Law Commons^™

The Supreme Court's Assault On Litigation: Why (And How) It Might Be A Good Thing For Health Law, Abigail R. Moncrieff

Abigail R. Moncrieff

In recent years, the Supreme Court has narrowed or eliminated private rights of action in many legal regimes, much to the chagrin of the legal academy. That trend has had a significant impact on health law; the Court’s decisions have eliminated the private enforcement mechanism for at least three important healthcare regimes: Medicaid, employer-sponsored insurance, and medical devices. In a similar trend outside the courts, state legislatures have capped noneconomic and punitive damages for medical malpractice litigation, weakening the tort system’s deterrent capacity in those states. This Article points out that the trend of eliminating private rights of action in …

“U.S. Consumer Protection: Striking A Balance Between The Fda Approval Process And State Tort Law Claims Through The Medical Device Safety Act Of 2009”, Rachel V. Rose

rachel v rose

No abstract provided.

Childhood Immunizations: Paralysis On Parental Rights, Demand On Taxpayer Dollars, Rena L. Holmes Jones

Rena L Holmes Jones

The rise in the incidence of Autism Spectrum Disorder (ASD) is one of the most serious public health issues in recent years. The current statistics suggests that roughly one child out of every 150 has autism or an autistic-like disorder, compared to earlier estimates placing the rate at four or five children out of every 10,000. Autism is a condition that typically reveals itself within the first 0-4 years of life. The wide continuum of associated cognitive and neurobehavioral disorders have three core-defining features: impairments in socialization, impairments in verbal and nonverbal communication, and restricted and repetitive patterns of behaviors. …

Legalizing Marijuana: California's Pot Of Gold?, Michael Vitiello

Michael Vitiello

Legalizing Marijuana: California’s Post of Gold? Abstract: In early 2009, a member of the California Assembly put a bill in the hopper that would have legalized marijuana in an effort to raise tax revenue and to reduce prison costs. While the bill’s proponent withdrew the bill, he vowed to renew his efforts in the next term. Other prominent California officials, including Governor Schwarzenegger, have indicated their willingness to study legalization in light of California’s budget shortfall. For the first time in over thirty years, politicians are giving serious consideration to a proposal to legalize marijuana. But already, the public debate …

Pharma’S Strategies On Fighting Generics And Healthcare Reform, Rongxiang Liu

Rongxiang Liu

This article first briefly reviews the Hatch-Waxman Act. The Act authorizes a scheme to make it much easier to obtain marketing approval for generics, as well as gives incentives to generic makers to bring generics to the market. The article then discusses the four strategies and their future impacts on drug market. Lastly, to eliminate these impacts, it proposes two legislations to ensure cheap generics be more widely available in order to reduce the healthcare cost.

Preserving Human Potential As Freedom: A Framework For Regulating Epigenetic Harms, Fazal Khan

Fazal Khan

Epigenetics is a rapidly evolving scientific field of inquiry examining how a wide range of environmental, social, and nutritional exposures can dramatically control how genes are expressed without changing the underlying DNA. Research has demonstrated that epigenetics plays a large role in human development, and disease causation. In a sense, epigenetics blurs the distinction between “nature” and “nurture” as experiences (nurture) become a part of intrinsic biology (nature). Remarkably, some epigenetic modifications are durable across generations, meaning that exposures from our grandparents’ generation might affect our health now, even if we have not experienced the same exposures. In the same …

The History Of Wisconsin’S Alcohol Laws: A Drunk Culture Or Lobbyists Drunk With Power?, Mark Gaber

Mark Gaber

Wisconsin leads the nation in a bevy of alcohol consumption statistics—from binge drinking to admitted drunk drivers to liquor licenses—and has among the most lenient alcohol laws in the nation as well. It is the only state that does not criminalize the first offense of drunk driving, one of a handful that does not permit drunk driving checkpoints, and the only state where children can be served alcohol at bars with the consent of their parents. Many point to the state’s German heritage to explain its affinity for alcohol. While this might explain the genesis of the state’s drinking culture, …

Science, Public Bioethics, And The Problem Of Integration, Orlando Carter Snead

O. Carter Snead

Public bioethics — the governance of science, medicine, and biotechnology in the name of ethical goods — is an emerging area of American law. The field uniquely combines scientific knowledge, moral reasoning, and prudential judgments about democratic decisionmaking. It has captured the attention of officials in every branch of government, as well as the American public. Public questions (such as those relating to the law of abortion, the federal funding of embryonic stem cell research, and the regulation of end-of-life decisionmaking) continue to roil the public square.

This article examines the question of how scientific methods and principles can and …

Science, Public Bioethics, And The Problem Of Integration, Orlando Carter Snead

O. Carter Snead

Public bioethics — the governance of science, medicine, and biotechnology in the name of ethical goods — is an emerging area of American law. The field uniquely combines scientific knowledge, moral reasoning, and prudential judgments about democratic decisionmaking. It has captured the attention of officials in every branch of government, as well as the American public. Public questions (such as those relating to the law of abortion, the federal funding of embryonic stem cell research, and the regulation of end-of-life decisionmaking) continue to roil the public square.

This article examines the question of how scientific methods and principles can and …

Antibiotics In Food Animals: The Convergence Of Animal And Public Health, Science, Policy, Politics And The Law, Nancy Halpern

Nancy E Halpern D.V.M.

ANTIBIOTICS IN FOOD ANIMALS: THE CONVERGENCE OF ANIMAL AND PUBLIC HEALTH, SCIENCE, POLICY, POLITICS AND THE LAW

BY NANCY E HALPERN, DVM

MAY 3, 2009

ABSTRACT

The use of antibiotics in food animals, to prevent and/or control disease in these animals, has been a subject of discussion between the medical and veterinary and animal agricultural sectors and related national and international government entities for decades, because of concerns about the resulting increase in antibiotic resistance such practices facilitate. The underlying premise is that use of antibiotics in food animals leads to resistance of the bacteria consumed by humans, and reducing …

The End Of The Red Queen's Race: Medical Marijuana In The New Century, Ruth C. Stern, J. Herbie Difonzo

J. Herbie DiFonzo

The road to marijuana prohibition is paved with prejudice, hysteria, and the outright rejection of science and rationality. Despite its proven medical value, marijuana remains misclassified under federal law, misrepresented and misunderstood by most of our drug policy makers. Seizing their role as innovators in our federalist system, California and twelve other states have declared their support for the many doctors and patients who believe in the therapeutic benefits of cannabis. The conflict between the federal government and the states on medical marijuana is a study in “cultural federalism,” the experience of citizenship in a divided polity. Whether the medical …

A Healthy Diet Of Preemption: The Power Of The Fda And The Battle Over Restricting High Fructose Corn Syrup From Food And Beverages Labeled ‘Natural’, Adam C. Schlosser

Adam C. Schlosser

Americans today are facing a health crisis. These same Americans are increasingly trying to improve their well-being by purchasing healthy food and beverages and are flocking towards the supposed health benefits of those foods and beverages labeled ‘natural.’ Due to the FDA’s liberal requirements, consumer confusion currently exists regarding what ingredients may be used in products labeled ‘natural.’ In fact, many ‘natural’ food and beverages are actually less healthy than their counterparts not featuring any specific labeling claims. High fructose corn syrup (HFCS) is produced by a complex scientific manufacturing process and is used as an ingredient in millions of …

Between Market And The State: Regulating Food Safety In The Wake Of Pet Food And Frozen Dumplings Incidents, Dongsheng Zang

Dongsheng Zang

Food safety has become a widespread concern for consumers in China’s major trading partners. This article looks into the details of legal responses to food safety incidents in Japan, the United States and China. What the three countries have in common is what I label “inspection-based” approach to food safety. In Japan, after the frozen dumpling incident, people are proposing setting up a “comprehensive” regulatory agency. In the United States, the Bush Administration signed a bilateral agreement with China, making China’s product quality agency—AQSIQ—a certifying agent of the FDA. In China, the government launches national law enforcement campaigns on food …

Promoting, Prescribing, And Pushing Pills: Understanding The Lessons Of Antipsychotic Drug Litigation, Douglas Mossman, Jill Louise Steinberg

Douglas Mossman

Ineffectiveness of prescription drugs, hidden drug hazards, and advertising violations have led to several drug recalls and numerous lawsuits against pharmaceutical companies in recent years. These suits have involved several varieties of medications, but psychoactive medications have figured especially prominently. A recent $1.4 billion settlement by Eli Lilly & Company related to improper promotion of its top-selling drug olanzapine included the largest individual corporate criminal fine in U.S. history. Improper promotion is far from the sole reason why olanzapine and other “second-generation” antipsychotic (SGA) drugs have become so successful. Rather, the widespread adoption of SGAs represents a collective judgment error …

Permissible Product Hopping: Why A Per Se Legal Rule Barring Antitrust Liability Is Necessary To Protect Future Innovation In The Pharmaceutical Industry, Michelle L. Ethier

Michelle L. Ethier

Pharmaceutical product hopping is a relatively new phenomenon in which a brand-name pharmaceutical company tactically reformulates a drug and patents the reformulation in an attempt to avoid competition by a generic competitor. When viewed in the context of the Hatch-Waxman framework, product hopping can effectively eliminate generic competitors from the market, thereby implicating § 2 of the Sherman Act. In addressing antitrust liability, this Note advocates a per se legal approach to product hopping so long as the hop is supported by a valid patent. Although some have argued that deference to the United States Patent and Trademark Office and …

Responding, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Michael J. Malinowski

This Commentary is part of a colloquy on race-based genetics research.

Toward A Distributive Commons In Patent Law, Peter Lee

Peter Lee

While patents provide incentives to invent and develop new inventions, they can constrain access to vital health technologies such as medicines, diagnostics, and nutritional innovations. These access constraints can severely compromise human health, particularly for low-income populations, and have elicited severe criticism. Against this seemingly intractable background, this Article explores methods for integrating distributive values in the patent system while remaining sensitive to property rights and private ordering. Rather than look inward to existing patent doctrine, this Article finds solutions in the political economy of life sciences research. In particular, this Article argues that public institutions, which contribute enormous amounts …

Homeland Security Planning: What Victory Gardens And Fidel Castro Can Teach Us In Preparing For Food Crises In The U.S., A. Bryan Endres, Jody M. Endres

A. Bryan Endres

Food security is an essential element of comprehensive government crisis response plans. The absence of a terrorist attack on the agricultural sector, however, has been “more by luck than design” and the American public has a false sense of food security due to the invisibility of its complicated food supply chain. Current planning efforts, grounded in the Bioterrorism Act of 2002 and a series of Presidential Directives, rely exclusively on the status quo of conventional agriculture and neglect the potential security benefits of regional and local food networks. Two historical examples, the World War II Victory Garden program and Cuba’s …

“Balancing Corporate Governance, Patients’ Interests, And Physicians’ Fiduciary Roles In The Healthcare Arena – What Would The Reasonable Person Do?”., Rachel V. Rose

rachel v rose

Oversight begins with disclosure. Part I of this article addresses corporate governance in the context of financial crisis and Sarbanes Oxley. Part II highlights both the role of pharmaceutical/medical device companies in compensating physicians for the time away from their practices for educational purposes, and the consequences of physician business relationships on the fiduciary duty owed by physicians to patients. The significance of voluntary compliance programs is set forth in Part III. Present and proposed policies for the oversight of business relationships between physicians and medical device/pharmaceutical companies are discussed in Part IV. Finally, Part V concludes that a “reasonable …

Cutting Funding For Oral Contraceptives: Violation Of Equal Protection Rights And The Disparate Impact On Women's Healthcare, Rachel V. Rose

rachel v rose

Cutting funding for oral contraceptives has far reaching implications for women, which include adverse impacts on women’s health, negative economic impacts on society, and constitutional violations. In a country whose governmental health plans (Medicare and Medicaid) reimburse men’s costs for Viagra® , it is hardly appropriate to deny women access to prescribed oral contraceptives that have traditionally been defined as supplementary services falling under the umbrella of primary care. Because of the wording of a provision, some contend that non-profit clinics and campus health centers can no longer offer oral contraceptives at reduced rates. This article will show how decreasing …

International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth

Gary E. Marchant

Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nanotechnologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether …

International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth

Gary E. Marchant

Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nanotechnologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether …

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Journal Articles

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Dealing With The Realities Of Race And Ethnicity: A Bioethics-Centered Argument In Favor Of Race-Based Genetics Research, Michael J. Malinowski

Journal Articles

No abstract provided.

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Journal Articles

This Commentary is part of a colloquy on race-based genetics research.

An Economic Justification For Open Access To Essential Medicine Patents In Developing Countries, Sean Flynn, Aidan Hollis, Mike Palmedo

Articles in Law Reviews & Other Academic Journals

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the “deadweight losses” caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which …

Biofuels, Subsidies, And Dispute Settlement In The Wto, Bryant Walker Smith

Bryant Walker Smith

The first WTO panels to tackle a biofuels dispute under the Agreement on Subsidies and Countervailing Measures will navigate a murky sea of conflict, gridlock, and uncertainty that the subsidies agreement did not contemplate and that the failed Doha round did not resolve. This article charts these waters. It identifies both the values that the panels will confront and the interpretive tools that they will wield. It further argues that dispute settlement may become the primary driver of an otherwise stagnant regime, and it sketches three competing visions for protecting the “legally binding security of expectations” that underscores that regime.