Health Law and Policy Commons^™

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 …

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 …

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 …

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 …

Information To Consumers On The Absence Or Reduced Presence Of Gluten In Food: Commission Implementing Regulation (Eu) No 828/2014 / July 17, 2015, Luis González Vaqué

Luis González Vaqué

On 30 July 2014, the European Commission adopted Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food.

In this article, renowned food lawyer Mr. Luis González Vaqué seeks to analyse what is new in this Community legislation. To do so he first look briefly at Commission Regulation (EC) No 41/2009 of 20 January 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten, especially because Implementing Regulation No. 828/2014 will only enter into force on …

Forfeiting Federalism: The Faustian Pact With Big Tobacco, Ryan Dreveskracht

Ryan Dreveskracht

This article discusses the effects of the largest legal settlement in United States history: the so-called Master Settlement Agreement, or “MSA.” Part I discusses the settlement generally, and its intended effect on the U.S. tobacco market. Parts II through IV discuss the unintended consequences of the settlement. Specifically, Part II considers how states got into their current disarray, and how a perceived state windfall of billions of dollars ended up putting states on what by all accounts now appears to be very real risk of insolvency. Part III examines how the major tobacco companies are using the states’ dire financial …

Mutual Pharmaceutical Co. V. Bartlett: A Need For “Explicit” Congressional Action And State Tort Law Reform, Kara A. Ritter

Kara A Ritter

No abstract provided.

The Continuing Battle Of Fda Regulation Of Dietary Supplements And Their Adverse Affect On Young Adults And Other Individuals, Andrew Bernard Jaffe

Andrew Bernard Jaffe

THE CONTINUING BATTLE OF FDA REGULATION OF DIETARY SUPPLEMENTS AND THEIR ADVERSE AFFECT ON YOUNG ADULTS AND OTHER INDIVIDUALS

Abstract

Ever since the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA) the Food and Drug Administration (FDA) has struggled to regulate dietary supplements. This is due to the definition of dietary supplements as foods in the act. This gives supplement manufacturers greater loopholes when introducing supplements on the market. The FDA’s inability to regulate dietary supplements efficiently has been present for decades. Multiple battles are still occurring today which is proven to have an adverse effect …

"¿Qué Información Hay Que Facilitar Al Consumidor Cuando Adquiere Productos Alimenticios Por Internet O Mediante Otros Sistemas De Comunicación A Distancia?", Luis González Vaqué

Luis González Vaqué

Para garantizar la información alimentaria, es necesario tener en cuenta todas las formas de suministrar alimentos a los consumidores, como la venta de alimentos mediante técnicas de comunicación a distancia. Es evidente que cualquier alimento suministrado a través de la venta a distancia debe cumplir los mismos requisitos de información que los alimentos vendidos en los comercios; por lo tanto, el art. 14 del Reglamento nº 1169/2011 establece la información alimentaria obligatoria pertinente en tales casos y que también debe estar disponible antes de realizar la compra.

The Aca’S Tobacco Use Rating: Implementation, Inconsistencies And Ironies, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

As the Affordable Care Act continues toward full implementation, the law’s complexity is on full display. As we have noted in earlier writings, the ACA continues the federal tradition of using a fragmented approach to allocating oversight responsibilities among federal and state regulators, while maintaining the role of private actors in health care insurance and delivery systems. The result is a dizzying array of plan types (self-insured, fully insured, small market, individual market, large market, grandfathered) subject to an equally dizzying blend of ACA, ERISA, and individual state requirements.

Medical Malpractice, The Affordable Care Act And State Provider Shield Laws: More Myth Than Necessity?, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, …

Our Bodies, Our Cells: Fda Regulation Of Autologous Adult Stem Cell Therapies, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly. Gurdon and Yamanaka demonstrated …

A Decade’S Quest For Safer Drugs: Congressional Committee Green Lights Regulation Of Drug Supply Chains And Compounding Manufacturers, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

On May 22. 2013, the Senate Health, Education, Labor and Pensions (HELP) Committee unanimously approved S.959, “The Pharmaceutical Compounding Quality and Accountability Act,” and S.957, “The Drug Supply and Security Act,” (now incorporated into S. 959 as an amendment). Congressional efforts to enact comprehensive legislation to improve drug safety and secure the nation’s drug supply chain have lingered for over a decade. The lack of federal uniformity has allowed a patchwork of state legislation to emerge, attracting the less scrupulous to those states with the lowest security. The issue finally gained traction among HELP Committee members when 55 people died …

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.

Shame, Blame, And The Emerging Law Of Obesity Control.Pdf, Lindsay Wiley

Lindsay Wiley

La Transparencia En La Protección De Datos Personales, Bruno L. Costantini García

Bruno L. Costantini García

La Transparencia en la Protección de Datos Personales, ponencia elaborada dentro de los trabajos del VII Congreso Nacional de Organismos Públicos Autónomos (OPAM)

The Alternative Forms Of Dispute Settlement And The Essential Difference Between These And Arbitration, Michael Diathesopoulos

Michael Diathesopoulos

The paper examines the characteristics of some common alternative forms of dispute settlement and their key differences from arbitration regarding their nature and scope. Its purpose is to explore each mechanism's suitability for specific types of disputes.

Aspectos Generales Dela Publicidad En México. "La Publicidad De Productos, Servicios, Y Actividades Reguladas Por La Ley General De Salud", Bruno L. Costantini García

Bruno L. Costantini García

Introducción a las generalidades de la regulación en materia de publicidad de insumos para el consumo humano (salud) en México.

Regulation Not Prohibition: The Comparative Case Against The Insurable Interest Doctrine, Sharo Michael Atmeh

Sharo M Atmeh

American law requires an insurable interest—a pecuniary or affective stake in the subject of an insurance policy—as a predi-cate to properly obtaining insurance. In theory, the rule prevents both wagering on individual lives and moral hazard. In practice, the doctrine is avoided by complex insurance transaction structuring to effectuate both origination and transfers of insurance by individuals without an insurable interest. This paper argues that it is time to ab-andon the insurable interest doctrine. As both the English and Aus-tralian experiences indicate, elimination of the insurable interest doctrine will have little detrimental pecuniary effect on the insurance industry, while freeing …

Minors & Cosmetic Surgery: An Argument For State Intervention, Derrick Diaz

Derrick Diaz Mr.

This article focuses on whether a state may intervene to prevent minors from obtaining medically unnecessary cosmetic surgery. The article concludes that a state may prohibit such a procedure without running afoul of parental liberty interests by showing severe risk of harm to the minor. Furthermore, the article proposes that minors not have access to cosmetic surgery unless found by a court to be medically necessary. If medical necessity has been shown, then the parental presumption must control. However, if medical necessity has not been shown, then the service should be prohibited the same as any regulated service or product …

Arctic Justice: Addressing Persistent Organic Pollutants, Prof. Elizabeth Burleson

Prof. Elizabeth Burleson

This article recommends enhanced governance of persistent organic pollutants through incentives to develop environmentally sound, climate friendly technologies as well as caution in developing the Arctic. It highlights the toxicity challenges presented by POPs to Arctic people and ecosystems.

Noción Y Elementos Existenciales Del Título De Crédito, Bruno L. Costantini García

Bruno L. Costantini García

Discernir la noción y elementos de existencia de los títulos de crédito, considerando la doctrina y la denominación expresada en nuestra Ley General de Títulos y Operaciones de Crédito, conceptualizando el término de los documentos que consignan un derecho crediticio propio de su naturaleza y deslindando de manera dogmatica y exegética los elementos que lo forman y le dan su funcionamiento, mediante una visión de las instituciones jurídicas que les dan su existencia y aplicación dentro del devenir de los actos de comercio.

Agency Cost Problems In Executive Compensation: An Evaluation Of Dividend Equivalent Rights On Restricted Stocks, Ufuoma Barbara Akpotaire

Ufuoma Barbara Akpotaire

Some authors argue that the integration of stock options as well as restricted stocks into executive compensation may reduce the conflicts between shareholders and management but may at the same time give rise to other agency problems connected to debt. While this line of argument may hold some merit, the structure of executive compensation packages, has over the years, focused less on stock options and more on restricted stocks. A classic example of this trend is Microsoft, who in 2003, switched from using stock options to restricted stock.

Compensating executives through restricted stocks has recently come under scrutiny due to …

Generalidades De La Propiedad Intelectual En México, Bruno L. Costantini García

Bruno L. Costantini García

Presentación de las Generalidades de la Propiedad Intelectual en México (Propiedad Industrial y Derechos de Autor), legislación que la rige, aplicación y modalidades

Ownership Unbundling In European Energy Market & Legal Problems Under Eu Law, Michael Diathesopoulos

Michael Diathesopoulos

In this paper we will examine the issue of ownership unbundling and forced divestiture remedies imposed in a series of recent competition law cases of the energy market - examined in other papers - in relation to the possible existence of a series of legal obstacles. These energy market decisions belong to a group of antitrust cases in which a structural divestiture remedy has been imposed under the provisions of Article 9 of Regulation 1/2003. This divestiture refers to transmission networks and to generation capacity and is meant to lead to severe structural changes, which are compatible with the findings …

La Jurisprudencia En México, Bruno L. Costantini García

Bruno L. Costantini García

Breve presentación de la jurisprudencia en México, su aplicación, objetivos y fines para el Derecho Mexicano. ¿Por qué es util para el derecho? ¿Quién la emite?

Notariado Y Correduria Y Su Registro En México, Bruno L. Costantini García

Bruno L. Costantini García

Introducción al Derecho Notarial y Registral en México, cuyo objeto es conocer los elementos de las figuras del notario y del corredor público, la formalización de sus actos y su registro.

Competition Law And Sector Regulation In The European Energy Market After The Third Energy Package: Hierarchy And Efficiency, Michael Diathesopoulos

Michael Diathesopoulos

The aim of this research is to provide the basic parameters for a model for the definition of the relation between the general competition and sector specific frameworks and rules regarding the regulation of the Internal Energy Market, especially after the Third Energy Package. The research considers the recent sector specific framework in relation to a series of recent competition law cases of the Energy Market where structural remedies were applied under the commitments procedure. Essential facilities doctrine and generally competition law tools do not seem to provide a suitable framework for effectively addressing the dynamic competition concept, treating the …