Todos tem direito ao meio ambiente ecologicamente equilibrado. Everyone has the right to an ecologically balanced environment. In 1988, the Brazilian Constitutional Assembly incorporated this imperative into the Brazilian Constitution as part of a chapter on environmental protection. After hundreds of years of environmental ignorance, our planet's inhabitants have experienced a growth of environmental awareness. One global environmental tragedy garnering substantial recent attention is the depletion of the planet's tropical rain forests. In addition to eternally altering the human environment, rain forest destruction poses a serious threat to both the pharmaceutical industry and individuals in need of medical care. A substantial portion of existing pharmaceuticals are plant-based and animal-based, and the pharmaceutical industry continues to explore additional species for medicinal potential, particularly in tropical regions. As mass deforestation of these areas forces countless species into extinction, specimens yet to be analyzed for their pharmaceutical potential will be eternally lost. As one noted conservationist explained, “Even severe pollution is reversible, but species extinction is irreversible.”

In justifying the cost of the Human Genome Project, supporters predicted fantastic benefits would result from decoding the human genome: cures for fatal diseases, effective treatments for common illnesses burdening individuals and society and a greater understanding of ourselves as human beings. Fear that genetic information will be misused to harm individuals, however, casts a shadow over this glowing portrait of the future of genomic medicine. Over the last decade, these concerns have led approximately twenty-six states to enact genetic nondiscrimination laws. Although no similar law has been passed by Congress, many, including Francis Collins, Director of the National Center for Human Genome Research, have repeatedly endorsed proposed federal legislation aimed at prohibiting health insurers and employers from using predictive genetic information. The result has been growing bipartisan support for The Genetic Nondiscrimination in Health Insurance and Employment Act introduced in February of 2001 by Representative Louise Slaughter in the House and by Senators Kennedy and Daschle in the Senate.

It has been nearly a decade since the first cases of AIDS were reported by the United States Centers for Disease Control (CDC). During that time there have been over 200 statutes enacted in every jurisdiction in the country. Unfortunately, the content of the legislation is highly diverse, even inconsistent, from state to state, and there is very little guiding federal legislation or regulation. The profound social, moral and public policy dilemmas that are magnified by the Human Immunodeficiency Virus (HIV) epidemic are still no closer to resolution. Should testing for HIV infection be voluntary, routine or compulsory when there is a higher risk of transmission of HIV? Should America return to traditional moral values of abstinence outside of marriage and zero tolerance of drug use, or should we teach safe sex and use of sterile injection equipment? Should health care professionals maintain strict confidentiality or do they have a duty to protect third parties in imminent danger?

Medical epidemiology is the cornerstone for understanding the safety and efficacy of drugs and medical devices. Epidemiologic principles provide a statistical basis for determining correlations, and ultimately mathematical causation, between two series of events. Medical epidemiologic evidence and statistical inferences are useful and are now routinely accepted in the courtroom.

The complex distribution systems that provide fungible goods throughout the country often preclude the identification of the specific source of an allegedly defective product. An expansion of the principles established in Summers v. Tice and Ybarra v. Spangard provide a logical and rational means for the courts to address products liability issues in cases involving multiple and unnamed defendants.

This Article discusses the impact of epidemiology on the judicial process, both in the nature of judicial decision-making and in the nature of the law itself. Part III B discusses the “weak” and “strong” versions of the traditional preponderance of the evidence rule, as recast by recent products liability litigation. The remainder of the Article defines the useful and appropriate scope of epidemiologic evidence, concluding that “intentless” epidemiologic evidence alone cannot support an award of punitive damages.

If the fundamental goals of the health care reform effort are to ensure universal access to an acceptable quality of health care at an affordable cost, then the threshold question for reform is: What health care services should be provided in an efficient, equitable system?

Answering this question requires weighing a complex mix of medical and social policy factors, a process not attempted in this article. But the starting point for that process should be determining what health care services “work” and what they cost. Outcomes assessment holds considerable promise in finding answers to these subsidiary questions, because it is intended to assess the effectiveness of health care services, that is, what works and what does not work for patients. It holds promise, not only for improving the quality of care, but also for identifying unnecessary or wasteful practices that increase health care costs.

In 2003, the University of Hawaii proposed patenting the Native Hawaiian genome with the purpose of generating both economic- and healthrelated benefits for the Native Hawaiian people. This proposal, however, was strongly opposed by the Native Hawaiian community, which viewed it as an unwelcome imposition of Western property concepts upon their traditional ideology. Population-based genetic databases are not an entirely new concept. The governments of Iceland and Estonia have created national genetic databases and assumed authority over their ownership and operation. Iceland has even licensed its genome to a private company. Furthermore, the United States has previously been involved in patenting the genetic code of other indigenous groups, such as the Hagahai tribe in Papua New Guinea and the native inhabitants of the Solomon Islands. A patent on the Native Hawaiian genome, however, would be unique because it would concern the rights of American citizens.

The Constitution protects, in some measure, each person's autonomy in making basic decisions about family, parenthood, and procreation. This Article examines the extent to which courts should protect from government intrusions a parent's access to technologies that influence specific characteristics of offspring. Beginning with Supreme Court opinions that articulate constitutional and social values regarding reproductive autonomy, the Article explores how important new insights from evolutionary biology may supplement an understanding of Human procreation. Specifically, the Article explains how trait selection can constitute an important part of larger “reproductive strategies” that powerfully affect an individual's “inclusive fitness” (itself a measure of reproductive success). It concludes that access to trait-selection technologies should receive the same federal protection from government intrusions as that afforded access to abortion. It proposes the first limit to that protection, however, when a parent seeks to select for a trait, or to use a technique, that would be clearly and significantly damaging to the future child. The Article subsequently divides the use of trait-selection technologies (TSTs) into eight contexts and proposes a preliminary framework by which a regulatory system could legitimately distinguish among them.

Dave and Susan brought five-year-old Liliana home from Romania in January. The couple was ecstatic about their new beautiful blonde-haired daughter. They had waited months for Liliana after beginning the international adoption process with a reputable agency based in the United States. Many aspects of the process—carrying large amounts of cash to Romania, bribing officials to release their new daughter from the orphanage and the total lack of information about Liliana's health or background—had disturbed them. Dave and Susan were relieved when Liliana received a visa to travel to the United States because they thought that the physical examination for her visa had revealed nothing of import. Their concerns disappeared when they boarded the plane to head home to the United States. Liliana seemed healthy and happy, and she would adjust in no time.

In May 2015, the first baby created through an emerging ova technology called AUGMENT, was born in Canada.1 Developed by OvaScience, AUGMENT essentially introduces mitochondria sourced from the genetic mother into her own ovum in order to revitalize the ovum.2 This technology is controversial because OvaScience is a publicly traded company, and it is driven by short-term results, such as earnings;3 and (2) OvaScience did not complete adequate clinical trials before offering AUGMENT to the public.4 Moreover, in its 2014 annual report, OvaScience declared that it was intentionally offering its products in countries where clinical trials are not required.5 The lack of adequate clinical trials is the primary reason underlying the Food and Drug Administration's (“FDA”) prohibition of the technology in the United States.6 Finally, as of August 2018, OvaScience has shifted its research away from AUGMENT, and it only offers it through an “exclusive license to IVF Japan Group in Japan.”7

For another thing, the division of medical opinion about the matter at most means uncertainty, a factor that signals the presence of risk, not its absence. That division here involves highly qualified knowledgeable experts on both sides of the issue.—Stenberg v. Carhart, 20001

While we find no reliable data to measure the phenomenon, it seems unexceptionable to conclude some women come to regret their choice to abort the infant life they once created and sustained.—Gonzales v. Carhart, 20072

The authors of this Comment—a lawyer and a physician—suggest that most physicians who are called upon to testify concerning medical issues in personal injury litigation do not understand that judges and attorneys view “causation” quite differently than do members of the medical community. For example, medical practitioners tend to be concerned with all possible causes of the patient's current medical condition, whereas legal practitioners in personal injury cases generally focus on a particular event as possibly precipitating, hastening, or aggravating a particular aspect of the patient's condition to the extent that the event in question is, in legal language, the “proximate cause” of an injurious result. The authors summarize and analyze the differences—and the occasional similarities—between the medical and the legal approaches to causation, in the hope that they will thereby (1) contribute to greater understanding by the two professions of each other's theory and practice, and (2) help the expert medical witness to be more comfortable and more effective in his courtroom role.

“Sex” is a complex thing. The word conjures up many images according to how it is used. When narrowed to the context of the law, however, a person’s sex can be broken down into three primary categories: biological sex, common law sex, and legal sex.

Biological sex has traditionally been determined according to the presence or absence of genitals and gonads (phenotype), and the configuration of the sex chromosomes (karyotype).

In response to the public outcry for mandatory testing for AIDS, this Article explores the major issues concerning the identification of persons with AIDS in society. The Article first studies testing procedures and the purposes behind them to determine if a call for mandatory testing of the general populace would better achieve society's objectives for identifying individuals with AIDS. Concluding that testing should not be required of the population as a whole, the Article then explores whether testing should be required of certain subpopulations which society perceives as likely to have or to spread the disease. In this context, too, the Article concludes that mandatory testing would be unwarranted, and that funds proposed for mandatory testing would be put to better use in education and universal precautions to prevent the further spread of AIDS.

As Hippocrates said to one of his students: “Let your best means of treating people be your love for them, your interest in their affairs, your knowledge of their condition, and your recognized attentiveness to them.“ A physician who is guided by this teaching must be a very caring person. He or she must care deeply about people. To care, in this sense, means to be troubled about the troubles of others. He or she must also care about being a good doctor, about being competent in all relevant respects. I believe that all thoughtful people want such women and men as their personal doctors. We want our doctors to be caring persons, to be attentive to our needs and responsive to our concerns. When our doctors talk with us, we hope that they will speak to the unique individuals we each correctly believe ourselves to be.

While state medical licensure laws ostensibly are intended to promote worthwhile goals, such as the maintenance of high standards in health care delivery, this Article argues that these laws in practice are detrimental to consumers. The Article takes the position that licensure contributes to high medical care costs and stifles competition, innovation and consumer autonomy. It concludes that delicensure would expand the range of health services available to consumers and reduce patient dependency, and that these developments would tend to make medical practice more satisfying to consumers and providers of health care services.

Mental health is currently one of the most expensive health care issues. The cost of treating mental illness’s effects not only impacts the health care industry as a whole, but also imposes indirect costs on businesses through absenteeism, lower productivity, and reduced earnings. Mental illness, and the effects of mental illness, costs the U.S. economy several billion dollars in losses every year, with predictions suggesting that these costs will only continue to rise in the next two decades. Between 2006 and 2009 alone the costs of mental health care rose from approximately $57 billion to more than $150 billion. These numbers will likely be exacerbated due to the mental health problems that are continuing to rise within the United States as teenagers and adolescents are experiencing mental illness at escalating rates. Despite the rapid growth of mental illness, mental health coverage has not been expanding to meet the increasing demand for treatment. It is estimated that about 28% of the U.S. population has a diagnosable mental illness, even though only 8% actually seek treatment.

A study of conflicts of interest in Canadian health care law supposes that Canadian law contains features that distinguish it from law in any other jurisdiction. There was a time when law applied in the Canadian Common Law jurisdictions lacked these features. The law and legal process of the Common Law jurisdictions derived directly from England, whereas the Civil Law of Quebec was fashioned on the French Code Napoléon. Indeed, as recently as 1959, a distinguished Canadian academic commentator observed that “a perusal of Canadian law reports … conveys the impression that most of the opinions reported there are those of English judges applying English law in Canada, rather than those of Canadian judges developing Canadian law to meet Canadian needs with guidance of English precedent.” However, modern developments in Canadian society in general, and in its health care system in particular, now justify the claim that Canadian law is sufficiently distinctive to warrant its inclusion in comparative studies of legal regulation of health care professionals’ conflicts of interest.

U.S. consumers and Canadian pharmacies have rushed to take advantage of the opportunity presented by price differences in patented pharmaceuticals. This rapidly growing parallel trade has brought the Canadian and U.S. systems for determining pharmaceutical pricing under increased scrutiny, and the pressure for change seems to be building. This paper examines why parallel trade in pharmaceuticals has grown and considers some of the policy options confronting both countries.

To do this we begin by identifying similarities and differences in the Canadian and U.S. regulatory frameworks governing trade in pharmaceuticals. While the differences are considerable, we show that they are not the only reason for the emergence of the price disparity that has fuelled the growth in parallel trade. In particular, we argue that the price discrimination strategies of pharmaceutical manufacturers and exchange rate fluctuations have played an underappreciated role. Following this, we examine the claims that this trade represents a threat to American and Canadian interests, and find that there are good reasons for policy makers on both sides of the border to be concerned. Unchecked, this rising trade presents a threat to R&D funding and continued Canadian consumer access to pharmaceutical products.

This Article argues that many seemingly disparate questions in health law are related to the issue of how experts are to be held accountable to nonexperts—show the principle that decisions should be made by those most affected is to be reconciled with the principle that decisions should be made by those with experience and training in the area. The basic subject matter of health law comprises a number of relationships between medical professionals, on the one hand, and laymen, on the other. In dealing with the proper allocation of decision-making authority within these relationships, the Article considers the social role of medical profession, the theoretical issues in the accountability of expertise, and the nature of medical expertise. On the basis of this discussion, the Article develops principles that can be applied throughout health law.

Community-based, long-term care has become an increasingly popular and needed service for the aged and disabled populations in recent years. These services witnessed a major expansion in 1981 when Congress created the Home and Community-Based Waiver authority for the Medicaid program. Currently, all states offer some complement of community-based, long-term care services to their elderly and disabled populations and nearly all states have Medicaid Home and Community-Based Services waivers which extend these services to their Medicaid eligible clients.

An ever increasing proportion of the population is in need of community-based, long-term care services. Between nine and eleven million Americans of all ages are chronically disabled and require some help with tasks of daily living. In 1990, thirty percent of the elderly with at least one impaired activity of daily living used a community-based, long-term care service. Not surprisingly, expenditures for community-based, long-term care have increased.