Abstract
Despite the general reduction in peri-operative morbidity and mortality following elective bariatric surgery, there has been an increase in the number of claims in bariatric surgery. The litigation risk for surgeons is layered due to high patient expectations, the technical demands of the surgery itself, the need for immediate management of complication and the need for long-term follow-up. This article explores the medicolegal implications for surgeons performing bariatric surgery and more importantly for those non-bariatric specialists who may encounter patients with post-operative complications and how to minimise risk. Consent is discussed in detail especially with key cases such as the ‘Montgomery vs. Lanarkshire’ and ‘Jones vs. Royal Devon’ brought into the context of bariatric surgery.
Introduction
Despite the general reduction in peri-operative morbidity and mortality following elective bariatric surgery seen over the last 20 years, there has been an increase in the number of claims in the bariatric surgery both in the UK and worldwide. In this article, we explore the current state of bariatric medicolegal activity and the pitfalls a surgeon face. We also attempt to define the role of the general surgeon and the medicolegal ramifications of looking after post-bariatric surgery patients who are admitted with complications.
Bariatric surgery
Despite the fact that bariatric surgery has one of the lowest peri-operative risk profiles of any elective procedures performed in the UK, 1 bariatric surgery is now classed one of the highest litigation risks by the major medical insurance companies. The reasons for this are multifactorial and include the following.
Rise in the number of bariatric procedures performed
An analysis of a retrospective study based on data from the Physician Insurers Association of America database from 1990 to 1999 and 2000 to 2009 for claims associated with obesity and morbid obesity showed the errors involved, severity of injury, the procedure and outcomes. Of the 575 claims that were identified, gastric bypass was the most common procedure and the number of morbid obesity claims rose from 9 during the first period to 249 in the later period. The authors concluded that the significant rise in morbid obesity claims between the two periods is likely caused by the substantial increase in the number of bariatric procedures performed. 2
Nature of the surgery
Bariatric surgery can be technically demanding. Surgeons whose primary training and experience is in resectional upper gastrointestinal surgery perform a significant proportion of bariatric surgery. Although a large number of these skills are transferable to bariatric surgery, some surgeons (particularly those trained in the era of open as opposed to laparoscopic surgery) may not have the training necessary to perform laparoscopic bariatric surgery to a high level. Many hospitals do not have the specialist equipment needed to deal with challenges of managing bariatric patients such as CT scanners capable of coping with the weight of the morbidly obese.
Patient expectations
There is a higher incidence of depression and psychological disorders in the bariatric surgical population as compared to the general population. This can lead to unrealistic expectations of what surgery has to offer to them. 3 This may also be complicated by the wealth of information (some accurate, some less so) available to patients through blogs and support groups available over the internet. Finally, in most countries with a predominantly state-funded healthcare system such as the UK but not the US, there is often an underprovision of bariatric surgery in the publically funded hospitals. 4 As a consequence of this, a large number of patients are forced to pay these operations privately and as such tend to have a lower threshold for complaining should something go wrong.
Postoperative care
Unlike a lot of traditional gastrointestinal surgery where the vast majority of clinical input occurs in the immediate postoperative period, bariatric patients tend to require continued longer term follow-up and supervision. For example, patients with gastric bands may require multiple band adjustments, whilst patients undergoing gastric bypass and duodenal switch require multivitamin supplementation for life and regular monitoring of their micronutrient levels. A small proportion of patients regain weight in the realms of 15% of maximal weight initially lost in the longer term following surgery, and this can be a source of dissatisfaction and potential litigation. 5
Despite the importance of medicolegal claims in bariatric surgery, there is surprisingly little in the medical literature on this subject. In the largest study on this topic, Cottam et al. 6 reviewed the case notes of 100 consecutive bariatric lawsuits. The most common adverse events initiating litigation were anastamotic leaks followed by intra-abdominal abscess, bowel obstruction, major airway events, organ injury and pulmonary embolism. In terms of clinical outcomes, 32 patients had a documented intra-operative complication and 72 required additional surgery. A total of 53 patients died and 28 had a full recovery with remainder having minor or major disability. Analysis by a medical malpractice lawyer found potential negligence in 28% of cases – the most common cause of negligence being delay in diagnosis of a complication or misinterpretation of vital signs.
Interestingly, surgeons with less than one year of experience in bariatric surgery were most likely to be involved in lawsuits. It should be noted that this analysis was performed on cases performed between 1997 and 2005, and as such included a significant number of operations such as vertical banded gastroplasty and open gastric bypass, which are no longer routinely undertaken. In addition, none of the patients in the cohort underwent gastric band insertion, which again probably reflects the timeframe during which this study was conducted. In a similar study, Bruguera et al. 7 reviewed the case files of 49 medicolegal bariatric cases presented to the Professional Liability Department of the Catalonian Medical Colleges Council from 1992 to 2009. In 47% of the cases, the patients died, 21% made a complete recovery and the remainder had some residual impairment. The most frequent causes of death were peritonitis due to anastomotic leaks (48%) and respiratory complications. Malpractice was considered to have occurred in 20% of cases, and interestingly in 6% of cases, the surgeons were convicted in criminal court of criminal negligence. In both of these studies, the finding of negligence was typically based on the failure to detect complications in a timely fashion as supposed to the complications themselves. It should also be noted that both studies focused on early postoperative complications associated with bariatric surgery and did not analyse litigation associated with late complications following surgery.
In the United Kingdom, the only paper addressing the issue of bariatric surgery was addressed by Ratnasingham et al. 8 They analysed the claims data from the UK National Health Service Litigation Authority and have found only a total of seven claims for bariatric surgery, of which four were successful with a payment sum of £210,000 over a period of 10 years. It should be noted that this figure is likely to be a gross underestimate of the actual medicolegal burden in the UK given that bariatric surgery has only recently developed into a high volume service in the UK, and these data did not take into account the claims in the private sector where a high proportion of cases are performed in the UK.
Medicolegal standards
Given the rising burden of the medicolegal claims, the obvious question for any bariatric surgeon is what are the medicolegal standards expected and how can they be achieved. Although there are no hard and fast rules on this subject, under English law, this has been governed by the so-called ‘Bolam principle’ – namely that provided a body of medical practitioners who would agree with the consenting process, it would be deemed to be of an acceptable standard. This approach of peer validation has been criticised as allowing too much leeway to medical practitioners and it should be noted that the majority of legal jurisdictions do have higher standards which medical practitioners need to attain in order to prevent successful claims of negligence. Indeed, this has been revised in the case of Bolitho to incorporate a test of reasonableness and is likely in the future to become more proscriptive.
With regard to specific areas of litigation, these can be divided into the following.
Consent
Although consent was governed by the ‘Bolam/Bolitho test’, this standard has now been overturned by a recent ruling in Montgomery vs. Lanarkshire. In this case, a lady with diabetes and small stature delivered her son vaginally; the baby had a complicated delivery due to shoulder dystocia with subsequent hypoxic injury resulting in cerebral palsy. The obstetrician had not informed her of the increased risk of this complication from vaginal birth, despite the patient asking if the baby’s size could be a potential problem. The UK Supreme Court found for the Claimant overturning the Bolan Principle, establishing that patient should be told what they want to know rather than it being a matter for clinical judgement to be assessed by the clinician. Although Montgomery changed the legal position, the General Medical Council has always advised doctors to that effect in its guidance. Particularly, paragraph 28 of the ‘Consent: doctors and patients making decisions together (2009)’ states ‘The amount of information will depend on the individual patient and what they want or need to know’. 9
On reviewing this, it is clear that in order to conform to accepted medicolegal standards, bariatric patients need to undergo a fully informed consenting process. This consists of pre-operative counselling as to the risks and benefits of bariatric surgery. Although individual patient’s medical co-morbidities must be taken into consideration in counselling patients as to the risks of surgery, the use of a generic bariatric surgery consent form may be helpful as a tool to reduce litigation. All patients should be counselled that there is a chance of weight regain after any bariatric procedure, and their expected weight loss will be determined by a number of factors including the technical aspects of the operation and the patient’s willingness to alter their behaviour in terms of the dietary intake following surgery. All patients should also be warned that they will have a significant risk of loose overhanging skin after surgery which may require plastic surgical intervention.
Following surgical consultation, patients should be discussed in a multidisciplinary team (MDT) environment with the involvement of dieticians, psychologists, anaesthetists and physicians. The purpose of the MDT involvement is to assess the suitability of the patient for bariatric surgery and also in conjunction with the patient to decide which bariatric operation best suits each individual patient. The patient should also be given a written summary of the risks and benefits of each of the bariatric operations and allowed a cooling period prior to surgery to allow them to take stock of their options before written consent is reconfirmed. The patients consent should also be re-affirmed prior to surgery and on the day in order to minimise the risks of an uninformed patient.
It should be noted that the Montgomery case has not to date had a major impact on bariatric surgery litigation. However, more recently, the Jones vs. Royal Devon case held that the failure of a Trust to provide the named surgeon to undertake a particular spinal procedure (it was in fact performed by a qualified but less experienced colleague) invalidated the consent and allowed the claimant to successfully sue for damages. Given the current waiting time pressures in the NHS collective (so-called ‘pooled’), waiting lists are becoming more common in bariatric surgery, meaning this case may have significant implications for bariatric surgeons.
Technical performance of the operation
There is surprisingly little in the literature on what constitutes an appropriate medicolegal standard in the performance of surgery. Clearly, gross technical errors (e.g. the attachment of the biliary limb to the gastric pouch during gastric bypass surgery – the so-called Roux en O) are indefensible, but these are relatively rare. As previously discussed, the most common cause of successful litigation is failure to detect and act on the complications in a timely manner. For example, although a leak following gastric bypass surgery is not in itself an indicator of negligence, ‘failure to rescue’ or death from a treatable complication would be regarded as a negligent error. This can be problematic as the signs of leak can be subtle and as such bariatric surgeons should have very low threshold for investigating patients whose clinical recovery appears to be delayed. In addition to surgical complications, it should be noted that bariatric patients often have significant co-morbidities that need to be optimally managed during their hospital stay. In particular, bariatric patients have a high risk of deep vein thrombosis and suitable thromboprophylaxis is an essential part of their care.
Postoperative care
Finally, following discharge from hospital, patients should be given written advice regarding their dietary intake in the immediate postoperative period and appropriate information regarding their vitamin supplementation. Although these patients should ideally be followed up for life by the bariatric team, this may not be logistically feasible; however, if a patient is to be discharged, it is incumbent on the bariatric surgeon to ensure that appropriate follow-up is arranged with their primary care physician.
Bariatric management by the non-specialist
There is an increasing burden of patients presenting to their primary care physician or emergency department, requiring either routine follow-up or emergency management of complications related to bariatric surgery. The reasons for this recent rise in the number of patients requiring clinical input from non-specialist, non-bariatric institutions due to a number of factors include:
There is a growing number of patients having bariatric surgery, increasing the pool of patients in the community susceptible to the potential long-term complications associated with bariatric surgery. There is a large, well-advertised international market for bariatric operations, and hence many patients do go abroad for their surgery and these classes of patient are likely to access their local health services as opposed to their original institution. Patients having bariatric surgery are often young, and as such there is a significant incidence of patient migration for work or personal reasons from the area where the original surgery was performed.
Patients presenting with a post-operative complication will typically go to their local emergency department, and these hospitals may not have surgeons with familiarity in bariatric surgery nor experience in dealing with post-bariatric surgical emergencies. In addition, the facilities in such hospitals may not be able to cater for the special needs of morbidly obese patients. The question which then arises is ‘what is the minimum medicolegal standard of care that these hospitals need to provide to such emergency bariatric patients?’ Although these standards can vary from jurisdiction to jurisdiction, under English law, the hospital will be expected to provide a standard of care provided by a reasonably competent general surgeon in a non-specialist hospital, as opposed to the optimum standard of care which would be afforded by a specialist bariatric unit. An important principle is that these patients should be discussed at the earliest opportunity with a bariatric unit (ideally the institution where the surgery was originally performed) and, where possible and appropriate, early transfer of the patient should be arranged. However, this should not delay treatment, as the majority of complications after bariatric surgery tend to be general surgical complications (e.g. intestinal obstruction) and as such the management of these complications should be within the remit and capacity of a general surgeon covering the emergency take. Failure to recognise these problems early and intervene in a timely fashion is one of the most common causes of preventable, major long-term disability or death in bariatric surgical patients and hence such failures should be considered to be sub-standard provision of care. In the future, as surgical education incorporates bariatrics as a routine part of the curriculum, this should be less of an issue. At present, however, the non-specialist can refer to guidelines from the British Obesity and Metabolic Surgery Society and the American Society for Metabolic and Bariatric Surgery which provides comprehensive information for integrated health professionals.
Finally, it should be noticed that we have so far focused exclusively on the medicolegal aspects of patients enrolled within a surgical programme. However, in countries such as the United Kingdom with a predominantly state-funded health care system, there is a growing problem with access to publically funded bariatric surgery. For example, in the United Kingdom, less than 1% of the patients who would benefit clinically from bariatric surgery are in fact funded for this operation. It is likely that this rationing of bariatric surgery will become a significant source of medicolegal claims in the future.
Conclusions
Bariatric surgery is designed in conjunction with other behavioural modifications to improve the long-term functional outcome of patients. Unlike traditional resectional gastrointestinal surgery, bariatric surgery requires a different paradigm with a truly multidisciplinary approach both pre- and post-operatively to improve the long-term functional outcomes of patients. As our experience in performing bariatric procedures increases, the procedure has become so safe that anything less than an ideal outcome may yield litigation. It is still viewed as a discretionary procedure and until that perception is changed to a life-saving procedure, these claims will unfortunately continue. However, with appropriate multidisciplinary involvement and robust protocols for the pre-, intra- and postoperative management of these patients, these risks can be mitigated and reduced.
Footnotes
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.