bluuebunny/crossref_metadata_2025 huggingface dataset:
The Legal Status of Unapproved Generic Drugs
Authors: Abood Richard R.
Published: June 2007

Generic drugs that have not been specifically approved by the Food and Drug Administration (FDA) are today being marketed, and considerable legal controversy surrounds the issue of whether the FDA can require premarketing approval of generic copy drugs (“me-toos”).

Prescribers and dispensers of drugs cannot blindly assume that every drug on the market has been approved by the FDA, and that it will be safe and effective, as can be seen from the following incident. In September 1981, in an unprecedented action, an Ohio grand jury indicted a pharmacist for manslaughter in the death of a woman to whom he sold a furosemide product unapproved by the Food and Drug Administration. The woman died of congestive heart failure and the grand jury found probable cause that the death was caused by the diuretic. The drug was dispensed despite a March 30,1979,news release from the Department of Health, Education and Welfare warning that unapproved furosemide tablets were being marketed and that these drugs might be ineffective and could possibly be harmful.
Health Law Teachers and ASLM: A New Alliance
Authors: Canny Julie
Published: June 2007

In an effort to broaden its scope in the area of medicolegal education, the Executive Committee of the American Society of Law & Medicine voted in Cktober 1981 to establish a Health Law Teachers Section for its members who teach health law related courses in any school of law, medicine, public health, health administration, or nursing.

Angela R. Holder, J.D., LL.M., Treasurer of the Society and Counsel for Medicolegal Affairs and Associate Professor at Yale University School of Medicine, recommended that the Society expand its efforts to assist multidisciplinary individuals who share a common interest—education. While the Society was a co-sponsor of a 1980 Health Law Teachers Workshop, chaired by George J. Annas, J.D., M.P.H., of Boston University School of Medicine, the Society had not given formal, organized attention to the specialized needs of health law teachers.
“If You Prick Us, Do We Not Bleed?”: Of Shylock, Fetuses, and the Concept of Person in the Law
Authors: Baron Charles H.
Published: June 2007

The focus of the abortion debate in the United States tends to be on whether and at what stage a fetus is a person. I believe this tendency has been unfortunate and counterproductive. Instead of advancing dialogue between opposing sides, such a focus seems to have stunted it, leaving advocates in the sort of I did not—You did too impasse we remember from childhood. Also reminiscent of that childhood scene has been the vain attempt to break the impasse by appeal to a higher authority. Thus, the pro-choice forces hoped they had proved the pro-life forces wrong by having had the Supreme Court of the United States decide inRoev. Wade that a fetus is not a person for purposes of the fourteenth amendment. Now the pro-life forces are trying to prove the pro-choice forces wrong by passing legislation or a constitutional amendment that declares a fetus to be a person after all
Antitrust Law and Exclusive Contracts: Obstacles to Patients' Benefits?
Authors: Nord Robert E.
Published: June 2007

Antitrust challenges to agreements between hospitals and physicians who provide patient services have become one of the most common types of antitrust litigation in the past few years. Two recent decisions by different circuit courts of appeal highlight the legal and medical principles on which such disputes will be decided.

In August 1982, the United States Court of Appeals for the Seventh Circuit vacated a preliminary injunction entered in favor of an individual anes-thesiologist who had complained that after an anesthesia group terminated her employment, the hospital wrongfully refused to allow her to continue to serve patients. The Seventh Circuit, in Dos Santos v. Columbus-Cuneo- Cabrini Medical Center, expressed serious doubt whether under antitrust analysis, a single hospital could ever be treated as a distinct market for the purchase and sale of health care services. The court remanded the case to the federal district court, where it is still pending.
Reporting and Review of Patient Care: The Nurse's Responsibility
Authors: Katz Barbara F.
Published: June 2007

The guidelines for the nursing staff of a health care facility in Boston include the following statement:

It is the intent of Massachusetts Law that physicians (and their employers when applicable) are ultimately responsible for the practice of medicine. Consistent with the Law it ispolicy that medical orders by the physician members of the staff are to be questioned by other members of the staff only if they are incomplete and inconsistent with accepted standards of practice or there is sound basis for believing that carrying out the orders would cause severe and ineversible ham to the patient. Normally, any questions about the manner in which medicine is practiced are to be brought to the attention of the Executive Director (a nonphysician) through the appropriate coordinators/supervisors. The Director will adequately consider all such questions and take any necessary action.
Considering a New Structure: The Health Services Holding Company
Authors: Kerr Frederick H.
Published: June 2007

American hospitals are in turmoil, experiencing declines in community esteem, reductions in Medicare payments, pressure for cost control by employers and insurers, and internal conflict between managements and medical staffs. Each of these conflicts is simply another facet of an overall problem: American society's recently conceived notion that unlimited access to the best available health services constitutes a right. Americans have adopted this idea, however, without considering the economic consequences in an environment of rapidly advancing technology and an aging population. Costs have escalated rapidly, reaching ten and one-half percent of the gross national product; the health services system is in strong competition with other important societal segments for scarce resources. The money may not be running out, but a rather naive institution, the community hospital, has suddenly found itself in an environment for which it is ill-prepared.

Governmental licensure of health professionals has a long history, but significant federal intervention in hospital financing did not begin until after World War II with the advent of the Hill-Burton program, which provided funds for hospital expansion. Medicare introduced federal payment for hospital care provided to the elderly and used formulas for cost reimbursement in 1966.
Preventive Medicine and Preventive Law: An Essay That Belongs to My Heart
Authors: Brown Louis M.
Published: June 2007

This essay reflects my experiences as an open heart surgery patient. It also makes some comparisons of the roles of lawyers and doctors. The skills of the medical profession in pursuing the concept of preventive medicine have for more than three decades stirred my interest in developing the concept of preventive law.

As is my custom, aided by the good practices of my personal physician for a decade, I received an annual medical examination on Tuesday, June 8, 1982. The preliminary results were reported to me with the customary comment that I would receive the complete results in a few days. I did notice a slight downcast expression on the good doctor's face as he looked at the electrocardiogram, but I remained silent. The E.K.G. included a four-minute bicycle exercise. For most previous years, the exercise was the Master's two-step test so I did not have a good basis of comparison of this year's test with my previous E.K.G.s. I excused the slight difference that I felt this year on the basis that each year I am getting older.
The Liability of the Occupational Health Nurse
Authors: Bowyer Elizabeth A.
Published: June 2007

Occupational health nurses exercise their professional skills in positions of enormous responsibility. An occupational health nurse works in industry or business, either alone or as part of a team, to ensure workers’ health and safety. Management is ultimately responsible for providing a safe and healthful work environment, and employs nurses and other professionals to provide health services for workers and to meet the mandates of the Occupational Health and Safety Act of 1970, which has imposed many responsibilities on employers and occupational health professionals.

Highly specialized professional nurses in recent years have gained recognition of their expanded responsibility, autonomy, and accountability. At the same time, an increased number of nurses have been named individually as defendants in negligence or malpractice actions. Occupational health nurses may become particularly vulnerable to a disproportionate number of malpractice suits, as a result of factors ranging from the independent setting in which occupational nurses work to the interplay of laws affecting workers and employers.
Reporting Incompetent Physicians: A Comparison of Requirements in Three States
Authors: Fama Andrew J.
Published: June 2007

Physician incompetence and impairment have become one of the most controversial issues of recent years in the health care industry. Legislators, attorneys, and the general public have become actively involved in an area which had previously been within the exclusive (and oftentimes clandestine) province of hospital administrators and medical staffs. As a result of increasing public awareness, the informal and unstructured system of the past has been transformed into a more organized, results-oriented, and equitable approach to a problem which, many now realize, cannot be ignored.

Several state legislatures have enacted statutory provisions relating to the investigation and reporting of incompetent physicians. Some, like New York, have begun working closely with the state medical societies to ensure what these physicians are not only disciplined, but also treated and made to realize that their impairment can be resolved by cooperating with those who want to help. Other states, like Massachusetts, have devised regimented reporting requirements, but have overlooked the need for early investigations of, and assistance to, impaired physicians.
The Living Will from the Nurse's Perspective
Authors: Cohn Sarah D.
Published: June 2007

A living will is a directive from a competent, seriously ill individual to medical personnel and family members regarding the treatment he wishes to receive when he becomes incompetent to make decisions for himself. It is important to remember that a living will is not necessary when an adult is competent and chooses to refuse treatment since it is clear that generally, an adult, whether critically ill or not, may refuse any treatment for any reason. A living will is applicable only when a previously competent patient is seriously ill and incompetent.

Recent concern about new medical technologies which can prolong the dying process without improving the quality of life has sparked interest in rhe living will. More than five million copies of sample living wills have been distributed throughout the country, often by churches and senior citizens groups. State governments have also responded to this interest; the first Natural Death Act was signed into law in California in 1976. Since then, thirteen states and the District of Columbia have passed similar legislation, sometimes referred to as right-to-die statutes (see table accompanying this column).
Biological Monitoring and Genetic Screening in the Industrial Workplace: A Synopsis and Analysis
Authors: Field Robert I.
Published: June 2007

Can new medical technologies decrease the incidence of occupational disease? Do they work to the detriment of other worker interests? Do they shift the burden of maintaining a healthy workplace from employers to employees, by keeping sensitive individuals from jobs that they are otherwise qualified to perform? These are among the central issues presented by the emerging occupational use of biological monitoring and genetic screening, as highlighted at the conference on Biological Monitoring and Genetic Screening in the Industrial Workplace, held in Washington, D.C., on May 12-13, 1983. The meeting was sponsored by the American Society of Law & Medicine and the Boston University Schools of Law, Medicine, and Public Health.

Research in progress on these issues, at the Center for Law and Health Sciences at Boston University School of Law, was one of the motivating forces for the conference. With funding from the National Science Foundation and the National Endowment for the Humanities, the study, led by Professor Michael Baram, LL.B., of Boston University School of Law, is providing a comprehensive overview and analysis of the major philosophical, ethical, and legal issues involved.
Adult Protective Services: Convincing the Patient to Consent
Authors: Kapp Marshall B.
Published: June 2007

Adult protective service systems in many of our states have been subjected to a good deal of public criticism. Much of this denunciation, particularly that emanating from civil libertarians who advocate on behalf of the legal and ethical rights of older citizens, centers on the legal aspects of protective services, and especially on the legal authority of the state to intervene unilaterally in the private life of an unwilling, protesting older individual.

Except in the most compelling of circumstances, society should avoid the coercive elements of protective services. Often overlooked, however, by commentators, policy-makers, and caregivers alike, is that protective services may be, and in the vast majority of instances are, accepted voluntarily (and gratefully) by the older recipient. A mentally competent individual may voluntarily give informed consent in the medical sphere, as well as in others, to the receipt of services that he or she currently needs. Additionally, legal mechanisms frequently enable a competent independent adult to foresee and prepare for the possibility that he or she might become incompetent and dependent, by providing for a substitute decisionmaking process of the individual's own choosing.
Should Hospitals be Responsible for Informed Consent?
Authors: Greenlaw Jane
Published: June 2007

Does a hospital bear a responsibility independent of that of the attending physician to ascertain that a patient has given an informed consent? Until recently, state appellate courts have provided a decidedly negative answer to this question. However, in Magana v. Elie, an Illinois appellate court recently adopted a different position, opening the door to a new area of hospital responsibility and, therefore, increased potential liability for hospitals. This column provides a brief review of the informed consent doctrine, discusses the traditional and the Magana approaches to the issue of hospitals‘ responsibility to obtain informed consent, and analyzes the implications, particularly for nurses, should the Magana approach be more widely followed.
Mandated Benefits: Their Social, Economic, and Legal Implications
Authors: Heitler George
Published: June 2007

Expenditures for health care have reached a point where they represent almost 10 percent of the gross national product; health care has become one of the country's largest industries. Moreover, the cost of health care continues to increase more rapidly than inflation. Many policy makers and critics of the health care system believe that the promotion of competition among health care providers can be instrumental in keeping the price of health services down.

The health care boom and ever accelerating health care expenditures have stimulated the availability of new providers, and many hope that these alternative providers will enhance competition in the health care system. Non-physician practitioners, such as podiatrists, optometrists, chiropractors, and nurse-midwives, and such non-traditional delivery mechanisms as health maintenance organizations (HMOs), preferred provider organizations (PPOs), ambulatory surgical centers, and birthing centers, have been gaining increasing support at both the federal and state levels of government. Proponents believe that these alternative providers and mechanisms not only produce more options for consumers but also help contain the cost of health care in the United States.
Is the Need for Treatment Constitutionally Acceptable as a Basis for Civil Commitment?
Authors: Appelbaum Paul S.
Published: June 2007

A number of indications suggest that we may be on the verge of another massive shift in the orientation of our system for the civil commitment of the mentally ill. After nearly one and one-half centuries during which commitment criteria were based on the mentally ill person's need for care and treatment, the late 1960s and 1970s saw a rejection of this standard in favor of criteria based solely on the individual's dangerousness to self or others. Now, in the 1980s, we are witnessing an outcry against dangerousness-oriented standards and the beginnings of a return to a need-for-treatment model.
Hospital-Sponsored Preferred Provider Organizations
Authors: Roble Daniel T. , Knowlton William A. , Rosenberg Gary A.
Published: June 2007

The recent growth of new forms of health care delivery has been encouraged by the increase in competition in the health care industry. Several factors account for this increase in competition. First, there is an overabundance of physicians in many areas of the United States. In addition, many overbedded hospitals now compete for the same patients to fill their beds. Finally, health maintenance organizations and other alternative delivery systems, such as ambulatory surgical care centers, ‘surgicenters,” and birthing centers, are capturing more of the patient market and reducing hospital inpatient utilization.

Employers, insurers, and the government, as the third-party payers who most often pay for an individual's medical care, hope to take advantage of this new competitive environment and to moderate the increase in their health care expenditures.
The Emergence of Institutional Ethics Committees
Authors: Cranford Ronald E. , Doudera A. Edward
Published: June 2007

The institutional ethics committee an entity that many have long believed capable of solving many of the medical, legal, and ethical problems that exist in modern health care-is now being adopted by increasing numbers of institutions. Utilized sporadically since the 1970s, ethics committees began to receive renewed and heightened attention in late 1982. Cases such as those in Los Angeles where two physicians who were charged with first degree murder for removing, at the request of the family, intravenous feeding tubes, from a comatose, severely brain-damaged patient, the Infant Doe case from Bloomington, Indiana, and the more recent case of Baby Jane Doe from New York State, have generated an enormous amount of interest and publicity and provided a new impetus toward institutional ethics committees.
Nursing Negligence in the Hospital Emergency Department
Authors: Greenlaw Jane
Published: June 2007

The hospital emergency department- those who receive care there and those who provide it-has changed rapidly in recent years. The number of patients going to emergency departments is steadily increasing, and the care which they seek is not confined to traditional emergency care. More and more patients utilize the hospital emergency department for routine health problems, either as substitutes for personal health care providers or as replacements when their own providers are unavailable.

Physicians, nurses, and other health care providers in the hospital emergency department have changed from generalists to emergency care specialists. The rotating, on-call staff physician serving in a department with low priority is being replaced by the emergency medicine practitioner. Since 1980, the American Board of Emergency Medicine has been certifying physicians qualified in this new specialty, and the Emergency Department Nurses’ Association has been administering an examination for certification in emergency nursing.
Mental Hospital Regulation and the Safe Environment: Liability for Sexual Assault
Authors: LeGrand Camille
Published: June 2007

A recent spate of allegations of sexual assaults by patients and staff upon mental patients has led to several lawsuits against hospitals. Research in this area has uncovered what appears to be a common but largely unacknowledged problem in mental hospital administration: hospitals sometimes fail to protect their mental patients from sexual attack. A study funded by the National Institute of Mental Health and conducted by the Institute for the Study of Sexual Assault, will provide some descriptive parameters of the problem, but the lawsuits themselves are already indicating directions for patient safety and hospital liability which can inform mental hospital staff and administration in preventing and dealing with complaints about sexual assaults within their facilities.
Regulating Heart and Liver Transplants in Massachusetts: An Overview of the Report of the Task Force on Organ Transplantation
Authors: Annas George J.
Published: June 2007

Organ transplantation has been a favorite topic of health lawyers since its inception. Organ procurement was addressed with the adoption of the Uniform Anatomical Gift Act in all fifty states, and “brain death” has been recognized both judicially and legislatively across the country. Nonetheless, it is now apparent that the major problems in organ transplantation are not legal and thus neither are their solutions. Heart and liver transplants are extreme and expensive interventions that few individuals can afford and few hospitals can offer. In an era of economic scarcity, how (if at all) should organ transplant procedures and other extreme and expensive treatment he introduced into the health delivery system?

Although it seems reasonable to expect federal leadership to establish a limited number of high-quality transplant centers, federal efforts to date have focused almost exclusively on trying to help the scattered organ procurement agencies become more efficient.
Equity and Costs
Authors: Pauly Mark V.
Published: June 2007

The task of determining who should or should not have access to a life-prolonging procedure would not be easy even if cost were no consideration. In an era in which rhe health industry has largely converted to the cost cutting religion, or at least the religion of budget limitation, a conversion for which health economics is partly responsible-the task becomes doubly difficult.

At one level, the Massachusetts Task Force on Organ Transplantation has dealt with this task simply by recommending that the final decision be postponed, and that a limited program of organ transplantation he introduced in an “Initial Social Assessment” phase.
Practical Issues in Obtaining Organs for Transplantation
Authors: Skelley Luke
Published: June 2007

The medical and social fascination with organ transplantation, beginning with Dr. Barnard's pioneering work with heart transplantation in the 1960s, has most recently resulted in the highly publicized and experimental baboon heart transplantation and artificial heart replacements. Transplants of proven efficacy, such as of corneas, kidneys. bone marrow, heart-lungs, hearts and livers, are a reality of modern medicine and embrace the most fundamental ideals of medicine by alleviating suffering and saving lives. Nevertheless, many question the increasing allocation of such a large proportion of our scarce medical and financial resources for such a relatively small population of recipients. The debate over how much of our limited health care resources we are willing to commit to transplantation has encouraged development of the federal Task Force on Organ Procurement and Transplantation and of statewide committees, such as the Massachusetts Task Force on Organ Transplantation.
Electronic Fetal Monitoring and Obstetrical Malpractice
Authors: Schifrin Barry S. , Weissman Henry , Wiley Jerry
Published: June 2007

The standard of care with regard to any new medical technology develops slowly. Attitudes must change, and equipment must be purchased, installed and utilized. Technical problems must be resolved and protocols established. Advances are better understood and more aggressively pursued by some physicians than others, with a consequent disparity in implementation. Electronic fetal monitoring (EFM) is an example of such a technology. Little known to obstetricians 15 years ago, EFM has been accepted by practitioners widely and rapidly. Today, armed with guidelines from the American College of Obstetricians and Gynecologists (ACOG) and the recommendations of the National Institutes of Health (NIH), we monitor with EFM most obstetrical patients during labor and almost all high-risk patients before labor. While the practice or custom of a majority of obstetricians does not necessarily define the standard of care, the use of EFM for fetal surveillance during labor represents the prevailing medical and legal standard of care.
The Dog and His Shadow: A Response to Overcast and Evans
Authors: Annas George J.
Published: June 2007

Aesop‘s Fable, “The Dog and the Shadow,” begins with a dog walking over a bridge with a piece of meat in his mouth. Looking down into the stream, he sees his shadow. Thinking it is a bigger dog, with a piece of meat twice the size of his own, the greedy dog decides to get it. Snarling, he opens his mouth to attack. At that moment the meat falls from his mouth, into the stream. The dog realizes his mistake, and sadly says to himself, “Grasp at the shadow and lose the substance.“

Drs. Overcast and Evans have not yet realized their mistake, but this response may help them see that what they characterize as their “strong exception” to “procedural and substantive” points made by the Massachusetts Task Force on Organ Transplantation and the “major shortcomings” they purport to identify really involve insubstantial “shadows.” Their “appraisal” indicates no disagreement of substance with any of the Task Force's policy recommendations. and their tangential quibbles shrink when their content and context is understood.
Computer-Assisted Research into Cross-Disciplinary Subjects
Authors: Johnson Sandra H.
Published: June 2007

Every lawyer and law teacher is familiar with the basic developments in computer-assisted legal research that have changed at least the method of legal research. Computer-assisted research has gone far beyond LEXIS and Westlaw (computerized collections of state and federal legislation and decisions, as well as other legal material) in areas that are of critical importance to effective research for the teacher of health law. The nature of health law research has special, although perhaps not unique, characteristics that are particularly benefited by computer assistance.

Research in health law, especially policy-oriented research, rarely relies entirely on case law. Rather, its reach extends to interdisciplinary or cross-disciplinary research, comparative research, and the popular, as well as the scholarly, view. While health law teachers develop the ability to keep abreast of the rapid changes in case law and federal statutes and regulations, it is more difficult to keep pace with legislative developments on a state-bystate basis.
Autonomy and Paternalism: Two Goals in Conflict
Authors: Cohen Elias S.
Published: June 2007

The development of concepts of autonomy and paternalism, as applied to children, women, the mentally ill and mentally retarded, and the elderly, has been a remarkable journey for philosophers, lawyers, physicians, caregivers, and politicians. Autonomy and paternalism have moved together in uneasy company to new definitions and applications derived in an extended dialectical process that has not only refined the definitions but also moved them away from the extreme ends of the gamut. To the extent that autonomy is equated with independence of action and paternalism is equated with coercive actions contrary to an individual's wishes or desires in order to achieve a beneficent end, we have exercised some of the most extreme and benighted paternalism while permitting in some sectors of our lives great independence on grounds of classical autonomy. Refinements of these concepts have moved us to new levels of sophistication and have made us aware of new issues and problems with which we have yet to wrestle.
The Impact of Broadened Civil Commitment Laws on Length of Stay in a State Mental Hospital
Authors: Pierce Glenn L. , Fisher William H. , Durham Mary L.
Published: June 2007

In the 1950s and 1960s considerable attention was focused on the deleterious effects of prolonged hospitalization for mental illness. Sociologists such as Goffman and clinicians such as Wing identified the psychosocial and clinical processes that led patients to become increasingly dependent on the routine of the hospital and progressively less able to live in the community. Along with this concern came growing criticism of the legal processes by which individuals were committed to and retained in state hospitals and of the procedural protections afforded them.

Landmark court decisions such as Lessard v. Schmidt led to sweeping changes in commitment laws across the nation during the 1970s. California's Lanterman-Petris-Short Act served as a model for the laws of many states by narrowing the substantive grounds for commitment and imposing procedural safeguards on the commitment process.
An Essay on Commitment and the Emergency Room: Implications for the Delivery of Mental Health Services
Authors: Churgin Michael J.
Published: June 2007

The civil commitment hearing, accompanied by the panoply of due process rights, is important. However, it is what happens when an individual first enters the mental health delivery system that is of fundamental significance. It is then that decisions on hospitalization, treatment, and disposition are made. The commitment hearing represents not the beginning of a process but, rather, the middle stage or the final chapter. This essay reports the results of an observational study of the functioning of nine emergency rooms or crisis units, with particular emphasis on implications for the civil commitment process.

Every U.S. statute concerning commitment, as well as the English and Canadian statutes I have reviewed, reads as though the individual being considered for commitment is at liberty pending a hearing. Each jurisdiction also has a statute to take care of emergency situations.
3. Experimenting and the New Biology: “A Consummation Devoutly to Be Wished”
Authors: Scott Russell
Published: June 2007

The rapid pace of medical innovation has raised the question: Can existing institutions, such as law reform commissions and other official bodies, and existing techniques, such as traditional legislation, deal effectively with the regulatory problems of today's world?

The New Biology has exhibited the capacity to arouse storms of public debate and to paralyze politicians or impel them towards unwise legislation. Examples of new and problematic technologies are the treatment of grossly defective newborn babies, live organ transplantation, cloning, the diagnosis of brain death, and, perhaps most important of all, manipulation of genes. But if there is one procedure that typifies the extreme reactions roused by the New Biology, it is in vitro fertilization (IVF), the technique whereby human eggs are fertilized outside the human body.

At the epicenter of the storm over IVF is the public debate concerning laboratory research and experiment on fertilized human eggs.
5. Debate: Embryo Research: The Ethics of Embryo Research
Authors: Singer Peter , Kuhse Helga
Published: June 2007

Research on the embryo offers the prospect of important medical advances. The first and most immediate prospect is in improving the success rate of in vitro fertilization. Without the prospect of such improvement, it may be doubted if the muchapplauded IVF program is worth the resources now being allocated to it. Embryo research is also needed to ensure that embryos created from frozen human ova will develop normally, and to test techniques for micro-injection of sperm directly into the ovum, which could overcome the problem of male infertility due to low sperm count or abnormal sperm. The next area of research will be into the prevention of genetic defects. If defects can be identified in early embryos, couples who carry defective genes and would otherwise seek testing during pregnancy, followed by abortion if the test is positive, will be able to use IVF followed by the transfer only of those embryos that are free from the defect. Further research may lead to the development of gene therapy, which could be effective in those cases where an individual has already been born with a single-gene defect like thalassemia, sickle-cell anemia, ADA and PNP deficiencies, and Lesch-Nyhan syndrome.
The Ethics of Embryo Research: Not as Easy as It Sounds
Authors: Annas George J.
Published: June 2007

Mark Twain once said of Wagner's music, “It's not as bad as it sounds.” Likewise, it may be said of Peter Singer and Helga Kuhse's stroll through the issues involving embryo research: “It's not as easy as it sounds.”

Today it seems clear that Aldous Huxley's version of a Brave New World is much closer to the mark than George Orwell's 1984. We will not have to be dragged into a technologically dominated future by a totalitarian government; we will go willingly, cheering almost any change as “better” and accepting science as always “improving” on nature. This childlike faith in science is at the heart of Prof. Singer and Dr. Kuhse's hymn to embryo research. They seem to believe that embryo research will not only lead to the prevention and cure of genetic disorders but also to a cure for cancer, and cultured tissues for transplantation. Even if one accepts this rosy view, the acquisition of important scientific knowledge is only a necessary, not a sufficient justification for experimentation.
1. Legal and Ethical Problems in Decisions for Death
Authors: Capron Alexander Morgan
Published: June 2007

What has happened to death? Why is this subject—virtually taboo in social and even in medical conversations a few decades ago—now so much a matter of debate in public policy settings, especially the courts? Four factors are primarily responsible, in my view. The first two—changes in the locale of death and development of ever more sophisticated forms of life-support—are by now familiar. Of growing significance are two further factors: increased fear of liability and the polarization of decisions about life-support as those decisions get swept up (at least in the United States) in the ferocious battles between freedom-of-choice and right-to-life supporters.

This paper attempts to analyze these four factors and, I hope, to uncover some of the confusion they have produced. I will then argue that despite consistent judicial endorsement of the right of competent adults to decide what medical care they wish to receive—even if they decide to forgo life-sustaining treatment, that is, to die—legal (like medical) attitudes are in fact ambivalent.
2. The Case for Active Voluntary Euthanasia
Authors: Kuhse Helga
Published: June 2007

I want to begin by making the fundamental point that the question is not whether decisions to end human lives ought to be made but, rather, who makes these decisions, and on the basis of what principles or values. For the fact is that such decisions are already being made, and inevitably must be made, in modern hospitals.

For almost any life-threatening condition, modern medical technology can now delay the moment of death. Death will often not occur until and unless the decision has been made to withhold or withdraw life-sustaining treatment. In other words, when and how a patient dies is increasingly the outcome of a deliberate human decision. Such decisions—not to resuscitate a terminally ill patient, not to continue to sustain the life of a permanently comatose patient. or to withhold antibiotics from the deaf and blind octogenarian—are all instances of the intentional termination of life and, if done for the patient's sake, are cases of passive euthanasia.
1. The Mental Health Act 1983 (England and Wales): Legal Safeguards in Limbo
Authors: Peay Jill
Published: June 2007

Is it possible to have an effective legal safeguard within an inherently therapeutic context? This is the issue underlying a significant contrast in the way that similar provisions of the Mental Health Act 1983 (England and Wales) have been interpreted and applied in two different settings: in the purely legal setting of the High Court and by a judicial body in a hospital setting, namely, the Mental Health Review Tribunal.

Before dealing explicitly with the legal framework adopted by the 1983 act, I will briefly set out the kinds of strategies the law can employ to regulate behavior. One technique used in some areas of the law is to draw up an exhaustive list of rules and principles in an attempt to determine the outcome of cases. In this respect the law is concerned to achieve substantive justice; little discretion is vested in decision- makers. Alternatively, the law may confer complete discretion on decision-makers, and insist merely that the rules of natural justice be complied with in the process of making decisions.
2. The Impact of the Canadian Charter of Rights and Freedoms upon Canadian Mental Health Law: The Dawn of a New Era or Business as Usual?
Authors: Gordon Robert M. , Verdun-Jones Simon N.
Published: June 2007

Canadian mental health law has traditionally held many themes in common with the mental health law of other Commonwealth countries such as Britain, Australia, and New Zealand. Until recently, this body of law bore only a passing resemblance to the system of mental health law that has emerged in the United States.

The existence of an entrenched Bill of Rights in the United States has meant that many major issues relating to the rights of mental health patients have been dealt with as constitutional matters of great import. Consequently, the 1960s and 1970s witnessed the burgeoning of an exciting body of case law establishing a number of critical rights for a constituency that had hitherto been powerless and tragically neglected. While many of the rights established in the so-called landmark cases were subsequently limited in their scope or were just not affirmed by the appellate courts, the widespread use of constitutional challenges by mental health advocates wrought wholesale changes in both federal and state legislation and permanently altered the balance of power between mental health professionals and their patients.
A Right to Choose Death: The Judicial Trilogy ofBrophy, Bouvia, andConroy
Authors: Gostin Larry
Published: June 2007

The law has characteristically defended life and proscribed any act to end it, for whatever reason. But sustaining life is increasingly a medical question, and decisions to end it are now cast as “treatment” decisions. Some treatment decisions that leave basic biological needs unmet are clearly intended to end a life that is “over.” The provision of food and water has a particularly intimate association with the nursing function of nurturance and care. The surgeon general, in another context, has said that nourishment in all cases is “the bottom line” and that removal of sustenance is medical neglectper se. I intend here to explore two questions: Have the courts endorsed, and should they endorse, decisions by or substitute decisions for patients who choose intentionally to end their lives in health care settings? And what rights and duties do the hospital and professional staff have to decline to withdraw artificial feeding?
Intravenous Drug Abusers and HIV Infections: A Consequence of Their Actions
Authors: Ginzburg Harold M.
Published: June 2007

This paper presents the available epidemiological data on human immunodeficiency virus (HIV) infection and AIDS among intravenous (IV) drug abusers, reviews HIV disease among intravenous drug abusers, and focuses on initial research findings that indicate intravenous drug abusers not only are educable but may indeed be altering their lifestyles as a direct consequence of their fear of HIV infection.

Although the initial clinical cases of AIDS were described in 1981, among gay men living in Los Angels, only a short time elapsed before IV drug abusers who shared their drug paraphernalia were identified as another risk group. A reasonable hypothesis, based on reports from the New York metropolitan area, is that there has been a relative increase in the percent of AIDS cases among IV drug abusers as compared to homosexuals. This may be explained by the transition group of sexually active homosexual men who also used intravenous drugs and thereby spread HIV from the gay community to IV drug abusers. In support of this hypothesis, the Centers for Disease Control (CDC) estimates that 8 percent of all reported AIDS cases from New York City have both risk factors.
Intrauterine Devices: Malpractice and Product Liability
Authors: Thornton Guerry R.
Published: June 2007

The use of a mechanical device is an ancient and crude form of contraception. Desert dwellers in ancient Africa placed stones in the uteruses of their camels to prevent conception during long treks across the Sahara. The metal intrauterine devices (IUDs) used in the late 1800s caused severe pelvic infections that, in the absence of antibiotics, often proved fatal. The first stainless steel and polyethelene IUDs were developed around 1960, and these attained a relatively reliable degree of safety. New compositions and materials decreased the risk of infection, and innovative devices could be inserted without dilating the cervix.

As mechanical means of contraception grew in popularity, pharmaceutical companies began to fight for a competitive edge, each touting the design or materials of its product as safer and niore efficient. By the mid-l970s, it is estimated, more than 15 million IUDs had been distributed throughout the world, many in developing nations.
Do-Not-Resuscitate Orders for the Incompetent Patient in the Absence of Family Consent
Authors: Brennan Troyen A.
Published: June 2007

Advances in medical technology have a habit of raising new, and usually unexpected, ethical and legal questions. Such questions arise when patients or physicians, for a variety of reasons, defer cardiopulmonary resuscitation (CPR) or other treatment with so-called no-code or do-not-resuscitate (DNR) orders. When all parties to the DNR order, including physicians, patient, and family, agree that it is appropriate in a given case, there is rarely controversy. However, when one party dissents from a no-code status, most commentators agree, grave moral, social, and legal questions are raised.

The most troublesome issues concerning DNR orders arise when physicians and family disagree about the appropriateness of such an order in the case of a mentally incompetent patient. These episodes not only raise complex legal issues but also go to the heart of, and challenge, modern medical ethics and the relationship of doctor to patient.
Tort Reform from Within
Authors: Gershonowitz Aaron
Published: June 2007

Most legislative proposals to solve the so-called malpractice crisis have been viewed by lawyers as attacks on lawyers and the legal system. Consequently, little thought has been given to whether we can find support for these proposals within the tort system. What I would like to suggest is that some of these proposals, including the increasingly popular cap on recovery for pain and suffering, are supported by the way the tort system has begun to look at injuries with several causes.

Initially, the legal system refused to recognize that the damages resulting from an injury could be apportioned among the various causes. Although we always recognized that every event has several causes, the law placed responsibility on “the proximate cause,” often the cause closest to the injury.

One of the first steps toward division of damages among causes was the replacement of contributory negligence with comparative negligence. Contributory negligence provided that if defendant and plaintiff were both negligent causes of the injury, plaintiff collected nothing.
Getting to Market: The Scientific and Legal Climate for Developing an AIDS Vaccine
Authors: Mariner Wendy K. , Gallo Robert C.
Published: June 2007

Expectations of a vaccine to prevent acquired immunodeficiency syndrome (AIDS) are rising. Not only are the prospects for an effective immunogen improving, but immunization appears to hold the greatest promise for halting the spread of infection and disease. Identification of the causal agent—the retrovirus called HTLV-IIII, LAV, or generically, HIV (human immunodeficiency virus)—has provided the direction and limited the options for containing the disease.

Prevention is, of course, critical where the disease must be presumed to be fatal in all cases. Although there is no clear evidence that any single exposure-to HIV will result in infection or disease, prudence dictates that all exposures be considered potentially infectious and, ultimately, disease-producing until more is known. Public education or, more specifically, behavior modification, intended to reduce or eliminate unsafe sexual contact and the sharing of syringes and needles by users of illicit intravenous (IV) drugs, is perhaps the only effective means of prevention that currently exists.
Withholding and Withdrawing Treatment: The Role of the Criminal Law
Authors: Glantz Leonard H.
Published: June 2007

Doctors or hospitals facing the issue of withholding or withdrawing treatment from patients voice a number of concerns, some factually based and some less so. One important concern is the possibility that such behavior will lead to an indictment for murder. How realistic is this fear? This article will review the U.S. cases involving withholding or withdrawing treatment, as they pertain to the issue of criminal liability.

The criminal law, in general, has not been used as a tool to regulate medical practice. While criminal actions against medical professionals are not unknown, few such actions arise dircctly from the practice of medicine. A physician charged with Medicaid fraud, sexually molesting patients, or prescribing drugs for non-therapeutic purposes has not been charged with a crime that involves scrutinizing the standard of care he or she uses in practicing medicine. For example, by definition, there is no medical standard for the non-therapeutic use of prescription drugs.
An Essay on Surrogacy and Feminist Thought
Authors: Mahoney Joan
Published: June 2007

Surrogacy is not an easy issue for feminists. On one hand, it raises concerns about exploitation; one is faced with images of poor women being enlisted to produce babies for wealthy men and their wives, either because of fertility problems or because pregnancy is simply too inconvenient for those women who can afford to hire someone to do it for them. On the other hand, there is the specter of the state passing laws, once again, that tell women what they can and cannot do with their bodies. If we believe, as many of us do, that the state has no right to prohibit a woman from selling the sexual use of her body, doesn't the also have the right to sell the reproductive use? And if many of us, doctors, lawyers, law professors, have been willing to employ other women, less privileged women, to take care of our children after they are born, what is so different in moving the date back a bit and hiring them to carry our childrenbeforebirth as well?

Assuming that surrogacy is not legally prohibited, does that mean that surrogacy contracts must be enforced? If we find something abhorrent in the idea of babies being taken from their mothers arms because, after all, a contract is a contract, we might argue that the contracts can be legal but unenforceable.