Medical Jurisprudence Commons^™

Revising Racial Patents In An Era Of Precision Medicine, Jonathan Kahn

Faculty Scholarship

In 2006, I published an article examining the rising use of racial categories in biomedical patents in the aftermath of the successful completion of the Human Genome Project and the production of the first draft of a complete human genome. Ten years on, it now seems time to revisit the issue and consider it in light of the current era of “Precision Medicine” so prominently promoted by President Obama in his 2015 State of the Union address where he announced a $215 million proposal for the Precision Medicine Initiative as “a bold new research effort to revolutionize how we improve …

Procedural Due Process And Intramural Hospital Dispute Resolution Mechanisms: The Texas Advance Directives Act, Thaddeus Pope

Faculty Scholarship

Increasingly, clinicians and commentators have been calling for the establishment of special adjudicatory dispute resolution mechanisms to resolve intractable medical futility disputes. As a leading model to follow, policymakers both around the United States and around the world have been looking to the conflict resolution provisions in the 1999 Texas Advance Directives Act (TADA).

In this article, I provide a complete and thorough review of the purpose, history, and operation of TADA. I conclude that TADA is a commendable attempt to balance the competing goals of efficiency and fairness in the resolution of these time-sensitive, life-and-death conflicts. But TADA is …

The Tip Of The Iceberg: A First Amendment Right To Promote Drugs Off-Label, Christopher Robertson

Faculty Scholarship

Scholars, advocates, and courts have begun to recognize a First Amendment right for the makers of drugs and medical devices to promote their products “off-label,” without proving safety and efficacy of new intended uses. Yet, so far, this debate has occurred in a vacuum of peculiar cases, where convoluted commercial speech doctrine underdetermines the outcome. Juxtaposing these cases against other routine prosecutions of those who peddle unapproved drugs reveals the common legal regime at issue. Review of the seven arguments deployed in the off-label domain finds that, if they were valid, they would undermine the FDA’s entire premarket approval regime. …

Avoiding Overtreatment At The End Of Life: Physician-Patient Communication And Truly Informed Consent, Barbara A. Noah, Neal R. Feigenson

Faculty Scholarship

This Article considers how best to ensure that patients have the tools to make informed choices about their care as they near death. Informed decision making can help reduce excessive end-of-life care and unnecessary suffering, and result in care that aligns with patients’ well-considered values and preferences. The many factors that contribute to dying patients receiving too much therapy and life-prolonging care include: the culture of denial of death, physicians’ professional culture and attitudes toward treatment, physicians’ fear of liability, physicians’ avoidance of discussions about prognosis, and the impact of payment incentives that encourage overutilization of medical technologies.

Under the …

Medical Malpractice Arbitration: Not Business As Usual, David Larson, David Dahl

Faculty Scholarship

There is an interesting exception to businesses’, employers’, and service providers’ seemingly universal embrace of arbitration processes, particularly mandatory pre-dispute arbitration. Although it may be difficult to believe given arbitration’s current popularity, not everyone requires his or her clients to sign mandatory pre-dispute arbitration agreements. In fact, some service providers prefer to avoid arbitration regardless of whether it is arranged pre- or post-dispute. So which merchants or service providers are choosing to forgo arbitration and, more importantly, why do they dislike arbitration? And do politics have anything to with their choices? Physicians are not, shall we say, the world’s greatest …

Texas Advance Directives Act: Nearly A Model Dispute Resolution Mechanism For Intractable Medical Futility Conflicts, Thaddeus Pope

Faculty Scholarship

Increasingly, clinicians and commentators have been calling for the establishment of special adjudicatory dispute resolution mechanisms to resolve intractable medical futility disputes. As a leading model to follow, policymakers both around the United States and around the world have been looking to the conflict resolution provisions in the 1999 Texas Advance Directives Act (‘TADA’). In this article, I provide a complete and thorough review of the purpose, history, and operation of TADA. I conclude that TADA is a commendable attempt to balance the competing goals of efficiency and fairness in the resolution of these time-sensitive life-and-death conflicts. But TADA is …

Use Of Facial Recognition Technology For Medical Purposes: Balancing Privacy With Innovation, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Religiously-Motivated Medical Neglect: A Response To Professors Levin, Jacobs, And Arora, Doriane Lambelet Coleman

Faculty Scholarship

This Response to Professors Levin, Jacobs, and Arora’s article To Accommodate or Not to Accommodate: (When) Should the State Regulate Religion to Protect the Rights of Children and Third Parties? focuses on their claim that the law governing religious exemptions to medical neglect is messy, unprincipled, and in need of reform, including because it violates the Establishment Clause. I disagree with this assessment and provide support for my position. Specifically, I summarize and assess the current state of this law and its foundation in the perennial tussle between parental rights and state authority to make decisions for and about the …

Does Medical Malpractice Law Improve Health Care Quality?, Michael D. Frakes, Anupam B. Jena

Faculty Scholarship

Despite the fundamental role of deterrence in justifying a system of medical malpractice law, surprisingly little evidence has been put forth to date bearing on the relationship between medical liability forces on the one hand and medical errors and health care quality on the other. In this paper, we estimate this relationship using clinically validated measures of health care treatment quality constructed using data from the 1979 to 2005 National Hospital Discharge Surveys and the 1987 to 2008 Behavioral Risk Factor Surveillance System records. Drawing upon traditional, remedy-centric tort reforms — e.g., damage caps — we estimate that the current …

Law In The Shadow Of Violence: Can Law Help To Improve Doctor-Patient Trust In China?, Benjamin L. Liebman

Faculty Scholarship

Can law help to address the lack of trust in doctor-patient relationships in China? This essay examines the role that law, on the books and in practice, has played in the rise and resolution of patient-doctor disputes and conflict in China. Law has generally played a secondary role in medical disputes: most patient claims never make it to court, and there is little evidence that negotiated outcomes are influenced by legal standards. Yet a legal framework weighted in favor of hospitals and doctors almost certainly exacerbated doctor-patient conflict in the 2000s. Patients facing legal procedures and rules that appeared to …

Common Law Fundamentals Of The Right To Abortion, Anita Bernstein

Faculty Scholarship

No abstract provided.

A Better Death In Britain?, Barbara A. Noah

Faculty Scholarship

In the United States, patients and physicians often avoid discussing the inevitability of death and planning for it. As a result, opportunities are missed to make choices that comport with patients’ values and preferences. In the absence of such decisions, the default model is to “err on the side of life,” which often results in overtreatment or inappropriate prolongation of life and avoidable suffering. This Article discusses the United States' end-of-life training and care and Britain’s Liverpool Care Pathway as related to end-of-life care availability, quality, and cost. It further sets forth the argument that while the United States' medical …

Adopting An International Convention On Surrogacy—A Lesson From Intercountry Adoption, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Adopting An International Convention On Surrogacy—A Lesson From Intercountry Adoption, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Do Physicians Respond To Liability Standards?, Michael D. Frakes, Matthew Frank, Seth Seabury

Faculty Scholarship

In this paper, we explore the sensitivity in the clinical decisions of physicians to the standards of care expected of them under the law, drawing on the abandonment by states over time of rules holding physicians to standards determined by local customs and the contemporaneous adoption of national-standard rules. Using data on broad rates of surgical interventions at the county-by-year level from the Area Resource File, we find that local surgery rates converge towards national surgery rates upon the adoption of national-standard rules. Moreover, we find that these effects are more pronounced among rural counties.

Dietary Supplements Are Not All Safe And Not All Food: How The Low Cost Of Dietary Supplements Preys On The Consumer, Joanna K. Sax

Faculty Scholarship

Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as 'natural.' This leads many consumers to fail to question the supplements' safety, and some consumers even equate 'natural' with safe. But, 'natural' does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco -- a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) only has limited ability to regulate the entry of …

Picturing Moral Arguments In A Fraught Legal Arena: Fetuses, Photographic Phantoms And Ultrasounds, Jessica Silbey

Faculty Scholarship

This article investigates the movement in the U.S. that seeks to regulate the abortion decision by mandating ultrasounds prior to the procedure. The article argues that this reform effort is misguided not only because it is ineffective, but also because ultrasounds provide misleading information and are part of shaming practices that degrade the dignity of women. Both of these problems violate the main tenets of Planned Parenthood of Southern Pennsylvania v. Casey (1992). Central to the article’s argument and novelty is that the pro-ultrasound movement’s mistake is both legal and cultural. It misunderstands the nature of visual technology by failing …

Limiting Liberty To Prevent Obesity: Justifiability Of Strong Hard Paternalism In Public Health Regulation, Thaddeus Mason Pope

Faculty Scholarship

Because of the largely self-regarding nature of obesity, many current and proposed public health regulatory measures are paternalistic. That is, these measures interfere with a person’s liberty with the primary goal of improving that person’s own welfare.

Paternalistic public health measures may be effective in reducing obesity. They may even be the only sufficiently effective type of regulation. But many commentators argue that paternalistic public health measures are not politically viable enough to get enacted. After all, paternalism is repugnant in our individualistic culture. It is "wrong" for the government to limit our liberty for our own good.

In this …

The Future Of Medicaid Supplemental Payments: Can They Promote Patient-Centered Care?, Laura Hermer, Merle Lenihan

Faculty Scholarship

Supplemental Medicaid payments such as DSH and UPL are the exception to the financing of specific services to specific patients. Medicaid DSH funds currently finance over 30 percent of hospital care to the uninsured. As a result of the Affordable Care Act (ACA), DSH funds will be substantially reduced. At the same time, their importance will be heightened, especially in states that refuse to take up the ACA’s Medicaid expansion. DSH payments to hospitals have been plagued by a lack of accountability and transparency and an inability to assess whether patients benefit from such payments. Flexibility in the DSH program …

Aligning Incentives In Accountable Care Organizations: The Role Of Medical Malpractice Reform, Laura Hermer

Faculty Scholarship

The Patient Protection and Affordable Care Act (ACA) encourages physicians, hospitals, and other health care providers to deliver better coordinated, high-quality care through the institution of the Medicare Shared Savings Program. Many physicians and other providers moved quickly after the ACA was enacted to enter into arrangements that would allow them to take advantage of the MSSP and similar programs sponsored by private insurers that likely would — and did — arrive on the MSSP’s heels.

Yet despite the initial enthusiasm, it is by no means clear that ACOs will succeed, whether individually or in the greater goal of changing …

The Growing Power Of Healthcare Ethics Committees Heightens Due Process Concerns, Thaddeus Mason Pope

Faculty Scholarship

Complex ethical situations, such as end-of-life medical treatment disputes, occur on a regular basis in healthcare settings. Healthcare ethics committees (HECs) have been a leading dispute resolution forum for many of these conflicts. But while the function of HECs has evolved from mediation to adjudication, the form of HECs has not evolved to adapt to this expanded and more consequential function.

HECs are typically multidisciplinary groups comprised of representatives from different departments of the healthcare facility: medicine, nursing, law, pastoral care, and social work, for example. HECs were established to support and advise patients, families, and caregivers as they work …

Rationalizing Home And Community-Based Services Under Medicaid, Laura Hermer

Faculty Scholarship

This article examines efforts states are making to expand access to community-based services for elderly and disabled Medicaid beneficiaries and suggests several options that might improve such access nationally. Like much of Medicaid, Medicaid long term services and supports (LTSS) have developed through a complex process of accretion. Policymakers appear only rarely to have considered an overarching view of such services and the needs of those who require them. Rationalizing Medicaid LTSS will accordingly require not only additions but also substantial pruning, and may even warrant a reconsideration of who should have ultimate authority to develop and direct such services. …

Medicaid Expansion As Completion Of The Great Society, Nicole Huberfeld

Faculty Scholarship

A state’s decision whether to expand Medicaid has become a highly politicized issue, spawning countless news stories and on-going debate. However, this Essay takes a step back from that highly charged discourse and situates Medicaid expansion in its historical context. We reveal that this latest change universalizes the program, holding the power to finally realize President Johnson’s vision for the Great Society, almost fifty years later. Medicaid can be understood as a universal program for three reasons: (1) the percentage of thepopulation of children, pregnant women, and non-elderly adults it covers; (2) the degree to which Medicaid funds long-term care …

Testing The Boundaries Of Family Privacy: The Special Case Of Pediatric Sibling Transplants, Doriane Lambelet Coleman

Faculty Scholarship

A six-year-old girl suffers third-degree burns over eighty percent of her body. Her chance of survival with minimal scarring is said to depend on her identical twin sister’s availability as an organ source. There are other transplant options—including the parents—but because the twins’ skin is “equivalent,” a “sibling transplant” is likely to result in a better medical and aesthetic outcome for the burned twin. Her doctor thus proposes to harvest her healthy sister’s skin on “her backside from her bra line down to the bottom of her buttocks or possibly her thighs.” This procedure would be repeated up to three …

Perceptions Of Efficacy, Morality, And Politics Of Potential Cadaveric Organ-Transplantation Reforms, Christopher Robertson

Faculty Scholarship

We sought to explore the political feasibility of potential policy reforms to address the shortage of cadaveric organs for transplantation in America. We recruited 730 human subjects from an online population and assigned them to writing tasks that experimentally manipulated the salience of moral and posthumous risks. Subjects read 95-word descriptions of six proposed policy reforms, rating efficacy, morality, and overall support for each. We created weighted estimates of the overall potential support for each reform (WEOS), correcting for the skew in our study population to very roughly approximate the political affiliations of the American public.

The data suggest that …

Loss Of Chance, Probabilistic Cause, And Damage Calculations: The Error In Matsuyama V. Birnbaum And The Majority Rule Of Damages In Many Jurisdictions More Generally, Robert J. Rhee

Faculty Scholarship

This short commentary corrects an erroneous understanding of probabilistic causation in the loss-of-chance doctrine and the damage calculation method adopted in Matsuyama v. Birnbaum. The Supreme Judicial Court of Massachusetts is not alone. Many other common law courts have made the same error, including Indiana, Nevada, New Mexico, Ohio, and Oklahoma. The consistency in the mistake suggests that the error is the majority rule of damages. I demonstrate here that this majority rule is based on erroneous mathematical reasoning and the fallacy of probabilistic logic.

Clinicians May Not Administer Life-Sustaining Treatment Without Consent: Civil, Criminal, And Disciplinary Sanctions, Thaddeus Mason Pope

Faculty Scholarship

Both medical and legal commentators contend that there is little legal risk for administering life-sustaining treatment without consent. In this Article, I argue that this perception is inaccurate. First, it is based on an outdated data set, primarily damages cases from the 1990s. More recent plaintiffs have been comparatively more successful in establishing civil liability. Second, the published assessments focus on too-limited data set. Even if the reviewed cases were not outdated, a focus limited to civil liability would still be too narrow. Legal sanctions have also included licensure discipline and other administrative sanctions. In short, the legal risks of …

Legal, Medical, And Ethical Issues In Minnesota End-Of-Life Care: An Introduction To The Symposium, Thaddeus Mason Pope

Faculty Scholarship

As America grays, and medicine’s ability to treat the sickest of patients expands, the legal, medical, and ethical issues in end-of-life care become more numerous, pressing, and intertwined. Because Minnesota’s citizens, clinicians, and courts are not far from these concerns, the Hamline University Health Law Institute and the Hamline Law Review hosted an interdisciplinary Symposium entitled "Legal, Medical, and Ethical Issues in Minnesota End-of-Life Care."

On November 9, 2012, we welcomed more than 200 participants to the newly opened Carol Young Anderson and Dennis L. Anderson Center on Hamline University’s Saint Paul campus. These participants included: attorneys, physicians, nurses, social …

Dispute Resolution Mechanisms For Intractable Medical Futility Disputes, Thaddeus Mason Pope

Faculty Scholarship

Medical futility disputes occur frequently in healthcare facilities across the United States. In this Article, I provide an overview of dispute resolution mechanisms through which healthcare providers can resolve these disputes. In Section I, identify three distinctive features of medical futility disputes. First, they usually concern life-sustaining medical treatment for patients in a hospital’s intensive care unit. Second, these patients typically lack decision making capacity. So, a surrogate must make treatment decisions on the patient’s behalf. Third, this surrogate and the patient’s physician disagree over the treatment plan. The surrogate wants to continue life-sustaining treatment. But the physician thinks that …

Machine Speech, Tim Wu

Faculty Scholarship

Computers are making an increasing number of important decisions in our lives. They fly airplanes, navigate traffic, and even recommend books. In the process, computers reason through automated algorithms and constantly send and receive information, sometimes in ways that mimic human expression. When can such communications, called here “algorithmic outputs,” claim First Amendment protection?