Analysis of Legal Liability in Medical Accident due to Nursing Practice through Precedents / 대한법의학회지

These days, medical practice tends to be highly specialized and divided into qualified medical personnel, including nurses. Recent amendments of medical law show the change of the nurse's role in medical practice. Traditionally, nursing has been an aid work to doctor's practices and is one of the core parts of medical practices. Nurses are a skilled occupational group and individuals are trained and licensed as professionals during their educational courses under government supervision. Because all of the nursing practices cannot be directed or recognized by doctors and nurses are building their own expertise as healthcare providers, they can be held accountable in medical malpractice. In the past, from the perspective of legal responsibility, the nurse was only regarded as an assistant to a doctor; hence, a nurse's malpractice was concluded as a supervising doctor's liability. In the case of medical malpractice caused by nurses, the range of responsibility will be different, depending on the scope of the work carried out by nurse and whether it was supervised by a doctor. Therefore, further discussion is needed regarding the scope of independent nursing practice in order to distribute the legal liability. The authors reviewed ten cases of precedents of medical dispute, examined the events in-depth, and analyzed the court rulings determining the legal responsibility of a doctor or nurse.

Pharmaceutical Analysis of Judicial Precedents Involving Off-label Drug Use / 中国药学杂志

OBJECTIVE: To analyze 13 judicial precedents involving off-label drug use and explore the legal interpretation on off-label drug use in China in order to provide experience for establishment of off-label drug use and clinical application. METHODS: Based on the law databases (China Judgements Online, Chinalawinfo, Jufaanli, Itslaw), 13 cases were searched and screened involving legal off-label drug use. The relationship was investigated and discussed between different results and characteristics of the 13 cases. RESULTS: In 13 cases, there are 2 cases probably reasonable for off-label use, 2 cases unreasonable but not correlated with patients′ outcomes, 9 unreasonable and with a causal relationship with patients′ outcomes. In the 9 unreasonable cases, there are 4 cases without sufficient evidence, 3 cases without informed consent, 1 case lack of monitoring after off-label use, 1 case with idiosyncratic reaction, and 1 case not consistent with the label of the drug used. CONCLUSION: Major deficiencies of off-label drug use in China are without sufficient evidence, lack of informed consent and with uncompleted system on off-label drug use. Establishing more completed and detailed system, investigating enough clinical evidence, better informed consent and monitoring after off-label use are important measurements to ensure safety on off-label drug use.

Legal Aspects of Medical Records / 医学教育

This paper discusses medical records, which are often disputed during lawsuits and play an important role in the factfinding process. There have been no published reports of problems related to medical records or concrete measures to deal with these problems on the basis of a review of judicial precedents. To avoid lawsuits, medical records should be considered in the context of judicial precedents (previous court rulings). The present paper therefore analyzes basic matters related to medical records that were disputed during lawsuits, in relation to judgments obtained in previous court rulings, to determine the judicial role of medical records and their ownership. Although the ownership of medical records is unclear, we believe that patients have some ownership rights over their medical records, that hospitals are responsible for the control of the records, and that physicians have the obligation to use and prepare them. Therefore, medical records can be seen as being jointly owned by the medical care provider and the patient. Analysis of relevant judicial precedents has also allowed us to clarify essential points related to avoiding lawsuits.