Food and Drug Law Commons^™

The Not So "Sweet Surprise": Lawsuits Blaming Big Sugar For Obesity-Related Health Conditions Face An Uphill Battle, Catherine Srithong Wicker

Journal of Law and Health

Because obesity and its associated health problems have been largely attributed to poor self-control, laziness, and various other personal failings, society has been unwilling to assign blame to food manufacturers for their role in contributing to this problem. But, as consumers are becoming more aware of the significantly harmful effect that poor diets can have on a person’s heath, the scales may be tipping in favor of bringing “Big Food” to court. Food manufacturers, however, are not exactly vulnerable. Armed with precedent disputing the causal link between consumption of fast food and adverse health effects, judicially-created barriers to admitting epidemiologic …

Ending Drunk Driving With A Flash Of Light, Andrew Sullivan

Law Student Publications

Among the methods used to combat drunk driving is mandating a person convicted of driving under the influence/driving while intoxicated install an ignition interlock device (“IID”) in his/her vehicle as a condition of restoring his/her driving privileges.This comment argues that the National Highway Traffic Safety Administration (“NHTSA”) has the authority to issue such a regulation; it need only be presented with a workable opportunity to do so. The present state of IID technology is a poor candidate to make this hypothetical regulation workable, but advances in Near Infrared (“near-IR”) Spectroscopy will provide the technology necessary to make a discussion of …

Rethinking The Childhood-Adult Divide: Meeting The Mental Health Needs Of Emerging Adults, Barbara L. Atwell

Elisabeth Haub School of Law Faculty Publications

Part I of this article describes ADHD and explores the extent of ADHD medication abuse, especially among young adults. Part II discusses the characteristics of emerging adults, who may be more likely than their older counterparts to make unwise decisions about medications and other life choices.34 While we protect minors by requiring parental consent for their medical treatments, emerging adults are effectively able to obtain any drug on the market if they convince the doctor that they have the requisite diagnosis. Part III explores HIPAA, the medical malpractice standard of care and the challenges associated with a society that is …

"Pay-For-Delay" Settlements Post-Actavis: Why Mediation Can Tackle The "Unreasonable" Antitrust Settlements, Sheena Ching

Cardozo Journal of Conflict Resolution

This Note discusses the benefits that mediation can have on the reverse payment settlement and antitrust debate, and how it can satisfy the "rule of reason" requirement post-Actavis. Accordingly, Section II discusses the legislative history and policy of the Hatch-Waxman Act. It elaborates on the pioneer drug development process and how the combination of legislation and the inherent nature of drug development resulted in "pay-for-delay" settlements. Section III discusses majority and dissenting opinions in the landmark Supreme Court case FTC v. Actavis as well as the circuit split decisions that led up to the Court's ultimate ruling and …

Orthodoxy And 'The Other Man's Doxy': Medical Licensing And Medical Freedom In The Gilded Age, Lewis Grossman

Scholarly Articles in Law Reviews & Journals

This is a draft of Chapter Two of my book-in-progress under contract with Oxford University Press titled You Can Choose Your Medicine: Freedom of Therapeutic Choice in American History and Law. This chapter shows how freedom of therapeutic choice remained an influential theme in American policy and thought in the Gilded Age. Despite the almost universal restoration of medical licensing after the Civil War, the new licensing regimes were drafted and enforced in ways that protected the rights of practitioners and patients of nonorthodox schools of medicine. This chapter starts by briefly describing the main alternative medical sects during the …

The Fda And The Rise Of The Empowered Patient, Lewis Grossman

Contributions to Books

No abstract provided.

Denaturalizing Transparency In Drug Regulation, Matthew Herder

Articles, Book Chapters, & Popular Press

In the arena of pharmaceutical drug regulation, transparency is the favoured focus of many current policy initiatives. Transparency is predominantly understood in terms of information disclosure. Requirements to register clinical trials, publish summary results, share clinical trial data, and disclose physician-industry relationships as well as rationales behind regulatory decision making are each predicated upon this idea that imparting information will both inform and deter unwanted behaviours. In this paper, I argue that understanding transparency qua disclosure has clear limitations and suggest transparency can and should serve an additional function - namely, of enabling standard setting through a more participatory, public …

Food Policy And Cognitive Bias, Paul F. Campos

Publications

No abstract provided.

The Risks We Are Willing To Eat: Food Imports And Safety, Alexia Brunet Marks

Publications

Recent efforts to regulate the safety of U.S. food imports have not kept up with the complexity of global trade and the risks that accompany globalization. Congress drafted the Food Safety Modernization Act of 2011 ("FSMA") in response to heightened food safety risks, surging imports, and an outdated food import safety system. While the FSMA provides the Food and Drug Administration ("FDA") additional authority to regulate food facilities, establish standards for safe produce, recall contaminated foods, and oversee imported foods, vulnerabilities still exist.

This article exposes problems with the old system of food import rules and significant challenges facing the …

The Importance Of The Right To Food For Achieving Global Health, Emilie K. Aguirre

Faculty Scholarship

The Framework Convention on Global Health (FCGH) represents a significant opportunity to realize the right to health globally. However, in order to succeed the FCGH must be carefully considered: it must take a new evidence-based approach that departs meaningfully from past shortcomings in realizing the right to health. Central to this approach is recognizing, formally incorporating, and operationalizing the right to adequate food. This right should be correctly interpreted as a right to a standard of nutritional quality and not as a right to a minimum number of calories. Because nutrition is critical to the achievement and maintenance of good …

The Implementation Of The Food Safety Modernization Act And The Strength Of The Sustainable Agriculture Movement, Samuel R. Wiseman

Scholarly Publications

In the wake of growing public concerns over salmonella outbreaks and other highly publicized food safety issues, Congress passed the FDA Food Safety Modernization Act in 2011, which placed more stringent standards on food growing and packaging operations. In negotiations preceding the Act's passage, farmers of local, sustainable food argued that these rules would unduly burden local agricultural operations or, at the extreme, drive them out of business by creating overly burdensome rules. These objections culminated in the addition of the Tester-Hagan Amendment to the Food Safety Modernization Act, which created certain exemptions for small farms. Proposed Food and Drug …

The Need For Adequate And Effective Protection Of Intellectual Property: Perspective Of The Private Sector - Patents, Peter C. Richardson

Georgia Journal of International & Comparative Law

No abstract provided.

Preventative V. Punitive: How Genetically Modified Rice Litigation Shaped Regulation And Remedy For Genetically Engineered Crops, Allison Waldrip Bragg

Journal of Food Law & Policy

As agricultural technology develops, new issues emerge. While genetically engineered crops can increase yields and productivity, they can also increase new legal concerns that had not previously existed. One such concern is the comingling of non-engineered crops with genetically engineered varieties. The corruption of plants that are not engineered is a problem not only because of the loss of that original plant itself if the entire plant population were to become comingled, but also because of the inability to sell a crop that has been intended as a non-engineered crop when it is infiltrated by genetically engineered material.

Paradise Found? Food Transportation Regulation: A Detour Through Regulatory Purgatory, William Nash

Journal of Food Law & Policy

On January 31, 2014, the Food and Drug Administration ("FDA") issued a Notice of Proposed Rulemaking ("NPRM") that would set requirements for shippers, carriers and receivers of food transported in intrastate and interstate commerce. The NPRM marks a potentially important step in a long history of the (non-)regulation of food transportation. In Parts I and II, this paper will provide some context of the history of food transportation, as well as the major incidents that placed the food transportation industry on the regulatory map. In Parts III and IV, the paper will consider the history of food transportation regulation from …

Let's Stop Worrying And Learn To Love Transparency: Food And Technology In The Information Age, Scarlettah Schaefer

Journal of Food Law & Policy

Food and technology have had a long and tempestuous relationship. Current methods of food production and processing in the industrialized world depend heavily on technological developments. However, all technologies are not created equal. Some can produce food that is safer, more sustainable, more nutritious, or longer lasting. Some can have the opposite effect: increasing opportunities for adulteration, increasing the difficulty in detecting food fraud, and contributing to both foreseeable and unforeseeable health or ecological costs. Increasingly sophisticated technologies often become less apparent to the average consumer. For example, consider irradiated meat or genetically modified foods as opposed to freezer storage …

The Hamburglar, Friend Or Foe: What Is The Best Solution For Lawsuits Alleging Obesity Caused By Fast Food Outlets When No Causal Link Between Consumption And Obesity Can Be Found?, Mary Hoshall Hodges

Journal of Food Law & Policy

When is the last time you ventured through the drive-thru of a fast food establishment? Maybe last night when it was just easier than taking the time to cook dinner, or maybe last weekend on your way home from vacation, or maybe when you were running low on funds and needed a cheap meal? Given the busy, fast-paced lives Americans lead, it is no wonder that many rely on the fast food industry, even though most would not care to admit it.

Toward A Just Food Regime: Consumption, Ideology, And Democratic Strategy, Adam B. Lichtenberger

Journal of Food Law & Policy

United States agricultural policies incentivize the growth and consumption of industrial foods. Industrial foods are linked to a host of social and ecological ills. However, agricultural policies are insulated from political criticism, in part, by the myth that consumers freely and rationally choose industrial foods. This neoliberal myth is congruous with the American preferences for "stealth democracy." That is, the neoliberal myth is an elegant, but ultimately erroneous, reconciliation of conflicting political preferences: Americans do not want to be involved in politics, but they also do not want the political process to be used by special interests or politicians to …

Who's Swallowing The "Bitter Pill"?: Reforming Write-Offs In The State Of Washington, Lauren M. Martin

Seattle University Law Review

Washington’s application of the collateral source rule permits recovery for medical expenses that were never incurred and have no relationship to their market value. This application is set forth in Hayes v. Wieber Enterprises, Inc., where the plaintiff sued a restaurant for injuries she sustained from falling down the restaurant’s basement stairs. Why should the collateral source rule compel the defendant in Hayes to pay the original amount billed, $5,800, when the physician accepted $3,300 as payment in full? Is not $3,300 the reasonable or market value of the medical services provided to the plaintiff? This Comment discusses whether Washington …

International Trade - Possible Undermining Of U.S. Pesticide And Food Safety Laws By The Draft Text Of The Uruguay Round Of Gatt Negotiations, Beth Sanders

Georgia Journal of International & Comparative Law

No abstract provided.

The Jurisprudence Of Nature: The Importance Of Defining What Is "Natural", Jill M. Fraley

Catholic University Law Review

Informal regulations defining nature, natural, and organic have proliferated across diverse fields of law from patents to agriculture, from taxation to gemstones. The unwritten jurisprudence of defining nature is primarily a story of the struggle to isolate mankind’s manipulations and interventions, creating a man-nature dichotomy that frustrates more than it explicates. This failure to define nature continues with the Supreme Court’s recent Myriad decision, which struggles to define the law of nature exception to patentability, highlighting the challenge of measuring levels of human intervention and manipulation. Our dichotomous definitions do not generate neat, binary answers, but rather complicated scales of …