Aspectos médico-legais do olho / Medicolegal aspects of the eye

RESUMO A oftalmologia fornece um campo vasto de conhecimentos necessários à medicina legal e às perícias médicas. O presente artigo objetivou revisar as informações na perícia criminal e cível, as repercussões da morte e os achados post-mortem que o exame ocular pode fornecer. Demonstrou-se que a perícia ocular é complexa e multifacetada, fornecendo ferramentas importantes para a classificação das lesões corporais, verificação da capacidade laboral, investigação da causa mortis e estimativa do tempo de morte.

ABSTRACT Ophthalmology provides a vast field of knowledge necessary for forensic medicine and medical expertise. The present article aimed to review the information on criminal and civil medical expertise, the repercussions of death, and the postmortem findings that the eye examination can provide. Ocular expertise has been shown to be complex and multifaceted, providing important tools to classify bodily injuries, verify work capacity, investigate the cause of death, and estimate the time of death.

Establishing the shadowline: the border between legally acceptable and unacceptable standards of surgical practice.

INTRODUCTION: Our study investigated how the standard of surgical care is assessed within the English and Welsh litigation process. The 'shadowline' represents the dividing line between acceptable and unacceptable standards of care. Our hypothesis was that different assessors risk adopting materially different interpretations regarding the acceptable standard of care. Any variation in the interpretation of where the shadowline falls will create uncertainty and unfairness to surgeons and patients alike. METHODS: We summarised the legal literature and suggested the factors affecting the assessment of surgical standards. We illustrated our findings on distribution curves. RESULTS: There was a risk that the shape of the curve and the location of the shadowline may vary according to the assessor. Importantly, a gap may have developed between the legal and clinical shadowlines in respect of the consenting process. DISCUSSION AND CONCLUSION: We suggested how a gap between the surgical and legal shadow lines could be narrowed. Clinical governance, balanced literature and realistic expert assessments were all part of the solution.

Navigating the Regulatory Landscape to Develop Pediatric Oncology Drugs: Expert Opinion Recommendations.

Regulatory changes have been enacted in the United States (US) and European Union (EU) to encourage the development of new treatments for pediatric cancer. Here, we review some of the factors that have hampered the development of pediatric cancer treatments and provide a comparison of the US and EU regulations implemented to address this clinical need. We then provide some recommendations for each stage of the oncology drug development pathway to help researchers maximize their chance of successful drug development while complying with regulations. A key recommendation is the engagement of key stakeholders such as regulatory authorities, pediatric oncologists, academic researchers, patient advocacy groups, and a Pediatric Expert Group early in the drug development process. During drug target selection, sponsors are encouraged to consult the Food and Drug Administration (FDA), European Medicines Agency (EMA), and the FDA target list, in addition to relevant US and European consortia that have been established to characterize and prioritize oncology drug targets. Sponsors also need to carefully consider the resourcing requirements for preclinical testing, which include ensuring appropriate access to the most relevant databases, clinical samples, and preclinical models (cell lines and animal models). During clinical development, sponsors can account for the pharmacodynamic (PD)/pharmacokinetic (PK) considerations specific to a pediatric population by developing pediatric formulations, selecting suitable PD endpoints, and employing sparse PK sampling or modeling/simulation of drug exposures where appropriate. Additional clinical considerations include the specific design of the clinical trial, the potential inclusion of children in adult trials, and the value of cooperative group trials.

In the last few decades, great progress has been made in developing new treatments for adult cancers. However, development of new treatments for childhood cancers has been much slower. To encourage drug companies (sponsors) to develop effective treatments for childhood cancer, authorities in the United States (US) and Europe have made new rules for drug development. Under these new rules, sponsors developing drugs for specific cancers in adults have to consider whether the target of that drug also causes cancers in children. If this is the case, sponsors have to carry out clinical studies of their drug in children who have cancer that is caused by the same drug target. In this article, we describe some reasons for why drug development for childhood cancers has been slow and the rules created to address this problem in the US and Europe. We share some recommendations to help sponsors maximize their chances of developing an effective drug in children while satisfying the new rules. Specifically, sponsors need to be aware of the differences between studying drugs in adults versus children and how these influence the way the drug is tested. We make several recommendations for each stage of the development process, beginning with what is needed even before human studies begin. Finally, we highlight some issues that sponsors need to think about during drug development, from the preclinical stage (testing drugs in cells and animals) through to clinical testing in adults and pediatric patients with cancer.

Analysis of forensic medical opinions issued in criminal cases of alleged medical error in obstetrics at the Department of Forensic Medicine, Jagiellonian University Medical College, in 2010-2016.

AIM OF THE STUDY: Analysis of forensic medical opinions in the field of obstetrics prepared at the Department of Forensic Medicine, Jagiellonian University Medical College in Krakow, in 2010-2016, in order to evaluate changes in the number of filed cases involving an alleged medical error over the years, and determine the most common situations where medical errors are suspected by patients, and the most prevalent types of medical errors in obstetrics. MATERIAL AND METHODS: The opinions were divided into two groups. In the first group, the medical management was appropriate, while in the second group medical errors were identified. The medical errors were categorised as diagnostic/therapeutic, technical, and organisational. The effects of medical errors were classified as death, impairment to health, exposure to death, and exposure to impairment to health, by considering them separately for post-natal women, and for foetuses and neonates (during the first days of life). RESULTS: A total of 73 forensic medical opinions were analysed. In 25 cases, a medical error was identified. The most common situations in which a medical error was committed, and in which the suspicion of medical error proved to be unfounded, were listed. Overall, there were 17 diagnostic/therapeutic errors, 7 organisational errors, and 4 technical errors. In cases where a medical error was identified, there were 15 deaths, and in cases without a medical error - 31 deaths. CONCLUSIONS: It was found that 66% of the analysed forensic medical opinions involved no medical errors. In most of these cases, a therapeutic failure occurred, including perinatal haemorrhage, tight wrapping of the umbilical cord around the foetal neck (nuchal cord), premature birth, and septic complications. A few cases involved uncooperative patients. The most prevalent medical error was failure to perform or delaying a caesarean section when it was needed (because of emergency or urgent indications). The second most common medical error was related to incorrect CTG interpretation.

Mycobacterium Chimaera: Clinical and medico-legal considerations starting from a case of sudden acoustic damage.

Mycobacterium Chimaera is a microorganism that can cause nosocomial infections particularly in patients undergoing cardiac surgery. The specific case presented herein shows an original clinical presentation of the infection: sudden unilateral deafness as a result of septic embolization. Medico-legal experts appointed by the court in a civil liability dispute analyzed the case and submitted their expert opinion. This article analyzes the peculiar and innovative aspect of professional liability that can be attributed to the healthcare facility and the manufacturer of the equipment used in the operating room from a medical-legal point of view.

A balanced opinion? Considering the role of the external clinical advisor in ACC processes.

The role of the external clinical advisor is critical to the adjudication of complex claims in the processes of the Accident Compensation Corporation (ACC). This is particularly true of claims for treatment injury that occur during birth, which are often very complicated. In most cases external clinical advisors are non-treating doctors, whose opinion strongly guides the hand of ACC. This viewpoint considers the impact of the role of the external clinical advisor by using extracts from an external clinical advisor's report to show how a power imbalance can be enacted in ACC decision making processes. Also considered are the way that the normal checks and balances in the system, particularly those provided by the Health & Disability Commissioner, are bypassed in most cases. Finally, a recommendation is made to potential external clinical advisors to precisely following the standards set by the Medical Council in all cases when writing reports for ACC.

El valor del informe pericial caligráfico emitido por un laboratorio acreditado / The value of the caligraphic expert report issued by an accredited laboratory

La mejora constante en el desarrollo y funcionamiento de los laboratorios es una máxima que deben tener todos presentes. En este sentido, al menos en la última década, los laboratorios forenses van implementando en su sistema de gestión las innovaciones que incorpora cualquier otro tipo de empresas u organizaciones como serían los aspectos relativos al personal, a través de normas sobre seguridad e higiene en el trabajo, cuestiones medioambientales dada la preocupación creciente en la sociedad sobre el deterioro medioambiental que se está acrecentando de forma alarmante y que se manifiesta de diversa constante dentro de lo que conocemos como "cambio climático", y por último, la implementación de un sistema de gestión de la calidad, con el fin de exteriorizar un imagen altamente positiva y obtener de esta forma ventajas competitivas sobre otro tipo de empresas que operan en el mismo ramo o sector. Este último aspecto resulta especialmente significativo para los ensayos que, sobre distintas ramas científicas, son realizados por los laboratorios forenses, ya que contribuye a fortalecer todo el proceso secuencial analítico seguido y consecuentemente las conclusiones alcanzadas en los análisis realizados...(AU)

Medicolegal structure, consequences, and recommendations for daily practice: The example of surgical infection.

Surgical infections are the leading cause of complications and have major economic consequences and medico-legal fallout. In this article, the author revisits the foundations of medical law in France and reviews the mechanisms of medical liability, the place of recommendations in the definition of "secundum Artem", or the "state-of-the-art", and the necessity to provide high quality information. The author then proposes an approach to improve safety in daily practice.

Expert witness testimony step by step and how to prepare it.

The medical expert witness testimony is a key moment in the pathway of patient complaints as well as in the line of defense of the defendant-physician. For the defendant, it is a difficult time, often experienced as humiliating, because his or her competences are questioned, appraised and discussed in public. However, the defendant must perceive and use this encounter as an opportunity to express his/her viewpoint on the medical accident. This article provides the principal juridical rules that govern the medical expert witness testimony that must be known, as well as some practical advice on how the medical expert witness testimony evolves and how to protect oneself from the complaints, In order to enable the defendant to best prepare for this confrontation between the involved parties.

Medical expert witness testimony in France and in Europe.

Health care professionals are usually at a loss when it comes to medical "complaints", essentially because they lack knowledge with regard to existing litigation procedures. After a short reminder of the different rights of appeal in France, we describe how medical appeals function in other European countries. Next, we give the details of how the evaluation of claims of bodily damage works, a process in which every physician may be called upon to participate several times in a career, either as the defendant, or as a medical counselor, or as an expert. The goal of this update is to understand the different compensation appeal circuits available to patients and help the surgeon demystify and dedramatize the situation while preparing for the medical expert witness testimony. All such testimony reports, via whatever appeal circuit, follow a similar procedure, even if they are not exactly identical.

Fear of imminent death - use of evidence in forensic-psychiatric expertise. / Obawa rychlej smierci ­ wykorzystanie materialu dowodowego w ekspertyzie sadowo-psychiatrycznej.

In accordance with the Polish civil law, there are at least several ways to dispose of property in the event of death. One of them is a special form of oral testament. The main issue to be determined by the court is to either confirm or deny the existence of fear of imminent death of the testator at the time of bequest. For this purpose, the court uses expert psychiatrists' opinions. The article presents a case of a man in the terminal phase of a malignant disease who used an oral form of bequest. Such cases are relatively rare and therefore the described case is intended to illustrate the complex nature of the expertise. It points to the need for the experts to take into account complex legal regulations, the observance of which stipulates the possibility of using this form of will. Factual assessment of the witnesses' testimony complicates elaboration of the material, as the testimony is generally contradictory. It was proposed that the witnesses' testimony should be sorted out in terms of substance (psychopathology), based on the analysis of the separated research areas. Medical records can be treated not only as a source of information about the dynamics of somatic diseases of the testator and secondary changes in his/her mental state. It can also be a valuable source of knowledge about the testator's attitude to health and disease issues, treatment processes, prognosis, threat to his/her life and death.

A Comparison of Defense and Plaintiff Expert Witnesses in Orthopaedic Surgery Malpractice Litigation.

BACKGROUND: According to the American Academy of Orthopaedic Surgeons (AAOS) Standards of Professionalism, the responsible testimony of expert witnesses in orthopaedic surgery malpractice lawsuits is important to the public interest. However, these expert witnesses are recruited and compensated without established standards, and their testimony can potentially sway court opinion, with substantial consequences. The objective of this study was to characterize defense and plaintiff expert orthopaedic surgeon witnesses in orthopaedic surgery malpractice litigation. METHODS: Utilizing the WestlawNext legal database, defense and plaintiff expert witnesses involved in orthopaedic surgery malpractice lawsuits from 2013 to 2017 were identified. Each witness's subspecialty, mean years of experience, involvement in academic or private practice, fellowship training, and scholarly impact, as measured by the Hirsch index (h-index), were determined through a query of professional profiles, the Scopus database, and a PubMed search. Statistical comparisons were made for each parameter among defense and plaintiff expert witnesses. RESULTS: Between 2013 and 2017, 306 expert medical witnesses for orthopaedic cases were identified; 174 (56.9%) testified on behalf of the plaintiff, and 132 (43.1%) testified on behalf of the defense. Orthopaedic surgeons who identified themselves as general orthopaedists comprised the largest share of expert witnesses on both the plaintiff (n = 61) and defense (n = 25) sides. The plaintiff witnesses averaged 36 years of experience versus 31 years for the defense witnesses (p < 0.001); 26% of the plaintiff witnesses held an academic position versus 43% of the defense witnesses (p = 0.013). Defense witnesses exhibited a higher proportion of fellowship training in comparison to plaintiff expert witnesses (80.5% versus 64.5%, respectively, p = 0.003). The h-index for the plaintiff group was 6.6 versus 9.1 for the defense group (p = 0.04). Two witnesses testified for both the plaintiff and defense sides. CONCLUSIONS: Defense expert witnesses held higher rates of academic appointments and exhibited greater scholarly impact than their plaintiff counterparts, with both sides averaging >30 years of experience. These data collectively show that there are differences in characteristics between plaintiff and defense witnesses. Additional study is needed to illuminate the etiology of these differences.

[Analysis of final judgements in cases of medical negligence occurred in Ukraine].

OBJECTIVE: Introduction: The peculiarities of the disadvantages of providing medical care in Ukraine are not well-known abroad. The aim: To study the peculiarities of court decisions in cases of unfavorable consequences of medical activity. PATIENTS AND METHODS: Materials and methods: The article analyzes the official data of the General Prosecutor's Office of Ukraine and the website of court decisions regarding criminal cases against medical practitioners. RESULTS: Review: Approximately 600 cases of alleged medical malpractice cases are registered annually in Ukraine. Only less than one percent of them are brought to the court. The guilt of medical practitioners was proven in majority (80,8%) of court decisions. Acquittals of defendants were pronounced in 5,9% of court verdicts. Obstetrics and gynecology, surgery, internal medicine and anesthesiology are in the top of high-risk medical specialties. CONCLUSION: Conclusions: Majority of medical malpractice litigations are sued in Ukraine baselessly. In cases of medical negligence majority of defendants are acquitted as usual.

[Medicolegal Assessment for Chronic Musculoskeletal Pain - 4th Update of the German Guideline for Medicolegal Assessment of Persons in Chronic Pain]. / Begutachtung chronischer muskuloskeletaler Schmerzen.

Medicolegal assessments of claimants with chronic muskuloskeletal pain conditions are frequent. The first German guideline published in 2005 for the medicolegal assessment of claimants in chronic pain is now available in its 4th version (AWMF register number 094 - 003). It gives recommendations for the procedure and serves to ensure the quality of expert opinions when complaints about chronic pain are the leading symptom. In the current version, the indications for ordering medical assessments in pain syndromes have been reformulated, the assessment criteria have been adapted to ICF specifications, and an unequivocal distinction has been introduced between questions of state and causal assessment. A separate chapter on symptom validity assessment has been engrafted.

[Handling of retrieved implants in orthopedic surgery : Results of a survey within the framework of the EndoCert initiative]. / Bestandsaufnahme zum Umgang mit ausgebauten Implantaten in der orthopädischen Chirurgie : Ergebnisse einer Umfrage im Rahmen der EndoCert-Initiative.

BACKGROUND: Although investigations of retrieved medical implants can provide valuable information about the cause of the revision, there is a lack of information, which could be avoided by consequent failure analyses. In the framework of the EndoCert certification system it is obligatory to record and report incidents. OBJECTIVES: The present work examines how the willingness to report has developed in certified arthroplasty centers and which method of handling retrievals is preferred and actually used. MATERIALS AND METHODS: On the basis of a questionnaire for handling retrievals, all 508 arthroplasty centers that were certified till June 1, 2016, were included (return rate = 97.2%). RESULTS: A total of 93.3% of the centers have established an algorithm for handling of retrievals and 83.0% of the centers prefer to hand out the retrieval to the patient, while only 25.7% wish to store it in the center for research purposes. In the case of a potential incident as the cause of revision, centers prefer to forward the retrieval to damage analysis, whereby the centers act in different ways, depending on the case. An implant fracture is, e.g., considered a reportable event in most cases without temporal limitation. On the other hand, breakage or failure of surgical instruments is considered not to be reported in the case of more than half of the centers. In 2014 and 2015, approximately 71% of EPZs reported no incidents. CONCLUSIONS: According to our survey, many certified arthroplasty centers are sensitized to careful handling of retrievals. The treatment of the explanted components is conducted in different ways. The assessment of whether an incident is to be reported shows large differences. In view of the relatively high number of revision surgeries, the number of reports to the authorities appears to be low.