Introdução: o aumento da cobertura vacinal reduziu a incidência das doenças imunopreveníveis, elevando os casos de Evento Adverso Pós-Vacinação e Erro de imunização. Objetivo: analisar os erros de imunização e a percepção de vacinadores sobre os fatores que contribuem para a sua ocorrência. Método: abordagem mista, desenvolvida em duas fases: primeira, quantitativa, descritiva, documental, retrospectiva, no período de 2003 a 2013. Utilizados dados secundários do Brasil e primários e secundários do Paraná Sistema de Informação de Eventos Adversos Pós-Vacinação e relatório de erros de imunização do Programa de Imunização. A segunda, qualitativa, exploratória, prospectiva, tendo como referencial a Teoria do Erro Humano, realizada com vacinadores da Região Metropolitana de Curitiba que notificaram erro de imunização em 2013. Classificação do erro de imunização: com evento adverso e sem evento adverso. Para o cálculo das taxas de incidência de erro e diagrama de dispersão, foi utilizado o software SPSS versão 23.0 ajustados pelo Modelo de Regressão Linear Simples. Na fase II, os dados foram coletados por meio de entrevistas e observação não participante, analisados segundo Bardin, utilizando o Web Qualitative Data Analysis WebQDA. Resultados: de 2003 a 2013, no Brasil e no Paraná, o abscesso subcutâneo quente foi o erro de imunização com evento adverso mais frequente. Os menores de um ano foram os mais atingidos pelos erros e a BCG teve taxa de incidência mais elevada. A incidência do erro de imunização com evento adverso aumentou ao longo do período, enquanto o sem evento adverso, elevou-se expressivamente em 2012. A análise da tendência no Paraná de 2003 a 2018, revelou crescimento anual, com elevação contínua da incidência, para ambos, mostrando ainda que a elevação dos percentuais e taxas ocorreu nas campanhas de vacinação, introdução de novas vacinas e mudanças no Calendário Nacional de Vacinação. Nas observações das 26 salas de vacinação, identificou-se: refrigerador não exclusivo, falhas na higienização das mãos (78%), não abordagem sobre possíveis contraindicações ou adiamento da vacinação. Foram entrevistados 115 vacinadores, 96% mulheres, 42% entre 30 a 39 anos, 54% com nível médio de escolaridade e 53% formados há cinco anos ou mais. Atuavam na sala de vacinação entre 3 a 11 anos, 71% realizavam atividades concomitantes em outros setores e 76% não tinham outro emprego. A entrevista revelou que 47% dos vacinadores tinham conhecimento de erro de imunização no seu trabalho, 8,7% estiveram envolvidos em erros e 1,7% referiram haver subnotificação. Dos discursos dos vacinadores emergiram três categorias analíticas: fatores humanos (57,3%), institucionais/organizacionais (34%) e ambientais (8,7%). Das categorias empíricas, destacou-se fatores psicológicos (43,2%) e das subcategorias: distração (21,4%) e estresse (20,9%). Conclusões: o erro de imunização é causado pela interação de múltiplos fatores. Mantendo-se os cenários, as incidências de erro de imunização, com ou sem evento adverso, tendem a continuar ascendentes até 2018. Campanhas, novas vacinas e mudanças no calendário de vacinação aumentam o risco de erro de imunização. Na visão dos vacinadores, a ocorrência de erro de imunização está relacionada, principalmente, a fatores psicológicos e gestão de pessoas. A maioria dos erros de imunização é potencialmente prevenível, desde que a sua ocorrência e causas sejam identificadas. / Introduction: the increase in vaccination coverage reduced the incidence of vaccine-preventable diseases, increasing the number of cases of Adverse Events Following Vaccination and Immunization Error. Objective: to analyze the immunization errors and the perception of vaccinators on the factors that contribute to their occurrence. Method: mixed approach, developed in two phases: the first being quantitative, descriptive, documentary, retrospective, in the period from 2003 to 2013. Secondary data from Brazil and primary data from Paraná were used Surveillance System of Adverse Events Following Vaccination and immunization error reports of the Immunization Program. The second, qualitative, exploratory, prospective phase had as reference the Theory of Human Error, performed with vaccinators of the Metropolitan Region of Curitiba who reported immunization errors in 2013. Classification of immunization error: with and without adverse event. For the calculation of the incidence rates of error and dispersion diagram, the SPSS software version 23.0 was used, adjusted through the Simple Linear Regression Model. In phase II, the data were collected through interviews and non-participant observation, analyzed according to Bardin, using the Web Qualitative Data Analysis WebQDA software. Results: from 2003 to 2013, in Brazil and Paraná, warm subcutaneous abscess was the most frequent immunization error with adverse event. Children under one year old were the most affected by the errors and BCG had higher incidence rate. The incidence of immunization error with adverse event increased over the period, while its incidence without adverse event increased significantly in 2012. The analysis of the trend in Paraná from 2003 to 2018 showed annual growth, with continuous increase in incidence, for both, also showing that the increase of the percentages and rates occurred during the vaccination campaigns, introduction of new vaccines and changes in the National Vaccination Calendar. During the observation of the 26 vaccination rooms, the following were identified: non-exclusive cooler, failures in the sanitation of hands (78%), no addressing of the possible contraindications or postponement of vaccination. 115 vaccinators were interviewed, 96% women, 42% between 30 and 39 years of age, 54% with average level of education and 53% graduated for five years or more. They had been working in the vaccination room for 3 to 11 years, 71% performed concomitant activities in other sectors and 76% did not have another job. The interview revealed that 47% of vaccinators were aware of immunization errors in their work, 8.7% were involved in errors and 1.7% declared there being underreporting. The speeches of the vaccinators resulted in three analytical categories: human (57.3%), institutional/organizational (34%) and environmental (8.7%) factors. Those which stood out, of the empirical categories, were the psychological factors (43.2%), and of the subcategories, distraction (21.4%) and stress (20.9%). Immunization error is caused by the interaction between multiple factors. Conclusions: if kept constant, the scenarios and incidence of immunization errors, with or without adverse event, tend to continue increasing up to 2018. Campaigns, new vaccines and changes in the vaccination calendar increase the risk of immunization error. For the vaccinators, the occurrence of immunization error is related mainly to psychological factors and people management. Most immunization errors are potentially preventable, provided their occurrence and causes are identified.

A presente pesquisa tem como objetivo analisar a responsabilidade do médico dentro do contexto doutrinário e jurisprudencial da atualidade e demonstrar, a partir da análise de ações judiciais por alegado erro médico, propostas perante o Poder Judiciário, que os direitos atribuídos ao consumidor pelo Código de Defesa do Consumidor, bem como as prerrogativas de facilitação do acesso ao judiciário atualmente são aplicados pelos profissionais do Direito ao exercício da atividade médica de forma generalizada, ou seja, tanto em relação às sociedades empresárias hospitais, clínicas e planos de saúde, quanto aos profissionais liberais, sem considerar que o §4º do artigo 14 do Código de Defesa do Consumidor, ao estabelecer como requisito para a responsabilidade do profissional liberal a comprovação de culpa (imprudência, negligência e imperícia), determina, a contrario sensu, a aplicação das normas do Código Civil, de forma que, também as prerrogativas de facilitação de acesso ao judiciário, exclusivas da legislação de consumo, não poderiam ser aplicadas ao exercício da atividade pelo profissional liberal. / This study aims at analyzing physicians responsibilities at both the doctrinal and jurisprudential levels to date. Thus, it also aims to show, from an analysis of alleged medical malpractice suits filed in the judiciary power, that the consumers rights guaranteed by the Code of Consumers Defense, as well as the privileges of access to the judiciary power, are currently applied by law professionals for the medical practice in a general way, meaning that both business corporations, hospitals, clinics and health insurance companies, as well as liberal professionals, not mentioning the fourth paragraph of clause 14 from the Code of Consumers Defense, which regulates liberal professionals responsibilities to establish guilt of imprudence, negligence or malpractice, it is, however, guided by the application of the rules from the Civil Code, in a sense that the privileges of access to the judiciary power could not be applied to the liberal Professionals medical practice, either.

Magister Legum - LLM / South Africa has seen a spike in medical malpractice litigation, including the number and size of claims instituted against healthcare practitioners. This has led to a backlog in medical malpractice court cases throughout South Africa and a strain on both the public and private healthcare sectors, affecting an already burdened healthcare system. The surge in medical malpractice litigation is not a new phenomenon in developed countries. Most have curbed this through alternative dispute resolution (ADR). This has been facilitated by effectively introducing efficient legal frameworks that promote ADR. Unfortunately, this is not the case in a developing country such as South Africa. To date, much research and literature has attributed blame for the large-scale increase in medical malpractice litigation to legal practitioners. This has been aided by comments made by the former Minister of Health, Dr Aaron Motsoaledi (Dr Motsoaledi). In as much as this may be the common perception, there appears, to the contrary, to be systematic problems in the South African healthcare system. The legal profession is only a minor contributing factor to the increase in medical malpractice litigation. The strained financial resources and shortage of healthcare staff in public hospitals contributes to the increased risk of medical malpractice cases. Furthermore, when considering the South African legal system, contingency fee arrangements have, in certain circumstances, increased vexatious litigation and, as such, it is on this basis that medical malpractice litigation has been on the increase in South African courts. This study seeks to analyse the current state of the South African healthcare system, and in light of the increasing number of medical practice claims and litigation, propose ADR mechanisms that offer efficient, cost effective, and expeditious channels to resolving these issues and to ensure that parties recognise the full benefits of ADR. This study proposes legal reform in medical malpractice litigation in South Africa. This thesis compares the experiences, legislative and policy frameworks in Australia and the United States of America (USA), in order to learn lessons that could assist South Africa in framing legislation and best practices for ADR. It contends that, in order to effectively develop and implement ADR to address medical malpractice litigation, it requires the involvement of the government, legislature, judiciary, legal profession and the public. It has identified court- iv annexed mediation as the appropriate ADR mechanism in addressing medical malpractice litigation.

The fastest growing field of law is undoubtedly that of Medical Law with the civil and disciplinary cases flowing from it. Globalization, international communication, development and evolution of Law as well as Medicine, cause this worldwide rising medical litigation. Humanitarian rights, post-modern scepticism and even iconoclastic attitudes contribute to this phenomenon. Medico-legal litigation and disciplinary complaints rise (in South Africa) up to 10 per cent per year. To assist the courts and legal profession, in medico-legal issues, helping the parties where the plaintiff has the burden of proof and the defendant for rebuttal, a medical expert witness must be used. The dilemmas and pitfalls arise, in that although knowledgeable medical experts could be used to guide the courts to the correct decision, the lack of a legal mind setting, court procedure and legal knowledge could affect the relevance, credibility and reliability, making the medical evidence of poor quality. The legal profession, deliberately, could “abuse” medical expert witnesses with demanding and coercion of results, which have unrealistic and unreasonable expectations. “Case building” occurs, especially in the adversarial systems of law, making the medical expert vulnerable under cross-examination, when it is shown that the witness has turned into a “hired gun” or is unfair. Thus, lacunae develop, making reasonable cases difficult and a quagmire of facts have to be evaluated for unreasonableness, credibility and appropriateness, compounded by the fact that seldom, cases are comparable. The danger is that the presiding officer could be misled and with limited medical knowledge and misplaced values, could reach the wrong findings. Several cases arguably show that this has led to wrongful outcomes and even unacceptable jurisprudence. The desire to “win” a case, can make a medical witness lose credibility and reasonableness with loss of objectivity, realism and relevance. With personality traits and subjectivity, the case becomes argumentative, obstinate and could even lead to lies. The miasmatic, hostile witness emerges, leading to embarrassing, unnecessary prolongation of court procedures. The medical expert witness should be well guided by the legal profession and well informed of the issues. Medical witnesses should have legal training and insight into the legal and court procedures. At the time of discovery of documents, via arbitration or mediation, medical experts should strive to reach consensus and then present their unified finding, helping the parties fairly and expediting the legal procedure and processes. / Private Law / LLM

As organizações de saúde, instituições de ensino, pesquisadores e profissionais têm investido em mecanismos que visam aperfeiçoar a assistência integral à saúde ofertada aos pacientes. Todavia, a assistência pode estar sujeita a falhas que podem acarretar danos indesejados aos pacientes, familiares e profissionais, além de prejuízos ao sistema de saúde. Acionar o Poder Judiciário é um dos mecanismos adotados para reparar o dano causado. Nos últimos anos, no Brasil, especialmente a partir de 2003, observa-se um crescimento das demandas judiciais relacionadas aos serviços prestados pelos profissionais da saúde, reflexo das mudanças ocorridas na sociedade e da ampliação dos direitos sociais e fundamentais. Justifica-se, assim, um estudo retrospectivo de casos julgados, com análise da jurisprudência do Superior Tribunal de Justiça (STJ), no período de 2003 a 2013, acerca das ações judiciais movidas em face dos profissionais de saúde e instituições de saúde no âmbito público e privado. Realizada analise quantitativa e qualitativa do conteúdo dos discursos dos Ministros do STJ sobre o tema erro médico, aplicando o método do Discurso do Sujeito Coletivo (DSC). O estudo das decisões proferidas contribuiu para a compreensão dos assuntos que têm predomínio na jurisprudência do STJ sobre o erro médico. O trabalho identificou o sexo feminino como o mais vulnerável aos supostos erros médicos e as especialidades médicas diretamente relacionadas com a saúde feminina como a mais acionadas judicialmente. Ginecologia/Obstetrícia (27,08%), Ortopedia (12,5%) e Cirurgia Plástica (10,42%) foram, respectivamente, as especialidades mais demandadas. Em conclusão, o estudo traz subsídio para as organizações de saúde identificarem possíveis áreas estratégicas de atuação, no sentido de implementarem ações para reduzir a probabilidade de erros médicos, identificando mecanismos eficientes para o acompanhamento e a racionalização de possíveis falhas e para atuarem, preventivamente, nas práticas de gestão visando reduzir danos aos pacientes, diminuir custos decorrentes das indenizações, possibilitando, uma prestação de serviço de saúde de maior excelência, qualificado e seguro no sistema único e no sistema suplementar de saúde. / Healthcare organizations, educational institutions, researchers and healthcare professionals have invested in mechanisms to improve the integral medical assistance offered to patients, but these assistance could have failures that may result in injury to patients, family members, and damage to system. One of the mechanisms to repair the damage is to claim to the Judiciary. In Brazil, especially since 2003, there has been an increase the lawsuit number related to medical malpractice, reflecting the changes in society and the expansion of social and fundamental rights. This is a retrospective study of judged cases by the Superior Court of Justice, in the period from 2003 to 2013, regarding the lawsuits against healthcare professionals and institutions in the public and private practice. Performed quantitative and qualitative analysis of the Superior Court of Justice Ministers speeches content, using the collective subject discourse method. Analyze of decisions contributed to understanding of the predominated issues in the malpractice lawsuit. The study identified the women as the most vulnerable to medical errors and medical specialties directly related to women\'s health as the most driven in court. Gynecology/Obstetrics (27.08%), Orthopedics (12.5%) and Plastic Surgery (10.42%) were, respectively, the most demanded specialties. In conclusion, the study provides subsidy for healthcare organizations identify potential areas of action to implement strategies to reduce the likelihood of injury to patients, decreasing costs and medical malpractice.

O presente trabalho aborda o tema da responsabilidade civil pelo nascimento indesejado no Direito Brasileiro. Trata-se de um conflito que emerge nos casos em que a falha de um método contraceptivo redunda no nascimento de uma criança, contra a vontade de seus genitores. A primeira parte do trabalho é dedicada ao fato gerador da responsabilidade nessa espécie de litígio, a saber, a culpa médica e o defeito do produto ou serviço de contracepção. Os métodos anticoncepcionais são agrupados em duas categorias: de um lado, os métodos cirúrgicos de esterilização, que envolvem a prestação de um serviço médico; e, de outro, os métodos que empregam dispositivos anticoncepcionais fabricados industrialmente, isto é, os produtos contraceptivos. A segunda parte do trabalho discorre sobre as implicações éticas da reparação do nascimento indesejado. De fato, a indenização fundada no nascimento de um filho traz à tona uma série de considerações relativas à dignidade da criança e ao valor das relações parentais. O trabalho procura apontar em que medida o nascimento de uma criança pode ser interpretado como um prejuízo legítimo experimentado por seus pais. Conclui-se que a reparação integral do nascimento indesejado é necessária para a afirmação da autonomia reprodutiva das vítimas de contraceptivos defeituosos. A análise das soluções controversas adotadas no Reino Unido e na França onde os tribunais afirmaram que apenas o nascimento de uma criança deficiente pode ser considerado um prejuízo reparável revela que o direito dos pais à reparação não pode ser subordinado às condições de saúde da criança nascida / This thesis is an inquiry into wrongful conception claims under Brazilian Tort Law. This type of lawsuit arises out of cases involving failure of contraceptive methods, causing the birth of a child against the parents desire. The first part of the thesis addresses the basis of liability in wrongful conception claims, namely, medical malpractice and defect of products or services. Contraceptive methods are grouped into two categories: on one side, surgical methods of sterilization, that rely upon the supply of medical services; on the other, contraception methods that employ manufactured devices, that is, contraceptive products. The second part of the thesis discusses the ethical implications of awarding damages in wrongful conception claims. Compensation based on the birth of a child raises a series of issues concerning the child\'s dignity and the value of parental relationships. It is argued that full compensation is necessary in order to reaffirm the reproductive autonomy of the victims of defective contraceptive methods. The analysis of controversial solutions adopted in United Kingdom and France where courts have stated that only the birth of a disabled child is a recoverable damage leads to the conclusion that the chillds health condition cannot be a requirement for his parents right to compensation.

隨著社會變遷，近一二十年來，我國醫療糾紛有大幅增加之現象，而經由媒體的報導，醫療糾紛在我國亦經常成為眾所矚目、備受爭議的社會焦點。由於醫療行為所導致的損害，直接侵害病人之身體權、健康權、甚至生命權，對於病人及其家屬生活所造成之影響，難謂非為鉅大，故醫療糾紛之妥善處理，實係吾人從事醫療法律之研究者，應予正視並深入探討之議題。 我國醫療糾紛之處理，向以刑事訴訟為主要之救濟途徑，惟晚近醫界、法界均已達成共識，認為醫療糾紛應回歸至以民事程序為主之處理模式。惟吾人若欲藉由民事法律關係妥善處理醫療糾紛，則須注意醫療民事訴訟之特殊性，亦即，因醫病雙方專業知識上之落差，導致雙方在民事程序上處於武器不平等之地位。為衡平此一武器不平等，我國實務上部分法官在審理醫療民事訴訟時，曾打破傳統民事過失歸責原則，將消費者保護法無過失責任與民法第191條之3一般危險責任之規定適用於醫療行為，惟自民國93年醫療法第82條第2項修正之後，該法既規定「醫療機構及其醫事人員因執行業務致生損害於病人，以故意或過失為限，負損害賠償責任。」邇近之實務判決遂多採醫療行為過失責任之見解，也多排除民法第191條之3之適用。我國醫療訴訟醫病爭執之重點，乃於近年由實體法之無過失責任之採擇與否，轉換至程序法之舉證責任分配。 於醫療訴訟等現代型訴訟事件中，被害人時常發生舉證上之困難，倘若依照僵化固定的舉證責任分配規則，則不免有失公平正義。因此，舉證責任分配於醫療訴訟上應如何操作方屬適當，實為醫療民事訴訟中值得觀察的重點所在。基於上述之問題意識，本論文的研究架構共分為七章，其內容綱要如下： 第一章 緒論：闡釋說明研究動機，並指明目前民事醫療糾紛事件之問題重心在於「程序法」，特別係在「舉證責任之分配」。進而說明本論文之研究動機、研究目的、研究範圍與研究方法。 第二章 醫療糾紛之發生及其處理：本章由醫療糾紛之發生談起，進而說明醫療糾紛之法律關係，探討不同法領域下醫療提供者違反義務時之法律責任，包括民事責任、刑事責任及行政責任等，並論證醫療糾紛實應回歸至以民事程序為主之處理模式。最後，介紹醫療糾紛發生後，國內外現今法制上之醫療糾紛處理機制，並分析其優缺點。 第三章 醫療糾紛之民事法律關係與醫療民事訴訟之特殊性：本章聚焦於醫療糾紛之民事法律關係，探討醫療提供者之契約責任、醫療無因管理與醫療提供者之侵權責任等。同時，討論醫療民事訴訟之特殊性，分析醫療民事訴訟被害人舉證困難之原因，並分析加重醫療提供者民事責任之法理基礎、以及過度加重醫療提供者民事責任所可能導致之反效果。 第四章 民事訴訟舉證責任分配之學說：按我國關於民事舉證責任之立法明文，係規定於民事訴訟法第277條：「當事人主張有利於己之事實者，就其事實有舉證之責任。但法律別有規定，或依其情形顯失公平者，不在此限。」學者乃認為，在我國法制下，所謂舉證責任分配法則係一總體概念，而可區分為「舉證責任分配一般原則」與「舉證責任分配減輕」二者，而以前者為原則，後者為例外。本章即由舉證責任之基礎觀念出發，藉由介紹國內外之學說，而分別處理「舉證責任分配之一般原則」與「舉證責任分配之減輕」等概念。 第五章 醫療民事訴訟舉證責任分配規則之具體適用：本章集中討論醫療民事訴訟之舉證責任。本章前半段介紹醫療民事訴訟舉證責任分配之一般規則、以及比較法上(包括德國、美國與日本)醫療糾紛舉證責任減輕之具體規則，後半段則分析我國實務操作醫療糾紛舉證責任分配之問題。本文一共歸納出實務判決於適用舉證責任分配時共六個問題，並分別找出判決加以闡釋。於本章末，則提出將醫療糾紛類型化，應有助於解決我國實務之問題。 第六章 醫療糾紛之類型化與舉證責任分配體系之建構：本章先試從「法學思維」、「醫學思維」、以及「綜合醫學思維與法學思維」出發，分別建立三套操作模組，以將醫療糾紛類型化，並建構其各別之舉證責任分配體系。關於純粹由「法學思維」或「醫學思維」所建立之操作模組，本文將分析其操作上之侷限，而針對本文所建議「綜合醫學思維與法學思維」之操作模組，亦將於各醫療糾紛分類，舉實務案例諸例實際操作之，以驗證本文所建議操作流程之可行性。章末則另提出法院於適用舉證責任分配規則時，其他與客觀舉證責任分配無直接相關，但應予考量之事項，以助於更正確地適用舉證責任分配規則。 第七章 結論、建議與展望：綜合前開章節討論，針對醫療民事爭訟程序中之舉證責任分類體系與操作模式，做出總結。並提出其他相關建議，以終極落實醫療需求者憲法上基本權之保障。 / The number of malpractice claims filed in Taiwan against physicians has increased significantly in the recent decades. Medical malpractice litigations are characterized by a huge gap in medical knowledge between physicians and patients, leading to an unequal status between both parties in the trials. To ensure that the principle of equality of arms is upheld in civil procedures, the courts applied the strict liability embodied in Article 7 of the Consumer Protection Law and Article 191-3 of the Civil Code to malpractice cases. However, since the amendment and promulgation of Article 82 of the Medical Care Act, there has been a consensus that strict liability is no longer applicable in medical litigations, and negligence becomes an essential element for establishing the liability of medical practitioners. In addition to modifying liability rules, an alternative for achieving equality of arms is to relieve the plaintiffs from the burden of proof. However, the burden of proof should be adjusted with precaution, because an excessive shift might contribute to defensive medicine. Accordingly, this study aims to standardize the algorithm for allocating the burden of proof by classifying medical malpractice disputes. The thesis is composed of the following seven chapters: Chapter 1 Introduction: This chapter outlines the background of the present study, with a special emphasis on the pivotal role of the burden of proof in medical litigations. Also delineated in this chapter are the objectives and methodology of the present study. Chapter 2 The occurrence and resolution of medical malpractice disputes: In this chapter, the incidence of medical injury and medical malpractice is discussed first, followed by an analysis of the civil, criminal, and administrative liabilities of medical professionals. The plethora of resolutions for settling medical malpractice disputes are summarized at the end of the chapter. Chapter 3 Civil liabilities of medical malpractice and characteristics of medical litigations: This chapter focuses on the civil liabilities of medical malpractice, which arise from failure to undertake contractual duties or tort liabilities. The characteristics of medical litigations, such as the unequal status in arms between plaintiffs and defendants and the difficulties in concluding negligence or deciphering causation, are discussed in the second half of the chapter. Chapter 4 Theories and rules in allocating the burden of proof: The allocation of the burden of proof is determined according to Article 277 of the Taiwan Code of Civil Procedure: A party bears the burden of proof with regard to the facts which he/she alleges in his/her favor, except either where the law provides otherwise or where the circumstances render it manifestly unfair. Consequently, in principle, the burden of proof is allocated according to the “Normentheorie,” with specific rules applied to ease the plaintiff’s burden of proof under exceptional and unfair circumstances. Chapter 5 Rules for allocating the burden of proof in medical litigations: German, American, and Japanese rules for allocating or relieving plaintiffs from the burden of proof in medical litigations are introduced. The current problems in applying these rules to medical litigations in Taiwan are inspected. The solution to these problems relies on a precise classification of medical malpractice disputes. Chapter 6 Establishing the algorithm for allocating the burden of proof by classifying medical malpractice disputes: Three models for allocating the burden of proof are created on the basis of three classification systems: classification from a legal perspective, classification from a medical perspective, and classification from a combined medical-and-legal perspective. A comparison of these three models reveals that the last might be the best algorithm. Specific tips for an accurate application of this algorithm are also provided. Chapter 7 Conclusions: This chapter highlights the importance of an appropriate allocation of the burden of proof in medical litigations, as well as the algorithm for allocating the burden of proof established in the present study. Also included are suggestions on how to ameliorate Taiwan’s medical litigation system in the future.

The fastest growing field of law is undoubtedly that of Medical Law with the civil and disciplinary cases flowing from it. Globalization, international communication, development and evolution of Law as well as Medicine, cause this worldwide rising medical litigation. Humanitarian rights, post-modern scepticism and even iconoclastic attitudes contribute to this phenomenon. Medico-legal litigation and disciplinary complaints rise (in South Africa) up to 10 per cent per year. To assist the courts and legal profession, in medico-legal issues, helping the parties where the plaintiff has the burden of proof and the defendant for rebuttal, a medical expert witness must be used. The dilemmas and pitfalls arise, in that although knowledgeable medical experts could be used to guide the courts to the correct decision, the lack of a legal mind setting, court procedure and legal knowledge could affect the relevance, credibility and reliability, making the medical evidence of poor quality. The legal profession, deliberately, could “abuse” medical expert witnesses with demanding and coercion of results, which have unrealistic and unreasonable expectations. “Case building” occurs, especially in the adversarial systems of law, making the medical expert vulnerable under cross-examination, when it is shown that the witness has turned into a “hired gun” or is unfair. Thus, lacunae develop, making reasonable cases difficult and a quagmire of facts have to be evaluated for unreasonableness, credibility and appropriateness, compounded by the fact that seldom, cases are comparable. The danger is that the presiding officer could be misled and with limited medical knowledge and misplaced values, could reach the wrong findings. Several cases arguably show that this has led to wrongful outcomes and even unacceptable jurisprudence. The desire to “win” a case, can make a medical witness lose credibility and reasonableness with loss of objectivity, realism and relevance. With personality traits and subjectivity, the case becomes argumentative, obstinate and could even lead to lies. The miasmatic, hostile witness emerges, leading to embarrassing, unnecessary prolongation of court procedures. The medical expert witness should be well guided by the legal profession and well informed of the issues. Medical witnesses should have legal training and insight into the legal and court procedures. At the time of discovery of documents, via arbitration or mediation, medical experts should strive to reach consensus and then present their unified finding, helping the parties fairly and expediting the legal procedure and processes. / Private Law / LLM

As organizações de saúde, instituições de ensino, pesquisadores e profissionais têm investido em mecanismos que visam aperfeiçoar a assistência integral à saúde ofertada aos pacientes. Todavia, a assistência pode estar sujeita a falhas que podem acarretar danos indesejados aos pacientes, familiares e profissionais, além de prejuízos ao sistema de saúde. Acionar o Poder Judiciário é um dos mecanismos adotados para reparar o dano causado. Nos últimos anos, no Brasil, especialmente a partir de 2003, observa-se um crescimento das demandas judiciais relacionadas aos serviços prestados pelos profissionais da saúde, reflexo das mudanças ocorridas na sociedade e da ampliação dos direitos sociais e fundamentais. Justifica-se, assim, um estudo retrospectivo de casos julgados, com análise da jurisprudência do Superior Tribunal de Justiça (STJ), no período de 2003 a 2013, acerca das ações judiciais movidas em face dos profissionais de saúde e instituições de saúde no âmbito público e privado. Realizada analise quantitativa e qualitativa do conteúdo dos discursos dos Ministros do STJ sobre o tema erro médico, aplicando o método do Discurso do Sujeito Coletivo (DSC). O estudo das decisões proferidas contribuiu para a compreensão dos assuntos que têm predomínio na jurisprudência do STJ sobre o erro médico. O trabalho identificou o sexo feminino como o mais vulnerável aos supostos erros médicos e as especialidades médicas diretamente relacionadas com a saúde feminina como a mais acionadas judicialmente. Ginecologia/Obstetrícia (27,08%), Ortopedia (12,5%) e Cirurgia Plástica (10,42%) foram, respectivamente, as especialidades mais demandadas. Em conclusão, o estudo traz subsídio para as organizações de saúde identificarem possíveis áreas estratégicas de atuação, no sentido de implementarem ações para reduzir a probabilidade de erros médicos, identificando mecanismos eficientes para o acompanhamento e a racionalização de possíveis falhas e para atuarem, preventivamente, nas práticas de gestão visando reduzir danos aos pacientes, diminuir custos decorrentes das indenizações, possibilitando, uma prestação de serviço de saúde de maior excelência, qualificado e seguro no sistema único e no sistema suplementar de saúde. / Healthcare organizations, educational institutions, researchers and healthcare professionals have invested in mechanisms to improve the integral medical assistance offered to patients, but these assistance could have failures that may result in injury to patients, family members, and damage to system. One of the mechanisms to repair the damage is to claim to the Judiciary. In Brazil, especially since 2003, there has been an increase the lawsuit number related to medical malpractice, reflecting the changes in society and the expansion of social and fundamental rights. This is a retrospective study of judged cases by the Superior Court of Justice, in the period from 2003 to 2013, regarding the lawsuits against healthcare professionals and institutions in the public and private practice. Performed quantitative and qualitative analysis of the Superior Court of Justice Ministers speeches content, using the collective subject discourse method. Analyze of decisions contributed to understanding of the predominated issues in the malpractice lawsuit. The study identified the women as the most vulnerable to medical errors and medical specialties directly related to women\'s health as the most driven in court. Gynecology/Obstetrics (27.08%), Orthopedics (12.5%) and Plastic Surgery (10.42%) were, respectively, the most demanded specialties. In conclusion, the study provides subsidy for healthcare organizations identify potential areas of action to implement strategies to reduce the likelihood of injury to patients, decreasing costs and medical malpractice.

As a point of departure in this inherently interdisciplinary endeavour, the concept "Holistic Multidisciplinary Management" ("HMM") is introduced a.s a macrocosmic adaption of principles of project management. In line with HMM, a number of submissions regarding terminology and definitions in the interdisciplinary context of medicine (and particularly clinical psychiatry) and law, are made, and the foundations of medical malpractice are examined. Building on the various foundations laid, specific types of conduct that can constitute clinical-psychiatric malpractice, are addressed. A common theme that emerges in the various contexts covered, is that the psychiatrist must negotiate various proverbial tightropes, involving inter alia tensions between restraint and freedom, excessive and insufficient medication, becoming too involved and not being involved enough with clients, as well as client confidentiality and the duty to warn third parties. It is concluded that law and medicine. must work harmoniously together to establish appropriate balance. This can be achieved only if mutual understanding and integrated functioning are promoted and translated into practice. / Law / LL.M.