What can be learned from litigation in otology? A review of clinical negligence claims in England 2013-2018.

BACKGROUND: Litigation in the National Health Service continues to rise with a 9.4 per cent increase in clinical negligence claims from the period 2018 and 2019 to the period 2019 and 2020. The cost of these claims now accounts for 1.8 per cent of the National Health Service 2019 to 2020 budget. This study aimed to identify the characteristics of clinical negligence claims in the subspecialty of otology. METHODS: This study was a retrospective review of all clinical negligence claims in otology in England held by National Health Service Resolution between April 2013 and April 2018. RESULTS: There were 171 claims in otology, 24 per cent of all otolaryngology claims, with a potential cost of £24.5 million. Over half of these were associated with hearing loss. Stapedectomy was the highest mean cost per claim operation at £769 438. The most common reasons for litigation were failure or delay in treatment (23 per cent), failure or delay in diagnosis (20 per cent), intra-operative complications (15 per cent) and inadequate consent (13 per cent). CONCLUSION: There is a risk of high-cost claims in otology, especially with objective injuries such as hearing loss and facial nerve injury.

[Patient in the otolaryngology office in the time of the COVID-19 pandemic in the light of current recommendations, legal regulations and authors' own experience]. / Pacjent w gabinecie otolaryngologicznym w dobie pandemii COVID-19 w swietle aktualnych wytycznych, przepisów prawnych i wlasnych doswiadczen.

Generally, COVID-19 is an acute contagious disease caused by the SARS­CoV-2 virus. The main route of human-to-human transmission is through contact with infectious secretions from the respiratory tract. Clinical manifestations vary from mild non-specific symptoms to life-threatening conditions. Since WHO declared COVID-19 a pandemic in March 2020, it has affected many medical, legal, social and economic aspects of everyday life in countries around the world. In this article, the authors present a summary of recommendations for taking care of otorhinolaryngology patients in outpatient settings and the legal basis referring to a risk of infection in doctor's office. In the selection of articles, the authors used English- and Polish-language online medical databases, typing the following keywords: SARS­CoV-2, COVID-19, otolaryngology, endoscopy, personal protective equipment, and legal responsibility of the physician. The mucosa of the upper respiratory tract is a potential site of virus replication. The specificity of an ear, nose and throat (ENT) examination and a direct patient-doctor contact favor the transmission of the infection. The authors discussed the elements of self-protection of medical personnel and the legal aspects a risk of the patient contracting the infection in the otolaryngology office. In the case of a direct contact with the patient, the following medical personal protective equipment is required: a cap, a mask with an FFP-2 filter, goggles, an apron and gloves. If, during the visit, exposure to secretions or aerosol from the respiratory tract is expected, the personnel should additionally wear a visor and a waterproof apron. The patient's visit in the clinic should be preceded by telemedicine consultation. Patients should be screened prior to having a direct contact with a physician, using a short patient questionnaire. The questionnaire may consist of simple questions about the characteristic symptoms of the SARS­CoV-2 infection and exposure to a sick person in the past 14 days. The question of staying in the areas of a high infection risk appears of little importance in view of the whole of Poland being perceived as constituting such an area. Due to the spread of the SARS­CoV-2 virus, new procedures for providing medical services have been introduced. In the case of claims on the part of the patient, the only protection the medical personnel or facility can provide is confirmation of scrupulous compliance with medical procedures . Med Pr. 2021;72(3):327-34.

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 Review of Otolaryngology Malpractice Cases with Associated Court Proceedings from 2010 to 2019.

OBJECTIVES/HYPOTHESIS: To report key characteristics of the landscape of malpractice litigation with associated court proceedings in otolaryngology over the previous decade. STUDY DESIGN: Retrospective database review. METHODS: The LexisNexis database was queried to identify otolaryngology-related malpractices cases that yielded court opinions, jury verdicts, and settlements from federal and state courts across the United States from 2010 to 2019. Cases settled outside of court were not identifiable. Provider subspecialty, procedures, error type, legal allegations, and case outcomes were recorded. Frequency of error type was compared between otolaryngology subspecialties using Fisher exact tests. RESULTS: Ninety-four medical malpractice cases related to otolaryngology with evidence of court proceedings were identified for the period between 2010 and 2019. An otolaryngologist was named as the sole defendant in 39 cases (41%). Rhinology was the most frequently implicated subspecialty (28% of all cases), followed by head and neck surgery (17%) and facial plastics (7%). Improper surgical performance was cited in nearly half of the identified cases (49%), followed by failure to diagnose/refer/treat (32%). Outcome and liability data were available for 56 cases (60%). Of these 56 cases, 50 (89%) were ruled in favor of the defendant otolaryngologist. Of the cases ruled in favor of the plaintiff, the average indemnity was $4.24 M (range, $150,000 M-$10.25 M). Fisher exact tests demonstrated statistically significant differences in consent issues (P = .040), failure to diagnose/refer/treat (P = .024), and improper surgical performance (P = .026) between subspecialties. CONCLUSIONS: In a limited, database-derived sample of medical malpractice cases involving otolaryngologists, trends in error type by subspecialty may warrant further investigation to identify specialty-wide and subspecialty-specific areas of practice improvement and education. LEVEL OF EVIDENCE: N/A Laryngoscope, 131:E1081-E1085, 2021.

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.

What can we learn from the last 20 years: A review of litigation trends in otolaryngology.

INTRODUCTION: Litigation in healthcare is a large financial burden to the NHS and can be a cause of great stress to clinicians. The overall number of claims across specialities, from the years 1995-2017 have increased. Despite being one of the smaller surgical specialities, litigation costs are still significant within Otolaryngology. In this piece we sought to analyse the available data to identify trends within litigation and therefore which areas of practise could be improved. METHODS: A freedom of information request was submitted to NHS Resolution for summarised data on claims coded under 'Otolaryngology' or 'ENT' between 1996 and 2017. Information was collected on the total number of claims, the number of successful claims and details on the reasons for making claims. RESULTS: The total number of claims made against Otolaryngology departments from 1996/97 to 2016/17 was 1952. The overall number of claims have increased during this time period. The total amount of money paid out between 1996 and 2017 was £108, 240, 323. The top causes of claim by injury were unnecessary pain and unnecessary operations. The highest number of claims by cause were for failure or delay in diagnosis and intraoperative problems. CONCLUSION: These results highlight areas that local units can focus on to reduce their litigation burden. Targeted initiatives aimed at improving patient-clinician communication, the consent process and improving local organisational efficiency will address a significant proportion of claims. Re-examination of this data on a regular basis can serve as a useful adjunct in assessing the impact of quality improvement initiatives and implementation of best practiseswithin the speciality.

Determination of legal responsibility in shared airway management between anesthesiology and otolaryngology.

BACKGROUND: Malpractice litigation remains an important point of contention in the United States. Airway management often sees multidisciplinary teams of anesthesiologists and otolaryngologists. This report analyzes lawsuits affecting both teams in airway management. METHODS: The Westlaw legal database (West Publishing Co., St. Paul, MN) was used to search for malpractice cases involving failed airway management, where both anesthesiology and otolaryngology were involved. RESULTS: Among the 28 cases analyzed, otolaryngology and anesthesiology were most commonly sued together (46.4%). When sued together, defendants were less likely to win and average award amounts ($4, 558 716) were higher. These cases most commonly occurred in the operating room (78.6%), involved a difficult/improper intubation (39.3%), alleged a failure to follow standard of care (57%), and resulted in death (60.7%). CONCLUSION: These cases primarily cited failure to follow standard of care and communication failures. Efforts should be directed toward multidisciplinary airway management protocols and effective communication.

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.

Ten years on from an appraisal of litigation against English Health Trusts in otolaryngology: What have we learnt?

NHS Resolution provides indemnity cover for legal claims against the NHS, assists the NHS with risk management and aims to share lessons from claims in order to improve safety. The study aimed to investigate the financial costs of litigation against English Health Trusts in otolaryngology over a 10-year period, to see if any lessons have been learned and identify trends that may lead to a potential reduction in costs and improve patient safety. A Freedom of Information request was made to NHS Resolution for information regarding claims made to otolaryngology departments over the last 10 years. There was a total of 612 successful claims in the 10-year period between 2008/2009 and 2017/2018 with costs of nearly £87 million. Overall, the costs of litigation have increased dramatically, and the main areas for these successful claims can be identified, but restrictions in the detail of information released allows too little insight for improvements to be made to avoid them in future. This continues to be a major problem for healthcare funding and practice.

Is the team leading surgeon criminally liable for his collaborators' errors? Judges confirm responsibility and condemn an otorhinolaryngologist.

SUMMARY: In current healthcare, delivery of medical and surgical treatment takes place in a multidisciplinary manner. This raises the problem of distinguishing the conditions under which the person who has properly carried out his duties, respecting the related leges artis, can be held responsible for damages materially caused by another member of the medical team. Jurisprudence has developed the so-called "principle of trust" for which every member of the team can rely on the fact that other members are acting in compliance with the leges artis of their specialisation. The Supreme Court has limited the application of this principle. The authors examine the jurisprudence on responsibility of the team in otolaryngology and conclude that individual liability should be limited to the specific expertise of the individual specialist.

Writing otorhinolaryngology head & neck surgery operative reports.

Only about ten articles devoted to operative reports have been published in the medical literature, but this document is essential, both medically and legally, to ensure optimal management of operated patients. In this technical note, based on published studies on this subject, the authors describe the key features of operating reports after otorhinolaryngology head & neck surgery and emphasize the need to write this document during the minutes after the end of the operation, the importance of standardization and its teaching role during surgical training.

A critical analysis of melanoma malpractice litigation: Should we biopsy everything?

OBJECTIVES/HYPOTHESIS: The aim of this study was to evaluate factors raised in malpractice litigation related to the diagnosis and management of melanoma and to further assess issues impacting outcome. STUDY DESIGN: Retrospective chart review. METHODS: The Westlaw legal database was searched for malpractice litigation resolved over the last 20 years relating to melanoma. Cases were evaluated for allegations, defendant specialty, outcome, and other issues raised. RESULTS: Of the 80 cases evaluated, 49% were resolved in the defendants' favor. In greater than 80% of cases, there was alleged misdiagnosis. In 35% of cases, the patient had expired secondary to melanoma at the time of litigation. There was no statistical difference in payments upon comparison of cases with and without mortality. A greater proportion of cases with dermatologists and pathologists as defendants involved alleged misdiagnosis. The most common locations for melanoma were the extremities and the head-and-neck region, at 32.5% and 22.5%, respectively. Location did not significantly impact the outcome of cases. CONCLUSION: Malpractice litigation relating to melanoma involves numerous physicians, including dermatologists, pathologists, and otolaryngologists. Alleged misdiagnosis of a pigmented lesion was the most common cause of litigation and involved physicians from numerous specialties. Patients who were misdiagnosed had a significantly higher likelihood of having active disease at the time of litigation. Ultimately improved methods of detecting concerning pigmented lesions need to be developed. Factors such as death and poor cosmetic outcome did not significantly impact litigation outcome. LEVEL OF EVIDENCE: NA Laryngoscope, 127:134-139, 2017.

Medicolegal aspects of rhinology practice.

OBJECTIVE: To investigate rhinology-related malpractice claims with the aim of optimising safe practice. METHODS: The database of the National Institute of Forensic Medicine was reviewed. In total, 241 otorhinolaryngology malpractice case reports dating from 2005 to 2012 were evaluated, and 83 malpractice cases related to rhinology treatments were separated. RESULTS: There was no significant difference between the number of male (n = 42) and female (n = 41) claimants. The mean patient age was 32.07 ± 10.53 years (range, 10-75 years). Seventy-nine cases involved surgical treatment in rhinology. The most common complaints were: unsatisfactory cosmetic results (n = 30), optic nerve injury (n = 10), septal perforation (n = 9) and intracranial penetration (n = 4). Malpractice was detected in 21 cases (25.3 per cent). No delinquency was found in 62 cases (74.7 per cent). CONCLUSION: Physicians should be aware of legal consequences related to rhinology practice. Further study is needed on this topic, as well as interdisciplinary collaboration, to ensure best practices and to avoid litigation.