Law Commons^™

Medical-Legal Partnerships Reinvigorate Systems Lawyering Using An Upstream Approach, Kate L. Mitchell, Debra Chopp

Articles

The upstream framework presented in public health and medicine considers health problems from a preventive perspective, seeking to understand and address the root causes of poor health. Medical-legal partnerships (MLPs) have demonstrated the value of this upstream framework in the practice of law and engage in upstream lawyering by utilizing systemic advocacy to address root causes of injustices and health inequities. This article explores upstreaming and its use by MLPs in reframing legal practice.

Original Public Meaning And Pregnancy’S Ambiguities, Evan D. Bernick, Jill Wieber Lens

Michigan Law Review

Relying on 1868 abortion statutes, the 2022 Supreme Court held in Dobbs v. Jackson Women’s Health Organization that no federal constitutional right to abortion exists. Mere months later, a petition for certiorari asked the Court to determine that “person” in the Fourteenth Amendment includes prenatal existence, which would require criminalization of abortion in all states. The petitioners cited Dobbs and claimed the authority of legal history in 1868 and before. These arguments will be heard again, and they are increasingly framed in terms of the “original public meaning” of the Fourteenth Amendment.

This Article refutes these arguments on their own …

Disability, Race, And Health Beyond The Carceral State, Benjamin A. Barsky, Craig Konnoth, Michael Ashley Stein

Michigan Law Review

A review of Embodied Injustice: Race, Disability, and Health. By Mary Crossley.

Why Medical Error Is Killing You (And Everyone Else), Phoebe Jean-Pierre

University of Michigan Journal of Law Reform

In 2000, the infamous report To Err is Human rocked society with its focus on the pervasive danger of medical error. More than two decades later, medical error rates remain high and pose a consistent danger to patients. Today, medical error ranks as the fourth leading cause of death behind heart disease, cancer, and COVID-19. Medical error reflects the vulnerabilities of the healthcare process and may be diagnostic in nature. A large concern in responding to medical error is an overemphasis on blame and the idea that good physicians do not make mistakes. Our perspective on how to address medical …

Rethinking Innovation At Fda, Rachel E. Sachs, Nicholson Price, Patricia J. Zeitler

Articles

In several controversial drug approval decisions in recent years, the Food & Drug Administration (“FDA”) has publicly justified its decision partly on the ground that approving the drugs in question would support innovation in those fields going forward. To some observers, these arguments were surprising, as the Agency’s determination whether a drug is “safe” and “effective” does not seem to depend on whether its approval also supports innovation. But FDA’s use of these innovation arguments in drug approval decisions is just one example of the ways in which the Agency has come to make many innovation-related judgments as part of …

Locating Liability For Medical Ai, W. Nicholson Price Ii, I. Glenn Cohen

Articles

When medical AI systems fail, who should be responsible, and how? We argue that various features of medical AI complicate the application of existing tort doctrines and render them ineffective at creating incentives for the safe and effective use of medical AI. In addition to complexity and opacity, the problem of contextual bias, where medical AI systems vary substantially in performance from place to place, hampers traditional doctrines. We suggest instead the application of enterprise liability to hospitals—making them broadly liable for negligent injuries occurring within the hospital system—with an important caveat: hospitals must have access to the information needed …

How Viable Is Viability? Artificial Womb Technology And The Threat To Abortion Access, James E. Brown

Michigan Journal of Gender & Law

The viability standard plays an important role in abortion access around much of the United States. In fact, before the Dobbs decision, the viability standard was the constitutional gatekeeper to abortion access and was uniform across the entire nation. Unfortunately, the Supreme Court has removed the constitutional right to abortion altogether. Nevertheless, I will provide an argument as to why Dobbs does not signal the end of viability-based abortion around the U.S. I will prove the importance of the viability standard even in a post-Dobbs society, highlighting its operation within various state laws, such as Michigan’s Prop. 3, as well …

Covid-19 Pandemic’S Impact On Online Sex Advertising And Sex Trafficking, Coxen O. Julia, Vanessa Castro, Bridgette Carr, Glen Redin

Articles

Disruptive social events such as the COVID-19 pandemic can have a significant impact on sex trafficking and the working conditions of victims, yet these effects have been little understood. This paper examines the effect of the COVID-19 pandemic on sex trafficking in the United States, based on analysis of over one million sexual service advertisements from the online platform Rubratings.com, using indicators of third-party management as potential proxies for trafficking. Our results show that there have been measurable changes in online commercial sexual service advertising, both with and without third-party management indicators, in the United States, with a significant decrease …

Cryptic Patent Reform Through The Inflation Reduction Act, Arti K. Rai, Rachel Sachs, Nicholson Price

Law & Economics Working Papers

If a statute substantially changes the way patents work in an industry where patents are central, but says almost nothing about patents, is it patent reform? We argue the answer is yes — and it’s not a hypothetical question. The Inflation Reduction Act (IRA) does not address patents, but its drug pricing provisions are likely to prompt major changes in how patents work in the pharmaceutical industry. For many years scholars have decried industry’s ever-evolving strategies that use combinations of patents to block competition for as long as possible, widely known as “evergreening,” but legislators have not been receptive to …

Inequitable By Design: The Patent Culture, Law, And Politics Behind Covid-19 Vaccine Global Access, Ximena Benavides

University of Michigan Journal of Law Reform

COVID-19 vaccine access has been highly inequitable worldwide, with coverage depending largely on a country’s wealth. By the end of 2021, 64.1% of people living in high-income countries had received at least one dose of the vaccine, compared to only 5.4% of those in low-income countries. Similarly, only high- and upper-middle-income countries had received the most effective vaccines.

The uneven distribution of these lifesaving vaccines is made complex due to the convergence of several factors, but it suggests that the extraordinary expanding and ossifying market and political power of a few vaccine manufacturers founded on intellectual property and complementary policies …

Policies For Expanding Hepatitis C Testing And Treatment In United States Prisons And Jails, Tessa Bialek, Dr. Matthew J. Akiyama M.D.

University of Michigan Journal of Law Reform

Hepatitis C virus (HCV) is highly prevalent in United States prisons and jails. In prisons and jails, rates of infection are ten to twenty times greater than national levels. And, more than thirty percent of all people living with HCV in the United States will spend time in prisons and jails in any given year. Rates are especially high among people who inject drugs (PWID), a population whose members are also likely to move between carceral settings and the community. Thus, addressing HCV among incarcerated populations would have a significant effect on the virus’s transmission both in and out of …

Cryptic Patent Reform Through The Inflation Reduction Act., Arti K. Rai, Rachel E. Sachs, Price W. Nicholson

Articles

If a statute substantially changes the way patents work in an industry where patents are central, but says almost nothing about patents, is it patent reform? We argue the answer is yes — and it’s not a hypothetical question. The Inflation Reduction Act (“IRA”) does not address patents, but its drug pricing provisions are likely to prompt major changes in how patents work in the pharmaceutical industry. For many years scholars have decried industry’s ever-evolving strategies that use combinations of patents to block competition for as long as possible, widely known as “evergreening,” but legislators have not been receptive to …

The Impact Of Post-Dobbs Abortion Bans On Prenatal Tort Claims, Aviva K. Diamond

Michigan Law Review

In June 2022, the Supreme Court revoked Americans’ fundamental right to abortion in Dobbs v. Jackson Women’s Health Organization. However, the Court said nothing about how its decision would impact tort claims related to reproductive care. Many states have since adopted near-total or early-gestational- age abortion bans, which has not only diminished access to reproductive care, but has also incidentally impaired the ability of plaintiffs to bring long-recognized prenatal tort claims. Prenatal tort claims—wrongful pregnancy, birth, and life—allow victims to recover when a medical professional negligently performs reproductive or prenatal care. This Note identifies the impact that post-Dobbs …

Trading Pain For Gain: Addressing Misaligned Interests In Prescription Drug Benefit Administration, Sheva J. Sanders, Jessica C. Wheeler

University of Michigan Journal of Law Reform

Over the last two decades, Pharmacy Benefit Managers (PBMs), organizations that act as middlemen between health plans and drug manufacturers, have become increasingly powerful players in the healthcare industry. PBMs promise to leverage their expertise and ability to aggregate buying power to negotiate lower drug prices and administer prescription drug benefit plans. In practice, however, PBMs are widely criticized for benefitting from, and contributing to, inefficiencies in the prescription drug market, particularly by imposing restrictions on beneficiary access to drugs in exchange for rebates paid to PBMs by manufacturers. To the extent that the rebates are retained by PBMs, or …

Open-Source Clinical Machine Learning Models: Critical Appraisal Of Feasibility, Advantages, And Challenges, Keerthi B. Harish, W. Nicholson Price Ii, Yindalon Aphinyanaphongs

Articles

Machine learning applications promise to augment clinical capabilities and at least 64 models have already been approved by the US Food and Drug Administration. These tools are developed, shared, and used in an environment in which regulations and market forces remain immature. An important consideration when evaluating this environment is the introduction of open-source solutions in which innovations are freely shared; such solutions have long been a facet of digital culture. We discuss the feasibility and implications of open-source machine learning in a health care infrastructure built upon proprietary information. The decreased cost of development as compared to drugs and …

Pregnant Transgender People: What To Expect From The Court Of Justice Of The European Union's Jurisprudence On Pregnancy Discrimination, Hannah Van Dijcke

Michigan Journal of Gender & Law

Pregnant transgender people’s experiences vary: they may identify as male or non-binary and may seek gender-affirming medical care to different degrees. This variety in gender identities and bodies puts additional pressure on CJEU’s pregnancy discrimination case law—a case law that is, as this Article argues, already flawed. Building on a critique of the CJEU’s decision in Dekker, this Article discusses three alternative approaches to addressing pregnancy discrimination in EU law. The first two approaches are different ways of construing pregnancy discrimination as sex discrimination. First, the Article discusses a gender-stereotyping approach to direct sex discrimination, and, second, an indirect sex …

Cruel Dilemmas In Contemporary Fertility Care: Problematizing America's Failure To Assure Access To Fertility Preservation For Trans Youth, Anna Reed

Michigan Journal of Gender & Law

Transgender youth are increasingly able to access gender-affirming healthcare. Because gender-affirming care such as hormone therapy is clinically shown to reduce gender dysphoria and ease physical and social transition, every major U.S. medical association recognizes that gender-affirming healthcare is medically necessary for the treatment of dysphoria. However, an important dimension of gender-affirming care remains under-insured and overpriced: fertility preservation (FP). Several studies indicate that hormone therapies and certain gender-affirming surgeries can have negative, long-term impacts on future fertility. Although these impacts can be mitigated through approved FP methods such as sperm cryopreservation and oocyte cryopreservation, such methods are rarely affordable …

Advancing Reproductive Justice In Latin America Through A Transitional Justice Lens, Rosario Grimà Algora

Michigan Journal of Gender & Law

Reproductive autonomy is a pivotal part of women’s access to equal citizenship, yet it has not been included in any international nor regional human rights treaty. In the past decades, the U.N. Committees, notably the CEDAW Committee, and regional human rights bodies, particularly the Inter-American System for the Protection of Human Rights, have timidly advanced reproductive justice through their jurisprudence, including through the use of reparations. Drawing from the standards of reparations developed in the field of transitional justice, human rights bodies increasingly rely on reparations to enhance the transformative effects of their decisions. These reparations intend to include a …

Reproduction And Gender Self-Determination: Fertile Grounds For Trans Legal Advocacy, Samira Seraji

Michigan Journal of Gender & Law

Current medical constructions of trans identities reflect heterosexist understandings of gender expression—understandings that deny access to gender-affirming healthcare to those who fail to perform normative binary genders. As medical providers establish norms for how to “properly” be trans, the state codifies these norms, basing trans existence on rigidly defined and harshly enforced understandings of binary gender. When this construction of transness is codified on an institutional level, such as with gender reclassification rules for government identification, it forces trans people to conform their bodies to cisgender norms, and dangerously disrupts trans people’s bodily autonomy and diminishes their control over their …

Ai Insurance: How Liability Insurance Can Drive The Responsible Adoption Of Artificial Intelligence In Health Care, Ariel Dora Stern, Avi Goldfarb, Timo Minssen, W. Nicholson Price Ii

Articles

Despite enthusiasm about the potential to apply artificial intelligence (AI) to medicine and health care delivery, adoption remains tepid, even for the most compelling technologies. In this article, the authors focus on one set of challenges to AI adoption: those related to liability. Well-designed AI liability insurance can mitigate predictable liability risks and uncertainties in a way that is aligned with the interests of health care’s main stakeholders, including patients, physicians, and health care organization leadership. A market for AI insurance will encourage the use of high-quality AI, because insurers will be most keen to underwrite those products that are …

Distributed Governance Of Medical Ai, W. Nicholson Price Ii

Law & Economics Working Papers

Artificial intelligence (AI) promises to bring substantial benefits to medicine. In addition to pushing the frontiers of what is humanly possible, like predicting kidney failure or sepsis before any human can notice, it can democratize expertise beyond the circle of highly specialized practitioners, like letting generalists diagnose diabetic degeneration of the retina. But AI doesn’t always work, and it doesn’t always work for everyone, and it doesn’t always work in every context. AI is likely to behave differently in well-resourced hospitals where it is developed than in poorly resourced frontline health environments where it might well make the biggest difference …

New Innovation Models In Medical Ai, W Nicholson Price Ii, Rachel E. Sachs, Rebecca S. Eisenberg

Articles

In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those that resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those related to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of as …

Take It With A Grain (Or More) Of Salt: Why Industry-Backed Dietary Guidelines Fail Americans And How To Fix Them, Caroline Farrington

University of Michigan Journal of Law Reform

The U.S. Dietary Guidelines lack oversight and accountability. The result: Guidelines that reflect food industry interests instead of modern science. This deleterious guidance goes on to govern federally-subsidized food assistance programs and to influence dietary choices throughout the private sector and private life. Ultimately, the Guidelines significantly contribute to the endemic chronic disease they seek to address.

The Guidelines Advisory Committee is notoriously rife with conflicts of interest, and thus most Guidelines scholarship has focused on reforming the Committee. But the 2015 and 2020 Guidelines show that these reforms are insufficient and agency-level change is necessary. In 2015, the Committee …

Liability For Use Of Artificial Intelligence In Medicine, W. Nicholson Price, Sara Gerke, I. Glenn Cohen

Law & Economics Working Papers

While artificial intelligence has substantial potential to improve medical practice, errors will certainly occur, sometimes resulting in injury. Who will be liable? Questions of liability for AI-related injury raise not only immediate concerns for potentially liable parties, but also broader systemic questions about how AI will be developed and adopted. The landscape of liability is complex, involving health-care providers and institutions and the developers of AI systems. In this chapter, we consider these three principal loci of liability: individual health-care providers, focused on physicians; institutions, focused on hospitals; and developers.

Exclusion Cycles: Reinforcing Disparities In Medicine, Ana Bracic, Shawneequa L. Callier, Nicholson Price

Articles

Minoritized populations face exclusion across contexts from politics to welfare to medicine. In medicine, exclusion manifests in substantial disparities in practice and in outcome. While these disparities arise from many sources, the interaction between institutions, dominant-group behaviors, and minoritized responses shape the overall pattern and are key to improving it. We apply the theory of exclusion cycles to medical practice, the collection of medical big data, and the development of artificial intelligence in medicine. These cycles are both self-reinforcing and other-reinforcing, leading to dismayingly persistent exclusion. The interactions between such cycles offer lessons and prescriptions for effective policy.

Congressional Myopia In Biomedical Innovation Policy, W. Nicholson Price Ii

Reviews

Innovation policy is hard. Getting it right requires balancing incentives for developers, consumer access, rewards for later innovators, safety concerns, and other factors. This balance is vitally important and wickedly difficult—even when it’s the focus of concerted, careful, informed effort. How well should we expect it to go when innovation policy is made by accident? Enter The Accidental Innovation Policymakers, an illuminating new project by Professor Rachel Sachs. Sachs persuasively shows how Congress has repeatedly made substantial changes to innovation policy, seemingly without talking about, seriously considering, or even recognizing that it is doing so. There’s an asymmetry to this …

Fostering Production Of Pharmaceutical Products In Developing Countries, William Fisher, Ruth L. Okediji, Padmashree Gehl Sampath

Michigan Journal of International Law

The ways in which pharmaceutical products are currently developed, manufactured, and distributed fail to meet the needs of developing countries. The recent emergence of new infectious diseases, the associated surge of healthcare nationalism, and the prevalence of substandard and falsified drugs have strengthened substantially the net benefits of augmenting the capacity of developing countries to produce such products locally. Most previous efforts to do so have foundered. The chance of success in the future would be maximized by the adoption of five strategies : (a) clarifying the zones of discretion created by the relevant treaties to ensure that local firms …

Structured To Fail: Lessons From The Trump Administration’S Faulty Pandemic Planning And Response, Alejandro E. Camacho, Robert L. Glicksman

Michigan Journal of Environmental & Administrative Law

The Trump Administration’s response to the COVID-19 pandemic is a stark reminder that poorly designed government can be a matter of life and death. This article explains how the Administration’s careless and delayed response to the crisis was made immeasurably worse by its confused and confusing reallocation of authority to perform or supervise tasks essential to reducing the virus’s ravages.

After exploring the rationale for and impact of prior federal reorganizations responding to public health crises, the article shows how a combination of unnecessary and unhelpful overlapping authority and a thoughtless mix of centralized and decentralized authority contributed to the …

Medicare Coverage Of Aducanumab - Implications For State Budgets, Rachel E. Sachs, Nicholas Bagley

Articles

Aducanumab (Aduhelm), the controversial $56,000-per-year Alzheimer’s disease drug approved by the Food and Drug Administration (FDA) in June 2021, has the potential to cost the federal government many billions of dollars — more, by one estimate, than it spends on agencies such as the Environmental Protection Agency or the National Aeronautics and Space Administration. The drug’s extraordinary price tag helps explain why, soon after its approval, the Centers for Medicare and Medicaid Services (CMS) opened a national coverage determination to decide whether and under what circumstances Medicare would pay for it.1

Problematic Interactions Between Ai And Health Privacy, W. Nicholson Price Ii

Articles

Problematic Interactions Between AI and Health Privacy Nicholson Price, University of Michigan Law SchoolFollow Abstract The interaction of artificial intelligence (AI) and health privacy is a two-way street. Both directions are problematic. This Essay makes two main points. First, the advent of artificial intelligence weakens the legal protections for health privacy by rendering deidentification less reliable and by inferring health information from unprotected data sources. Second, the legal rules that protect health privacy nonetheless detrimentally impact the development of AI used in the health system by introducing multiple sources of bias: collection and sharing of data by a small set …