and outcome of litigation claims in England after laparoscopic cholecystectomy.

BACKGROUND: Approximately, 50,000 cholecystectomies are performed annually in the United Kingdom resulting in a number of negligence claims referred to the NHS Litigation Authority (NHSLA). The aim of this study was to assess the prevalence and outcomes of claims reported to the NHSLA after laparoscopic cholecystectomy performed in England between 1995 and 2008. METHODS: Data were requested from the NHSLA on all claims related to laparoscopic cholecystectomy which occurred in England between 1995 and 2008. RESULTS: A review of the data provided by the NHSLA data identified over 300 claims in this time period. Of the claims identified, 244 have been completed. Common bile duct injury (41%), bile leak (12%), bowel injury (9%), haemorrhage (9%) and fatality (9%) were the most frequent types of claim. Common bile duct injury resulted in the highest proportion of successful claims (86%) and the largest sums paid to the claimant (average £65,000). DISCUSSION: Common bile duct injury is the most common claim to the NHSLA after laparoscopic cholecystectomy and results in the highest proportion of successful claims and the largest sums paid to the claimant.

Risk factors for litigation following major transectional bile duct injury sustained at laparoscopic cholecystectomy.

BACKGROUND: Bile duct injuries after laparoscopic cholecystectomy often cause long-term morbidity, with a number of patients resorting to litigation. The present study aimed to analyze risk factors for litigation and to quantify the subsequent medicolegal burden. METHODS: A total of 67/106 patients (26 male) with major laparoscopic cholecystectomy bile duct injuries (LCBDI) and a minimum 2-year follow-up, replied to a questionnaire covering patient perception toward the complication, physical/psychological recovery, and subsequent litigation. These data were collated with prospectively collected data related to the LCBDI and subsequent management, and a multivariate regression model was designed to identify potential risk factors associated with litigation. RESULTS: Most patients felt they had been inadequately informed prior to surgery [47/67 (70%)] and after the LCBDI [50/67 (75%)], and a majority remained psychologically traumatized at the time of evaluation [50/67 (75%)]. Of these, 22 patients had started litigation by means of a "letter of demand" (LOD; n = 10) or prosecution (n = 12). Nineteen (19/22%) cases have been closed in favor of the plaintiff. There was no difference between the awards for LOD versus prosecution cases, and average compensation was £40,800 versus £89,875, respectively (p = n.s). On multivariate analysis, age < 52 years (p = 0.03), associated vascular injury (p = 0.014), immediate nonspecialist repair (p = 0.009), and perceived incomplete recovery following LCBDI (p = 0.017) were identified as independent predictors for possible litigation. CONCLUSIONS: On the basis of the present study, nearly one third of patients with major transectional LCBDI are likely to resort to litigation. Younger patients and those in whom repair is attempted prior to specialist referral are likely to initiate litigation.

15 years of litigation following laparoscopic cholecystectomy in England.

OBJECTIVE: We aimed to analyze trends in litigation following laparoscopic cholecystectomy (LC) in England and compare our findings with data from the United States. BACKGROUND: Several studies from the United States have highlighted the medico-legal repercussions of complications following LC. In 2007-2008, litigation claims cost the National Health Service in England over 660 million Great British Pounds (GBP) (1.1 billion USD). Despite this, there has been little examination of litigation following LC in England. METHODS: Data from the National Health Service Litigation Authority on clinical negligence claims between 1995 and 2009 following LC were obtained and analyzed. RESULTS: Four hundred eighteen claims were made of which 303 were settled. One hundred ninety-eight (65%) were found to be in the claimants favor for a total cost of 20.4 million GBP (33.4 million USD). Litigation claims have leveled since 2001. Operator error was the most likely cause to result in a claim and the only cause associated with a successful claim (P = 0.023). A delay in the recognition of complications was the second most common reason for initiation of a claim. Bile duct injury was the most frequent injury resulting in litigation and the most likely injury associated with a successful claim (P < 0.001). The average payout for a successful claim was 102,827 GBP/168,337 USD. Findings from US studies were similar, although the magnitude of payouts was 4 times higher. CONCLUSION: Strategies that minimize bile duct injury and speed up recognition of injuries should be adopted to reduce the litigation burden and improve patient care.

Poor agreement among expert witnesses in bile duct injury malpractice litigation: an expert panel survey.

OBJECTIVE: To determine the inter-rater agreement of expert witness testimonies in bile duct injury malpractice litigation. BACKGROUND DATA: Malpractice litigation is an increasing concern in modern surgical practice. As most of the lawyers are not educated in medicine, expert witnesses are asked to testify about negligence of care in most jurisdictions. Although expert witnesses greatly determine the outcome of a claim, the reliability of expert testimony may be arbitrary. METHODS: Surgical expert witnesses independently assessed whether negligence of care occurred by reviewing the complete medical history of closed litigation cases. All cases concerned iatrogenic bile duct injury, which occurred during laparoscopic cholecystectomy. The level of agreement was measured and case characteristics associated with negligence were determined. RESULTS: Thirteen independent experts reviewed 10 closed litigation cases. In 1 of the 10 cases, full agreement was observed. In 7 of the 10 cases, the highest percentage of agreeing experts was 53% or less. Chance-corrected levels of agreement were in the slight to fair range (Kendall W coefficient of concordance = 0.16-0.25). Disease-related mortality was associated with judgments on negligence (P = 0.02). Judgments on negligence of care were not associated with delay in diagnosis or the severity of injury. Experts with more years of clinical experience agreed more about negligence. Experts working in an academic setting agreed less than experts working in a teaching hospital. Finally, 8 of the 13 experts plead for the assignment of more than 1 expert witness to review and comment in a surgical litigation case. CONCLUSIONS: The reliability of expert witness testimonies in bile duct injury litigation is frail. Defendants, plaintiffs, experts, and lawyers should be aware of the drawbacks of expert witness testimonies. Raising consensus concerning the standards of surgical care may be required to improve agreement in judgments on negligence.

Litigation after laparoscopic cholecystectomy: an evaluation of the Dutch arbitration system for medical malpractice.

BACKGROUND: Medical liability is a great concern in current surgical practice. The medical liability system in the US is under discussion in surgical literature, as the system is associated with high costs and expensive liability premiums. The aim of this study was to evaluate the Dutch arbitration system for claims filed after bile duct injury (BDI). STUDY DESIGN: Data were extracted from the largest Dutch insurance company for medical liability. Outcomes of the claim and factors associated with awarded financial compensation were determined. RESULTS: BDI litigation after laparoscopic cholecystectomy occurred in 0.08% (+/- 0.02% SD) without a substantial increase. Currently, 88 of 133 claims are closed after a median duration of 2 years (range 5 months to 6.5 years). In 61 of 88 cases (69%) liability was rejected, and in 16 cases (18%) liability was acknowledged. Median compensation (in Euros) was euro 9.826,07 (range euro 15,88 to euro 55.301,06). Rejection of liability increased from 50% in the period 1994 to 1998 versus 72% in 2004 to 2006 (p = 0.023). Factors associated with recognition were patient employment (p = 0.005) and patient death (p = 0.01). Factors associated with an increase in financial compensation are delay in imaging (p = 0.033), delay in diagnosis (p = 0.009), and relaparotomy with repair in the initial hospital (p = 0.028). CONCLUSIONS: The Dutch arbitration system for medical liability after BDI is associated with a short time to resolution and high rejection rates, and payments to BDI patients are low.

[Iatrogenic biliary ducts lesions after laparoscopic cholecystectomy: a medical technical error or a therapeutic failure in a routinely performed procedure. A medico-legal evaluation of selected cases]. / Jatrogenne uszkodzenie dróg zólciowych z nastepowa szkoda zólciowa w przypadkach cholecystektomii metoda laparoskopowa: blad medyczny techniczny czy niepowodzenie lecznicze. Ocena sadowo-lekarska wybranych przypadków.

Laparoscopic cholecystectomy due to cholelithiasis is associated with a higher risk of intraoperative lesions of biliary duct in comparison to classic surgery. Technical difficulties, a limited access to operating area, the presence of cholecystic adhesions and inflammatory lesions, as well as possible anomalies or anatomical variations of the extrahepatic biliary ducts pose the risk of damaging the biliary tract. At times, laparoscopic procedures are performed by surgeons with insufficient operator skills and qualifications. The medico-legal evaluation of intraoperative damage to the biliary tract with resulting complications--the so-called "biliary damage"--is very difficult. The presented analysis included six cases of intraoperative biliary ducts lesions evaluated by the Forensic Medicine Department, Medical University, Katowice. Three instances were associated with investigations carried out by public prosecutors in medical error cases, and in three others, civil cases were brought in the court, with the plaintiffs advancing a claim. While defining the scope of the management--both diagnostic, therapeutic and decision-making--in the pre-, intra- and postoperative period, attention was drawn to the prescriptive character of patient management in such cases, including indications for laparoscopic surgery, an increased potential therapeutic risk that also included a possibility of the patient developing "normal, typical" complications, referring the above factors to the scope and limits of the physician's professional and criminal liability and analyzing them to assess whether a medical error had been committed, or else the events had represented a therapeutic failure within the limits of the accepted therapeutic risk. A separate problem emphasized by the authors focused on difficulties in objective evaluation of health-associated consequences that might be defined in a tabular manner as long-term or permanent detriment to health.

Monetary lessons from litigation involving laparoscopic cholecystectomy.

Limited information exists on the relationship between adverse events associated with laparoscopic cholecystectomy (LC) and subsequent litigation. Out of 104 suits concerning LC, 18 cases were settled for 628,138 dollars; 48 cases resulted in a plaintiff's verdict with the plaintiff receiving 2,891,421 dollars; and 18 cases resulted in a surgeon's verdict. However, when multiple defendant cases were excluded, there was <20,000 dollars difference between a negotiated settlement and plaintiff's verdict. Given the minimal monetary differences between a settlement and a plaintiff's verdict, when a surgeon is the sole defendant in a malpractice case concerning LC, the surgeon should encourage their carriers not to settle before trial; as only a trial will exonerate the surgeon. However, this encouragement should be tempered when there are "red flags" that favor the plaintiff, including multiple defendants (especially a hospital), male plaintiffs, bile duct injuries, knowledgeable and well-financed plaintiff's attorneys, and certain plaintiff's venues.

Major bile duct injuries associated with laparoscopic cholecystectomy: effect of surgical repair on quality of life.

OBJECTIVE: To assess the quality of life (QOL) of patients after surgical reconstruction of a major bile duct injury from laparoscopic cholecystectomy (LC). SUMMARY BACKGROUND DATA: The incidence of bile duct injuries has increased dramatically since the introduction and widespread use of LC. Previous reports show that at long-term follow-up, most patients surgically repaired will have a successful outcome as measured by standard clinical parameters. However, there is a general impression that these patients have an impaired QOL. Data addressing QOL of these patients are limited. METHODS: A standard QOL questionnaire was sent to 89 patients after successful surgical repair of a major bile duct injury from a LC treated at the Johns Hopkins Hospital between 1990 and 2000. The instrument consisted of 30 items on a visual analog scale categorized into physical (15 items), psychological (10 items), and social (5 items) domains. The same questionnaire was sent to age- and sex-matched healthy controls (n = 100) and to patients who underwent uncomplicated LC (n = 100). An additional portion of the questionnaire inquired about outcome measures and legal action undertaken by patients. RESULTS: Overall QOL scores for bile duct injury patients in the three domains (physical, psychological, and social) were 76%, 77%, and 75%, respectively. QOL scores were comparable to those of patients undergoing uncomplicated LC and healthy controls in the physical and social domains but were significantly different in the psychological domain. Presenting symptoms, prior repair, level of injury, number of stents, length of postoperative stenting, and length of follow-up did not influence QOL scores. Repaired patients reported similar rates of abdominal pain, change in bowel habits, use of pain medications, and recent symptoms of fever or chills as LC controls. Thirty-one percent of responding bile duct injury patients reported having sought legal recourse for their injury. All QOL domain scores were significantly lower in the patients who pursued a lawsuit versus those who did not. CONCLUSIONS: This study provides formal data evaluating QOL after surgical repair of major bile duct injuries from LC. Although there was a significant difference in the QOL as evaluated from a psychological dimension, bile duct injury patients reported QOL scores in the physical and social domains comparable to those of control patients. The decreased QOL assessment in the psychological dimension may be attributable to the prolonged, complicated, and unexpected nature of these injuries. The presence of a lawsuit appears to be associated with a poorer QOL assessment.