Law Commons^™

3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom

Evan R. Youngstrom

Today, our society is on a precipice of significant advancement in healthcare because 3D printing will usher in the next generation of medicine. The next generation will be driven by customization, which will allow doctors to replace limbs and individualize drugs. However, the next generation will be without large pharmaceutical companies and their justifications for strong intellectual property rights. However, the current patent system (which is underpinned by a social tradeoff made from property incentives) is not flexible enough to cope with 3D printing’s rapid development. Very soon, the social tradeoff will no longer benefit society, so it must be …

Gandhi’S Prophecy: Corporate Violence And A Mindful Law For Bhopal, Nehal A. Patel

Nehal A. Patel

AbstractOver thirty years have passed since the Bhopal chemical disaster began,and in that time scholars of corporate social responsibility (CSR) havediscussed and debated several frameworks for improving corporate responseto social and environmental problems. However, CSR discourse rarelydelves into the fundamental architecture of legal thought that oftenbuttresses corporate dominance in the global economy. Moreover, CSRdiscourse does little to challenge the ontological and epistemologicalassumptions that form the foundation for modern economics and the role ofcorporations in the world.I explore methods of transforming CSR by employing the thought ofMohandas Gandhi. I pay particular attention to Gandhi’s critique ofindustrialization and principle of swadeshi (self-sufficiency) …

The Interstate Commerce Of Abortion: A Constitutional Argument For The Federal Invalidation Of Restrictive State Abortion Laws, Kaiya Amelia Lyons

Kaiya Amelia Lyons

No abstract provided.

Health Care And The Balance Billing Problem: The Solution Is The Common Law Of Contracts And Strengthening The Free Market For Health Care., George A. Nation Iii

George A Nation III

A large and growing group of insured patients is being unfairly burdened by hospitals’ exorbitant chargemaster prices. The burden is brought to bear on these patients through a process known as balance billing. For a variety of reasons hospital networks are becoming narrower as hospital systems contract with fewer insurers, and as a result, more and more patients are receiving balance bills. The practice of balance billing puts upward pressure on health care prices in general. That is, this practice leads to higher prices across the board for the uninsured, the out-of-network insured and even the in-network insured. This article …

The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah W. Brennan

Hannah W Brennan

The United States spends nearly $1,000 per person annually on drugs—40 percent more than the next highest spender, Canada, and more than twice the amount France and Germany spend. Although myriad factors contribute to high drug spending in the United States, the crucial role that intellectual property laws play in inhibiting access to cheaper, generic medications is among one of the best documented. Yet, for the most part, the discussion of the relationship between intellectual property law and drug spending has centered on patent protection. Recently, however, a few researchers have turned their attention to a different exclusivity—trademark law. New …

Hospital Chargemaster Insanity: Heeling The Healers, George A. Nation Iii

George A Nation III

Hospital list prices, contained in something called a chargemaster are insanely high, often running 10 times the amount that hospitals routinely accept as full payment from insurers. Moreover, the relative level of a particular hospital’s chargemaster prices bears no relationship to either the quality of the services the hospital provides or, to the cost of the services provided. The purpose of these fictitious list prices is to serve as a starting point or anchoring point, for negotiations with third-party payers regarding the amount that they will actually pay the hospital for it’s goods and services.

Ironically, there is widespread agreement, …

The Drug Shortage Crisis: What Happens When Generic Manufacturers "Just Say No", Stacey B. Lee

Stacey B. Lee

In the past five years, the number of drug shortages in the United States has nearly quintupled. The majority of shortages involve generic sterile injectables used to fight infectious diseases and treat cancer. These complex drugs are produced in a concentrated market consisting of only a few generic manufacturers. Any disruption in their supply can result in shortages that leave patients without access to life-saving drugs which in some cases are the only treatment for their condition. These chronic shortages have been linked to many possible factors including product quality concerns, discontinuation of product lines, changes in supply and demand, …

Licensure Of Health Care Professionals: The Consumer's Case For Abolition, Charles H. Baron

Charles H. Baron

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.

Medical Paternalism And The Rule Of Law: A Reply To Dr. Relman, Charles Baron

Charles H. Baron

In this Article, Professor Baron challenges the position taken recently by Dr. Arnold Relman in this journal that the 1977 Saikewicz decision of the Supreme Judicial Court of Massachusetts was incorrect in calling for routine judicial resolution of decisions whether to provide life-prolonging treatment to terminally ill incompetent patients. First, Professor Baron argues that Dr. Relman's position that doctors should make such decisions is based upon an outmoded, paternalistic view of the doctor-patient relationship. Second, he points out the importance of guaranteeing to such decisions the special qualities of process which characterize decision making by courts and which are not …

Waging War On Specialty Pharmaceutical Tiering In Pharmacy Benefit Design, Chad I. Brooker

Chad I Brooker

Specialty drugs represent a growing concern for both health insurance issuers and beneficiaries given their exceedingly high (and growing) costs—representing almost half of all drug spend by 2017. Payers have sought to reduce their specialty drug spend by sharing more of the cost of these drugs with the beneficiaries who depend on them through the creation of specialty drug tiers. This has forced some patients to choose between forgoing other needs to pay for their medications or not take them at all. While several states have sought to outlaw the use of specialty drug tiers or limit pharmaceutical OOP cost-sharing, …

Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower

Richard Cameron Gower

Despite some difficulties, state tort law can be argued to create a unique exception to patent law. Specifically, the prevented rescue doctrine suggests that charities and others can circumvent patents on certain critical medications when such actions are necessary to save individuals from death or serious harm. Although this Article finds that the prevented rescue tort doctrines is preempted by federal patent law, all hope is not lost. A federal substantive due process claim may be brought that uses the common law to demonstrate a fundamental right that has long been protected by our Nation’s legal traditions. Moreover, this Article …

Free Rider – A Justification For Mandatory Medical Insurance Under Health Care Reform?, Douglas A. Kahn, Jeffrey H. Kahn

Law & Economics Working Papers

Section 1501 of the Patient Protection and Affordable Care Act added section 5000A to the Internal Revenue Code to require most individuals in the United States to purchase a minimum level of medical insurance. This requirement, which is enforced by a penalty imposed on those who fail to comply, is sometimes referred to as the “individual mandate.” A frequently stated defense of the individual mandate is that there are a vast number of persons who do not purchase medical insurance and then obtain free medical care when the need arises, and the individual mandate will require those persons (often referred …

Law, Society, And Medical Malpractice Litigation In Japan, Eric Feldman

All Faculty Scholarship

No abstract provided.

Comments On Liebman And Zeckhauser, Simple Humans, Complex Insurance, Subtle Subsidies, Edward J. Mccaffery

Edward J McCaffery

These are brief comments on an excellent paper by Jeffrey Liebman and Richard Zeckhauser, prepared for a conference sponsored by the Urban Institute and Brookings on tax and health care policy. Liebman and Zeckhauser summarize the complexities involved in making optimal health insurance decisions, and offer generally cautionary notes about conflating these with tax law (a theme of the conference). Most importantly, Liebman and Zeckhauser suggest a positive role for employers in health care and insurance decisions, as better setters or framers of choice sets—witness 401(k) plans. In this Commentary, I applaud Leibman and Zeckhauser’s general work and particular observation, …

Diabetes Treatments And Moral Hazard, Jonathan Klick, Thomas Stratmann

All Faculty Scholarship

In the face of rising rates of diabetes, many states have passed laws requiring health insurance plans to cover medical treatments for the disease. Although supporters of the mandates expect them to improve the health of diabetics, the mandates have the potential to generate a moral hazard to the extent that medical treatments might displace individual behavioral improvements. Another possibility is that the mandates do little to improve insurance coverage for most individuals, as previous research on benefit mandates has suggested that mandates often duplicate what plans already cover. To examine the effects of these mandates, we employ a triple-differences …

Patent Political Economy - Indian Lessons On Pharmaceutical Patent, Julien L. Chaisse, Samira Guennif

ExpressO

The Intellectual Property Rights (IPR) regime adopted by any country is essentially a tool that strives to ensure both the growth of the domestic pharmaceutical industry and people’s access to medicines. But, contrary to the very easily advanced theory, there is no paradox between the two. From this perspective, the Indian experience has shown that it is precisely the relaxation of its national IPR regime that promoted the growth of its domestic industry, thereby ensuring a better patient access to medicines. However, the globalisation process does not overlook any sector, which means that medicines too are submitted to the new …

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.

Zoning And Eminent Domain Under The New Minimum Scrutiny, John H. Ryskamp

ExpressO

Recently the Supreme Court has made it clearer that minimum scrutiny is a factual analysis. Whether in any government action there is a rational relation to a legitimate interest is a matter of determining whether there is a policy maintaining important facts. This has come about in the Court’s emerging emphasis on developing fact-based criteria for determining government purpose. Thus, those who want to affect zoning and eminent domain outcomes should look to what the Court sees as important facts, and whether government action is maintaining those facts with its proposed land use or eminent domain action.

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 …

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 …

Mandatory Waiting Periods For Abortions And Female Mental Health, Jonathan Klick

All Faculty Scholarship

Proponents of laws requiring a waiting period before a woman can receive an abortion argue that these cooling off periods protect against rash decisions on the part of women in the event of unplanned pregnancies. Opponents claim, at best, waiting periods have no effect on decision-making and, at worst, they subject women to additional mental anguish and stress. In this article, I examine these competing claims using adult female suicide rates at the state level as a proxy for mental health. Panel data analyses suggest that the adoption of mandatory waiting periods reduce suicide rates by about 10 percent, and …

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 …

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

ExpressO

No abstract provided.

Obesity And Advertising Policy, Todd J. Zywicki, Debra Holt, Maureen Ohlhausen

George Mason University School of Law Working Papers Series

It is clear that Americans are getting fatter, both adults and children. This development has led some to call for a ban on food advertising directed at children. There are numerous practical and constitutional difficulties with such a policy. This article poses a more fundamental question - even if feasible, would restricting food advertising do anything to reduce obesity or even slow its trends? The article also considers whether the social costs of banning advertising could outweigh the social benefits of such an action.

This article provides a review of the literature on the fundamental causes of the American obesity …

Modern Bootlegging And The Prohibition On Fair Prices: Last Call For The Repeal Of Pharmaceutical Price Gouging, Luke W. Cleland

ExpressO

This article discusses the recent passage of the Medicare Prescription Drug, Modernization and Improvement Act of 2003, and the executive and judicial decisions affecting the ability of the general public to access foreign pharmaceutical markets. The article examines the recent actions taken by the U.S. government, explore various state movements within the United States aimed at reducing pharmaceutical drug prices, outline the process of pharmaceutical drug prices in foreign countries, and advocate for a workable integration of all available mechanisms to feasibly reduce prescription drug prices for the benefit of both U.S. consumers and U.S. drug companies. As avenues to …

The Poor State Of Health Care Quality In The U.S.: Is Malpractice Liability Part Of The Problem Or Part Of The Solution?, Charles Silver

ExpressO

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 …

Why We Need The Independent Sector: The Behavior, Law, & Ethics Of Not-For-Profit Hospitals, Jill R. Horwitz

Law & Economics Working Papers Archive: 2003-2009

Among the major forms of corporate ownership, the not-for-profit ownership form is distinct in its behavior, legal constraints, and moral obligations. A new empirical analysis of the American hospital industry, using eleven years of data for all urban general hospitals in the country, shows that corporate form accounts for large differences in the provision of specific medical services. Not-for-profit hospitals systematically provide both private and public goods that are in the public interest, and that other forms fail to provide. Two hypotheses are proposed to account for the findings, one legal and one moral. While no causal claims are made, …

The Unrealized Power Of Mother, Dorothy E. Roberts

All Faculty Scholarship

No abstract provided.

Licensure Of Health Care Professionals: The Consumer's Case For Abolition, Charles Baron

Charles H. Baron

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.