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 …

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 …

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 …

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 …

The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah

Michigan Telecommunications & Technology Law Review

Until the December 2016 passage of the Cures Act, the FDA had regulatory power over clinical decision support (CDS) software; however, the Act removed a large group of CDS software from the FDA’s statutory authority. Congressional intent was to increase innovation by removing regulatory blockades—such as device testing and certification—from the FDA’s purview. This note argues that the enactment of this specific provision of the Act will instead stymie innovation and overlook the unfortunate safety consequences inherent in its deregulation. CDS software is a burgeoning field ripe for innovation; however, rapid innovation can often lead to a slew of mistakes—mistakes …

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 …

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 …

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 …

Protecting Human Health And Stewarding The Environment: An Essay Exploring Values In U.S. Environmental Protection Law, Tracy Bach

Michigan Journal of Environmental & Administrative Law

The purpose of this conference is to explore “the relationship between environmental protection and public health and how it should inform our efforts to become better stewards of the environment.” No one would disagree with the assertion that during the last forty years of federal environmental protection, air and water quality have improved and led to concomitant improvements in human health. Exploring the contours of this “relationship,” Environmental Protection Agency (EPA) Administrator Gina McCarthy said in her keynote speech that “[t]he thing is, the word ‘relationship’ is too neutral. The link between the health of our planet and the health …

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 …

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 …

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 …

Clearing The Way For An Effective Federal-State Partnership In Health Reform, Eleanor D. Kinney

University of Michigan Journal of Law Reform

At century's end, states have assumed a very different role in the design, implementation, and operation of health service programs than they did twenty-five years ago. In the current volatile political atmosphere particularly at the federal level, states have taken up the mantle of healthcare reform in the final years of the 1990s. Yet there remain problems and difficulties with the current federal-state relationship in health reform. The critical question is whether states can successfully accomplish genuine reform given its politically charged, complex and costly nature. This question takes on particular significance for the most important reform-expanding coverage to the …

Managed Care Regulation: Can We Learn From Others? The Chilean Experience, Timothy Stoltzfus Jost

University of Michigan Journal of Law Reform

Because the United States relies on private insurance for financing health care to a much greater degree than do other nations, and because managed care as a form of private insurance is further developed in the United States than elsewhere, it is arguable that we have little to learn from other nations about managed care regulation. This Article tests this hypothesis with respect to Chile, a country where private insurance is widespread and managed care is emerging. It concludes that by studying the experience of other nations we might gain a larger perspective on the context of our concerns in …

How Many Libertarians Does It Take To Fix The Health Care System?, Thomas L. Greaney

Michigan Law Review

There's an old joke about a Southern preacher who is asked whether he believes in the sacrament of infant baptism. "Believe in it?" thunders the preacher. "Hell, son, I've seen it done." In Mortal Peril: Our Inalienable Right to Health Care?, Richard Epstein gives testimony that markets should be left unfettered to distribute health care services. Arguing from first principles, he aims to persuade that the messy, confusing business of health care is best dealt with by simple legal rules: permit free contracting, countenance no government-induced subsidies, recognize no positive rights. One leaves this particular revival tent feeling he …

Fda Approved? A Critique Of The Artificial Insemination Industry In The United States, Karen M. Ginsberg

University of Michigan Journal of Law Reform

Artificial insemination by donor is becoming an increasingly popular means to achieving parenthood. While the majority of couples use artificial insemination to overcome fertility problems, many recipients use artificial insemination to avoid passing a genetic disease to their children. However, case studies reveal the inherent dangers of artificial insemination, namely the lack of proper screening methods to avoid passing genetic diseases to children born by artificial insemination. State-by-state regulation, federal guidelines, and private adjudication have all proven to be inadequate methods of regulating the artificial insemination industry. Ginsberg proposes federal regulation as the only means of achieving a safe artificial …

Democratizing Hmo Regulation To Enforce The "Rule Of Rescue", Kent G. Rutter

University of Michigan Journal of Law Reform

Despite heightened public concern about HMOs, misguided regulatory measures have not guaranteed HMO patients access to the treatment options many consider vital. This Note recommends four changes to the current regulatory system that would preserve HMOs' ability to control health care costs while allowing patients and doctors, rather than lawmakers or HMO administrators, to set health care priorities.

Regulating Viatical Settlements: Is The Invisible Hand Picking The Pockets Of The Terminally Ill?, Russell J. Herron

University of Michigan Journal of Law Reform

The newly emerging viatical settlement industry has attracted considerable attention from both insurance regulators and advocates for the terminally ill. In a viatical settlement, a terminally ill person names a viatical settlement company as beneficiary under his life insurance policy in exchange for an immediate lump-sum cash payment of less than face value of the policy. To date, viatical settlement payments to people with AIDS (PWAs) have been disturbingly low as a percentage of the face value of PWA policies. This Note examines the few enacted viatical settlement regulations and the National Association of Insurance Commissioners' model regulations as they …

Cumulative Trauma Disorders: Osha's General Duty Clause And The Need For An Ergonomics Standard, David J. Kolesar

Michigan Law Review

This Note argues that neither the Act nor its underlying policies supports OSHA's current use of the general duty clause to prosecute alleged ergonomics violations and that the only way to protect workers from CTDs fairly and effectively is through the promulgation of an ergonomics standard. Part I examines the purposes of the Act, as well as the function of the Act's general duty clause. Part II analyzes the four requirements of the general duty clause in the context of CTDs and finds that the clause does not apply to CTDs. Part III argues that the Act's intended policies support …

In The Regulation Of Manmade Carcinogens, If Feasibility Analysis Is The Answer, What Is The Question?, Christopher H. Schroeder

Michigan Law Review

A Review of Environmentally Induced Cancer and the Law by Frank B. Cross

Of Foxes And Hen Houses: Licensing And The Health Professions, Michigan Law Review

Michigan Law Review

A Review of Of Foxes and Hen Houses: Licensing and the Health Professions by Stanley J. Gross

Regulation Through The Looking Glass: Hospitals, Blue Cross, And Certificate-Of-Need, Sallyanne Payton, Rhoda M. Powsner

Michigan Law Review

A clear focus on the commitment of the public health and hospital establishments to the large teaching hospital and their belief in rationalizing the health care system through community-based planning allows us to understand the ideas and institutions that have produced our present system of hospital regulation. It can also help us to understand the structure and behavior of the hospital industry and can illuminate current controversies over health care policy.

What follows is a narrative account of the development of regional planning and certificate-of-need legislation. As part of that story, we trace the evolution of the Blue Cross, explain …

Michigan's Nursing Home Reform Law, John D. Croll

University of Michigan Journal of Law Reform

This article examines Michigan's new nursing home reform law, which has been hailed as "landmark legislation" and as a model for the entire country. Part I examines the past failures of nursing home regulation and the need for reform. Part II analyzes the law's key provisions. Part III examines the weaknesses of certain enforcement measures. The article proposes the following improvements: (1) extension of the law's protection to residents of homes for the aged; (2) greater access to patients by approved organizations; (3) adoption of nurse-patient ratios; (4) improvement of inspection procedures; and (5) allowance for patients or their representatives …

International Control Of The Safety Of Nuclear-Powered Merchant Ships, William H. Berman, Lee M. Hydeman

Michigan Law Review

In recent years we have witnessed the transition of nuclear-powered ships from an imaginative dream to an engineering reality. This vast step from the drawing board to successful operation on the high-seas has taken place in a remarkably short span of time. Nevertheless, in the :flush of enthusiasm over the technological achievement, we must not lose sight of the fact that the promise of nuclear power for the propulsion of ships will not have been fulfilled until nuclear vessels are operating safely and economically over the maritime trade routes of the world. It would be unrealistic to assume that further …