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Articles 241 - 270 of 405
Full-Text Articles in Food and Drug Law
Time For A Fresh Look At Strict Liability For Pharmaceuticals, Mary J. Davis
Time For A Fresh Look At Strict Liability For Pharmaceuticals, Mary J. Davis
Law Faculty Scholarly Articles
Part I provides a brief and basic explanation of pharmaceutical liability treatment. Part II explains the impact of federal preemption doctrine, which has dramatically limited the operation of tort law in pharmaceutical liability cases. Part III explains the parallel trends in the marketing and use of pharmaceuticals that increase the incidence of adverse drug events, affect prescribing practices, and fail to enhance informed practitioner and consumer choice in use of pharmaceuticals. Part IV provides support for the application of strict liability given the convergence of these trends. This Part also provides a theoretical justification for strict liability in tort for …
Legal Implications Of "Organic" Seafood Labeling Based On Foreign Standards, Read Porter, Kathryn Kulaga
Legal Implications Of "Organic" Seafood Labeling Based On Foreign Standards, Read Porter, Kathryn Kulaga
Sea Grant Law Fellow Publications
No abstract provided.
Table Of Contents, Seattle University Law Review
Table Of Contents, Seattle University Law Review
Seattle University Law Review
No abstract provided.
Finding A Forest Through The Trees: Georgia-Pacific As Guidance For Arbitration Of International Compulsory Licensing Disputes, Karen Mckenzie
Finding A Forest Through The Trees: Georgia-Pacific As Guidance For Arbitration Of International Compulsory Licensing Disputes, Karen Mckenzie
Marquette Intellectual Property Law Review
This paper will examine the challenges of international compulsory licensing by examining the issue historically and legally as well as offer possible solutions. Thus, this paper will explore the challenge of balancing corporate interests against the affordability and availability of pharmaceuticals by focusing on discrete situations in developing countries, the history of compulsory licensing, and how the World Health Organization (the “WHO”) and the WTO have attempted to tackle these challenges through compulsory licensing, and it will suggest a possible framework for use in arbitration, which balances equities through a Georgia-Pacific analysis.
Rethinking Consumer Protection: Escaping Death By Regulation, Thomas L. Tacker
Rethinking Consumer Protection: Escaping Death By Regulation, Thomas L. Tacker
Publications
This book is designed to appeal to anyone who is at all interested in topics related to making life better and safer—for all us consumers. Our current approach to consumer protection is extremely flawed; sometimes costing lives rather than saving them. There are better ways to protect ourselves and the people we love.
The Opioid Crisis: The States' And Local Governments' Response To Bigpharma's Deception And Why The Supremacy Clause May Provide A Cloak For Opioid Manufacturers To Hide Behind, Tracie Childers
Barry Law Review
No abstract provided.
The Pharma Barons: Corporate Law's Dangerous New Race To The Bottom In The Pharmaceutical Industry, Eugene Mccarthy
The Pharma Barons: Corporate Law's Dangerous New Race To The Bottom In The Pharmaceutical Industry, Eugene Mccarthy
Michigan Business & Entrepreneurial Law Review
In this Article, I argue that drug companies have created a highly profitable but dangerous business model by employing the same legal tactics as the nineteenth-century “robber barons,” the group of financiers who orchestrated corporate law’s infamous race to the bottom. Like these historical financiers, drug company executives have captured the legal apparatus and regulatory bodies that oversee them. In so doing, they have transformed the law from a system of governance into a set of enabling doctrines. The pharmaceutical industry has turned legislation intended to protect the public into a legal justification for marketing ineffective and unsafe prescription drugs. …
The Gm Food Debate: An Evaluation Of The National Bioengineered Food Disclosure Standard And Recommendations For The United States Based On Food Justice, Courtnee Grego
Seattle University Law Review
This Note aims to identify the food justice issues caused by the National Bioengineered Food Disclosure Standard (NBFDS) and make recommendations for the United States to minimize these concerns. The NBFDS requires the United States Department of Agriculture (USDA) to draft regulations establishing a mandatory disclosure standard for GM food and ultimately, will require a disclosure on the package of any GM food sold in the United States. Part I of the Note provides an overview of the genetically modified (GM) food debate. Part II reviews the NBFDS. Part III explains the food justice implications of GM food production. Part …
The Gm Food Debate: An Evaluation Of The Nationalbioengineered Food Disclosure Standard Andrecommendations For The United States Based On Foodjustice, Courtnee Grego
Seattle University Law Review
This Note aims to identify the food justice issues caused by the National Bioengineered Food Disclosure Standard (NBFDS) and make recommendations for the United States to minimize these concerns. The NBFDS requires the United States Department of Agriculture (USDA) to draft regulations establishing a mandatory disclosure standard for GM food and ultimately, will require a disclosure on the package of any GM food sold in the United States. Part I of the Note provides an overview of the genetically modified (GM) food debate. Part II reviews the NBFDS. Part III explains the food justice implications of GM food production. Part …
How Commonsense Consumption Acts Are Preventing “Big Food” Litigation, Grace Thompson
How Commonsense Consumption Acts Are Preventing “Big Food” Litigation, Grace Thompson
Seattle University Law Review
This Note takes a critical look at Commonsense Consumption Acts and how they are detrimental to the possibility of “Big Food” litigation. The tobacco industry was held accountable through the effective use of tort litigation (commonly referred to as “Big Tobacco” litigation), and the food industry could theoretically be held similarly accountable, but CCAs are preventing the possibility of similar reform. Therefore, in order for health reform to be as effective as tobacco reform, CCAs must be repealed in the states where they exist. Part I of this Note discusses why the food industry needs tort reform. Specifically, it argues …
Privacy Of Information And Dna Testing Kits, Shanna Raye Mason
Privacy Of Information And Dna Testing Kits, Shanna Raye Mason
Catholic University Journal of Law and Technology
In modern times, consumers desire for more control over their own health and healthcare. With this growing interest of control, direct to consumer DNA testing kits have never been more popular. However, many consumers are unaware of the potential privacy concerns associated with such use. This comment examines the popularity and privacy risks that are likely unknown to the individual consumer. This comment also addresses the shortcomings of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the Genetic Information Nondiscrimination Act of 2008 (GINA) in regard to protecting individual’s genetic information from misuse. This comment …
Crafting Next Generation Eco-Label Policy, Jason J. Czarnezki, Katrina F. Kuh
Crafting Next Generation Eco-Label Policy, Jason J. Czarnezki, Katrina F. Kuh
Elisabeth Haub School of Law Faculty Publications
Eco-labels present a promising policy tool in the effort to achieve sustainable consumption. Many questions remain, however, about the extent to which eco-labels can contribute to sustainability efforts and how to maximize their effectiveness. This Article deploys research from evolutionary psychology, behavioral law and economics, and norm theory to offer specific insights for the design and implementation of eco-labels to enhance their influence on sustainable consumer choice. Notably, this research suggests possibilities for eco-labels to shape or expand consumer preferences for green goods, and thereby enhance eco-label influence on consumer behavior by extending it beyond eco-minded consumers. We suggest that …
Gender, Race & The Inadequate Regulation Of Cosmetics, Marie C. Boyd
Gender, Race & The Inadequate Regulation Of Cosmetics, Marie C. Boyd
Faculty Publications
Scholars and other commentators have identified failures in the regulation of cosmetics-which depends heavily on voluntary industry self- regulation-and called for more stringent regulation of these products. Yet these calls have largely neglected an important dimension of the problem: the current laissez-faire approach to the regulation of cosmetics disproportionally places women, and particularly women who are members of other excluded groups, at risk. This Article examines federal cosmetics law and regulation through a feminist lens. It argues that cosmetics law and regulation have lagged behind that of the other major product categories regulated by the Food and Drug Administration under …
Salmon With A Side Of Genetic Modification: The Fda’S Approval Of Aquadvantage Salmon And Why The Precautionary Principle Is Essential For Biotechnology Regulation, Kara M. Van Slyck
Salmon With A Side Of Genetic Modification: The Fda’S Approval Of Aquadvantage Salmon And Why The Precautionary Principle Is Essential For Biotechnology Regulation, Kara M. Van Slyck
Seattle University Law Review
This Note seeks to address the issues concerning the FDA’s approval of genetically modified salmon for consumption, arguing that the FDA did not properly vet AquAdvantage salmon, as well as relied on inappropriate criteria in their approval of its market use. Part I provides a brief history of AquAdvantage salmon’s introduction to U.S. markets and the legal actions taken in response to the FDA ruling. Part II discusses the statutes and regulations fundamentally relevant to GE products, as well as a critique of the way each regulation was used to approve AquAdvantage. Part III offers a comparison to the European …
"Fowl" Practice Of Humane Labeling: Proposed Amendments To Federal Standards Governing Chicken Welfare And Poultry Labeling Practices, Latravia Smith
"Fowl" Practice Of Humane Labeling: Proposed Amendments To Federal Standards Governing Chicken Welfare And Poultry Labeling Practices, Latravia Smith
Alumni Works
Chickens raised specifically for meat production are the world’s most intensively farmed land animals. Yet, the existing legal frameworks that regulate the production and labeling of poultry products in the United States allow poultry producers to mistreat chickens, falsely distinguish poultry products, and defraud conscious consumers. This article proposes unique opportunities to improve poultry welfare in the United States’ agricultural industry and offers methods to ensure the accurate labeling of poultry products.
“Safe Harbor” On The Rocks: Ttb Label Approval For Beer, Wine, And Spirits, And The Uncertain Status Of The “Safe Harbor” Defense, Michael Mercurio
“Safe Harbor” On The Rocks: Ttb Label Approval For Beer, Wine, And Spirits, And The Uncertain Status Of The “Safe Harbor” Defense, Michael Mercurio
Notre Dame Journal of International & Comparative Law
This Note examines the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB)’s label review process and the judicial split regarding the “safe harbor” doctrine in the context of alcoholic beverage labels. This Note observes that the judicial split is a result of the tension between two conflicting priorities stemming from the TTB’s purpose and identity: on one hand, courts apply Chevron deference to the TTB as a federal agency enforcing federal law, but on the other hand, courts aim to uphold the central purpose of the Federal Alcohol Administration (FAA) Act—protecting consumers from misinformation. Ultimately, this Note, by examining …
Commercial Deception By Anti-Vaccine Homeopathic Websites: A Consumer Protection Approach, Donald C. Arthur
Commercial Deception By Anti-Vaccine Homeopathic Websites: A Consumer Protection Approach, Donald C. Arthur
North Carolina Central University Science & Intellectual Property Law Review
No abstract provided.
Pay-For-Delay: How Brand-Name And Generic Pharmaceutical Drug Companies Collude And Cost Consumer Billions, Raymond J. Prince
Pay-For-Delay: How Brand-Name And Generic Pharmaceutical Drug Companies Collude And Cost Consumer Billions, Raymond J. Prince
South Carolina Law Review
No abstract provided.
The Death Of Private Practice: How The Rising Cost Of Healthcare Is Destroying Physician Autonomy, Oliver Owaid
The Death Of Private Practice: How The Rising Cost Of Healthcare Is Destroying Physician Autonomy, Oliver Owaid
Brooklyn Journal of Corporate, Financial & Commercial Law
Over the past two decades, the number of physicians in private practice has dropped dramatically. This trend is the result of the financial pressure imposed by the federal government in response to the skyrocketing cost of healthcare. Physicians, frustrated by stagnant reimbursement rates in conjunction with increased administrative costs and overhead, are choosing hospital staff employment in favor of private practice. This trend is to the detriment of the physician, the taxpayers, and, most importantly, the patients. Patients treated in hospital outpatient settings have worse outcomes than those treated in private practice. In addition, hospital procedures cost both the government …
Abuse Of The Hatch-Waxman Act: Mylan's Ability To Monopolize Reflects Weaknesses, Kieran Meagher
Abuse Of The Hatch-Waxman Act: Mylan's Ability To Monopolize Reflects Weaknesses, Kieran Meagher
Brooklyn Journal of Corporate, Financial & Commercial Law
The Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act, is intended to lower the average price paid by consumers for prescription drugs. The Hatch-Waxman Act attempts to do so by simplifying the application process for generic drug manufacturers, allowing generic drug applications to circumvent the lengthy FDA testing and approval process that brand-name manufacturers must undergo. Though the Hatch-Waxman Act has successfully created a clear path to the market for generic drugs, it contains loopholes that allow brand name and generic companies to engage in practices aimed at maximizing monopoly profits, effectively …
Local And State Governments Are Taking The Stage When It Is Fda's Curtain Call - Are Local And State Governments' Safety Warnings Preempted By Federal Law?, Melissa M. Card
Journal of Food Law & Policy
Eliminated from fad diets, sworn off by celebrities, and frantically reformulated out of processed foods, added sugars have been deemed the new nutritional scoundrel. Recent studies from the American Heart Association, the World Health Organization, and the American Cancer Association demonstrate that the consumption of added sugar leads to increased risks of obesity, diabetes, heart disease, and gout. While all foods containing added sugar are deemed unhealthy, Sugary-Sweetened Beverages ("SSBs") are said to be especially toxic by the American health community, by virtue of these beverages' being excessively high in added sugar content, low in satiety, and incomplete in compensation …
Moving Towards Harmonization Of The Food Safety Standards: Role Of The Tpp And Ttip Agreements, Ksenia A. Petrovets
Moving Towards Harmonization Of The Food Safety Standards: Role Of The Tpp And Ttip Agreements, Ksenia A. Petrovets
Journal of Food Law & Policy
We are now less dependent on locally available food resources that we have ever been. The continuing industrialization of food production, the advancement in technologies and the rapid development of supply chains granted us the luxury of immediate access to a variety of products originating from local supermarkets all over the world. This, along with the greater level of food production industrialization, inevitably comes the rise of related food safety risks. Because of the enlargement of producing operations, an emerging safety threat in one place may result in a foodborne illness outbreak thousands of miles away from its place of …
Will Consumers Be In The "Dark" About Labels On Genetically Engineered And Modified Foods?, Hilary Nat
Will Consumers Be In The "Dark" About Labels On Genetically Engineered And Modified Foods?, Hilary Nat
Journal of Food Law & Policy
In the 1900s, the United States began to sell genetically engineered foods. One of the first genetically engineered foods sold in the United States and approved by the Food and Drug Administration (FDA) was the Flavr Savr tomato. The tomato's genetic structure was modified to prevent softening which allowed it to ripen after being picked. In the United States, statistics demonstrate that 92% of com, 94% of soybeans, and 94% of cotton sold is genetically engineered. In addition, it is estimated that 75% of the processed foods sold in supermarkets around the United States contain ingredients that are products of …
Energy Drink Regulations: Why The Time For More Fda Authority Is Not Ripe And How States Can Protect Children Without Unjustly Infringing On Adult Autonomy, Larry D. Treat
Journal of Food Law & Policy
In December of 2011, Anais Fournier ("Anais"), a fourteen-year-old from Maryland, was at the mall with her friends when she drank a twenty-four ounce Monster energy drink. Within twenty-four hours, Anais consumed a second twenty-four ounce energy drink. Together, the two Monster energy drinks Anais consumed contained around 480 milligrams ("mg") of caffeine. A few hours after the second drink, Anais went into cardiac arrest and later died from cardiac arrhythmia. An autopsy found that caffeine toxicity caused Anais's arrhythmia and impeded her heart's ability to pump blood. As it turns out, Anais suffered from a preexisting heart condition called …
2016 China Food Law Update, Michael T. Roberts, Ching-Fu Lin
2016 China Food Law Update, Michael T. Roberts, Ching-Fu Lin
Journal of Food Law & Policy
This update of China food law builds on a unique feature for the Journal of Food Law & Policy that has been provided since the Journal's inception - separate food law updates for both the United States and European Union. "Recognizing the globalness of the modem food system, these updates have served an invaluable role in keeping scholars and practitioners abreast of the world's leading food regulatory systems." China's emergence as a developed, modem food regulatory system with the potential of being a leading food regulatory system makes sense given its position as a world economic powerhouse. China's role in …
Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete
Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete
Catholic University Law Review
The manufacturing of innovative medical devices is important for the continued success and growth of the U.S. health care system and economy. The medical device industry is almost exclusively comprised of small businesses. The U.S. Food and Drug Administration (FDA) regulates the medical device industry and employs a rigorous approval process to determine when products may enter the market. While the FDA’s goal is to authorize the sale of innovative devices that are safe for patient use, device manufacturers argue that the process to obtain FDA approval is unnecessarily expensive, burdensome, and has systemic problems. As a result of the …
Getting A Handle On Growler Laws, Adam Star
Getting A Handle On Growler Laws, Adam Star
Seattle University Law Review
This Note will begin with a brief general history of growlers in the United States and the benefits they provide to consumers, retailers, and small craft brewers. Part II will provide an overview of national alcohol distribution regulation and how the present growler law exists within this larger framework. To complete the necessary background information, Part III will provide context to the competitive landscape by way of an examination of the craft beer industry’s explosive growth. The substantive portion of the Note will follow in Part IV, beginning with an outline of the various key types of growler restrictions such …
Animal Legal Defense Fund V. Otter: Industrial Food Production Simply Is Not A Private Matter, Lucy L. Holifield
Animal Legal Defense Fund V. Otter: Industrial Food Production Simply Is Not A Private Matter, Lucy L. Holifield
Journal of Food Law & Policy
About half of the states have either passed or attempted to pass laws aimed at stifling criticism and exposure of factory farms throughout the country. This unwanted exposure is often the result of undercover reporters gaining access to the interior of meat-producing entities by seeking and obtaining employment. Their reports often expose filthy and dangerous conditions, substantial animal abuse, and the incorporation of unfit animal products into the public's food supply.
"All I Do Is Win": The No-Lose Strategy Of Cafo Regulation Under The Caa, Karl J. Worsham
"All I Do Is Win": The No-Lose Strategy Of Cafo Regulation Under The Caa, Karl J. Worsham
Journal of Food Law & Policy
Corporate farms, often known as concentrated animal feeding operations ("CAFO'), provide inexpensive animal products but do so by externalizing the cost of their operation in the form of environmental harms and risks to human health. This article explores one possible approach to mitigating CAFO-caused harms. It argues that CAFO regulation under any one of three Clean Air Act ("CAA ") programs will result in net benefits, not just for air quality, but also for other CAFO-caused harms and thus, that CAA regulation of CAFOs is a no-lose strategy. The article then goes further to conclude that, while regulation under any …
Wiggle Room: Problems And Virtues Of The Inwood Standard, Rian C. Dawson
Wiggle Room: Problems And Virtues Of The Inwood Standard, Rian C. Dawson
Indiana Law Journal
This Note investigates the origins of Inwood that led to the slim opinion with wide influence. It argues that the very vagueness for which scholars and practitioners have decried Inwood is the case's greatest virtue: Inwood provides a flexible standard that has allowed the common law to evolve and address new business models. Part I discusses the origins of contributory infringement in intellectual property. Part II investigates the Inwood case and the climate of trademark law at the time Inwood was litigated. It also dissects the majority opinion and Justice White's concurrance. Part III examines the Inwood standard's evolution at …