Law Commons^™

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 …

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 …

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 …

21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen

University of Michigan Journal of Law Reform

The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any …

Constitutional Cohesion And The Right To Public Health, James G. Hodge Jr., Daniel Aaron, Haley R. Augur, Ashley Cheff, Joseph Daval, Drew Hensley

University of Michigan Journal of Law Reform

Despite years of significant legal improvements stemming from a renaissance in public health law, Americans still face major challenges and barriers in assuring their communal health. Reversals of legal reforms coupled with maligned policies and chronic underfunding contribute to diminished public health outcomes. Underlying preventable morbidity and mortality nationally are realities of our existing constitutional infrastructure. In essence, there is no general obligation of government to protect or promote the public’s health. Under principles of “constitutional cohesion,” structural facets and rights-based principles interwoven within the Constitution protect individuals and groups from governmental vices (i.e., oppression, overreaching, tyranny, and malfeasance). Structural …

Environmental Health Regulation In The Trump Era: How President Trump’S Two-For-One Regulatory Plan Impacts Environmental Regulation, Elizabeth Ann Glass Geltman

University of Michigan Journal of Law Reform

This Article explores the Trump regulatory reform agenda and its potential impact on environmental determinants of health. The Article begins with a discussion of the Department of Commerce’s (DOC or Commerce) initial fact-finding investigation to evaluate the impact of federal regulations on domestic manufacturing. The Article next presents an overview of the Trump administration’s regulatory reform formula as announced in E.O. 13771 and the interim guidance explaining E.O. 13771 and E.O. 13777 (the executive order announcing the Trump administration’s plans to enforce the regulatory reform plan announced in E.O. 13771). The Article then examines the federal agency initiatives undertaken in …

Spending Medicare’S Dollars Wisely: Taking Aim At Hospitals’ Cultures Of Overtreatment, Jessica Mantel

University of Michigan Journal of Law Reform

With Medicare’s rising costs threatening the country’s fiscal health, policymakers have focused their attention on a primary cause of Medicare’s high price tag—the overtreatment of patients. Guided by professional norms that demand they do “everything possible” for their patients, physicians frequently order additional diagnostic tests, perform more procedures, utilize costly technologies, and provide more inpatient care. Much of this care, however, does not improve Medicare patients’ health, but only increases Medicare spending. Reducing the overtreatment of patients requires aligning physicians’ interests with the government’s goal of spending Medicare’s dollars wisely. Toward that end, recent Medicare payment reforms establish a range …

Piercing The Veil: The Limits Of Brain Death As A Legal Fiction, Seema K. Shah

University of Michigan Journal of Law Reform

Brain death is different from the traditional, biological conception of death. Although there is no possibility of a meaningful recovery, considerable scientific evidence shows that neurological and other functions persist in patients accurately diagnosed as brain dead. Elsewhere with others, I have argued that brain death should be understood as an unacknowledged status legal fiction. A legal fiction arises when the law treats something as true, though it is known to be false or not known to be true, for a particular legal purpose (like the fiction that corporations are persons). Moving towards greater transparency, it is legally and ethically …

Can You Diagnose Me Now? A Proposal To Modify The Fda’S Regulation Of Smartphone Mobile Health Applications With A Pre-Market Notification And Application Database Program, Stephen Mcinerney

University of Michigan Journal of Law Reform

Advances in mobile technology continually create new possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has the authority to regulate a broad spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if the FDA has the statutory authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, the FDA published Final Guidance on Mobile Medical Applications; in it, the Agency limited its oversight to …

The Fourth Trimester, Saru M. Matambanadzo

University of Michigan Journal of Law Reform

This Article introduces a new conceptual framework to the legal literature on pregnancy and pregnancy discrimination: the fourth trimester. The concept of a fourth trimester, drawn from maternal nursing and midwifery, refers to the crucial three to six month period after birth when many of the physical, psychological, emotional, and social effects of pregnancy continue. Giving this concept legal relevance extends the scope of pregnancy beyond the narrow period defined by conception, gestation, and birth and acknowledges that pregnancy is a relational process, not an individual event. In the United States, however, antidiscrimination law has failed to acknowledge the demands …

Taxing Food And Beverage Products: A Public Health Perspective And A New Strategy For Prevention, Jennifer L. Pomeranz

University of Michigan Journal of Law Reform

The power to tax and spend is considered a primary government power, and the use thereof is associated with great public health achievements. The greatest public health challenge at present stems from the increase in obesity and chronic diseases due to poor nutrition. Several taxation strategies have emerged in the health and economic literature to raise revenue, deter consumption, and address food prices and obesity directly. These proposals include taxing obese individuals, taxing problematic food products, and instituting a tax based on certain food components. This article weighs each proposal's value and disadvantages and concludes by proposing a new tax …

An Insurance Structure To Encourage Investment In Preventative Health Care, Nicholas Georgakopoulos

University of Michigan Journal of Law Reform

The incentives for investments in Americans' health are poorly aligned. Health insurers are not sufficiently motivated to invest for the long term. The structure of health insurance does not compensate insurers for investments in lasting health, such as measures preventing chronic disease. If an American changes insurers, the new insurer reaps the benefits of the good health the prior insurer's investment produced. This Essay explores insurers' incentives to invest in health, illustrates how those incentives fail, explores possible improvements, and shows that subsequent insurers should have an obligation to compensate the prior insurer for the averted expenses of expected diseases …

Family Caregiving And The Law Of Succession: A Proposal, Thomas P. Gallanis, Josephine Gittler

University of Michigan Journal of Law Reform

As the American population ages, the need for long-term care, already great, will become even greater. Some of this care is paid for by government programs, such as Medicaid, and by individual long-term care insurance policies. But the combination of the public fisc and private insurance are, and will continue to be, insufficient to pay for all of the care our seniors and adults with disabilities need. The provision of care in a family residence by one or more family members is an important component of our health care delivery system and must be supported and encouraged by public policy …

When Coercion Lacks Care: Competency To Make Medical Treatment Decisions And Parens Patriae Civil Commitments, Dora W. Klein

University of Michigan Journal of Law Reform

The subject of this Article is people who have been civilly committed under a state's parens patriae authority to care for those who are unable to care for themselves. These are people who, because of a mental illness, are a danger to themselves. Even after they have been determined to be so disabled by their mental illness that they cannot care for themselves, many are nonetheless found to be competent to refuse medical treatment. Competency to make medical treatment decisions generally requires only a capacity to understand a proposed treatment, not an actual or rational understanding of that treatment. This …

Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang

University of Michigan Journal of Law Reform

Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …

Augmenting Advocacy: Giving Voice To The Medical-Legal Partnership Model In Medicaid Proceedings And Beyond, Marybeth Musumeci

University of Michigan Journal of Law Reform

The denial of Medicaid coverage for augmentative communication devices, despite an existing legal framework that mandates the opposite result, raises fundamental questions about what independence means for people with disabilities. This situation, compounded by the barriers in the Medicaid administrative appeal process encountered by such beneficiaries, invites new approaches to the delivery of civil legal services, such as medical-legal partnerships (MLPs). MLPs are formalized arrangements that bring lawyers into a healthcare setting to provide specialist consultations when patients experience legal problems that affect health. While there is an emerging scholarship on MLPs, this Article offers the first in-depth analysis of …

Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang

University of Michigan Journal of Law Reform

Organ transplant candidates are often denied life saving organs on account of their medical marijuana drug use. Individuals who smoke medicinal marijuana are typically classified as substance abusers, and ultimately deemed ineligible for transplantation, despite their receipt of the drug under a physician's supervision and prescription. However, patients who smoke cigarettes or engage in excessive alcohol consumption are routinely considered for placement on the national organ transplant waiting list. Transplant facilities have the freedom to regulate patient selection criteria with minimal oversight. As a result, the current organ allocation system in the United States is rife with inconsistencies and results …

Crisis On Campus: Student Access To Health Care, Bryan A. Liang

University of Michigan Journal of Law Reform

College-aged adults are an overrepresented group in the uninsured population of the United States, and traditionally underserved minorities are disproportionately affected. Students with private health insurance are often functionally uninsured as well, since most schools refuse to accept this traditionally elite calling card on campus. Consequently, the large uninsured and functionally uninsured populations often rely on school-sponsored health insurance plans for access to care. These plans have uneven coverage, limited benefits, exclusions and high co-pays and deductibles, and provide little health care security for their beneficiaries. Further, schools and insurance companies have profited substantially from these student plans, raising the …

Risky Ventures: The Impact Of Irs Health Care Joint Venture Policy, Roger P. Meyers

University of Michigan Journal of Law Reform

IRS oversight of joint ventures between exempt and for-profit organizations has undergone substantial change over the past thirty years. This change has important consequences for the health care industry, where joint ventures have grown increasingly common. In the face of unclear guidance and aggressive enforcement of exemption-policing tools such as the private benefit doctrine and the control test, a hospital risks revocation of its tax-exempt status, or liability for unrelated business income tax, when it engages in a joint venture directly. It may be able to eliminate this risk by operating the same joint venture through a for-profit subsidiary; however, …

The Choice To Limit Choice: Using Psychiatric Advance Directives To Manage The Effects Of Mental Illness And Support Self-Responsibility, Breanne M. Sheetz

University of Michigan Journal of Law Reform

Psychiatric advance directives are a valuable tool for individuals with mental illnesses. Ulysses directives, in particular, allow individuals to bind themselves to treatment in advance of needing it for the purpose of overcoming illness-induced refusals. This Note evaluates the effectiveness of state advance directive statutes in three areas that are especially important for Ulysses directives: defining competency to execute, activate, and revoke directives; waiving the constitutional right to refuse treatment; and encouraging provider compliance. This Note ultimately advocates for other states to adopt provisions similar to a Washington State statute. The Washington statute authorizes Ulysses directives by allowing advance consent …

Something Must Be Done: An Argument For The Partial Deregulation Of Research On Bipolar Disorder And The Implementation Of Rolling Informed Consent, Janalee S. Kraschnewski

University of Michigan Journal of Law Reform

Bipolar disorder (BD) cripples the lives of countless individuals across the globe. The healthcare community has had difficulty securing effective, long-term treatment for this disease. This Note argues that enlarging the pool of possible research subjects through partial deregulation of BD research would facilitate the development of better treatment. This Note further proposes the implementation of a system of rolling informed consent to ensure that actual and full consent is obtained from BD research subjects.

Consumer-Directed Health Care And The Chronically Ill, John V. Jacobi

University of Michigan Journal of Law Reform

Insurance plans with consumer-controlled spending accounts are advocated as tools for reducing health costs and empowering consumers. This Article describes their recent development and argues that they are likely to fail. Instead of focusing on the small number of consumers with chronic illnesses who account for the bulk of health spending they focus on the majority of relatively well consumers. This Article proposes market-based and regulatory changes focused on high-cost patients. To best serve cost and quality goals, health finance responsibility should be divided between consumers and their employers for predictable and routine costs, and government for chronic and catastrophic …

Balancing The Demands Of The Workplace With The Needs Of The Modern Family: Expanding Family And Medical Leave To Protect Domestic Partners, Kimberly Menashe Glassman

University of Michigan Journal of Law Reform

This Note addresses the importance of expanding the federal Family and Medical Leave Act and state family and medical leave laws to protect domestic partners. Congress passed the Family and Medical Leave Act to allow workers to balance their work lives and family lives by granting workers the right to take leave time to care for an immediate family member in times of medical necessity. The term 'family member," however, is generally limited to relation y blood, adoption, or marriage, and does not include an individual's domestic partner. The concept of family has evolved in our legal system and is …

Liberty, Justice, And Insurance For All: Re-Imagining The Employment-Based Health Insurance System, Carolyn V. Juárez

University of Michigan Journal of Law Reform

This Note examines the history of employment-based health insurance and the inherent historical limitations that have led to an erosion of health insurance coverage. Based on a review of several studies, this Note argues that the number of uninsured Americans has reached crisis proportions. State reform efforts, legislative proposals, and other proposed solutions have failed to repair the system. Nonetheless, this Note argues that employment-based health care is integral to the structure of national health care. Furthermore, health insurance coverage can be increased by combining employment-based health care with three reforms: large employer mandates, refundable tax credits, and purchasing pools. …

Vanishing Vaccinations: Why Are So Many Americans Opting Out Of Vaccinating Their Children?, Steve P. Calandrillo

University of Michigan Journal of Law Reform

Vaccinations against life-threatening diseases are one of the greatest public health achievements in history. Literally millions of premature deaths have been prevented, and countless more children have been saved from disfiguring illness. While vaccinations carry unavoidable risks, the medical, social and economic benefits they confer have led all fifty states to enact compulsory childhood vaccination laws to stop the spread of preventable diseases. Today, however, vaccines are becoming a victim of their success-many individuals have never witnessed the debilitating diseases that vaccines protect against, allowing complacency toward immunization requirements to build. Antivaccination sentiment is growing fast in the United States, …

Lengthening The Stem: Allowing Federally Funded Researchers To Derive Human Pluripotent Stem Cells From Embryos, Jason H. Casell

University of Michigan Journal of Law Reform

Recent developments in fetal tissue research and stem cell research have led to dramatic breakthroughs in the search for cures for Parkinson's disease, Alzheimer's disease, diabetes, and a host of neurological disorders. Because this research involves fetal tissue and stem cells from human embryos, many complicated ethical and legal implications surround it. This Note explores the history of fetal tissue research and stem cell research, examines the surrounding ethical and legal issues, looks at the current state of federal law, and concludes that Congress should allow federally funded researchers to derive stem cells from discarded human embryos obtained from in …

What Money Cannot Buy: A Legislative Response To C.Rac.K., Adam B. Wolf

University of Michigan Journal of Law Reform

Children Requiring a Caring Kommunity (C.R.A.C.K.) is an organization that pays current or former drug addicts $200 to be sterilized. While generating great public controversy, C.R.A.C.K. is expanding rapidly throughout the country. Its clients are disproportionately poor women of color, who are coerced by the offer of money into permanently relinquishing their reproductive rights. This Note argues that C.R.A.C.K. is a program of eugenical sterilization that cannot be tolerated. Moreover, C.R.A.C.K. further violates settled national public policy by offensively commodifying the ill-commodifiable, by demeaning women, and by starting down a slippery slope with devastating consequences. This Note proposes legislation that …

Increasing Consumer Power In The Grievance And Appeal Process For Medicare Hmo Enrollees, Kenneth J. Pippin

University of Michigan Journal of Law Reform

Federal law requires that Health Maintenance Organizations (HMOs) and Managed Care Organizations (MCOs) provide Medicare beneficiaries with specific grievance and appeal rights for challenging adverse decisions of these organizations. The Health Care Financing Administration (HCFA) is charged with enforcing these regulations. Currently, however, HCFA contracts with HMOs, allowing them to enroll Medicare beneficiaries despite the fact that many of the statutory and regulatory requirements are ignored by the Medicare HMOs. This is problematic because the elderly Medicare population may not be able to independently and adequately challenge the HMO's denial of care or reimbursement. Because HCFA has been reluctant and …

Managed Care- The First Chapter Comes To A Close, Sallyanne Payton

University of Michigan Journal of Law Reform

Introduction to the symposium, Managed Care: What's the Prognosis: Managing Care in the Next Century.