Human Experimentation: A Legal & Ethical Review of Implanting Artificial Hearts in Human Beings
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 physician making the proper disclosure to the patient (the patient was given too little information to be able to give an informed consent). 1 Med. Malpractice ¦ 8.06 (1993).
Two standards have been developed as to what constitutes informed consent. The first, or "professional" standard says that the scope of the physician's duty to disclose is determined by the prevailing medical practice in the community. The physician has the duty to disclose the risks which a reasonable phy...