Food and Drug Law Commons^™

A Bone To Pick: Back To The Basics In Food Product Liability With A Necessary Reformation Of The "Hybrid" Negligence Standard, Clay Cutteridge

Cleveland State Law Review

Ohio does not use the traditional negligence standard in determining negligence in food product liability cases. Instead, Ohio uses what is called the hybrid test. The hybrid test analyzes what a consumer would reasonably expect to find in their food, and Ohio courts consider the naturalness of an object to the food it is in to be the determinative factor: natural objects should be reasonably expected and cannot give rise to successful claims of negligence. This hybrid test fails to consider that food is complex, and consumers often cannot know what to reasonably expect in the food they buy. The …

The Retreat Of Federal Power And The Rise Of Post-Supremacy Federalism, Victoria Grace Litman

Cleveland State Law Review

This Article introduces the theory of post-supremacy federalism to describe a structural condition in which federal law remains formally binding, but enforcement has durably receded or collapsed. Unlike frameworks grounded in intergovernmental friction or negotiated cooperation, this account begins from federal retreat—the cumulative erosion of enforcement capacity across judicial, administrative, legislative, and executive institutions. Post-supremacy federalism arises when three conditions are met: (1) federal law remains intact; (2) enforcement retreats; and (3) no formal devolution occurs. In this vacuum, states are not merely filling gaps. They are governing by default—under laws that still bind but no longer structure governance in …

For The Greater Good: Civil Commitment For Addiction Amid The Overdose Epidemic, Steven P. Meerschaert

Cleveland State Law Review

America is facing a reckoning born of its own duality. Our society is gradually embracing an increasingly permissive stance on recreational drug use, while at the same time we lament the human costs of addiction. What the media has dubbed the “opioid epidemic” has seen increases in drug addiction diagnoses and opioid-involved overdose deaths nearly every year since 1999. In a rush to designate guilty parties and to crown a “gold standard” for treatment options, we have focused on theoretically flawed approaches that fail to follow the science precisely. At the same time, we dismiss validated treatment modalities in their …

Amgen Enablement And Its Undue Burden On An Overburdened Biomedical Industry, Carter Chippi

Journal of Law and Health

This paper examines the Supreme Court decision in Amgen Inc. v. Sanofi and its profound impact on the patentability of biotechnology inventions, particularly biologic drugs. By virtually eliminating the possibility of claiming genera patents, the decision exacerbates existing challenges within the biologic sector, including high development costs and rigorous regulatory hurdles. The analysis sets forth the enablement requirement’s precedent, emphasizing historical case law and the unforeseen implications of setting a stringent standard for biotechnology patents. This paper further critiques suggested industry compromises, deeming them insufficient to address the ramifications of Amgen, and proposes legislative intervention. Options include granting biologics …

Cannabis In The Clink: An Argument In Favor Of Medical Marijuana For Disabled Inmates, Sophia Dechurch

Journal of Law and Health

In recent decades, medical marijuana programs have become commonplace, and most states in the United States of America are ready to accept marijuana as a natural alternative to treat symptoms of certain conditions such as chronic pain, cancer, mental illness, multiple sclerosis (MS), HIV/AIDS, and substance use disorder; as such, medical marijuana is readily accessible to those who have a qualifying diagnosis – the exception being those who are incarcerated. Although disability, substance abuse, and mental illness are prevalent among those under state supervision, these individuals are effectively prohibited from enjoying the benefits of medical marijuana. This Note will provide …

The Dope On Marijuana Consumption And Impaired Driving, Samuel D. Hodge, Jr., Lauren Williams

Cleveland State Law Review

Marijuana is the most frequently used psychotropic drug in the United States, following alcohol consumption. Its use is becoming socially acceptable as more and more states legalize recreational consumption. Nevertheless, marijuana is still a drug, and individuals must understand that it has adverse health effects and potential therapeutic benefits.

Marijuana can influence a user’s judgment and impair a person’s driving abilities. A significant problem with its consumption and driving is that there is no statistical link to show what level of marijuana in the blood causes impairment. Roadside tests for the appropriate blood alcohol content to show intoxication are well …

Is It Really Safe To Provide Banking Services To Marijuana-Related Businesses? The Marijuana Banking Dilemma, Caitlin Steiner

Et Cetera

As more and more states begin to legalize marijuana, marijuana-related businesses such as dispensaries are cropping up all over the United States. Like most other legitimate businesses, marijuana-related businesses need a safe place to keep their money. However, unlike most other legitimate businesses, marijuana-related businesses often cannot find banks that are willing to do business with them. This is because banks are heavily governed and regulated by federal law, and marijuana is still illegal on a federal level—even where states have legalized its use. Although federal guidance on the subject has been issued, many legal “gray areas” continue to exist, …

The War On Drugs: Moral Panic And Excessive Sentences, Michael Vitiello

Cleveland State Law Review

The United States’ War on Drugs has not been pretty. Moral panic has repeatedly driven policy when states and the federal government have regulated drugs. Responding to that panic, legislators have authorized severe sentences for drug offenses.

By design, Article III gives federal judges independence, in part, to protect fundamental rights against mob rule. Unfortunately, the Supreme Court has often failed to protect fundamental rights in times of moral panic. For example, it eroded Fourth Amendment protections during the War on Drugs. Similarly, it failed to protect drug offenders from excessive prison sentences during the War on Drugs. This Article …

A History Of United States Cannabis Law, David V. Patton

Journal of Law and Health

Perhaps the best way to understand early-Twenty-First Century state and federal cannabis law in the United States is to examine the relevant history. Justice Oliver Wendell Holmes, Jr.’s statement is apropos: "[A] page of history is worth a volume of logic." This article begins by discussing the early history of cannabis and its uses. Next, the article examines the first state and federal marijuana laws. After a brief comparison of alcohol prohibition to cannabis prohibition, this article addresses cannabis laws from the 1920s to the early 1950s. Then, the article takes up the reorganization of the federal drug regulatory bureaucracy …

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. …

Solving The Opioid Epidemic In Ohio, Lacy Leduc

Journal of Law and Health

On May 31, 2017, Ohio Attorney General Mike DeWine took a step in fighting Ohio's opioid epidemic, bringing the first of many lawsuits against five top pharmaceutical companies. However, under Federal and State law, there is an exception called the Learned Intermediary Doctrine, which can absolve drug manufacturers of liability from any misconduct that might be found and transfer that liability to a treating physician. This exception is the way many drug manufacturers were able to avoid being held responsible in the past. This Note proposes that with the current pending lawsuit in the State of Ohio, an exception to …

A Surging Drug Epidemic: Time For Congress To Enact A Mandate On Insurance Companies And Rehabilitation Facilities For Opioid And Opiate Addiction, Alanna Guy

Journal of Law and Health

This Note begins with a discussion of both the national opioid problem as well as the specific epidemic in Ohio as an example of how it has grown within all of the states. Part II discusses the differences between prescription opioids and opiates, how they can be obtained, what effects they have on the human body, and why the government has an interest in this growing problem. Next, this Note explains how and why there was an increase in access and addiction to prescription opioid pain medication. Following this explanation, the steps the government has taken to try to rectify …

Circling The Drain: Regulating Nutrient Pollution From Agricultural Sources, William Gutermuth

Journal of Law and Health

The 2014 Toledo, Ohio tap water ban has, at least temporarily, put a spotlight on United States water supplies. Consequently, many Americans have begun to take a closer look at the quality of the fresh water bodies being used to supply tap water to their homes. Therefore, this Note analyzes the problems currently threatening the lakes, rivers, and other surface waters that are the source of fresh drinking water for huge populations in the United States. Part II examines the problem of nutrient pollution and explains the harmful effects it has on human health. Part III provides an overview of …

Weird Science: Frankenstein Foods And States As Laboratories Of Democracy, Jennifer Mcgee

Journal of Law and Health

The National Bioengineered Food Disclosure Standard (the 'National Standard') was signed into law July 29, 2016. This Article analyzes the National Standard and posits that Vermont’s Act 120 was a more effective labeling law because it safeguarded consumer sovereignty. The State regulatory scheme in place prior to the passage of the National Standard satisfied consumer demand for disclosure while allowing for necessary experimentation with GMO labeling. Part I provides an overview of the current federal scheme regulating GMOs. Part II analyzes of the conflict surrounding GMOs and labeling. Given that analysis, Part III compares the disclosure requirement of the National …

Mending Invisible Wounds: The Efficacy And Legality Of Mdma-Assisted Psychotherapy In United States' Veterans Suffering With Post-Traumatic Stress Disorder, Jonathan Perry

Journal of Law and Health

Though Veteran Affairs has provided crucial life sustaining—and often lifesaving—treatments to returning soldiers, the substantial and ever-increasing rates of veteran suicides, drug addictions, and criminal behavior indicate a need for broader options in treatment. One of the most profound discoveries uncovered through MDMA-assisted psychotherapy research is MDMA’s facilitation of the alleviation of addictive behavior in subjects, and, as a result, an alleviation of addictions in general. Addiction is one of the key symptoms of post-traumatic stress disorder (PTSD) and drug abuse plays a large role in the other afflictions suffered by veterans, namely criminal activity and a high rate of …

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 …

Squashing The Superbugs: A Proposed Multifaceted Approach To Combatting Antibiotic-Resistant Bacteria , Lauren Orrico

Journal of Law and Health

Section II of this Note will provide background on the practices of the United States farming system, which fosters the creation of antibiotic-resistant bacteria. This section will also provide background on the detrimental effects that antibiotic resistance has on human health and will briefly describe the legal history of food and drug regulations. After establishing an informational foundation, Part III will elaborate on current laws and describe the legal authority of key players, before pointing out the shortcomings in current animal feed policy and recommending the development of further regulation in this area. Additionally, Part III will propose new legislation …

Who Can Afford It?: The Patient Protection And Affordable Care Act's Failure To Regulate Excessive Cost-Sharing Of Prescription Biologic Drugs , Michael Callam

Journal of Law and Health

This Note will discuss how the PPACA’s abbreviated approval pathway for biological products creates an expedited procedure to bring less expensive biologic drugs to the market, but ultimately fails to make those biologic drugs affordable because of its lack of provisions limiting insurers’ use of excessive cost-sharing requirements. Part II provides an overview of prescription drugs, compares biologics with traditional prescription drugs, and provides a brief legislative history of prescription drug laws. Part III analyzes the impact of the abbreviated approval pathway on biologic drugs’ costs to prescribed patients. It also examines the PPACA’s effects on biologics inclusion into health …

Smoking Out A Compromise: Splitting The Difference Through A Public Policy Approach To Resolving The Graphic Cigarette Warning Label Circuit Split, Amelia B. Larsen

Cleveland State Law Review

The imposition of graphic warning labels is necessary; the tobacco market exploits the lower class by capitalizing on their under-education regarding the negative health consequences of smoking. This injustice can be corrected by providing the most direct and clear communication imaginable to consumers to ensure they are completely informed of the peril they are placing themselves in when they choose to smoke—the graphic warning labels provide this kind of communication. This Note discusses why the FDA’s warning labels meet First Amendment constitutional scrutiny and serve a substantial governmental interest regarding the country’s public health, socioeconomic equality, and economy. Part II …

Excluding Patentability Of Therapeutic Methods, Including Methods Using Pharmaceuticals, For The Treatment Of Humans Under Trade Related Aspects Of Intellectual Property Rights Article 27(3)(A), Michael Henry Davis

Law Faculty Articles and Essays

The Agreement on Trade Related Aspects of Intellectual Property Rights ("TRIPS"), the General Agreement on Tariffs and Trade ("GATT"), and the World Trade Organization ("WTO") debacle has radically altered the traditional ability of nations to adopt whatever patent regime seems appropriate to them. Instead, TRIPS requires all member nations, even those which never thought it appropriate to grant such state monopolies, to afford patent protection to areas which had never been granted before-most dramatically in the area of health related innovations and, most expensively, pharmaceuticals. Until TRIPS, most -- or at least a number approaching half -- countries simply did …

The Highs Of Tomorrow: Why New Laws And Policies Are Needed To Meet The Unique Challenges Of Synthetic Drugs , Joseph A. Cohen

Journal of Law and Health

This article reviews the federal government’s attempts to control the influx of synthetic drugs, particularly synthetic cannabinoids and cathinones, into the U.S. recreational drug market since 2008. It offers three recommendations targeted at Congress, the DEA, and the Department of State on ways to prevent and control synthetic drug use in America: (1) Congress should grant the DEA a new “immediate scheduling” authority; (2) the DEA should improve information sharing with states; and (3) the Department of State and the DEA should prioritize the development of a global early warning system.

Pharmageddon: A Statutory Solution To Curb Ohio's Prescription Abuse Problem, Ed Woodworth

Journal of Law and Health

Prescription abuse in Ohio continues to be a serious and complex issue that should be addressed. Accordingly, Part II of this Note examines the background of prescription drug abuse generally. It identifies the dangers of prescription drug abuse, the cost drug abuse places on society, some reasons for prescription drug abuse, sources of prescription drugs, and discusses the current state and federal laws regarding prescription drug abuse and prescription reporting. Part III discusses the positive and negative aspects of H.B. 93 and Medical Rule 4731-11-11 and then offers proposals to more effectively prevent prescription drug abuse. Part IV discusses various …

Finding A Cure: Incentivizing Partnerships Between Disease Advocacy Groups And Academic Commercial Researchers , Anne M. Readel

Journal of Law and Health

Collaborations between for-profit drug companies and not-for-profit disease advocacy groups have risen in recent years in an effort to find cures for orphan diseases. These unique and beneficial collaborations are a result of disease advocacy groups assuming a more active role in drug development through the use of “venture philanthropy,” which employs concepts and techniques from venture capitalism and applies them to achieving philanthropic goals. While these collaborations have found remarkable success, such as the discovery of the first known cure for cystic fibrosis in 2012, venture philanthropy for drug discovery presents numerous legal and social challenges. This Article examines …

Where Are Your Drugs Really Made And Who Is Regulating It?, Floyd Trillis Iii

In the Balance

No abstract provided.

Time To Cut The Fat: The Case For Government Anti-Obesity Legislation , Stephen A. Mcguinness

Journal of Law and Health

This Article examines—and ultimately rejects—this anti-paternalism argument against government anti-obesity policies. It argues that government intervention in the food industry for the purpose of stemming the American obesity epidemic is justified and survives paternalistic objections to the contrary. This Article begins by briefly outlining the nature, severity, and causes of the obesity epidemic. It considers what can be done about the problem, finding that only government intervention is capable of effectively combating the crisis. It also outlines several types of potentially successful government anti-obesity strategies. Finally, it considers the primary topic of this Article: whether government anti-obesity policies constitute unjustified …

Beyond Nuremberg: A Critique Of Informed Consent In Third World Human Subject Research , Jacob Schuman

Journal of Law and Health

This Article discusses the history of informed consent, critically analyzes this principle, and suggests an alternative approach to informed consent. Part II explores the concept of informed consent, including its philosophical bases, its implementation through FDA regulations, and current proposals on how to protect the principle in drug testing conducted abroad. Part III performs a critical analysis of the principle of informed consent; first providing an empirical examination of the realities of Third World human subject research, and then questioning both the coherence of an abstract “right” to informed consent, as well as the possibility of truly autonomous “consent” to …

Food-Borne Ultimatum: Proposing Federal Legislation To Create Humane Living Conditions For Animals Raised For Food In Order To Improve Human Health, The, Lynn M. Boris

Journal of Law and Health

In order to reduce the large number of human health risks associated with reckless farming practices, Congress must enact federal legislation that requires humane living conditions for farm animals and declares a moratorium on the routine use of unnecessary antibiotics. Part II of this Note will briefly review traditional farming and animal husbandry practices and examine the shift to the modern practices used by producers of animal products today. Part II will also present several farming practices utilized today that are particularly dangerous to human health. Part III of this Note will explore the immense human suffering that is occurring …

Dying To Wait: How The Abigail Court Got It Wrong, Juan Joel Tovanche

Journal of Law and Health

At age twenty-one, Abigail Kathleen Burroughs met a fate usually reserved for aged men who have spent much of their lives drinking and smoking. Diagnosed with cancer at nineteen, Abigail battled the squamous cell carcinoma that invaded her body even as she struggled to maintain her characteristic optimism. Abigail struggled with more than her illness, however. In the last years of her life, Abigail and her family also wrestled with Food and Drug Administration (FDA) regulations that denied her access to medication that could have saved her life. The policy at issue was the FDA's practice of progressive testing, which …

Combating The Unfair Competitive Edge: Random Drug Testing Should Be Implemented In Standardized Testing To Deter Illicit And Unfair Use Of Prescription Stimulants, Shawn Romer

Journal of Law and Health

This note will first give an overview of prescription stimulants and will then explore the prevalent number of students who illicitly take prescription stimulants to enhance their academic performance. A description of how illicit use can be harmful to a student follows, and thereafter the note describes the scant current safeguards that currently exist against the use of illicit prescription stimulants. An explanation of the importance of standardized test scores to admissions follows, along with a description of how this importance has motivated students to seek an unfair competitive edge through illicit drug usage, which happens in many sporting competitions. …