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Legal liability for injury to research subjects.

In Weiss vs Solomon, the heirs of a subject who died while a volunteer in a nontherapeutic study successfully sued the investigator and his university-affiliated hospital. Without referring to any 'standard of practice', including the MRC Guidelines, the judge found the principal investigator and the hospital (for its research ethics committee) equivalently responsible for not disclosing a rare but fatal complication caused by fluorescein dye and not adequately screening the subject, who suffered from undisclosed hypertropic cardiomyopathy. From the point of view of research institutions, members of research committees, and the investigators themselves, the judgement has left serious uncertainty and ambiguity concerning their responsibilities for subject selection and safety, and disclosure for the purposes of informed consent.

Clinical Trials as Topic↗

[Legal liability of the hospital].

Civil liability of the hospital institution for damages due to hospital treatment means liability for malpractice by the hospital staff. Such liability depends on whether the mistake was made during inpatient or out-patient care; it further depends on the hospitalization contract. If a health-service patient or a private patient has been harmed during treatment in a hospital, the hospital institution is liable for all staff members including the coordinator of the medical staff. However, if the hospitalization agreement stipulates that the coordinator of the medical staff shall be the contracting party only with respect to medical treatment, the hospital institution is not liable for the coordinator's behaviour. In case of outpatient treatment, the hospital institution is liable only for medical treatment provided by the hospital itself (i.e. in case of out-patient surgery) and not for medical treatment within the coordinators own out-patient department. The hospital institution has to organize the hospital's activities properly to avoid liability for faulty organisation. I.e the hospital institution has to provide sufficient staff out of office hours, to lay nonskidding floors or to instruct the staff properly in case a patient wishes to make his last will and testament. Regardless of a fault, the hospital institution is always liable for use of defective medical instruments. The hospital institution may try to avoid liability for tort (including compensation for immaterial damage) by proof of proper selection and supervision of the staff. However, such relief is very difficult and not available for key personnel.

Germany↗

[Legal liability in drug trials].

Studies on humans are carried out in all nations with scientific trials. These studies are concerned with all kinds of goals, i.e. pharmacological treatment procedures. This necessitates clinical and pharmaceutical testing on healthy volunteers or patients. Lawyers watch over the activities of the clinical drug testing. The participation on human tests requires voluntariness and information. The documentation of the voluntariness and the information about goals, methods, and risks are very important.

Adult↗

[Legal liability in clinical trials from the viewpoint of the clinician].

After a long-term work in the U.S., the liability for clinical trials is explained. The researching physician carries the responsibility for new drugs. He has to apply for the license for the study by the appropriate authority and he carries the responsibility for the consent of the volunteers which have to be informed before the trial. The studies initiated by the pharmaceutical companies relieve the researching physician from some of the responsibilities. They exert a strong control during the drug tests. The researching physician has the responsibility as a "scholarly mediator". The ethic commission inspects all stages of the study.

Attitude of Health Personnel↗

[Legal liability in suicide risk from the physician's viewpoint].

Liability after physical harm or death due to a suicide attempt is mainly caused by an insufficient medical care. This is true when the known rules regarding recognition and assessment of a possible suicide as well as the selection and the realization of securing actions are not observed or deviation from such actions cannot be explained. However, such deviations have to be possible within the scope of the physician's latitude since the recognition and the treatment of a possible suicide are linked to the multitude of the actual and individual situations. The necessary risk-benefit assessment may be very difficult regarding the necessary securing actions as well as regarding the treatment.

Germany↗

[Legal liability in failed sterilization from the physician's viewpoint].

Recanalization of oviducts as well as spermatic ducts occur at a low promille rate after sterilization even if correctly performed. Therefore, pregnancies after unsuccessful sterilization cannot be taken as an immediate proof for a faulty surgical procedure. The surgeon is recommended to have the correctness of a sterilization confirmed in writing by competent witness of the operation (assistant doctor, nurse). Whenever possible, tissues of the occluded organs should be sent to the pathologist for histologic proof. In addition, special attention must be payed to a proper information of the patient on the failure rate in order to avoid the risk to become sued subsequently for incomplete information if the woman becomes pregnant. In the German jurisdiction, a child born after a faulty performed sterilization is classified as damage or cause of a damage according to the law of contract. Based on this judicial principle, a physicians may be sentenced to pay alimonies. This is felt by many physicians as an abasement of their professional engagement. It is also criticized, that suffering from an unwanted but otherwise normal pregnancy following faulty sterilization entitles a woman to financial compensations. Very recently, judicial differences in this respect have become known between the Federal Constitutional Court and the Federal Court. At present, it is still open which of the judicial points of view will finally predominate.

Attitude of Health Personnel↗

Reuse and reprocessing of disposable medical devices. Legal liability issues.

Reuse and reprocessing of disposable medical devices raises issues of legal liability, especially among physicians, hospitals, and device manufacturers. The practice of reuse has been, at least informally, reported to be fairly widespread. However, the medical risks associated with reuse are unresolved in most cases, which may lead to circumstances conducive to litigation. In this paper, the characteristics of reuse pertaining to legal liability, the parties potentially subject to civil liability suits as a result of reuse, the legal theories underlying claims of injury, and the legal implications of possible policy actions will be examined.

Disposable Equipment↗