A case of surgical site infection with severe spondylitis caused by Streptococcus gordonii in an adult healthy woman: how to apply medico-legal method to deny malpractice hypothesis in suspected healthcare-associated infection.

We describe a rare case of severe primary spondylitis caused by Streptococcus gordonii in a 45-year-old immunocompetent woman with no relevant comorbidities. The surgical site infection arose after a L4-L5 microdiscectomy and resulted in severe clinical disability. Allegations of possible negligence as the cause prompted a forensic review to clarify the original source and transmission of this uncommon pathogen, which dismissed its cause as due to malpractice during treatment.

Acute methotrexate toxicity in a patient with psoriasis: a case report.

Aside from rheumatoid arthritis, methotrexate is also used to treat cancer, psoriasis, and other diseases. Side effects with methotrexate are possible, as they are with any medication. This drug is extremely potent and has the potential to produce serious adverse effects. Those who use this medication need to be tracked often. We provide a case of a patient with psoriasis vulgaris who died due to methotrexate administration without proper dosage verification. A female patient in her forties had a history of psoriasis vulgaris of the lower limbs. Under treatment, she developed acute methotrexate toxicity. This drug was taken as an intramuscular injection per day in an infirmary without checking that the dose regimen prescribed was per week. She developed extensive bullous and pustular lesions associated with digestive signs related to generalized toxiderma. But at that point, she had septic shock, which led to her death a few weeks after the methotrexate injection. The medical responsibilities of the doctor, pharmacist, and nurse were discussed. To conclude, methotrexate is not a killer drug in most cases, but it can be extremely harmful if it's overused. Acute toxicity is a potentially fatal condition, and a deeper understanding of its potential toxicity is still necessary.

Behind the mask: a critical perspective on the ethical, moral, and legal implications of AI in ophthalmology.

PURPOSE: This narrative review aims to provide an overview of the dangers, controversial aspects, and implications of artificial intelligence (AI) use in ophthalmology and other medical-related fields. METHODS: We conducted a decade-long comprehensive search (January 2013-May 2023) of both academic and grey literature, focusing on the application of AI in ophthalmology and healthcare. This search included key web-based academic databases, non-traditional sources, and targeted searches of specific organizations and institutions. We reviewed and selected documents for relevance to AI, healthcare, ethics, and guidelines, aiming for a critical analysis of ethical, moral, and legal implications of AI in healthcare. RESULTS: Six main issues were identified, analyzed, and discussed. These include bias and clinical safety, cybersecurity, health data and AI algorithm ownership, the "black-box" problem, medical liability, and the risk of widening inequality in healthcare. CONCLUSION: Solutions to address these issues include collecting high-quality data of the target population, incorporating stronger security measures, using explainable AI algorithms and ensemble methods, and making AI-based solutions accessible to everyone. With careful oversight and regulation, AI-based systems can be used to supplement physician decision-making and improve patient care and outcomes.

Virtual reality evidence on the impact of physicians' open versus defensive communication on patients.

Using virtual reality (VR) in an experimental setting, we analyse how communicating more openly about a medical incident influences patients' feelings and behavioural intentions. Using VR headsets, participants were immersed in an actual hospital room where they were told by a physician that a medical incident had occurred. In a given scenario, half of the participants were confronted by a physician who communicated openly about the medical incident, while the other half were confronted with the exact same scenario except that the physician employed a very defensive communication strategy. The employed technology allowed us to keep everything else in the environment constant. Participants exposed to open disclosure were significantly more likely to take further steps (such as contacting a lawyer to discuss options and filing a complaint against the hospital) and express more feelings of blame against the physician. At the same time, these participants rated the physician's communication skills and general impression more highly than those who were confronted with a defensive physician. Nevertheless, communicating openly about the medical incident does not affect trust in the physician and his competence, perceived incident severity and likelihood of changing physician and filing suit.

Defining medical liability when artificial intelligence is applied on diagnostic algorithms: a systematic review.

Artificial intelligence (AI) in medicine is an increasingly studied and widespread phenomenon, applied in multiple clinical settings. Alongside its many potential advantages, such as easing clinicians' workload and improving diagnostic accuracy, the use of AI raises ethical and legal concerns, to which there is still no unanimous response. A systematic literature review on medical professional liability related to the use of AI-based diagnostic algorithms was conducted using the public electronic database PubMed selecting studies published from 2020 to 2023. The systematic review was performed according to 2020 PRISMA guidelines. The literature review highlights how the issue of liability in case of AI-related error and patient's damage has received growing attention in recent years. The application of AI and diagnostic algorithm moreover raises questions about the risks of using unrepresentative populations during the development and about the completeness of information given to the patient. Concerns about the impact on the fiduciary relationship between physician and patient and on the subject of empathy have also been raised. The use of AI in medical field and the application of diagnostic algorithms introduced a revolution in the doctor-patient relationship resulting in multiple possible medico-legal consequences. The regulatory framework on medical liability when AI is applied is therefore inadequate and requires urgent intervention, as there is no single and specific regulation governing the liability of various parties involved in the AI supply chain, nor on end-users. Greater attention should be paid to inherent risk in AI and the consequent need for regulations regarding product safety as well as the maintenance of minimum safety standards through appropriate updates.

Alleged Malpractice in Orthopedic Surgery in The Netherlands: Lessons Learned from Medical Disciplinary Jurisprudence.

BACKGROUND: Orthopedic surgery is a specialty at risk for medical malpractice claims. We aimed to assess the frequency of alleged malpractice cases related to orthopedic surgery in the Netherlands from the last 15 years. METHODS: We systematically searched the database of the Dutch Medical Disciplinary Court for verdicts related to orthopedic surgery between January 2009 and July 2023 and extracted case data and data on allegations and outcomes. RESULTS: We identified 158 verdicts (mean of 10.5 per year), of which 151 (96%) were filed against specialists and 7 (4%) against residents. Cases were most frequently classified as incorrect treatment/diagnosis (n = 107, 67.7%). Cases were related to the subspecialties of knee (n = 34, 21.5%), hip (n = 31, 19.6%), ankle (n = 25, 15.8%), spine (n = 22, 13.9%), and shoulder (n = 19, 12.0%). A total of 32 cases (20.3%) were judged as partially founded and 9 (6%) as founded. The Dutch Medical Disciplinary Court imposed 28 warnings, 10 reprimands, and 3 temporary suspensions. A total of 68 appeals were submitted, of which 95% were rejected for filing patients. In three instances, unfounded verdicts were changed to two warnings and a reprimand. In four appeals by an orthopedic surgeon, a warning and reprimand were dismissed, and two reprimands were changed to warnings. CONCLUSIONS: The amount of malpractice cases against orthopedic surgeons in the Netherlands is relatively low. The cases in our study may improve our understanding of allegations against physicians and improve the quality of patient care.

[Legal integration of artificial intelligence into internal medicine : Data protection, regulatory, reimbursement and liability questions]. / Rechtliche Einordnung von künstlicher Intelligenz in der Inneren Medizin : Von Datenschutz und Regulatorik, Erstattungs- und Haftungsfragen.

Artificial intelligence (AI) opens up new opportunities to improve medical care in internal medicine; however, legal uncertainties in the application of AI impede its integration into the daily practice of internal medicine. To clarify the situation this paper gives an overview of the legal aspects related to AI and shows which frameworks must be adhered to in order to exploit the benefits of AI without neglecting the rights and protection of patients. The paper first addresses data protection issues which arise when sensitive health data are processed by AI. This is followed by a discussion of the key regulatory requirements for the use of AI in internal medicine. As the establishment of AI in practice also depends on sufficient funding, legal issues of reimbursement are additionally examined. Finally, the specific features that need to be considered when using AI to avoid medical liability consequences are highlighted.

The regulatory environment for artificial intelligence-enabled devices in the United States.

The regulatory environment in the United States has not kept pace with the rapidly developing market for artificial intelligence (AI)-enabled devices. The number of AI-enabled devices has increased year after year. All of these devices are registered or cleared by the US Food and Drug Administration through exempt or 510(k) premarket notification pathways, and the majority are related to the radiology or cardiovascular spaces. US Food and Drug Administration guidance has not yet addressed the unique challenges of AI-enabled devices, including development, comprehensibility, and continuously learning models. The liability aspects of AI-enabled devices deployed into use by clinicians in practice have yet to be addressed. Future guidance from government regulatory sources will be necessary as the field moves forward.

Does patient behaviour drive physicians to practice defensive medicine? Evidence from a video experiment.

OBJECTIVE: By manipulating patients' critical attitude in a video experiment, we examined whether physicians are more intended to perform defensive acts because of a higher perceived liability risk in Belgium. METHODS: We assigned 85 practicing gynaecologists/obstetricians and orthopaedists randomly to four hypothetical video consultations, in which the patients show either a critical attitude (i.e., getting ahead of the facts, showing distrust) or a non-critical attitude (i.e., displaying more neutral questions and expressions). We asked the physicians about the care they would administer in the presented cases and the expected likelihood that the patient would sue the physician in case of a medical incident. RESULTS: By manipulating patients' verbal critical attitude (which indicates patients' intention to take further steps), while keeping constant physician's communication, patients' clinical situation, preferences, and non-verbal behaviour in the videos, we were able to discover differential treatment styles driven by physicians' perceived liability risk among patients with a different critical attitude. We found that physicians perform 17 percentage points more defensive acts (e.g., surgeries and diagnostic tests that are not medically necessary) when experiencing a high liability risk. CONCLUSIONS: Our results show that patients' critical attitude drives physicians' perceived liability risk and consequent defensive behaviour among obstetricians/gynaecologists and orthopaedists.

Malpratice claims in cardiology and cardiac surgery: A medico-legal issue.

Medical liability has become a challenge in every physician's modern practice with the consequent loss of the physician's autonomy and an increase in "defensive medicine". From this perspective, the role of Legal Medicine in assessing medical liability has become increasingly specific and a homogenization of the methods of ascertainment is increasingly necessary, since such a process can contribute to strengthening the guarantees in professional liability procedures. Focusing on malpractice claims in the field of cardiology, the complexity of the management of cardiac pathologies and the frequency of severe adverse events implies the importance of a multi-disciplinary approach, together with the application of a shared ascertainment methodology. In particular, it is essential for the forensic pathologist to collaborate with experts in cardio-pathology, cardiology and/or cardiac surgery in cases of alleged medical liability in the cardiologic field and to follow the guidelines which have been produced to assist the expert dealing with deaths reflecting cardiac disease, in order to prevent criticism of case analysis in medico-legal environments and to promote the standardization of the structure of the juridical-legislative medical malpractice lawsuits.

Serious complications related to regional anaesthesia: Study of Greek Courts' Decisions.

BACKGROUND: Regional anaesthesia and analgesia present many advantages. Related complications are few and have been fully described. Information on regional anaesthesia malpractice is lacking in Greece. The objectives of the analysis were to highlight areas of high litigation risk and report the financial impact of claims. METHODS: Published judicial decisions of criminal, civil, administrative and disciplinary content, from 1995 to 2020, were searched in the legal information banks. The court decisions were analysed by an expert in collaboration with the lawyers of the investigation. RESULTS: A total of 26 court decisions related to complications from regional anaesthesia were found involving 10 cases, which comprised: 8 convictions, 1 referral of the case for a new expert opinion and 1 acquittal. In 6 cases the medical negligence involved complications after epidural anaesthesia and in 2 after subarachnoid anaesthesia. In 1 case there was collective liability of the anaesthesiologist and the obstetrician for negligent homicide and in 7 cases liability of the anaesthesiologist for bodily injuries. The duration of the litigation was 5-16 years. CONCLUSIONS: Analysis of court cases made it possible to identify the causes that led to complications during regional anaesthesia. Informed consent, non-traumatic technique, careful patient selection, adherence to safety rules, and early diagnosis and treatment of complications are essential to avoid permanent injury.

A History of Medical Liability: From Ancient Times to Today.

Medical liability is a term associated with medical procedures and acts that has been a topic of controversy and research since ancient times all over the world. In ancient times, it was usually explained based on theocratic conceptions and was directly related to the social position of the patient to whom the physician applied medicine, while the capacity of the physician implied specific qualities. The present review of ancient history and geography provides a detailed description of the issues concerning medical responsibility through the years in ancient Greece, the birthplace of Asclepius and Hippocrates, the fathers of medical science, and the medical oath of conscientious performance of physician duties. Furthermore, it discusses the issue of medical liability globally from ancient times till more recently. Finally, medical liability and the interaction of its various aspects in Greece in recent years is presented according to Greek legislation to provide a good review for the reader to acknowledge the changes in medical liability through the centuries.

Medical Malpractice Among Orthopedic Surgeons in Greece: An Analysis of Court Decisions.

Introduction Medical malpractice occurs when a physician, through incorrect medical action or omission, causes the patient to suffer physical harm or loss of life. Orthopedics is a high-risk medical specialty. Orthopedic surgery encompasses a wide range of procedures, including joint replacements, fracture repairs, and spinal surgeries. While orthopedic surgeons strive to provide optimal care to their patients, medical liability claims are a reality they must face. The aim of this study is to analyze the epidemiological data of judicial decisions and cases in Greece for the Specialty of Orthopedics. Material and methods Published court decisions involving medical liabilities of orthopedic surgeons and anesthesiologists, or only orthopedic surgeons were searched, in the period between 1985 and 2021. The judicial decisions were analyzed by an experienced anesthesiologist and an orthopedic surgeon based on medical knowledge and experience. Patients' age, gender, date of operation and the causes that led to the doctors' persecution were also recorded. Results Seventy court decisions of the first, second, and third degree were found. These decisions related to 34 cases: seven convictions for manslaughter, 18 convictions for bodily harm, and nine acquittals - exempting compensation. They involved 11 men and 13 women. The claims mainly related to intraoperative and postoperative complications in 20 (83.3%) of the 24 cases. Complications in elective spinal and lower extremity surgeries represent 50% (n = 12) of cases, while postoperative complications account for 16.7% of cases (n = 4). Conclusions The present study concluded that an accumulation of experience in large orthopedic centers is needed to improve the performance of orthopedic surgeons during surgery and patient monitoring. Many legal cases are due to the mismatch between patient expectations and the limitations in medicine. Thorough preoperative control and better preoperative communication with the patient are needed, in order to improve the performance of orthopedic surgeons and prevent a significant part of the claims.

Professional liability due to complete esophagus section during thyroidectomy: a rare case report.

Background: Several diagnostic and therapeutic processes are regulated by guidelines and recommendations provided by International and National Societies which offer standardized indications for health-care practitioners, including the treatment of pathologies that may affect the thyroid gland. These documents are very important for patient health promotion and, also, for preventing adverse events associated with patient injuries and related malpractice litigations. Particularly, thyroid surgery can be a cause of professional liability due to complications from surgical errors. Even if the most frequent complications are hypocalcemia and recurrent laryngeal nerve injury, this surgical specialty can be also burdened by other rare and serious adverse events such as esophagus lesions. Case Description: Here a case of alleged medical malpractice involving a 22-year-old woman reporting a complete esophagus section during thyroidectomy was described. The case analysis highlighted that the surgical treatment was performed for an unconfirmed Graves-Basedow disease which was then assessed as Hashimoto thyroiditis by histological exam of the removed gland. The esophagus section was treated by termino-terminal pharyngo-jejunal anastomosis and termino-terminal jejuno-esophagus anastomosis. The medico-legal analysis of the case revealed two different profiles of medical malpractice related, respectively, to the misdiagnosis of the pathology due to an inappropriate diagnostic-therapeutic procedure and the production of the complete section of the esophagus, representing an extremely rare complication of thyroidectomy. Conclusions: Clinicians should ensure an adequate diagnostic-therapeutic path based on guidelines, operational procedures, and evidence-based publications. The non-observance of the "required rules" for diagnosis and treatment of thyroid disease can be associated with a very rare and severe complication that strongly compromises the patient quality of life.

Street Medicine: Barrier Considerations for Healthcare Providers in the U.S.

In the last decade, a movement known as "street medicine" has emerged. It is a relatively new medical field in which healthcare providers deliver medical care to homeless populations outside of traditional healthcare facilities, on the streets, and in various settings where unsheltered people live. Physicians essentially visit people living in camps, along riverbanks, in alleys, and abandoned buildings to provide medical care. During the pandemic, street medicine in the U.S. was often the first line of defense for people living on the streets. As the practice of street medicine continues to grow and expand across the country, there is an increasing demand to standardize patient care delivered outside traditional healthcare facilities.

Analysis of Medico-Legal Complaint Data: A Retrospective Study of Three Large Italian University Hospitals.

(1) Background: Identifying hospital-related critical, and excellent, areas represents the main goal of this paper, in both a national and local setting. Information was collected and organized for an internal company's reports, regarding civil litigation that has been affecting the hospital, to relate the obtained results with the phenomenon of medical malpractice on a national scale. This is for the development of targeted improvement strategies, and for investing available resources in a proficient way. (2) Methods: In the present study, data from claims management in Umberto I General Hospital, Agostino Gemelli University Hospital Foundation and Campus Bio-Medico University Hospital Foundation, from 2013 to 2020 were collected. A total of 2098 files were examined, and a set of 13 outcome indicators in the assessment of "quality of care" was proposed. (3) Results: From the total number, only 779 records (37.1%) were attributable to the categories indexable for the present analysis. This data highlights how, following a correct and rigorous categorization of hospital events, it is possible to analyze these medico-legal aspects using a small number of indicators. Furthermore, it is important to consider how a consistent percentage of remaining events was difficult to index, and was also of poor scientific interest. (4) Conclusions: The proposed indicators do not require standards to be compared to, but provide a useful instrument for comparative purposes. In fact, in addition to comparative assessment between different business realities distributed throughout the territory, the use of outcome indicators allows for a longitudinal analysis evaluating the performance of an individual structure over time.

Neonatal serial creatinine levels as an adjunct biomarker in timing of fetal neurologic injury.

Objective: To investigate the rise and clearance of newborn creatinine in perinatal asphyxia as an adjunct biomarker to support or refute allegations of acute intrapartum asphyxia. Study design: In this retrospective chart review, newborns > 35 weeks gestational age were evaluated from closed medicolegal cases of confirmed perinatal asphyxia and reviewed for causation. Data collected included newborn demographic data, patterns of hypoxic ischemic encephalopathy, brain magnetic resonance imaging, Apgar scores, cord and initial newborn blood gases, and serial newborn creatinine levels during the first 96 h of life. Newborn serum creatinine values were collected at 0-12, 13-24, 25-48, and 49-96 h. Newborn brain magnetic resonance imaging was used to define 3 patterns of asphyxial injury: acute profound, partial prolonged, or Both. Results: Two hundred and eleven cases of neonatal encephalopathy from multiple institutions were reviewed from 1987 to 2019 with only 76 cases having serial creatinine values during the first 96 h of life. A total of 187 creatinine values were collected. Partial prolonged and Both had significantly greater degree of metabolic acidosis in the first newborn arterial blood gas in comparison to acute profound. Acute profound and Both had significantly lower 5- and 10- minute Apgar scores in comparison to partial prolonged. Newborn creatinine values were stratified by asphyxial injury. Acute profound injury showed minimally elevated creatinine trends with rapid normalization. Partial prolonged and Both demonstrated higher creatinine trends with delayed normalization. Mean creatinine values were significantly different between the three types of asphyxial injuries within 13-24 h of life at the time when creatinine values peaked (p = 0.01). Conclusion: Serial newborn serum creatinine levels taken within the first 96 h of life can provide objective data of timing and duration of perinatal asphyxia.

A Fifteen-Year Survey for Orthopedic Malpractice Claims in the Criminal Court of Rome.

The number of legal disputes in the field of medical liability has increased exponentially in the last decades. The aim of this study is to investigate the outcomes of criminal cases against healthcare professionals in Italian criminal courts. The hypothesis is that the majority of cases are dismissed and/or most professionals in these cases are acquitted. This retrospective analysis considers criminal proceedings related to medical professional liability registered with the general register of crime reports of the Public Prosecutor's Office of Rome in the time interval between 1 January 2000 and 31 December 2015. A total of 4793 criminal proceedings were ultimately identified. Proceedings related to the field of orthopedic trauma were then examined and identified. A complete analysis of 132 of the identified files (76.7%) was carried out. The field with the highest risk of disputes was determined to be the field of trauma. The most frequent complaint was found to arise from unsatisfactory surgical outcomes following elective surgery. The most affected anatomical district is the lower limb in both elective and trauma cases, followed by the upper limb in traumatology and spine cases. The surgeon is the most frequently quoted role of the professional involved. The number of physicians actually convicted (3.93%) and for whom liability was thus recognized, i.e., the existence of a causal link between their conduct and the event that took place was established, appears to be extremely small when compared with the far more significant values related to dismissals (53%) and acquittals (14.2%). Adequate legal reform aiming to reduce this disproportion is necessary to ensure physicians experience a more relaxed daily profession and to restore the original connotations of the doctor-patient relationship with the abolition of defensive medicine.

Infection Induced Fetal Inflammatory Response Syndrome (FIRS): State-of- the-Art and Medico-Legal Implications-A Narrative Review.

Fetal inflammatory response syndrome (FIRS) represents the fetal inflammatory reaction to intrauterine infection or injury, potentially leading to multiorgan impairment, neonatal mortality, and morbidity. Infections induce FIRS after chorioamnionitis (CA), defined as acute maternal inflammatory response to amniotic fluid infection, acute funisitis and chorionic vasculitis. FIRS involves many molecules, i.e., cytokines and/or chemokines, able to directly or indirectly damage fetal organs. Therefore, due to FIRS being a condition with a complex etiopathogenesis and multiple organ dysfunction, especially brain injury, medical liability is frequently claimed. In medical malpractice, reconstruction of the pathological pathways is paramount. However, in cases of FIRS, ideal medical conduct is hard to delineate, due to uncertainty in diagnosis, treatment, and prognosis of this highly complex condition. This narrative review revises the current knowledge of FIRS caused by infections, maternal and neonatal diagnosis and treatments, the main consequences of the disease and their prognoses, and discusses the medico-legal implications.

COVID-19 Risk Management: a Survey among Italian physicians.

Abstract: The COVID-19 pandemic had a significant global impact on public health. The increasing demand for intensive care and the closure of several health facilities has led to a reduction in the assistance of non-COVID patients. In our study, we investigated what changes health professionals have experienced in their professional activities and how they coped with them. A questionnaire was sent to 146 doctors, focused on three subjects: type of activity carried out during the pandemic; use of personal protective equipment (PPE) and recourse to vaccination; current medical liability profiles related to COVID-19. The questionnaire was completed by 111 doctors. The study showed no significant differences in the questionnaire response as regards the demographic and work variables of the participants (gender, age, area of specialties). Most of doctors assisted potentially positive patients, which also imposed derogations on their safety. Most of the complaints were about the low adequacy of PPE provision and about the compromission of specialist medical care. The interest in safety among participants was revealed by the high compliance to vaccination, with almost complete coverage. The questionnaires showed that most doctors (72,7%) believe that specialist medical care has been impaired during the COVID-19 pandemic. Secondly, a high percentage of participants (79.8%) expressed the need for both civil and criminal limitation of liability in connection with work in the management of SARS-Cov-2 patients. In conclusion, this survey tried to contribute to the identification of the main problems presented by healthcare professionals. Their versatility was a crucial element for the management of the pandemic, but also highlighted the need for health institutions to prepare pandemic plans in the future, with adequate and constant updating. Concerns were raised regarding financial deficits and legal protection. Political decisions must be entrusted to enhance medical assistance and to avoid the increasing phenomenon of defensive medicine.