We present a review of litigation claims relating to foot and ankle surgery in the NHS in England during the 17-year period between 1995 and 2012.

A freedom of information request was made to obtain data from the NHS litigation authority (NHSLA) relating to orthopaedic claims, and the foot and ankle claims were reviewed.

During this period of time, a total of 10 273 orthopaedic claims were made, of which 1294 (12.6%) were related to the foot and ankle. 1036 were closed, which comprised of 1104 specific complaints. Analysis was performed using the complaints as the denominator. The cost of settling these claims was more than £36 million.

There were 372 complaints (33.7%) involving the ankle, of which 273 (73.4%) were related to trauma. Conditions affecting the first ray accounted for 236 (21.4%), of which 232 (98.3%) concerned elective practice. Overall, claims due to diagnostic errors accounted for 210 (19.0%) complaints, 208 (18.8%) from alleged incompetent surgery and 149 (13.5%) from alleged mismanagement.

Our findings show that the incorrect, delayed or missed diagnosis of conditions affecting the foot and ankle is a key area for improvement, especially in trauma practice.

Cite this article: Bone Joint J 2014;96-B:1510–14.

The number of clinical negligence claims in the UK is constantly increasing. As a specialty, trauma and orthopaedic surgery has one of the highest numbers of negligence claims. 1. This study analyses NHS Litigation Authority (NHSLA) claims in trauma and orthopaedics between 2004 and 2014. . A formal request was made to the NHSLA under the Freedom of Information Act in order to obtain all data related to claims against orthopaedic surgery. It was found that the number of claims, and percentage of successful claims, has been constantly increasing over this period, with compensation paid of over £349 million.* Errors in clinical management accounted for the highest number of closed claims (2933 claims), costing over £119 million.*. The level of compensation paid out has a significant financial impact on the NHS. Reforms need to be made in order to tackle the high cost of legal fees generated by these claims, which further drain the limited resources available to the NHS

Payments by the NHS Litigation Authority continue to rise each year, and reflect an increase in successful claims for negligence against NHS Trusts. Information about the reasons for which Trusts are sued in the field of trauma and orthopaedic surgery is scarce. We analysed 130 consecutive cases of alleged clinical negligence in which the senior author had been requested to act as an expert witness between 2004 and 2006, and received information on the outcome of 97 concluded cases from the relevant solicitors. None of the 97 cases proceeded to a court hearing. Overall, 55% of cases were abandoned by the claimants’ solicitors, and the remaining 45% were settled out of court. The cases were settled for sums ranging from £4500 to £2.7 million, the median settlement being £45 000. The cases that were settled out of court were usually the result of delay in treatment or diagnosis, or because of substandard surgical technique

Background. In the UK 70,000 knee arthroplasties are performed each year. Although outcomes from knee arthroplasties are usually excellent, they can nevertheless lead to negligence claims. The aim of this study was to establish the incidence, cost and cause of negligence claims arising from knee arthroplasties. Method. All claims made to the NHS Litigation Authority between 2003 and 2008, where the operation was knee arthroplasty, were included in this study. Data obtained from the NHS Litigation Authority were reviewed, coded and analysed. For negligence to have occurred, patients must have suffered harm as a result of substandard care. Hence the cause of negligence claims was analysed in terms of: (1) Substandard care and (2) Harm caused. Results. There were 326 claims over the five-year period, resulting in an incidence of 65 claims per year. Of the 326 claims, 246 have been closed with 80 remaining open. 40% of closed claims resulted in the payment of damages. The total cost of negligence claims over the period was £6.6 million. Substandard care commonly encountered in negligence claims was: surgical quality (56%), post-op care (23%), and infection control (8%). Harms commonly encountered in negligence claims were: additional/unnecessary operation (30%), pain (23%) and amputation (8%). Conclusion. There is a significant litigation burden associated with knee arthroplasties. The unexpected prominence of additional/unnecessary operation, pain and amputation in negligence claims emphasise the need for patients to be warned about these risks

Claims for clinical negligence are increasing annually. Limb reconstructive surgery recognises ‘problems, obstacles, and complications’ as part of the treatment process, but this does not prevent a claim for an alleged poor result or a complication. We analysed claims for clinical negligence in the National Health Service in England and Wales for issues following limb reconstructive surgery. A database of all 10,456 claims related to Trauma and Orthopaedic Surgery from 1995–2010 was obtained from the NHS Litigation Authority. A Search Function for keywords “Ilizarov, limb reconstruction, external fixation, and pin-site” was used for subset analysis. Data was analysed for type of complaint, whether defended or not, and for costs. 52 claims fitted our filters - 48 were closed, and 4 ongoing. The claims included damage to local structures (n=3), missed compartment syndrome (n=2), premature frame removal (n=5), infection (n=13), wrong-site-surgery (n=1), poor outcome (n=16) and technical error (n=10). Seven patients underwent amputation. The total cost of litigation was £4,444,344, with a mean of £90,700 per settled claim. 40% were successfully defended, with defence cost of £15,322. The mean pay-out for confirmed negligence/liability was £90,056 (£1,500-£419,999, median £45,000) per case. We believe this is the first study looking at complications following limb reconstruction from this perspective. Analysis reveals a spectrum of claims for negligence. Perceived technical errors and poor outcome predominate. Whilst the limitations of the database preclude against identification of whether the procedures were carried out in specialist units, claims for technical errors are a cause for concern. These will be discussed in detail. Outcomes following limb reconstruction are difficult to quantify, and the settling of claims for a perceived poor outcome makes the case for pre-operative counselling and the need for robust outcome measures in our specialty

Definitions and perceptions of good and poor outcome vary between patients and surgeons, and perceived inadequate outcome can lead to litigation. We investigated outcomes of litigation claims relating to non-union and deformity following lower limb long bone fractures from 1995 to 2010. The database of all 10456 claims related to Trauma and Orthopaedic Surgery was obtained from the NHS Litigation Authority. Data was searched for “deformity, non-union and mal-union”, excluding spine, arthroplasty, foot and upper limb surgery. The type of complaint, whether defended or not, and costs was analysed. 241 claims met our criteria, 204 of which were closed, and 37 unsettled. Deformity/mal-union constituted 97, and non-union 143. Coronal/sagittal deformity cost £4.2 million, mean £45,487 (60% received compensation). Rotational mal-unions cost £1.6 million, mean £114,263 (87% received compensation). Non-union cost £5.3 million, mean £75,866 (60% received compensation). Mean legal fees for coronal/sagittal deformity was £18,772, rotational deformity £37,384, and non-union £24,680. The total cost of litigation was £12.2 million, with a mean of £59,597 per settled claim. The mean pay-out for all confirmed negligence/liability was £56,046 (£1,300–£500,000, median £21,500) per case. Non-union is an accepted complication following fracture surgery. However, this does not mitigate against non-union being seen as representing a poor standard of care. While it is unclear whether the payouts reflect a defensive culture or were due to avoidable errors, and notwithstanding the limitations of the database, we argue that failure of the index surgery should prompt a referral to a specialist centre. The cosmetic appearances of rotational malalignment results in higher compensation, reinforcing outward perception of outcome as being more important than harmful effects. We also note that the database sometimes contained conflicting and incomplete data, and make a case for standardisation of this component of the outcome process to allow for learning and reflection

The cost of clinical negligence in the UK has continued to rise despite no increase in claims numbers from 2016 to 2019. In the US, medical malpractice claim rates have fallen each year since 2001 and the payout rate has stabilized. In Germany, malpractice claim rates for spinal surgery fell yearly from 2012 to 2017, despite the number of spinal operations increasing. In Australia, public healthcare claim rates were largely static from 2008 to 2013, but private claims rose marginally. The cost of claims rose during the period. UK and Australian trends are therefore out of alignment with other international comparisons. Many of the claims in orthopaedics occur as a result of “failure to warn”, i.e. lack of adequately documented and appropriate consent. The UK and USA have similar rates (26% and 24% respectively), but in Germany the rate is 14% and in Australia only 2%. This paper considers the drivers for the increased cost of clinical negligence claims in the UK compared to the USA, Germany and Australia, from a spinal and orthopaedic point of view, with a focus on “failure to warn” and lack of compliance with the principles established in February 2015 in the Supreme Court in the case of Montgomery v Lanarkshire Health Board. The article provides a description of the prevailing medicolegal situation in the UK and also calculates, from publicly available data, the cost to the public purse of the failure to comply with the principles established. It shows that compliance with the Montgomery principles would have an immediate and lasting positive impact on the sums paid by NHS Resolution to settle negligence cases in a way that has already been established in the USA. Cite this article: Bone Joint J 2020;102-B(5):550–555

Background. FORECAST is a prospective longitudinal cohort study exploring mechanism-based prognostic factors for pain persistence in sciatica. Here, we share an update on this largest deeply-phenotyped primary care sciatica cohort. Methods/results. Our cohort includes 180 people with sciatica (score >4 on Stynes’ Sum Score), aged 18–85, within 3 months of symptom onset. Psychosocial factors, self-reported sensory profiling, clinical examination, quantitative sensory testing (QST), biological samples (blood and skin samples), and Magnetic Resonance Neurography of lumbar nerve roots were collected at baseline. Pain persistence was determined at three and twelve months with the Sciatica Bothersomeness Index (SBI) and a numeric pain rating scale (NRS) as primary outcomes. Recruitment nears completion, with 160 participants enrolled to date. 127 and 96 participants have completed 3 and 12 months follow-up respectively. Overall, 56% of our cohort are female, with a mean age (SD) of 54.14yrs (16.57). Ethnicity data approximates local populations. SBI at baseline was (median [IQR]) 13[10-17], and interim longitudinal data shows stepwise improvement at 3 and 12 months. Baseline ‘average’ pain intensity was 5.56 (2.15) for leg pain, and 4.14(2.82) for low back pain (LBP). Overall, pain scores decreased at 3 and 12 months, with greater reductions in leg pain than LBP at 12 months. However, around 55–80% and 40–65% of people reported persistent pain at 3 and 12 months respectively. Conclusion. Leg pain severity was moderate and higher than LBP at baseline. All primary outcome measures demonstrate improvement over time, however 40–65% of patients report persistent pain at 12 months. Conflicts of interest. LR: Paid facilitation of post-graduate courses internationally. SK, MT, FP, KM, WS, CP, CR, SC: No conflicts of interest. GC: Editor in Chief of Health Psychology Review. Director of board of directors, MentalCHealth Care setting NoordWestVlaanderen. JF: Copyright holder of ODI (Oswestry Disability Index). Served on a data monitoring committee for a clinical trial of 2 different surgical approaches to cervical disc herniation (FORVAD). Member of HTA Prioritisation Committee B: Inside hospital Care from 2015-February 2019. Member of HTA Interventional Procedures Panel from 2010–2015. Trustee and board member of 3 spine related charities – Back to Back; British Scoliosis Research Foundation and BackCare. Expert instructed by both claimant and defendant solicitors in negligence and person injury cases. GB: Paid consultancy (RNA-seq) with Ivy Farm and Coding.bio. ABS: Paid post-graduate lecturing internationally. Co-chair NeupSig sciatica working group (unpaid). Sources of funding. This project is funded by UKRI and Versus Arthritis as part of the UKRI Strategic Priorities Fund (SPF) Advanced Pain Discovery Platform (APDP), a co-funded initiative by UKRI (MRC, BBSRC, ESRC), Versus Arthritis, the Medical Research Foundation and Eli Lilly and Company Ltd (Grant MR/W027003/1). Additional funding has been received from the back to back charity to expand longitudinal components of the study. LR has received support with PhD fees from the CSP charitable trust. ABS is supported by a Wellcome Trust Clinical Career Development Fellowship. (222101/Z/20/Z). WS is partly funded through the National Institute for Health and Care Research (NIHR) Biomedical Research Centre at the South London and Maudsley NHS Foundation Trust and King's College London. FP is funded by a Dorothy Hodgkin Career Development Fellowship in Chemistry in association with Somerville College. GB is supported by the Wellcome Trust (223149/Z/21/Z) and Diabetes UK (19/0005984). GC and KRM are partly funded by UKRI and Versus Arthritis as part of the Advanced Pain Discovery Platform (APDP) PAINSTORM (MR/W002388/1). The UKRI and Versus Arhthritis (APDP) are the major funders of FORECAST. All other funders provided either some people support, or funded projects with legacy data that we reuse

The aim of this study was to review the data held with the NHSLA database over the last 10 years for negligence in spine surgery with particular focus on why patients ‘claim’ and what is the likely outcome. Anonymous retrospective review. We contacted the NHSLA and asked them to provide all data held on their database under the search terms ‘spine surgery or spine surgeon.’. An excel sheet was provided, and this was then studied for reason of ‘claim’, whether the claim was open/closed and outcome. A total of 67 claims of negligence were made against spinal surgeries during this time (2000-09). The number of claims had increased over the last few years: 2000-03, n= 8, 2004-06, n= 46. The lumbar spine remains the most common area (Lumbar: 55/67, Thoracic : 6/67, Cervical 6/67). Documented reasons for claims were post-operative complications (n= 28; 42%), delayed/failure to diagnose (n=24; 36%), discontent with preoperative assessment including consent (n=2; 3%), intra-operative complications (n= 10; 15%) and anaesthesia complication (n=3; 4%). Twenty were closed and 47 remained open. The number of successful claims was 8/20 (40%). The mean compensation paid out was £33,409 (range was £820.5 to £60,693). The number of claims brought against spinal surgeries is on the increase, with the most common area being the lumbar spine which perhaps is not surprising as this is the most common area of spinal surgery. Common reasons are post-operative complications and delay/failure to diagnose. The ‘success’ of these claims over the last 10 years was 8/20 (40%) with mean compensation paid out was £33,409. Ethics approval: None;. Interest Statement: The lead author is the CEO and founder of a Personal Injury/Medico-Legal company

Our aim was to determine from the general community an understanding of the implications of informed consent, expectations in regard to self-autonomy, appreciation of risk in surgery, the implications of surgical complications, the degree of acceptability of risk for a given complication and views on surgeon liability. One thousand questionnaires were distributed to members of the general public attending the Palmerston North Hospital as outpatients or visitors (inpatients were excluded). Less than 20% of respondents appreciated the concepts of battery, negligence, self-autonomy and confidentiality. 59% wanted to know about potential complications in order to assist them in making a decision on whether or not to proceed with surgery. Given options and a discussion of the risks, 64% wished to take responsibility for which surgical procedure they would undergo. 9% were unaware that surgical procedures had risks of serious complications. 10% would not undertake surgery if the risk of a serious complication was one in a million, while 30% would undertake surgery regardless of the risk involved. 21% felt the surgeon would be liable in the event of an unmentioned rare complication. The grasp of the perceived objective of informed consent is poor amongst the general population. The tolerance for medical negligence is low and expectations in regard to self-autonomy seem unrealistically high. We feel it is necessary to revisit ‘informed consent’ and for the public (and the legal profession) to make ‘informed consent’ a practical goal-orientated patient/doctor friendly process rather than the existing ‘legal obstacle’ that it is

The aim is: to point out, in respect of Italian case law trends, the concept and the boundaries of surgeon malpractice liability in evaluating and implanting new prosthesic materials. The surgeon is liable for damages caused by fraudulent intention or fault during his clinical and operating activity. In a civil perspective, it could be the result of either a breach of a contract or a tort, depending on the existing relationship between the surgeon and the patient; but in both case there might be a serious inexperience or a light imprudence or negligence to admit a fair compensation for damages. While in a criminal perspective, the personal injuries might be the result of a serious fault also in the area of imprudence and negligence to admit the application of criminal sanctions. Of course, personal liability of surgeon stands by vicarious liability of health unit. Civil sanctions are more effective than criminal sanctions, not only because they have a wider area of application, but also because they are more incisive in quantitative terms, considering the new guidelines on pecuniary and biological damages that make out, at the same time, a compensatory and punitive function. The surgeon, to be sure not to be affected by civil and criminal actions, might inform the patient about the operating features and the consequences of non operating, follow standardized protocols, use products and materials tested and certified by the most influential scientific literature, be care of post-operating effects and adopt all remedies and treatments that can eliminate or reduce post-operating risks, use the best and up-to-date techniques available. In any case he is not liable for unforeseeable events, even if they are in a causative relationship with surgical activity

Shoulder injury related to vaccine administration (SIRVA) is a prolonged episode of shoulder dysfunction that commences within 24 to 48 hours of a vaccination. Symptoms include a combination of shoulder pain, stiffness, and weakness. There has been a recent rapid increase in reported cases of SIRVA within the literature, particularly in adults, and is likely related to the mass vaccination programmes associated with COVID-19 and influenza. The pathophysiology is not certain, but placement of the vaccination in the subdeltoid bursa or other pericapsular tissue has been suggested to result in an inflammatory capsular process. It has been hypothesized that this is associated with a vaccine injection site that is “too high” and predisposes to the development of SIRVA. Nerve conduction studies are routinely normal, but further imaging can reveal deep-deltoid collections, rotator cuff tendinopathy and tears, or subacromial subdeltoid bursitis. However, all of these are common findings within a general asymptomatic population. Medicolegal claims in the UK, based on an incorrect injection site, are unlikely to meet the legal threshold to determine liability.

Cite this article: Bone Joint J 2023;105-B(8):839–842.

We assessed the frequency and causes of neurological deterioration in 59 patients with spinal cord injury on whom reports were prepared for clinical negligence litigation. In those who deteriorated neurologically we assessed the causes of the change in neurology and whether that neurological deterioration was potentially preventable. In all 27 patients (46%) changed neurologically, 20 patients (74% of those who deteriorated) had no primary neurological deficit. Of those who deteriorated, 13 (48%) became Frankel A. Neurological deterioration occurred in 23 of 38 patients (61%) with unstable fractures and/or dislocations; all 23 patients probably deteriorated either because of failures to immobilise the spine or because of inappropriate removal of spinal immobilisation. Of the 27 patients who altered neurologically, neurological deterioration was, probably, avoidable in 25 (excess movement in 23 patients with unstable injuries, failure to evacuate an epidural haematoma in one patient and over-distraction following manipulation of the cervical spine in one patient). If existing guidelines and standards for the management of actual or potential spinal cord injury had been followed, neurological deterioration would have been prevented in 25 of the 27 patients (93%) who experienced a deterioration in their neurological status. Cite this article: Bone Joint J 2015;97-B:527–31

Two discrete legal factors enable the surgeon to treat an injured patient the fully informed, autonomous consent of the adult patient with capacity via civil law; and the medical exception to the criminal law. This article discusses current concepts in consent in trauma; and also considers the perhaps less well known medical exception to the Offences against the Person Act 1861, which exempts surgeons from criminal liability as long as they provide ‘proper medical treatment’.

Cite this article: Bone Jt Open 2024;5(7):565–569.