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.

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.

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.

Craniofacial Surgery and Adverse Outcomes: An Inquiry Into Medical Negligence.

OBJECTIVE: This study aimed to evaluate factors contributing to medical negligence relevant to craniofacial surgery. METHODS: Retrospective analysis of verdict and settlement reports on the Westlaw legal database for outcome, awards, physician defendants, and other specific factors raised in malpractice litigation. RESULTS: Of 42 verdicts and settlement reports included, 52.4% were resolved with either an out-of-court settlement or plaintiff verdict, with aggregate payments totaling $50.1M (in 2013 dollars). Median settlements and jury-awarded damages were $988,000 and $555,000, respectively. Payments in pediatric cases ($1.2M) were significantly higher. Plastic surgeons, oral surgeons, and otolaryngologists were the most commonly named defendants. The most common alleged factors included intraoperative negligence (69.0%), permanent deficits (54.8%), requiring additional surgery (52.4%), missed/delayed diagnosis of a complication (42.9%), disfigurement/scarring (28.6%), postoperative negligence (28.6%), and inadequate informed consent (20.6% of surgical cases). Failure to diagnose a fracture (19.0%) and cleft-reparative procedures (14.3%) were the most frequently litigated entities. CONCLUSION: Medical negligence related to craniofacial surgery involves plaintiffs in a wide age range as well as physician defendants in numerous specialties, and proceedings resolved with settlement and plaintiff verdict involve substantial payments. Cases with death, allegedly permanent injuries, and pediatric plaintiffs had significantly higher payments.

Meningitis and legal liability: an otolaryngology perspective.

PURPOSE: Meningitis is a potential complication in otolaryngologic procedures and conditions. Severe sequelae make understanding factors involved in relevant malpractice litigation critical. We analyze pertinent litigation for awards, outcomes, patient demographic factors, and other alleged causes of malpractice. METHODS: Pertinent jury verdict and settlement reports were examined using the Westlaw legal database (Thomson Reuters, New York, NY). RESULTS: Twenty-three cases (60.5%) involved non-iatrogenic injuries, including inadequate treatment or failure to diagnose sinusitis or otitis media, while 15 (39.5%) involved iatrogenic cases, mostly rhinologic procedures. 36.8% of cases were resolved for the defendant, 28.9% with juries awarding damages, and 34.2% with settlements. Although not statistically significant, mean damages awarded were higher than settlements ($2.1 vs. 1.5M, p=0.056), and cases involving pediatric patients were more likely to be resolved with payment than those with adult litigants (80.0% vs. 52.2%, p=0.08 respectively). Other frequent alleged factors included permanent deficits (63.2%), requiring additional surgery (41.1%), death (34.2%), cognitive deficits (21.2%), deafness (15.8%), and inadequate informed consent (33.0% of iatrogenic cases). CONCLUSIONS: Practitioners facing litigation related to meningitis may wish to consider these findings, notably for cases involving death or permanent functional deficits, as cases with out of court settlements tended to be resolved with lower payments. Cases involving misdiagnosis may be more likely to be resolved with payment compared with iatrogenic cases. By understanding the issues detailed in this analysis and including them in the informed consent process for patients undergoing rhinologic and otologic procedures, otolaryngologists may potentially improve patient safety and decrease liability.

Risks and medico-legal aspects of endoscopic sinus surgery: a review.

The aim of this study was to perform a systematic literature review of risks and medico-legal aspects of endoscopic sinus surgery. The development of sophisticated technologies and instruments for endoscopic sinus surgery (ESS) has caused a dramatic increase in the number of otolaryngologists performing sinus surgery and the number of cases performed. This expansion was accompanied by an increase in malpractice lawsuits. Over the past 20 years, rhinology claims represented 70 % of the total indemnity compensation for otolaryngology claims and ESS was the surgical procedure most often involved. Only then will a careful analysis and assessment of the possible and potential risk factors of ESS, which may mislead the surgeon, allow a correct clinical risk management, with activities and procedures aimed at reducing the possibility of complications that may expose the physician to a malpractice suit.

[Implementation of the new quality assurance agreement for the fitting of hearing aids in daily practice. Part 1: New regulations pertaining to hearing aid fitting]. / Umsetzung der neuen Qualitätssicherungsvereinbarung zur Hörgeräteversorgung im Praxisalltag. Teil 1: Neue Regeln der Hörgeräteverordnung.

Alongside evidence-based medicine, quality assurance has becoming increasingly important in daily medical practice during the last decade. The introduction of a specific quality assurance questionnaire in connection with hearing aid fitting represents the first large-scale assessment of certain elements of patient satisfaction within Germany's public healthcare system. Part 1 of this review describes the most important new regulations pertaining to hearing aid fitting in the context of statutory health insurance. Since the vast majority of diagnostic and therapeutic procedures constituting the treatment of hearing loss patients--particularly the subsequent rehabilitation of hearing aid wearers in cooperation with hearing aid acousticians--occur outside the clinic, this review concentrates on the rules relevant to this area. After studying this part of the overview, readers should be able to understand and apply the sections of the statutory health insurance reimbursement guidelines relating to ambulant hearing aid fitting; furthermore, they should be able to understand and apply the standard evaluation criteria (Einheitlicher Bewertungsmaßstab, EBM).

[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.

[The implementation of risk management in a department of otolaryngology]. / Implementierung eines Risikomanagements in einer Hals-, Nasen-, Ohrenklinik.

The reasons for introducing risk management in hospitals are manifold. Not only legal but also ethical and moral aspects are of great importance.The implementation of risk management in a German department of otolaryngology is presented. Although various instruments were introduced, the main emphasis was placed on the establishment of a risk management team with the aim of prospectively and retrospectively addressing critical situations in hospital operation management and also with the goal of achieving a change of attitude towards mistakes, complications and damages in the clinic.Many aspects of the in-house processes were critically analyzed and optimization strategies were developed such as the introduction of checklists for preoperative patient identification. Furthermore the implemented CIRS has been well accepted.A meaningful objectivity of the results seems difficult. A main reason is that the index "reduction of damage and medical malpractice" is too small to make a conclusive statistical analysis. However, implementation of risk management is advisable for every ENT clinic.

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.

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.

[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.

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.

[Medical education in otorhinolaryngology in Germany. Implementation of the new licensing regulations for physicians]. / Lehre der HNO-Heilkunde in Deutschland. Umsetzung der neuen ärztlichen Approbationsordnung.

BACKGROUND: In 2003 new regulations for the licensing of German physicians came into effect. The aim of this study was to survey the present status of realization in German otorhinolaryngology (ORL) university departments. METHODS: A questionnaire containing 31 items was sent to all German ORL university departments. RESULTS: A total of 31 (86%) ORL departments responded to the questionnaire. Most faculties reacted correctly in the practical realization of the new regulation demands. Regarding the quality of written and practical examinations, some changes have to be considered in order to maintain high quality standards. CONCLUSION: The demands of the new licensing regulations have not yet been fully implemented. Therefore, medical education must gain importance in the daily clinical routine. Establishment of nationwide learning objectives and resources pooling for written examinations would be helpful.

[Traffic medicine expert opinions in otorhinolaryngology: current aspects]. / Verkehrsmedizinische Begutachtung in der HNO-Heilkunde : Aktuelle Aspekte.

According to German law granting of driving licenses depends on the proof of an adequate driving capability. The corresponding guidelines are at present in the process of being revised. At the moment bilateral deafness and high-grade hearing loss (> or = 60% in pure tone audiometry) are not exclusion criteria for driving licenses grades A, B and C, while driving licenses grade D and licenses for public transport are generally excluded. In the forthcoming revised edition of the guidelines it has been suggested that the latter group will also not be excluded. The regulations concerning dizziness are wide-sweeping at the moment as no driving license will be granted if dizziness is present but will be more specific in the next issue. In particular a division will be made between single axle and two axle vehicles. An expert assessment about driving suitability can only be made by a certified specialist with qualifications in traffic medicine.

[Problematic medical expertise concerning simulation and aggravation in audiology]. / Zur Problematik der Simulation und Aggravation in der HNO-ärztlichen Begutachtung.

BACKGROUND: The effect of an incorrect audiological medical assessment of noise trauma deafness can be substantial. The impact will be demonstrated using a case example. The reasons for incorrect assessment are often insufficient examination conditions or simulation and aggression of the subject. The results of a study on this topic will be presented. PATIENTS AND METHODS: A total of 61 patients who underwent a psycho-acoustic medical assessment were grouped into 1 of 4 categories ranging from category 0 for no simulation or aggravation to category III for severe simulation and aggravation. For category III reliable and valid thresholds of pure tone audiometry can only be achieved using objective audiological measurements. The frequency, extent and socio-economic factors were evaluated. RESULTS: Of the 61 individuals 26 showed no simulation or aggravation behavior (category 0), 10% were grouped into category III and 48% into categories I and II. The tendency to simulation and aggravation increased with the patients' age, the level of education and the frequency of medical examinations prior to this investigation. CONCLUSIONS: Simulation and aggravation is a more frequent phenomenon than previously assumed (approximately 58% of all audiological examinations). The effect in terms of economical damage could be substantial. The usage of a well-defined classification is highly recommended in order to improve the quality of medical assessment in ENT.