Food and Drug Law Commons^™

The Costs Of Cigarettes: The Economic Case For Ex Post Incentive-Based Regulation, Jon D. Hanson, Kyle D. Logue

Articles

Cigarette smoking causes over 420,000 deaths annually in the United States, roughly twenty percent of all U.S. deaths, making cigarettes the single greatest preventable cause of death in this country. Indeed, tobacco kills more people every year than alcohol, illicit drugs, automobile accidents, violent crime, and AIDS combined. And not only are cigarettes deadly to smokers; they kill nonsmokers as well. According to a recent report from the Environmental Protection Agency (EPA), the "sidestream" or "passive" smoke from cigarettes - so-called environmental tobacco smoke (ETS) - is responsible annually for approximately 3000 lung cancer deaths, between 150,000 and 300,000 lower …

Smokers' Compensation: Toward A Blueprint For Federal Regulation Of Cigarette Manufacturers, Jon D. Hanson, Kyle D. Logue, Michael S. Zamore

Articles

Although nothing is certain in Washington, sweeping federal legislation in the cigarette area is more likely now than has ever been the case. Congress is currently considering several proposals for comprehensive federal regulation of the cigarette market, a market that has until now gone largely untouched by government intervention. Among those proposals, the one that has received the most attention, and the one that in fact motivated policy makers to look anew at the problems posed by cigarettes, is the proposed national tobacco resolution (the "Proposed Resolution"). The Proposed Resolution, which has been advanced by a coalition of state attorneys …

Rehabilitative Punishment And The Drug Treatment Court Movement, Richard C. Boldt

Faculty Scholarship

No abstract provided.

In Memoriam: Ralph Seeley Obscured By Smoke: Medicinal Marijuana And The Need For Representation Reinforcement Review, Aryeh Y. Brown

Seattle University Law Review

This Comment contends that because of the continuing legislative inability to deal adequately with this issue the courts must apply strict judicial scrutiny by way of a representational reinforcement theory to cases concerning the medicinal use of marijuana. Failure to do so perpetuates the dysfunction of the judicial and legislative process. It additionally detracts from the legitimacy of that process by fostering cynicism and contempt toward the legislature that promulgates such oppressive laws and toward the judiciary that allows their enforcement.

Race For Perfection: Children's Rights And Enhancement Drugs, Therese Powers

Journal of Law and Health

This Note will address the question of what are a child's rights when the child's views differ from his or her parents regarding the child's use or refusal of enhancement drugs such as Ritalin and Human Growth Hormone. This Note will begin with a description of Ritalin and Human Growth Hormone along with the uses and abuses of each drug. It will then discuss the evolution of children's rights dealing with situations such as civil commitment, abortion, and medical treatment over religious objection. Furthermore, it will draw comparisons from the case law in these situations to a child's right to …

Does The Fda Have Authority To Regulate Human Cloning?, Elizabeth Price Foley, Elizabeth C. Price

Faculty Publications

Examines the FDA's statutory authority to regulate human cloning.

The Hemp Controversy: Can Industrial Hemp Save Kentucky?, Susan David Demaine

Articles by Maurer Faculty

In the wake of litigation over the responsibility of tobacco companies for harm caused by cigarettes and in the face of increased public hostility toward smoking, Kentucky's tobacco farmers are apprehensive about the future. While not all growers depend entirely on tobacco for their income, the potential shrinking of the tobacco market will have serious ramifications throughout the state. Some farmers are turning to organic vegetable farming, or to com and soybeans as alternative crops, but the potential of industrial hemp as an option remains uncertain. Touted by many as the answer to the tobacco farmer's quandary, industrial hemp remains …

Federal Regulation Of Tobacco Products And Products That Treat Tobacco Dependence: Are The Playing Fields Level?, Joseph A. Page

Georgetown Law Faculty Publications and Other Works

Company A is thinking about launching a traditional tobacco product, perhaps a cigarette or a smokeless tobacco confection, with a new ingredient, ingredient level, or ingredient mix that in the past has never been sold. Company B contemplates putting on the market an innovative medication, medical device, or dietary supplement intended to help consumers to free themselves from physical dependence on tobacco products. Company C ponders the possibility of introducing a smoking product whose novelty derives from express or implied marketing claims that the product will decrease or perhaps even eliminate physical dependence on tobacco, or reduce other risks associated …

The 1988 U.N. Convention Against Illicit Traffic In Narcotic Drugs And Psychotropic Substances - A Ten Year Perspective: Is International Cooperation Merely Illusory?, Jimmy Gurulé

Journal Articles

On the ten-year anniversary of the adoption of the 1988 U.N. Drug Convention, this Article analyzes whether signatory- parties have complied with the duties and obligations imposed thereunder, and, in particular, whether the Convention has enhanced international cooperation in narcotics enforcement. Part I of this Article examines the legal obligations and duties imposed under the 1988 U.N. Drug Convention, with special emphasis on the provisions aimed at criminalizing money laundering and at forfeiture of illicit drug proceeds and instrumentalities of narcotics trafficking. Additionally, Part I examines the requirement that parties afford one another the "widest measure of mutual legal assistance …

Statutory Compliance And Tort Liability: Examining The Strongest Case, Michael D. Green

University of Michigan Journal of Law Reform

Professor Green addresses the matter of the proper balance between the tort system and regulation in the context of prescription drugs and the FDA's vigorous oversight of the industry. He articulates several reasons why a regulatory compliance defense, in which tort law would defer to FDA regulation, is quite attractive. Despite the superior expertise of the FDA in assessing the benefits and risks of a drug, a regulatory compliance defense is considerably more problematical than might appear at first glance. Ascertaining compliance with FDA requirements could be a lengthy and complicated inquiry that would either replace or supplement the issues …

Formed By Thalidomide: Mass Torts As A False Cure For Toxic Exposure, Anita Bernstein

Faculty Scholarship

No abstract provided.

Bolivia And Coca: Law, Policy, And Drug Control, Melanie R. Hallums

Vanderbilt Journal of Transnational Law

International drug trafficking looms large in the future of international relations. Although drug production and consumption can no longer be labeled as problems belonging to a few discrete nations, some countries' identities in the international arena are still shaped by their perception as drug-producing nations. Bolivia is one such country. Coca and cocaine have dominated its modern history and will continue to dominate its future. Bolivia's experience, however, is representative of not only other Andean nations' struggles with the drug epidemic, but of the international community's struggle with drug trafficking.

This Note sheds light on the legal tools to address …

Contingency Fees: Should Plaintiffs Lawyers In The Tobacco Settlement Receive Billions Of Dollars?, Charles Silver, Lester Brickman

Articles

The article debates the fairness of contingency fees for plaintiff lawyers in the $368.5 billion tobacco settlement, with one side arguing the fees are justified due to the high risks and successful outcome, while the other advocates for congressional intervention to set a uniform, sliding-scale fee structure.

Introduction: Three Contributions To Three Important Problems In Evidence Scholarship, Peter Tillers

Cardozo Law Review

This issue of the Cardozo Law Review is graced with original contributions about three fundamental problems in evidence scholarship and the law of evidence. First, in an exchange of views about legal remedies for the wrongful infliction of "evidential damage," Professors Ariel Porat and Alex Stein, on the one hand, and Professor Richard Friedman, on the other, touch on some of the difficulties that are associated with the nearly oxymoronic task of measuring the harm done by the destruction or loss of unknown evidence. Second, in an article about the relationship between estimation of drug quantities and burdens of proof, …

Ru 486 Examined: Impact Of A New Technology On An 0 Id Controversy, Gwendolyn Prothro

University of Michigan Journal of Law Reform

Abortion is an extremely divisive issue in American politics and culture. Prothro begins this Article by analyzing the current legal standards governing reproduction, which draw a sharp distinction between abortion and contraception. Prothro then examines the function of RU 486, demonstrating that it acts both as a contraceptive and as an abortifacient. Because of this dual capacity, RU 486 does not fit neatly into the current legal framework. Prothro concludes this Article by arguing that RU 486 should force the Supreme Court to create a new framework for the "procreative right." Prothro argues that this new framework should treat the …

Unitedstates V. Ursery: Drug Offenders Forfeit Their Fifth Amendment Rights , Sean M. Dunn

American University Law Review

No abstract provided.

The Drug Courier Profile: In Planes, Trains, And Automobiles; And Now In The Jury Box , Mark J. Kadish

American University Law Review

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The Food Quality Protection Act Of 1996: Does The Delaney Clause Effectively Protect Against Cancer Or Is It Outdated Legislation, 30 J. Marshall L. Rev. 1127 (1997), Erin E. Moran

UIC Law Review

No abstract provided.

Gluttony, William I. Miller

Articles

Gluttony does not have the grandeur of pride, the often brilliant strategic meanness of envy and avarice, the glory of wrath. It does manage to gain some small allure by its association with lust, its sexy sibling sin of the flesh. Yet there is something irrevocably unseemly about gluttony, vulgar and lowbrow, self-indulgent in a swinish way. Gluttony is not the stuff of tragedy or epic. Imagine Hamlet too fat to take revenge or Homer making his topic the gluttony of Achilles rather than his wrath. With gluttony, compare pride and anger, sins that mark the grand action of revenge, …

Deaccession: Not Such A Dirty Word, Jason R. Goldstein

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Des Third-Generation Liability: A Proximate Cause, Tracey I. Batt

Cardozo Law Review

The drug DES has been associated with multigenerational injuries. Although courts in a number of states have allowed many second-generation DES victims to recover from the drug's manufacturers, this remedy, to date, has not been extended to thirdgeneration DES casualties. A number of reasons have been cited for this refusal, but the fear of requiring a drug manufacturer to be perpetually liable to descendants of those who ingested DES as well as the tricky issue of proximate causation predominate. This Note argues that at least some third-generation DES victims could (and should) be allowed to recover, without changing any laws …

Liquor And Lemon: The Establishment Clause And State Regulation Of Alcohol Sales, Steven L. Lane

Vanderbilt Law Review

Approximately half of the fifty states and numerous municipalities maintain and enforce legislation that prohibits the sale of alcohol close to churches. A number of other states allow their liquor- licensing authorities to consider proposed vendors' proximity to churches. Likewise, states and municipalities in all regions of the country have laws that restrict the sale of alcohol on Sunday. Notwithstanding the secular justifications offered by the proponents of such legislation, analysis reveals that it is religiously motivated. Although the Bible contains no clear mandate against the sale, purchase, or consumption of alcohol, history illustrates that prohibitions on the sale of …

Is Random Suspicionless Drug Testing In The Schools Reasonable - An Analysis Of Vernonia School District 47j V. Acton, Katharine J.M. Chester

North Carolina Central Law Review

No abstract provided.

The International Conference On Harmonization Of Pharmaceutical Regulations, The European Medicines Evaluation Agency, And The Fda: Who's Zooming Who?, Dan Kidd

Indiana Journal of Global Legal Studies

No abstract provided.

Implementing The Public Welfare Requirement In New Mexico's Water Code, Consuelo Bokum

Publications

Despite the fact that the New Mexico legislature added a public welfare criterion to the water code over 10 years ago, the State Engineer Office has not addressed the application of the criterion by regulation and has only addressed the public welfare briefly in a few decisions. There is almost no case law in New Mexico addressing this issue. More and more participants, however, are raising public welfare in water rights protests. This paper addresses how the public welfare criterion has developed in western water law and proposes an approach for use of the criterion in New Mexico.

When Discretion Leads To Distortion: Recognizing Pre-Arrest Sentence-Manipulation Claims Under The Federal Sentencing Guidelines, Jeffrey L. Fisher

Michigan Law Review

This Note argues that sentence manipulation should be a legally viable partial defense - a defense that does not warrant complete exoneration, but does warrant a reduced sentence when the government's investigative techniques place a quantity of drugs before the court that overrepresents the defendant's culpability, or individual blameworthiness. Part I describes the policies and objectives that underlie the Guidelines, but then demonstrates how the rigid application of quantity-based sentencing provisions can lead to sentence manipulation that thwarts these goals, particularly the goal of sentencing according to culpability. Part II describes how courts have responded to sentence manipulation claims. It …

Teaching The Elephant To Dance: Privatizing The Fda Review Process, Elizabeth Price Foley, Elizabeth C. Price

Faculty Publications

Considers the implications of privatizing the Food and Drug Administration's (FDA) review of the safety and efficacy of medical devices and drugs. Concludes that the FDA's flaws - namely, a risk avoidance culture and autocratic style of regulation - can only be accomplished by breaking the agency's monopolization of this review function.

Pharmaceuticals: The Battle For Control In The 21st Century, Rachel F. Ochs

Journal of Law and Health

To explore these concepts, this paper focuses on the Japanese motivation for taking control in the pharmaceutical industry and efforts that the US can take to ensure its role as a leader in the pharmaceutical industry. First, the paper discusses how Japan is poised to invade the US pharmaceutical market, reasons for Japanese entry into the market, the Japanese focus on research, recent examples of Japanese expansion and how US policy may affect Japanese expansion into the pharmaceutical market. The next section describes the need for the FDA to protect consumer interests in the US since market forces and / …

The Politics Of Reducing Tobacco Use Among Children And Adolescents: Why The Food And Drug Administration Cannot Regulate Tobacco And A Proposed Policy For States And Local Communities, Timothy J. Degeeter

Journal of Law and Health

This paper will reveal that although the FDA has a compelling argument from a public health point of view to regulate tobacco products, the proposed federal rule is beyond the scope of the FDA's authority. The FDA cannot unilaterally assert jurisdiction over tobacco products in order to implement restrictions for children and adolescents without specific Congressional action. Instead, Congress has specifically delegated such regulatory authority to the states. Moreover, the proposed rule lacks necessary enforcement mechanisms to adequately keep tobacco products out of the hands of children and adolescents.

Protecting Our Children: A Call To Reform State Policies To Hold Pregnant Drug Addicts Accountable, 29 J. Marshall L. Rev. 765 (1996), Julie J. Zitella

UIC Law Review

No abstract provided.