Clinical Negligence in Ophthalmology: Fifteen Years of National Health Service Litigation Authority Data

Clinical Negligence in Ophthalmology: Fifteen Years of National Health Service Litigation Authority Data Rashmi G. Mathew, MRCOphth, MBBS, 1 Veronica Ferguson, FRCOphth, 2 Melanie Hingorani, FRCOphth 1 Objective: To categorize and understand the reasons behind ophthalmic clinical negligence claims in the National Health Service and how such claims can be avoided. Design: Retrospective analyses of all ophthalmic clinical negligence claims between 1995 and 2009 were carried out. Data were obtained from the National Health Service Litigation Authority through the Freedom of Information Act. Claims were classified according to ophthalmic subspecialty, mean payment per subspecialty, severity, paid-to-closed ratio, and cost. Participants: One thousand two hundred fifty-three ophthalmology-related claims occurring from 1995 through 2009. Of these, 963 claims were closed over the 15-year period. Eighty-four were excluded because of insufficient case data. Intervention: Retrospective analysis of all public sector ophthalmology litigation claims over a 15-year period in England. Main Outcome Measures: Subspecialty pertaining to claim, mean payment per claim, and severity of outcome of clinical incident. Results: Nine hundred sixty-three claims were closed over a 15-year period, of which 67% resulted in payment. The total cost of claims was 32.1 million ($50.3 million), with a mean payment per claim of 33 300 ($52 300). The specialties with the highest mean payment per claim were neuro-ophthalmology and pediatric ophthalmology. Cataract subspecialty had the highest number of claims, accounting for 34% of all claims. Conclusions: Overall, the number of litigation claims in ophthalmology is low, relative to the high volume of outpatient and surgical workload. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. Ophthalmology 2013;120:859 864 2013 by the American Academy of Ophthalmology. Clinical negligence is defined as a deviation from accepted standards of practice, whether by act or omission, that results in harm to the patient. Examination of negligence claims in ophthalmology is an important method of promoting learning from adverse events, but often information is poorly disseminated when such events occur. Published reports on ophthalmic negligence claims are sparse. The National Health Service Litigation Authority (NHSLA) was formed in 1995 in England to provide a national framework for handling claims in the National Health Service (NHS; public sector). The costs incurred by the NHSLA include damages paid to patients and legal fees on both sides in cases of defeat. In the last 6 fiscal years, claims-related costs paid out by the NHSLA have more than doubled, rising from 329 million ($517 million) in the 2004 2005 fiscal year to 863 million ($1.36 billion) in the 2010 2011 fiscal year. A recent report from the United States estimated the annual cost of malpractice claims at $9.85 billion. In addition, the annual cost for practice of defensive medicine (practice of diagnostic and therapeutic measures conducted primarily to safeguard against litigation) was estimated to be $45.6 billion. 1 In the United Kingdom, there has been much media coverage about the perceived inordinate use of public sector funds by litigation lawyers. It was reported that, of 5398 clinical negligence claims closed by the NHSLA with damage payments in 2010 2011, 257 million ($386 million) was paid in legal costs, of which almost 200 million ($314 million) was paid to claimants lawyers. Interestingly, of all NHSLA claims, 43% are settled out of court and only 4% are settled in court, with 40% of claims abandoned by the claimant. This article examines the outcomes of clinical negligence claims in ophthalmology that were handled by the NHSLA over the last 15 years. The main objective of this report was to understand the reasons for filing ophthalmic negligence claims and how such claims can be minimized. Identifying areas of high medicolegal risk is also valuable for developing risk management strategies and for improving patient safety. The financial impact that litigation claims have on ophthalmology as a specialty was also determined. Materials and Methods In February 2010, the NHSLA was contacted and a request for ophthalmic litigation data was filed. The data were received in the form of a Microsoft Excel spreadsheet in an anonymized format, listing all claims relating to ophthalmology between 1995 and 2013 by the American Academy of Ophthalmology ISSN 0161-6420/13/$ see front matter Published by Elsevier Inc. doi:10.1016/j.ophtha.2012.01.009 859

Ophthalmology Volume 120, Number 4, April 2013 2009. The data set did not include information on claims that were settled out of court. The data set included the following information: year of incident, year of claim, whether the claim remained open or closed, claim details, and cost to the NHS. The details of each incident and outcome data were used to classify cases according to subspecialty and severity of claim. The data set is for financial management and not a clinical risk data set. Therefore, clinical data on certain claims were very limited. Where data were insufficient to classify a claim, the claim was excluded from analysis. Claims were classified as follows: (1) year of claim, (2) open or closed claims, (3) clinical subspecialty category, (4) severity of outcome using the National Patient Safety Agency tool for grading patient safety incidents 2 (Table 1), and (5) cost of claim. The clinical subspecialty categories used were: cataract, cornea, glaucoma, vitreoretina, medical retina, uveitis, neuro-ophthalmology, strabismus, pediatrics, oculoplastics, ocular anesthesia, oncology laser, LASIK, and pharmacy. A separate category called neuroophthalmology/glaucoma was included for patients diagnosed with pituitary tumors, because these patients could end up in either clinic with suspicious visual fields. For each subspecialty, the number of closed claims and number of claims with payment damages were determined. The total and mean level of damages, as well as the paid-to-closed ratio 3 (indicator of the likelihood of a claim resulting in payment) also were calculated for each subspecialty. Results The data set contained 1253 ophthalmology-related reports relating to claims occurring from 1995 through 2009. Eighty-four cases were excluded from the final data set because of inadequate information. Overall, 963 closed cases were reviewed. Classification of cases was as follows (see Table 2): cataract, 357 cases (37%); vitreoretinal, 82 cases (9%); medical retina, 89 cases (8%); oculoplastics, 64 cases (7%); cornea, 40 cases (4%); glaucoma, 39 cases (4%); neuro-ophthalmology, 32 cases (3%); strabismus, 30 cases (3%); uveitis, 25 cases (3%); trauma, 25 cases (3%); ocular anesthesia, 22 cases (2%); pediatrics, 21 cases (2%); accident and emergency, 20 cases (2%); ocular oncology, 12 cases (1%); laser (nonretinal), 9 cases (1%); LASIK, 4 cases (0.4%); and pharmacy, 3 cases (0.3%; Fig 1). Table 1. National Patient Safety Agency Severity of Outcome Scale for Patient Safety Incidents Severity Grade Description None No harm (whether lack of harm was due to prevention or not) Low Minimal harm necessitating extra observation or minor treatment* Moderate Significant, but not permanent harm, or moderate increase in treatment Severe Permanent harm resulting from the incident Death Death resulting from the incident *First aid, additional therapy, or additional medication; excludes extra stay in hospital, return to surgery, or readmission. Return to surgery, unplanned readmission, prolonged episode of care as inpatient or out-patient, or transfer to another area such as intensive care. Permanent reduction of bodily functions: sensory, motor, physiological, or intellectual. Table 2. Severity of Ophthalmic Claims, Graded Using National Patient Safety Agency Severity of Outcome Scale Severity Grade No. of Claims None 26 Low 76 Moderate 337 Severe 470 Death 4 Claim Costs The overall cost of the 963 closed claims was 32.1 million ($50.3 million). This gave a mean payment of 33 300 ($52 300) per claim. The specialties with the highest total pay out were cataract ( 7.7 million [$12.1 million]) and medical retina ( 3.7 million [$5.7 million]). The specialties with the highest mean payment per claim were neuro-ophthalmology ( 126 000 [$197 000]) and pediatrics ( 112 000 [$175 000]); uveitis had the lowest mean payment per claim ( 16 800 [$26 400]; Fig 2). The highest individual pay-out amounted to 767 952 ($1.21 million) for a patient in whom a brain tumor had been missed. Failure to treat retinopathy of prematurity leading to blindness was the second highest payment, at 752 248 ($1.18 million). The third highest payment was for failure to diagnose acute angle closure with ensuing blindness, leading to a payment of 690 738 ($1.08 million). Fatal Claims Four cases had a fatal outcome: 2 in oculoplastics, 1 in glaucoma, and 1 in vitreoretinal ophthalmology. The causes of fatality in oculoplastics were an intracranial bleed related to orbital decompression surgery and an inability to stem bleeding after removal of an eyelid lesion, which led to a fatal cerebrovascular accident. The glaucoma case was related to delayed diagnosis of a choroidal melanoma, which was causing secondary glaucoma, such that the tumor had metastasized by the time it was diagnosed. The vitreoretinal case was a patient being followed up with a subluxed lens, where a diagnosis of homocystinuria was missed. This claim resulted in the highest compensatory pay out for the fatal claims at 169 000 ($264 000). Severe Claims The National Patient Safety Agency severity outcome scale for patient safety incidents grades a severe incident as one in which permanent harm is sustained. The severity of claims pertaining to subspecialties are outlined in Table 2. Forty-nine percent of all closed claims were related to severe incidents. The subspecialties with the highest percentage of severe claims were: neuro-ophthalmology/glaucoma (100%), ocular oncology (91%), neuro-ophthalmology (88%), pediatric ophthalmology (86%), and ocular anesthesia (77%). Paid-to-Closed Ratio Overall, 77% claims were closed, of which 67% resulted in payment. The subspecialties most likely to result in payment were: neuro-ophthalmology/glaucoma (89%), neuro-ophthalmology (85%), ocular oncology (82%), pediatric ophthalmology (81%), and glaucoma (78%). Frequent Clinical Negligence Scenarios Cataract had the highest number of claims (37% of all claims). The most common causes (19%) for a cataract claim was insertion of an 860

Mathew et al Fifteen Years of Ophthalmic Litigation in England Figure 1. Bar graph showing the number of claims per ophthalmic subspecialty between 1995 and 2009. A&E accident and emergency. incorrect intraocular lens (IOL), inaccuracies in biometry, or both. Sixty-five percent of ocular anesthesia-related claims pertained to globe perforation. In medical retina, most cases were related to delayed diagnosis of diabetic retinopathy and loss of vision after retinal laser. Fifty-nine percent of vitreoretinal cases were related to missed or delayed diagnosis of retinal detachments and tears. Poor surgical outcome was the most frequent cause for claim in strabismology. Delayed management and mismanagement of amblyopia were the most common claim in pediatric ophthalmology, although delayed or missed retinopathy of prematurity led to the highest pay-outs. Surprisingly, only 5 of the 963 complaints specifically stated that a trainee was involved in their care as part of their reason for seeking legal compensation. Discussion Analysis of negligence claims can provide a proclivity for enhancing patient safety, identifying areas of risk, and minimizing the chance of litigation; yet, very little information is disseminated about litigation in ophthalmic practice. This study highlights the areas of risk for, and financial implications of, ophthalmology-related medicolegal cases in the NHS. The Medical Defence Union reported that the typical ophthalmologist faces a claim once every 15 years and that 1 in 3 ophthalmic claims resulted in settlement in the private Figure 2. Bar graph showing the mean payments per claim within each ophthalmic subspecialty between 1995 and 2009. A&E accident and emergency. 861

Ophthalmology Volume 120, Number 4, April 2013 Figure 3. Bar graph showing the total number of claims per clinical specialty handled by the National Health Service Litigation Authority (NHSLA) between 1995 and 2009. The NHSLA handles all clinical negligence claims against the National Health Service in England. A&E accident and emergency; GP general practice; O&G obstetrics and gynecology. sector. 4 Their highest recorded indemnity payment was 1.3 million ($2.04 million) for failure to diagnose a pituitary tumor. Specialists in higher-risk fields such as cosmetic surgery could expect to be sued once every 2 years, and those in lower-risk specialties such as anesthesia could expect only 1 claim in their entire career in the private sector. A study in the United States looking at malpractice data for physicians covered by a large professional liability insurer showed that approximately 6% of 807 insured ophthalmologists received a malpractice claim each year over a 15-year period. Less than 2% of all claims led to payment of damages. 5 The current study adds to a previous analysis of 651 ophthalmic negligence claims handled by the NHSLA over a 10-year period. 3 We analyzed 963 closed claims which occured over 15 years; the overall cost of the claims was 32.1 million ($50.3 million). Sixty-seven percent of closed claims led to cost. In England, there are currently 947 practicing ophthalmic consultants, making the likelihood of encountering negligence at just over 1 claim every 15 years in the public sector. Taking into consideration that ophthalmology is a specialty with one of the highest number of outpatients and surgeries every year, this is a relatively small number of claims. In comparison, anesthesia, which is considered relatively low risk in terms of litigation, had 841 closed claims over a 12-year period (Fig 3). 6 Medical negligence occurs when, either by omission or act, care provided by a health care professional does not conform to acceptable standards of practice. A plaintiff must establish all 4 elements of negligence for a successful malpractice claim: the defendant (doctor) was duty bound to deliver care, the defendant was in breach of that duty, the breach of care caused the patient injury, and there was a causal relationship between injury and breach of care. Conversely, for a claim to be defended successfully, tort law requires evidence that the defendant practitioner provided care in accordance with a responsible body of medical opinion 7,8 and that there was a logical basis for their decision. 9 After an adverse event has occurred, there are a number of key areas where clinician behavior can reduce the likelihood of litigation in any branch of medicine. Communication can be key, and studies have shown that, in a medical consultation, how a message is conveyed may be as important as what is being said. A team of Harvard psychologists studied short clips of medical consultations by surgeons with and without previous malpractice claims. 10 The clips were rated by masked judges and filtered for content. Only expressive features, such as intonation, speed, pitch, and rhythm, remained. Ratings of higher dominance and lower concern in their voice significantly identified surgeons with previous malpractice claims compared with those with no claims. Levinson et al 11 studied audio-taped consultations of primary care physicians and found that those who spent longer in routine visits were less likely to have a previous history of malpractice claims. They also found that physicians with no claims used statements of orientation (informing patients about what to expect), facilitation (checking understanding and encouraging patients to talk), and humor. Several studies have shown that patients want disclosure, an apology after an adverse event, and to know how recurrences can be prevented. 12,13 An apology is not an admission of guilt, and it often serves to diffuse potential litigation claims. The UK General Medical Council advocates that a full, honest explanation and an apology be given after an adverse event as part of Good Medical Practice. 14 A timely referral for a second opinion also can serve as a strong defense in court 15 and is vital in cases where the patient seems dissatisfied with the opinion or care provided. It clarifies for the patient what the correct approach is and allows time to decide about a preferred course of action. In many cases, it helps to avoid the litigation process altogether. 862

Mathew et al Fifteen Years of Ophthalmic Litigation in England An effective large-scale intervention in minimizing surgical risk is the introduction of the surgical safety checklist. The World Health Organization s pilot study of the checklist showed that at least half a million deaths per year were preventable with effective worldwide implementation. 16 The checklist is designed to verify that critical steps have been completed and to detect their omission at remediable time points. An Australian population-based study also confirmed that half of hospital adverse events were preventable. 17 For organizations seeking to manage medicolegal exposure, an understanding of the ophthalmic subspecialties most likely to be implicated in negligence claims can lead to the development of targeted risk management strategies. Cataract Surgery Cataract surgery is the most common day-case operation performed on the NHS in England. 18 It therefore is not surprising that it has the largest number of claims, 34%. A study of 121 ophthalmic claims in the United States also found cataract surgery to be the most common cause of litigation, accounting for 29% of all claims. 19 The current study found incorrect IOL insertion and biometry inaccuracies to be the most common reasons (19%), both of which potentially are avoidable. A study in the United States also found the most common cataract surgery error to be IOL related and found that incorrect IOL insertion claims were defensible, provided that there was sufficient documentation explaining why the surgeon had chosen that particular IOL. 15 A study by Ali and Little of over 300 UK cataract claims handled by the NHSLA confirmed biometry errors and incorrect IOL insertion as a major cause of claims, and negligent surgery and reduced vision after surgery to be the commonest cause for claims. 20 Interestingly, the study also found inadequate anesthesia and complications of anesthesia, such as globe perforation to have the highest paidto-closed ratio in the cataract subspecialty and made the point that whilst the modern trend toward topical anesthesia will reduce globe damage, it may increase claims for pain suffered during surgery. 20 Other reasons for cataract-related claims in this study included inadequate consent, damage resulting from ocular anesthesia, poor outcomes, and well-recognized complications such as dropped nuclei and endophthalmitis. In a study by Bhan et al 21 of cataract negligence claims, 22 patients claimed compensation for posterior capsule rupture, a wellknown complication of cataract surgery. English law states that it is the duty of a surgeon to inform a patient of the risks before undergoing an operation and that patients must be given sufficient information to make an informed choice about whether to accept or refute a treatment and details about all other viable treatment options. 22 A study on informed consent for nonophthalmic procedures showed that only 25% of risks explained to patients were retained; indicating that information may need to be repeated on several occasions. 23 All patients should be provided with a hardcopy of their signed consent form and the consent process should be documented, because this is a vital source of evidence in litigation cases. Even if a patient is given written literature and all known complications are documented in the consent form and patient records, if a complication occurs that is not handled to an acceptable standard, the defendant is still considered negligent. 23 A study of 96 private sector negligence claims in cataract surgery found that only 45% of cases had documented evidence of the complication being explained to the patient after it had occurred. 21 A further study in the United States looking at cataract surgery claims found that documentation tended to be less comprehensive for routine cases; however, 50% of all claims did not have a complication at the time of surgery. 15 They concluded that the absence of a complication during surgery should not preclude complete documentation of surgical notes. Other Subspecialties The specialties most likely to lead to cost were neuroophthalmology/glaucoma, neuro-ophthalmology, ocular oncology, pediatric ophthalmology, and glaucoma. Most claims within these subspecialties related to delayed or missed diagnoses. This spread of specialties was similar to those with the most number of severe claims: neuro-ophthalmology/glaucoma, ocular oncology, neuro-ophthalmology, pediatric ophthalmology, and ocular anesthesia. In the category of neuro-ophthalmology/glaucoma, all cases related to tumors (pituitary adenomas, craniopharyngioma). Although the exact clinical circumstances are not detailed, one can assume that these patients were referred to the ophthalmologist with a visual field defect. In one case, a magnetic resonance imaging scan was ordered, but the results of the test were not reviewed by the ophthalmologist, causing a delay in diagnosis. In another patient, a pituitary tumor was identified, but the patient was not referred for a specialist opinion. Two invaluable lessons are highlighted by these cases: first, investigations requested must be evaluated by the ordering clinician or their team; and second, when pathologic features outside the remit of a particular specialty are identified, they must be referred promptly to the appropriate specialist. In the category of ocular oncology, most claims related to delayed or missed choroidal melanomas, one of which required an orbital exenteration after it was diagnosed. Conversely, one claimant was noted to have a suspicious fundal lesion, which 2 consultants agreed had features consistent with a choroidal melanoma. Histopathologic analysis after enucleation revealed inflammatory changes and no evidence of malignancy. Glaucoma cases mostly related to loss of visual field either in primary open-angle glaucoma or in acute angle closure. Overall, the number of litigation claims in ophthalmology is low, relative to the high outpatient and surgical workload. As a specialty and as individual clinicians, we continually should seek to improve patient care and safety, and this study highlights areas where robust risk-reduction strategies need to be implemented into the delivery of ophthalmic care. Acknowledgement.We would like to thank Ruth Symons from the NHSLA for providing the raw data and her guidance. 863

Ophthalmology Volume 120, Number 4, April 2013 References 1. Mello MM, Chandra A, Gawande AA, Studdert DM. National costs of the medical liability system. Health Aff (Millwood) 2010;29:1569 77. 2. National Patient Safety Agency. National Reporting and Learning Service. Seven steps to patient safety for primary care. 2006: 89. Available at: http://www.nrls.npsa.nhs.uk/resources/?entryid 45 59804&q 0improving patient safety. Accessed October 6, 2011. 3. Ali N. A decade of clinical negligence in ophthalmology. 2007;7:20. 4. Tomkins C. Over 120 years of defending ophthalmologists. Br J Ophthalmol 2006;90:1084 5. 5. Jena AB, Seabury S, Lakdawalla D, Chandra A. Malpractice risk according to physician specialty. N Engl J Med 2011;365: 629 36. 6. Cook TM, Bland L, Mihai R, Scott S. Litigation related to anaesthesia: an analysis of claims against the NHS in England 1995 2007. Anaesthesia 2009;64:706 18. 7. Bolam v. Friern Hospital Management Committee [1957] 1 WLR 582 [UK tort law]. 8. Brazier M. Medicine, Patients and the Law. 2nd ed. Harmondsworth, England: Penguin; 1992: 112 39. 9. Bolitho v. City and Hackney Health Authority [1997] 4 All ER 771 [UK tort law]. 10. Ambady N, Laplante D, Nguyen T, et al. Surgeons tone of voice: a clue to malpractice history. Surgery 2002;132:5 9. 11. Levinson W, Roter DL, Mullooly JP, et al. Physician-patient communication: the relationship with malpractice claims among primary care physicians and surgeons. JAMA 1997;277:553 9. 12. Hingorani M, Wong T, Vafidis G. Patients and doctors attitudes to amount of information given after unintended injury during treatment: cross sectional, questionnaire survey. BMJ 1999;318:640 1. 13. Gallagher TH, Waterman AD, Ebers AG, et al. Patients and physicians attitudes regarding the disclosure of medical errors. JAMA 2003;289:1001 7. 14. General Medical Council. Good Medical Practice. London: GMC; 1998:18. Available at: http://www.gmc-uk.org/static/ documents/content/gmp_0910.pdf. Accessed December 16, 2011. 15. Brick DC. Risk management lessons from a review of 168 cataract surgery claims. Surv Ophthalmol 1999;43:356 60. 16. Haynes AB, Wesier TG, Berry WR, et al, Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 2009;360:491 9. 17. Wilson RM, Runciman WB, Gibberd RW, et al. The Quality in Australian Health Care Study. Med J Aust 1995;163:458 71. 18. Hospital Episode Statistics: HESonline [database online]. Main procedures and interventions: 4 character. 2000 2010. Available at: http://www.hesonline.nhs.uk/ease/servlet/contentserver?site ID 1937&categoryID 215. Accessed October 6, 2011. 19. Kraushar MF, Turner MF. Medical malpractice litigation in ophthalmology: the New Jersey experience. Ophthalmic Surg 1986;17:671 4. 20. Ali N, Little BC. Causes of cataract surgery malpractice claims in England 1995 2008. Br J Ophthalmol 2011;95: 490 2. 21. Bhan A, Dave D, Vernon SA, et al. Risk management strategies following analysis of cataract negligence claims. Eye (Lond) 2005;19:264 8. 22. Sidaway v. Board of Governors of the Bethlem Royal Hospital Governors [1985] AC 871 [UK tort law]. 23. Godwin Y. Do they listen? A review of information retained by patients following consent for reduction mammoplasty. Br J Plast Surg 2000;53:121 5. Footnotes and Financial Disclosures Originally received: September 12, 2011. Final revision: January 4, 2012. Accepted: January 6, 2012. Available online: January 21, 2013. Manuscript no. 2011-1351. 1 Moorfields Eye Hospital, London, United Kingdom. 2 Western Eye Hospital, London, United Kingdom. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. Correspondence: Rashmi G. Mathew, MRCOphth, MBBS, Moorfields Eye Hospital, London, United Kingdom. E-mail: rashmi.mathew22@googlemail.com 864