Learning from lawsuits: Ten-years of NHS litigation authority claims against 11 surgical specialities in England

Introduction

Medico-legal claims are a drain on NHS resources and promote defencive practice. The litigious burden of surgery in England has not been previously described. This paper describes trends over ten years of claims made against the NHS across 11 surgical specialities.

Litigation related to anaesthesia: an analysis of claims against the NHS in England 1995–2007

The distribution of medico-legal claims in English anaesthetic practice is unreported. We studied National Health Service Litigation Authority claims related to anaesthesia since 1995. All claims were reviewed by three clinicians and variously categorised, including by type of incident, claimed outcome and cost. Anaesthesia-related claims account for 2.5% of all claims and 2.4% of the value of all claims. Of 841 relevant claims 366 (44%) were related to regional anaesthesia, 245 (29%) obstetric anaesthesia, 164 (20%) inadequate anaesthesia, 95 (11%) dental damage, 71 (8%) airway (excluding dental damage), 63 (7%) drug related (excluding allergy), 31 (4%) drug allergy related, 31 (4%) positioning, 29 (3%) respiratory, 26 (3%) consent, 21 (2%) central venous cannulation and 18 (2%) peripheral venous cannulation. Defining which cases are, from a medico-legal viewpoint, 'high risk' is uncertain, but the clinical categories with the largest number of claims were regional anaesthesia, obstetric anaesthesia, inadequate anaesthesia, dental damage and airway, those with the highest overall cost were regional anaesthesia, obstetric anaesthesia, and airway and those with the highest mean cost per closed claim were respiratory, central venous cannulation and drug error excluding allergy. The data currently available have limitations but offer useful information. A closed claims analysis similar to that in the USA would improve the clinical usefulness of analysis.     

Can povidone-iodine solution be used safely in a spinal surgery?

Intra-operative incidental contamination of surgical wounds is not rare. Povidone-iodine solution can be used to disinfect surgical wounds. Although povidone-iodine is a good broad-spectrum disinfecting agent, it has occasionally been reported to have a negative effect on wound healing and bone union. Therefore, its safety in a spinal surgery is unclear. A prospective, single-blinded, randomized study was accordingly conducted to evaluate the safety of povidone-iodine solution in spinal surgeries. Ascertained herein was the effect of wound irrigation with diluted povidone-iodine solution on wound healing, infection rate, fusion status and clinical outcome of spinal surgeries. Materials and methods: From January 2002 to August 2003, 244 consecutive cases undergoing primary instrumented lumbosacral posterolateral fusion due to degenerative spinal disorder with segmental instability had been collected and randomly divided into two groups: the study group (120 cases, 212 fusion levels) and the control group (124 cases, 223 fusion levels). Excluded were those patients with a prior spinal surgery, spinal trauma, malignant tumor, infectious spondylitis, rheumatoid arthritis, ankylosing spondylitis, metabolic bone disease, skeletal immaturity or with an immunosuppressive treatment. In the former group, wounds were irrigated with 0.35% povidone-iodine solution followed by normal saline solution just before the bone-grafting and instrumentation procedure. However, only with normal saline solution in the latter. All the operations were done by the same surgeon with a standard technique. All the patients were treated in the same postoperative fashion as well. Later on, wound healing, infection rate, spinal bone fusion and clinical outcome were evaluated in both groups. Results: A significant improvement of back and leg pain scores, modified Japanese Orthopedic Association function scores (JOA) and ambulatory capacity have been observed in both groups. One hundred and seven patients in the study group and one hundred and nine in the control group achieved solid union. There was no infection in the study group but six deep infections in the control group. Wound dehiscence was noted in one group 1 and two group 2 patients. A subsequent statistical analysis revealed higher infection rate in the control group (P<0.05), but no significant difference in fusion rate, wound healing, improvement of pain score, function score and ambulatory capacity between the two groups. Conclusion: Diluted povidone-iodine solution can be used safely in spinal surgeries, and it will not influence wound healing, bone union and clinical outcome.     

Litigation related to inadequate anaesthesia: an analysis of claims against the NHS in England 1995–2007

Inadequate anaesthesia may cause distress to the patient and lead to medical litigation. All claims made to the NHS Litigation Authority 1995–2007 were obtained and the data was examined independently by all authors and classified. In a dataset of 1067 claims there were 161 cases of inadequate anaesthesia and data were suitable for analysis in 159: intra-operative awareness (79), brief awake paralysis (20) and inadequate regional anaesthesia (60). The total cost of closed claims was £3.2m. Cost was incurred in 100% of claims of brief awake paralysis, 87% of claims of awareness and 80% of claims of inadequate regional blockade. Mean cost of closed claims was £32 680 for anaesthetic awareness, £29 345 for inadequate regional blockade and £24 364 for brief awake paralysis. Inadequate anaesthesia accounts for 19% of anaesthesia-related claims in the NHS in England. Strategies that reduce anaesthetic awareness, drug errors and inadequate regional blockade are known and their improved implementation is likely to reduce such claims.     

Litigation related to drug errors in anaesthesia: an analysis of claims against the NHS in England 1995–2007

Ninety-three claims (total cost £4 915 450) filed under 'anaesthesia' in the NHS Litigation Authority database between 1995 and 2007, alleging patient harm directly by drug administration error or by an allergic reaction, were analysed. Alleged errors were categorised using systems employed by the National Coordinating Council for Medication Error Reporting and Prevention, the American Society of Anesthesiologists Closed Claims Project and the UK Health and Safety Executive. The severity of outcome in each claim was categorised using adapted National Patient Safety Agency definitions. Sixty-two claims involved alleged drug administration errors (total cost £4 283 677) and 15 resulted in severe harm or death. Half alleged the administration of the wrong drug, in most (16) a neuromuscular blocker. Of the claims alleging the wrong dose had been given (25), nine alleged opioid overdose including by neuraxial routes. The most frequently recorded adverse outcomes were awake paralysis (19 claims; total cost £182 347) and respiratory depression requiring intensive care treatment (13 claims; total cost £2 752 853). Thirty-one claims involved allergic reactions (total cost £631 773). In 20 claims, the patient allegedly received a drug to which they were known to be allergic (total cost £130 794). All claims in which it was possible to categorise the nature of the error involved human error. Fewer than half the claims appeared likely to have been preventable by an 'ideal double checking process'.     

Litigation related to regional anaesthesia: an analysis of claims against the NHS in England 1995–2007*

We analysed 366 claims related to regional anaesthesia and analgesia from the 841 anaesthesia‐related claims handled by the National Health Service Litigation Authority between 1995 and 2007. The majority of claims (281/366, 77%) were closed at the time of analysis. The total cost of closed claims was £12 724 017 (34% of the cost of the anaesthesia dataset) with a median (IQR [range]) of £4772 (£0–28 907 [£0–2 070 092]). Approximately half of the claims (186/366; 51%) were related to obstetric anaesthesia and analgesia and of the non‐obstetric claims, the majority (148/180; 82%) were related to neuraxial block. The total cost for obstetric closed claims was £5 433 920 (median (IQR [range]) £5678 (£0–27 690 [£0–1 597 565]) while that for non‐obstetric closed claims was £7 290 097 (£3337 (£0–31 405 [£0–2 070 062]). Non‐obstetric claims were more likely to relate to severe outcomes than obstetric ones. The maximum values of claims were higher for claims related to neuraxial blocks and eye blocks than for peripheral nerve blocks. Despite many limitations, including lack of clinical detail for each case, the dataset provides a useful overview of the extent, patterns and cost associated with the claims.     

Malpractice litigation in elective lumbar spinal fusion: a comprehensive review of reported legal claims in the U.S. in the past 50 years

BACKGROUND CONTEXTIn the U.S., medical malpractice litigation is associated with significant financial costs and often leads to the practice of defensive medicine. Among medical subspecialities, spine surgery is disproportionately impacted by malpractice claims.PURPOSETo provide a comprehensive assessment of reported malpractice litigation claims involving elective lumbar spinal fusion (LSF) surgery during the modern era of spine surgery instrumentation in the U.S., to identify factors associated with verdict outcomes, and to compare malpractice claims characteristics between different approaches for LSF.STUDY DESIGN/SETTINGA retrospective review.PATIENT SAMPLEPatients undergoing elective lumbar spinal fusion surgery.OUTCOME MEASURESThe primary outcome measure was verdict outcome (defendant vs. plaintiff verdict). Secondary outcome measures included alleged malpractice, injury/damage claimed, and award payouts.METHODSThe Westlaw legal database (Thomson Reuters, New York, NY, USA) was queried for verdict and settlement reports pertaining to elective LSF cases from 1970 to 2021. Data were collected regarding patient demographics, surgeon specialty, fellowship training, state/region, procedure, institutional setting (academic vs. community hospital), alleged malpractice, injury sustained, case outcomes, and monetary award.RESULTSA total of 310 cases were identified, yielding 67% (n=181) defendant and 24% (n=65) plaintiff verdicts, with 9% (n=26) settlements. Neurosurgeons and orthopedic spine surgeons were equally named as the defendant (45% vs. 51% respectively, p=0.59). When adjusted for inflation, the median final award for plaintiff verdicts was $1,241,286 (95% CI: $884,850–$2,311,706) while the median settlement award was $925,000 (95% CI: $574,800–$1,787,130), with no stastistically significant differences between verdict and reported settlement payouts (p=0.49). The Northeast region displayed significantly higher award payouts compared to other U.S. regions (p=0.02). There were no associations in awards outcomes when comparing alleged malpractice, alleged injuries/damages, institutional setting, surgical procedures, and surgeon specialty or fellowship training. The most common claims were intraoperative error (28%, n=107) followed by failure to obtain informed consent (24%, n=94). In the analyzed cohort, the most common injuries leading to litigation were refractory pain and suffering (37%, n=149) followed by permanent neurological deficits (26%, n=106). There were no differences in alleged malpractice or injury sustained between cases in which the outcome was favorable to defendant versus plaintiff. Anterior lumbar interbody fusion (ALIF) cases were 2.75 times more likely to be cited for excessive or inappropriate surgery (OR: 2.75 [95% CI: 1.14, 6.86], p=0.02) when compared to posterior surgical approaches.CONCLUSIONThe results of our analysis of reported claims suggest that medical malpractice litigation involving elective LSF is associated with jury verdicts over $1 million per case, with the most common alleged malpractice being intraoperative error and failure to obtain informed consent. Surgeon specialty, fellowship training, procedure type, and institution type were not associated with greater litigation risks; however, ALIF surgery had a significantly higher risk of involving claims of excessive or inappropriate surgery compared to posterior approaches for lumbar fusion. In addition, claims were significantly higher in the Northeast compared to other U.S. regions. Efforts to improve patient education through shared-decision making and proactive strategies to avoid, detect, and mitigate intra-operative procedural errors may decrease the risk of litigation in elective LSF.     

Urological litigation in the UK National Health Service (NHS): an analysis of 14 years of successful claims

What’s known on the subject? and What does the study add? There are no previous studies for urology in the UK but several studies from physician insurance groups in North America. There is anecdotal evidence of common reasons for litigation, e.g. missed testicular torsion. This is the first analysis of the claims data compiled by the NHS litigation authority for the speciality of urology; it provides realistic insight into the areas and procedures of the speciality most commonly affected by litigation. The article identifies areas of high risk, both clinical and medico‐legal.

OBJECTIVES

? To present a summary of the collected data on urological litigation within the UK National Health Service (NHS). ? Knowledge of the main areas of litigation is essential for maintaining good clinical practice as well as risk management procedures in any specialty.

MATERIALS AND METHODS

? Details of all claims closed with indemnity payment pertaining to the specialty of urology as practiced by urologists, general surgeons and paediatric surgeons was obtained from the NHS Litigation Authority (NHSLA) for the years since its creation in 1995 to 2009. ? The data was then classified and analysed.

RESULTS

? In all, 493 cases were closed with indemnity payment with a total of £20 508 686.18 paid. The average payment per claim was £41 599.77. ? Most of the claims were related to non‐operative events (232), followed by postoperative events (168) and intraoperative events (92). ? The most common reason for non‐operative‐related claims was failure to diagnose/treat cancer (69), perforation/organ injury (38) was the highest intraoperative‐related claim and a forgotten ureteric stent (23) was the most frequent postoperative‐related claim. ? The five most commonly implicated procedures were ureteroscopy/ureteric stenting (45), transurethral resection of the prostate (30), nephrectomy (26), vasectomy (19) and urethral catheterisation (15).

CONCLUSIONS

? The present study once again emphasizes the importance of thorough clinical assessment, record keeping and follow‐up as well as informed consent and good communication with patients. ? Recognising the areas of highest risk and improving practice should limit future claims.     

Litigation related to airway and respiratory complications of anaesthesia: an analysis of claims against the NHS in England 1995–2007

Claims notified to the NHS Litigation Authority in England between 1995 and 2007 and filed under anaesthesia were analysed to explore patterns of injury and cost related to airway or respiratory events. Of 841 interpretable claims the final dataset contained 96 claims of dental damage, 67 airway‐related claims and 24 respiratory claims. Claims of dental damage contributed a numerically important (11%), but financially modest (0.5%) proportion of claims. These claims predominantly described injury during tracheal intubation or extubation; a minority associated with electroconvulsive therapy led to substantial cost per claim. The total cost of (non‐dental) airway claims was £4.9 million (84% closed, median cost £30 000) and that of respiratory claims was £3.3 million (81% closed, median £27 000). Airway and respiratory claims account for 12% of anaesthesia‐related claims, 53% of deaths, 27% of cost and ten of the 50 most expensive claims in the dataset. Airway claims most frequently described events at induction of anaesthesia, involved airway management with a tracheal tube and typically led to hypoxia and patient death or brain injury. Airway trauma accounted for one third of airway claims and these included deaths from mediastinal injury at intubation. Pulmonary aspiration and tube misplacement, including oesophageal intubation, led to several claims. Among respiratory claims, ventilation problems, combined with hypoxia, were an important source of claims. Although limited clinical details hamper analysis, the data suggest that most airway and respiratory‐related claims arise from sentinel events. The absence of clinical detail and denominators limit opportunities to learn from such events; much more could be learnt from a closed claim or sentinel event analysis scheme.     

Rods in spinal surgery: a review of the literature

Background context

Spinal instrumentation has been used for more than five decades. Since the introduction of the Harrington rod in 1962, new rod materials and concepts have been developed. Rigid rod fixation has achieved higher fusion rates than previous methods. Recently, semirigid rod fixation devices have been used for both dynamic stabilization and fusion fixation. Memory rods, which have an interesting ability to return to their pre-bent shape when the temperature increases, are expected to be used for scoliosis correction.

Purpose

To review the previous literature regarding biofunctionality and biocompatibility of rods in spinal surgery.

Conclusion

The properties of each type of rod need to be taken into consideration when performing spinal instrumentation surgery.     

Fourteen years of litigation claims in cardiothoracic surgery in the United Kingdom National Health Service

Approximately 36 400 cardiac and 23 100 thoracic operations are carried out in the United Kingdom between 2006 and 2015. National Health Service (NHS) resolution, as known as the NHS litigation authority, is one of the essential bodies of the Department of Health. Its purpose is to provide NHS expertise to resolve concerns fair and square share learning for improvement. We aim to evaluate and increase awareness of medicolegal cases in cardiothoracic surgery. Total numbers and details of claims coded by NHS resolution in cardiothoracic surgery from 2004 to 2017 were requested under the Freedom of Information Act 2000. The data provided in successful claims is further breakdown into damages paid to the claimant, defence cost, claimant cost paid and the sum of the three. In contrast, unsuccessful claims only include the defence cost. Moreover, data provided also includes further analysis of primary causes and primary injuries for Claims Closed/Settled with damages paid. There were 753 claims recorded from 2004 to 2017, of which 415 (55.11%) were successful. The number of claims has been steadily increasing since 2004, with two significant raises from 2009/10 to 2010/11 (37‐55, 48.64% raise) and 2012/13 to 2013/14 (49‐69, 40.82% raise). The mean successful claim ratio was 69.58% (range, 47.56%‐ 83.33%) There is also a steady increase in the successful ratio from 2004 to 2017. In summary, this is the first study published in relation to litigation claims on cardiothoracic surgery in the United Kingdom. The results have provided insight on claims made against cardiothoracic surgery.     

Bloodless spinal surgery: a review of the normovolemic hemodilution technique

BACKGROUND: "Bloodless spinal surgery" predominantly refers to NH, a procedure that minimizes blood transfusion requirements. By limiting or eliminating allogeneic transfusions, NH reduces the risk of transmitting HIV or hepatitis, and the need for predonating autologous blood with the risks of blood bank contamination, misidentification, or the removal of coagulation factors (fresh frozen plasma, platelets). METHODS: The NH technique technically requires the controlled removal of a volume of whole blood at the beginning of surgery. The quantity removed is dependent upon the preoperative hematocrit and varies from 1 to 3 U. Each 1 mL of whole blood removed is then replaced with 3 to 4 mL of colloid or crystalloid. Intraoperatively, NH typically reduces the hematocrit to 28%, taking care to avoid hemodynamic compromise through adequate volume replacement. RESULTS: For adolescents undergoing scoliosis/spinal fusions, NH reduced allogeneic transfusion requirements from 79% to 37% [Cha CW, Deible C, Muzzonigro T, et al. Allogeneic transfusion requirements after autologous donations in posterior lumbar surgeries. Spine. 2002; 27(1) 99-104]. Without NH, 40% of patients undergoing instrumented lumbar spine fusions in one series required allogeneic blood transfusions [Catoire P, Saada M, Liu N, et al. Effect of preoperative normovolemic hemodilution on left ventricular segmental wall motion during abdominal aortic surgery. Anesth Analg (US). 1992; 75(5): 654-9.]. With the use of NH in a comparable series, this frequency was reduced to 23.5% [Epstein NE, Peller A, Korsh J, et al. Impact of intraoperative normovolemic hemodilution on transfusion requirements for 68 patients undergoing lumbar laminectomies with instrumented posterolateral fusion. Spine. 2006; 31(19): 2227-2230]. CONCLUSIONS: This study reviews how NH may be safely and effectively used by spinal surgeons, particularly for those who perform multilevel lumbar laminectomies with or without fusion.     

Risk of aspirin continuation in spinal surgery: a systematic review and meta-analysis

Background Context

Aspirin is typically discontinued in spinal surgery because of increased risk of hemorrhagic complications. The risk of perioperative continuation of aspirin in neurosurgery needed to be evaluated.