Civil liability: characterization of the demand for lawsuits against dentists

Abstract In light of the fact that dentists may be held civilly liable for their practice, it is important to understand the current situation of lawsuits filed against these professionals by studying current legal decisions and the literature. The objective of this study was to analyze the case law of the Court of Justice of São Paulo, Brazil, relative to the profile of patients and professionals, the most commonly involved specialties, the amounts litigated and the court decisions pertaining to civil liability lawsuits against dentists. In an inductive approach, a single researcher screened and collected civil liability rulings by accessing the Court's website, and following a statistical-descriptive procedure and an indirect observation technique. The most frequently involved specialty was prosthodontics. However, oral and maxillofacial surgery was related to a higher incidence of damages awarded to settle claims and to higher damage amounts. The dentist was found guilty in 44.32% of the cases researched. Pecuniary damages ranged between R$ 485.50 and R$ 12,530.00, and non-pecuniary damages ranged between R$ 2,500.00 and R$ 70,000.00. Most lawsuits were filed by women against male dentists. An increase in the relative number of lawsuits against companies versus individuals was observed.

Uso racional de medicamentos antineoplásicos e ações judiciais no Estado de São Paulo / Uso racional de medicamentos antineoplásicos y acciones judiciales en el estado de Sao Paulo, Sureste de Brasil / Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, southeastern Brazil

OBJETIVO: Avaliar a racionalidade das ações judiciais e pedidos administrativos recebidos pela Secretaria de Estado da Saúde de São Paulo segundo evidências científicas de eficácia e segurança. MÉTODOS: Estudo descritivo, transversal, baseado em informações da Secretaria de Saúde sobre os medicamentos antineoplásicos solicitados por via judicial, com maior impacto financeiro para o Sistema Único de Saúde em 2006 e 2007. Os fármacos foram avaliados quanto às evidências clínicas de eficácia e segurança, com base na classificação do Micromedex®, em metanálises e revisões sistemáticas. As indicações foram confrontadas com aquelas aprovadas em agências reguladoras. RESULTADOS: Os medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe e temozolomida geraram gastos superiores a R$ 40 milhões para atender 1.220 solicitações, com custo médio de R$ 33,5 mil por paciente. Os estudos selecionados não recomendam parte das indicações dos medicamentos prescritos. Cerca de 17 por cento dos pedidos não tinham evidência para a indicação mencionada no pleito, o que equivale a um gasto inadequado de, no mínimo, R$ 6,8 milhões...

OBJECTIVE: To assess the rationality of legal suits and administrative requests requiring anticancer drugs filed against and submitted to the São Paulo State Department of Health, in view of scientific evidence on efficacy and safety. METHODS: A descriptive cross-sectional study was carried out based on information on lawsuits filed by cancer patients requiring anticancer drugs were furnished by the Department of Health. These drugs are among those having the greatest financial impact on the Brazilian Health System in 2006 and 2007. The drugs were assessed according to clinical evidence on efficacy and safety, based on Micromedex® categorization, on systematic reviews and meta-analyses. Indications present in the legal documentation were compared to the indications approved by regulatory agencies. RESULTS: Bevacizumab, capecitabine, cetuximab, erlotinib, rituximab, imatinib, and temozolomide accounted for expenses over R$ 40 million to meet 1220 requests and lawsuits, at an average cost of R$ 33,500 per patient. Selected studies do not recommend all the indications for the prescribed drugs. Approximately 17 percent of requests and lawsuits did not provide evidence for the required indication, and these amounted to inappropriate expenses of, at least, R$ 6.8 million...

OBJETIVO: Evaluar la racionalidad de las acciones judiciales y pedidos administrativos recibidos por la Secretaria Estatal de Salud de Sao Paulo según evidencias científicas de eficacia y seguridad. MÉTODOS: Estudio descriptivo, transversal basado en informaciones de la Secretaria sobre los medicamentos antineoplásicos solicitados por vía judicial, con mayor impacto financiero para el Sistema Único de Salud en 2006 y 2007. Los fármacos fueron evaluados considerando las evidencias clínicas de eficacia y seguridad, con base en la clasificación de Micromedx®, metanálisis y revisiones sistemáticas. Las indicaciones fueron confrontadas con las aprobadas en agencias reguladoras. RESULTADOS: Los medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe y temozolomida generaron gastos superiores a R$ 40 millones para atender 1.220 solicitudes, con costo promedio de R$ 33,5 mil por paciente. Los estudios seleccionados no recomiendan parte de las indicaciones de los medicamentos prescritos. Cerca de 17 por ciento de los pedidos no tenían evidencia para la indicación mencionada en el pleito, lo que equivale a un gasto inadecuado de, mínimo, R$ 6,8 millones...

Informed consent documents submitted for initial review: What do they state about compensation for injured research participants.

Background : Research carries a small but definite risk of injury to participants. However, there is no unanimity amongst the stakeholders regarding the nature and extent of compensation to be provided to an injured participant. Aims : To determine the extent to which issues related to the provision of free treatment and compensation for research-related injury are addressed in the protocols submitted to Ethics Committees (ECs). Setting and Design : Retrospective review of protocols submitted to two ECs in India. Material and Methods : Initial protocols submitted to two ECs during the calendar years 2007 and 2008 were reviewed. Statements related to treatment and compensations for study-related injury were studied for adequacy regarding provisions for free emergency treatment, and free treatment and compensation for research-related injury. Presence of special conditions, exclusions, and caveats, if any, were noted. Statistical Analysis Used : The proportion of protocols providing free treatment and compensation for research-related injury was presented as a percentage. Results : The Informed Consent Documents (ICD) of 138 protocols were accessed. These included 115 (83.33%) industry-sponsored, 20 (14.49%) government-sponsored and three (2.17%) investigator-initiated projects. Forty-six (33.33%) intended to provide free treatment for a trial-related injury. Forty-two (30.43%) projects did not have any policy about providing treatment for a trial-related injury, whereas several others included statements that intended to provide treatment, but with certain restrictions. Thirty-three (23.91%) ICDs had statements indicating that there was no provision for compensation and 65(47.10%) ICDs stated nothing on the issue. Conclusion : ICDs submitted for initial review are not in conformity with the provisions for treatment of and compensation for research-related injuries enunciated in national guidelines and draft guidelines.

Del síntoma al tratamiento: compra de medicamentos sin prescripción médica / From sympton to treatment: buying of drugs without medical prescription

Con el objetivo de investigar la magnitud de la prescripción de medicamentos en las farmacias sin receta médica se realizó la visita a 50 establecimientos farmacéuticos de la ciudad de Corrientes seleccionados al azar. La investigación consistió en la simulación de una enfermedad por un grupo de alumnos de la Cátedra de Semiotecnia y Fisiopatología, que concurrían a las farmacias solicitando un tratamiento. Del análisis de los resultados obtenidos se observó que en 45/50 (90 por ciento) farmacias se realizó una prescripción de medicamentos, y solo 5/50 (10 por ciento) indicaron específicamente una consulta médica. Ante la requisitoria, 10 de las 45 que medicaron (20 por ciento) indicaron la consulta luego de un período de tratamiento. Del análisis de las indicaciones, 42 de las 45 (93,33 por ciento) son de medicamentos catalogados como de "venta bajo receta". 86,67 por ciento fueron de antibióticos, en monodrogas o en combinaciones fijas, siendo la indicación más frecuente la de una asociación de uno o dos antibióticos con un analgésico urinario. Las drogas más indicadas fueron combinaciones de dos drogas un quimioterápico con una analgésico urinario (37,78 por ciento), y una combinación de tres drogas o dosis fijas (35,55 por ciento), de dos quimioterápicos con un analgésico urinario. No se pudo establecer una relación de costo con la indicación, ya que los medicamentos indicados no eran los más costosos. Se analizan aspectos relacionados al problema estudiado y se realizan propuestas a fin de tratar de conseguir una utilización más racional de los medicamentos