Health Law and Policy Commons^™

Against The ‘Safety Net’, Matthew Lawrence

Matthew B. Lawrence

Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa

Ryan B. Stoa

Marijuana legalization is sweeping the nation. Recreational marijuana use is legal in eight states. Medical marijuana use is legal in thirteen states. Only three states maintain an absolute criminal prohibition on marijuana use. Many of these legalization initiatives propose to regulate marijuana in a manner similar to alcohol, and many titles are variations of the "Regulate Marijuana Like Alcohol Act." For political and public health reasons the analogy makes sense, but it also reveals a regulatory blind spot. States may be using alcohol as a model for regulating the distribution, retail, and consumption of marijuana, but marijuana is much more …

Comparative Cannabis: Approaches To Marijuana Agriculture Regulation In The United States And Canada, Ryan Stoa

Ryan B. Stoa

The United States and Canada may be friends and allies, but the two countries' approaches to the regulation of marijuana agriculture have not evolved in tandem. On the contrary, their respective paths toward legalization and regulation of marijuana agriculture are remarkably divergent. In the United States, where marijuana remains a federally prohibited and tightly-controlled substance, legalization and regulation have remained the province of state legislatures and their administrative agencies for decades. In Canada, a succession of court cases paving the way toward medicinal marijuana use has prompted the federal government to develop a national framework committed to "legalize, regulate, and …

Modernizing The Emergency Medical Treatment And Labor Act To Harmonize With The Affordable Care Act To Improve Equality, Quality And Cost Of Emergency Care, Katharine A. Van Tassel

Katharine Van Tassel

This Article will propose a very simple, two-step way to modernize EMTALA [Emergency Medical Treatment and Active Labor Act (1986)] to deal with this cascade of problems. This solution converts EMTALA into a powerful tool to enhance equal access to healthcare while at the same time changing EMTALA so that it works in tandem with, instead of against, the efforts of the Affordable Care Act, Medicare and Medicaid to improve healthcare quality, cost and equal access.

This solution also works across systems to resolve the conflict between the tort, licensure and hospital peer review systems that all discourage evidence-based treatment …

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel

Katharine Van Tassel

This Article discusses the public health, regulatory, legal, and ethical issues raised by the developing appreciation of the negative physical effects and potential health risks associated with nanotech products, and is arranged as follows. After this Introduction, this Article describes the present scientific understanding of the health risks associated with the consumption of nanoparticles. Next, a summary of the existing FDA regulatory structure that governs food, dietary supplements, cosmetics, and sunscreens is provided along with an explanation of why these regulations fail to protect public health when applied to regulate the nanotech versions of these products. The Article goes on …

Harmonizing The Affordable Care Act With The Three Main National Systems For Healthcare Quality Improvement: The Tort, Licensure, And Hospital Peer Review Hearing Systems, Katharine Van Tassel

Katharine Van Tassel

.. [W]hile the ACA [Affordable Care Act] has at least some provisions addressing the need to make changes in the medical malpractice and licensure systems to encourage the use of evidence-based standards of care, the ACA completely ignores the hospital peer review system. This article makes specific suggestions for how to revise all three major systems [the tort, licensure, and hospital peer review] so that they can work in tandem with federal law to encourage physicians to adopt [an] evidence-based model of medical practice in order to improve healthcare quality, cost, and access. This article starts by explaining the difference …

Genetically Modified Plants Used For Food, Risk Assessment And Uncertainty Principles: Does The Transition From Ignorance To Indeterminacy Trigger The Need For Post-Market Surveillance?, Katharine Van Tassel

Katharine Van Tassel

In the context of GM foods, a genetic modification changes the biochemical cross-talk between genes, creating genetic material that has never existed before in nature. This novel genetic material can create unintended health risks, as seen with the case of the GM peas that contained a novel and unexpected allergenic protein and primed test mice to react to other allergens.6 The bottom line is that the scientific acceptance of the existence of the networked gene establishes that the FDA’s presumption that GM plant food is bioequivalent to traditional plant food is no longer scientifically supportable and that a new system …

Using Clinical Practice Guidelines And Knowledge Translation Theory To Cure The Negative Impact Of The National Hospital Peer Review Hearing System On Healthcare Quality, Cost, And Access, Katharine Van Tassel

Katharine Van Tassel

This Article starts with a history of the growth of hospital peer review and then examines the merits of the rationales that motivated the passage of the Health Care Quality Improvement Act of 1986 ('HCQIA'), which catapulted peer review into the national system that exists today. The Article next explains how the peer review hearing process works and how HCQIA turns private hospitals into small, individual quasi-regulatory agencies. The Article goes on to critique the 'bad apples' approach taken by hospital peer review in light of the growing body of empirical research that supports a systems improvement approach to dealing …

Hospital Peer Review Standards And Due Process: Moving From Tort Doctrine Toward Contract Principles Based On Clinical Practice Guidelines, Katharine A. Van Tassel

Katharine Van Tassel

This Article proposes a solution to the problems associated with the current use of vague standards in peer review. This Article will examine the proposal that medical staffs switch from ad hoc judicial decision-making to rule-making. This switch will allow medical staffs to abandon the troublesome practice of applying vague 'standard of care' measures ex post facto. In its stead, express contractual terminology could be adopted, such as 'expectations of performance,' which incorporates specifically chosen and uniquely tailored clinical practice guidelines ('CPGs') directly into the medical staff by-laws. Describing the expectations of physician performance in express contractual terms enables physicians …

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Katharine Van Tassel

This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is …

The Introduction Of Biotech Foods To The Tort System: Creating A New Duty To Identify, Katharine Van Tassel

Katharine Van Tassel

This Article examines the question of whether an unsuspecting consumer who dies from an allergic or toxic reaction to an undisclosed biotech ingredient in food can recover damages through the tort system. The surprising answer is that recovery is very unlikely. This Article outlines why this is the case, then evaluates the merits of several potential solutions to this problem including the possible creation of a common law 'duty to identify' biotech ingredients in food.

This Article is arranged as follows. First, a brief primer on the nature of biotech foods is provided. For the reader unfamiliar with the regulatory …

Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

Aaron Edlin

The Supreme Court’s opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court’s analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements.As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply, serve to confirm …

Introduction: Marijuana Laws And Federalism, Erwin Chemerinsky

Erwin Chemerinsky

No abstract provided.

Dignity, Vol 1, Issue 1, 2016, Donna M. Hughes Dr.

Donna M. Hughes

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 …

What Should Law Enforcement Role Be In Addressing Quality Of Life Issues Associated With Section 8 Housing?, D'Andre D. Lampkin

D'Andre Devon Lampkin

The purpose of this research project is to discuss the challenges law enforcement face when attempting to address quality of life issues for residents residing in and around Section 8 federal housing. The paper introduces readers to the purpose of Section 8 housing, the process in which residents choose subsidized housing, and the legal challenges presented when law enforcement agencies are assisting city government to address quality of life issues. For purposes of this research project, studies were sampled to illustrate where law enforcement participation worked and where law enforcement participation leads to unintended legal ramifications.

What Impact The Supreme Court’S Recent Hobby Lobby Decision Might Have For Lgbt Civil Rights?, Vincent Samar

Vincent Samar

Abstract

What Impact the Supreme Court’s Recent Hobby Lobby

Decision Might Have for LGBT Civil Rights?

Vincent J. Samar

The U.S. Supreme Court’s recent decision in the Hobby Lobby case has created shockwaves of concern among civil rights groups questioning whether for-profit corporations can assert a religious exemption from civil rights legislation under a 1993 federal law, the Religious Freedom Restoration Act. The matter is of particular concern in the LGBT community given the possible impact it could have on services traditionally offered to those getting married as more and more states legalize same-sex marriage. Though the Court’s conservative majority …

Bridging The Gap Between Intent And Status: A New Framework For Modern Parentage, Yehezkel Margalit

Hezi Margalit

The last few decades have witnessed dramatic changes in the conceptualization and methodologies of determining legal parentage in the U.S. and other countries in the western world. Through various sociological shifts, growing social openness and bio-medical innovations, the traditional definitions of family and parenthood have been dramatically transformed. This transformation has led to an acute and urgent need for legal and social frameworks to regulate the process of determining legal parentage. Moreover, instead of progressing in a piecemeal, ad-hoc manner, the framework for determining legal parentage should be comprehensive. Only a comprehensive solution will address the differing needs of today’s …

From Baby M To Baby M(Anji): Regulating International Surrogacy Agreements, Yehezkel Margalit

Hezi Margalit

In 1985, when Kim Cotton became Britain’s first commercial surrogate mother, Europe was exposed to the issue of surrogacy for the first time on a large scale. Three years later, in 1988, the famous case of Baby M drew the attention of the American public to surrogacy as well. These two cases implicated fundamental ethical and legal issues regarding domestic surrogacy and triggered a fierce debate about motherhood, child-bearing, and the relationship between procreation, science and commerce. These two cases exemplified the debate regarding domestic surrogacy - a debate that has now been raging for decades. Contrary to the well-known …

Can Dna Be Speech?, Jorge R. Roig

Jorge R Roig

From Patient Rights To Health Justice.Pdf, Lindsay Wiley

Lindsay Wiley

Bridging The Quality Gap With Medical-Legal Partnerships, Lisa Bliss, Sylvia Caley, Robert Pettignano

Sylvia B. Caley

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 Treatment For Malpractice – Physician, Enhance Thyself: The Impact Of Neuroenhancements For Medical Malpractice, Harvey L. Fiser

Harvey L. Fiser

No abstract provided.

The Role Of Courts In The Debate On Assisted Suicide: A Communitarian Approach, 9 Notre Dame J.L. Ethics & Pub. Pol'y 367 (1995), Donald L. Beschle

Donald L. Beschle

No abstract provided.

Shared Responsibility Regulation Model For Cross-Border Reproductive Transactions, Sharon Bassan

Sharon Bassan

The term “cross-border reproductive transactions” refers to the phenomenon of tens of thousands of people who travel from one country to another to purchase reproductive services, in order to have a child. The foci of this paper are the lion share of cross-border reproductive transactions, specifically between consumers, i.e., intended parents from affluent countries, and suppliers of reproductive services, egg sellers and surrogate mothers, the majority of whom are from lower middle-income countries. Strong concerns regarding the morality of consumers’ states’ policy arise when a country nationally restricts or bans commercial surrogacy, while accepting the results of cross-border reproductive transactions …

The "Uberization" Of Healthcare: The Forthcoming Legal Storm Over Mobile Health Technology's Impact On The Medical Profession, Fazal Khan

Fazal Khan

The nascent field of mobile health technology is still very small but is predicted to grow exponentially as major technology companies such as Apple, Google, Samsung, and even Facebook have announced mobile health initiatives alongside influential healthcare provider networks. Given the highly regulated nature of healthcare, significant legal barriers stand in the way of mobile health’s potential ascension. I contend that the most difficult legal challenges facing this industry will be restrictive professional licensing and scope of practice laws. The primary reason is that mobile health threatens to disrupt historical power dynamics within the healthcare profession that have legally enshrined …

Broad Shareholder Value And The Inevitable Role Of Conscience, Paul D. Weitzel, Zachariah J. Rodgers

Paul D. Weitzel

This article proposes an integrative solution to the modern debate on corporate purpose, the question of whether directors and officers must solely maximize profits or whether they may consider the effects on employees, the environment or the community. Many find pure profit maximization unseemly and suggest alternative theories, typically arguing that corporations owe a duty to a broader range of stakeholders. This position is inconsistent with the case law and unnecessary to allow conscience in the board room. We resolve the issue more simply by acknowledging that the purpose of a corporation is to promote the shareholders’ interests, which includes …

California’S Good Samaritan Law: Correcting Ambiguities To Induce Action, Sara Popovich

Sara Popovich

This Note argues that California should amend its Good Samaritan law by either creating a duty to assist or clarifying the statute. It first outlines the history of Good Samaritan law in California and describe developments in the law through today. It then argues that Good Samaritan law in California is ineffective because citizens still fear legal liability and thus refuse to assist during emergencies. Finally, it proposes specific changes to the California Good Samaritan law.

The Determination Of Occupational Health And Safety Standards In Ontario 1860-1982: From Markets To Politics To...?, Eric Tucker

Eric M. Tucker

The author reviews the historical development of the decision-making frameworks within which courts and the Legislature have made choices regarding the allocation of risks to health and safety in the workplace. Arguing that this development has been conditioned by the necessity of satisfying in a capitalist democracy conflicting demands to facilitate capital accumulation and to justify to the electorate the manner in which choices regarding the structure of the processes of production have been made, the author contends that recent pressure to adopt cost-benefit analysis to satisfy the demands of legitimation and accumulation, and challenges its adequacy as a normative …