The cost of consent: why healthcare providers must be compliant with the Montgomery principles.

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.

Malpractice Litigation for Compartment Syndrome.

BACKGROUND: The aim of this study was to analyze litigation involving compartment syndrome to identify the causes and outcomes of such malpractice suits. A better understanding of such litigation may provide insight into areas where clinicians may make improvements in the delivery of care. METHODS: Jury verdict reviews from the Westlaw database from January 1, 2010 to January 1, 2018 were reviewed. The search term "compartment syndrome" was used to identify cases and extract data on the specialty of the physician defendant, the demographics of the plaintiff, the allegation, and the verdict. RESULTS: A total of 124 individual cases involving the diagnosis of compartment syndrome were identified. Medical centers or the hospital was included as a defendant in 51.6% of cases. The most frequent physician defendants were orthopedic surgeons (45.96%) and emergency medicine physicians (20.16%), followed by cardiothoracic/vascular surgeons (16.93%). Failure to diagnose was the most frequently cited claim (71.8% of cases). Most plaintiffs were men, with a mean age of 36.7 years, suffering injuries for an average of 5 years before their verdict. Traumatic compartment syndrome of the lower extremity causing nerve damage was the most common complication attributed to failure to diagnose, leading to litigation. Forty cases (32.25%) were found for the plaintiff or settled, with an average award of $1,553,993.66. CONCLUSIONS: Our study offers a brief overview of the most common defendants, plaintiffs, and injuries involved in legal disputes involving compartment syndrome. Orthopedic surgeons were most commonly named; however, vascular surgeons may also be involved in these cases because of the large number of cases with associated arterial involvement. A significant percentage of cases were plaintiff verdicts or settled cases. Failure to diagnosis or delay in treatment was the most common causes of malpractice litigation. Compartment syndrome is a clinical diagnosis and requires a high level of suspicion for a timely diagnosis. Lack of objective criteria for diagnosis increases the chances of medical errors and makes it an area vulnerable to litigation.

Risk Management and Avoiding Legal Pitfalls in the Emergency Treatment of High-Risk Orthopedic Injuries.

Many orthopedic injuries can have hidden risks that result in increased liability for the emergency medicine practitioner. It is imperative that emergency medicine practitioners consider the diagnoses of compartment syndrome, high-pressure injury, spinal epidural abscess, and tendon lacerations in the right patient. Consideration of the diagnosis and prompt referrals can help to minimize the complications these patients often develop.

Can spinal surgery in England be saved from litigation: a review of 978 clinical negligence claims against the NHS.

PURPOSE: The aim of this study is to evaluate the true incidence of all clinical negligence claims against spinal surgery performed by orthopaedic spinal surgeons and neurosurgeons in the National Health Service (NHS) in England, including both open and closed claims. METHODS: This study was a retrospective review of 978 clinical negligence claims held by NHS Resolution against spinal surgery cases identified from claims against 'Neurosurgery' and 'Orthopaedic Surgery'. This category included all emergency, trauma and elective work and all open and closed cases without exclusion between April 2012 and April 2017. RESULTS: Clinical negligence claims in spinal surgery were estimated to cost £535.5 million over this five-year period. There is a trend of both increasing volume and estimated costs of claims. The most common causes for claims were 'judgement/timing' (512 claims, 52.35%), 'interpretation of results/clinical picture' (255 claims, 26.07%), 'unsatisfactory outcome to surgery' (192 claims, 19.63%), 'fail to warn/informed consent' (80 claims, 8.13%) and 'never events' including 'wrong site surgery' or 'retained instrument post-operation' (26 claims, 2.66%). A sub-analysis of 3 years including 574 claims revealed the most prevalent pathologies were iatrogenic nerve damage (132 claims, 23.00%), cauda equina syndrome (CES) (131 claims, 22.82%), inadequate decompression (91 claims, 15.85%), iatrogenic cord damage (72 claims, 12.54%), and infection (51 claims, 8.89%). CONCLUSIONS: The volume and costs of clinical negligence claims is threatening the future of spinal surgery. If spinal surgery is to continue to serve the patients who need it, most thorough investigation, implementation and sharing of lessons learned from litigation claims must be systematically carried out. These slides can be retrieved under Electronic Supplementary Material.

Alleged malpractice in orthopaedics. Analysis of a series of medmal insurance claims.

BACKGROUND: Medical malpractice is an important topic worldwide, and orthopedics is a clinical branch that is considered to be at a high risk for claims. The analysis of a series of medmal insurance claims allows forensic pathologists, clinicians, and insurance companies to probe the risk of a specific clinical branch for medical malpractice claims and highlights areas where care may be improved. We investigated the main features of a major Italian insurance broker's archive in order to identify recurrent pitfalls in this field. MATERIALS AND METHODS: A retrospective study was carried out on orthopedics claims. The archive covered claims from 2002 to 2013 that targeted 1980 orthopedists. RESULTS: 635 claims were found and analyzed with a focus on the clinical activity invocked in the claim, the presence of alleged team malpractice, the clinical outcome of the case, and the final forensic decision regarding the claim. 299 orthopedists had at least one malpractice claim made against them during the available period; 146 orthopedists were subject to more than one malpractice claim. Most of the claims regarded perioperative and operative cases, usually originating from civil litigation. The anatomical sites most commonly involved were the hip or knees, and sciatic nerve lesions were the main contributor. CONCLUSIONS: Orthopedics is a medical specialty with a high risk for malpractice claims. In our study, medical malpractice was observed in nearly 50% of the cases-typically in surgery-linked cases resulting in permanent impairment of the patient. Death from orthopedics malpractice seemed to be rare. LEVEL OF EVIDENCE: IV.

No-go decision: A newly identified adverse event in orthopaedic surgery - causes and medico-legal implications.

BACKGROUND: No-go designates a decision not to perform surgery when it becomes apparent that safety and/or feasibility requirements are not met. No-go decisions can occur at any time between patient admission to a hospital department and immediately before the first incision. The primary objective of this study was to assess the causes of no-go decisions reported as healthcare-associated adverse events (HAAEs). HYPOTHESIS: Most no-go decisions in orthopaedic surgery are related to problems with medical devices. MATERIAL AND METHODS: A preliminary retrospective study assessed HAAEs reported over the 1-year period from 1st October 2014 to 30th September 2015, using the risk-management tool ALARM. A prospective survey was then performed by emailing a 15-item questionnaire to the 1828 members of Orthorisq (the French orthopaedic surgeon accreditation agency). Responses were either yes/no or open. Statistical comparisons were performed, using the paired Wilcoxon signed-rank test to estimate p values. RESULTS: Among reported HAAEs, 5.6% were no-go decisions. Of the 101 reported no-go decisions, 43.5% and 45.2% were due to problems with managing implantable medical devices in the retrospective and prospective assessments, respectively. In over 85% of cases, surgery was cancelled or postponed. Over half the no-go decisions were associated with unnecessary anaesthesia. Checklist completion was performed in only half the cases and was not associated with no-go decisions (p>0.8). DISCUSSION: This study provides descriptive data on no-go decisions in orthopaedic surgery. Healthcare professionals use many methods to enhance patient safety by preventing adverse events or diminishing their impact. Errors in managing implantable medical devices are the leading cause of no-go decisions. The current checklist is not appropriate for managing implantable medical devices in orthopaedic surgery, in part because it does not include checking devices upon receipt. Before surgery, patients should be informed of the risk of a no-go decision, since unnecessary anaesthesia occurs in over half the cases. LEVEL OF EVIDENCE: IV, prospective study.

Epidemiology of malpractice claims in the orthopedic and trauma surgery department of a French teaching hospital: A 10-year retrospective study.

INTRODUCTION: Orthopedic and trauma surgery is the specialty for which claims for compensation are most often filed. Little data exists on the subject in France, especially in a teaching hospital. We conducted a retrospective study aimed at (1) identifying the epidemiological characteristics of patients filing claims against the orthopedic surgery and traumatology department of a teaching hospital in France, (2) analyzing the surgical procedures involved, the type of legal proceedings, and the financial consequences. HYPOTHESIS: The epidemiological profile of proceedings seeking damages in France is consistent with the data from European and American studies. MATERIALS AND METHODS: An observational, retrospective, single-center study of all claims for damages between 2007 and 2016 involving the orthopedic and trauma surgery department of a teaching hospital was carried out. Patients' epidemiological data, the surgical procedure, type of legal proceeding, and financial consequences were analyzed. RESULTS: Of the 51,582 surgical procedures performed, 71 claims (0.0014%) were analyzed (i.e., 1/726 procedures). A significant increase in the number of cases (p=0.040) was found over a 10-year period. Of these, 36/71 (53.7%) were submitted to the French regional conciliation and compensation commission (CRCI), 23/71 (32.8%) were filed with the administrative court, and 12/71 (13.4%) were submitted for an amicable settlement. The most common reason for which patients filed claims was hospital-acquired infections, with 36/71 (50.7%) cases. Twenty-nine complaints (40.8%) resulted in monetary damages being awarded to the patient, with an average award of € 28,301 (€ 2,400-299,508). Damage awards were significantly higher (p<0.05) for cases involving surgery on a lower limb than those involving an upper limb. CONCLUSION: Claims against orthopedic surgeons have been increasing significantly over the last 10 years. Although rare, they represent a significant cost to society. Hospital-acquired infections are the main reason for disputes in our specialization. LEVEL OF EVIDENCE: IV, retrospective study.

Litigation in orthopedic surgery: What can we do to prevent it? Systematic analysis of 126 legal actions involving four university hospitals in France.

INTRODUCTION: Orthopedic surgery produces 20% of medical malpractice claims. However only a few studies have examined the reasons for and consequences of these disputes, and they have usually been limited to a single hospital. This led us to perform a retrospective analysis of the claims at four teaching hospitals in northwestern France. The goals were (1) to describe the circumstances that led to these claims and recommend ways to prevent them, and (2) to describe the conduct of the proceedings and their financial and social outcomes. HYPOTHESIS: A systematic analysis of litigation cases will provide accurate information on the circumstances leading to these claims. METHODS: The study included 126 disputes settled between 2000 and 2010 and related to orthopedic or trauma care given at one of four teaching hospitals in northwestern France. The method of recourse, grounds of the complaint, type of surgical procedure, expert findings and amount of the award were systematically analyzed. RESULTS: Of these 126 cases, 54 (43%) of them were submitted to the French CRCI (regional conciliation and compensation commission), 48 (39%) to the French administrative courts and 51 (41%) were settled amicably. Multiple methods of recourse were used in 21% of cases (n=27/126). The average length of administrative court proceedings was 36.7±27 months [4-102], which was significantly longer than the CRCI proceedings (22.7±17.9 months [3-80]) or out-of-court settlement (23.7±21.5 months [0-52]) (p<0.0001). Damages were sought for medical error or treatment-related risk in 67.5% of the complaints (n=85/126), and for failure to inform in 15.8% of cases (n=20/126). There was a suspected surgical site infection in 79.3% of cases (n=100/126). There were multiple grounds for complaint in 68.3% of cases (n=86/126). Poor communication between the physician and patient was identified in 26.2% of cases (n=33/126). Damages were awarded in 25% of cases (n=31/126), with an average award of €58,303±€91,601 [0-357,970]. CONCLUSION: The primary grounds for legal action are infection-related complications combined with a deterioration in the doctor-patient relationship. Disputes could be prevented by continuing efforts to combat hospital-acquired infections and providing better communications training. LEVEL OF PROOF: IV (retrospective study).

Litigation related to casting in Orthopaedics-An analysis of claims against the National Health Service in England.

Orthopaedic casts have been used to treat musculoskeletal conditions for hundreds of years and are still a fundamental component of treating a variety of disorders. As surgical techniques have advanced the frequency of use of orthopaedic casts has declined. With Orthopaedics being is one of the most litigious specialties in medicine we sough to evaluate how this related to casting in Orthopaedics and how we could learn from past mistakes. We analysed litigation claims related to Orthopaedic casts from 1995 to 2010 in which the claims were closed. 43 cases were related to orthopaedic casts. The total costs of these claims were over £2.3 million with an average total cost of £48,500 per claim. The most common cause for claim was harm caused when a cast was applied too tight and secondly from removing the cast. This is the first study to evaluate litigation claims related to Orthopaedic casts and highlights potential complications that if avoided will certainly improve the care of the patients and avoid unnecessary litigation.

Litigation costs of wrong-site surgery and other non-technical errors in orthopaedic operating theatres.

INTRODUCTION: This study reviews the litigation costs of avoidable errors in orthopaedic operating theatres (OOTs) in England and Wales from 1995 to 2010 using the National Health Service Litigation Authority Database. MATERIALS AND METHODS: Litigation specifically against non-technical errors (NTEs) in OOTs and issues regarding obtaining adequate consent was identified and analysed for the year of incident, compensation fee, cost of legal defence, and likelihood of compensation. RESULTS: There were 550 claims relating to consent and NTEs in OOTs. Negligence was related to consent (n=126), wrong-site surgery (104), injuries in the OOT (54), foreign body left in situ (54), diathermy and skin-preparation burns (54), operator error (40), incorrect equipment (25), medication errors (15) and tourniquet injuries (10). Mean cost per claim was £40,322. Cumulative cost for all cases was £20 million. Wrong-site surgery was error that elicited the most successful litigation (89% of cases). Litigation relating to implantation of an incorrect prosthesis (eg right-sided prosthesis in a left knee) cost £2.9 million. Prevalence of litigation against NTEs has declined since 2007. CONCLUSIONS: Improved patient-safety strategies such as the World Health Organization Surgical Checklist may be responsible for the recent reduction in prevalence of litigation for NTEs. However, addition of a specific feature in orthopaedic surgery, an 'implant time-out' could translate into a cost benefit for National Health Service hospital trusts and improve patient safety.

Clinical negligence in foot and ankle surgery: A 17-year review of claims to the NHS Litigation Authority.

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.

Doctor's delay in diagnosis of slipped capital femoral epiphysis.

INTRODUCTION: Slipped capital femoral epiphysis (SCFE) is one of the most common hip disorders in the adolescent child. The primary treatment is acute epiphysiodesis. Diffuse symptomology seems to delay diagnosis and delayed treatment entails a risk of complications. Via the independent Danish Patient Insurance Association (DPIA), Danish patients have been able to file a claim when an unexpected side effect or injury has resulted from their medical treatment. The DPIA is based on a no-blame, no-fault case evaluation, which is free of charge and without any legal action. We wanted to examine the causes of complaints through closed claim analysis. MATERIAL AND METHODS: In the DPIA, all medical statements and internal DPIA notes are stored and available for detailed scrutiny. Cases from 1996 to 2011 were investigated for treatment failures. RESULTS: A total of 40 cases were included. The mean age of the children was 12.4 years. A doctor's delay (DD) of the diagnosis was found in 27 case files, with an average 181-day delay. The education and specialisation of the doctors responsible was diverse. Often orthopaedic surgeons would make the correct diagnosis. Complications to surgery were found in 16 cases. In all, 22 of the 40 cases were economially compensated, 16 cases were categorised as "severe disability" by the DPIA. CONCLUSION: This study used closed claim analysis to determine that DD might result in a deteriorated treatment result in children with SCFE. Hopefully, awareness of the disease may lead to an earlier correct diagnosis and hence improve the outcome for the child. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.

Litigation relating to conditions affecting the shoulder and elbow: an analysis of claims against the National Health Service.

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.