Law Commons^™

Telemedicine Scams, Katrice B. Copeland

Journal Articles

Telemedicine emerged as a lifeline during the COVID-10 pandemic. Although the technology existed long before the pandemic, its use was limited due to strict government regulations that limited reimbursement for telemedicine visits. In response to the pandemic, the Government waiver many of its restrictions for the duration of the Public Health Emergency. These changes fueled the growth of telemedicine.

The problem, however, is that telemedicine makes it easier to conduct fraud on a larger scale because without in-person visits, medical providers can reach many more beneficiaries in a short period of time. Thus, the size and scale of typical health …

Nothing Generic About It: Promoting Therapeutic Access By Overcoming Regulatory And Legal Barriers To A Robust Generic Medical Device Market, Megan S. Wright, Zachary Shapiro, Adam Pan, Keturah James, Joseph Fins

Journal Articles

This Article addresses a paradox in American healthcare technology: a thriving market for generic drugs but a paucity of generic medical devices. Despite the success of generic pharmaceuticals in reducing healthcare costs, no analogous market exists for generic medical devices. This plays a part in keeping prices high while limiting access to affordable therapies. In this Article, we highlight the regulatory and legal barriers currently impeding the development of a generic medical device market in the United States. We explore differences between generic drugs and generic devices in FDA regulation, products liability, and patentability, all of which contribute to the …

Covid-19 Business Interruption Insurance Losses: The Cases For And Against Coverage, Christopher French

Journal Articles

The financial consequences of the government-ordered shutdowns of businesses across America to mitigate the COVID-19 health crisis are enormous. Estimates indicate that small businesses have lost $255 to $431 billion per month and more than 44 million workers have been laid off. When businesses have requested reimbursement of their business interruption losses from their insurers under business interruption policies, their insurers have denied the claims. The insurance industry also has announced that business interruption policies do not cover pandemic losses, so they intend to fight COVID-19 claims “tooth and nail.” More than 450 lawsuits throughout the country already have been …

Dementia, Autonomy, And Supported Healthcare Decisionmaking, Megan S. Wright

Journal Articles

Healthcare providers often rely on surrogates to decide on behalf of their patients with dementia who are deemed incapable of exercising autonomy. There is a longstanding debate about the appropriate standard of surrogate healthcare decisionmaking for these patients. Many influential scholars argue that the precedent autonomy of the person with dementia should be respected, and healthcare decision-making laws generally reflect this principle. These laws direct surrogate decisionmakers to follow instructions in living wills or to decide on the basis of the wishes and values of the person before the onset of dementia.But other prominent scholars have questioned whether surrogates should …

Liquid Gold, Katrice Bridges Copeland

Journal Articles

According to federal health and census data, addiction treatment was a $21 billion business in 2003. By 2020, it is expected to double to $42 billion. The opioid crisis has fueled the growth of the industry by increasing the demand for residential drug treatment programs. Astronomical growth of an industry, however, often invites bad actors.

Bad actors have swarmed the residential drug treatment industry. One category of bad actors includes patient brokers, who recruit drug addicts with health insurance to residential drug treatment centers for sizeable kickbacks. Another category of bad actors are the owners and operators of treatment centers …

The Invisible Prison: Pathways And Prevention, Margaret Brinig, Marsha Garrison

Journal Articles

In this paper, we propose a new strategy for curbing crime and delinquency and demonstrate the inadequacy of current reform efforts. Our analysis relies on our own, original research involving a large, multi-generational sample of unmarried fathers from a rust-belt region of the United States as well as the conclusions of earlier researchers.

Our own research data are unusual in that they are holistic and multigenerational: The Court-based record system we utilized for data collection provided detailed information on child maltreatment, juvenile status and delinquency charges, child support, parenting time, orders of protection, and residential mobility for focal children (the …

Biting The Hands That Feed “The Alligators”: A Case Study In Morbid Obesity Extremes, End-Of-Life Care, And Prohibitions On Harming And Accelerating The End Of Life, Michael J. Malinowski

Journal Articles

Obesity, recognized as a disease in the U.S. and at times as a terminal illness due to associated medical complications, is an American epidemic according to the Centers for Disease Control and Prevention (“CDC”), American Heart Association (“AHA”), and other authorities. More than one third of Americans (39.8% of adults and 18.5% of children) are medically obese. This article focuses on cases of “extreme morbid obesity” (“EMO”)—situations in which death is imminent without aggressive medical interventions, and bariatric surgery is the only treatment option with a realistic possibility of success. Bariatric surgeries themselves are very high risk for EMO patients. …

End Of Life And Autonomy: The Case For Relational Nudges In End-Of-Life Decision-Making Law And Policy, Megan S. Wright

Journal Articles

Autonomy is a central principle in many areas of health law. In the case of end-of-life decision-making law and policy, however, the principle of autonomy requires revision. On the whole, law conceptualizes autonomy at the end of life as an individual making private, personal decisions based solely on their interests and values, and independent of others. But ordinary people understand autonomous decisionmaking at the end of life differently, in a way that acknowledges the importance of their interpersonal relationships. Social science research has documented that strengthening relationships with others, sharing responsibility in the decision-making process with healthcare providers, and taking …

Improving Outcomes In Child Poverty And Wellness In Appalachia In The "New Normal" Era: Infusing Empathy Into Law, Jill C. Engle

Journal Articles

No abstract provided.

The U.S. Science And Technology “Triple Threat”: A Regulatory Treatment Plan For The Nation’S Addiction To Prescription Opioids, Michael J. Malinowski

Journal Articles

No abstract provided.

Personhood Seeking New Life With Republican Control, Jonathan Will, I. Glenn Cohen, Eli Y. Adashi

Journal Articles

Just three days prior to the inauguration of Donald J. Trump as President of the United States, Representative Jody B. Hice (R-GA) introduced the Sanctity of Human Life Act (H R. 586), which, if enacted, would provide that the rights associated with legal personhood begin at fertilization. Then, in October 2017, the Department of Health and Human Services released its draft strategic plan, which identifies a core policy of protecting Americans at every stage of life, beginning at conception. While often touted as a means to outlaw abortion, protecting the "lives" of single-celled zygotes may also have implications for the …

Prolegomenon On Pornography, Gerard V. Bradley

Journal Articles

Debates about pornography have always included arguments about its “effects.” Now we can gauge the effects of specifically computerized pornography. These novel effects include scientific research showing that digitalized pornography affects the brain and nervous system in harmful ways that no centerfold ever could. Accessing pornography online makes interactive and directive engagement with it possible, so that the consumer is no longer limited to staring at a two-dimensional representation of a stranger in the nude. The action now is more adventurous. The consumer’s involvement is more intimate and directive. What he does lies somewhere between looking at a centerfold and …

The Rules Of Maternity, Dara Purvis

Journal Articles

A diverse body of laws and regulations speaking to reproductive rights, healthcare, criminal punishment of drug use, termination of parental rights, and more creates the rules of maternity. These rules are guidance provided both obliquely and explicitly by the law's coercive power telling women both how to and who should mother. Rule one begins in pregnancy, with the message that "your body is your child's vessel." During pregnancy, women are counselled that doctor knows best. After the child's birth, the mother remains responsible for the people who enter a child's life, leading to rule 3: "mothers must always protect." …

Avoiding Unintended Disclosure: Representing Clients With Hiv And Aids, Lashanda Taylor Adams

Journal Articles

When the HIV/AIDS epidemic was initially recognized in the United States, many attorneys wondered what it would mean to represent a client with HIV. As the number of HIV-infected individuals grew, so did the need for attorneys to represent them. Specifically, attorneys questioned whether or not their duty of confidentiality would expose them to civil liability from failing to protect a third party.1 In response to this concern, several law review articles were written discussing the dilemma faced by attorneys bound by professional rules of conduct.2 These articles focused on the needs of the attorney and the public rather than …

Expectant Fathers, Abortion, And Embryos, Dara Purvis

Journal Articles

One thread of abortion criticism, arguing that gender equality requires that men be allowed to terminate legal parental status and obligations, has reinforced the stereotype of men as uninterested in fatherhood. As courts facing disputes over stored pre-embryos weigh the equities of allowing implantation of the pre-embryos, this same gender stereotype has been increasingly incorporated into a legal balancing test, leading to troubling implications for ART and family law.

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Journal Articles

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

The Priority Of Persons Revisited, John Finnis

Journal Articles

This essay, in the context of a conference on justice, reviews and reaffirms the main theses of “The Priority of Persons” (2000), and supplements them with the benefit of hindsight in six theses. The wrongness of Roe v. Wade goes wider than was indicated. The secularist scientistic or naturalist dimension of the reigning contemporary ideology is inconsistent with the spiritual reality manifested in every word or gesture of its proponents. The temporal continuity of the existence of human persons and their communities is highly significant for the common good, which is the point and measure of social justice, properly understood. …

Filial Support Laws In The Modern Era: Domestic And International Comparison Of Enforcement Practices For Laws Requiring Adult Children To Support Indigent Parents, Katherine C. Pearson

Journal Articles

Family responsibility and support laws have a long but mixed history. When first enacted, policy makers used such laws to declare an official policy that family members should support each other, rather than draw upon public resources. This article tracks modern developments with filial support laws that purport to obligate adult children to financially assist their parents, if indigent or needy. The author diagrams filial support laws that have survived in the 21st Century and compares core components in the United States (including Puerto Rico) and post-Soviet Union Ukraine. While the laws are often similar in wording and declared intent, …

Beyond Abortion: Why The Personhood Movement Implicates Reproductive Choice, Jonathan Will

Journal Articles

In 2008, an amendment was proposed to the Colorado Constitution that sought to attach the rights and protections associated with legal “personhood” to any human being from the moment of fertilization. Although the initiative was defeated, it sparked a nation-wide Personhood Movement that has spurred similar efforts at the federal level and in over a dozen states. Personhood advocates choose terms like “fertilization,” or phrases such as “human being at any stage of development,” to identify the “person”-defining moment in the reproductive process, and these designations have profound implications for reproductive choice. Proponents are outspoken in their desire to outlaw …

Measure 26: Fear Mongering, Self-Execution & Potential Implications For Birth Control, Jonathan Will

Journal Articles

Depending on what we mean by “fertilization,” there could be impacts on many reproductive choices including birth control, fertility treatments like in vitro fertilization (IVF), and of course, women’s ability to choose to have an abortion. Certain proponents of Measure 26 suggest that even discussing these implications (other than perhaps abortion) amounts to fear mongering. While primarily focusing on birth control, the goal of this essay is to introduce readers to why the concerns regarding these reproductive choices are very real, and how these concerns are further complicated by the issue of whether, if passed, Measure 26 would be deemed …

Diagnosing American Health Care: Economic Stakeholders And Bioethical Considerations, Jonathan Will

Journal Articles

Cost. Access. Quality. These are three objectives that must drive a responsible discussion regarding reform of the delivery of health care in this country, and specifically, decreasing (or at least controlling) cost while increasing access and quality.

Science, Public Bioethics, And The Problem Of Integration, O. Carter Snead

Journal Articles

Public bioethics — the governance of science, medicine, and biotechnology in the name of ethical goods — is an emerging area of American law. The field uniquely combines scientific knowledge, moral reasoning, and prudential judgments about democratic decision making. It has captured the attention of officials in every branch of government, as well as the American public itself. Public questions (such as those relating to the law of abortion, the federal funding of embryonic stem cell research, and the regulation of end-of-life decision making) continue to roil the public square.

This Article examines the question of how scientific methods and …

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Journal Articles

This Commentary is part of a colloquy on race-based genetics research.

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Journal Articles

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Public Bioethics And The Bush Presidency, O. Carter Snead

Journal Articles

Public bioethics figured prominently during the tenure of President George W. Bush. This Article explores the Bush legacy in this domain. It begins by articulating and examining the grounding norms of President Bush’s approach to public bioethics. Next, it analyzes how these norms were applied to concrete areas of concern. Building on this analysis, the next section reflects on what the President’s actions illustrate about the capacity of the Executive Branch to shape public bioethics. The Article concludes with a brief discussion of the possible metrics by which the Bush Administration’s efforts might be judged, and then offers several assessments …

United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski

Journal Articles

This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.

Unenumerated Rights And The Limits Of Analogy: A Critque Of The Right To Medical Self-Defense, O. Carter Snead

Journal Articles

Volokh’s project stands or falls with the claim that the entitlement he proposes is of constitutional dimension. If there is no fundamental right to medical self-defense, the individual must, for better or worse, yield to the regulation of this domain in the name of the values agreed to by the political branches of government. Indeed, the government routinely restricts the instrumentalities of self-help (including self-defense) in the name of avoiding what it takes to be more significant harms. This same rationale accounts for current governmental limitations on access to unapproved drugs and the current ban on organ sales. The FDA …

Federalism Doctrines And Abortion Cases: A Response To Professor Fallon, Anthony J. Bellia

Journal Articles

This Essay is a response to Professor Richard Fallon's article, If Roe Were Overruled: Abortion and the Constitution in a Post-Roe World. In that article, Professor Fallon argues that if the Supreme Court were to overrule Roe v. Wade, courts might well remain in the abortion-umpiring business. This Essay proposes a refinement on that analysis. It argues that in a post-Roe world courts would not necessarily subject questions involving abortion to the same kind of constitutional analysis in which the Court has engaged in Roe and its progeny, that is, balancing a state's interest in protecting life against a pregnant …

My God, My Choice: The Mature Minor Doctrine And Adolescent Refusal Of Life-Saving Or Sustaining Medical Treatment Based Upon Religious Beliefs, Jonathan Will

Journal Articles

No abstract provided.

Prophecy And Casuistry: Abortion, Torture And Moral Discourse, M. Cathleen Kaveny

Journal Articles

In turn of the 21st century United States there are serious moral disputes over issues such as abortion and torture among persons who see themselves as belonging to the same moral tradition. These disputes have not given rise to fruitful discussion about differences, but instead led to a breakdown of conversation and even of community. A part of these clashes and breakdowns are not the result of mutually inconsistent moral premises, but are driven by tensions between two styles of moral discourse, the prophetic and casuistical. The former invokes the absolute and fiery rhetorical style of biblical prophets while the …