Otorhinolaryngology litigation in England: 727 clinical negligence cases against the National Health Service.

INTRODUCTION: Litigation against the National Health Service (NHS) in England is rising. The aim of this study was to determine the incidence and characteristics of otorhinolaryngology clinical negligence claims in England. METHODS: A retrospective review was undertaken of all clinical negligence claims in England held by NHS Resolution relating to otorhinolaryngology between April 2013 and April 2018. Analysis was performed using information for cause, patient injury and claim cost. Where claim information was adequately detailed, the authors categorised claims by subspecialty, diagnosis and surgery. RESULTS: A total number of 727 claims were identified with an estimated potential cost of £108 million. Out of these, 463 were closed claims. Including open claim reserves, the mean cost of a claim was £148 923. Head and neck surgery was the subspecialty with the highest number of claims (n = 313, 43%) and highest cost (£51.5 million) followed by otology (n = 171, £24.5 million) and rhinology (n = 171, £13.6 million). Over half of claims were associated with an operation (n = 429, 59%) where mastoid surgery (n = 46) and endoscopic sinus surgery (n = 46) were equally associated with the greatest number of claims. The most frequent causes for clinical negligence claims included failure or delay to diagnose (n = 178, 25%), failure or delay to treat (n = 136, 19%), intra-operative complications (n = 130, 18%) and failure of the consent process (n = 107, 15%). DISCUSSION: Clinical negligence claims in otorhinolaryngology are related to several different components of patient management and are not limited to postoperative complications. This study highlights the importance of robust pathways in out-patient diagnostics and the consenting process in order to deliver better patient care and reduce the impact of litigation. Keywords informed consent, malpractice, clinical negligence claims, litigation, otolaryngology.

A Century in Review: Medicolegal Implications of Facial Nerve Paralysis.

Importance: It is important to recognize factors that may mitigate the risk of a potential lawsuit and increase knowledge and awareness of physicians. Objective: To evaluate and characterize facial nerve paralysis litigation claims and related potential causes. Design, Setting, and Participants: These data were extracted from the two main computerized legal databases: WestLaw and LexisNexis. The data were queried on April 2, 2020. The records from 1919 to 2020 were obtained from a population-based setting. A total of 186 cases were included. Data were gathered for all alleged cases of facial nerve paralysis. Main Outcomes and Measures: There was a continuous rise in the amount of malpractice payments with the highest mean amount being in the past decade. Results: From 1919 to 2020, a total of 186 malpractice cases for facial nerve damage were identified. A total amount of $89,178,857.99 was rewarded to plaintiffs in 66 cases. The mean amount of paid malpractice claim was $1,351,194.80. Improper performance/treatment was the most common reason for alleged litigation (n = 97). This was followed by misdiagnosis/delayed diagnosis (n = 47), and failure of informed consent (n = 34). The highest number of malpractice claims with a total of 53 cases was from 1991 to 2000. The highest mean amount per payment was in the past decade (2011-2020) with a mean of $3,841,052.68. Conclusions and Relevance: Over the past century, improper performance/procedure, delayed/misdiagnosis, and failure of informed consent were the most common reasons for litigations related to facial nerve paralysis.

A Long, Unnerving Road: Malpractice Claims Involving the Surgical Management of Thyroid and Parathyroid Disease.

BACKGROUND: Given their profound emotional, physical, and financial toll on patients and surgeons, we studied the characteristics, costs, and contributing factors of thyroid and parathyroid surgical malpractice claims. METHODS: Using the Controlled Risk Insurance Company Strategies' Comparative Benchmarking System database, representing ~30% of all US paid and unpaid malpractice claims, 5384 claims filed against general surgeons and otolaryngologists from 1995-2015 were reviewed to isolate claims involving the surgical management of thyroid and parathyroid disease. These claims were studied, and multivariable regression analysis was performed to identify factors associated with plaintiff payout. RESULTS: One hundred twenty-eight thyroid and parathyroid surgical malpractice claims were isolated. The median time from alleged harm event to closure of a malpractice case was 39 months. The most common associated complications were bilateral recurrent laryngeal nerve (RLN) injury (n = 23) and hematoma (n = 18). Complications led to death in 18 cases. Patient payout occurred in 33% of claims (n = 42), and the median cost per claim was $277,913 (IQR $87,343-$783,663). On multivariable analysis, bilateral RLN injury was predictive of patient payout (OR 3.58, p = 0.03), while procedure, death, and surgeon specialty were not. CONCLUSION: Though rare, malpractice claims related to thyroid and parathyroid surgery are costly, time-consuming, and reveal opportunities for early surgeon-patient resolution after poor outcomes.

Otorhinolaryngology litigations in Japan.

PURPOSE: The purpose of this study was to examine the malpractice litigations pertaining to otorhinolaryngology in Japan. METHODS: A retrospective review was undertaken of cases tried in the Japanese civil court system during the 26-year period from 1990 to 2015 as identified in a computerized legal database. Data including patient demographics, disease, chief allegations, court's decisions, and the year decision was made were collected and analyzed. Patients' chief allegations were assigned to one of the five categories: delayed diagnosis, complication during diagnostic procedure, inappropriate treatment, complication during treatment procedure, or lack of informed consent. RESULTS: Thirty-one malpractice litigations were identified. Eight (26%) malpractice litigations pertained to tumors, 1 (3%) to a tumor-like lesion, 14 (45%) to inflammation, and 8 (26%) to others. Among the patients' chief allegations, inappropriate treatment and complication during treatment procedure were the most frequent [11 (36%) for each], followed by delayed diagnosis [6 (19%)], complication during diagnostic procedure [2 (6%)], and lack of informed consent [1 (3%)]. CONCLUSION: These data may aid in the design of risk-prevention strategies to be used by otorhinolaryngologists.

Laryngology litigation in the United States: Thirty years in review.

OBJECTIVES/HYPOTHESIS: Malpractice claims pertaining to laryngology procedures are a potentially important source of information that could be used to minimize the risk of future litigation and improve patient care. STUDY DESIGN: A retrospective review of two publicly available databases containing jury verdicts and settlements. METHODS: The LexisNexis Jury Verdicts and Settlements and WestlawNext legal databases were reviewed for all lawsuits and out-of-court adjudications related to the practice of laryngology. Data including patient demographics, type of surgery performed, plaintiff allegation, nature of injury, outcomes, and indemnities were collected and analyzed. RESULTS: Of 87 cases meeting inclusion criteria, 56 were decided by a jury and 31 were adjudicated out of court. Vocal cord surgery was the most commonly litigated surgery. The two most commonly cited legal allegations were physical injury and negligence. No statistical difference for legal outcome was found when death or vocal cord injuries occurred. Complications in procedures that utilized a laser predicted an unfavorable outcome (P = 0.013). A payout was made in over one-half of cases, but defendants were favored in over two-thirds of cases decided by a jury. The average indemnities were significant for both jury verdicts ($4.6 million) and out-of-court settlements ($0.9 million). CONCLUSION: An awareness of laryngology malpractice litigation has the potential to provide better patient care and help laryngologists avoid potential risks for litigation. The factors determining legal responsibility in laryngology cases underscore the importance of close communication with anesthesiologists and careful evaluation of hoarseness in all patients regardless of risk factors. LEVEL OF EVIDENCE: N/A. Laryngoscope, 126:2301-2304, 2016.

Litigation trends and costs in otorhinolaryngology.

BACKGROUND: Litigation in surgery is increasing and liabilities are becoming unsustainable. This study aimed to analyse trends in claims, and identify areas for potential risk reduction, improved patient safety and a reduction in the number, and cost, of future claims. METHODS: Ten years of retrospective data on claims in otorhinolaryngology (2003-2013) were obtained from the National Health Service Litigation Authority via a Freedom of Information request. Data were re-entered into a spreadsheet and coded for analysis. RESULTS: A total of 1031 claims were identified; of these, 604 were successful and 427 were unsuccessful. Successful claims cost a total of £41 000 000 (mean, £68 000). The most common areas for successful claims were: failure or delay in diagnosis (137 cases), intra-operative problems (116 cases), failure or delay in treatment (66 cases), failure to warn - informed consent issue (54 cases), and inappropriate treatment (47 cases). CONCLUSION: Over half of the claims in ENT relate to the five most common areas of liability. Recent policy changes by the National Health Service Litigation Authority, over the level of information divulged, limits our learning from claims.

Litigation in English rhinology.

OBJECTIVE: Litigation is a rising financial burden on the National Health Service. This study aims to show if litigation is increasing in rhinology and which procedures lead to the most claims. METHODS: Ten years of data were obtained from the National Health Service Litigation Authority. Rhinology claims were examined for cost, injury, diagnosis and operation type. RESULTS: Of the 123 rhinology claims identified, 52 per cent were successful. There was a 56 per cent increase in the average annual number of claims between the first half of the study period and the second (p = 0.0451). The commonest reasons for a claim were poor cosmesis (15.6 per cent) and lack of informed consent (14 per cent). CONCLUSION: The number of claims in rhinology increased over the study period. Most claims resulted from poor cosmetic outcome, lack of consent or recognised complications. It is suggested that enhanced communication and management of patient expectations could reduce litigation and improve patient satisfaction.

A report on 15 years of clinical negligence claims in rhinology.

BACKGROUND: This study was designed to determine the characteristics of medical negligence claims in rhinology. In 2010-2011 the National Health Service (NHS) litigation bill surpassed 1 billion Great British Pounds (GBP; 1.52 billion U.S. dollars [US$]). Systematic analysis of malpractice complaints allows for the identification of errors and can thereby improve patient safety and reduce the burden of litigation claims on health services. METHODS: Claims relating to ear, nose, and throat between 1995 and 2010 were obtained from the NHS Litigation Authority and were analyzed. RESULTS: The series contains 65 closed claims that resulted in payment totaling 3.1 million GBP (US$4.7 million). Fifty claims were related to surgical complications. Functional endoscopic sinus surgery and septoplasty were the procedures most commonly associated with successful claims. There were 11 cases of orbital injury including 6 cases of visual loss and 5 cases of diplopia. The most common cause of a claim was failure to recognize the complication or manage it appropriately. Lack of informed consent was claimed in eight cases. Other claims arose because of errors in outpatient procedures (two), diagnosis (six), delayed surgery (one), and errors in medical management (three). CONCLUSION: This is the first study to report the outcomes of negligence claims in rhinology in the United Kingdom. Claims in rhinology are associated with a high success rate. Steps that can be taken to reduce litigation include careful patient workup and ensuring adequate informed consent. Where there is a suspicion of orbital damage early recognition and intervention is needed to reduce long-term injury to the patient.

Sleep surgery and medical malpractice.

OBJECTIVES/HYPOTHESIS: To describe and analyze the causes and outcomes of lawsuits pertaining to sleep surgery to mitigate future litigation and improve physician education. STUDY DESIGN: A retrospective review of a publicly available database containing jury verdicts and settlements. METHODS: The LexisNexis MEGA Jury Verdicts and Settlements database was reviewed for all lawsuits including settlements and trial verdicts related to sleep surgery. Data including type of surgery performed, plaintiff allegation, nature of injury, outcomes, and indemnities were collected and analyzed. RESULTS: Fifty-one cases met the inclusion criteria. Of these, 30 were decided by a jury, nine were settled out of court, and 10 were resolved by other means. Overall, 57% of known outcomes favored the defendant. The most common surgery performed was tonsillectomy (57%), followed by uvulopalatopharyngoplasty (45%), adenoidectomy (31%), and septoplasty (31%). No difference was found between outcomes when comparing the most common injuries cited, including wrongful death (P = .572), airway compromise (P = .376), and drug reaction (P = .443). If failure to recognize a complication (P = .034) or delay in diagnosis (P = .026) was a component of the legal allegations, the outcome significantly favored the plaintiff. The median settlement ($545,000) and plaintiff award ($1.45 million) were not significantly different (P = .13). CONCLUSIONS: The majority of outcomes favored the defendant. Type of injury did not predict outcome. Failure to recognize complications and delay in diagnosis strongly predicted a verdict in favor of the plaintiff. LEVEL OF EVIDENCE: 2c.

Epistaxis: the factors involved in determining medicolegal liability.

BACKGROUND: The purpose of this study was to examine litigation involving epistaxis and analyze factors that determine liability. METHODS: Jury verdicts and settlements regarding cases involving epistaxis were gathered utilizing the Westlaw database. Factors involved in litigation gathered included demographics, defendant specialty, procedure, alleged cause of malpractice, outcome, monetary award, and other variables. RESULTS: A total of 26 cases were analyzed. The majority of cases (57.7%) were decided in favor of the plaintiff or settled out of court. Total awards amounted to $24,501,252. Average awards for cases decided in favor of the plaintiff were $2,260,893 and ranged from $499,845 to $9,022,643. Settlements averaged $1,084,375 and ranged from $300,000 to $3,800,000. Common causes of malpractice encountered included delay in diagnosis, complications from medical procedures, and failure to recognize complications in a timely manner. CONCLUSION: Contrary to previous reports analyzing malpractice for varying medical procedures and complications, litigation in epistaxis is more commonly resolved in favor of the plaintiff or resolved through out-of-court settlements. Substantial financial awards and therapeutic complications from blindness to death make epistaxis a candidate for litigation. Of importance from a medicolegal stand is the fact that 30.8% (8) of the patients involved in epistaxis litigation died, either from complications of therapy or from experiencing epistaxis as a complication of another procedure/pathology. Using necessary diagnostic imaging, ensuring proper management techniques, and recognizing complications in a timely manner can serve to limit legal liability and enhance patient safety.

Malpractice in otology.

OBJECTIVE: (1) Analyze otologic procedural malpractice litigation in the United States of America. (2) Discuss ways to prevent future malpractice litigation. STUDY DESIGN AND SETTING: Case series with record review. METHODS: The study is a case series with review of court records pertaining to otologic procedures using the Westlaw legal database. The phrase medical malpractice was searched with terms related to otology and neurotology obtained from the AAO-HNS website. RESULTS: Of the 47 claims that met inclusion criteria, 63.8% were decided in the physician's favor, 25.5% were decided in the plaintiff's favor (average payment $446,697), and 10.6% were settled out of court (average payment $372,607). Cerumen removal was the most common procedure leading to complaint (21.3%) and the most likely procedure to lead to payment (50.0%). Hearing loss was the most common injury claimed among all cases (53.2%) and resulted in a high proportion of cases that led to payment (40.0%). Other common alleged injuries were facial nerve injury (27.7%), tympanic membrane perforation (23.4%), need for additional surgery (42.6%), and lack of informed consent (31.9%). In addition, cases resulting from acoustic neuroma or stapedectomy resulted in higher payments to the plaintiffs (average $3,498,597 and $2,733,000, respectively). CONCLUSIONS: Malpractice trials were resolved in the defendant's favor in the majority of cases. Cerumen removal was the most common procedure leading to complaint and the procedure most likely to result in payment. Hearing loss was the most common injury cited. Payment was highest in acoustic neuroma and stapedectomy cases.

Conflict of interest reporting in otolaryngology clinical practice guidelines.

Clinical practice guidelines (CPGs) have become increasingly important in recent years due to an increasing emphasis on evidence-based practice, as well as serious discussions in academic, medical, and legal circles about their possible role in measuring physician performance, setting provider reimbursement strategy, and establishing protection from litigation in the future. At the same time, CPGs are costly to develop. Thus, as CPGs gain influence in medical practice, it will become essential that CPGs are developed using trustworthy standards and that the authors of CPGs are not being unduly influenced by financial pressures from external stakeholders. Since 2004, the 9 CPGs sponsored by the American Academy of Otolaryngology-Head and Neck Surgery Foundation have been developed with full disclosure and appropriate management of potential financial conflicts of interest. This commentary discusses the potential for conflict of interest in otolaryngology CPGs and how the otolaryngology guideline development process can serve as a model for other professional medical organizations.

[Briefing and accusation of medical malpractice--the second victim]. / Aufklärung und Behandlungsfehlervorwurf--Das zweite Opfer.

In June 2012, the German Medical Association (Bundesärztekammer) published the statistics of medical malpractice for 2011 [1]. Still ENT-specific accusations of medical malpractice are by far the fewest in the field of hospitals and actually even in the outpatient context. Clearly most of the unforeseen incidents still occur in the disciplines of trauma surgery and orthopedics. In total, however, an increasing number of errors in treatment can be noticed on the multidisciplinary level: in 25.5% of the registered cases, an error in treatment was found to be the origin of damage to health justifying a claim for compensation of the patient. In the year before, it was only 24.7%. The reasons may be manifold, but the medical system itself certainly plays a major role in this context: the recent developments related to health policy lead to a continuous economisation of medical care. Rationing and limited remuneration more and more result in the fact that therapeutic decisions are not exclusively made for the benefit of the patient but that they are oriented at economic or bureaucratic aspects. Thus, in the long term, practising medicine undergoes a change. According to the §§ 1, 3 of the professional code of conduct for doctors (Musterberufsordnung für Ärzte; MBO-Ä) medical practice as liberal profession is principally incompatible with the pursuit of profit, however, even doctors have to earn money which more and more makes him play the role of a businessman. Lack of personnel and staff savings lead to excessive workloads of physicians, caregivers, and nurses, which also favour errors. The quality and even the confidential relationship between doctor and patient, which is important for the treatment success, are necessarily affected by the cost pressure. The victims in this context are not only the patients but also the physicians find themselves in the continuous conflict between ethical requirements of their profession and the actual requirements of the realities in the healthcare field. But also the technical and scientific progress bear new risks beside the therapeutic successes, further especially bigger hospitals require high efforts regarding organisation favouring errors in cases of deficiencies. Even the increasing juridification of the medicine that is expected to achieve a provisional highlight with the planned law of patients' rights leads to an important focus on the quality of medical care [2]. The explicit legal regulation of patients' rights, which have never been out of question up to now, confirms the impression of patients who have to be protected from their doctors. This development favours a natural mistrust in the quality of the treatment and the desire of legal verification in cases of treatment failures. A totally perfect and error-free treatment, however, will never occur. Already this fact leads to the obligation to do everything possible to reduce the risk to an absolute minimum. The risks that might arise from a relation of treatment are manifold. Not only may the patient undergo risks that arise in particular from lacking or insufficient briefing, complications, or medical malpractice. Also the doctor has to fear legal consequences if he does not stick clearly to the increasing requirements that jurisdiction and legislation impose - not least by the planned law of patients' rights. In the following, the basic principles and particularities will be described that apply for the patients' briefing. Further the different types of medical malpractice will be explained in relation to the resulting procedural consequences. Finally some current problematic fields will be described with regard to other possible liabilities or responsibilities of physicians in hospitals or doctor's offices.