AI in radiology: Legal responsibilities and the car paradox.

The integration of AI in radiology raises significant legal questions about responsibility for errors. Radiologists fear AI may introduce new legal challenges, despite its potential to enhance diagnostic accuracy. AI tools, even those approved by regulatory bodies like the FDA or CE, are not perfect, posing a risk of failure. The key issue is how AI is implemented: as a stand-alone diagnostic tool or as an aid to radiologists. The latter approach could reduce undesired side effects. However, it's unclear who should be held liable for AI failures, with potential candidates ranging from engineers and radiologists involved in AI development to companies and department heads who integrate these tools into clinical practice. The EU's AI Act, recognizing AI's risks, categorizes applications by risk level, with many radiology-related AI tools considered high risk. Legal precedents in autonomous vehicles offer some guidance on assigning responsibility. Yet, the existing legal challenges in radiology, such as diagnostic errors, persist. AI's potential to improve diagnostics raises questions about the legal implications of not using available AI tools. For instance, an AI tool improving the detection of pediatric fractures could reduce legal risks. This situation parallels innovations like car turn signals, where ignoring available safety enhancements could lead to legal problems. The debate underscores the need for further research and regulation to clarify AI's role in radiology, balancing innovation with legal and ethical considerations.

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.

Civil liability for clinical misdiagnosis of suicidal intention: procedure and guidelines to minimize fatal diagnostic error / La responsabilidad civil por el diagnóstico clínico erróneo de la intención suicida: procedimiento y pautas para minimizar el error diagnóstico mortal

Background/Objectives: A fatal diagnostic error of suicidal intention, i.e., an error implying death or serious injuries (i.e., incapacitating, chronic injury) to the patient, may have civil liability (punishable error) for the clinician. The Scale for Suicidal Ideation (SSI) is the reference psychometric instrument used to measure suicidal intention. A meta-analytical review was designed with the aim of estimating the true reliability of the SSI in general and in different settings (moderators) with the aim of correcting unreliability raw scores. Method: A total of 90 primary studies reporting SSI's reliability (internal consistency) was found in the literature, yielding a total of 92 effect sizes. Bare-bones meta-analysis of correlation coefficients correcting effect by sampling error were run. Results: The results showed an overall mean true internal consistency of .8904, 95% CI [.8878, .8930], meaning that 42.6% of the population standard deviation is error and 18.11% of an individual's measure is error. Additional estimations (moderators) of SSI's reliability for gender (men: .8873, women: .8808) adaptation version (English: .9212, Korean: .9052, Chinese: .8402, Italian: .9163, Persian: .8612), and population (subclinical: .8769, general: .9230, mental illness: .9040) were obtained. All mean true estimations were under the desirable standard for applied settings where critical decisions are made, .95. Furthermore, for populations with risk of suicide, such as prison inmates and militaries, mean true reliability could not be computed as k was insufficient. Conclusion: Implications of true reliabilities obtained for the estimation of individuals' true scores and population standard deviations are discussed. Examples of computation of true scores to minimize fatal diagnosis errors were performed for both known reliability and unknown reliability settings (e.g., risk populations). (AU)

Antecedentes/Objetivo: Un error diagnóstico mortal de intención suicida, es decir, un error que implique la muerte o lesiones graves (es decir, incapacitantes, crónicas) para el paciente, puede tener responsabilidad civil (error punible) para el clínico. La Escala de Ideación Suicida (SSI) es el instrumento psicométrico de referencia utilizado para medir la intención suicida. En este estudio se diseñó una revisión metaanalítica para medir la fiabilidad real de la SSI en general y en diferentes ámbitos (moderadores), con el fin de corregir las puntuaciones brutas por la falta de fiabilidad de la medida. Método: En la búsqueda de estudios se encontró un total de 90 estudios primarios que trataban de la fiabilidad (consistencia interna) del SSI, lo que arrojó un total de 92 tamaños del efecto. Se ejecutaron meta-análisis del tipo bare-bone corrigiendo el efecto por el error de muestreo. Resultados: Se obtuvo una consistencia interna verdadera media global de .8904, IC 95% [.8878, .8930], es decir, el 42.6% de la desviación estándar de la población es error y el 18.11% de la medida de un sujeto es error. Se obtuvieron estimaciones adicionales (moderadores) de la fiabilidad del SSI para el género (hombres: .8873, mujeres: .8808), versión de adaptación (inglés: .9212, coreano: .9052, chino: .8402, italiano: .9163, persa: .8612) y población (subclínica: .8769, general: .9230, enfermedad mental: .9040). Todas las estimaciones verdaderas medias estaban por debajo del estándar deseable para entornos aplicados donde se toman decisiones críticas, .95. Además, para las poblaciones de riesgo de suicidio, como reclusos y militares, no se pudo calcular la fiabilidad media verdadera, ya que k era insuficiente. Conclusiones: Se discuten las implicaciones de la fiabilidad verdadera obtenida para la estimación de las puntuaciones verdaderas de los individuos y las desviaciones típicas de las poblaciones. ... (AU)

High-Risk Medicolegal Conditions in Pediatric Emergency Medicine.

The top 5 reasons for pediatric malpractice are cardiac or cardiorespiratory arrest, appendicitis, disorder of male genital organs, encephalopathy, and meningitis. Malpractice is most likely to result from an "error in diagnosis." Claims involving a "major permanent injury" were more likely to pay out money, but of all claims, only 30% result in a monetary pay out. Consideration of "high-risk misses" may help to direct a history, examination, testing, and discharge instructions.

Brady v Southend University Hospital NHS Foundation Trust [2020] EWHC 158: 'Pure Diagnosis' Claims and Setting the Professional Standard of Care.

In Brady v Southend University Hospital NHS Trust, the High Court was asked to consider the applicability of Bolam and Bolitho principles in a so-called 'pure diagnosis' claim. The claimant suffered from the long-term effects of an undiagnosed bacterial infection after presenting at the defendant hospital with acute appendicitis. It was argued by claimant's counsel that where the primary allegation of fault concerns diagnosis, no issues of acceptable practice arise and therefore Bolam and Bolitho do not apply. Rejecting this, the High Court confirmed the applicability of Bolam and Bolitho and found that the defendant hospital had not been negligent. Initially, this result may signal a continued deference towards those in the medical profession, however, it is suggested that an alternative reading evidences a case which lays the groundwork for reconsidering the doctor-patient relationship in the context of treatment and diagnosis actions.

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.

Analysis of lawsuits related to diagnostic errors from point-of-care ultrasound in internal medicine, paediatrics, family medicine and critical care in the USA.

PURPOSE: The purpose of this study is to identify the extent of diagnostic error lawsuits related to point-of-care ultrasound (POCUS) in internal medicine, paediatrics, family medicine and critical care, of which little is known. METHODS: We conducted a retrospective review of the Westlaw legal database for indexed state and federal lawsuits involving the diagnostic use of POCUS in internal medicine, paediatrics, family medicine and critical care. Retrieved cases were reviewed independently by three physicians to identify cases relevant to our study objective. A lawyer secondarily reviewed any cases with discrepancies between the three reviewers. RESULTS: Our search criteria returned 131 total cases. Ultrasound was mentioned in relation to the lawsuit claim in 70 of the cases returned. In these cases, the majority were formal ultrasounds performed and reviewed by the radiology department, echocardiography studies performed by cardiologists or obstetrical ultrasounds. There were no cases of internal medicine, paediatrics, family medicine or critical care physicians being subjected to adverse legal action for their diagnostic use of POCUS. CONCLUSION: Our results suggest that concerns regarding the potential for lawsuits related to POCUS in the fields of internal medicine, paediatrics, family medicine and critical care are not substantiated by indexed state and federal filed lawsuits.

The paralyzing legal costs of facial nerve injury in head and neck tumors.

PURPOSE: Facial nerve paralysis from head and neck tumors can result from disease progression or iatrogenic causes, leading to litigation. The aim of this study was to investigate lawsuits regarding facial paralysis as a consequence of these tumors to understand and better educate physicians behind the reasons for litigation. METHODS: Jury verdict reviews were obtained from the Westlaw database from 1985 to 2018. Gathered data, including verdicts, litigation reasons, defendant specialties, and amounts awarded, were analyzed via Statistical Package for the Social Sciences. RESULTS: Of the 26 lawsuits analyzed, the leading reason for litigation was failure to diagnose (53.8%), followed by iatrogenic injury (34.6%). The average award was $2,704,470. Otolaryngologists were the most common defendants. Defendants that included an otolaryngologist had shorter delays of diagnosis compared to those that did not (p < 0.05). CONCLUSION: Failure to diagnose parotid injury was the leading cause of litigation. In instances where the jury found for the plaintiff, the amount was material. There were equivalent incidences of cases in favor of plaintiffs and defendants.

Factors and impact of physicians' diagnostic errors in malpractice claims in Japan.

BACKGROUND: Diagnostic errors are prevalent and associated with increased economic burden; however, little is known about their characteristics at the national level in Japan. This study aimed to investigate clinical outcomes and indemnity payment in cases of diagnostic errors using Japan's largest database of national claims. METHODS: We analyzed characteristics of diagnostic error cases closed between 1961 and 2017, accessed through the national Japanese malpractice claims database. We compared diagnostic error-related claims (DERC) with non-diagnostic error-related claims (non-DERC) in terms of indemnity, clinical outcomes, and factors underlying physicians' diagnostic errors. RESULTS: All 1,802 malpractice claims were included in the analysis. The median patient age was 33 years (interquartile range = 10-54), and 54.2% were men. Deaths were the most common outcome of claims (939/1747; 53.8%). In total, 709 (39.3%, 95% CI: 37.0%-41.6%) DERC cases were observed. The adjusted total billing amount, acceptance rate, adjusted median claims payments, and proportion of deaths were significantly higher in DERC than non-DERC cases. Departments of internal medicine and surgery were 1.42 and 1.55 times more likely, respectively, to have DERC cases than others. Claims involving the emergency room (adjusted odds ratio [OR] = 5.88) and outpatient office (adjusted OR = 2.87) were more likely to be DERC than other cases. The initial diagnoses most likely to lead to diagnostic error were upper respiratory tract infection, non-bleeding digestive tract disease, and "no abnormality." CONCLUSIONS: Cases of diagnostic errors produced severe patient outcomes and were associated with high indemnity. These cases were frequently noted in general exam and emergency rooms as well as internal medicine and surgery departments and were initially considered to be common, mild diseases.

Disorders of Consciousness and Disability Law.

In 2018, the American Academy of Neurology, the American Congress of Rehabilitation Medicine, and the National Institute on Disability, Independent Living, and Rehabilitation Research published a systematic evidence-based review and an associated practice guideline for improved assessment, treatment, and rehabilitation of patients with disorders of consciousness. Patients with disorders of consciousness include individuals in the vegetative and minimally conscious states, as well as others with covert consciousness and cognitive motor dissociation. These landmark publications (concurrently published in Neurology and Archives of Physical Medicine and Rehabilitation) supplant the 1994 New England Journal of Medicine Multi-Society Task Force report on the vegetative state and the 2002 criteria establishing minimally conscious states. The guideline re-designates the permanent vegetative state as chronic. In our article, we consider the legal and ethical implications of the practice guideline for clinical practice and explain the vulnerability of these patients who suffer from high rates of misdiagnosis, inadequate medical surveillance, undertreatment of pain, inadequate rehabilitation, and segregation in chronic care. We argue that these deficiencies in medical care are inconsistent with our growing appreciation of the dynamic nature of these brain states and an emerging standard of care as articulated by the national guideline. These deficiencies also violate domestic and international disability law. To substantiate this latter claim, we apply disability law to this population, focusing on key Americans with Disabilities Act mandates, the relevance of the 1999 Supreme Court, Olmstead v. L.C., and the utility of Olmstead enforcement actions to integrate the care of these individuals into the medical mainstream.

Medico-legal importance of necrotizing fasciitis.

Despite the rarity of necrotizing fasciitis (NF), it is a relatively common cause of death in many lawsuits. Families seek financial compensation or legal charges against those they believe to be involved in the death, usually physicians who did not identify the infection soon enough. This paper explores six cases in forensic pathology practice where NF posed a unique medico-legal dilemma.

The medico-legal implications in medical malpractice claims during Covid-19 pandemic: Increase or trend reversal?

The Covid-19 pandemic caused a marked increase in admissions to intensive care units. The critically ill patients' condition from the infection resulted in their deaths. The healthcare facilities have got into trouble because of the pandemic. In fact, they had to create additional beds in a very short time and to protect health workers with personal protective equipment. Healthcare professionals fear that there will be an increase in complaints and medico-legal malpractice claims and hence they have urged politicians to discuss this. The Italian Parliament recently debated the topic of medical liability and passed the Decree-Law no. 18 of 17 March 2020 (DL - so called Cura Italia) by which they want to extend the concept of "gross negligence" to healthcare facilities. Several Extended Care Units have suffered from outbreaks of Covid-19, so the Prosecutor's Office of several cities initiated investigations against them. This situation has reached Sicily, where the Prosecutor's Office of Palermo has opened an inquiry against an Extended Care Unit. Simultaneously, the Covid-19 pandemic may change patients' attitudes towards healthcare professionals, who are risking their lives daily. So the Italian medico-legal community is debating these questions, with one last pending question remaining: is the number of medico-legal claims likely to increase or trend down?

Letter to Editor. Thromboembolic complications in psychiatry from the perspective of legal claims - authors response. / List do redakcji. Powiklania zakrzepowo-zatorowe w psychiatrii z perspektywy roszczen prawnych ­ odpowiedz autorów.

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Emergency Radiology: An Underappreciated Source of Liability Risk.

PURPOSE: While several studies analyze radiology malpractice lawsuits, none specifically examines the site of service. The purpose of this study is to estimate the relative likelihood of a lawsuit arising from a radiology study performed in emergency (ED), inpatient (IP) and outpatient (OP) settings. METHODS: Referrals from a malpractice review consulting company over a six year period were compared to the 2016 Medicare Part B file and stratified by site of service. The proportion of exams for each site of service was estimated, and using absolute differences in proportions and odds ratios (ORs), differences in the place of service were calculated. RESULTS: The Cleareview cohort contained 25 (17%) IP, 56 (38%) OP, and 68 (46%) ED exams. In 2016, Medicare assigned benefits for 27,009,053 (20%) IP, 84,075,848 (62%) OP and 23,964,794 (18%) ED exams. The ORs (Cleareview: Medicare) of the ED to IP, OP, and IP+OP were 3.07 (95% CI: 1.56-6.03), 4.26 (95% CI: 2.76-6.59), 3.89 (95% CI: 2.60-5.83), respectively. By contrast, the OR for IP:OP between Cleareview and Medicare was not significantly different than 1 (OR: 1.39, 95% CI: 0.68-2.83, P = .38). DISCUSSION: Radiological studies performed in the ED accounted for a disproportionate number of liability claims against radiologists. Further study is warranted to confirm this finding with a more robust data set.

Diagnostic errors in the neonatal intensive care unit: State of the science and new directions.

Diagnostic errors remain understudied in neonatology. The limited available evidence, however, suggests that diagnostic errors in the neonatal intensive care unit (NICU) result in significant and long-term consequences. In this narrative review, we discuss how the concept of diagnostic errors framed as missed opportunities can be applied to the non-linear nature of diagnosis in a critical care environment such as the NICU. We then explore how the etiology of an error in diagnosis can be related to both individual cognitive factors as well as organizational and systemic factors - all of which often contribute to the error. This multifactorial causation has limited the development of methodology to measure diagnostic errors as well as strategies to mitigate and prevent their adverse effects. We recommend research focused on the frequency and etiology of diagnostic error in the NICU as well as potential mitigation strategies to advance this important field in neonatal intensive care.

Evaluation of malpractice litigation in thyroid disease in the National Health Service.

Objectives: Thyroid disease is managed by primary and a range of secondary care specialties. Interventions for common thyroid conditions are effective, but delays in diagnosis, ineffective or inappropriate treatment may affect outcomes and be subject to litigation. This study aimed to analyze trends in thyroid malpractice litigation in the UK over a 14-year period.Methods: This retrospective cohort study analyzed negligence claims recorded by the NHS Litigation Authority from 2002 to 2016. Data on incident details, outcomes, time to settlement, costs, and specialties involved were collected and analyzed.Results: Out of 189 cases reviewed, an outcome was decided in 134 cases; of which, 67.9% were successful for the claimant, resulting in compensation being paid. The most common reasons for successful claims were treatment complications (47 cases) and delay or failure of diagnosis (22 cases). Nerve and/or vocal cord damage and hypoparathyroidism were cited in 12 and 3 cases, respectively. Common specialties involved in successful claims were general surgery, ENT and endocrinology. The median (range) costs paid for compensation were £50,701.35 (£189.00 to £4.5 million). The median (interquartile range) time from incident to settlement was 1254 (992-1756) days. The number of claims (overall and successful) has reduced over the 14-year period, but there has been no change in the total cost per successful claim from 2002 to 2014 (p = 0.151).Conclusion: This overview demonstrates common causes and identifies trends in thyroid malpractice litigation in the UK, highlighting the significant costs incurred. The outcomes of the study will provide a basis to enable clinicians to avoid potential pitfalls and formulate guidelines to minimize risk.

Missed diagnosis of cancer in primary care: Insights from malpractice claims data.

BACKGROUND: In the ambulatory setting, missed cancer diagnoses are leading contributors to patient harm and malpractice risk; however, there are limited data on the malpractice case characteristics for these cases. OBJECTIVE: The aim of this study was to examine key features and factors identified in missed cancer diagnosis malpractice claims filed related to primary care and evaluate predictors of clinical and claim outcomes. METHODS: We analyzed 2155 diagnostic error closed malpractice claims in outpatient general medicine. We created multivariate models to determine factors that predicted case outcomes. RESULTS: Missed cancer diagnoses represented 980 (46%) cases of primary care diagnostic errors, most commonly from lung, colorectal, prostate, or breast cancer. The majority (76%) involved errors in clinical judgment, such as a failure or delay in ordering a diagnostic test (51%) or failure or delay in obtaining a consult or referral (37%). These factors were independently associated with higher-severity patient harm. The majority of these errors were of high severity (85%). CONCLUSIONS: Malpractice claims involving missed diagnoses of cancer in primary care most often involve routine screening examinations or delays in testing or referral. Our findings suggest that more reliable closed-loop systems for diagnostic testing and referrals are crucial for preventing diagnostic errors in the ambulatory setting.