Digital Commons Network^™

Standard Errors: How Budget Rules Distort Lawmaking, Timothy M. Westmoreland

ExpressO

The article argues that the Congress’s budget process has invisibly influenced its legislative activities and structurally skewed its policy choices. The budgetary structure and tools as they affect lawmaking are largely unanalyzed. Until they are widely appreciated, they may often be random, inefficient, unrepresentative, and even deceptive. Review, critique, and change are overdue in any case. Inasmuch as the Congress is now, after a period of budget anarchy, debating how to refocus on the budget, this is a particularly good time for such activities.

The article also argues that additional structures are needed to “counter-balance” both the skewing that results …

Tackling The "Evils" Of Interlocking Directorates In Healthcare Nonprofits, Nicole Huberfeld

ExpressO

No abstract provided.

The Weldon Amendment: The Ongoing Restrictions On A Woman's Right To Choose, John Patton Fortuno

ExpressO

Under the Weldon Amendment, a “physician or other health care professional, a hospital, a provider-sponsored organization, a health maintenance organization, a health insurance plan, or any other kind of health care facility” may refuse abortions, counseling, or referrals, even in cases of rape, incest, or medical emergency.

Reproductive Cloning Case:How Law And Bioethics Measure A Compelling Governmental Interest, Paulo Farias

ExpressO

Law and Bioethics should be partners in developing public policies to deal with cloning. Law as a Government tool must enforce decisions made in Bioethics Commissions such as the NBAC and the President’s Council, because the Commissions’ discussions offer an array of principles to help legislators and policy makers understand how to find compelling governmental interests. For instance, human dignity is not a vague and obscure legal or bioethical concept. In truth, it is a way of connecting Law and Bioethics to answer questions such as the relationship between the legal protection of procreation and the Report of the President’s …

The Three Faces Of Retainer Care, Frank A. Pasquale

ExpressO

Retainer care arrangements allow patients to pay a fee directly to a physician’s office in order to obtain special access to care. Practices usually convert to retainer status by concentrating their attention on a small panel and dropping the majority of their patients. Proponents call retainer care a triumph of consumer-directed health care; opponents deride it as “boutique medicine.” Both sides are deploying a variety of legal tactics in order to attain their goals.

After surveying these conflicts, this article clarifies what is at stake by analyzing the three key features of retainer care: preventive care, queue-jumping, and amenity-bundling. Most …

Vioxx: How Strong Is The Case Against Merck?, Jason M. Weigand

ExpressO

The thousands of personal injury cases filed after Merck’s voluntary withdrawal of Vioxx appear difficult to prove. A large obstacle for plaintiffs is the admissibility of epidemiologic studies, which are required to prove specific causation. Pharmaceutical companies spend countless hours and resources developing and researching new drugs. Clinical research began to indicate that there may be an increase in adverse cardiovascular (“CV”) side effects associated with Vioxx. The reliability of this data and how it will work in our courts is a great concern.

Fluconomics--Preserving Our Hospital Infrastructure During And After A Pandemic, Vickie Williams

ExpressO

Influenza pandemics occur regularly. The deadly Spanish flu pandemic of 1918 infected more than 25% of the United States population, and killed 2.5% of those infected. Virtually all experts agree that it is not a question of if another influenza pandemic as deadly as the Spanish flu will occur, but a question of when. The Centers for Disease Control and Prevention estimates that the direct and indirect medical costs in the United States associated with a “medium-level” influenza pandemic would range from $71 billion to $167 billion.

Although public health officials are rapidly implementing pandemic preparedness plans on both the …

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …

The Children Of Science: Property, People, Or Something In Between?, Star Q. Lopez

ExpressO

How should states classify embryos? The war has often waged between two classifications, people versus property. But what if a state assumed something in between, finding the embryo to be a potential person entitled to special respect? If a state adopted this position, how would the law affect medical research?

Presuming embryos constitute potential persons, the debate would continue with how to define “special respect.” The status of a potential person runs along a spectrum between property and personhood. How one defines “special respect” determines where the potential person falls along this spectrum. Special respect would create a spectrum of …

Fair Housing Is Good Medicine: Applying The Fair Housing Act's No-Inquiry Regulation When Housing And Health Care Are Provided Together, Eric M. Carlson

ExpressO

The Fair Housing Act (FHA) protects individuals with disabilities from discrimination in the housing or rental markets. The FHA’s no-inquiry regulation prohibits a landlord from inquiring into an applicant’s health condition.

Although the FHA routinely has been applied to long-term care facilities – usually to protect a group home or similar facility from unfair zoning practices – the no-inquiry regulation has not been utilized to challenge the admissions practices of assisted living facilities, nursing facilities, and other long-term care facilities. Indeed, at first glance, a no-inquiry rule seems a poor fit for a facility that provides health care along with …

The Expressive Impact Of Patents, Timothy R. Holbrook

ExpressO

Patents represent a quid pro quo between the public and the inventor: in exchange for disclosing the invention, the inventor receives the right to exclude others from practicing her invention. They therefore serve as a source technical information. Patents also communicate information to markets and companies that serve to reduce various transaction costs, allowing more efficient transactions and investment. Patents consequently communicate various types of information beyond the technical.

There is no reason, however, that such messages must be limited to the technical or the pecuniary. This Article explores whether patents, like other governmental acts such as legislation, can create …

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …

The Legalization Of Fat: Law, Science, And The Construction Of A Moral Panic, Paul Campos

ExpressO

Over the past decade, American public health authorities have made increasingly alarming claims regarding how obesity is becoming the nation’s leading public health problem. These warnings have inspired a flurry of legislative, administrative, and judicial responses, and calls for further legal intervention are issuing constantly from obesity researchers and public health officials. This article surveys and critiques the sudden wave of attempts to use the American legal system to shrink the nation’s waistline The article demonstrates that the health risks associated with the populace’s fairly modest increasing average weight have been greatly exaggerated; that the causal links, if any, between …

Guarding Against The High Risk Of High-Deductible Health Plans: A Proposal For Regulatory Protections, Michele Melden

ExpressO

High deductible health plans are a cornerstone of "consumer-driven health care." This article explores a number of myths promoted by proponents of such plans and challenges these myths to discuss the various ways such plans pose risks to consumers both individually and generally. While most articles on this topic explore the arguments for and against such plans, this article, unlike others, proposes specific regulatory protections with model language. In fact, this article already has been used as the basis for testimony before the California State Assembly which, for the first time, has introduced legislation aimed at regulating such plans and …

“It’S The [Tort System], Stupid:” Consumer Deductibles; How To More Equitably Distribute The Risks Of Medical Malpractice And Adequately Compensate Victims Without Statutory Damage Caps., Bradford Luke Ledbetter

ExpressO

No abstract provided.

Genetic Databases And Biobanks: Who Controls Our Genetic Privacy?, Yael Bregman-Eschet

ExpressO

In the past several years a growing number of private biotech companies have been collecting and storing our genetic information and bodily tissues and linking it to life-long medical histories. Many of these commercial companies have close relationships with the public sector: they rely on public institutions to get access to certain medical data and tissue samples, while the public sector relies on those companies for commercial exploitation of the research. Despite the unique nature of the information collected and the sensitivity of genetic databases, these private bio-libraries are largely unregulated in the United States. This article examines who has …

“A Modest Proposal”: Universal Cesarean Section To Reduce Professional Liability Costs, James A. Greenberg, Katherine E. Economy, Andrew W. Beckwith, Jeffrey L. Ecker

ExpressO

ABSTRACT OBJECTIVE: To model the effect of universal cesarean delivery on professional liability costs.

STUDY DESIGN: We examined all obstetric professional liability claims covered by a single insurer between January 1, 1990 and December 31, 2000. We reviewed each case to determine if an alternate route of delivery might reasonably have prevented the lawsuit. Costs were calculated by adding the cost of processing the claim, the legal defense, the settlement payments and/or the actuarially derived adjustments. Using a 20% cesarean rate as our baseline, we modeled the effect on liability costs of cesarean delivery in all patients.

RESULTS: There were …

Reinvigorating First Year Criminal Law: Integrating Mental Disability Issues Into The Criminal Law Course, Linda C. Fentiman

ExpressO

This article explores how mental disability issues can be incorporated into a traditional criminal law class, in order to enrich student understanding of both mental disability law and criminal law doctrine. The intersection of mental disability with the doctrinal aspects of criminal law can be broken into five major categories: 1) the justifications for punishment; 2) the definition of crime in general, e.g., the requirements of a voluntary act, mens rea, and causation; 3) the definition of particular crimes, such as murder, manslaughter, rape, and burglary; 4) defenses to crime, including mistake of law and of fact, as well as …

The Custody Battle Over Cryogenically Preserved Embryos After Divorce: Advocating For Infertile Women’S Rights, Cori S. Annapolen

ExpressO

This paper focuses on the struggles that infertile women face to achieve motherhood because their rights are underrepresented in the American court system. It specifically centers on how the process of in vitro fertilization (IVF) helps infertile women conceive children, but then details the problems that increasing technology now causes for these women after they freeze embryos and then divorce. Because the courts of only four states have determined who gets custody of these embryos after a divorce, and because the divorce rate and the number of couples utilizing IVF are increasing, future states will likely be forced to answer …

Deadly Discounts: How Reimportation Jeopardizes The Safety Of The U.S. Pharmaceutical Drug Supply Under The Federal Trade Commission Amendment, Nicole C. Bates

ExpressO

The amendment to a Federal Trade Commission (FTC) reauthorization bill, previously introduced as Senate Bill 334 (S.334) Pharmaceutical Market Access and Drug Safety Act of 2005 allows for the reimportation of prescription drugs into the United States from approximately 25 countries, including Canada via Internet pharmacies. There are no guarantees that the internet websites advertising as Canadian pharmacies are legitimate. The shipping of pharmaceutical drugs occurs through importation, which refers to drugs produced abroad then later shipped to the U.S., or re-importation, a term applied when drugs are produced in the U.S. and exported for sale to foreign countries and …

Blame Canada (And The Rest Of The World): The Twenty-Year War On Imported Prescription Drugs, Daniel L. Pollock

ExpressO

Rising budget deficits and sticker shock over the new Medicare drug benefit have put the issue of prescription drug costs back into the spotlight. The growth in the cost of prescription drugs continues to represent a staggering burden for taxpayer-funded health care programs, even while costs of non-drug health care services have slowed or even decreased. Among the many proposals for cutting prescription drug costs, drug importation is unique. Although bipartisan support for drug importation has existed in Congress for over five years, the federal government continues to maintain that a system of safe and effective drug importation is impossible. …

How It Works: Sobriety Sentencing, The Constitution And Alcoholics Anonymous. A Perspective From Aa's Founding Community, Max E. Dehn

ExpressO

This paper analyzes the public health as well as constitutional issues that arise when persons are required by courts to participate in 12-step recovery programs.

An Economic Assessment Of Damage Caps In Medical Malpracitce Litigation Imposed By State Laws And The Implications For Federal Policy And Law, Paul Wazzan

ExpressO

Many states have implemented laws which limit non-economic (e.g., pain and suffering) damages as a result of medical malpractice. These laws are seen by proponents as reducing medical malpractice insurance costs and preserving access to health care – especially for lower income individuals. Opponents believe that individuals are harmed through being prevented from seeking a full measure of redress for medical malpractice incidents, by reducing access to the court system, and that these laws simply enrich insurance companies and doctors.

Federal lawmakers are currently studying the potential effect of uniform medical malpractice damage limits at the national level. It is …

Project Bioshield, More Than Meets The Eye: A Critique Of The U.S.’S Proposed Silver Bullet For Responding To Bio-Terrorism, Jodi A. Phillipo

ExpressO

No abstract provided.

Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor

ExpressO

No abstract provided.

“Racially-Tailored” Medicine Unraveled, Sharona Hoffman

ExpressO

In June 2005, the FDA approved BiDil, a heart failure medication that is labeled for use only by African-Americans and thus, is the first treatment of its kind. The drug likely portends a future of growing interest in “race-based” medicine. This phenomenon is emerging at the same time that scientists, in light of the Human Genome Project, are reaching an understanding that “race” has no biological meaning, and consequently, “racially-tailored” medicine is both puzzling and troubling.

This Article explores the reasons for the new focus on “racial-profiling” in medicine. It analyzes the risks and dangers of this approach, including medical …

Principles Of Fairness For International Economic Treaties: Constructivism And Contractualism, John Linarelli

ExpressO

No legal system deserving of continued support can exist without an adequate theory of justice. This paper is about the elaboration of a theory of justice to underpin international economic law and international economic institutions. A world trade constitution cannot credibly exist without a clear notion of justice upon which to base a consensus. There is yet no consensus on the public reason underpinning the rules and the institutions. Economic efficiency concepts are widely used in the assessment of the welfare effects of world trade institutions and policies. Efficiency, however, is one of several standards that may be used, but …

Learning The Wrong Lessons From "An American Tragedy": A Critique Of The Berger-Twerski Informed Choice Proposal, David E. Bernstein

George Mason University School of Law Working Papers Series

This paper is a critique of Margaret Berger and Aaron Twerski, “Uncertainty and Informed Choice: Unmasking Daubert”, forthcoming the Michigan Law Review. Berger and Twerski propose that courts recognize a cause of action that would allow plaintiffs who claim injury from pharmaceutical products, but who do not have sufficient evidence to prove causation, to recover damages for deprivation of informed choice. Berger and Twerski claim inspiration from the litigation over allegations that the morning sickness drug Bendectin caused birth defects. Considering the criteria Berger and Twerski suggest for their proposed cause of action in the context of Bendectin, it appears …

Tragedy & Remedy: Black Reparations For Racial Disparities In Health, Kevin Outterson

ExpressO

This Article makes unique and powerful contributions to Black reparations, health care law, biomedical and social science research into racial disparities in health, and critical race theory.

The starting point is the tragedy of Black health in America, with dramatically higher death rates and shorter life expectancies. Current research is ill-equipped to consider the deeper historical roots of Black health disparities; while the development of racially-specific therapies (such as the FDA’s approval in July 2005 of BiDil, a heart drug for Blacks) actually contributes to racial profiling in medicine. Biomedical research has a race problem.

The Black reparations movement suffers …

On Hastening Death Without Violating Legal Or Moral Prohibitions, Norman L. Cantor

Rutgers Law School (Newark) Faculty Papers

While the vast majority of fatally afflicted persons have a powerful wish to remain alive, some stricken persons may, for any of a host of reasons, desire to hasten death. Some persons are afflicted with chronic degenerative diseases that take a grievous toll. Chronic pain may be severe and intractable, anxiety about a future treatment regimen may be distressing, and helplessness may erode personal dignity and soil the image that the afflicted person wants to leave behind.

A dying patient’s interest in hastening death is often said to be in tension with a bedrock social principle that respect for sanctity …