Law Commons^™

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 …

Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox

Michigan Telecommunications & Technology Law Review

Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …

Improving Generic Drug Approval At The Fda, Kathleen Craddock

Michigan Journal of Environmental & Administrative Law

Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “cultural capture of rhetoric about …

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

Regulating Black-Box Medicine, W. Nicholson Price Ii

Michigan Law Review

Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they …

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 …

Medicine As A Public Calling, Nicholas Bagley

Michigan Law Review

The debate over how to tame private medical spending tends to pit advocates of government-provided insurance—a single-payer scheme—against those who would prefer to harness market forces to hold down costs. When it is mentioned at all, the possibility of regulating the medical industry as a public utility is brusquely dismissed as anathema to the American regulatory tradition. This dismissiveness, however, rests on a failure to appreciate just how deeply the public utility model shaped health law in the twentieth century— and how it continues to shape health law today. Closer economic regulation of the medical industry may or may not …

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 …

For The Love Of The Game: The Case For State Bans On Youth Tackle Football, Adam Bulkley

University of Michigan Journal of Law Reform Caveat

This football season, millions of Americans enjoying their favorite pastime might feel pangs of a guilty conscience. Years of scientific research into the long-term neurological effects of tackle football and a recent settlement between the National Football League (NFL) and thousands of retired NFL players have made football-related traumatic brain injuries (TBI) a topic of national conversation. Current and former NFL players and even President Obama have participated in the conversation, saying that they would hesitate to let their sons play the game for fear of possible brain injury. Because research has uncovered signs of permanent brain damage in players …

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 …

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 …

Re-Thinking Health Insurance, Hans Biebl

University of Michigan Journal of Law Reform Caveat

In May 2009, while promoting the legislation that would become the Patient Protection and Affordable Care Act (PPACA), President Obama said that rising health care costs threatened the balance sheets of both the federal government and private enterprise. He noted that any increase in health care spending consumes funds that “companies could be using to innovate and to grow, making it harder for them to compete around the world.” Despite the rancorous debate that surrounded this health care legislation and which culminated with the Supreme Court’s decision in National Federation of Independent Businesses, the PPACA was not a radical piece …

The Tangled Thicket Of Health Care Reform: The Judicial System In Action, Gene Magidenko

University of Michigan Journal of Law Reform Caveat

On March 23, 2010, after a lengthy political debate on health care reform, President Barack Obama signed the Patient Protection and Affordable Care Act (PPACA) into law. A week later, he signed the Health Care and Education Reconciliation Act of 2010, which amended certain provisions of PPACA. But far from ending the intense national debate on the issue, these enactments opened a new front of battle in the federal courts that will almost certainly make its way to the United States Supreme Court. Much of this litigation focuses on § 1501 of PPACA, which contains the controversial individual mandate requiring …

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 …

Reconstructing The Individual Mandate As An Escrow Account, Gregg D. Polsky

Michigan Law Review First Impressions

The recent health care reform law's most controversial provision is the individual mandate, which imposes a fine on individuals who fail to obtain a minimum level of health insurance coverage. Many object to this policy, arguing that the government shouldn't force individuals to purchase health insurance. Others believe that the mandate is a necessary component to health care reform. What has been missed in the discussion is that Congress could restructure the individual mandate to avoid the requirement that individuals purchase health insurance while still fulfilling its principal function. The principal purpose of the mandate is not to require individuals …

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, …

Pdufa And Initial U.S. Drug Launches, Mary K. Olson

Michigan Telecommunications & Technology Law Review

In the 1970s and 1980s, many pharmaceutical firms launched new drugs abroad prior to gaining U.S. approval. Consequently, U.S. patients often faced delays in accessing important new medicines. High regulatory barriers to entry, such as a stringent regulation and a lengthy drug review process, contributed to this problem. This Article examines the impact of the Prescription Drug User Fee Act (PDUFA), and subsequent increases in the speed of FDA review, on the likelihood of initial U.S. drug launches. These factors are hypothesized to lower regulatory barriers to entry in the U.S. pharmaceutical market. The results show that increased drug review …

Pursuing The Perfect Mother: Why America's Criminalization Of Maternal Substance Abuse Is Not The Answer- A Compartive Legal Analysis, Linda C. Fentiman

Michigan Journal of Gender & Law

In this Article the author will examine not only the substantive legal differences between the United States, Canada, and France, but will also explore how these legal rules fit within a broader social, political, and religious setting. This Article will pursue four lines of inquiry. First, it will briefly chronicle the history of criminal prosecution of pregnant women in America and show how these prosecutions have become markedly more aggressive over the last twenty years. Second, it will situate these prosecutions in the full context of American law and culture, demonstrating how the fetus has received increasing legal recognition in …

The Culture Of Legal Change: A Case Study Of Tobacco Control In Twenty-First Century Japan, Eric A. Feldman

Michigan Journal of International Law

This Article argues that the interaction of international norms and local culture is a central factor in the creation and transformation of legal rules. Like Alan Watson's influential theory of legal transplants, it emphasizes that legal change is frequently a consequence of learning from other jurisdictions. And like those who have argued that rational, self-interested lawmakers responding to incentives such as reelection are the engine of legal change, this Article treats incentives as critical motivators of human behavior. But in place of the cutting-and-pasting of black-letter legal doctrine it highlights the cross-border flow of social norms, and rather than material …

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. …

Telemedicine: Rx For The Future Of Health Care, Susan E. Volkert

Michigan Telecommunications & Technology Law Review

Quite simply, telemedicine symbolizes and catalyzes the clash between the reality of our legal and political approach to health care and the American dream of bringing health care to all patients. Telemedicine, like our health care delivery systems, is regulated by many layers of government. Unlike other issues, telemedicine cuts through and challenges the traditional controls of access and cost. As such, telemedicine is a microcosm of our health care delivery system and a lens through which one may analyze the obstacles to access in the current system. This article examines these issues, proposes that telemedicine's goal should be to …

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 …

Accountable Managed Care: Should We Be Careful What We Wish For?, David A. Hyman

University of Michigan Journal of Law Reform

Managed care is exceedingly unpopular of late. Many people believe that the problem is managed care organizations (MCOs) are unaccountable. Indeed, for many people, the creation of tort-based accountability for MCOs is the touchstone for assessing legislative "reform." The case for tort-based accountability is actually quite complex, and the merits of tort-based accountability cannot be resolved with sound bites and bad anecdotes. Tort-based accountability has both costs and benefits, and little attention has been paid to the extent to which alternatives to tort-based accountability are found in existing institutional arrangements.

This Article systematically considers the extent to which alternatives to …

The Competitive Impact Of Small Group Health Insurance Reform Laws, Mark A. Hall

University of Michigan Journal of Law Reform

This Article reports on findings from an extensive study of small group health insurance market reforms in seven states, enacted during the early 1990s. After summarizing the content and purpose of these reforms, this evaluation focuses on the impact these reforms have had on the nature and degree of market competition. The principal findings are: (1) small group health insurance markets are highly competitive, both in price and in product innovation and diversity; (2) although some insurers have left some or all of these states in part because of these reforms, an ample number of active competitors remain, even in …

Competing On Quality Of Care: The Need To Develop A Competition Policy For Health Care Markets, William M. Sage, Peter J. Hammer

University of Michigan Journal of Law Reform

As American health care moves from a professionally dominated to a market-dominated model, concerns have been voiced that competition, once unleashed, will focus on price to the detriment of quality. Although quality has been extensively analyzed in health services research, the role of quality in competition policy has not been elucidated. While economists may theorize about non-price competition, courts in antitrust cases often follow simpler models of competition based on price and output, either ignoring quality as a competitive dimension or assuming that it will occur in tandem with price competition. This unsystematic approach is inadequate for the formulation of …