Food and Drug Law Commons^™

Standing Up For Consumers: Whether Third Party Payors Can Establish Standing To Sue Against Drug Manufacturers Under Civil Rico, Brianna Vollman

University of Cincinnati Law Review

No abstract provided.

The Opioid Crisis Or Climate Change: Which Is More Likely To Succeed Under The Tobacco Litigation Model?, Elizabeth W. De Leon

Texas A&M Law Review

Societal problems can occasionally have legal solutions, and several tools exist to implement change, including litigation and regulation. However, what elements make a societal problem more suitable for litigation or regulation? This Article examines four different societal issues (tobacco use, obesity, opioid addiction, and climate change) to determine whether litigation or regulation is the more appropriate route for success. The tobacco litigation serves as a successful example, while the fast food litigation serves as an unsuccessful example. Six signs of success are derived from the tobacco litigation: a large settlement agreement, evidence of corporate wrongdoing, change in public opinion, the …

Coronavirus "Cures" And The Courts, Chad G. Marzen, Michael Conklin

William & Mary Business Law Review

The coronavirus pandemic has drastically affected nearly every aspect of American life. Unfortunately, it has also created an opportunity for those willing to exploit vulnerable citizens by selling fake “cures.” This Article analyzes a lawsuit against televangelist Jim Bakker for doing just that. This Article also calls for increased protection for individuals when a global health pandemic and national emergency have been declared. This Article advocates a novel proposal—the enacting of a federal statute making it a felony for an individual to knowingly sell a fraudulent cure for any disease that has been designated a pandemic by the World Health …

Big Pharma, Big Problems: Covid-19 Heightens Patent-Antitrust Tension Caused By Reverse Payments, Hannah M. Lasting

Seattle University Law Review

In the wake of COVID-19, pharmaceutical companies rushed to produce vaccinations and continue to work on developing treatments, while the tension caused by reverse payments intensifies between patent and antitrust law. Lawmakers must address this tension, and the current pandemic should serve as a catalyst to prompt reform at the legislative level. By amending the Hatch-Waxman Act, lawmakers can ease the increasing strain between patent and antitrust policy concerns. In 2013, the U.S. Supreme Court attempted to resolve this tension in its landmark decision, F.T.C. v. Actavis, but the tension remains as lower courts struggle to produce a uniform standard …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents and Special Thanks.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Trademark Enforcement And Statutory Incentives, Leah Chan Grinvald

Cardozo Arts & Entertainment Law Journal

The combination of the recent U.S. Supreme Court case, Romag Fasteners v. Fossil Group, Inc., and the diamond anniversary of the Lanham Act provides good grounds to reflect on how trademark enforcement and statutory incentives have evolved through the years. Although enforcement of one's trademarks through the use of the courts can be traced back to England in the 1790s, trademark litigation and other enforcement activities have exploded, in relative terms, since the enactment of the Lanham Act in 1946. Although not subject to an easy empirical correlation, this trend suggests that the statute has had an impact on increasing …

The Spirit Is Willing: A Proposal For American Single Malt Whiskey, Raymond Cleaveland

Seattle University Law Review

Over the past twenty-five years, small, independent American distilleries have carved out a new niche in the United States liquor market: craft single malt whiskey. Inspired by the success of single malt Scotch and other single malts, American craft distillers are now fighting for their own shelf behind the bar and in the liquor store aisle. In 2018, a cadre of these distillers petitioned the U.S. Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau to formally recognize a new category of whiskey in the Code of Federal Regulations: American Single Malt Whiskey. For purposes of consumer protection, the Treasury …

Enough Is As Good As A Feast, Noah C. Chauvin

Seattle University Law Review

Ipse Dixit, the podcast on legal scholarship, provides a valuable service to the legal community and particularly to the legal academy. The podcast’s hosts skillfully interview guests about their legal and law-related scholarship, helping those guests communicate their ideas clearly and concisely. In this review essay, I argue that Ipse Dixit has made a major contribution to legal scholarship by demonstrating in its interview episodes that law review articles are neither the only nor the best way of communicating scholarly ideas. This contribution should be considered “scholarship,” because one of the primary goals of scholarship is to communicate new ideas.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

21 In The 21st—An Evaluation Of The Tobacco Regulation Trend, Casey Kellum

St. Mary's Law Journal

Tobacco regulation persists as a controversial issue both legally and politically in the United States. Throughout American history, states rely on local legislation to provide adequate protection to consumers of tobacco products, as “Big Tobacco” targets consumers for its addictive product. One of the most recent amendments in this arena is the state by state decision to raise the minimum legal sales age for tobacco to twenty-one.

Despite rigorous regulation of tobacco products in the United States, however, tobacco remains the leading cause of preventable deaths in the country. These “Tobacco 21” ordinances come at a critical time when the …

Competing Free Speech Rights: Evaluating Compelled Disclosures On Food Packaging In A Way That Reflects Scientific Realities - Or A Lack Thereof, Rakelle Shapiro

Cardozo Law Review

No abstract provided.

The Heavy Hand Of Amazon: A Seller Not A Neutral Platform, Edward J. Janger, Aaron D. Twerski

Brooklyn Journal of Corporate, Financial & Commercial Law

Since the adoption of Section 402A of the Second Restatement of Torts, every party in a product’s distribution chain has been potentially liable for injuries caused by product defects. Consumers who buy from reputable sellers are almost always guaranteed to have a solvent defendant if injured by a product defect. Amazon, though responsible for a vast number of retail sales, has sought to avoid liability by claiming that it is not a seller but a neutral platform that merely facilitates third-party sales to consumers. With two significant exceptions, most courts have sided with Amazon and concluded that Amazon is not …

False Foods: Harmonizing The Eu And Us Organics Programs, Elizabeth G. Fudge

Brooklyn Journal of International Law

The growth of the importation and exportation of organic foods in recent years has led governments around the globe to take more aggressive approaches in overseeing and certifying such products. Currently, there is a discrepancy in how states certify and respond to non-compliance issues for imported organic products. This creates a strong need to harmonize organics programs, specifically between the EU and US programs, as they are the two largest consumers of organic products. Through auditing both the EU and US organic import programs, significant issues of non-compliance became exceedingly clear. This Note argues that the best solution for addressing …

The Incredible Edible: Protecting Businesses And Consumers In A Society Of Legalized Cannabis, Brandon M. Thompson

Nevada Law Journal Forum

This Article briefly discusses the history and origin of marijuana, or more precisely the cannabis plant, before branching into an examination of its chemical properties, forms, and uses. Including a concise survey of the various effects—including adverse side effects—of cannabis use. Additionally, it provides an introduction to products liability as it relates to drugs, in general, and then more specifically to the production and distribution of edibles. It will discuss some of the dangers that edibles pose to children. The focus will be primarily on issues with the marketing and presentation of edibles that have led to unintended cannabis consumption …

Pharmaceutical "Pay-For-Delay" Reexamined: A Dwindling Practice Or A Persistent Problem?, Laura Karas, Gerard F. Anderson, Robin Feldman

Articles

The Supreme Court ruled in FTC v. Actavis that a delay in generic entry may be anticompetitive when part of a patent settlement includes a large and otherwise unjustified value transfer to the generic company, termed a reverse payment patent settlement, or "pay-for-delay." Following Actavis, drug companies have limited the size of reverse payments and have fashioned settlement terms that include more discreet categories of compensation to generic companies. In light of the fact that such settlements retain the potential for anticompetitive effects, the apparent size of the reverse payment may no longer be a useful gauge of the …

(Almost) No Bad Drugs: Near-Total Products Liability Immunity For Pharmaceuticals Explained, Anita Bernstein

Washington and Lee Law Review

This Article explores four beliefs about supposed pharma-benevolence that appear to be shared by more than the industry, reaching the level almost of conventional wisdom. These figurative pillars help support one-sided results in court. However, each of the pillars on examination turns out at least a bit shaky. This Article puts them forward for review to start a necessary discussion.

The locus of this Article is products liability, where a court concludes that a manufactured object is defective or could be called defective by a factfinder following a trial. Drug manufacturers enjoy near-immunity from this consequence. Modern products liability identifies …

Non-Transparent Pbm Cash Flows: Balancing Market Forces Under A Reluctant Legislative Regime, John Mcguinness

William & Mary Business Law Review

No abstract provided.

Planting The Seed: A Proposal For A Farm Operation Test Under The Fsma Produce Safety Rule, Sophia Kruszewski, Samuel Ingraham

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

In Memory Of Professor James E. Bond, Janet Ainsworth

Seattle University Law Review

Janet Ainsworth, Professor of Law at Seattle University School of Law: In Memory of Professor James E. Bond.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

A New Age Of Evolution: Protecting The Consumer’S Moral And Legal Right To Know Through The Clear And Transparent Labeling Of All Genetically Modified Foods, Halie M. Evans

Journal of Law and Health

The United States government, until recently, did not require the labeling of genetically modified organisms (GMOs). On July 29, 2016, President Barack Obama signed into law the National Bioengineered Food Disclosure Standard (NBFDS). This law directs the United States Department of Agriculture (USDA) to create regulations that require manufacturers to disclose certain bioengineered products on food labels. On December 20, 2018, the USDA released the final regulations for the NBFDS, which requires food manufactures, importers, and certain retailers to ensure bioengineered foods are appropriately disclosed. The final regulations include provisions that will leave the majority of GMO derived foods unlabeled. …

Time For Change: Stepping Up The Fda's Regulation Of Dietary Supplements To Promote Consumer Safety And Awareness, George Kennett

Journal of Law and Health

People are often looking for that quick fix when it comes to their health. With dietary supplements so readily available on the market, the public assume that they have been through rigorous testing. Dietary supplements are not tested as much as consumers believe. The Food and Drug Administration (FDA) does not initiate the same type of testing and analysis for supplements as it does for food, drink and medication. Given that people are now choosing supplemental meal replacements and the like, as opposed to whole foods, regulations drastically need to be stepped up in an effort to emphasise public safety. …

Beauty Shouldn’T Cause Pain: A Makeover Proposal For The Fda’S Cosmetics Regulation, Lauren Jacobs

Journal of the National Association of Administrative Law Judiciary

The American cosmetics industry is not required by the Food and Drug Administration (FDA) to conduct pre-market safety assessments of cosmetics. The FDA only reviews personal care products when people voluntarily report problems. Further, companies continue to test animals for cosmetics, despite the FDA’s recommendation that manufacturers seek more humane and accurate testing. Although the FDA does not require animal testing for product safety or premarket approval, the United States is one of the largest users of laboratory animals for product testing. There are two pending pieces of legislation, which if passed would be the first acts of cosmetic regulation …

Combatting The Opioid Epidemic In Texas By Holding Big Pharma Manufacturers Liable, Katherine Spiser

St. Mary's Law Journal

Abstract forthcoming

The "Natural" Response To Adjudicating Current Litigation When The Creation Of A Related Agency Rule Is Simultaneously Underway, Lauren Kostman

Cardozo Law Review

No abstract provided.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

Due Process Supreme Court Appellate Division Second Department

Touro Law Review

No abstract provided.

Something To Wine About: What Proposed Revisions To Wine Labeling Requirements Mean For Growers, Producers, And Consumers, Deborah Soh

Brooklyn Journal of Corporate, Financial & Commercial Law

Title 27 of the Code of Federal Regulations governs the standards for the information that is printed on wine bottle labels, including the appellation of origin. Currently, however, wines are exempt from these regulations if they will not be introduced in interstate commerce. There is a proposed amendment to the Code that would bring all wines, regardless of whether they are sold interstate or solely intrastate, under the federal standards for wine labeling. Between the current system, which permits exempt wines to sidestep the regulations, and the proposal, which would exact strict standards of compliance uniformly, lies a middle-ground approach …

Makeup Call: How Cosmetic Product Use Affects Women Absent Federal Regulation, Gabrielle Eriquez

William & Mary Journal of Race, Gender, and Social Justice

No abstract provided.