The 21st century has brought a great number of changes to the medical paradigm, however. As the population ages, there are more and more people requiring care; and more who have or are experiencing debilitating conditions that, up to now, have had no medical or pharmacological treatment. The contemporary physician, therefore must respect patient value and individuality, the education of the patient, as well as provide the best service possible under the realities of contemporary medical care. At times, this may result in working with an experimental procedure or drug that may not have predictable effects and may actually go against the medical paradigm of "do no harm," while staying to the letter of the ethical maxim of "intentionally do no harm"
Miller, W. (1985). Herkovits v. Group Health Cooperative: Negligent Creation of Substantial Risk of Injury is a Compensable Harm. Puget Sound Law Review.
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Within any discipline, there are various ethical issues that constitute an overall rubric of the topic. In the case medicine, the thrust of the ethical template surrounds the reasons for, and moral imperatives surrounding the use experimental drugs and/or procedures. There are mandates and global legal maxims in place to protect human subjects; however the very nature of the topic also requires specific ethical paradigms that govern the field: beneficence, justice and autonomy for instance. .Beneficence is the core of the Hippocratic Oath -- "as to disease & #8230; do no harm." Justice -- models fairness and equity in all medical research regardless of race, age, or cognitive ability, and autonomy -- the respect for the individual in making a cogent, informed, and un-coerced decision about their participation in any research project (Timko, 2001). The 21st century has brought a great number of changes to the medical paradigm, however. As the population ages, there are more and more people requiring care; and more who have or are experiencing debilitating conditions that, up to now, have had no medical or pharmacological treatment. The contemporary physician, therefore must respect patient value and individuality, the education of the patient, as well as provide the best service possible under the realities of contemporary medical care. At times, this may result in working with an experimental procedure or drug that may not have predictable effects and may actually go against the medical paradigm of "do no harm," while staying to the letter of the ethical maxim of "intentionally do no harm" (Bleich, 2006).
The idea of physician immunity really began to draw political and media attention with the 1993 Pallin case. Pallin sued fellow doctor Jack Singer for infringing on a procedural patent and focused attention on patents; but more specifically resulting in Congress passing 35 U.S.C. 287 © which made medical professionals and their healthcare entities immune from infringement liability (Dirksen, 2001).
Taking this to a logical conclusion, we must then ask: in an era in which there are more and more experimental procedures and drugs, should a physician be immune from liability for any potential harm in which potential risks have not been discovered?
In Hardi v. Mezzanotte the Physician, Hardi, decided not to utilize a series of typical tests on patient Mezzanotte and made an incorrect diagnosis, resulting in surgical procedures and medical difficulties that caused an additional four operations and three months in the hospital. The Jury was unable to render a verdict, and the Court awarded $900,000 to Mezzanotte. Hardi appealed, but the District of Columbia Court of Appeals affirmed the Court's judgment (Hardi v. Mezzanotte, 2001; Hardi v. Mezzanotte Appeal, 2003).
In Herskovits v. Group Health Cooperative of Puget Sound the claim was made that the physicians at Group Health failed to appropriately diagnose the decedent's lung cancer, reducing chances of surival from 39% to less than 25%. The difficulty arises in the fact that the plantiff was unlikely to survive anyway. The case asks us to look at whether the misdiagnosis was substantial in leading to death. There is a vast difference from reduction of survival to 1-2% than moving from 39 to 25. The Court found that it while there may have been a misdiagnosis, the plaintiff's cancer was serious enough that he would have likely died regardless, and it was not the fault of the diagnosis that the disease progressed. Four of the nine justices, however, believed that there was a legitimate basis for tort recovery based on the diagnosis (Miller, 1985).
Both of these cases ask us to look at intent. Was there intent to harm? In both cases, it does not appear that there was intent to harm either party. In one case, a diagnosis was made based on a set of probabilities but follow up tests were not done. In the other case the diagnosis was incorrectly made but it did not substantially reduce the patient's life expectency. We are asking a very basic question about physicians in both of these cases -- is medicine, particularly diagnosis, an art or a science? If it were strictly a science, then all procedures and conditions would be logical, follow set patterns, and be diagnosable by anyone with the right tools. We know this to be untrue because of the complexity of the human body. Standard of care also implies intent, and since the human body does not react to every situation in exactly the same manner, one cannot expect a physican to have a 100% correct diagnosis or treatment plan. Each individual may, in fact, react to drugs or treatments in different ways based on their own history, genetic make up, health condition, allergies, condition, exercise, etc.
When dealing with an experimental procedure or pharmaceutical, the key is the medical ethics of informed consent, autonomy, and fidelity. Informed consent implies that the physician has explained the risk/reward issue to the patient, that the patient is competent and able to make decisions appropriate for themselves. Autonomy is a concept that allows this same rational person to make an informed, un-coerced, decision on their own, and the medical community to respect that decision. Fidelity implies that there is a truthful connection between doctor and patient, and that the patient's ultimate need comes first (Kamm, 2007).
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