Litigation in Trauma and Orthopaedic Surgery

Introduction
Litigation in health has dramatically increased since it became mandatory for the National Health Service Litigation Authority (NHSLA) to be informed of all claims against NHS trusts in England. Before 2002 there was no complete record of litigation as trusts did not routinely inform the NHSLA regarding smaller claims. This
rise in litigation is not surprising; there has been a change in society as a whole reflected in a less trusting public and a more active promotion of legal services. These changes have been matched by key rulings from the House of Lords. Chester vs Afshar (2004) raised the standard of acceptable care and confirmed the responsibilities of the surgeon to provide informed consent1 . The rate of litigation and its cost continue to rise at an uncontrollable rate.

The NHSLA has reported a year on year increase in claims. Between 2007/2008 and 2011/2012 there was a mean number of claims per year of 7202 with a total of 9143 new clinical claims in 2011/20122. NHSLA estimates there are £18.9 billion of potential clinical negligence claims against the NHS2. Surgical specialities are associated with higher rates of litigation3 . In the NHSLA report and accounts 2012/13 orthopaedics was found to have the largest expenditure with the exception of obstetrics and gynaecology. Trauma and orthopaedic surgery has always been considered a highly litigious specialty due to the quantity of work
undertaken and the subsequent problems if mistakes or complications occur. Medical indemnity insurance companies classify orthopaedics as the third highest risk specialty behind obstetrics and neurosurgery. The Medical Defence Union (MDU) expects a claim against orthopaedic surgeons practicing independently every eight years compared to every 35 years in specialities such as anaesthetics4

The total cost of orthopaedic claims has risen by 60% over the last three years compared to a 12% rise in overall NHS litigation claims during the same time period5 . The MDU, Britain’s largest defence union’s review of claims in orthopaedic surgery found that the average settlement was in excess of £60,0006 . Especially concerning is the rise in proportion of total legal costs accounted for by the claimants’ lawyer which has risen to nearly 80%. The NHSLA has found that the growing use of Conditional Fee Agreements in NHS litigation cases has resulted in the legal costs outstripping the value of damages paid to the patient2.

Previously published work relates to claims before the NHSLA received all claims and as a result do not reflect the total litigation in orthopaedics3,7,8,9. The majority of studies have focused on closed or successful litigation against the NHS. However the mean claim in 2012/13 took over a year to close and in previous years this was an even longer process resulting in a delay in publication of current trends2 . The importance of reviewing both closed and open claims is well summarised by the Rt. Hon Lord Justice Jackson. He said ‘Litigation is, however, a matter of last resort. There is a huge need to prevent claims arising in the first place. That is by far the most effective way to reduce legal costs and to promote patient satisfaction’3 . The aim of this study therefore was to provide current
trends in ligation against trauma and orthopaedic surgery from the NHSLA database from the first year of full notification. To determine whether there was a rise in litigation in orthopaedic surgery consistent with the rise seen across the NHS and to elicit the main causes in order to aid awareness and to allow the development of strategies to improve practice, improve patient satisfaction and reduce legal costs.

Materials and Methods
We made a formal request to obtain all data regarding claims against ‘Orthopaedic Surgery’ from the NHSLA database of NHS trusts in England since the registration of all claims became mandatory. This category included all trauma and elective work and all open and closed cases without exclusion between April 2003 and April 2012. The information supplied included: claim status (whether open or closed), incident date, claim details, the costs incurred of closed claims (damages paid, defence costs paid, claimant costs paid and total paid) and the Strategic Health Authority (SHA) to which the provider receiving the claim had previously been associated. Global trends were reviewed for all financial years from 2003/2004 to 2011/12. A claim by claim analysis was made during the last five years of data from 2007/2008 to 2011/12, during which period there has been the greatest rise in claims. A team of researchers using a set protocol divided claims according to trauma and elective work, sub-specialty, operation performed and cause of claim. Causes of claims were determined by the definitions in Table 1. Due to the multifactorial nature of the claims often more than one cause was attributed to each claim. This has therefore resulted in more causes identified than claims listed. Of the closed cases those that had no costs were defined as those that were successfully defended. An estimated cost is calculated by the NHSLA based on the current costs from closed cases and the predicted cost of open cases. The percentage of cases in each former SHA per head of population was calculated. This was displayed on a funnel plot using the variance between SHAs to determine those that are greater than 3 standard deviations from the mean which were regarded as outliers.
Results
From 2003/2004 to 2011/12 there were 9009 claims registered with the NHSLA against ‘Orthopaedic Surgery’. Of these 6989 claims (77.58%) were closed with a combined cost of £384 million. However the NHSLA estimates that closing the remaining claims could result in an overall total cost of £897 million (calculated from NHSLA July 2012 estimates). Over the nine year period a total of 36 of the closed claims cost over £1 million to settle.

Of these claims 13 were related to spinal surgery with claims resulting from delayed/failed treatment of cauda equina syndrome, negligent spinal decompression and failure to remove haematoma from the spine resulting in neurological deficit. A further five of the most expensive claims related to negligent total knee replacements resulting in amputation. The remainder of claims costing over £1 million were related to delayed or inappropriate surgical treatment of long bone trauma, failure to diagnose bone tumour, failure to diagnosis compartment syndrome, acetabular fracture during hip surgery, vascular injury during total hip
replacement and knee arthroscopy. The highest single claim was £2.3 million paid in 2006/2007 for allegation of a failure to act to reduce dislocation and relieve pressure on the spinal cord resulting in the claimant becoming quadriplegic following a sporting injury.

Comparison with other surgical specialities
When comparing against other surgical specialities, claims against orthopaedics are increasing (Figure1). Over 25% of all surgical interventions in the NHS are musculoskeletal5 . In 2003/2004 orthopaedics represented 45.46% of all surgical claims, which rose to 49.93% by 2011/12. Throughout orthopaedics has remained the specialty against which most litigation claims have been made in surgery, with the exclusion of obstetrics and gynaecology.

Trends
Total Claims against orthopaedics have increased yearly since 2004/2005, peaking at 2011/2012 with 1474 claims (Table 2). When 2003/2004 is compared to 2011/2012 we find a 74.23% increase in yearly claim volume. During the same period the estimated cost of yearly claims rose 356% from £41million to £187million (as calculated by the NHSLA, July 2012). There is a geographical variation in the percentage of a population making clinical negligence claims when the country is divided up into the former SHAs. Rates of litigation are highest in the Yorkshire and the Humber and North West (Figure 2).

Causes of claim
The most common causes contributing to claims from 2007/2008 to 2011/2012 were ‘unsatisfactory outcome to surgery’ (3030 claims, 53.19%),  ‘judgement/timing’ (2904 claims, 50.97%), ‘interpretation of results/clinical picture’ (2369 claims, 41.58%), ‘tissue damage’ (1801 claims, 31.61%) and ‘mobility’ (1545 claims, 27.12%) (Figure 3). The same claims are seen to be most common in each year when reviewed separately. Furthermore, when reviewing the claims by sub-specialty from 2011/2012 these five causes are the most common in foot & ankle, hand, hip, knee and shoulder & elbow. Even in spinal surgery the common causes are the same with the addition of nerve injury instead of mobility in the top five causes (Table 3).

Discussion
The rate of litigation in orthopaedic surgery is increasing on a year on year basis in the NHS with a 16% increase between 2010/2011 and 2011/2012 compared to only 6% increase in claim volume for the NHS as a whole. It has been suggested that orthopaedics and more specifically spinal surgery as well as total hip and knee arthroplasty are not suffering from the same clinical negligence problem as the rest of the NHS8, 10. One of the key limitations of studies using the NHSLA records is NHSLA principally collects data for legal purposes. As a result there is an issue concerning the clinical information that is available for analysis. Despite full access to the database some claims are unable to be fully categorised including by sub-specialty and procedure due to insufficient clinical detail. Unfortunately, studies carrying out such specific analysis are at risk of under reporting litigation rates.

It has been proposed that although there is a rise in litigation in total hip and knee arthroplasty this increase has been out-stripped by the rise in activity8. However looking at trauma and orthopaedics as a whole between 2010/2011 and 2011/2012 there was a 1.6% rise in activity as indicated by Finished Consultant Episodes (FCE) recorded by the Hospital Episode Statistics, far less than the increase in claims11. Even considering that patients have three years from an event to commence their legal claim, the rise in FCE from 2008/2009 to 2011/12 was only 8%11. When comparing orthopaedics to other surgical specialities its growing size and dominance (49.93% of surgical claims) over other surgical specialities illustrates that litigation in orthopaedic surgery is a problem increasing at a greater rate than litigation as a whole in the NHS

The rise in costs related to this trend cannot be ignored with a potential estimated cost of £897 million over a nine year period in a specialty attempting to reduce costs to contribute to £15-20 billion of efficiency savings by 201512. This is a not insignificant number when it is considered this equates to the cost of between 163,000 and 176,000 primary joint replacements13.14. It is clear that the financial problem must be addressed if the specialty is to avoid rationing of even its most effective treatments. The financial costs for certain orthopaedic sub-specialities are higher than others with over a third of cases costing greater than £1
million being related to spinal surgery. This is a pattern that is borne out in other studies both in the United States and in private practice in the UK and therefore surgeons working in this area especially must adapt their practice to reduce suspicion of negligent care4,14.

It is possible that not all claims have been included in the complete dataset and this may be due to some cases where negligence has not been proven but a
settlement has been made to avoid the creation of a case. Certain claims may be under reported in the dataset due to co-liability. These claims may have not reached the NHSLA even though they could have been brought against the NHS as they have been instead brought against another party. An example of this is a patient making claims against an implant manufacturer rather than the NHS trust that carried out their operation. This issue of co-liability may in part explain why there were only two claims in 2011/12 related to metal on metal hip replacements.

Unfortunately, ‘never events’ still occur on a yearly basis. Between 2007/2008 and 2011/2012 128 claims were made regarding ‘retained instruments’ and 62 claims relating to ‘incorrect site of surgery.’ These events represent system failure and are patient safety issues that can be eradicated by more diligent organisation and closer adherence to tools including the World Health Organisation checklist. It is encouraging that claims relating to consent are fairly infrequent, 62 claims (4.21%) in 2011/12. However, it is important to recognise that the benefit of informed consent with a discussion including the possible risks would not only reduce claims directly linked by the patient to consent but would also decrease patient’s dissatisfaction with surgery which is the major cause of claims.

These submitted claims are based on the patient’s perception of negligence. Although there is not an agreed method of claim analysis between studies there is common themes amongst the causes of litigation. ‘Failure to protect structures in the surgical field’, ‘technical errors’ and ‘other surgical errors’ are frequently reported as common causes and would include the claims identified in our study as ‘unsatisfactory outcome to surgery’ and ‘tissue damage6,15. Strategies to prevent these claims could include an increased number of procedures in surgical training and the improvement in education provided to surgeons once trained. Other common causes such as ‘judgement/ timing’ and ‘interpretation of results/clinical picture’ could also be overcome by increased experience while training
as well as the creation of structured approaches to patient management. Regrettably the NHSLA does not record the seniority of the surgeon against which claims have been made so we cannot provide evidence of the expected benefit of experience and training.

There is concern that the rise in litigation has promoted the practice of defensive medicine which although in the main can lead to an improvement in care has also led to surgeons ordering unnecessary investigations and restricting their practice to avoid patients or procedures that are thought to be high risk16. However, surgeons should be advised when considering high risk procedures, which are not part of their regular practice, to consider referral to a high volume specialist centre which has the critical mass of expertise to maximise patient safety and satisfaction in such procedures. Indeed analysis of claims by division of providers into the former SHA’s demonstrates that litigation rates are not uniform throughout the country however, it is beyond the scope of this study to explain these differences as a more detailed analysis of each individual healthcare provider within the SHAs would be required.

Conclusion
Litigation is a growing problem for orthopaedic surgery. The current trend and resulting costs are unsustainable. Most orthopaedic surgeons will face a negligence claim during their career17,18. Lessons can be learned from all claims brought whether or not they are successfully defended and these need to be disseminated to the profession. We believe the common causes for claims are preventable. Specialists being given sufficient time to analyse and discuss the patient’s problems, proposed treatment and manage expectations could reduce claim volume.

John Machin is a Specialist Registrar at Queen Medical Centre in Nottingham. He is a contributor to the ‘Chavasse Report’ and the national pilot of ‘Getting It Right First Time’. He is a member of the BOA Medical Negligence working party set up in response to the pilot.

Professor Briggs is Consultant Orthopaedic Surgeon at the Royal National Orthopaedic Hospital Trust and also Medical Director until May 2012. He is the President of the British Orthopaedic Association and is also the Chairman of the Federation of Specialist Hospitals and Chairman of the National Clinical Reference Group for Specialist Orthopaedics. His special interests are reconstruction of the lower limb, as well as sports injuries of the knee and orthopaedic oncology.

References
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11. No authors listed. Hospital Episode Statistics. www.hscic.gov.uk/hes (date last accessed 5 December 2013)

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13. No authors listed. Primary Hip Replacement Surgery. http://info.wirral.nhs.uk/document_uploads/ evidence-reviews/PrimaryHipreplacement.pdf (date last
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