Law Commons^™

Biotechnology Entrepreneurship And Ethics: Principles, Paradigms, And Products, Patricia C. Kuszler

Articles

Biotechnology, whether in the context of new drugs derived from DNA and genetic technology, genetically modified food, or biologics making use of living cells, raises ethical concerns at a variety of different levels. At the research level, there is concern that the very nature of research is being subverted, rather than enhanced, by entrepreneurship. This area of ethical concern has intensified in the United States as a result of the conflicts of interests resulting from the growing alliance between University academia and private industry in the research enterprise. As we travel down the research path into development of a drug …

Syringes In The Sea: Why Federal Regulation Of Medical Waste Is Long Overdue, Chryssa V. Deliganis, Steve P. Calandrillo

Articles

Medical waste is produced everywhere that people live and by almost everyone at some point in their lives. Its treatment and disposal implicates the environment, public health, the economy, human dignity, and aesthetics. With the many issues involved, the need for federal regulation of medical waste today is manifest.

This Article examines the problem of medical waste disposal and evaluates the current state-based approach to regulation. Although many states have implemented stringent medical waste programs with some success, the absence of direct federal regulation in this area is problematic. The need for national leadership is clear, especially with respect to …

Intellectual Property Rights And Stem Cell Research: Who Owns The Medical Breakthroughs?, Sean M. O'Connor

Articles

This article will not address the science and ethics of stem cell research—at least as far as those topics are normally addressed in the existing literature. Instead, this article argues that an even more contentious battle is looming on the horizon, with dire practical consequences: Namely, who will own the revolutionary medical breakthroughs that are supposed to emerge from this research? Along the way, this article will assume that stem cell research will progress in some fashion and that at least some of the purported benefits will materialize.

But the central premise is that the pitch of the ownership battle …

Vanishing Vaccinations: Why Are So Many Americans Opting Out Of Vaccinating Their Children?, Steve P. Calandrillo

Articles

Part I of this Article details the historical development and medical achievements made possible by vaccines. From Edward Jenner to Jonas Salk to Albert Sabin, immense strides have been made in eradicating or substantially eliminating some of the worst diseases in human history. Smallpox, polio, measles, mumps, rubella, diphtheria, pertussis, tetanus, influenza, hepatitis A and B, and even the chicken pox are all now largely preventable.

Literally hundreds of millions of deaths have been avoided and many more lives markedly improved, to say nothing of the financial ramifications for the American healthcare system. All fifty states have therefore enacted compulsory …

Cash For Kidneys? Utilizing Incentives To End America's Organ Shortage, Steve P. Calandrillo

Articles

This article addresses the growing organ shortage in America, analyzes current donation and procurement law, and explores both monetary and nonmonetary incentives aimed at eliminating the worsening crisis.

Part I details the law governing human organ donation. Under both the Uniform Anatomical Gift Act (“UAGA”) and the National Organ Transplant Act (“NOTA”), no donor of a human organ may receive “valuable consideration” for providing it. Congress’ intention was simply that the organ recipient be given the “gift” of life—not one which she had to purchase on the market. In reality, the consequences of the Act bear little resemblance to its …

Images Of Health Insurance In Popular Film: The Dissolving Critique, Elizabeth Pendo

Articles

Several recent films have villainized the health insurance industry as central elements of their plots. This Article examines three of those films: Critical Care, The Rainmaker, and John Q. It analyzes these films through the context of the consumer backlash against managed care that began in the 1990s and shows how these films reflect the consumer sentiment regarding health insurance companies and the cost controlling strategies they employ. In addition, the Article identifies three key premises about health insurance in the films that, although exaggerated and incomplete, have significant factual support. Ultimately, the author argues that, despite their passionately critical …

Responsible Regulation: A Sensible Cost-Benefit, Risk Versus Risk Approach To Federal Health And Safety Regulation, Steve Calandrillo

Articles

Federal health and safety regulations have saved or improved the lives of thousands of Americans, but protecting our citizens from risk entails significant costs. In a world of limited resources, we must spend our regulatory dollars responsibly in order to do the most we can with the money we have. Given the infeasibility of creating a risk-free society, this paper argues that a sensible cost-benefit, risk versus risk approach be taken in the design of U.S. regulatory oversight policy. The goal should always be to further the best interests of the nation, rather than to satisfy the narrow agenda of …

Curing Conflicts Of Interest In Clinical Research: Impossible Dreams And Harsh Realities, Patricia C. Kuszler

Articles

This article will explore conflicts of interest in the context of clinical research, focusing on the incentives and practices that foster such conflicts. Part I will briefly define and categorize the revenue streams at play in clinical research—both contemporaneous with the clinical trial, and the downstream, long-term gains available to the researcher and research university. Part II will discuss how these entangled revenue streams result in financial and non-financial conflicts of interest that affect the nature and balance of the research enterprise and potentially endanger patients and human subjects. Part III will summarize current conflicts of interest regulations and policies, …

Financing Clinical Research And Experimental Therapies: Payment Due, But From Whom?, Patricia C. Kuszler

Articles

This article will explore the realm of clinical research and the question of who should finance such research. The first part will define the various types and levels of clinical research in terms of the regulatory controls and oversight applied to such research. Then the article will summarize how the costs of clinical research and experimental therapies have been covered in the past. Finally, the article will evaluate the risks and benefits derived by the various stakeholders and propose a financing rationale for therapies that places the burden of cost squarely on the stakeholders most likely to benefit.

Telemedicine And Integrated Health Care Delivery: Compounding Malpractice Liability, Patricia C. Kuszler

Articles

This Article considers how theories of medical negligence might be applied in the context of telemedicine and integrated delivery health plans. Part Two summarizes the history of telemedicine, its increasing breadth of application and opportunity and promise for the future. Part Three reviews traditional negligence principles and precedents and demonstrates how they might be applied when a telemedicine interaction results in negligence and harm to the patient. Part Four discusses evolving theories of shared liability applicable to health plans and managed care entities. Finally, Part Five demonstrates how shared liability theories will be applied to situations involving telemedicine technologies.

Corralling Kevorkian: Regulating Physician-Assisted Suicide In America, Steve Calandrillo

Articles

This article examines the evolution and history of the development of the right-to-die in America, the ethical considerations surrounding physician-assisted suicide (P.A.S.), and the dangers posed by the rise of managed care. I then explore and analyze efforts to legalize and regulate assisted suicide (Netherlands, Oregon, The Model State Act), and suggest the criteria I believe are essential to include in any P.A.S. regulatory scheme.

Balancing The Barriers: Exploiting And Creating Incentives To Promote Development Of New Tuberculosis Treatments, Patricia C. Kuszler

Articles

This Article considers the many barriers that health-care providers and public health authorities face in stemming the modem TB epidemic. Part II reviews historical public health measures, their results, and their adaptability to resurgent and MDR-TB. Part III considers the fundamental barriers to a successful global effort using these public health strategies, concluding that these barriers are insurmountable given the current arsenal of anti-tuberculosis therapies. Part IV examines the reasons why research and development of new anti-tuberculosis drugs and vaccines have stagnated over the last quarter century. Finally, part V explores incentives that might revive research and development of such …