Food and Drug Law Commons^™

From Harm To Robustness: A Principled Approach To Vice Regulation, Jim Leitzel

ExpressO

John Stuart Mill’s harm principle maintains that adult behavior cannot justifiably be subject to social coercion unless the behavior involves harm or a significant risk of harm to non-consenting others. The absence of harms to others, however, is one of the distinguishing features of many manifestations of “vices” such as the consumption of alcohol, nicotine, recreational drugs, prostitution, pornography, and gambling. It is with respect to vice policy, then, that the harm principle tends to be most constraining, and some current vice controls, such as prohibitions on drug possession and prostitution, violate Mill’s precept. In the vice arena, we seem …

Medicaid Third-Party Liability And Claims For Restitution: Defining The Proper Role For The Tort System In Regulating The Food Industry, Coby Warren Logan

Journal of Food Law & Policy

This comment contends that tort liability can complement legislative and administrative government regulation of the food industry, providing sellers and manufacturers of food with an incentive to prevent consumers from over-consumption and becoming obese. Specifically, this comment supports the proposition that after government regulations are promulgated by Congress, claims should be allowed by state attorneys general to recoup Medicaid costs incurred in treating health conditions and illnesses caused by obesity.

From The Farm To The Factory: An Overview Of The American And European Approaches To Regulation Of The Beef Industry, Crisarla S. Houston

Journal of Food Law & Policy

First, this article briefly describes the existing regulatory requirements under both systems. Second, it compares the two approaches. In comparing the two systems, attention is concentrated on the quality of legislative drafting, the likelihood of implementation, the adequacy of consumer protection, the voluntary or compulsory nature of the measures, and the requirement of records retention.

Contents, Journal Editors

Journal of Food Law & Policy

No abstract provided.

European Union Food Law Update, Nicole Coutrelis

Journal of Food Law & Policy

Update on European Union Food Law 2005.

United States Food Law Update, Michael Tingey Roberts

Journal of Food Law & Policy

This update summarizes significant changes and developments in food law over the first half of 2005. Not every change in national food law for the first half of 2005 is included; instead, this update is limited to significant changes in national law. New developments in state law, while certainly important and deserving of attention, are beyond the scope of this update. These updates provide a starting point for scholars, practitioners, food scientists, and policymakers determined to understand the shaping of food law in modem society. Tracing the development of food law through these updates also builds an important historical context …

The Food Safety And Inspection Service's Lack Of Statutory Authority To Suspend Inspection For Failure To Comply With Haccp Regulations, Dennis R. Johnson, Jolyda O. Swaim

Journal of Food Law & Policy

Since the implementation of the Mega-Reg, the agency has had mixed success with its new enforcement procedures. Although most establishments have chosen to work with FSIS to modify their procedures to allay any concerns the agency had, on a few occasions, no compromise was reached. In these cases, the establishment filed suit in federal district court challenging the agency's authority to remove inspectors for failure to comply with the Mega-Reg. In the three cases where the agency's authority was challenged, the establishment was successful and inspection was restored.

Preempting Food Safety: An Examination Of Usda Rulemaking And Its E.Coli O157:H7 Policy In Light Of Estate Of Kriefall Ex Rel. Kriefall V. Excel Corporation, Denis Stearns

Journal of Food Law & Policy

This article will use the Kriefall decision to examine USDA rulemaking and its still-evolving E. coli 0157:H7 policy. Part II of the article will briefly describe the development and implementation of the USDA E. coli 0157:H7 policy as a reaction to an enormous and widely-publicized outbreak of E. coli infections that occurred in 1993-the so-called Jack in the Box outbreak. Following the outbreak, E. coli 0157:H7 was declared by USDA to be an adulterant per se according to FMIA. It was also at this time that the first steps were taken by USDA to move from a "command and control" …

Journal Of Food Law & Polic - Fall 2005, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Uncertainty And Informed Choice: Unmasking Daubert, Margaret A. Berger, Aaron D. Twerski

Michigan Law Review

This Article will first examine why it is that plaintiffs have been unable to prove causation under the Daubert guidelines in toxic tort litigation. Second, it will look at the two existing models for informed choice litigation medical malpractice and products liability-and demonstrate why neither of these models gives toxic tort plaintiffs a fair opportunity to recover for the deprivation of patient autonomy against drug manufacturers who have breached their duty to warn of known or knowable risks. Finally, this Article will explore the elements of a causation-free informed choice cause of action. It will suggest the appropriate standard for …

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 …

A Mathematical Approach To Benefit-Detriment Analysis As A Solution To Compulsory Licensing Of Pharmaceuticals Under The Trips Agreement, Vishal Gupta

Cardozo Journal of International and Comparative Law

The note proposes a mathematical approach to benefit-detriment analysis as a solution to the challenges posed by compulsory licensing of pharmaceuticals under the TRIPS Agreement. The core argument is that a socio-economic framework, comparing the monetary detriment to pharmaceutical companies (D) with the aggregate societal benefit (H x C), where H is the average health benefit per person and C is the number of affected citizens, can provide a balanced and objective method to determine when compulsory licenses should be granted. This approach aims to address the "Paragraph 6 problem" and improve access to essential medicines in developing countries while …

Furthering Consumer Safety Of Medical Devices: The Necessity Of A Device-Specific State Law As Required For Express Preemption Under The Mda, Rachel Mervis

Cardozo Law Review

No abstract provided.

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. …

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 …

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 …

Liability For Direct Advertising Of Drugs To Consumers: An Idea Whose Time Has Not Come, Aaron Twerski

Faculty Scholarship

No abstract provided.

A Government Of Limited Powers, Carl E. Schneider

Articles

Roscoe C. Filburn owned a small farm in Ohio where he raised poultry, dairy cows, and a modest acreage of winter wheat. Some wheat he fed his animals, some he sold, and some he kept for his family's daily bread. The Agricultural Adjustment Act of 1938 limited the wheat Mr. Filburn could grow without incurring penalties, but his 1941 crop exceeded those limits. Mr. Filburn sued. He said Claude Wickard, the Secretary of Agriculture, could not enforce the AAI's limits because Congress lacked authority to regulate wheat grown for one's own use. He reasoned: In our federal system, the states …

The Effects Of Price Regulation On Pharmaceutical R&D And Innovation, Heather M. O'Neill, Lena Clarissa Crain

Business and Economics Faculty Publications

As rising health care expenditures focus government attention on slowing the growth, the pharmaceutical industry comes under increasing pressure to curb prices of ethical drugs. Pharmaceutical price regulations have been implemented in many countries to control pharmaceutical expenditures. Yet, creating innovative drugs requires enormous R&D costs, which in turn require adequate expected economic returns. Since price controls reduce profits and expected returns, as countries invoke stricter price regulations, firms will either move their R&D process into less regulated markets or move out of innovative R&D. This paper assesses the impact of drug price regulations in Japan compared to market-priced drugs …

Food Democracy Ii: Revolution Or Restoration?, Neil D. Hamilton

Journal of Food Law & Policy

Author's Note: This essay is a companion to the essay 'Food Democracy, "which appears in 9 Drake Journal of Agricultural Law 9 (2004). In that essay, the author discussed many of the progressive trends that are helping reshape America's food system. These trends have a common denominator in their reflection of the democratic tendencies of the American populace. The desire of an increasing number of consumers to eat better food and to have access to the information, choices, and alternatives that make better food available are helping drive shifts in food production and marketing. Accompanying these shifts are political and …

Food Law & Policy: An Essay, Peter Barton Hutt

Journal of Food Law & Policy

Food has been the driving preoccupation of humans since the dawn of evolution. Exactly when food processing began and when the original hunter-gatherers settled down to develop agriculture-or even the question of which of these occurred first-remain issues of scholarly pursuit and debate. It is clear, however, that these events occurred millennia before the advent of recorded history; therefore, we must rely on largely adventitious discoveries of archeological artifacts to advance our developing knowledge of these events.

Traceability And Labeling Of Genetically Modified Crops, Food, And Feed In The European Union, Margaret Rosso Grossman

Journal of Food Law & Policy

In the last several years, European Union (E.U.) policy has encouraged development of biotechnology, including genetically modified (GM) (that is, bioengineered) agricultural crops. The E.U. developed a strategy for life sciences and biotechnology, directed toward improving the competitiveness of the European biotechnology sector and the general situation for European biotechnology. E.U. documents have acknowledged the potential significance of genetically modified crops-for example, the conclusion in a recent report that "the potential of plant genomics and biotechnology to deliver major advances in our lifestyles and prosperity is enormous. [Biotechnology] can also maintain and enhance the competitiveness of E.U. farmers and food …

European Union Food Law Update, Nicole Coutrelis

Journal of Food Law & Policy

The purpose of this update is to present the main events that have taken place each six months in the food law sector in the European Union (E.U.). This presentation will cover June through December 2004, but is not exhaustive. This update will not include detailed discussions of regulations, such as authorizations of new additives for animal feed or registrations of new geographic names. Instead it will concentrate on fundamental topics and focus on food, which excludes from our scope questions regarding the management of agricultural products (Common Agricultural Policy, or CAP). However, some questions which legally pertain to the …

Do European Union Non-Tariff Barriers Create Economic Nuisances In The United States?, Thomas P. Redick, Michael J. Adrian

Journal of Food Law & Policy

The European Union's new traceability system for biotech crops will lead to the proliferation of non-tariff barriers affecting biotech crops. This, in turn, will lead to economic dislocation and attendant liability in the United States, which is losing billions of dollars in export trade. A chain of complex legal problems will arise for United States-based companies as they strive to trace particular genetically modified (GM) events and avoid commingling. The European Union (E. U) tracing law for biotech crops applies at each stage of commodity commerce, from grain shippers leading back through elevators, growers, and seed companies. Warranty liability could …

Journal Of Food Law & Policy - Spring 2005, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Revising Seed Purity Laws To Account For The Adventitious Presence Of Genetically Modified Varieties: A First Step Towards Coexistence, A. Bryan Endres

Journal of Food Law & Policy

Adoption of genetically modified (GM) seed varieties in the United States, Canada, and South America continues to expand, with GM crops comprising almost 76 million hectares and over 93 percent of the total biotech cropland worldwide. As an increasing number of farmers plant GM varieties, the potential for adventitious mixture of genetically modified DNA with products produced via organic and conventional (non-GM) methods also increases. Many consumers of organic and identity-preserved products, however, object to the adventitious presence of genetically modified DNA at even low levels. Accordingly, the ability of farmers to choose between conventional, organic, or GM crop production …

United States Food Law Update, Michael T. Roberts, Margie Alsbrook

Journal of Food Law & Policy

The one constancy about food law in the United States is change, especially in a rapidly-developing food industry. Innovations in food technology, shifts in popular culture and tastes, concerns of safety and nutrition, pressures from international markets, all contribute to the changing landscape of food law. These changes are reflected in new federal statutes, regulations, administrative decisions, and judicial decisions.

Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde

Michigan Telecommunications & Technology Law Review

Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the …