Implanting Artificial Hearts

This paper will discuss the issues involved in human experimentation with regard to the implantation of artificial hearts. The first part of the paper will examine the issue of informed consent in this area. The second part of the paper will discuss the federal regulations regarding the experimental procedure of implanting artificial hearts, how these regulations are enforced, and how they affect research in this area. The third part of the paper will discuss the laws concerning medical devices and artificial hearts, including the federal regulation of such devices.

The general rule in all cases involving medical treatment is that the prior consent of the patient is required in order for a physician to provide such treatment. Schloendorff v. New York Hospital, 211 N.Y. 125, 105 N.E. 92 (1914). The patient must be advised of the nature and the risks of the proposed treatment in order for the consent to be valid. Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972), cert. denied, 409 U.S. 1064 (1972). There has traditionally been confusion as to whether the doctrine of informed consent was rooted in assault and battery or negligence. Most courts now reserve the assault in battery theory for those cases where the patient did not consent to the procedure performed. Negligence has become the basis for cases where the consent was obtained without the physici

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al Regulations Concerning Artificial Heart Transplants Federal regulations govern the use of human subjects in medical research. The principle protection afforded patients/subjects in these situations is the requirement that all research funded by the government be reviewed and approved by an Institutional Review Board (IRB). 46 C.F.R. º 46.103 (1987). Since the use of artificial hearts is experimental but therapeutic in nature, it is unclear whether these regulations apply to such transplant operations. The primary requirement of these regulations is that the patient/subject give informed consent to the procedure. As discussed above, this means that the physician must provide the patient/subject with enough information concerning the risks of the operation and the experimental nature of the procedure. See 46 C.F.R. º 46.116 and 21 C.F.R. º 50.20 (1987). These regulations are enforced by the agencies charged with enforcement, principally the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS). Patients or their families may bring actions for failure on the part of the physician to obtain informed consent, but such actions are based upon state tort law, rather than federal administra
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Approximate Word count = 1900
Approximate Pages = 8 (250 words per page)