Health Law and Policy Commons^™

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. …

Parens Patriae And Parental Rights: When Should The State Override Parental Medical Decisions?, Elchanan G. Stern

Journal of Law and Health

Alfie Evans was a terminally ill British child whose parents, clinging to hope, were desperately trying to save his life. Hospital authorities disagreed and petitioned the court to enjoin the parents from removing him and taking him elsewhere for treatment. The court stepped in and compelled the hospital to discontinue life support and claimed that further treatment was not in the child’s best interest. This note discusses the heartbreaking stories of Alfie and two other children whose parents’ medical decisions on their behalf were overridden by the court. It argues that courts should never decide that death is in a …

Concussions And Contracts: The National Football League's Limitations To Protecting Its Players From Chronic Traumatic Encephalopathy, Julia Wolpert

Journal of Law and Health

Chronic Traumatic Encephalopathy (CTE) is a neurodegenerative brain injury that has become prevalent among high-contact professional sports, especially American football. More and more retired players are exhibiting symptoms of CTE and being diagnosed with CTE post-mortem. While the neuroscience community constantly releases studies showing a causal connection between brain trauma and CTE, the National Football League (NFL) continues to deny that any brain injury can arise from playing football. The NFL must implement provisions in their contracts to fully inform and protect players from this lethal brain injury. This article examines the repercussions of CTE, how players’ contracts do and …

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. …

From Fitbits To Pacemakers: Protecting Consumer Privacy And Security In The Healthtech Age, Justin Evans, Katelyn Ringrose

Et Cetera

As wearable and analytics technology continues to be aggressively adopted, there is a congruent rise in data collection from wearable healthtech devices. This unprecedented rise in data collection poses massive privacy and security issues. This note addresses the benefits of IoT healthcare wearables and implants, as well as identifies where the privacy and security of data accrued by such devices could be improved. In an effort to better encapsulate the issue surrounding wearable device data collection, the authors analyze the many benefits of wearable healthcare devices, as well as look into the false sense of trust consumers have in the …

Congress Prescribes Preemption Of State Tort-Reform Laws To Remedy Healthcare "Crisis": An Improper Prognosis?, Jason C. Sheffield

Journal of Law and Health

Say what you want about the tort-reform debate, but it has staying power. Over the last half-century, legislators and commentators have extensively debated every aspect of tort reform and the litigation "crisis" arguably giving rise to it, without resolving much of anything. Despite this ideological stalemate, tort-reform proponents have managed to push measures through every state legislature. With fifty tries come fifty results, and for the most part, fifty failures. But have all these efforts been in vain? As of yet, no. Although the healthcare system does not appear to be improving, the numerous tort-reform measures states have adopted provide …

Puffing Away Parental Rights: A Survey And Analysis Of Whether Secondhand Smoke Exposure Is Child Abuse, Karly Huml

Journal of Law and Health

The steps taken thus far to protect children in public areas, custody cases, and in vehicles show the legislature's awareness of the chemical harms of secondhand smoke for children. This article will analyze those steps and discuss what they mean for both parents' and children's constitutional rights. This article proposes that the legislature take a vital fourth step by including secondhand smoke exposure in child abuse laws. Section II of this article provides the history of smoking tobacco and its transition from a trendy social status to an unpopular, harmful habit. Section II also introduces the steps that have been …

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 …

Keep Your Friends Close And Your Medical Records Closer: Defining The Extent To Which A Constitutional Right To Informational Privacy Protects Medical Records, Lauren Newman

Journal of Law and Health

The following Article discusses the extent to which the constitutional right to informational privacy protects medical data from improper acquisition or dissemination by state agents. Part I provides background on Whalen v. Roe, the Supreme Court case that has been understood to establish the right to informational privacy. Part I also discusses the variations across the circuit courts as to what medical information is afforded protection by the right. Part II analyzes the well-established approaches adopted by the Second and Third Circuits as they present opposing interpretations of Whalen, one wholly protecting medical information and the other protecting …

The Bell Has Rung: Answering The Door For Student-Athlete Concussion Issues In The National Collegiate Athletic Association, Aaron Caputo

Journal of Law and Health

This Note examines the NCAA's unwillingness to enforce the requirement that all NCAA institutions must implement a concussion management plan; the NCAA's refusal to apply its appropriate enforcement mechanism when member institutions violate their concussion management plans, which are instituted in order to protect student-athletes from concussions; how both of these failures result in more concussions and a higher probability of debilitating long-term effects; and solutions to remedy this grave injustice. Part II describes what a concussion is, the long-term effects of concussions, the NCAA's management of concussions, and lawsuits challenging the NCAA in relation to concussions. Part III analyzes …

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 …

Bridging The Ncaa's Accident Insurance Coverage Gaps? A Deep Dive Into The Uncertainties Of Injury Coverage In College Contact Sports, And The Impact That Has On Athletes' Future Physical And Financial Comfort, Nicole Kline

Journal of Law and Health

This Note analyzes the flaws in the NCAA’s current accidental injury health coverage policies for student-athletes and suggests ways to remedy the issues that plague student-athletes incurring serious injuries that may not be covered under current policies. Part I of this Note outlines the history of the NCAA and the policies relevant to the issues with accidental injury coverage currently in place. Part II looks at the significance of these coverage gaps in today’s world of modern medicine and technology as well as the impact they have on the everyday life of college athletes. Part III suggests solutions to bridge …

A Leap To Hybrid Governance For European Union Healthcare On Organ Donations, Tasnim Ahmed

Journal of Law and Health

This article evaluates two proposals that the Organs Directive along with the commission’s Action Plan 2009-2015 can be viewed as a form of hybrid governance. The Organs Directive is the first legally-binding supranational risk regulation devised in the field of organ donation and transplantation. The Directive is modelled on the earlier Directive dealing with blood, tissue, and cells. The Action Plan, which is soft law, will complement the Directive. The Directive and Action Plan requires additional administration procedures from the Member States with the EU Commission regularly monitoring the implementation of the work programme to ensure it is manageable for …

Insane: James Holmes, Clark V. Arizona, And America's Insanity Defense, Eric Collins

Journal of Law and Health

Insanity is a legal term of art that changes definitions depending on the legal standard in American jurisprudence, which explains why a man who mental health professionals described as having an uncontrollable obsession with killing people can be found not insane and guilty. This Note addresses the current state of the Insanity Defense Reform Act of 1984 and its widespread implementation at the state level. Part II supplies background information on the history of the insanity defense and how it has transformed over the years in American jurisprudence. Part III provides an analysis of the of the insanity defense. Part …

The Ethics In Synthetics: Statistics In The Service Of Ethics And Law In Health-Related Research In Big Data From Multiple Sources, Sharon Bassan Ph.D., Ofer Harel Ph.D.

Journal of Law and Health

An ethical advancement of scientific knowledge demands a delicate equilibrium between benefits and harms, in particular in health-related research. When applying and advancing scientific knowledge or technologies, Article 4 of UNESCO’s Universal Declaration on Bioethics and Human Rights, ethically justifiable research requires maximizing direct and indirect benefits and minimizing possible harms. The National Institution of Health [NIH] Data Sharing Policy and Implementation Guidance similarly states that data necessary for drawing valid conclusions and advancing medical research should be made as widely and freely available as possible (in order to share the benefits) while safeguarding the privacy of participants from potentially …

Controlling Health Care Costs Under The Aca – Chaos, Uncertainty, And Transition With The Centers For Medicare And Medicaid Innovation And The Independent Payment Advisory Board, Gwendolyn R. Majette

Law Faculty Articles and Essays

This article addresses two components of the new governing architecture (NGA) that help to reform the delivery of health care and to control costs of the health care system: the Center for Medicare and Medicaid Innovation (CMMI) and the Independent Payment Advisory Board (IPAB). The republican controlled federal government has partially disassembled these two components, threatening the effectiveness of federal delivery system reform and cost control initiatives.

Depression: The Often Overlooked Sequela Of Head Trauma, Samuel D. Hodge Jr., Jack E. Hubbard

Cleveland State Law Review

Depression is a common sequela of head trauma. Approximately half of all individuals with a cranial injury will experience depression within the first year, regardless of the severity of the injury. The ailment is characterized clinically as a mood disorder, often associated with intense feelings of sadness. However, depression is more complex than mood disorders, as many mental and bodily complaints—such as insomnia, fatigue, anxiety, appetite changes, aches and pains, and lack of interest in previously enjoyable activities—are associated with depression. These intense feelings, particularly when combined with despair and hopelessness, can lead to suicide, a dreaded potential complication of …

Supporting Mothers With Mental Illness: Postpartum Mental Health Service Linkage As A Matter Of Public Health And Child Welfare Policy, Jesse Krohn, Msed, Jd, Meredith Matone, Drph, Mhs

Journal of Law and Health

Through our work in youth advocacy as, respectively, legal and public health professionals, we are all too aware of the high levels of health care fragmentation experienced during pregnancy and postpartum by poor, young mothers of color. Meredith Matone’s research highlights the heightened risk of fragmentation for girls with histories of child welfare involvement. For example, she found that 66.7% of young mothers who had resided in out-of-home placements and who had taken antipsychotic medication prior to becoming pregnant failed to fill prescriptions for antipsychotics in their first postpartum year. Put another way, two-thirds of these vulnerable young mothers—a far …

Germ-Line Gene Editing And Congressional Reaction In Context: Learning From Almost 50 Years Of Congressional Reactions To Biomedical Breakthroughs, Russell A. Spivak, J.D., I. Glenn Cohen, J.D., Eli Y. Adashi, M.D., M.S.

Journal of Law and Health

On December 18, 2015, President Obama signed into law a policy rider forestalling the therapeutic modification of the human germ line. The rider, motivated by the science’s potential unethical ends, is only the most recent instance in which the legislature cut short the ongoing national conversation on the acceptability of a developing science. This essay offers historical perspective on what bills were proposed and passed surrounding four other then-developing scientific breakthroughs—Recombinant DNA, in vitro fertilization, Cloning, Stem Cells—to better analyze how Congress is, and should, regulate this exciting and promising science.

Analysis Of The Proposed Tpp-Related Patent Linkage System In Taiwan, Ping-Hsun Chen

Journal of Law and Health

The Trans-Pacific Partnership (TPP) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan’s proposal includes both measures. Taiwan’s patent linkage system allows a pioneer drug company to register patents claiming (a) a material, (b) a combination or formula, or (c) pharmaceutical use. The …

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 …

A Whole Lot Of Shakin' Going On: Movement Disorders Caused By Brain Trauma, Jack E. Hubbard, Samuel D. Hodge, Jr.

Cleveland State Law Review

There has been a lot of publicity directed to the consequence of brain trauma, such as headaches forgetfulness, irritability, and depression. That is only part of the sequelae. A little-known but challenging result of brain trauma is the development of or aggravation of a movement disorder such as a tremor, dystonia, a tic, or Parkinson’s Disease.

A movement disorder is an all-encompassing term that refers to a constellation of neurological issues that cause involuntary or voluntary movements or abnormal positioning of a body part. Various regions of the brain interact with each other to control movements of the body. If …

In The "Best Interests" Of The Disabled: Legislating Morality And The Power To Initiate Support Orders For Disabled Adults In Ohio, Kalynne Proctor

Cleveland State Law Review

Today’s reality is that many families have children who are faced with disabling conditions that prevent them from relinquishing their dependency on others. Often, the need for specialized treatment and care does not terminate once a severely disabled child reaches adulthood. While typically parents are relieved of their legal parental obligations to their adult-aged children, this is not the same case for parents with severely disabled children. In some respects, Ohio has recognized the financial difficulties divorced parents face when they are the sole caregivers of disabled adult children. Although Ohio law requires that the noncustodial parent in a divorce …

A Healthy Amount Of Privacy: Quantifying Privacy Concerns In Medicine, Ignacio N. Cofone

Cleveland State Law Review

With recent developments in e-health, concerns have been raised regarding the privacy of patients who are monitored with such treatments. I propose a simple method to incorporate these concerns into a standard health impact evaluation, based on quality-adjusted life years and the incremental cost-effectiveness ratio. This method provides a way to objectively value privacy concerns and balance them with health benefits. Hence, it can guide doctors and policymakers into incorporating privacy considerations and making better choices regarding e-health programs. This method can also be tested on existing economic evaluations to compare outcomes and gauge the extent to which privacy issues …

A Deliberate Departure: Making Physician-Assisted Suicide Comfortable For Vulnerable Patients, Browne C. Lewis

Law Faculty Articles and Essays

This Article is divided into four parts. Part I discusses the history and evolution of the "right to die movement" in the United States. The current legal landscape in the United States is examined in Part II. In Part III, I analyze some of the relevant ethical concerns caused by the availability of physician-assisted suicide. My analysis primarily focuses on the Oregon statutes because it is the oldest physician-assisted suicide law in the United States and has served as a model for laws in the United States and abroad. For example, Lord Falconer's Bill, which was defeated by the British …

Funding Long-Term Services And Supports (Ltss) For Working Aged Disabled Americans, Helen L. Rapp

Journal of Law and Health

There are a multitude of dilemmas faced today by over 3 million significantly disabled Americans, many of whom depend on Medicaid for Long-Term Services and Supports (LTSS) in obtaining the services they need to simply live. While the landmark 1990 Americans with Disabilities Act (ADA) has done a lot to improve the lives of people with disabilities, the reality is that using Medicaid as the vehicle for funding LTSS places unreasonable restrictions on disabled people who want to live independent lives and be as successful as possible.

The Federal Government must change funding for LTSS in order to provide disabled …

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 …

Quintavalle: The Quandary In Bioethics, Lisa Cherkassky

Journal of Law and Health

The case of R. (Quintavalle) v. Human Fertilisation Embryology Authority (and Secretary of State for Health) presents a handful of legal problems. The biggest legal query to arise from the case is the inevitable harvest of babies, toddlers and very young children for their bone marrow. This article unpacks the judicial story behind Quintavalle to reveal how the strict provisions of the Human Fertilisation and Embryology Act 1990 - namely ‘suitable condition’ under schedule 2 paragraph 1(1)(a) and ‘treatment services’ and ‘assisting’ under section 2(1) - were widely misinterpreted to introduce the social selection of embryos into law. The legal …

Expansion Of Employee Wellness Programs Under Ppaca Creates Additional Barriers To Healthcare Insurance For Individuals With Disabilities, Amy B. Cheng

Journal of Law and Health

There are many barriers to healthcare for the general population that has been documented throughout the years, with one particularly affected group being individuals with disabilities. One identified healthcare barrier for individuals with disabilities is the inability to gain access to the healthcare system through health insurance. While many attempts have been made to resolve this issue, serious problems have yet to be resolved. The Patient Protection Affordable Care Act (PPACA) attempted to solve the issue by expanding Health Insurance Portability and Accountability Act of 1996’s (HIPAA) current regulations on employee wellness programs. The relevant regulations govern employee wellness programs …