A tumultuous time for MSNJ. Robert S. Rigolosi, MD, discusses events of the past year. Interview by Leah Z. Ziskin.
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These four areas in risk management are most often the cause of failure to eliminate patient risks. If these four major areas were incorporated into the medical student's curriculum or into the continuing educational upgrading of the physician, he would be developing risk control habits as well as knowledge that would allow him to practice quality medicine. He would also be able to enjoy the practice of medicine with less concern for malpractice reprisal and peer review. The ability to minimize the risk of medical care to the patient is an important responsibility of every physician. It is essential for the provision of quality medical care and for preventing or reducing an adversary relationship between the patient-public and the physician.
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Because of its history Germany has many rules concerning the protection of persons in medical research. In fact Germany was the first state to issue a directive regulating medical experimentation with human beings in the year 1900. The ten principles of Nuremberg originated out of the medical case. Germany adheres to the Revised Declaration of Helsinki of the World Medical Association and will probably sign the European convention on biomedicine. The pharmaceutical act contains elaborate provisions for the protection of the patient or proband, e.g. informed consent, risk-benefit ratio, no experimentation on prisoners, approval of a local ethics committee. Moreover in pharmaceutical trials there has to be third party accident insurance for the experimental subject. There is no strict liability for medical experimentation, but the standard of care is high. In general the German law seems to be adequate for the protection of experimental subjects.
Medical malpractice and the problems associated with it remain an important issue in the US medical community. Yet relatively little information regarding the long-term history of malpractice litigation can be found in the literature. This article addresses 2 questions: (1) when and why did medical malpractice litigation originate in the United States and (2) what historical factors best explain its subsequent perpetuation and growth? Medical malpractice litigation appeared in the United States around 1840 for reasons specific to that period. Those reasons are discussed in the context of marketplace professionalism, an environment that provided few quality controls over medical practitioners. Medical malpractice litigation has since been sustained for a century and a half by an interacting combination of 6 principal factors. Three of these factors are medical: the innovative pressures on American medicine, the spread of uniform standards, and the advent of medical malpractice liability insurance. Three are legal factors: contingent fees, citizen juries, and the nature of tort pleading in the United States. Knowledge of these historical factors may prove useful to those seeking to reform the current medical malpractice litigation system.
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Clinical integration of complementary and alternative medical (CAM) therapies, such as acupuncture and traditional oriental medicine, chiropractic, herbal medicine, massage therapy, and "mind-body" therapies, into conventional health care raises important legal and risk management issues. Understanding which CAM therapies patients use is legally prudent, as conventional treatment advice may interact with patients' own efforts toward self-care. In addition, nephrologists may limit potential liability for medical malpractice by classifying any given therapy as follows: (1) the medical evidence supports both safety and efficacy--recommend; (2) the medical evidence supports safety, but evidence regarding efficacy is inconclusive-accept but monitor; (3) the medical evidence supports efficacy, but evidence regarding safety is inconclusive-accept but monitor; and (4) the medical evidence indicates either serious risk or inefficacy--avoid and discourage. Applying this framework whether a therapy is labeled "conventional" or "CAM" is consistent with the key recommendation of the recent report by the Institute of Medicine at the National Academy of Sciences on Complementary and Alternative Medicine, namely, to apply the same principles and standards of evidence of treatment effectiveness to all treatments. Liability risk management also includes going beyond legal and ethical informed consent requirements by engaging the patient in shared decision making concerning all material treatment options, including CAM therapies, if supported by evidence. Physicians further should familiarize themselves with documentation standards suggested by the Federation of State Medical Board Guidelines and whether these are applicable in their state or home institution. These steps aim to enable nephrologists to respond to patient interest in CAM therapies in a way that is clinically responsible, ethically appropriate, and legally defensible.
The legal ramifications of diagnosis-related groups (DRGs) on the health-care system in general and on pharmacists in particular are undetermined. As pharmacists continue to play an increasing role in therapeutic decisions, their exposure to malpractice suits will continue to rise. Pharmacists' liability in medical malpractice actually began prior to the introduction of DRGs, with the adoption by many states of "generic substitute" laws. Situations that can lead to judgments against pharmacists are reviewed. The majority rule of joint and several liability is explained. The conclusion that "DRGs are not a legal defense" is underscored by a dramatic presentation of a hypothetical court case.
In Germany, pharmaceutical trials and the testing of medical devices is regulated by statute. Any other kind of medical experimentation is handled according to the Declaration of Helsinki. Medical experimentation has to be reviewed by an ethics committee before the start and there has to be an elaborate research protocol, which provides for the protection of the experimental subject. In case of an accident, there is compulsory accident insurance as far as pharmaceutical trials and the testing of medical devices are concerned. The third party accident insurance just covers material loss, there is no provision paying and suffering. The sum paid by the insurance company is set off against damages for negligence. There is no strict liability for medical experimentation, but the German courts are expected to set very high standards for medical care in experimentation. The data protection and medical confidentiality have been lessened because of the European law that requires the experimental subject to give his consent to the inspection of the data or the file and if he takes part in the experimentation, that his data and some of his cells might be with the pharmaceutical company forever. In general, the German law seems to be adequate to the protection of experimental subjects.
Medical professional liability insurance (also known as malpractice insurance) is designed specifically to protect physicians, clinics, hospitals and health care facilities, and other health personnel in the event that a patient files a claim against them, alleging negligence, with resulting injury or harm. It is one of the largest expenses for any medical practice and is a high priority concern of every physician. The market for this insurance, the approach to evaluating it, and the cost of it have changed dramatically in the last 20 years.
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Advances in medical science have done much to improve the quality of life but in some cases medical treatment may result in the prolonging of death rather than the enhancement of life. Patients may wish to refuse or withdraw from medical treatment even though they realise that this will lead to an early death. Medical attendants may, however, see it as their legal or ethical duty to impose medical treatment in the interest of preserving life. At a broad level two crucial interests come into headlong conflict--the patient's right to self-determination and society's interest in the preservation of human life. In this article the legal principles which are invoked to resolve this conflict both at common law and under recent Victorian legislation, the Medical Treatment Act 1988, are discussed and the thesis advanced that, in relation to competent patients, the law favours the right to self-determination.
Some patients who attempt suicide refuse treatment. These patients are invariably treated if brought to hospital. There are several reasons for this. These reasons justify the treatment of many of these patients, but not all. Some patients who attempt suicide ought to be allowed to die. My argument for this claim turns on judging some patients who attempt suicide to be sufficiently competent and rational be allowed to die.