Civil liability of orthodontists and aligner manufacturers in the treatment with orthodontic aligners

ABSTRACT Introduction: The use of clear aligners as an alternative to fixed orthodontic appliances has become popular due to the aesthetic demands of adult patients seeking orthodontic treatment. However, orthodontists' lack of knowledge about the legal consequences of their activities, and the lack of solid scientific evidence raise concerns regarding civil liability in this type of treatment. Marketing campaigns of manufacturing companies often exaggerate promises of results, and ignore the lack of scientific evidence. Patients, as consumers, are protected by the Consumer Protection Code, whereas orthodontists are considered treatment providers. Therefore, they can be held liable for damage caused to patients, whether by subjective or objective fault. Objective: This article aims to identify the civil responsibilities of orthodontists and aligner manufacturing companies, by means of a literature review, providing basic legal guidance to help professionals protect themselves from possible lawsuits related to treatment with orthodontic aligners. Conclusions: The study highlights the importance of knowledge of legal notions in treatments with orthodontic aligners by orthodontists, who should legally safeguard themselves through individual written contracts, avoiding obligation of results. In addition, in cases of legal claims, it is possible that the manufacturing companies are jointly and severally liable for possible damages claimed by the patient.

RESUMO Introdução: O uso de alinhadores transparentes como alternativa aos aparelhos ortodônticos fixos tem se tornado popular, devido às demandas estéticas dos pacientes adultos em busca de tratamento ortodôntico. No entanto, a falta de conhecimento dos ortodontistas sobre as consequências jurídicas de suas atividades, e a falta de evidências científicas sólidas levantam preocupações em relação à responsabilidade civil nesse tipo de tratamento. Muitas vezes, as campanhas de marketing das empresas fabricantes exageram nas promessas de resultados e desconsideram a falta de evidências científicas. O paciente, como consumidor, é protegido pelo Código de Defesa do Consumidor, e o ortodontista é considerado um fornecedor de tratamento. Portanto, ele pode ser responsabilizado por danos causados ao paciente, seja por culpa subjetiva ou objetiva. Objetivo: Identificar, por meio de uma revisão bibliográfica, as responsabilidades civis dos ortodontistas e das empresas fabricantes de alinhadores, fornecendo orientações jurídicas básicas para ajudar os profissionais a se protegerem de possíveis demandas judiciais relacionadas ao tratamento com alinhadores ortodônticos. Conclusões: O estudo destaca a importância do conhecimento de noções jurídicas em tratamentos com alinhadores ortodônticos, devendo o profissional resguardar-se juridicamente por meio de contratos individuais por escrito, prevenindo-se de assumir uma obrigação de resultado com o paciente. Além disso, em casos de demandas judiciais, é possível que as empresas fabricantes respondam solidariamente a possíveis danos reclamados pelo paciente.

Análise dos processos de responsabilidade civil envolvendo o cirurgião-dentista no estado do Piauí, Brasil / Analysis of the lawsuits involving professional liability in Dentistry, in Piauí state, Brazil

O objetivo deste trabalho foi levantar e analisar os processos de responsabilidade civil envolvendo cirurgiões-dentistas do estado do Piauí, entre os anos de 2015 a 2019, a fim de verificar o número de processos instaurados e suas características. Foram encontrados (n=11) processos referentes a pessoas físicas, sendo a especialidade mais incidente a Implantodontia. Em 63% dos dados, os requeridos não possuíam especialidade registrada no Conselho Federal de Odontologia na área envolvida no litígio. Os valores indenizatórios solicitados variaram de R$ 15.000,00 a R$ 101.985,00. Não houve acionamento de seguro de responsabilidade civil nos processos encontrados. A maioria dos processos foi instaurada nos últimos dois anos da realização da pesquisa e encontravam-se em trâmite, não permitindo a obtenção das sentenças. Conclui-se que houve um aumento do número de processos instaurados no último ano verificado, acompanhando uma realidade crescente e observada em todo o país

The objective of this study was to analyze the civil liability lawsuits against dentists in the Piauí State, Brazil, from 2015 to 2019, to verify whether there was a significant increase in their number in recent years, and to investigate their main features. Eleven lawsuits were found, and the most incident dental specialty was Implantology. In 63% of the lawsuits, the dentists had not registered their specialist title on the Brazilian Federal Council of Dentistry, in the area involved in the litigation. Restitution amounts ranged from R$ 15,000.00 to R$ 101,985.00. There was no triggering of civil liability insurances in any of the processes found. Most of the lawsuits initiated in the last two years and are still in progress, thus their judicial sentences were not obtainable. We concluded that there was an increase in the number of cases in the last year analyzed, in agreement with the reality observed throughout the country.

[Problems of bringing to civil and criminal liability for improper provision of medical services].

The purpose of this work is to consider the problems arising from the improper provision of medical services and bringing to civil and criminal liability for these actions of medical organizations and medical workers. The author investigates the issues of bringing to responsibility for violations related to improper provision of medical care in medical organizations of the healthcare system of the Russian Federation. Russian legislation enshrines the right of a patient to complain about the improper provision of medical services, both when applying to a state medical organization and when receiving medical care in private structures of the healthcare system. The problem of bringing to civil and criminal liability for improper provision of medical care in Russian healthcare has been standing for quite a long time, nevertheless, today it is coming to the fore, despite attempts to improve the legislative regulation of this issue. In conclusion, authors conclude that in order to achieve high-quality medical services, it is necessary not only to comply with the requirements for the contractor, provided by licensing of medical activities and accreditation of medical specialists, but also to establish requirements for the activities of medical workers themselves. Thus, the provision of medical services should be considered improper if they are provided in violation of the requirements imposed on the subject and are provided in an improper way, i.e. in violation of the requirements that must be met by medical workers.

Study of court decisions on dental errors in the state of Rio Grande do Sul, Brazil.

The professional relationship between dentists and patients is considered as a service provider-client. When the patient-client feels harmed due to dental error, he may seek economic reparation by lodging a lawsuit. The present research analyzed appellate court decisions on dental errors in the state of Rio Grande do Sul, Brazil, from 2003 to 2019. The results show an increase in judgments. The most cited specialties were surgery, orthodontics, implantology, prosthesis, endodontics, periodontics, and general practice. Most appellate court decisions upheld the sentences. A decrease in the number of outcomes pronouncing dentists and/or clinics guilty was observed over the period. Most of the lawsuits were lodged under the Free Legal Assistance program. The high percentage of court decisions citing inclusion of an expert report highlights the importance of expertise in providing judges with technical clarification. Moral injury recorded the highest pecuniary sums, followed by compensation for material damage and aesthetic damage.

COVID-19 off-label uses of medicines: the role of civil liability and regulation.

Physicians can prescribe medicines for different indications than the tested and authorised ones. Such 'off-label' uses expand therapeutic options but also create uncertainties. The COVID-19 pandemic triggered new off-label uses and, despite issues being reported in the literature, these have not resulted in substantial personal injury litigation in the EU. Against this backdrop, this article argues that civil liability plays, in fact, a limited role in off-label uses. In particular, civil liability may incentivise health actors to follow and react to the development of the evidence basis for off-label uses. However, it is ultimately unable to incentivise the conduct of additional research on off-label uses. This is problematic, as off-label research is key to protecting patients and is recommended by international medical ethics. The article concludes by critically discussing proposed mechanisms to incentivise off-label research. It argues that extending civil liability for unknown risks may have undesired effects on insurability and innovation, and most regulatory proposals seem ineffective. Building on the 2014 Italian reform of off-label uses, the article proposes the establishment of a fund financed by mandatory contributions from the industry, which should be used by pharmaceutical regulators to promote off-label research and develop guidelines for prescribers.

A responsabilização de empresas por acidentes de trabalho no judiciário trabalhista de São Paulo - TRT15 / The liability of companies for work accidents in the São Paulo labor judiciary - TRT15

Resumo A teoria do risco ou da responsabilidade objetiva dispensa a comprovação da culpa ou do dolo e tem como requisitos a ocorrência do dano e o nexo causal. Embora a constituição disponha a responsabilidade por acidente de trabalho como subjetiva, se tem observado na doutrina e no judiciário a adoção da responsabilidade objetiva em alguns casos de acidentes e doenças ocupacionais. Este estudo tem por objetivo analisar decisões do Tribunal Regional do Trabalho da 15ª Região - São Paulo para conhecer em que situações a corte tem utilizado a responsabilidade objetiva. A pesquisa quanti-qualitativa, de caráter exploratório e descritivo, foi desenvolvida com base em análise documental e revisão bibliográfica. A pesquisa documental foi realizada em acórdãos que continham o descritor "acidente de trabalho", disponíveis na base de dados do Tribunal Regional do Trabalho da 15ª Região, julgados no período entre 11/11/2015 e 10/11/2017. Os resultados indicaram que, do total de 559 casos julgados, em 275 a decisão foi de procedência, sendo 15% por responsabilidade objetiva. Considerando apenas os casos procedentes, a responsabilidade objetiva apareceu em 30,5% deles. Esse percentual revela que já é expressiva nessa corte a tomada de decisão com base na noção de responsabilidade objetiva, e que tal adoção tem potencial para afetar práticas de prevenção de acidentes.

Abstract The risk theory or objective liability dispenses proof of guilt or intent and requires only the occurrence of damage and the causal link. Although the constitution establishes the responsibility for work accidents as subjective, it has been observed in the doctrine and in the judiciary the adoption of objective liability in some cases of accidents and occupational diseases. This study aims to analyze the decisions of the Regional Labor Court of the 15th Region - São Paulo to know in which situations the court has used objective liability. The quantitative-qualitative, exploratory and descriptive research was developed based on document analysis and literature review. The document research was carried out in judgments that contained the descriptor "work accident," available in the database of the Regional Labor Court of the 15th Region, judged between 11/11/2015 and 10/11/2017. The results indicated that, of the total of 559 cases judged, in 275 the decision was founded, being 15% by objective liability. Considering only the founded cases, objective liability appeared in 30.5% of them. This percentage reveals that decision-making based on the notion of objective liability is already expressive in this court, and that such adoption has the potential to affect accident prevention practices.

The Standard of Care Test Revisited: Competing Approaches to Defining Competent Profession Practice in Australia.

This section examines the recent decision of the New South Wales Court of Appeal in Dean v Pope [2022] NSWCA 260. The decision settles a long-running dispute in New South Wales about the test for the standard of care under s 5O of the Civil Liability Act 2002 (NSW). That provision was introduced following the medical indemnity crisis of the early 2000s and provided for a modified Bolam test to protect professionals from claims in negligence when they had acted in accordance with a standard of "competent professional practice". In recent years there has been controversy regarding whether that section required the practice to be one already established to satisfy the section. This section examines the decision, how it fits into the history of the Ipp reforms and what it means for other jurisdictions in Australia.

[THE IMPACT OF THE COVID-19 PANDEMIC ON THE FORMATION OF THE ATTITUDE OF THE POPULATION OF THE RUSSIAN FEDERATION TO THE PREVENTION OF INFECTIOUS DISEASES].

The pandemic of new coronavirus infection continues affecting many areas of public life. Against the background of arising variations, occur changes in people's psychological condition and in belief systems and attitudes to many fields of human knowledge, including medicine. The purpose of the study is to evaluate potential effect of COVID-19 pandemic on developing civil liability of the population of the Russian Federation regarding anti-epidemic activities to fight infectious diseases. MATERIALS AND METHODS: The special anonymous on-line questionnaire was developed and placed on popular social platforms in open access. The questionnaire included two parts and contained 27 closed alternative questions with only one alternative to answer. The respondents included persons older than 18 years agreed to participate in survey. The data gathering provided for three subsequent stages. The final sampling consisted of 1350 respondents, out of them 1230 were citizen of the Russian Federation and 120 representatives of the near abroad. RESULTS AND DISCUSSION: More than 65% of respondents confirmed positive changes of one's attitude to sanitary hygienic activities to better sense. Among them, 63.3% began to wash hands more regularly and 62.2% began to apply hand antiseptic more often. The comparing of study results by individual characteristics revealed a significant effect of primary hygienic status of respondents on magnitude of fixed changes. It is established that during 5 months the population readiness to be vaccinated by one of the registered national vaccines was increasing and level of uncertainty was decreasing. Among respondents 73.5% marked increasing of individual responsibility of citizens for hygienic practices. CONCLUSION: The study demonstrated significant improvement of population attitude to sanitary hygienic practices after onset of pandemic. The greatest changes are observed in individuals with initially sufficient levels of hygienic commitment. On the basis of study results, the conclusion can be made about significant increasing of civil liability of the population of the Russian Federation for hygienic practices, especially against the background of COVID-19 pandemic.

Criminal Liability for Nursing and Medical Harm.

There is a ubiquitous problem with medical errors and the concomitant costs it brings in terms of human suffering and financial loss for patients, families, and caregivers. Professional caregivers, including physicians, nurses, and others who have made clinical errors normally will fall under the risk management and quality improvement policies of the organization at which they are employed and subsequent investigation and response occurs internally. Sometimes further consequences can entail the caregiver being named as a defendant or codefendant in a civil lawsuit, and sometimes the caregiver can have professional licensure restricted or even revoked. More rarely, a caregiver can be prosecuted in a criminal legal action. When criminal prosecution occurred, it was usually for purposeful wrongdoing such as fraud, diversion of drugs, or even the intentional or reckless killing of elderly or other vulnerable people. The recent criminal prosecution of a Tennessee nurse for the reckless series of mistakes that led to the death of a single patient opens new considerations for nurses, physicians, and all caregivers, along with hospitals and healthcare systems that employ and/or work with them. The "dynamic tension" of encouraging all caregivers to own up to mistakes with patients as quickly as possible in healthcare organizations seems to be especially challenged now by the Vaught decision. This was mitigated somewhat by a relatively lenient sentence ordered by the judge in this noteworthy case.

Negligence and Health Innovation: Issues with the Standard of Care and the Need to Revisit the Voluntary Assumption of Risk.

This section examines current debates about the test for standards of care in negligence under the Civil Liability Acts in Australia, and how those debates may impact adversely on innovations in health care. It examines the recent history of attempts to define and regulate health innovation and compares them to judicial determinations from New South Wales that have potential to limit the protections otherwise afforded to competent professional practice. The section argues that, if those protections are eroded, alternative options to protect and encourage innovation should be explored, most especially a resuscitated defence of the voluntary assumption of risk.

Is the Unequal Treatment of Maternal and Paternal Liability Under the Congenital Disabilities (Civil Liability) Act 1976 Justified?

Under the Congenital Disabilities (Civil Liability) Act 1976 (CDCLA) a child born disabled as a result of an occurrence prior to its birth can bring a claim against the individual responsible for that occurrence. Significantly, mothers are exempt from liability (except in relation to negligent driving) but fathers are not. Since the CDCLA came into force in 1976, there have been significant shifts in the landscape in which it operates: a more gender-neutral model of parenting; transmission of an infection to a sexual partner can be a criminal offence; and growing evidence regarding the impact of prenatal events. In addition, there is a trend for presenting prenatal harm as a problem of individual behaviour. This article presents a timely consideration of the potential for parental liability under the CDCLA and asks whether restricting the exemption of parental liability to mothers but not fathers can be justified. It is argued that the reasons for unequal parental liability in relation to gestational harm are not sufficient to justify restricting the broad exemption to mothers but not fathers and a change in the law is required to bring the CDCLA up to date with advances in the criminal law, society, and medical science.

In support of "no-fault" civil liability rules for artificial intelligence.

Civil liability is traditionally understood as indirect market regulation, since the risk of incurring liability for damages gives incentives to invest in safety. Such an approach, however, is inappropriate in the markets of artificial intelligence devices. In fact, according to the current paradigm of civil liability, compensation is allowed only to the extent that "someone" is identified as a debtor. However, in many cases it would not be useful to impose the obligation to pay such compensation to producers and programmers: the algorithms, in fact, can "behave" far independently from the instructions initially provided by programmers so that they can err despite no flaw in design or implementation. Therefore, application of "traditional" civil liability to AI may represent a disincentive to new technologies based on artificial intelligence. This is why I think artificial intelligence requires that the law evolves, on this matter, from an issue of civil liability into one of financial management of losses. No-fault redress schemes could be an interesting and worthy regulatory strategy in order to enable this evolution. Of course, such schemes should apply only in cases where there is no evidence that producers and programmers have acted under conditions of negligence, imprudence or unskillfulness and their activity is adequately compliant with scientifically validated standards.

Civil Liability of Regional Health Services: The Case of the Piedmont Region.

Civil liability represents one of the main responsibilities for healthcare facilities; it is the legal responsibility of paying money for damage to a person's health. Even though this responsibility plays a key role in the economic sustainability of healthcare facilities, the literature does not enough investigate this responsibility in regional health services. The paper aims to define the evolution of compensation models for health civil liability adopted by regional health services. Through a longitudinal case study, the paper investigates the compensation model by a leading regional health service. The finding highlights the evolution of the compensation model for health civil liability adopted by a leading Regional Health Service from 1990 to 2021. It describes a transition from an insurance model to a mixed model based on self-coverage up to a set economic level, an insurance policy with self-insurance retention and deductible for all claims. The research contributes to the literature and practice throughout the definition of a compensation model for damages based on self-insurance of regional health service and insurance policies. The research promotes a compensation model used by a leading regional health service.

The Role of Medical Evidence in Determining the Outcome of Medical Negligence Cases When Peer Professional Opinion Is Used.

Important changes in civil liability laws arose from the Review of the Law of Negligence in Australia undertaken in 2002 (the Ipp Report). One key recommendation of this review was the introduction of a modification of the Bolam Principle: "Medical Practitioners will not be found negligent if the treatment provided is in accordance with a significant body of opinion in the medical profession." This article examines the concept of practitioner competence in medical negligence cases. It also examines the diverse forms of medical evidence used and evaluates whether the changes in laws have altered the legal approach to the use of medical evidence in cases utilising peer professional opinion. This article argues that, despite the amendments in 2002, regulatory concepts of medical competence are little used by the courts. Peer professional opinion utilising medical evidence has played only a minor role in determining the outcome of medical negligence cases.

Consentimiento informado en las prestaciones de salud / Informed consent in health care services / Consentimento informado nas prestações de saúde

Resumen: Por regla general, las prestaciones de salud requieren el consentimiento informado del paciente. Los fundamentos éticos detrás de esta exigencia son la autonomía del paciente para decidir sobre su propio cuerpo y el respeto a su dignidad, que impide instrumentalizarlo. La manera en que el ordenamiento jurídico materializa estos fines es consagrando deberes de información y de consejo, y disciplinando las condiciones bajo las cuales debe prestarse el consentimiento. Jurídicamente, estos deberes delimitan la relación médico-paciente y ayudan a definir hipótesis de responsabilidad civil. En este artículo se revisan las condiciones para la satisfacción de estos deberes, así como los supuestos en que su infracción pueden dar lugar a responsabilidad civil.

Abstract: As a general rule, medical interventions require to be informingly consented by the patient. This requirement is ethically founded in the autonomy of the patient to decide on his own body and the respect for his dignity that prevent to instrumentalise it. The way in which the law materialises those ends is by implementing duties to inform and duties to advise, and regulating the conditions under which the consent must be given. Legally, those duties delimit the relation physician-patient and give guidance to define hypothesis of civil liability. In this article, we revise the conditions for the satisfaction of those duties and the cases in which their breach give rise to civil liability.

Resumo: Por regra general, as prestações de saúde requerem o consentimento informado do paciente. Os fundamentos éticos por trás dessa exigência são a autonomia do paciente para decidir sobre seu próprio corpo e o respeito à sua dignidade, que impede instrumentalizálo. A maneira em que o ordenamento jurídico materializa estes fins é consagrando deveres de informação e de aconselhamento, e disciplinando as condições sob as quais deve prestar-se o consentimento. Juridicamente, estes deveres delimitam a relação médico-paciente e ajudam a definir hipóteses de responsabilidade civil. Neste artigo se revisam as condições para a satisfação destes deveres, assim como os pressupostos em que sua infração podem dar lugar à responsabilidade civil.

O termo de consentimento livre esclarecido na visão dos médicos da rede pública municipal de saúde de um município paulista: um estudo sobre a ética e suas implicações jurídicas em saúde / The Informed Consent term in the viewpoint of physicians from the municipal public health network of a São Paulo state municipality: a study of ethics and its legal implications in health

O Termo de Consentimento Livre e Esclarecido é um instrumento utilizado no âmbito profissional em diversas áreas. Na medicina, tem sido empregado como uma forma de garantia de direitos para os pacientes e para os profissionais. Por meio desse documento promove-se o direito à informação, o direito à autonomia, o direito à vida, o direito de escolha, o direito de consentir ao seu tratamento e à promoção do direito à saúde. Sua composição expressa questões que envolvem a ética em termos de principialismo. O estudo tem por objetivo analisar a importância, atribuída por médicos de uma rede municipal de saúde, da utilização do TCLE. Trata-se de um documento que consiste, por meio de seus pressupostos, na execução de desdobramentos jurídicos bem como seus efeitos. O estudo é exploratório e de abordagem qualitativa. Participaram do estudo 26 médicos que atuam em serviços da atenção primária à saúde no interior do Estado de São Paulo. A coleta de dados foi realizada por meio de entrevista semiestruturada. Os resultados evidenciam a escassez de estruturas para a compreensão da totalidade do que constitui o TCLE e da sua aplicabilidade na atuação profissional, mormente em relação às questões jurídicas, abarcando como alternativa para esta lacuna de conhecimento a realização de atividades no âmbito da educação permanente, através de minicursos, palestras e outras

The Free and Informed Consent Form is an instrument used in the professional scope in several areas. In medicine, it serves as a way of guaranteeing rights for patients and professionals. This document promotes the right to information, the right to be autonomous, the right to live, the right to choose, the right to consent to their treatment and the promotion of the right to health. Its composition expresses that it involves ethics in terms of principlism. The purpose of the study is to examine just how important IC (informed consent) is to physicians in a municipal health network. It is a document that employs the execution of legal developments alongside their effects through its presuppositions. The research takes a qualitative exploratory approach. The study included twenty-six physicians who work in primary health care services in the interior of São Paulo's state. Semi-structured interviews served as the way to gather information. The findings reveal a scarcity of structures for comprehending the entirety of what the IC is and its applicability in professional practice, particularly in legal matters, with activities in the field of permanent education serving as an alternative to this knowledge gap

Civil claims related to dental care in Chile according to court rulings 2011-2017 / Reclamaciones civiles relacionadas con la atención odontológica en Chile según sentencias judiciales 2011-2017

Objective: To describe Civil Claims (CCs) related to the provision of dental care according to court rulings published on the website of the Chilean Judicial Power. Material and methods: Descriptive study of 62 CCs filed against dentists or dental clinics according to court rulings available on the website of the Chilean Judicial Power between the years 2011 ­ 2017, identified by court rulings using a keyword search. Data were tabulated and analyzed using EXCEL and Stata.15, through descriptive statistics, proportions comparison test, and Spearman's Rho test. Results: An increase in the number of CCs according to the 2011-2017 court rulings was observed. CCs were filed on average 27.5 months after the events occurred. Judicial processes lasted a mean of 27 months, and the Araucanía region accounted for the highest rate. The highest number of lawsuits were placed against male general dentists with a mean age of 44, filed by female patients with a mean age of 46. A total of 66.13% of the CCs were rejected by the court, and 33.87% were ruled in favor of the plaintiffs. The financial compensation claims reached an average of $37,751,516 CLP (1500.32 Chilean UF), approximately $47,000 USD as of the date of the data collection process. Conclusion: There is an upward trend in the filing of CCs in Chile, although most were rejected by the court. A better understanding of the reasons that lead to the legal processes is necessary to prevent their occurrence.

Objetivo: Describir los Reclamos Civiles (CC) relacionados con la prestación de atención odontológica según sentencias judiciales publicadas en el sitio web del Poder Judicial de Chile. Material y Métodos: Estudio descriptivo de 62 CC interpuestas contra dentistas o clínicas dentales según sentencias judiciales disponibles en el sitio web del Poder Judicial de Chile entre los años 2011 - 2017, identificadas por sentencias judiciales mediante búsqueda por palabra clave. Los datos se tabularon y analizaron mediante EXCEL y Stata.15, mediante estadística descriptiva, prueba de comparación de proporciones y prueba Rho de Spearman. Resultados: Se observó un aumento en el número de CC según las sentencias judiciales de 2011-2017. Los CC se presentaron en promedio 27,5 meses después de ocurridos los hechos. Los procesos judiciales duraron una media de 27 meses y la región de la Araucanía registró la tasa más alta. El mayor número de demandas se presentaron contra dentistas generales varones con una edad media de 44 años, interpuestas por pacientes mujeres con una edad media de 46 años. El 66,13% de las CC fueron rechazadas por el tribunal y el 33,87% falló a favor. de los demandantes. Los reclamos de compensación económica alcanzaron un promedio de $ 37.751.516 CLP (1500,32 UF chilenas), aproximadamente $ 47.000 USD a la fecha del proceso de recolección de datos. Conclusión: Existe una tendencia ascendente en la presentación de CC en Chile, aunque la mayoría fueron rechazadas por el tribunal. Es necesario comprender mejor las razones que conducen a los procesos legales para prevenir su ocurrencia.

Procedimentos cirúrgicos assistidos pelo robô Da Vinci: benefícios, riscos e responsabilidade civil / Surgeryprocedures assisted by the Da Vinci robot: benefits, risks and civil liability / Procedimientos quirúrgicos asistidos por el robot Da Vinci: beneficios, riesgos y responsabilidad civil

Objetivo: verificar benefícios, riscos e eventos adversos na utilização da cirurgia assistida pelo robô Da Vinci, a fim de estabelecer a forma de atribuição de responsabilidade entre os diversos agentes envolvidos, quais sejam,médico, hospital, equipe de enfermagem e fabricante. Metodologia:o presente estudo centra-se na coleta e interpretação de material doutrinário e jurisprudencial relacionado à temática,sendo,inicialmente, realizado por meio da investigação dos benefícios, riscos e litígios que discutem eventos adversos na cirurgia assistida pelo robô Da Vinci,à luz do ordenamento jurídico norte-americano. Num segundo momento, é traçado um estudo comparatístico dessas demandas, sob a ótica do sistema jurídico brasileiro. Resultados e discussão: agrande complexidade na análise da responsabilidade civil na cirurgia robótica dá-se, sobretudo, na determinação da causa eficiente do dano­e a quem se atribuir o dever de indenizar.Nos Estados Unidos,essas demandas indenizatórias são conhecidas como finger-pointing cases, pois há sempre o dilema de quem deve responder quando há um dano ao paciente submetido à cirurgia robótica: o médico (e/ou o hospital) ou o fabricante do equipamento. Conclusão:para determinar a responsabilidade civil por eventos adversos na cirurgia robótica, torna-se imprescindível determinar a gênese do dano, isto é, se o dano é decorrente de serviço essencialmente médico, para médico ou extramédico. Além disso, na eventualidade de defeito do próprio robô Da Vinci, responderá o fabricante, independentemente da existência de culpa, pela reparação dos danos causados ao paciente.

Objectives: to verify benefits, risks and adverse events in the use of Da Vinci robot in surgical procedures in order to establish a means to attribute the responsibility between the many agents involved, whomever they may be doctors, the hospital, nursing team and manufacturer. Methods: the present study is based on the collection and interpretation of legal doctrinal and case law material related to the topic. This is initially achieved through the investigation of the benefits, risks and litigations that revolve around adverse events in surgery assisted by the Da Vinci robot, in the context of the North American legal order. In a second instance, a comparative study of these demands is drawn from the perspective of the Brazilian law system. Results and discussion: the great complexity of the analysis of civil liability in robotic surgery is mainly to determine the efficient cause of damage-and to whom should the duty to indemnify be attributed. In the United States of America, these indemnifying claims are known asfinger-pointing cases, as there is always the dilemma of who should respond when there is a damage to the patient who is submitted to robotic surgery, the doctor (and/or the hospital) or the equipment's manufacturer. Conclusion: in order to establish the civil liability due to adverse events in robotic surgery it is imperative to determine the source of the damage, whether it was from an essentially medical, paramedical or extra medical service. Furthermore, in the eventuality of a malfunction of the Da Vinci robot itself, the manufacturer must answer regardless of the existence of guilt to repair the damages caused to the patient.

Objetivo: verificar beneficios, riesgos y eventos adversos en la utilización del robot Da Vinci en procedimientos quirúrgicos, con el objetivo de establecer la forma de atribución de responsabilidad entre los diversos agentes involucrados, ya sean médico, hospital, equipo de enfermería y fabricante. Metodología:el presente estudio se centra en la recolección e interpretación de material doctrinario y jurisprudencial relacionado a la temática, siendo, inicialmente, realizado por medio de la investigación de los beneficios, riesgos y litigios que discuten eventos adversos en la cirugía asistida por el robot Da Vinci, a la luz del ordenamiento jurídico norteamericano. En un segundo momento, se traza un estudio comparativo de esas demandas, bajo la óptica del sistema jurídico brasileño. Resultados y discusiones:la gran complejidad en el análisis de la responsabilidad civil en la cirugía robótica se da, sobretodo, en la determinación de la causa eficiente del daño ­y a quien se le atribuya el deber de indemnizar. En los Estados Unidos, esas demandas indemnizatorias son conocidas como finger-pointing cases, ya que siempre existe el dilema de quién debe responder cuando hay un daño al paciente sometido a la cirugía robótica: el médico (y/o el hospital) o el fabricante del equipamiento.Conclusión:para determinar la responsabilidad civil por eventos adversos en la cirugía robótica, se hace imprescindible determinar el origen del daño, esto quiere decir, si el daño es un resultado del servicio esencialmente médico, paramédico o extramédico. Además, en la eventualidad de defecto del propio robot Da Vinci, responderá el fabricante, independiente de la existencia de culpa, por la reparación de los daños causados al paciente.

Medical negligence - Key cases and application of legislation.

BACKGROUND: Law entails precedent-based common law and parliamentary-legislation-based statutory law. Australian courts recognise civil wrongs, called torts. The most common tort worldwide is negligence. The first aim of the paper is to educate the Australian nursing community about medicolegal issues, statutes, important cases, legal applications, and negligence statistics pertaining to clinical practice. The second aim is to determine whether medicolegal negligence claim-numbers are commensurate with recorded statistics on adverse events. The third aim is to determine and discuss preventative approaches to minimise culpability. MATERIALS AND METHODS: Relevant searches were done using Pubmed, Google Scholar, and Austlii. Data, negligence legislation, key cases, and law processes were collated and analysed based on court decision citations, legal impact, and relationships between legislation application and case law. Although New South Wales legislation was used throughout this paper, parallel statutes exist across Australian jurisdictions. RESULTS: The basics of the civil tort offence of negligence are explained with step-by-step explanations. Key judgments and application of legislation in key medical negligence cases are discussed. Relevant medicolegal issues and negligence statistics are discussed. The civil tort of negligence is elaborately discussed, step-by-step, with relevant Common Law and legislation relevant to NSW. The watershed cases of Hadiza Bawa-Garba and Nurse Amaro are summarised with the ramifications for doctors and nurses. Expedient strategies to assist doctors and nurses in minimising unlawful action are discussed. CONCLUSIONS: Adverse medical events are high in Australia. However, new claims are decreasing. Negligence claim-numbers are disproportionate to statistics on adverse events. The Hadiza Bawa-Garba and Nurse Amaro cases have opened a legal can of worms with manifold negative ramifications for the nursing community.

Danos causados por medicamentos: responsabilidade civil do produtor no âmbito da legislação portuguesa / Damage caused by medical drug: producer liability under Portuguese law / Daño causado por medicamentos: responsabilidad del productor según la ley portuguesa

Objetivo: analisar, por um lado, o regime jurídico aplicável em caso de danos causados por medicamentos e, por outro lado, as dificuldades que se erigem com as (in)suficiências desse mesmo regime. Metodologia: foi realizada análise bibliográfica sobre este tema. Resultados: muito embora o regime legal em vigor se revele adequado à generalidade dos produtos, não se pode afirmar o mesmo em relação a alguns aspetos de regime quando em causa esteja um produto-medicamento, atentas as suas características próprias e a interação com o corpo humano que de imediato se estabelece. Conclusão: à imagem do que sucedeu em outros ordenamentos jurídicos europeus, poderia equacionar-se legislar especificamente sobre a responsabilidade civil decorrente de danos causados por medicamentos, como é o caso da Alemanha, ou consagrar algumas diferenças de regime quando em causa esteja um medicamento, como sucedeu em Espanha.

Objective: to analyze, on the one hand, the legal regime applicable in case of damages caused by medicines and, on the other hand, the difficulties that arise with the (in) sufficiencies of that same regime. Methodology: a bibliographic analysis was carried out on this topic. Results: although the legal regime in force proves to be adequate to most products, the same cannot be said when a medicine is concerned, taking into account its own characteristics and the interaction with the human body that immediately establishes itself. Conclusion: as in other European legal systems, it could be envisaged to legislate specifically on civil liability arising from damage caused by drugs, as is the case in Germany, or to enshrine some regime differences when a drug is concerned, as happened in Spain.

Objetivo: analizar, por un lado, el régimen legal aplicable en caso de daños causados por medicamentos y, por otro lado, las dificultades que surgen con la (in)suficiencia de ese mismo régimen. Metodología: se realizó un análisis bibliográfico sobre este tema. Resultados: aunque el régimen legal vigente resulta adecuado para la mayoría de los productos, no se puede decir lo mismo cuando se trata de un medicamento, teniendo en cuenta sus características propias y la interacción con el cuerpo humano que se establece de inmediato. Conclusión: como fue el caso en otros sistemas legales europeos, podría preverse legislar específicamente sobre la responsabilidad civil derivada del daño causado por los medicamentos, como es el caso en Alemania, o consagrar algunas diferencias de régimen cuando se trata de uno medicamento, como sucedió en España.