Malpractice Trends Involving Active Surveillance Across Cancers.

OBJECTIVE: To characterize malpractice trends related to active surveillance (AS) as a treatment strategy across cancers. BACKGROUND: Active surveillance is increasingly considered a viable management strategy for low-risk cancers. Since a subset of AS cases will progress, metastasize, or exhibit cancer-related mortality, a significant barrier to implementation is the perceived risk of litigation from missing the window for cure. Data on malpractice trends across cancers are lacking. METHODS: Westlaw Edge and LexisNexis Advance databases were searched from 1990 to 2022 for malpractice cases involving active surveillance in conjunction with thyroid cancer, prostate cancer, kidney cancer, breast cancer, or lymphoma. Queries included unpublished cases, trial orders, jury verdicts, and administrative decisions. Data were compiled on legal allegations, procedures performed, and verdicts or settlements rendered. RESULTS: Five prostate cancer cases were identified that pertained to active surveillance. Two cases involved alleged deliberate indifference from AS as a management strategy but were ruled as following the appropriate standard of care. In contrast, 3 cases involved alleged physician negligence for not explicitly recommending AS as a treatment option after complications from surgery occurred. All cases showed documented informed consent for AS, leading to defense verdicts in favor of the physicians. No cases of AS-related malpractice were identified for other cancer types. CONCLUSIONS: To date, no evidence of successful malpractice litigation for active surveillance in cancer has been identified. Given the legal precedent detailed in the identified cases and increasing support across national guidelines, active surveillance represents a sound management option in appropriate low-risk cancers, with no increased risk of medicolegal exposure.

Assessment of Claimant, Clinical, and Financial Characteristics of Teleradiology Medical Malpractice Cases.

Background The increasing use of teleradiology has been accompanied by concerns relating to risk management and patient safety. Purpose To compare characteristics of teleradiology and nonteleradiology radiology malpractice cases and identify contributing factors underlying these cases. Materials and Methods In this retrospective analysis, a national database of medical malpractice cases was queried to identify cases involving telemedicine that closed between January 2010 and March 2022. Teleradiology malpractice cases were identified based on manual review of cases in which telemedicine was coded as one of the contributing factors. These cases were compared with nonteleradiology cases that closed during the same time period in which radiology had been determined to be the primary responsible clinical service. Claimant, clinical, and financial characteristics of the cases were recorded, and continuous or categorical data were compared using the Wilcoxon rank-sum test or Fisher exact test, respectively. Results This study included 135 teleradiology and 3474 radiology malpractices cases. The death of a patient occurred more frequently in teleradiology cases (48 of 135 [35.6%]) than in radiology cases (685 of 3474 [19.7%]; P < .001). Cerebrovascular disease was a more common final diagnosis in the teleradiology cases (13 of 135 [9.6%]) compared with the radiology cases (124 of 3474 [3.6%]; P = .002). Problems with communication among providers was a more frequent contributing factor in the teleradiology cases (35 of 135 [25.9%]) than in the radiology cases (439 of 3474 [12.6%]; P < .001). Teleradiology cases were more likely to close with indemnity payment (79 of 135 [58.5%]) than the radiology cases (1416 of 3474 [40.8%]; P < .001) and had a higher median indemnity payment than the radiology cases ($339 230 [IQR, $120 790-$731 615] vs $214 063 [IQR, $66 620-$585 424]; P = .01). Conclusion Compared with radiology cases, teleradiology cases had higher clinical and financial severity and were more likely to involve issues with communication. © RSNA, 2024 See also the editorial by Mezrich in this issue.

Malpractice Claims Following Major Liver and Pancreatic Surgeries: What Can we Learn?

INTRODUCTION: General surgery is a highly litigious specialty. Lawsuits can be a source of emotional distress and burnout for surgeons. Major hepatic and pancreatic surgeries are technically challenging general surgical oncology procedures associated with an increased risk of complications and mortality. It is unclear whether these operations are associated with an increased risk of lawsuits. The objective of the present study was to summarize the medical malpractice claims surrounding pancreatic and hepatic surgeries from publicly available court records. METHODS: The Westlaw legal database was searched and analyzed for relevant malpractice claims from the last two decades. RESULTS: Of 165 search results, 30 (18.2%) cases were eligible for inclusion. Appellant cases comprised 53.3% of them. Half involved a patient death. Including co-defendants, a majority (n = 21, 70%) named surgeons as defendants, whereas several claims (n = 13, 43%) also named non-surgeons. The most common cause of alleged malpractice was a delay in diagnosis (n = 12, 40%). In eight of these, surgery could not be performed. The second most common were claims alleging the follow-up surgery was due to negligence (n = 6). Collectively, 20 claims were found in favor of the defendant. Seven verdicts (23.3%) returned in favor of the plaintiff, two of which resulted in monetary awards (totaling $1,608,325 and $424,933.85). Three cases went to trial or delayed motion for summary judgment. There were no settlements. CONCLUSIONS: A defendant verdict was reached in two-thirds of malpractice cases involving major hepatic or pancreatic surgery. A delay in diagnosis was the most cited claim in hepatopancreaticobiliary lawsuits, and defendants may often practice in nonsurgical specialties. While rulings favoring plaintiffs are less frequent, the payouts may be substantial.

Malpractice claims after antireflux surgery and paraesophageal hernia repair: a population-based analysis.

BACKGROUND: The complication rate of modern antireflux surgery or paraesophageal hernia repair is unknown, and previous estimates have been extrapolated from institutional cohorts. METHODS: A population-based retrospective cohort study of patient injury cases involving antireflux surgery and paraesophageal hernia repair from the Finnish National Patient Injury Centre (PIC) register between Jan 2010 and Dec 2020. Additionally, the baseline data of all the patients who underwent antireflux and paraesophageal hernia operations between Jan 2010 and Dec 2018 were collected from the Finnish national care register. RESULTS: During the study period, 5734 operations were performed, and the mean age of the patients was 54.9 ± 14.7 years, with 59.3% (n = 3402) being women. Out of all operations, 341 (5.9%) were revision antireflux or paraesophageal hernia repair procedures. Antireflux surgery was the primary operation for 79.9% (n = 4384) of patients, and paraesophageal hernia repair was the primary operation for 20.1% (n = 1101) of patients. A total of 92.5% (5302) of all the operations were laparoscopic. From 2010 to 2020, 60 patient injury claims were identified, with half (50.0%) of the claims being related to paraesophageal hernia repair. One of the claims was made due to an injury that resulted in a patient's death (1.7%). The mean Comprehensive Complication Index scores were 35.9 (± 20.7) and 47.6 (± 20.8) (p = 0.033) for antireflux surgery and paraesophageal hernia repair, respectively. Eleven (18.3%) of the claims pertained to redo surgery. CONCLUSIONS: The rate of antireflux surgery has diminished and the rate of paraesophageal hernia repair has risen in Finland during the era of minimally invasive surgery. Claims to the PIC remain rare, but claims regarding paraesophageal hernia repairs and redo surgery are overrepresented. Additionally, paraesophageal hernia repair is associated with more serious complications.

Medical negligence under pressure: obligations of clinicians and healthcare services in the setting of resource limitations.

Healthcare provision takes place in a variety of contexts, with variations of resources available to practitioners and their patients. Effects from the COVID-19 pandemic superimposed on existing system demands have driven increasing concern about resource limitations, particularly in rural and remote settings. This article explores the legal liability of medical practitioners and healthcare services with respect to actions in negligence arising from harm to patients suffered, either partly or wholly, as a result of resource limitations.

Retrospective Analysis of US Litigations Involving Dermatologists From 2011 to 2022.

BACKGROUND: Physician malpractice lawsuits are climbing, and the reasons underlying litigation against dermatologists are unclear. OBJECTIVE: To determine the reasons patients pursue litigation against dermatologists or dermatology practices. MATERIALS AND METHODS: A retrospective analysis of all state and federal cases between 2011 and 2022 was performed after a query using "Dermatology" and "dermatologist" as search terms on 2 national legal data repositories. RESULTS: The authors identified a total of 48 (37 state and 11 federal) lawsuits in which a practicing dermatologist or dermatology group practice was the defendant. The most common reason for litigation was unexpected harm (26 cases, 54.2%), followed by diagnostic error (e.g. incorrect or delayed diagnoses) (16 cases, 33.3%). Six cases resulted from the dermatologist failing to communicate important information, such as medication side effects or obtaining informed consent. Male dermatologists were sued at a rate 3.1 times higher than female dermatologists. CONCLUSION: Although lawsuits from patients against dermatologists largely involve injury from elective procedures, clinicians should practice caution regarding missed diagnoses and ensure critical information is shared with patients to safeguard against easily avoidable litigation.

Medical Malpractice Claims Related to Performance of Transesophageal Echocardiography by Anesthesiologists.

More than 300,000 adults have cardiac surgery in the United States annually, and most undergo intraoperative transesophageal echocardiography (TEE). This patient population is often older with multiple comorbidities, increasing their risk for complications for even routine procedures. Major morbidity or mortality caused by TEE is rare, and it is unknown how often such complications lead to malpractice lawsuits. The authors identified 13 cases out of 2,564 in a closed claims database that involved TEE and reviewed their etiology. Esophageal injury accounted for most of the suits, and only 2 were related to diagnosis. Most expert reviews deemed the care provided by the anesthesiologist to be appropriate.

Risk management and empirical study of the doctor-patient relationship: based on 1790 litigation cases of medical damage liability disputes in China.

BACKGROUND: Compensation for medical damage liability disputes (CMDLD) seriously hinders the healthy development of hospitals and undermines the harmony of the doctor-patient relationships (DPR). Risk management in the DPR has become an urgent issue of the day. The study aims to provide a comprehensive description of CMDLD in China and explore its influencing factors, and make corresponding recommendations for the management of risks in the DPR. METHODS: This study extracted data from the China Judgment Online - the official judicial search website with the most comprehensive coverage. Statistical analysis of 1,790 litigation cases of medical damage liability disputes (COMDLD) available from 2015 to 2021. RESULTS: COMDLD generally tended to increase with the year and was unevenly distributed by regions; the compensation rate was 52.46%, the median compensation was 134,900 yuan and the maximum was 2,234,666 yuan; the results of the single factor analysis showed that there were statistically significant differences between the compensation for different years, regions, treatment attributes, and trial procedures (P < 0.05); the correlation analysis showed that types of hospitals were significantly negatively associated with regions (R=-0.082, P < 0.05); trial procedures were significantly negatively correlated with years (R=-0.484, P < 0.001); compensat- ion was significantly positively correlated with years, regions, and treatment attributes (R = 0.098-0.294, P < 0.001) and negatively correlated with trial procedures (R=-0.090, P < 0.01); regression analysis showed that years, treatment attributes, and regions were the main factors affecting the CMDLD (P < 0.05). CONCLUSIONS: Years, regions, treatment attributes, and trial procedures affect the outcome of CMDLD. This paper further puts forward relevant suggestions and countermeasures for the governance of doctor-patient risks based on the empirical results. Including rational allocation of medical resources to narrow the differences between regions; promoting the expansion and sinking of high-quality resources to improve the level of medical services in hospitals at all levels; and developing a third-party negotiation mechanism for medical disputes to reduce the cost of medical litigation.

Decoding the meaning of medical guidelines and their medicolegal implications.

Medical practice guidelines (MPGs) are important in medicine to ensure well tolerated and effective healthcare. They provide evidence-based recommendations for healthcare professionals in daily clinical settings. MPGs help patients and practitioners make informed decisions, ensure quality of care, allocate healthcare resources effectively and reduce legal liability. MPGs have medicolegal implications, as they influence clinical decision-making and patient outcomes, which can impact liability and malpractice cases. They define the standard of care within the healthcare industry and provide best practice recommendations. MPGs are a cornerstone of the informed consent process, as they facilitate a shared decision support system and they provide valuable evidence-based recommendations on various treatments or medical options. Finally, MPGs are also relevant in medical claims; thus, adherence to MPGs is highly encouraged in order to assure the best medical care. Nonetheless, MPGs have limitations and we advocate for wise usage of MPGs combined with the expertise of trained physicians that allows for individualisation and evidence-based recommendations. In this review, we describe the potential legal implications that MPGs may represent for healthcare providers and the role that MPGs have in daily practice at different stages in the doctor--patient relationship.

An Updated Analysis of Body Contouring Malpractice Cases.

INTRODUCTION: Body contouring procedures are commonly performed in the United States for patients seeking to sculpt specific areas of their bodies. The aim of this study was to provide an updated analysis of the factors that influence medical malpractice litigation surrounding body contouring surgery. METHODS: The following terms were used to search the Westlaw Campus Legal research Database for cases with earliest documentation after January 2013: ("contouring" OR "abdominoplasty" OR "liposuction" OR "tummy tuck" OR "body lift" OR "thigh lift" OR "arm lift" OR "brachioplasty" OR "thighplasty" OR "lipectomy" OR "panniculectomy") AND "surgery" AND "medical malpractice." Cases were only included if there was a complaint of medical malpractice subsequent to a body contouring procedure, and details of the cases were provided. Information was collected on the location of the lawsuit, the earliest year of available case documentation, patient demographics, procedure(s) performed, alleged injury, specialty involvement, and verdicts. RESULTS: A total of 32 cases were included in the study. Most of the patients involved in the cases were women (n = 30, 93.8%) and alive (n = 28, 87.5%). New York state had the most cases (n = 7, 21.9%). Abdominoplasty (56.3%), liposuction (53.1%), and buttock augmentations (15.6%) were the most common procedures. Plastic surgeons were involved in 93.8% (n = 30) of the cases, and anesthesia, emergency medicine, dermatology, and oncology were also involved. Claims of malpractice most often discussed negligent technique (71.9%) and poor postoperative management (62.5%). Common postoperative complications were infection/sepsis (40.6%), scarring (31.3%), and emotional distress/prolonged pain (31.3%). One available ruling was in favor of the plaintiff. CONCLUSION: Although many of the cases in this analysis cited negligent technique, none were founded in their argument. Because involvement in these cases can place a burden on attending physicians, clear expectations of postoperative infections, scarring, and prolonged pain should be addressed during the informed consent process.

A 23-year analysis of litigation in orthopedic elbow surgery.

BACKGROUND: The reasons for malpractice litigation in elbow surgery are not well understood. The aim of this study is to report the most frequently litigated surgeries of the elbow and analyze the reasons for litigation and case outcomes. METHODS: A retrospective review of the Westlaw legal database was performed, and all federal and state jurisdiction litigation cases involving the elbow from 2000 to 2023 were queried. Cases were excluded if they did not involve an orthopedic surgeon, nor primary elbow injury or procedure. Cases were reviewed for demographic information, surgical procedure based on reference Current Procedural Terminology codes, complications, symptoms, and reasons for litigation. Quantitative information, including settlement and indemnity cost to the defendant orthopedic surgeon, was analyzed. Cases were subdivided based on United States Census Bureau regions and states to assess regional frequency of litigation with analyses of variance. RESULTS: There were 59 cases meeting inclusion criteria from 2000 to 2023. The most litigated cases involved were ulnar nerve transposition/release and open reduction and internal fixation of the proximal radius and/or ulna at the elbow. The most litigated complication was claimed nerve damage (46%) and permanent disability (27%). Of the total cases, the most frequently litigated symptoms were nerve damage (46%) and loss of function (37%), whereas the least frequent was postoperative stiffness (2%). The Pacific region demonstrated the highest litigation rate (20%), whereas the East South Central, Mountain, and New England regions had the lowest litigation rate (3% each). A favorable verdict was given to the defendant orthopedic surgeon in 59% of the cases. The average loss incurred through settlement was $245,590, whereas the average indemnity paid through verdict was $523,334. CONCLUSION: Operative fixation of the proximal ulna/radius and ulnar nerve release/transposition are the most litigated procedures of the elbow. Litigation is most associated with nerve injury. Across Census Bureau regions, there is no significant difference in monetary cost incurred through settlements and verdict losses. Although a majority of litigated cases are won by the defending orthopedic surgeon, thorough informed consent and perioperative expectation management may mitigate litigation risk.

An examination of erroneous medical practices in circumcision surgery in light of supreme court decisions.

PURPOSE: Global interest in circumcision, one of the oldest and most frequently performed surgical procedures worldwide, continues. There is a significant increase in cases regarding medical malpractice claims in the world and in our country. It is aimed to identify situations that lead to malpractice claims in circumcision surgery, which has question marks regarding its psychological and ethical aspects, to identify situations that are considered errors and professionally risky, and to contribute to eliminating these deficiencies. METHODS: We examined the Supreme Court appeal decisions related to circumcision malpractice cases resolved between 2012 and 2022, using the keyword "circumcision" on the official website of the Republic of Turkiye Supreme Court. RESULTS: We examined 30 Supreme Court decisions that met our criteria. It was determined that the most common lawsuit was filed due to negligence (43.3%), followed by carelessness (20%) and faulty action (20%). CONCLUSION: Physical conditions must be appropriate and healthcare personnel must be adequately trained for circumcision, which is frequently performed especially in pediatric patients and is more frequently subject to malpractice lawsuits than other pediatric operations.

Help, I've been sued! Demystifying the steps of malpractice litigation for the emergency radiologist.

Being sued can have significant emotional and psychological impact and has implications on the wellness of emergency radiologists. A better understanding of the steps involved in a medical malpractice suit can help defuse some of the anxiety of litigation. This process starts with the inception of the case, the summons, and complaint, then progresses to discovery, including document production, interrogatories, and deposition, and thereafter to settlement or trial. The discussion includes a number of tips and outlines a number of pitfalls inherent in litigation. It is hoped that this discussion will alleviate some of the anxiety that accompanies this long and arduous process.

Characteristics and contributing factors of diagnostic error in surgery: analysis of closed medico-legal cases and complaints in Canada.

BACKGROUND: Diagnostic errors lead to patient harm; however, most research has been conducted in nonsurgical disciplines. We sought to characterize diagnostic error in the pre-, intra-, and postoperative surgical phases, describe their contributing factors, and quantify their impact related to patient harm. METHODS: We performed a retrospective analysis of closed medico-legal cases and complaints using a database representing more than 95% of all Canadian physicians. We included cases if they involved a legal action or complaint that closed between 2014 and 2018 and involved a diagnostic error assigned by peer expert review to a surgeon. RESULTS: We identified 387 surgical cases that involved a diagnostic error. The surgical specialties most often associated with diagnostic error were general surgery (n = 151, 39.0%), gynecology (n = 71, 18.3%), and orthopedic surgery (n = 48, 12.4%), but most surgical specialties were represented. Errors occurred more often in the postoperative phase (n = 171, 44.2%) than in the pre- (n = 127, 32.8%) or intra-operative (n = 120, 31.0%) phases of surgical care. More than 80% of the contributing factors for diagnostic errors were related to providers, with clinical decision-making being the principal contributing factor. Half of the contributing factors were related to the health care team (n = 194, 50.1%), the most common of which was communication breakdown. More than half of patients involved in a surgical diagnostic error experienced at least moderate harm, with 1 in 7 cases resulting in death. CONCLUSION: In our cohort, diagnostic errors occurred in most surgical disciplines and across all surgical phases of care; contributing factors were commonly attributed to provider clinical decision-making and communication breakdown. Surgical patient safety efforts should include diagnostic errors with a focus on understanding and reducing errors in surgical clinical decision-making and improving communication.

[Learning from Errors: Qualitative Analysis of Expert Reports on Malpractice in Family Medicine]. / Aus Fehlern lernen ­ qualitative Analyse von Gutachten zu hausärztlichen Behandlungsfehlern.

BACKGROUND: Expert committees of the German medical associations provide a free and out-of-court evaluation of putative cases of medical malpractice. They prepare reports that contain valuable information on process steps that precede the actual treatment error. The aim of the present study was to identify and systematically categorize individual process steps in the expert reports and thus to lay the foundations for the understanding of malpractice evaluation processes. METHODS: In this study, ten randomly selected and anonymized expert reports of the Expert Committee for Questions of Medical Liability of the District Medical Association of South Württemberg with identified GP treatment errors were evaluated, using the method of qualitative content analysis. In an iterative process, central elements of expert reports were classified into a deductively and inductively built category system. RESULTS: Six main categories with associated subcategories were identified: 1) structural aspects of the report, 2) doctor-patient communication, 3) medical course, 4) patient's experience, 5) action by the GP team, and 6) coordinative role in the health care system. The category system showed sufficient reliability with repeated use. CONCLUSION: This study offers an opportunity to learn from errors. The proposed system allows to structure the complexity of expert reports on GP malpractice and may thus serve as a tool in various contexts. In particular, it facilitates the preparation and comparative analysis of reports in a structured way. It could also be used in health care research as well as in education and training.

Complications and complaints in craniofacial fractures - Finnish national data for 20 years.

OBJECTIVE: Research on reasons for malpractice claims in oral and maxillofacial surgery is scarce. The aim of this study was to investigate the causes and prevalence of permanent harm among craniofacial fracture related malpractice claims. MATERIALS AND METHODS: A retrospective register study was designed and implemented. All patients with a complaint and a diagnosis of facial or cranial fracture were included. The main outcome was the presence of permanent harm, and the predictor variable was the cause of complaint. Chi-square test was used for estimation of statistical significance. RESULTS: Delay in correct diagnosis was the leading cause of malpractice claims (63.2%), and permanent harm was found in 23.1% of the population. 82.4% of injuries were facial fractures in total population. 65.3% (n = 98) of facial trauma were related with delayed diagnostics (p < 0.001). Permanent harm was more frequent in patients with delayed diagnosis (71.4%) than those without (60.7%, p = 0.299). CONCLUSIONS: Claims of craniofacial trauma are related with under-diagnostics, and un-diagnosed facial fracture can lead to a high rate of permanent harm. Systematic clinical evaluation and facial trauma specialist consultation is recommended to set early correct diagnosis for and improve treatment of craniofacial trauma patients.

A Decade of Lawsuits Against Surgeons Performing Female Genital Cosmetic Surgery (FGCS) in Tehran, Iran.

BACKGROUND: The objective of this study is to evaluate the legal proceedings that arise from Female Genital Cosmetic Surgeries (FGCS) and analyze the reasons why women file complaints against their surgeons. Additionally, we examined the outcomes of the legal decisions associated with these complaints. METHODS: This descriptive cross-sectional study was conducted in Tehran province, Iran, from 2012 to 2021. The primary data source for this study was forensic medical records, which were reviewed to gather relevant information. The collected data included the characteristics of the participants, the reasons for lawsuits, the procedure setting, and the outcomes of the legal decisions. RESULTS: A total of 121 patients were examined in the study, revealing that Labiaplasty was the most prevalent procedure (49.6%), followed by vaginoplasty (19.8%) and perineoplasty (13.2%). The most common complaints were related to cosmetic concerns (57%), lack of recovery (26.4%), and sexual dysfunctions (22.3%). Healthcare providers were found liable for malpractice in 52.1% of cases. Additionally, having the surgery performed by a gynecologist decreased the risk of malpractice (ß = 0.21, p= 0.034), while procedures in private clinics increased the risk (ß = 2.95, p = 0.040). CONCLUSION: The study's findings emphasized the importance of providing women with comprehensive education and consultations to ensure they are well-informed about the potential outcomes and risks of FGCS. Furthermore, the study highlighted the significance of having these surgical procedures performed by skilled and experienced surgeons. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Doctors, FIRs, and Arrest in Alleged Medical Negligence Cases in India: Demystifying the Legal Tenability.

The relationship between a doctor and a patient is a contract, retaining the essential elements of the tort. Modern medical practice has evolved alongside the court of law to regulate the conduct of doctors and hospitals to reduce litigations of medical negligence. Lately, Indian patients have become more aware of their rights and the Consumer Protection Act. This awareness encourages patients to litigate and seek the help of redressal forums to mitigate their loss/injury in cases of medical negligence. Though there is a rise in complaints of medical negligence filed against doctors and hospitals, these allegations are often frivolous. The specter of litigation constantly looms over medical practitioners, who frequently struggle to defend themselves in a court of law, causing undue anxiety and anguish. Thus, a doctor can be considered the second victim in a medical negligence case. Lack of awareness regarding their legal rights and pertinent laws coupled with contradictory actions of the law enforcement agencies while handling alleged medical negligence cases worsens a doctor's trepidation. Hence, this article attempts to raise awareness among medical professionals, which will thereby allay undue fear while facing an allegation.

Cystic Fibrosis and the Law: The Ramifications of New Treatments.

Until the discovery of the gene for cystic fibrosis (CF) in 1989, diagnostic developments were limited, and treatment focused on symptom alleviation. However, following the genetic breakthrough, some 2,000 mutations of the gene have been identified. More recently CF transmembrane conductance regulator modulator triple therapy (CFTRm) has been introduced in the form of triple therapy with ivacaftor, lumacaftor and tezacaftor (ETI), in the United States from 2019, Europe from 2020 and then Australia from 2021. The new treatment option has revolutionised both the quality of life and life expectancy of many persons diagnosed with CF. This editorial reviews major developments in the clinical care that can now be provided to patients, and reflects on the legal and ethical ramifications of the improved situation for many patients in the contexts of medical negligence, damages assessment, family law and criminal law. It also considers the difficult issues of access and equity caused by the limited availability of the triple therapy in low- and middle-income countries.

Commentary on "Fatal cardiac air embolism after CT-guided percutaneous needle lung biopsy: medical complication or medical malpractice?"

To differentiate between medical malpractice and expected, but rare, medical complication in a medicolegal autopsy context is often difficult. Such an assessment requires knowledge about the clinical practice associated with the procedure at hand, and that findings of the autopsy, including medical relevant information such as patient chart, radiological imaging, and statements from witnesses about the medical procedure itself, provides evidence that substantiate either conclusion. In a case report published in the journal such an assessment is discussed by presenting findings and circumstances surrounding the death of a patient during a percutaneous needle lung biopsy procedure. The authors conclude that the death was not due to medical malpractice. However, in this commentary it is highlighted that the reasoning behind the conclusion needs to be further substantiated.