Litigation relating to conditions affecting the shoulder and elbow

Transcription

1 SPECIALTY UPDATE: SHOULDER AND ELBOW Litigation relating to conditions affecting the shoulder and elbow AN ANALYSIS OF CLAIMS AGAINST THE NATIONAL HEALTH SERVICE C. L. Talbot, J. Ring, E. M. Holt From University Hospital of South Manchester NHS Foundation Trust, Manchester, United Kingdom We present a review of claims made to the NHS Litigation Authority (NHSLA) by patients with conditions affecting the shoulder and elbow, and identify areas of dissatisfaction and potential improvement. Between 1995 and 2012, the NHSLA recorded 811 claims related to the shoulder and elbow, 581 of which were settled. This comprised 364 shoulder (64%), and 217 elbow (36%) claims. A total of 18.2 million was paid out in settled claims. Overall diagnosis, mismanagement and intra-operative nerve injury were the most common reasons for litigation. The highest cost paid out resulted from claims dealing with incorrect, missed or delayed diagnosis, with just under 6 million paid out overall. Fractures and dislocations around the shoulder and elbow were common injuries in this category. All 11 claims following wrong-site surgery that were settled led to successful payouts. This study highlights the diagnoses and procedures that need to be treated with particular vigilance. Having an awareness of the areas that lead to litigation in shoulder and elbow surgery will help to reduce inadvertent risks to patients and prevent dissatisfaction and possible litigation. Cite this article: Bone Joint J 2014; 96-B: C. L. Talbot, MBChB (Hons), MRCS (Eng), Specialty Registrar, Trauma & Orthopaedics University Hospital of South Manchester NHS Foundation Trust, Department of Orthopaedics, Southmoor Rd, Wythenshawe, Manchester, Greater Manchester M23 9LT, UK. J. Ring, BSc (Hons), MBChB, MRCS (Eng), Specialty Registrar, Trauma & Orthopaedics Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust, Haslingden Road, Blackburn, BB2 3HH, UK. E. M. Holt, FRCSEd(Orth), Consultant Orthopaedic Surgeon University Hospital of South Manchester, Department of Orthopaedics, Southmoor Rd, Wythenshawe, Manchester, Greater Manchester M23 9LT, UK. Correspondence should be sent to Mr C. L. Talbot; christalbot@doctors.org.uk 2014 The British Editorial Society of Bone & Joint Surgery doi: / x.96b $2.00 Bone Joint J 2014;96-B: In 1995, the National Health Service Litigation Authority (NHSLA) in the United Kingdom was set up as a Special Health Authority with the task of indemnifying legal claims. Initially it was responsible for handling only larger claims; however, since 2002 it has dealt with all clinical negligence claims regardless of cost, and it holds information on claims made against the NHS. 1 During the last two years, there has been a twofold increase in payments made by NHSLA for negligence claims against the NHS. 2 Damages awarded to orthopaedic patients are increasing steadily, 3 despite a greater emphasis placed on patient safety in recent years. 4 In June 2008, the World Health Organization (WHO) launched a Global Patient Safety Challenge, Safe Surgery Saves Lives, with the intention of reducing the number of deaths following surgery throughout the world. 4 Part of this initiative was a WHO checklist. This was introduced throughout NHS Trusts in England and Wales to help prevent never events, including wrong-site surgery (WSS) and retained instrument post operation. More recently, in 2012, insertion of the wrong implant or prosthesis was added to the list of never events. 5 There has been a great expansion in shoulder and elbow surgery during the last 40 years, 6 with arthroscopic subacromial decompressive surgery alone showing a 746% increase in the past decade. 7 Although in general this procedure, and many others commonly undertaken on the upper limb, has a high level of patient satisfaction, as with all surgery there are also complications, with the potential for dissatisfaction and litigation. Litigation in general orthopaedic practice in both the NHS 8 and the private sector 9 has been analysed. In addition, several studies have been published on litigation within the subspecialties, including spine, hip and knee surgery. 10,11 There is little information, however, about litigation claims in shoulder and elbow surgery. 12 The purpose of this study was to review the data from the NHSLA over a 17-year period (1995 to 2012) and examine the reasons for litigation in patients who present with conditions affecting the shoulder and elbow within the NHS, with the aim of identifying areas of practice that require improvement. Patients and Methods Following a Freedom of Information (FOI) request being made to the NHSLA in 2012 for all data relating to claims involving orthopaedics and trauma, data were provided for the period 1995/1996 to 2011/2012. The data contained information related to the year of 574 THE BONE & JOINT JOURNAL

2 LITIGATION RELATING TO CONDITIONS AFFECTING THE SHOULDER AND ELBOW Wrist and Hand, 13.2% (n = 1356) No region specified, 19.7% (n = 2021) Foot and Ankle, Spine, 9.9% 12.6% (n = 1015) (n = 1294) Arm, 1.4% Leg, 9.6% (n = 141) (n = 985) Hip and Knee, 25.8% (n = 2650) Shoulder and Elbow, 7.9% (n = 811) Shoulder, 5.1% (n = 519) Elbow, 2.8% (n = 292) Number of claims Elbow Shoulder Fig. 1 Pie chart showing the proportion of all claims (open and settled) made to the NHSLA during the 17-year study period, separated into anatomical site. Year claim made Fig. 2 Bar chart showing the trend in total number of shoulder and elbow claims made to the NHSLA between 1995 and 2012, including the open and settled claims. Table I. Causes and cost of litigation in shoulder claims Claim category Number of settled claims % closed claims * claims lost % lost claims Total cost ( ) Highest cost ( ) Mean cost ( ) Diagnosis Mismanagement Patient care Other Neurological deficit Peri-operative injury Technical error Surgeon error Consent/explanation Infection Wrong-site surgery Retained material Vascular injury Fatality Tendon injury Fall * Percentage of each claim category to overall number of settled shoulder claims (n = 364) Cost in pounds to the nearest 100 the alleged incident, the date of the claim, a description of the claim, the NHSLA classification of the type of claim, information about the outcome of the claim, and the costs or damages that were paid. The data were filtered by the authors and a site of the body was identified. Claims that involved the shoulder girdle, elbow and humerus were included. All cases from other areas, and unspecified or ambiguous descriptions such as arm, were excluded. All claims involving the shoulder or elbow were categorised according to the principal reason for the claim. The data were then analysed to compare trends in the types of claim. Successfully defended claims were defined as being where either no costs or only defence costs were incurred. The total payments are presented without the complete breakdown of the costs. All costs are quoted to the nearest 100. Non-settled cases were not included in the final analysis. The Department of Health (2012) criteria 5 were used to classify never events. Results During the study period, a total of trauma and orthopaedic claims were made to the NHSLA; 811 (7.9%) of these were categorised into shoulder and elbow claims (Fig. 1). A total of 581 (72%) were settled, 333 (57.3%) in VOL. 96-B, No. 5, MAY 2014

3 576 C. L. TALBOT, J. RING, E. M. HOLT Table II. Causes and cost of litigation in elbow claims Claim category claims % settled claims * Number of settled claims lost % lost claims Total cost ( ) Highest cost ( ) Mean cost ( ) Diagnosis Mismanagement Neurological deficit Patient care Surgeon error Wrong-site surgery Other Infection Consent/explanation Technical error Retained material Peri-operative injury Tendon injury Fall *Percentage for each claim category to overall number of settled elbow claims (n = 217) Cost in pounds to nearest 100 the claimants favour, accounting for an overall payout of There were 195 claims (58.6%) involving the shoulder, costing with a mean cost per lost case of ( 700 to ), and 138 claims (41.4%) involving the elbow, costing with a mean cost per lost case of ( 500 to ). Figure 2 shows the overall trend in the number of claims made during this time, with a steady increase throughout the 2000s, mainly due to an increase in the number of claims involving conditions affecting the shoulder. The overall number of claims has subsequently declined. In both shoulder and elbow groups, the most common reason for litigation concerned the diagnosis. This included missed, incorrect and delayed diagnoses (Tables I and II). Of the settled claims lost (n = 100), a total of 43 (43%) occurred in the emergency department, 31 (31%) in orthopaedic outpatients, and 26 (26%) either on the ward or in another clinical area. Failure to diagnose and late diagnosis of fractures and dislocations were the most common reasons for claims in the diagnosis group. These findings are summarised in Tables III, IV and V. The second most common area for litigation was claims for alleged mismanagement: 19.5% (n = 71) and 19.4% (n = 42) for shoulder and elbow claims, respectively. Delays in referral to specialists, incorrect choice of treatment, and problems arising during or following an operation were the reasons for claims categorised as mismanagement, according to the descriptions of claims in the NHSLA. Neurological deficit was the third most common area for litigation in all claims. However, upon subdivision, patient care was the third most common reason for litigation in shoulder claims, accounting for 53 claims (14.6%). This group involved delays in treatment, premature discharge from hospital care and poor care as an in- or out-patient. In elbow claims, neurological deficit was the third most common reason for litigation. The most commonly injured nerves were the ulnar (n = 10) and radial nerves (n = 8), although there were claims for damage to the brachial plexus, posterior interosseous, median and musculocutaneous nerves. Other claims were as a result of incorrect consent and explanation of procedures, surgeon and technical error, infection related to surgery and peri-operative injury (Tables I and II), which included iatrogenic fractures and tourniquet and diathermy burns sustained during surgery. Never events, including wrong-site surgery (WSS), accounted for 11 settled claims (1.9%), all involving elective procedures. All these resulted in a successful payout, totalling (Tables I and II). More than 90% (n = 10) of wrong-site surgery (WSS) claims were made prior to the introduction of the WHO Global Patient Safety Challenge. In shoulder surgery, both successful claims resulted from excision of the wrong part of the clavicle during acromioclavicular surgery. In the elbow group, five claims involved a release for tennis elbow instead of an ulnar nerve decompression, or vice versa; two involved a release for golfer s elbow being performed instead of one for tennis elbow. One ulnar nerve decompression at the elbow was performed instead of a carpal tunnel decompression, and one release for tennis elbow was performed instead of an exploration of the biceps tendon. Intra-operative retained material accounted for five settled shoulder and elbow claims (0.9%), including a retained wire in the distal humerus following open reduction and internal fixation of a distal humeral fracture, and retained foreign material during total shoulder replacement, which required further surgery to remove following a check THE BONE & JOINT JOURNAL

4 LITIGATION RELATING TO CONDITIONS AFFECTING THE SHOULDER AND ELBOW 577 Table III. Causes and cost of litigation in shoulder claims relating to diagnostic errors Diagnostic category claims claims lost % lost claims Total cost ( ) * Mean cost ( ) * Dislocation Fracture Rotator cuff tear/injury Nerve injury Tumour Other Total *Cost in pounds to nearest 100 No specific nerve defined One claim due to osteosarcoma of the proximal humerus Table IV. Causes and cost of litigation in elbow claims relating to diagnostic errors Diagnostic category claims claims lost % lost claims Total cost ( ) * Mean cost ( ) * Fracture Dislocation Tendon rupture/injury Infection Other Total *Cost in pounds to nearest 100 Distal biceps rupture post-operative radiograph. The total damages awarded for retained material was No claims were made regarding the use of the wrong implant or prosthesis. Discussion Litigation in the NHS has been extensively reported in the media and the medical literature, with millions of pounds being paid out annually for diagnostic, clinical and surgical errors The overall payout for shoulder and elbow claims in this study was > 18 million. Reassuringly, the number of claims made in more recent years has reduced (Fig. 2). This should be viewed with caution, however, as it may be an underestimation owing to delays in claimants making claims. The three most common reasons for litigation in this area of practice were diagnosis (delayed, missed or incorrect), mismanagement and neurological deficit. Missed fractures and dislocations accounted for over three-quarters of lost claims in the diagnosis category, with dislocation of the glenohumeral joint accounting for approximately half of the diagnostic claims in the dislocation subgroup. A high index of suspicion is required, with emphasis on a thorough clinical assessment and obtaining adequate imaging when dealing with these particular injuries. In addition, with 43% of claims relating to delayed, missed or wrong diagnosis arising in the emergency department, our study supports previous authors who have reported that the misdiagnosis of injuries in emergency departments is not uncommon and can have serious consequences, with long-term disability 14 and negligence claims. Many reasons have been proposed for WSS. 15,16 The use of the WHO checklist, sign your site and an effective team briefing have changed surgeons habits and helped to reduce never events. 4,5,17,18 Of all settled shoulder and elbow claims, 11 (1.9%) were due to WSS. Nine successful WSS claims involved surgery at the elbow, several mistaking the medial side of the elbow for the lateral, or vice versa. Despite occurring rarely, intra-operative injury resulted in successful claims for clinical negligence. A total of was paid for dermal burns sustained during arthroscopy of the shoulder. Burns from radiofrequency devices and preparation agents during arthroscopy have been reported Care is required to avoid exposing patients to the elevated fluid temperatures created by radiofrequency devices, in order to reduce the risk of injury to the skin. This study has limitations. First, the database from which the data were extracted was designed to manage claims rather than for research purposes. There may therefore be inconsistencies in the coding system used. Second, the brief descriptions detailing each claim in the database were at times ambiguous or non-specific, and so these claims were excluded from the analysis. Finally, the data only address the legal challenges made through the NHSLA following alleged negligence, and will miss examples of negligence that have occurred but have not been pursued. VOL. 96-B, No. 5, MAY 2014

5 578 C. L. TALBOT, J. RING, E. M. HOLT Table V. Incorrect, delayed or missed diagnosis of fractures and dislocations resulting in a successful claim Injury Diagnosis % (number) Fracture (n = 41) Unspecified elbow fracture * 41.5 (17) Unspecified shoulder fracture * 22.0 (9) Monteggia fracture 7.3 (3) Lateral condyle of humerus fracture 7.3 (3) Proximal humeral fracture 7.3 (3) Radial head fracture 4.9 (2) Clavicle fracture 4.9 (2) Glenoid fracture 2.4 (1) Supracondylar humeral fracture 2.4 (1) Dislocation (n = 38) Glenohumeral joint 60.5 (23) Elbow joint 23.7 (9) Radial head 13.2 (5) Acromioclavicular joint 2.6 (1) * Insufficient detail to assign specific region of shoulder and elbow, respectively Combined anterior and posterior dislocation Table VI. Recommended strategies to avoid claims by patients presenting with conditions affecting the shoulder and elbow Obtain adequate radiographs Shoulder trauma series, true lateral of the elbow, full forearm images, ensure two views are obtained Senior review of radiographs acutely On-call senior input, discussion in trauma meeting, on-call radiology services, early specialist upper limb surgical advice Discussion with relevant specialist Informal/formal, multidisciplinary trauma meetings, access to specialist meetings/clinics e.g. acute shoulder injury clinic Appropriate use of further imaging Further radiographic views, CT/MR scans in selected cases Clear patient counselling/consenting Informed consent for operative/non-operative treatment, predesigned consent forms containing a full list of complications and risks Clear pre-op marking sign-your-site Clearly mark and write type of surgery (especially in elbow cases) care in use of diathermy and radiofrequency Protective equipment (stand/holster), short bursts rather than prolonged use to allow tissue cooling, appropriate vacuum equipment CT, computed tomography; MR, magnetic resonance In addition, ex gratia payments where Trusts decide to settle claims in order to reduce the legal costs, are not included, and therefore the data underestimate the number of patients who have suffered clinical negligence in relation to conditions affecting the shoulder and elbow, as well as the overall financial burden to the NHS. In conclusion, there is no single way by which litigation in the practice of shoulder and elbow surgery can be reduced. However, this study provides orthopaedic surgeons who are involved in treating patients with conditions affecting the shoulder and elbow, with valuable information relating to the reasons why errors occur. Overall diagnosis, mismanagement and neurological injury were the most common reasons for litigation in shoulder and elbow practice. We have identified key diagnoses requiring extra clinical vigilance and suggest recommendations which may help avoid litigation in this area (Table VI). No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. This article was primary edited by J Scott and first proof edited by D Rowley. References 1. No authors listed. The NHS Litigation Authority Factsheet 1: Background Informa- tion Backgroundinformation pdf (date last accessed 20 August 2013). 2. No authors listed. NHSLA. The NHS Litigation Authority Factsheet 2: Financial Information, Factsheet 2-financialinformation doc (date last accessed 24 August 2013). 3. No authors listed. Bones of Contention. MDU Journal 2011;27: No authors listed. World Health Organization. World Alliance For Patient Safety. The Second Global Patient Safety Challenge: Safe Surgery Saves Lives, SSSL_Brochure_finalJun08.pdf (date last accessed 12 February 2014). 5. No authors listed. Department of Health. The Never Events list 2012/2013, /dh_ pdf (date last accessed 12 February 2014). 6. No authors listed. British Elbow and Shoulder Society. About BESS. (date last accessed 12 February 2014). 7. Murphy RJ, Maxwell R, Kulkarni R, et al. Rates of arthroscopic subacromial decompression and rotator cuff repair in the NHS in England from 2000 to BESS Annual Scientific Meeting, Khan IH, Jamil W, Lynn SM, et al. Analysis of NHSLA claims in orthopedic surgery. Orthopedics 2012;35: Roberts K. MDU Services Ltd. Orthopaedic Claims in Private Practice, (date last accessed 20 August 2013). 10. McWilliams AB, Douglas SL, Redmond AC, et al. Litigation after hip and knee replacement in the National Health Service. Bone Joint J 2013;95-B: THE BONE & JOINT JOURNAL

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