Georgetown University Law Center

About: Georgetown University Law Center is a based out in . It is known for research contribution in the topics: Supreme court & Global health. The organization has 585 authors who have published 2488 publications receiving 36650 citations. The organization is also known as: Georgetown Law & GULC.

The Difficult Case of Direct-to-Consumer Advertising

Abstract: This article will appear in a symposium to pay tribute to Professor Steven H. Shiffrin, one of the leading First Amendment theorists of our time. The author was asked to focus on Professor Shiffrin's contribution to the development of the commercial speech doctrine. To reflect on the wisdom of Professor Shiffrin's refusal to rely on general First Amendment theories, the article focuses on the difficult First Amendment problem of regulating direct-to-consumer (DTC) advertising of prescription drugs. In his famous dissent in Virginia Pharmacy Board, then-Justice Rehnquist forecast that, as a consequence of the Court's ruling, drug companies would soon advertise directly to consumers on television and other media. Justice Rehnquist argued that "there are sufficient dangers attending" the use of drugs "that they simply may not be promoted in the same manner as hair creams, deodorants, and toothpaste." Today drugs are promoted in much the same way as other products. Drug companies devote forty percent of their advertising expenditures - over $4 billion per year - to DTC ads. The average American views as many as 16 hours of prescription drug ads per year, far exceeding the average time spent with a primary care physician. The question is whether proposals before Congress to limit or ban DTC advertising would pass constitutional muster. The article canvasses the arguments in some detail and concludes that legislation restricting DTC advertising to enable the FDA to assess the risks of a drug might withstand constitutional attack, but that an all-out ban on DTC advertising would not likely be sustained. The point of this discussion is to illustrate the complexity of commercial speech questions and to demonstrate that Professor Shiffrin was correct when he observed that "the commercial speech problem is in fact many problems," and that "the small questions [it poses] will not go away."

The Poor State of Health Care Quality in the U.S.: Is Malpractice Liability Part of the Problem or Part of the Solution?

Abstract: The belief that malpractice lawsuits impede efforts to improve health care quality by encouraging providers to hide mistakes is the conventional wisdom among patient safety advocates and scholars It also provides the normative basis for efforts currently proceeding at the state and federal levels to curtail medical malpractice exposure Groups pressing for tort reform, including the American Medical Association, contend that when doctors and other providers are insulated from liability, patients will be better protected from harm This article canvasses the evidence bearing on the connection between malpractice exposure and health care quality Some of this evidence, such as the Harvard Medical Practice Study, shows that the quality of health care improves as the risk of being sued rises; none of it shows that malpractice lawsuits cause the quality of health care to decline The widely held belief that fear of malpractice liability impedes efforts to improve the reliability of health care delivery systems is unfounded The central causes of the high error rates that persist in the health care sector appear to be providers' defective incentives and professional norms Providers lose money when quality improves, and their norms discourage the creation of non-punitive working environments in which efforts to improve quality can flourish The business case for quality is missing, and providers' attitudes are antithetical to quality improvement The tort system's major deficiency is its failure to subject providers to sufficient economic pressure to overcome these impediments The cause of this shortcoming is the rarity with which injured patients assert legal claims

Risk Governance and Democracy in Health Care

Abstract: I argue in this article that the concept of risk-centered governance is the best theoretical paradigm for understanding health law and the health care system. Over the past 20 years, an insurance-inflected discourse has migrated from the purely financial side of the health system into the heart of traditional medicine - the doctor-patient relationship. Rather than focus on doctrinal strands, I argue that scholars should analyze the law of health care as a set of governance practices organized around managing and allocating financial, as well as clinical, risk. Over the same period, the body of law that structures most private group health insurance - ERISA - has effectively delegated control of risk pooling and resource allocation to the employers that sponsor group plans. Drawing on a history of ERISA that has not been explored in legal scholarship, I demonstrate how the private welfare state of workplace-based health insurance has evolved into the creation of what amounts to corporate sovereignty in controlling access to health coverage. The discourse of managing risk bonds these two components of health law and the health care system: patient care and access to coverage. From a normative perspective, the greatest problem with risk-centered governance arises from a democracy deficit. Because almost all health insurance risk pools are based in workplaces, there is potential to draw on the social networks created by work as a mechanism for building new, localized publics engaged with health policy. Treating insurance risk pools as potential mechanisms of governance, rather than merely as actuarial units, would force the publicizing (at least within the workplace) of myriad political decisions: who gets included and excluded in the pooling process, how allocation decisions are made, and whether there are systems of accountability and checks and balances sufficient to produce a risk allocation system that is equitable, as well as efficient and flexible. The article builds on the egalitarian potential of social insurance as a technology of governance, and argues for filling a gap that exists not only in the current system, but also in all proposals for reform.

Legal Battles Over Embryos After In Vitro Fertilization: Is There a Way to Avoid Them?

Abstract: The hypothetical legal case presented by Fournier 1 highlights critical issues surrounding embryo disposition in the field of oncofertility. As presented, the case involves an unmarried couple who cryopreserved embryos prior to the woman starting chemotherapy for breast cancer. The couple separated soon after the embryos were created, and the previous partner filed a lawsuit to prevent the woman from using the embryos to conceive. Disputes over embryo disposition continue to plague the field of reproductive medicine, and in an era where embryo cryopreservation has become routine, updated guidance on how to avoid these situations would be welcome. The case put forth by Fournier does not address what steps, counseling, agreements, and/or documents the former couple were offered or undertook. We believe there can be different medical and legal sensitivities involved and precautions taken but also common, fundamental principles that need to be adhered to for those who are using reproductive technologies for fertility preservation with plans to conceive sometime in the future, as well as for couples who cryopreserve embryos as part of the process of actively trying to conceive.

Governing for Health as the World Grows Older: Healthy Lifespans in Aging Societies

Abstract: So much of global health governance focuses intensely on a brief moment in the human lifespan — from a safe birth to infant and child survival. Yet, with all the attention to this early window of life (infancy to age five), the opposite end of the life spectrum is comparatively neglected. The Millennium Development Goals (MDGs) do not mention a healthy lifespan or a healthy old age. This inadequate attention to the older years of the life appears to be a glaring omission given the universal challenges posed by aging societies. Aging is a demographic fact in almost all countries, but it is occurring more rapidly in low- and middle-income countries. Today, almost two in three people aged 60 or over live in developing countries. By 2050, nearly four in five of those aged over 60 will live in the developing world.Across the globe, declining fertility rates, lower infant mortality, and greater longevity drive population aging: people live longer because of improved nutrition, sanitation, health care, education and economic wellbeing. In many respects, therefore, global aging is a triumph of social and economic development. But sitting alongside the stunning success of longer lives (and the future prospect of still longer lives), are the personal, social, and economic consequences of a global demographic transition to a decidedly older population. A fundamental dynamic for global health in the coming decades is to find innovative governance tools to shape the way the international community can enhance the well-being of older people living in aging societies — from civil society, philanthropy, industry, and governments to international agencies and global public-private partnerships. Reflecting on the journey from the new millennium to today, there has been undeniable — although decidedly inadequate — progress. The 2002 Madrid International Plan of Action on Aging (“Madrid Plan”) framed aging policies as integral aspects of economic development and human rights — a form of mainstreaming we support. Yet, more than a decade later, the United Nations processes have failed to yield concrete changes in law and governance.The goal of healthy aging is unmistakable, and benefits everyone equally in society. Society should afford all human beings the opportunity to live dignified and long lives where they are healthy and active for as long as possible, allowing them to continue to enrich their own lives and that of those around them. The challenge of global aging is significant and universal. Almost 700 million people are now over the age of 60, and by 2050, 2 billion people — over 20 percent of the world’s population — will be 60 or older. Recognizing the need to combat this population shift, Anna Garsia and Professor Gostin look at the impact this changing dynamic will have on global health and the structures currently in place. In this Article, Garsia and Gostin analyze the current state of affairs for older persons around the world, looking at both international and domestic efforts and ultimately calling for a course of action that enhances the application of existing human rights law while campaigning for a robust new international treaty on the treatment of elder individuals.