Kenneth A. De Ville

Bioterrorism and patent rights: "Compulsory licensure" and the case of cipro

This paper discusses ethical and policy issues relating to the U.S. governments decision not to override Bayers patent on Cipro in response to increased demands for the drug in the wake of the anthrax bioterrorism scare. Although the government had the legal authority to override the patent, the decision to not override the patent was morally justified. What is true for Cipro is also true for most other patented pharmaceutical agents. While the federal government clearly possesses the legal power to use and sanction the use of patented intellectual property without the consent of the patentee, this authority should be exercised only sparingly with regard to pharmaceutical products. Instead, government policy makers should maintain a strong presumption against overriding patents, and are morally justified in overriding patents only if the action satisfies five stringent conditions: 1) the medication plays a key role in the governments response to a bona fide national medical emergency; 2) there are no alternative remedies; 3) negotiations made in good faith to obtain the medication or a license to produce the medication have failed; 4) the government compensates the company nonetheless; and 5) the action is limited in time or has a sunset clause. We recognize that this series of threshold tests, if followed, will limit government action against pharmaceutical patents in all but a few cases, but believe that moral considerations and overall social good warrant these narrow and exacting criteria.

Act First and Look Up the Law Afterward?: Medical Malpractice and the Ethics of Defensive Medicine

This essay examines the so-called phenomenon of ‘defensive medicine’ and the problematic aspects of attempting to maintain the safest legal position possible. While physicians face genuine litigation threats they frequently overestimate legal peril. Many defensive practices are benign, but others alter patient care and increase costs in ways that are ethically suspect. Physicians should learn to evaluate realistically the legal risks of their profession and weigh the emotional, physical, and financial costs to the patient before employing a defensive measure.

Fetal Protection in Wisconsin's Revised Child Abuse Law: Right Goal, Wrong Remedy

Authors examine Wisconsins recent revision of its child abuse and protection laws to address substance abuse by pregnant women. The new statute enables the state to take the fetus into protective custody. Authors argue that approaching fetal protection using a child abuse model creates a series of symbolic, conceptual, and practical problems of such severity as to undermine its justifiability as a public health measure.

The Role of Litigation in Human Research Accountability

This essay examines and analyzes the recent and dramatic series of personal injury lawsuits instituted against those individuals and institutions that conduct and monitor human research. It discusses the social engineering functions of tort litigation, outlines the legal elements and viability of lawsuits against those who conduct and monitor human research, and evaluates and predicts what role tort litigation will play in fulfilling the goals of accountability in the context of human research and human research regulation. In general, tort law engenders two forms of accountability: retrospective and prospective. Retrospective accountability is backward looking, focusing on harms that have already occurred, their culprits, and the reimbursement of individuals for their injuries. Prospective accountability is forward looking in that it encourages actors and institutions to fulfill responsibilities toward individuals in order that harm does not occur, or at least that the risk of harm is decreased. This article argues that research litigation is not, and will probably never become, an effective means of ensuring retrospective accountability in regard to research injuries and ethical violations. Paradoxically though, the current wave of research litigation may serve an important and even key role in encouraging and ensuring prospective accountability.This essay examines and analyzes the recent and dramatic series of personal injury lawsuits instituted against those individuals and institutions that conduct and monitor human research. It discusses the social engineering functions of tort litigation, outlines the legal elements and viability of lawsuits against those who conduct and monitor human research, and evaluates and predicts what role tort litigation will play in fulfilling the goals of accountability in the context of human research and human research regulation. In general, tort law engenders two forms of accountability: retrospective and prospective. Retrospective accountability is backward looking, focusing on harms that have already occurred, their culprits, and the reimbursement of individuals for their injuries. Prospective accountability is forward looking in that it encourages actors and institutions to fulfill responsibilities toward individuals in order that harm does not occur, or at least that the risk of harm is decreased. This art...

Bariatric Surgery, Ethical Obligation, and the Life Cycle of Medical Innovation

Many ethical questions raised in the first category can be adequately addressed without taking a wider social perspective. Hofmann does a thorough job of identifying these questions, many of which occur in the ethical analysis of any medical treatment or surgical procedure: risk/benefit analysis, issues surrounding consent, concerns about the profit motivations of physicians and their relationship with industry, and the special considerations that arise when treating children. Other questions that arise in a clinical setting, however, cannot be adequately addressed without considering how they parallel those at play in wider population-level responses to the obesity epidemic. Concerns about access to the procedure, cost-effectiveness, and pervasive fat discrimination hold on both levels. However, acknowledging the social dimensions of these issues may significantly alter our conclusions. For example, viewing bariatric surgery as part of a public health response to the obesity epidemic mitigates some concerns about access to the procedure because there will be alternatives available to affected populations. Similarly, if full-scale public health initiatives were mounted, the comparative cost-effectiveness of various treatments, including bariatric surgery, might change dramatically. So, rather than pointing out the need for additional research on bariatric surgery, the call should be for additional study of all the possible parts of a public health response and new comparative analysis. Bariatric surgery is, by nature of its costs and risks, a limited and short-term “solution” to the problem of obesity. It is limited in that it ought to be regarded as a lastresort strategy for a relatively small number of adults who are already seriously obese and whose health is significantly compromised as a result. The risk-benefit calculus, and hence the presumption of legitimacy, changes significantly as one departs further from this kind of paradigm case. Bariatric surgery is short-term in that it is highly individualized (rather than population-based) and focused on post facto treatment (rather than prevention). As such, it should not be the sole, or even primary, response to a genuine public health crisis. It is critical that the social sources of the obesity epidemic be taken seriously in order to prevent a skewed analysis of bariatric surgery that vastly overestimates its potential as a solution.

The Case Against Contract: Participant and Investigator Duty in Clinical Trials

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The Contemporary Debate Over Physician-Assisted Suicide

The debate over physician-assisted suicide is momentous, complex, and contentious. Since ancient times reasonable and informed people of good will have disagreed about the permissibility of suicide, assisted suicide, and physician-assisted suicide and discussed the proper legal, ethical or professional response to people prepared to assist others with suicide or euthanasia. Some Hippocratic writings instructed early physicians about how to help patients who might wish to commit suicide or relieve their suffering through euthanasia. Yet the influential Hippocratic Oath from the same period forbids doctors from participating in such activities. Some philosophers, including Plato and Aristotle, offered principled objections to suicide or killing even for merciful reasons, while other early philosophers, most notably the Stoics, defended the rationality of such policies in some cases.

Nothing to Fear But Fear Itself: HIV‐Infected Physicians and the Law of Informed Consent

n March 9, 1993, in the first ruling of its kind, the Maryland Court of Appeals declared that phy0 sicians and hospitals may be sued for failing to inform patients of a practitioner’s human immunodeficiency virus (HIV) status.’ What is more significant, these suits may be pursued even in instances when the physician has followed universal precautions and the patient did not contract the virus that causes acquired immunodeficiency syndrome (AIDS). The Maryland court addressed two central questions in Faya v. Almaruz. First, do HIV-infected physicians have a legal duty to inform their patients of their HIV status? And, second, can patients recover damages for fear induced by a physician’s conduct? While one finds numerous precedents that authorize actions to recover damages based purely on fear of disease and emotional distress, the Faya court’s holdings on the issue significantly expand the scope of potential liability. Moreover, the court’s analysis of the informed consent and HIV-infected physician issue is incomplete, inconsistent, and represents an unjustified and unwise departure from traditional informed consent theory. It, and its progeny, may have widespread and dire repercussions.

Physician-assisted suicide : What are the issues?

Acknowledgements. The Contemporary Debate over Physician-Assisted Suicide L.M. Kopelman, K.A. De Ville. On the Permissibility of Physician-Assisted Suicide. Physician-Assisted Suicide and Euthanasia: Another Battle in the Culture Wars H.T. Engelhardt, Jr. Refusals/Withdrawals and Physician-Assisted Suicide R.G. Frey. Physician-Assisted Suicide - The Worry About Abuse D.W. Brock. Challenging the Case for Physician-Assisted Suicide. Is There a Slippery Slope From Suicide, to Assisted Suicide, to Consensual Euthanasia? R.L. Holmes. Does Physician-Assisted Suicide Promote Liberty and Compassion? L.M. Kopelman. Job Openings for Moral Philosophers in Oregon: Physician-Assisted Suicide and the Culture of Romantic Rescue L. Zoloth. Physician-Assisted Suicide: Views from the Clinic. Physician-Assisted Suicide - A Clinicians Perspective G.J. Povar. Physician-Assisted Suicide: The Culture of Medicine and the Undertreatment of Pain D.B. Resnik. Managed Health Care at the End of Life S.H. Miles. Visions of the Future for Physician-Assisted Suicide. Physician-Assisted Suicide and the States: Short, Medium, and Long Term K.A. De Ville. Safe, Legal, Rare? Physician-Assisted Suicide and Cultural Change in the Future M.P. Battin. A Proposal for Legalizing Assisted Suicide and Euthanasia in South Africa W.A. Landman. Notes on Contributors. Index.

Physician-Assisted Suicide and the States: Short, Medium and Long Term

In Washington et al v. Glucksberg et al. and Vacco, Attorney General of New York et al. v. Quill et al., the United States (U.S.) Supreme Court was asked to determine whether a state’s criminal prohibition of assisted suicide violated the Fourteenth Amendment of the U.S. Constitution. The court held that it did not (Glucksberg, 1997; Vacco, 1997). Simply stated, the court’s June 1997 decisions in these two cases mean that the physician-assisted suicide (PAS) debate will move to state legislatures, to the realm of moral and social debate and to the arena of criminal and civil law. It is now within the power of voters and state legislatures to grant citizens legal access to physician-assisted suicide. Whether they will do so though, and how assisted suicide will actually evolve in practice will depend on an interlocking complex of social, legal and professional factors. Both the law as written and the law as practiced are influenced by the endemic social, legal and medical professional contexts in which the law is applied.