Abstract
Introduction
With the increasing number of Arthroscopic surgeries, comes with it, the undesirable problem of litigation associated with it. Arthroscopy does possess certain unique aspects which need to be understood from the legal point of view as well.
Materials and Methods
We obtained information on specific medico-legal cases involving arthroscopy from books and websites containing collections of medico-legal judgments in Indian legal courts, consumer dispute redressal forums at the state and national levels, and state medical councils..
Results
We assimilated and analysed all this information, combined it with our experience in the field of medical law, and have provided practical, enforceable ways to decrease the medicolegal risk for arthroscopy surgeons.
Conclusion
This review provides a comprehensive overview of pressing issues in relation to the medicolegal aspects of arthroscopic surgery.
Keywords: Arthroscopy, arthoscopic surgery, medicolegal, litigation, lawsuits
Introduction
Arthroscopy has gained widespread popularity and acceptance in the past two decades in India [1]. Today arthroscopy has already developed into a subspecialty of orthopaedics, with arthroscopy of the knee, hip, ankle, shoulder, elbow and wrist being done across the country [2, 3]. With the increasing number of these surgeries, comes with it, the undesirable problem of litigation associated with it. While litigation is not a problem restricted to arthroscopy surgeons, arthroscopy does possess certain unique aspects which need to be considered and understood from the legal point of view as well. This review is an attempt at exploring all of those aspects and provide a comprehensive overview of the pressing medicolegal issues in relation to arthroscopic surgery.
Material and Methods
We conducted a thorough search of the literature to find studies on the medico-legal aspects of arthroscopy. We used PubMed and Cochrane Library databases, employing search terms and Boolean operators such as 'medico-legal' OR 'lawsuit' OR 'malpractice' OR 'litigation' AND ‘arthroscopy' OR 'arthroscopic surgery' OR. We did not limit the publication date and only included studies in English. Additionally, we searched the reference lists of identified articles to find more studies. We obtained information on specific medico-legal cases involving arthroscopy from books and websites containing collections of medico-legal judgments in Indian legal courts, consumer dispute redressal forums at the state and national levels, and state medical councils. We reviewed Indian legal databases for information on such cases, to identify the issue at hand, analysed the facts of the case, judgements delivered, and drew our learnings from such cases. We assimilated and analysed all this information, combined it with our experience in the field of medical law, and have provided practical, enforceable ways to decrease the medicolegal risk for arthroscopy surgeons.
Causes of Litigation
Any surgical procedure is associated with possible complications. But it is important to understand that not all complications lead to lawsuits. Furthermore, the mere occurrence of a complication, does not constitute medical negligence. Therefore data and reports of lawsuits following arthroscopy were analysed to identify the reasoning for malpractice claims (Table 1).
Table 1.
Most common reasons for litigation in arthroscopy cases
The 5 most common reasons for litigation in arthroscopy cases |
---|
Persistence of pain |
Post-operative infection |
Technical errors |
Nerve damage |
Vascular injury |
Rougereau et al. identified that the most common reason lawsuits following arthroscopy were persistence of pain (43%), postoperative infection (29%), technical errors (10%), nerve damage (5%), and vascular injury (2%) [4]. The two joints most commonly involved in litigation are, not surprisingly, the knee and shoulder [4–6], considering that they are most frequently operated joints. A failure to inform patients about possible complications was also a common reason for lawsuits [5]. A point of significance is that complications like vascular injury are much more likely to result in the surgeon being held guilty of negligence than claims like surgeon technical error. [7] Pulmonary embolism was noted to be most major complication that could lead to death of a patient [7]. Unfortunately there is no such organised data available for medicolegal cases in India. From our own experience dealing with medicolegal cases in India though, we found that disputed diagnosis, and change in surgical plan are common reasons for lawsuits in India. We explore some such cases in the later part of this paper.
Wrong sided Surgery
Wrong sided surgery is not uncommon with arthroscopy for obvious reasons that there may be no external markers of injury and similar appearance of anatomy on both sides. In fact arthroscopy is second most common type of surgical procedure to result in wrong sided surgery, second only to spine surgeries [8]. Wrong sided surgeries are one of those instances when even an excellent attorney may be unable to defend the surgeon successfully. Miller too remarks that wrong-site surgery results in a successful verdict for the plaintiff in all the court cases [9]. It is therefore paramount that wrong sided surgery be prevented from occurring in the first place. We recommend using the World Health Organisation surgical safety checklist in all surgical cases [10]. The extra minutes spent, if done in a timely manner, need not increase surgical time significantly, while possibly preventing a mishap and trouble for the patient and surgeon alike. It has proven to be successful in reducing the number of wrong sided surgeries [11]. It is our recommendation that the surgical site marking be done after confirming the site and side with the patient orally rather than only relying on the medical records. While the side marking of radiographs, computed tomography or Magnetic Resonance Imaging (MRI) films and reports should be used to reconfirm the side of surgery and procedure planned, they should be cross verified by other means as these imaging reports can occasionally be incorrectly marked.
Deep Vein Thrombosis (DVT) and its prophylaxis
Deep vein thrombosis is a serious complication that can occur following lower limb surgeries and can be a potential cause of litigation if it occurs. So use of prophylaxis for DVT becomes a very pertinent decision to consider for arthroscopy surgeons. The incidence of DVT following arthroscopic surgeries is low, with studies reporting it to be as low as 0.25%, [12] but some studies have also found the incidence to much higher when checked by venography, though most of those tend to remain asymptomatic [13]. DVT prophylaxis does come with its own drawbacks of increased risk of bleed and increased medical expense. So the question of whether DVT prophylaxis needs to be given in all patients undergoing arthroscopic surgeries becomes important from practical and legal perspectives [14]. While some studies concluded that it is beneficial in decreasing incidence of DVT and should be routinely used, [15, 16] some authors have cited the lack of clear benefit to warrant its use [17–21]. Overall, there appears to be a lack of consensus even among arthroscopy surgeons regarding its utility [22]. In this regard, a consensus study done in collaboration with several leading arthroscopy surgeons in India in 2022 is a pivotal point in this debate. The study concluded that the usage of DVT prophylaxis is justified only in a select group of patients undergoing arthroscopic surgery. The expert responses favoured usage of DVT prophylaxis based on patient factors like advanced age, past history of DVT, smoking, oral contraceptive use etc.[23] We believe this consensus report maybe the closest we have to act as a guideline for DVT prophylaxis, and would recommend following the same.
Infection
Infection is a difficult problem to manage for surgeons, and one that is aggravated by the fact that patients almost always attribute the cause to be a lapse by the surgeon or the surgical team. It is therefore not surprising that occurrence of a post-operative infection can pose not only a clinical problem, but a medicolegal one as well [24]. This is especially true for infection within a short period of time after surgery, which becomes arduous to defend. An analysis of the legal judgements by Indian courts in cases involving post-operative complications reveals that the courts acknowledge that the mere occurrence of a post-operative complication cannot be construed to be medical negligence [25]. However, it is imperative that infections be recognised early and treated accordingly [26]. We believe the failure to diagnose and appropriately treat the infection would be actual deficiency exposing oneself to legal retribution, rather than the occurrence of the infection itself. The legal defence we employ in cases involving post-operative infection would be to demonstrate that sufficient precautionary measures were employed throughout the surgery and follow up by the medical team.
A contentious point in relation to infection in arthroscopy cases would be the use of perioperative prophylactic antibiotics. The overall incidence of infection following arthroscopy is very low, and significantly lower than orthopaedic trauma surgeries and arthroplasties [27, 28]. This is attributed to the smaller incision size, shorter duration of surgeries and minimal soft tissue handling. But this does not mean infections do not occur. The risk of infection is increased considerably in patients with uncontrolled diabetes, immune disorders, etc. The increased use of implants, increased complexity of arthroscopic surgeries and corresponding increase in duration of arthroscopic surgeries can increase the risk of infection further [29]. This then gives rise to the question of prophylactic antibiotics. The use of perioperative prophylactic antibiotics has to be justified sufficiently as they increase costs, can cause adverse drug effects, and possibly contribute to the development of antibiotic resistance [30]. Studies have shown that use of perioperative antibiotics decreases the incidence of septic arthritis and defend its use [31, 32]. Other studies argue that their use may still not be warranted as the benefit in reduction of infection rate is insignificant.[33, 34]. Some authors therefore recommend a middle path of using prophylactic antibiotics only in selectively patients having risk factors for infection and in cases where implants are inserted [35]. While the cost–benefit analysis is still to be conclusively established, we recommend the use of prophylactic antibiotics in all arthroscopy surgeries, as it would be valuable in the legal defence if infection occurs, to demonstrate that all necessary and possible measures to prevent infection were employed by the surgeon.
Other Complications
Arthroscopy involving different joints can potentially cause distinct complications. While the complications are rare, we’d like to address two specific complications that are very often attributed to surgeon negligence. Nerve injury can occur during arthroscopy due to direct damage to nerves while making arthroscopic portals or during surgical manoeuvres, or indirect damage due to traction or pressure mechanisms. The use of a tourniquet can also lead to compression and ischemic nerve injury [36]. Nerve injuries are one of the complications that are difficult to defend in courts of law as it is difficult to attribute it to any reason other than iatrogenic, if it were to arise only after the surgery [37]. Hence it is imperative that arthroscopy surgeons be aware of possible neurological structures that can be damaged in the course of the surgery. If any degree of neurological injury is present before the surgery, it is imperative that the same be documented in the medical records. Prevention of such injuries not only entails a meticulous surgical technique but also simple, yet significant steps, like proper patient positioning and adequate padding of possible nerve compression sites.
Another potential complication which has been pinned on the surgeon is implant failure. There are several instances where, even though the surgical technique was impeccable, a failure of implant due to a manufacturing defect, has left the surgeon facing litigation [38]. Therefore it is vital that the surgeon be aware of various aspects of the implants being used, including verifying the presence of required licences for use of the implant. Discussing the implants with the patient pre-operatively is recommendable as it demonstrates transparency and fosters trust [39].
Operative Notes
One aspect of arthroscopic surgeries distinct from other orthopaedic procedures like trauma surgery, deformity correct, or arthroplasty, is that there it is seldom possible to visually demonstrate the correction of the problem to the patient. Radiographs are useful only if metallic anchors or interference screws are used and even then only depict a part of the procedure conducted and do not reveal the ligament or tendon repaired/reconstructed as such. Post-operative MRIs can depict the soft tissue repair to some extent, but are not commonly done due the expenses involved. When done, they do not necessarily provide a clear picture of the anatomy, and can get further obscured by the presence of metallic implants and artefacts. When there is such lack of demonstrable evidence of the surgical procedure performed, it further increases the significance of proper documentation of operative notes. The operative notes therefore become the most important medicolegal document to settle any legal matter in relation to the surgical procedure [40]. It is important to list all the procedures that were performed, brief steps of the procedures, the findings encountered, any difficulties faced, and implants used. One must remember, that no matter how meticulous the procedure performed, the documentation of operatives notes is still going to be what the courts will assume being representative of what was actually performed. We would also like to mention here that the operative notes are also going to be relied upon heavily by insurance companies and are routinely reviewed before approvals for claims. An omission error of not mentioning the complete procedure or implant used can lead to insurers approving an insufficient amount. If a disputed insurance claim is being reviewed in a court of law, you can be rest assured that the operative notes will be the focal document to determining what procedure was done or which implants were used.
Intraoperative Videography
Another unique problem faced by arthroscopic surgeons is convincing the patient and patient attenders about what was encountered intra-operatively and what was done for it. A few decades back recording the arthroscopic procedure was cumbersome and there were several issues of compatibility and formatting, but today most arthroscopic systems have the provision for simultaneous recording of the arthroscopic visuals, which can be retrieved easily. They say if a picture is worth a thousand words, then a video is worth an entire book. Apart from using the video recordings for teaching purposes, technique demonstrations at medical conferences, publications and surgical review, this has also made it possible for patients to be provided a copy of the recording of the surgery. Many surgeons however would not be willing to hand over the complete video of the surgery to the patient to avoid scrutiny [41]. There may be some justification to that opinion as patients or medical professionals not trained in arthroscopy may incorrectly interpret visuals and create suspicion. The recordings are not without fallacies as well. When only still images are captured, it may be hard to orient oneself to the anatomy, and an image may not be able accurately demonstrate certain dynamic findings. Video recordings provide the entire picture, though not in its truest sense. One must remember that while video recordings of an entire procedure would demonstrate all the arthroscopic visuals seen by the surgeon, it cannot indicate the limb position, clinical assessments of stability, and steps like screw sizing and tightening that still require a ‘feel’ and not just visual assistance. There is also the problem that most recordings may not necessarily display the patient’s name, identification number or date and time of surgery. This would make it susceptible for such videos to be mixed up with those of another patient. If the recordings are being stored, it would have to be done securely, as it contains medical information of the patient, that needs to be kept confidential.
There is no law mandating that the video recording of the surgery has to be handed over the patient, and it remains the individual surgeon’s choice. Keeping these recordings could also turn out to be beneficial for the orthopaedic surgeons. It can act as a proof of the findings encountered intra-operatively and of the procedure performed. This is especially useful if there is claim of incorrect diagnosis, incorrect procedure or inadequate surgical technique made against the surgeon. But its utility in a court of law is not full proof. The validity of the video can be challenged by the counsel of the patient if it does not contain the patient details, and can easily be alleged to be of another patient. Providing the copy of the video to the patient at or before the time of discharge and documenting the same, can help indicate transparency, but does not necessarily prove authenticity. Considering all of the above, our recommendation is to store the recordings of all arthroscopic surgeries, but not necessarily handover the same to patients or attenders, or to do so only in selective cases where the surgeon believes it will do more good than harm. We do recommend that, if the patient is not under general anaesthesia during the procedure, he/she be made to view the monitor and be shown the important findings and the final status after the procedure is done.
Specific Arthroscopic Procedures
We analysed the medicolegal cases involving some common arthroscopic procedures with the aim of identifying similarities, trends and valuable lessons from it (Table 2).
Table 2.
Most common reasons for litigation following specific arthroscopic surgeries
Most common reasons for litigation following specific arthroscopic surgeries | |
---|---|
Anterior cruciate ligament reconstruction | Post-operative infection |
Inadequate surgical technique/graft malpositioning | |
Persistent pain | |
Rotator cuff repair | Persistent pain |
Loss of range of motion | |
Cuff weakness |
Arthroscopic Anterior Cruciate Ligament (ACL) reconstruction and rotator cuff repair of shoulder were focused upon as they are among the most commonly done arthroscopic procedures of the knee and shoulder respectively [42]. With respect to ACL reconstruction, the most common cause for litigations were postoperative septic arthritis followed by the claim of suboptimal surgery [43]. Available data shows that the arthroscopy surgeon is more likely to win the malpractice suit if pain or limited range of motion is the only complaint and less likely to win if a surgical error was alleged [44]. While the mere occurrence of infection following surgery does not necessarily amount of medical negligence, the delay in identification and treatment of post-operative infection has led to the surgeon being held guilty [45]. Interestingly, cases involving the use of hamstring graft for ACL reconstruction were found to have thrice the risk of the surgeon losing the litigation than when bone- patellar tendon- bone grafts were used [46]. One important learning from many of these medicolegal cases involving ACL reconstruction is the need to set realistic expectations of the surgery for the patient [47]. We cannot emphasise enough how important proper patient counselling prior to surgery is, for establishing trust, managing patient expectations and avoiding lawsuits. In many cases the information given to the patient prior to the surgery were found to be inadequate, especially with regards to the need for post-operative rehabilitation therapy [48]. Providing comprehensive information to the patient before the surgery even improves patient satisfaction rates after surgery thereby decreasing the incidence of lawsuits [49]. When it comes to arthroscopic rotator cuff repair, the most common reason for malpractice claims were decreased range of motion, rotator cuff weakness and residual pain [50–52].
Some Indian Cases and Valuable lessons
Lastly we are going to discuss four medicolegal cases involving arthroscopy that have verdicts delivered in Indian Courts. These four cases were chosen for discussion because they are representative of the unique challenges that arthroscopy surgeons may face and have novel learnings not previously addressed in this paper. The names of the individuals and doctors have not been mentioned for the sake of anonymity. We have had to summarise the case details for the sake of brevity, but have attempted to ensure an accurate overview of the case has been given. The purpose of this discussion is not to criticise individuals or pin blame, but rather to have an insightful discussion of the case in order to take away some valuable lessons which can help the readers in their own clinical practice. One must also note the verdicts delivered in these cases are not necessarily to be taken as representative or unequivocal as they could have been/are still being challenged in higher courts.
Case 1: Before the State Consumer Disputes Redressal Commission, Punjab, verdict delivered in December 2015. { First Appeal No. 1466 of 2013} [53]
The patient approached Doctor No.1 due to pain in his left knee and was diagnosed to have left knee ACL tear, and was recommended surgery, to be performed by Doctor No.2, an arthroscopy specialist from another city. On the day of the surgery, there was a delay, and it was discovered that the complainant's name was not on the theatre list. Eventually, the surgery started, but Doctor No.2 stopped it midway, stating that there was an additional problem of Posterior Cruciate Ligament (PCL) tear in the same knee and advised the patient to come to his city for both ACL and PCL surgeries. The patient alleged incomplete surgery and requested a refund, but only a partial amount was returned. The patient filed a complaint seeking compensation. The doctors argued that there was no negligence on their part and claimed that the surgery was not completed due to the discovery of additional damage during the procedure.
The district forum delivered the verdict in favour of the patient. The reasoning given for the same by the district forum was that the additional procedure required for reconstruction of PCL was similar to ACL reconstruction, entailed a counselling or consent similar to the lines of those ACL suggesting it could have been obtained intra-operatively, and if the surgeon did not have the sufficient time for the surgery it should not have been taken up and scheduled at a different time instead. While we do not necessarily agree completely with the remarks of the forum that the PCL reconstruction did not require additional instrumentation, expertise and consent process, there are still some valuable lessons that orthopaedic surgeons can take from this case.
The first is to recognise this problem that arthroscopic surgeons often face, of encountering different problems intra-operatively than those discernable in MRI or pre-operative clinical examination. This is very common, especially with meniscal injuries of the knee. Hence we recommend that all patients be counselled pre-operatively that there is always the possibility of additional/different findings being encountered intra-operatively, that were not revealed/expected preoperatively, and secondly be prepared with a plan of action if such a situation arises. The plan of action would include establishing a policy that an attendant/family member always be available in the hospital premises at the time of the surgery. Preferably this patient representative be chosen by the patient preoperatively and be documented in the case files. Having additional instruments and implants for commonly encountered intra-op conditions would enable the additional procedure to be performed if required. When faced with such a situation intra-operatively, if equipped to perform the additional/different procedure, we recommend giving the choice to the patient and patient representatives and obtain written documentation of their preference to proceed with the procedure/defer it.
Case 2: Before the State Consumer Disputes Redressal Commission, Punjab, verdict delivered in January 2017. {First Appeal No.626 of 2014} [54]
In this case a patient had knee pain and the MRI showed a tear in the lateral meniscus. The surgeon advised the patient to undergo arthroscopic repair of the lateral meniscus. Post the surgery the patient was informed that intra-operatively the lateral meniscus was found to be normal but the ACL was torn, and hence the ACL was reconstructed. The patient claimed that the wrong surgery was done, that the lateral meniscus should have been repaired, and that there was no ACL Tear as it was not seen in the MRI. Despite the doctors’ attempts at explaining to the commission that the MRI is only predictive and not as accurate as seeing the structures arthroscopically, the courts delivered a verdict against the doctor.
This case is a reversal of the previous case. Here there was a new intraoperative finding, which was treated, and yet the surgeons were held to be negligent. This reiterates the point we made earlier that when faced with new findings intra-operatively compared to what was anticipated preoperatively, there is no one option (proceeding with the new procedure or not performing the procedure) that can necessarily ensure legal safety. Instead the choice should be made by the patient and their choice among the two options should be documented in writing. There are other learning opportunities here. We believe the reason why the verdict went against the surgeon was that they had no evidence to show that intra-operatively there was an ACL tear and lateral meniscus was normal. A video recording of the surgery could have been quite useful in this case to convince the patient and the judge about the intra-operative findings.
Case 3: Before the National Consumer Disputes Redressal Commission, New Delhi, verdict delivered in October 2020. {Revision Petition No. 5028 of 2008} [55]
A patient complaining of knee pain was found to have loose bodies in the knee joint in the radiographs and MRI, and was recommended to undergo arthroscopic loose body removal by the orthopaedic surgeon. The patient filed a lawsuit against the surgeon stating that instead of an arthroscopic procedure, an open procedure (arthrotomy) was done for the loose body removal. The surgeon contested that during the arthroscopy the loose bodies were found to be quite large, measuring approximately 1 cm, and hence required to be removed by arthrotomy. The court ruled in favour of the surgeon in this case.
It is important to note here that what swung the case in the favour of the surgeon was the fact that the patient was explained before the surgery itself that if the arthroscopy was not successful, open surgery would be done and the same was documented in the case sheet. The reason we chose to discuss this case is because it deals with the scenario of having to change an arthroscopy case to an open case intra-operatively, a situation commonly encountered by arthroscopic surgeons for a host of different conditions. While it is less common for conditions of the knee, it is much more common for certain conditions of the shoulder, especially severely retracted rotator cuff tears. It is our recommendation therefore, that the informed consent form obtained for arthroscopic procedure, have it mentioned that, if it is found intra-operatively that the condition cannot be address sufficiently arthroscopically, then a mini-open/open procedure will be required.
Case 4: Before the National Consumer Disputes Redressal Commission, New Delhi, verdict delivered in October 2020 {Revision Petition No. 2195 of 2016} [56]
A patient was diagnosed to have meniscus tear based on MRI. The patient underwent an open meniscectomy. The patient claimed that this was the wrong treatment advised and performed by the surgeon, and that an arthroscopic meniscal repair should have been done instead. The court gave the verdict in favour of the surgeon.
In the previous case no.3 discussed above an arthroscopic procedure was advised, attempted and converted to an open approach. In this case however, the surgeon had advised an open procedure itself as there was no arthroscope at the hospital. So the question here was whether it was acceptable for a procedure that is routinely done arthroscopically to be done as an open procedure. The court remarked that it is not negligence for a surgeon to choose to perform a procedure as long as it is an accepted mode of treatment. While it may be inferior to arthroscopic procedure in some ways, it would still not constitute to be negligence as it was an established, accepted procedure for the treatment of meniscal tear. We must also be aware that not all medical establishments in the country have the same resources and instrumentation, and such factors also play a role in deciding the appropriateness of treatment.
We have summarised our recommendations to decrease the medicolegal risk for arthroscopic surgeries in Table 3. We believe the recommendations are practical and enforceable by individual surgeons, departments and hospitals across country without requiring additional significant effort or resources. They would not only safeguard the doctors from litigation, but also help improve patient-doctor communication, increase trust and clinical outcomes.
Table 3.
Our recommendations to decrease the medicolegal risk for arthroscopic surgeries
12 recommendations to decrease medicolegal risk for arthroscopic surgeries |
---|
Use a WHO Surgical Safety Checklist for every surgery to avoid wrong sided surgery |
Cross check side of surgery with patient, case file and imaging films before incision |
Give DVT prophylaxis for high risk patients like advanced age, past history of DVT, smoking and oral contraceptive use |
Use prophylactic antibiotics during the perioperative period |
Identify any post-operative complication early and treat it appropriately. Avoid trying to conceal the complication or dismissing it |
Use good quality implants which have the necessary licences for use |
Ensure operative notes are detailed and include all the procedures performed and implants used |
Store video-recordings of all the surgeries if possible |
Ensure patient has realistic expectations from the surgery |
Explain to the patient before the surgery that the MRI and clinical examination are not always entirely accurate, and the condition can only be conclusively known after arthroscopy |
When faced with an unplanned situation intra-operatively, obtain informed written consent of the patient to proceed with/defer the procedure |
In the informed consent, always mention that the procedure may need to be converted to an open procedure if arthroscopic management is deemed insufficient for the case |
Conclusion
Malpractice lawsuits are constantly on the rise, and arthroscopic surgeons are going to have to encounter them. It is therefore important for surgeons to be aware of some of the unique medicolegal aspects of arthroscopy. Being cognizant of these factors and incorporating the necessary changes in one’s clinical practice will help prevent litigation and make the surgeon’s defence much stronger in a court of law.
Funding
None.
Declarations
Conflict of interest
None.
Ethical standard statement
This article does not contain any studies with human or animal subjects performed by the any of the authors.
Informed consent
For this type of study informed consent is not required.
Footnotes
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