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Nonfinancial Conflict Of Interest In Medical Research: Is Regulation The Right Answer, Nehad Mikhael Apr 2024

Nonfinancial Conflict Of Interest In Medical Research: Is Regulation The Right Answer, Nehad Mikhael

Journal of Law and Health

Medical research plays a vital role in advancing human knowledge, developing new therapies and procedures, and reducing human suffering. Following the atrocities committed in the name of medical research by German physicians during the Nazi era, the Nuremberg trials were held, and an ethical code was created to establish the limits within which medical research can operate. Consequently, legal regimes built upon this ethical foundation to develop laws that ensure the integrity of medical research and the safety of human subjects. These laws sought to protect human subjects by minimizing conflicts of interest that may arise during the process. Furthermore, …


Death By Detox: Substance Withdrawal, A Possible Death Row For Individuals In Custody, Dorothea R. Carleton May 2023

Death By Detox: Substance Withdrawal, A Possible Death Row For Individuals In Custody, Dorothea R. Carleton

Journal of Law and Health

Suffering through substance withdrawal is a major problem for the majority of individuals in custody, yet there are no guidelines or standards to ensure their safety. Instead, individuals in custody are having their Constitutional rights violated and many die at the hands of the justice system. When their families seek accountability for the lack of adequate care provided by correctional facilities and employees, families are faced with a lack of consistency from one circuit to the next for knowing as to the correct standard to have a successful claim. Strain v. Regalado was a chance for the Supreme Court to …


O-High-O: A Policy Note On Ohio's Current Push For Recreational Marijuana Legislation And How Other States Have Created Successful Recreational Marijuana Laws, Alexander M. Stewart Apr 2023

O-High-O: A Policy Note On Ohio's Current Push For Recreational Marijuana Legislation And How Other States Have Created Successful Recreational Marijuana Laws, Alexander M. Stewart

Et Cetera

Many states have gone on to pass comprehensive recreational marijuana laws that have greatly benefitted their economy, public health, and criminal justice system. Ohio currently allows for the use of marijuana for medicinal purposes, and there has been past attempts to enact legislation that would legalize the recreational use of marijuana, but the past proposals failed to gain the widespread support required to become law. This Note seeks to analyze and understand other states’ legislation in an attempt to understand what successful recreational marijuana legislation looks like. This Note concludes with a comprehensive proposal that contains all the essential elements …


Don't Tread On My Ip Rights: A Law And Economics Analysis Of "March-In Rights" Under The Bayh-Dole Act, Caitlin Grow Dec 2022

Don't Tread On My Ip Rights: A Law And Economics Analysis Of "March-In Rights" Under The Bayh-Dole Act, Caitlin Grow

Cleveland State Law Review

The Bayh-Dole Act has been imperative to the development of the United States’ dynamic pharma-biotech sector. However, the use of march-in rights under the Bayh- Dole Act has remained controversial. On the one hand, there is the idea of market equilibrium with a need to secure health care for the public. Many believe march-in rights should be used to create this balance by regulating the pricing of drugs that were developed using federally funded research. On the other hand, some advocates recognize that the current relationship between public-sector institutions and business as the developers of basic research, and private-sector biotechnology …


Contract Remedies Need Not Undercompensate Aspiring Parents When Cryopreserved Reproductive Material Is Lost Or Destroyed: Recovery Of Consequential Damages For Emotional Disturbance When Breach Of Contract Results In The Lost Opportunity To Become Pregnant With One's Own Biological Child, Joseph M. Hnylka Dec 2021

Contract Remedies Need Not Undercompensate Aspiring Parents When Cryopreserved Reproductive Material Is Lost Or Destroyed: Recovery Of Consequential Damages For Emotional Disturbance When Breach Of Contract Results In The Lost Opportunity To Become Pregnant With One's Own Biological Child, Joseph M. Hnylka

Journal of Law and Health

The Center for Disease Control and Prevention (CDC) has reported that the use of assisted reproductive technology (ART) has doubled over the past decade. In vitro fertilization (IVF) is the most prevalent form of ART. During IVF, a woman’s eggs are extracted, fertilized in a laboratory setting, and then implanted in the uterus. Many IVF procedures use eggs or sperm that were stored using a process called cryopreservation. A recent survey reported that cryopreservation consultations increased exponentially during the coronavirus pandemic, rising as much as 60 percent. It is estimated that more than one million embryos are stored in cryopreservation …


Hacking Hipaa: "Best Practices" For Avoiding Oversight In The Sale Of Your Identifiable Medical Information, Riyad A. Omar Nov 2020

Hacking Hipaa: "Best Practices" For Avoiding Oversight In The Sale Of Your Identifiable Medical Information, Riyad A. Omar

Journal of Law and Health

In light of the confusion invited by applying the label "de-identified" to information that can be used to identify patients, it is paramount that regulators, compliance professionals, patient advocates and the general public understand the significant differences between the standards applied by HIPAA and those applied by permissive "de-identification guidelines." This Article discusses those differences in detail. The discussion proceeds in four Parts. Part II (HIPAA’s Heartbeat: Why HIPAA Protects Identifiable Patient Information) examines Congress’s motivations for defining individually identifiable health information broadly, which included to stop the harms patients endured prior to 1996 arising from the commercial sale of …


The Public Health Demand For Revoking Non-Medical Exemptions To Compulsory Vaccination Statutes, Emma Tomsick Nov 2020

The Public Health Demand For Revoking Non-Medical Exemptions To Compulsory Vaccination Statutes, Emma Tomsick

Journal of Law and Health

In 2019, the United States saw the single largest outbreak of measles in recent history. The measles crisis has prompted state legislative bodies to face a seemingly impossible dilemma: eliminate both religious and philosophical exemptions to mandatory school vaccination statutes or sit by idly and allow measles to continue to run its course. As of June 2019, five states have neither religious nor philosophical exemptions to their mandatory vaccination statutes. This Note argues that states should remove all religious and philosophical exemptions to compulsory vaccination statutes. The 2019 measles outbreak demonstrates that the anti-vaccination movement poses a legitimate risk to …


International Law And The Legalization Of Abortion In Northern Ireland, Emily Uterhark Nov 2020

International Law And The Legalization Of Abortion In Northern Ireland, Emily Uterhark

Journal of Law and Health

On July 24, 2019, the Parliament of the United Kingdom passed an act that included an amendment requiring Northern Ireland to implement recommendations from the Committee on the Elimination on Discrimination Against Women. The amendment required Northern Ireland to repeal the 1861 abortion act and requires the decriminalization of abortion. The law went into effect on October 22, 2019, since the Northern Ireland power-sharing government (Stormont) did not reconvene before October 21, 2019. Since the law did go into effect, it gave women the right to obtain abortions under the CEDAW recommendations; however, when the Northern Irish government (Stormont) reconvenes, …


Should A Physician Apologize For A Medical Mistake? – The Controversy Over The Effectiveness Of Apology Law Statutes, Samuel D. Hodge, Jr. Nov 2020

Should A Physician Apologize For A Medical Mistake? – The Controversy Over The Effectiveness Of Apology Law Statutes, Samuel D. Hodge, Jr.

Cleveland State Law Review

There are two approaches that health care providers can pursue in handling a medical error. Is it better for a physician not to admit a mistake and aggressively defend the claim or apologize and try to amicably resolve the matter? There has been a growing movement for physicians to offer words of sympathy or to apologize for a medical mistake as a way of minimizing the impact of a medical error and reducing the chances of a malpractice claim. There are a number of benefits to this approach but critics maintain that an apology is a useless gesture with an …


Parens Patriae And Parental Rights: When Should The State Override Parental Medical Decisions?, Elchanan G. Stern Dec 2019

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 …


A Surging Drug Epidemic: Time For Congress To Enact A Mandate On Insurance Companies And Rehabilitation Facilities For Opioid And Opiate Addiction, Alanna Guy May 2018

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 …


Depression: The Often Overlooked Sequela Of Head Trauma, Samuel D. Hodge Jr., Jack E. Hubbard Dec 2017

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 …


Analysis Of The Proposed Tpp-Related Patent Linkage System In Taiwan, Ping-Hsun Chen Jul 2017

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 …


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. Jul 2017

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.


In The "Best Interests" Of The Disabled: Legislating Morality And The Power To Initiate Support Orders For Disabled Adults In Ohio, Kalynne Proctor Jun 2017

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 …


Bioprospecting Legislation In The United States: What We Are Doing, What We Are Not Doing, And What Should We Do Next, Emily J. Stolfer Mar 2017

Bioprospecting Legislation In The United States: What We Are Doing, What We Are Not Doing, And What Should We Do Next, Emily J. Stolfer

Cleveland State Law Review

Bioprospecting is a growing worldwide effort to protect knowledge and the environment. With its potential economic benefit and technological advancements, bioprospecting will continue to grow as the world advances. Other nations have begun to protect the information available and continue to develop legislation. However, the United States has been hesitant to ratify international treaties or implement its own legislation. This Note examines both domestic and international efforts to protect both indigenous people and the environment. It analyzes the legislation the United States currently has in place but also examines where the United States is lacking. Regarding the United States’ failure …


A Healthy Amount Of Privacy: Quantifying Privacy Concerns In Medicine, Ignacio N. Cofone Mar 2017

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 …


Expansion Of Employee Wellness Programs Under Ppaca Creates Additional Barriers To Healthcare Insurance For Individuals With Disabilities, Amy B. Cheng Dec 2016

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 …


Save Thousands Of Lives Every Year: Resuscitate The Peer Review Privilege, Alan G. Williams Dec 2016

Save Thousands Of Lives Every Year: Resuscitate The Peer Review Privilege, Alan G. Williams

Journal of Law and Health

Doctors make mistakes—preventable medical mistakes—that kill or seriously injure patients. The best way to reduce these preventable errors is through a medical peer review process typically referred to as a "morbidity and mortality conference." However, over the past twenty years, federal and state courts, state legislatures, and state voters have effectively gutted the morbidity and mortality conference (M&M) as a remedial and preventative tool, resulting in tens of thousands of unnecessary deaths every year. Doctors need our help restoring the effectiveness of M&Ms. Congress has created the means to do so; now, all the courts need do is use it. …


Quintavalle: The Quandary In Bioethics, Lisa Cherkassky Dec 2016

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 …


Healer, Witness, Or Double Agent? Reexamining The Ethics Of Forensic Psychiatry, Matthew U. Scherer Dec 2016

Healer, Witness, Or Double Agent? Reexamining The Ethics Of Forensic Psychiatry, Matthew U. Scherer

Journal of Law and Health

In recent years, psychiatrists have become ever more prevalent in American courtrooms. Consequently, the issue of when the usual rules of medical ethics should apply to forensic psychiatric encounters has taken on increased importance and is a continuing topic of discussion among both legal and medical scholars. A number of approaches to the problem of forensic psychiatric ethics have been proposed, but none adequately addresses the issues that arise when a forensic encounter develops therapeutic characteristics. This article looks to the rules governing the lawyer-client relationship as a model for a new approach to forensic psychiatric ethics. This new model …


Mending Invisible Wounds: The Efficacy And Legality Of Mdma-Assisted Psychotherapy In United States' Veterans Suffering With Post-Traumatic Stress Disorder, Jonathan Perry Dec 2016

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 …


Shifting Our Focus From Retribution To Social Justice: An Alternative Vision For The Treatment Of Pregnant Women Who Harm Their Fetuses, April L. Cherry Jan 2015

Shifting Our Focus From Retribution To Social Justice: An Alternative Vision For The Treatment Of Pregnant Women Who Harm Their Fetuses, April L. Cherry

Journal of Law and Health

The ways in which society responds to pregnant women whose behavior purportedly harms their fetuses can be explored from a variety of legal vantage points. This article argues that the criminal law model currently used is ineffective. The assignment of criminal liability to pregnant women is often rooted in fetal personhood and maternal deviance discourse. Criminal law solutions fail because they fail to take into account the fact that maternal behavior is often the result of a myriad of the social and economic conditions over which pregnant women have little or no control. The criminal law model, therefore, simply punishes …


Introduction: Issues Of Reproductive Rights: Life, Liberty & The Pursuit Of Policy, Lauren Orrico, Gordon Gantt Jr. Jan 2015

Introduction: Issues Of Reproductive Rights: Life, Liberty & The Pursuit Of Policy, Lauren Orrico, Gordon Gantt Jr.

Journal of Law and Health

On March 7, 2014, the Journal of Law and Health of Cleveland-Marshall College of Law hosted a symposium entitled “Issues of Reproductive Rights: Life, Liberty, and the Pursuit of Policy” in response to recent developments in the regulation of women’s reproductive rights. The discussion about women’s reproductive rights has expanded far beyond the morality of abortion and right to privacy, established by the United States Supreme Court in Roe v. Wade, and has been complicated by new technology, statutory developments, and case law discussing the nature of a corporation. The symposium presenters addressed key legal developments in each stage of …


Reproductive Justice, Public Policy, And Abortion On The Basis Of Fetal Impairment: Lessons From International Human Rights Law And The Potential Impact Of The Convention On The Rights Of Persons With Disabilities, Carole J. Petersen Jan 2015

Reproductive Justice, Public Policy, And Abortion On The Basis Of Fetal Impairment: Lessons From International Human Rights Law And The Potential Impact Of The Convention On The Rights Of Persons With Disabilities, Carole J. Petersen

Journal of Law and Health

This article argues that we should consider not only American constitutional law but also comparative law and emerging international human rights norms, in order to navigate the difficult issue of abortion on the basis of fetal impairment. The United States is a State Party to the International Covenant on Civil and Political Rights (ICCPR)13 and the Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment (CAT). It is also a signatory (but not a full State Party) to several other relevant treaties, including the Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW), the …


Kicking Ohio Medicaid Recipients When They Are Down: How Ohio's Third Party Liability Medicaid Statute Violates Federal Law As Interpreted By Ahlborn, Kelly Voyles Jan 2013

Kicking Ohio Medicaid Recipients When They Are Down: How Ohio's Third Party Liability Medicaid Statute Violates Federal Law As Interpreted By Ahlborn, Kelly Voyles

Cleveland State Law Review

This Note argues that Ohio’s Medicaid third party liability statute must either be invalidated by the Ohio Supreme Court or repealed by the Ohio General Assembly. This Note then goes on to argue that the Ohio General Assembly must amend its Medicaid third party liability statute to require settlement allocation before ODJFS can recover the medical payments it made on behalf of Ohio Medicaid recipients. Finally, this Note argues that Ohio should also amend its Medicaid third party liability statute to require that the parties come to an allocation agreement themselves or, if that proves impossible, to require a judicial …


Proving Medical Child Abuse: The Time Is Now For Ohio To Focus On The Victim And Not The Abuser, Tiffany S. Allison Jan 2012

Proving Medical Child Abuse: The Time Is Now For Ohio To Focus On The Victim And Not The Abuser, Tiffany S. Allison

Journal of Law and Health

Part I of this Note will discuss the history of Munchausen's Syndrome by Proxy and how the medical community is trying to make the general public aware of medical child abuse. Part II provides a history of Munchausen's Syndrome by Proxy and medical child abuse. It also highlights the differences in how litigation was previously handled under the nomenclature of Munchausen's Syndrome by Proxy and how litigation should be handled in the future under the nomenclature of medical child abuse. Part III identifies Ohio's current statutes and federal legislation that have an effect on child abuse. Part III also identifies …


Beyond Nuremberg: A Critique Of Informed Consent In Third World Human Subject Research , Jacob Schuman Jan 2012

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 …


Organ Conscription: How The Dead Can Save The Living, David Schwark Jan 2011

Organ Conscription: How The Dead Can Save The Living, David Schwark

Journal of Law and Health

This Note will examine the failures of uncompensated and voluntary donation and argue that the only way to meet our country's organ needs is to make donation mandatory. Part II of this Note examines the history of voluntary organ donation in the United States. This history describes the evolution of organ donation laws from the first transplant until the present day. Part II also details the consequences and shortcomings of the current system. Part III examines three other proposed solutions to the organ deficit. These possible solutions include routine requests, an organ market, and presumed consent. However, none of these …


Tale Of Two Policies: A Defense Of China's Population Policy And An Examination Of U.S. Asylum Policy, Mona Ma Jan 2011

Tale Of Two Policies: A Defense Of China's Population Policy And An Examination Of U.S. Asylum Policy, Mona Ma

Cleveland State Law Review

The U.S. asylum law presents a distorted view of China's policy to the world and unfairly taints China's image in the international arena. It also undermines the effectiveness of the policy by encouraging Chinese citizens to break the law. This article advocates the repeal of IIRAIRA § 601 by demonstrating that China's population policy is a necessary and responsible social policy. Part II gives a brief history of the U.S. asylum law relating to China's population policy, including the pre-1996 court split on whether to grant Chinese nationals asylum based on violations of China's population policy. In re Chang, a …