Litigation in Ophthalmology against the National Health Service in England
Authors: Varo Kirthi, James E. Neffendorf, Annakan V. Navaratnam, John T. Machin, Melanie Hingorani, Timothy W.R. Briggs, Alison Davis, Caroline MacEwen, Timothy L. Jackson
Journal: Ophthalmology (2021)

The annual clinical negligence bill against the National Health Service (NHS) in England has increased substantially from £0.3 billion ($0.4 billion) in 2004 and 2005 to £2.3 billion ($3.0 billion) in 2019 and 2020.1NHS ResolutionAnnual report and outcomes 2019/20.https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/901085/nhs-resolution-2019-20-annual-report-and-accounts.pdfDate: 2020Date accessed: August 1, 2020Google Scholar Clinical negligence accounts for more than 1.5% of the annual NHS budget in England (£148.8 billion, $193.4 billion).2Yau C.W.H. Leigh B. Liberati E. et al.Clinical negligence costs: taking action to safeguard NHS sustainability.BMJ. 2020; 368: m552Crossref PubMed Scopus (23) Google Scholar The rising costs have been attributed to increases in both claim volume and costs.2Yau C.W.H. Leigh B. Liberati E. et al.Clinical negligence costs: taking action to safeguard NHS sustainability.BMJ. 2020; 368: m552Crossref PubMed Scopus (23) Google ScholarOphthalmology attracts significant litigation, which is unsurprising in that cataract surgery is the most frequently performed operation in the NHS.3NHS DigitalNHS hospital episode statistics: hospital admitted patient care activity 2019-20. Department of Health & Social Care, 2020https://digital.nhs.uk/data-and-information/publications/statistical/hospital-admitted-patient-care-activity/2019-20Date accessed: August 1, 2020Google Scholar Previous studies have used incomplete datasets because before 2002, NHS hospitals did not register all claims on a national database with NHS Resolution (NHSR). Our aim was to evaluate recent ophthalmology litigation claims in England and provide a comprehensive national analysis.Information was provided by the NHSR for all ophthalmology clinical negligence claims between April 2013 and April 2018. The dataset included claim status (open, closed, or related to a clinical incident in anticipation of an impending claim), incident date, claim details, cause of claim, and the alleged injury. More than 1 cause and injury could be assigned depending on claim complexity. All research adhered to the tenets of the Declaration of Helsinki. This study did not involve human participants or any personal identifiable information. Ethical approval and informed consent were not required.Over the 5-year period, 1254 ophthalmology claims were reported to the NHSR, costing an estimated £193 million ($251 million). Across all surgical specialties, ophthalmology had the sixth highest total number and the seventh highest total cost of claims (Table S1, available at www.aaojournal.org). The mean cost per claim in ophthalmology was higher than most other surgical specialties, including orthopedics and urology (Table S1).The annual cost increased from £28.1 million ($36.5 million) to £40.2 million ($52.3 million) over the same period, with an average increase of £2.4 million ($3.1 million; 9%) per annum. Of the claims, 485 (39%) remained open and 743 (59%) were closed. Damages were paid in 420 (57%) of closed claims. Of the 319 claims for which no damages or claimant costs were paid, 74 (23%) had no claim costs for the NHS, but the remaining 249 cost £696 000 ($903 000) in defense costs (Table S2, available at www.aaojournal.org).The most common subspecialty involved in litigation was cataract surgery (n = 295, 24%), followed by vitreoretinal surgery (n = 127, 10%) and medical retina (n = 120, 10%). Pediatric ophthalmology accounted for only 14 claims (1%) but had the highest mean cost per claim of £1.7 million ($2.2 million). Failure/delay in treatment (n = 375, 30%) and failure/delay in diagnosis (n = 201, 16%) were the most common causes with costs of £70.0 million ($91.0 million) and £45.8 million ($59.5 million), respectively (Table 1). “Other visual problems” (n = 563, 45%), “blindness” (n = 315, 25%), and “unnecessary pain” (n = 119, 10%) were the most commonly coded injuries.Table 1Most Frequent Cause and Injury Codes in OphthalmologyNo. of ClaimsEstimated Potential Total CostMean Cost per ClaimGBP (£M)USD ($M)GBP (£)USD ($)Cause CodesFailure/delay in treatment37570.091.0187 691243 998Failure/delay in diagnosis20145.859.5227 745296 069Intraoperative problems1039.912.996 506125 458Operator error1024.45.743 55256 618Inappropriate treatment877.29.482 797107 636Injury CodesOther visual problems56357.775.0102 558133 325Blindness31789.0115.7281 476365 919Unnecessary pain1204.86.239 60651 488Additional/unnecessary operations1127.49.666 05785 874Other231.11.449 90764 879GBP = United Kingdom Pound; M = million; USD = United States Dollar. Currency conversion: £1 GBP = $1.3 USD.Data include all claims between April 1, 2013, and April 1, 2018. Open table in a new tab Among the 454 claims with sufficient clinical information for thematic analysis, the most common causes were failure to diagnose or treat glaucoma (n = 58, 13%), retinal detachment (n = 37, 8%), and neovascular age-related macular degeneration (n = 24, 5%). Sixteen claims were settled for a total cost greater than £1 million ($1.3 million). These included missed or delayed treatment of raised intracranial pressure or tumors (n = 4; mean £3.6 million [$4.7 million] per claim), retinopathy of prematurity (n = 3; mean £4.8 million [$6.2 million] per claim), and retinal detachment (n = 2; mean £1.3 million [$1.7 million] per claim).A similar study in 2013 looked at 963 closed claims over a 15-year period (1995–2009).4Mathew R.G. Ferguson V. Hingorani M. Clinical negligence in ophthalmology: fifteen years of National Health Service litigation authority data.Ophthalmology. 2013; 120: 859-864Abstract Full Text Full Text PDF PubMed Scopus (34) Google Scholar Although their dataset was incomplete, it does provide comparative data. The percentage of successfully defended claims was higher in our study period than before (43% vs. 33%). The mean cost per closed claim was also higher in our dataset (£41 000 [$54 000] vs. £33 000 [$43 000], respectively). However, it is difficult to establish the specific factors involved; this could simply reflect rising legal costs across all specialties or could relate to changes in patient care or expectations.1NHS ResolutionAnnual report and outcomes 2019/20.https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/901085/nhs-resolution-2019-20-annual-report-and-accounts.pdfDate: 2020Date accessed: August 1, 2020Google Scholar However, the volume of activity is likely to be an important factor in the total cost of litigation because it has increased dramatically. In 2019 and 2020, there were approximately 6 times as many ophthalmology outpatient attendances (7.9 million) and approximately 50% more cataract operations (445 000) compared with 2004/2005 (1.2 million and 294 000, respectively).3NHS DigitalNHS hospital episode statistics: hospital admitted patient care activity 2019-20. Department of Health & Social Care, 2020https://digital.nhs.uk/data-and-information/publications/statistical/hospital-admitted-patient-care-activity/2019-20Date accessed: August 1, 2020Google Scholar,5NHS DigitalNHS hospital episode statistics: hospital outpatient activity 2019-2020. Department of Health & Social Care, 2020https://digital.nhs.uk/data-and-information/publications/statistical/hospital-outpatient-activity/2019-20Date accessed: November 1, 2020Google ScholarAnalysis by the National Audit Office in the United Kingdom suggests that increases in damages awarded are related to (1) more high-value claims; (2) increased life expectancy and costs of care; and (3) cost inflation from time elapsed between reporting and resolving cases.6National Audit OfficeManaging the costs of clinical negligence in trusts.https://www.nao.org.uk/wp-content/uploads/2017/09/Managing-the-costs-of-clinical-negligence-in-trusts.pdfDate: 2017Date accessed: August 2, 2020Google Scholar Between 2010/2011 and 2016/2017, the average time taken to resolve a claim after notification increased from 300 to 426 days.6National Audit OfficeManaging the costs of clinical negligence in trusts.https://www.nao.org.uk/wp-content/uploads/2017/09/Managing-the-costs-of-clinical-negligence-in-trusts.pdfDate: 2017Date accessed: August 2, 2020Google Scholar Over the same period, claimant legal costs have also dramatically increased from £77 million ($100 million) to £487 million ($633 million); this has been linked to an increase in low- and medium-value “no-win-no-fee” claims (<£250 000; <$325 000).6National Audit OfficeManaging the costs of clinical negligence in trusts.https://www.nao.org.uk/wp-content/uploads/2017/09/Managing-the-costs-of-clinical-negligence-in-trusts.pdfDate: 2017Date accessed: August 2, 2020Google ScholarSeveral factors drive litigation, but key themes from this dataset were the number related to failures and delays in treatment (30%) or diagnosis (16%). Many of the most expensive claims (>£3 million; >$3.9 million) were related to retinopathy of prematurity, reflecting the significant long-term morbidity associated with missing this diagnosis. Despite guidance from the National Institute for Health and Care Excellence on improving case finding, timely assessments, and treatment for glaucoma, the most commonly missed diagnosis was glaucoma. This is in keeping with UK evidence that at least 22 patients per month lose vision due to delayed follow-up.7Foot B. MacEwen C. Surveillance of sight loss due to delay in ophthalmic treatment or review: frequency, cause and outcome.Eye. 2017; 31: 771-775Crossref PubMed Scopus (78) Google ScholarLimitations of our study include incomplete clinical details, for example, on comorbidities, treatment compliance, misdiagnosis, or the precise nature of any negligent act(s), because the national dataset is designed for claims handling only. In 22% of claims, there was insufficient information to assign a diagnosis or subspecialty. The authors are collaborating with NHSR to improve claim coding, so future studies can report with greater detail. Furthermore, many litigation proceedings are ongoing and open; thus, estimated costs were used instead. However, including open claims allows a better understanding of the most up-to-date claim trends and learning relevant to current practice.In conclusion, a lack of timely diagnosis or treatment accounts for a significant proportion of clinical negligence claims in ophthalmology. This reinforces the importance of improving referral pathways, risk stratification, and clinical governance to prioritize resources to those with sight-threatening disease. With demand for ophthalmic services expected to remain high, rigorous and secure patient-centered improvements are needed to enhance outcomes, support clinical staff, and decrease litigation. The annual clinical negligence bill against the National Health Service (NHS) in England has increased substantially from £0.3 billion ($0.4 billion) in 2004 and 2005 to £2.3 billion ($3.0 billion) in 2019 and 2020.1NHS ResolutionAnnual report and outcomes 2019/20.https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/901085/nhs-resolution-2019-20-annual-report-and-accounts.pdfDate: 2020Date accessed: August 1, 2020Google Scholar Clinical negligence accounts for more than 1.5% of the annual NHS budget in England (£148.8 billion, $193.4 billion).2Yau C.W.H. Leigh B. Liberati E. et al.Clinical negligence costs: taking action to safeguard NHS sustainability.BMJ. 2020; 368: m552Crossref PubMed Scopus (23) Google Scholar The rising costs have been attributed to increases in both claim volume and costs.2Yau C.W.H. Leigh B. Liberati E. et al.Clinical negligence costs: taking action to safeguard NHS sustainability.BMJ. 2020; 368: m552Crossref PubMed Scopus (23) Google Scholar Ophthalmology attracts significant litigation, which is unsurprising in that cataract surgery is the most frequently performed operation in the NHS.3NHS DigitalNHS hospital episode statistics: hospital admitted patient care activity 2019-20. Department of Health & Social Care, 2020https://digital.nhs.uk/data-and-information/publications/statistical/hospital-admitted-patient-care-activity/2019-20Date accessed: August 1, 2020Google Scholar Previous studies have used incomplete datasets because before 2002, NHS hospitals did not register all claims on a national database with NHS Resolution (NHSR). Our aim was to evaluate recent ophthalmology litigation claims in England and provide a comprehensive national analysis. Information was provided by the NHSR for all ophthalmology clinical negligence claims between April 2013 and April 2018. The dataset included claim status (open, closed, or related to a clinical incident in anticipation of an impending claim), incident date, claim details, cause of claim, and the alleged injury. More than 1 cause and injury could be assigned depending on claim complexity. All research adhered to the tenets of the Declaration of Helsinki. This study did not involve human participants or any personal identifiable information. Ethical approval and informed consent were not required. Over the 5-year period, 1254 ophthalmology claims were reported to the NHSR, costing an estimated £193 million ($251 million). Across all surgical specialties, ophthalmology had the sixth highest total number and the seventh highest total cost of claims (Table S1, available at www.aaojournal.org). The mean cost per claim in ophthalmology was higher than most other surgical specialties, including orthopedics and urology (Table S1). The annual cost increased from £28.1 million ($36.5 million) to £40.2 million ($52.3 million) over the same period, with an average increase of £2.4 million ($3.1 million; 9%) per annum. Of the claims, 485 (39%) remained open and 743 (59%) were closed. Damages were paid in 420 (57%) of closed claims. Of the 319 claims for which no damages or claimant costs were paid, 74 (23%) had no claim costs for the NHS, but the remaining 249 cost £696 000 ($903 000) in defense costs (Table S2, available at www.aaojournal.org). The most common subspecialty involved in litigation was cataract surgery (n = 295, 24%), followed by vitreoretinal surgery (n = 127, 10%) and medical retina (n = 120, 10%). Pediatric ophthalmology accounted for only 14 claims (1%) but had the highest mean cost per claim of £1.7 million ($2.2 million). Failure/delay in treatment (n = 375, 30%) and failure/delay in diagnosis (n = 201, 16%) were the most common causes with costs of £70.0 million ($91.0 million) and £45.8 million ($59.5 million), respectively (Table 1). “Other visual problems” (n = 563, 45%), “blindness” (n = 315, 25%), and “unnecessary pain” (n = 119, 10%) were the most commonly coded injuries. GBP = United Kingdom Pound; M = million; USD = United States Dollar. Currency conversion: £1 GBP = $1.3 USD. Data include all claims between April 1, 2013, and April 1, 2018. Among the 454 claims with sufficient clinical information for thematic analysis, the most common causes were failure to diagnose or treat glaucoma (n = 58, 13%), retinal detachment (n = 37, 8%), and neovascular age-related macular degeneration (n = 24, 5%). Sixteen claims were settled for a total cost greater than £1 million ($1.3 million). These included missed or delayed treatment of raised intracranial pressure or tumors (n = 4; mean £3.6 million [$4.7 million] per claim), retinopathy of prematurity (n = 3; mean £4.8 million [$6.2 million] per claim), and retinal detachment (n = 2; mean £1.3 million [$1.7 million] per claim). A similar study in 2013 looked at 963 closed claims over a 15-year period (1995–2009).4Mathew R.G. Ferguson V. Hingorani M. Clinical negligence in ophthalmology: fifteen years of National Health Service litigation authority data.Ophthalmology. 2013; 120: 859-864Abstract Full Text Full Text PDF PubMed Scopus (34) Google Scholar Although their dataset was incomplete, it does provide comparative data. The percentage of successfully defended claims was higher in our study period than before (43% vs. 33%). The mean cost per closed claim was also higher in our dataset (£41 000 [$54 000] vs. £33 000 [$43 000], respectively). However, it is difficult to establish the specific factors involved; this could simply reflect rising legal costs across all specialties or could relate to changes in patient care or expectations.1NHS ResolutionAnnual report and outcomes 2019/20.https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/901085/nhs-resolution-2019-20-annual-report-and-accounts.pdfDate: 2020Date accessed: August 1, 2020Google Scholar However, the volume of activity is likely to be an important factor in the total cost of litigation because it has increased dramatically. In 2019 and 2020, there were approximately 6 times as many ophthalmology outpatient attendances (7.9 million) and approximately 50% more cataract operations (445 000) compared with 2004/2005 (1.2 million and 294 000, respectively).3NHS DigitalNHS hospital episode statistics: hospital admitted patient care activity 2019-20. Department of Health & Social Care, 2020https://digital.nhs.uk/data-and-information/publications/statistical/hospital-admitted-patient-care-activity/2019-20Date accessed: August 1, 2020Google Scholar,5NHS DigitalNHS hospital episode statistics: hospital outpatient activity 2019-2020. Department of Health & Social Care, 2020https://digital.nhs.uk/data-and-information/publications/statistical/hospital-outpatient-activity/2019-20Date accessed: November 1, 2020Google Scholar Analysis by the National Audit Office in the United Kingdom suggests that increases in damages awarded are related to (1) more high-value claims; (2) increased life expectancy and costs of care; and (3) cost inflation from time elapsed between reporting and resolving cases.6National Audit OfficeManaging the costs of clinical negligence in trusts.https://www.nao.org.uk/wp-content/uploads/2017/09/Managing-the-costs-of-clinical-negligence-in-trusts.pdfDate: 2017Date accessed: August 2, 2020Google Scholar Between 2010/2011 and 2016/2017, the average time taken to resolve a claim after notification increased from 300 to 426 days.6National Audit OfficeManaging the costs of clinical negligence in trusts.https://www.nao.org.uk/wp-content/uploads/2017/09/Managing-the-costs-of-clinical-negligence-in-trusts.pdfDate: 2017Date accessed: August 2, 2020Google Scholar Over the same period, claimant legal costs have also dramatically increased from £77 million ($100 million) to £487 million ($633 million); this has been linked to an increase in low- and medium-value “no-win-no-fee” claims (<£250 000; <$325 000).6National Audit OfficeManaging the costs of clinical negligence in trusts.https://www.nao.org.uk/wp-content/uploads/2017/09/Managing-the-costs-of-clinical-negligence-in-trusts.pdfDate: 2017Date accessed: August 2, 2020Google Scholar Several factors drive litigation, but key themes from this dataset were the number related to failures and delays in treatment (30%) or diagnosis (16%). Many of the most expensive claims (>£3 million; >$3.9 million) were related to retinopathy of prematurity, reflecting the significant long-term morbidity associated with missing this diagnosis. Despite guidance from the National Institute for Health and Care Excellence on improving case finding, timely assessments, and treatment for glaucoma, the most commonly missed diagnosis was glaucoma. This is in keeping with UK evidence that at least 22 patients per month lose vision due to delayed follow-up.7Foot B. MacEwen C. Surveillance of sight loss due to delay in ophthalmic treatment or review: frequency, cause and outcome.Eye. 2017; 31: 771-775Crossref PubMed Scopus (78) Google Scholar Limitations of our study include incomplete clinical details, for example, on comorbidities, treatment compliance, misdiagnosis, or the precise nature of any negligent act(s), because the national dataset is designed for claims handling only. In 22% of claims, there was insufficient information to assign a diagnosis or subspecialty. The authors are collaborating with NHSR to improve claim coding, so future studies can report with greater detail. Furthermore, many litigation proceedings are ongoing and open; thus, estimated costs were used instead. However, including open claims allows a better understanding of the most up-to-date claim trends and learning relevant to current practice. In conclusion, a lack of timely diagnosis or treatment accounts for a significant proportion of clinical negligence claims in ophthalmology. This reinforces the importance of improving referral pathways, risk stratification, and clinical governance to prioritize resources to those with sight-threatening disease. With demand for ophthalmic services expected to remain high, rigorous and secure patient-centered improvements are needed to enhance outcomes, support clinical staff, and decrease litigation. Supplementary Data Download .docx (.02 MB) Help with docx files Table S1 Download .docx (.01 MB) Help with docx files Table S2 Download .docx (.02 MB) Help with docx files Table S1 Download .docx (.01 MB) Help with docx files Table S2