Law Commons^™

More Than Troubling: The Alarming Absence Of ‘Troubled Teen Industry’ Regulation And Proposals For Reform, Morgan Rubino

Journal of Legislation

This Note will advocate for immediate and wide-reaching legislative action on juvenile residential treatment. Part I will provide a brief history of the origins of the Troubled Teen Industry ("TTI") and the most common types of facilities operating today. Part II will analyze some of the limited state legislation on the TTI, along with the Stop Institutional Child Abuse Act pending before Congress. Finally, Part III will lay out the most pressing injustices and abuses that arise out of the TTI and argue that an integrated framework of local and federal legislation, including the adoption of state bills of rights …

Certificates Of Public Advantage: A Valuable Tool Or Diminishing Allure?, Abdur Rahman Amin

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

Health Care Fraud And The Erosion Of Trust, Katrice Bridges Copeland

Northwestern University Law Review

In health care, trust is a foundational concept. Patients must trust that their medical practitioners are competent to treat them. The trustworthiness of medical practitioners encourages patients to disclose intimate facts about their medical issues. Further, patients must trust health care providers to demonstrate impartial concern for the patients’ well-being, also known as fidelity. In providing care, the needs of the patients, rather than financial incentives, must drive medical practitioners. Without this trust, patients may not cooperate with diagnosis and treatment. In addition to trusting providers, care outcomes are better if patients trust the health care system as a whole. …

The Relevance Of Fda Regulation In Medical Device Product Defect Cases, Edward Correia

DePaul Journal of Health Care Law

Medical device product cases typically involve a jury determination whether a product is unreasonably dangerous. If the product has been cleared for marketing by the Food and Drug Administration, it has been through an extensive regulatory process in which the safety of the product is potentially reviewed by experts. Nevertheless, a number of courts have concluded that juries should not hear about FDA regulation in making factual findings regarding liability and damages.

What the FDA concludes about the safety of a product can be extremely relevant to juries in deciding whether to find there was a defective product and whether …

Cosmetic Crisis: The Obsolete Regulatory Framework Of The Ever-Evolving Cosmetic Industry, Isabelle M. Carbajales

University of Miami Law Review

Cosmetics only first became regulated after a series of tragic events where users were seriously harmed from the use of cosmetic products. These tragic events prompted legislators to enact the Food, Drug, and Cosmetics Act of 1938. Before then, law makers feared that regulating the cosmetic industry would lower the tone of legislation because they considered the cosmetic industry to be inconsequential. At present, the regulatory system in place to protect vulnerable cosmetic consumers is nearly identical to when it was enacted over eighty-six years ago—even though the cosmetic market looks nothing like it did back then. The consumer base …

Taking Care Of Business: An Empirical Examination Of The Top S&P 500 Companies And Their Role As Public Health Regulators During The Covid-19 Pandemic, Megan M. O’Malley

University of Miami Business Law Review

Data from the top 15 constituents by weight on the S&P 500 is assembled to identify trends among the policies these companies implemented in the United States during the COVID-19 pandemic. Some policies were fairly consistent across the board, especially in regard to remote work opportunities and health and safety measures for essential and/or in-person employees. Other policies, including vaccination requirements and vaccine incentives, varied across and within industries. Some companies that were examined went beyond the relevant federal, state, or local requirements in effect at the time, while other companies pushed back against public health guidance.

Sb 140 - Treatment Of Gender Dysphoria In Minors, Kathleen Kassa, Alexander J. Merritt

Georgia State University Law Review

The Act adds two new subsections that prohibit licensed physicians, hospitals, and related institutions from performing or providing certain forms of gender‑affirming medical treatment, while also defining mechanisms for promulgating and enforcing new prohibitions and exceptions allowing such treatment.

Cafo’S Are A Public Health Crisis:The Creation Of Covid-19, Helena Masiello

University of Miami Law Review

Concentrated Animal Feeding Operations (“CAFO’s”) are largely unregulated by State or Federal Laws in the United States. As a result of this lack of oversight, they are a breeding ground for deadly infectious diseases. The COVID-19 epidemic has demonstrated the threat that diseases pose to the United State like H1N1, SARS, and Ebola.
The USDA needs to regulate CAFOs under the mandate given to them by congress in the AHPA to ensure that they are not the epicenter of the next wave of deadly infectious diseases. Scientists have been warning about the disease potential of CAFOs for the last decade, …

Risk Regulation And Management Against Illegal Wildlife Trade: Europe And America, Olonyi Bosire

Sustainable Development Law & Policy

Introduction

The source or initial crime in the illegal wildlife trade chain is mostly committed beyond the shores of North America and Europe. However, the two regions continue to be massive destination markets and key transit hubs for illegal wildlife products. Illegal trade networks are shadowy and therefore problematic to study. This helps explain the wide valuation of illegal wildlife trade currently estimated by the Global Environment Facility (“GEF”) as ranging between 7 and 23 billion dollars per annum.

Policies and strategies to pre-empt or respond to illegal wildlife trade keep evolving as appreciation grows for the previously underestimated complexities, …

Underserved Communities Trashed By Plastic: Slowing The Proliferation Of Petroleum Based Products Through Stewardship Laws And Enhanced Back-End Regulatory Solutions, Joan F. Chu

Sustainable Development Law & Policy

Introduction

Plastic pollution has attracted a tremendous amount of attention and press coverage in early 2021 as evidenced in news stories; an episode of John Oliver’s show, “Last Week Tonight”; and a viral tweet from Greta Thunberg highlighting a study linking plastic pollution to human penises shrinking. These eye-catching pieces stemmed from Dr. Shanna H. Swan’s work that culminated in her book, Count Down: How Our Modern World Is Threatening Sperm Counts, Altering Male and Female Reproductive Development, and Imperiling the Future of the Human Race. Other articles have highlighted plastic pollution’s impact on polar bears, which causes their penis …

The Limits Of Regulation By Insurance, Kenneth S. Abraham, Daniel Benjamin Schwarcz

Indiana Law Journal

Insurance is an enormously powerful and beneficial method of spreading risk and compensating for loss. But even insurance has its limits. A new and misleading aspiration for insurance—that it also can and often does substitute for or significantly complement health and safety regulation—is increasingly in vogue. This vision starts from the uncontroversial recognition that insurers typically adopt measures designed to counteract “moral hazard,” the tendency of insurance to blunt policyholders’ incentives to take care. But proponents of this vision go on to contend that the risk-reducing potential of insurance is significantly more extensive than is traditionally imagined, because insurers are …

Creating Balance: Problems Within Dshea And Suggestions For Reform, Jennifer Akre Hill

Journal of Food Law & Policy

The Dietary Supplement Health and Education Act of 1994 (DSHEA) was signed into law on October 25, 1994. At the signing, President Clinton endorsed the "intense efforts" of manufacturers and legislators to change the "treatment of dietary supplements under regulation and law." Further, the bill was signed with the hope that it would benefit consumers by permitting more access to dietary supplements and more choices for consumer directed healthcare. In support, politicians on both sides of the aisle claimed the DSHEA as a victory for consumer freedom, populist protection, and preventative medicine.

The Battle Of The Bulge: Evaluating Law As A Weapon Against Obesity, Margaret Sova Mccabe

Journal of Food Law & Policy

"Silly rabbit, Trix are for kids." Since the 1970s, kids have gotten to know the silly rabbit created to promote sugary, fruit-flavored cereal in television ads. Today, "i'm lovin' it" is the McDonald's slogan, but to millions of children the more recognizable symbol is Ronald McDonald. Ronald McDonald is so recognizable that one study pegged recognition of Ronald among American children at 96% and another at 80% by children in nine other countries. Giventhe "obesity crisis," many question whether these ads should be permitted, with some questioning whether such products are even safe for children's consumption. The Trix Rabbit and …

Safe Consumption Sites And The Perverse Dynamics Of Federalism In The Aftermath Of The War On Drugs, Deborah Ahrens

Dickinson Law Review (2017-Present)

In this Article, I explore the complicated regulatory and federalism issues posed by creating safe consumption sites for drug users—an effort which would regulate drugs through use of a public health paradigm. This Article details the difficulties that localities pursuing such sites and other non-criminal-law responses have faced as a result of both federal and state interference. It contrasts those difficulties with the carte blanche local and state officials typically receive from federal regulators when creatively adopting new punitive policies to combat drugs. In so doing, this Article identifies systemic asymmetries of federalism that threaten drug policy reform. While traditional …

The Opioid Litigation: The Fda Is Mia, Catherine M. Sharkey

Dickinson Law Review (2017-Present)

It is readily agreed that federal preemption of state tort law alters the balance between federal and state power. Federal preemption is a high-profile defense in almost all modern products liability cases. It is thus surprising to see how little attention has been given to federal preemption by courts and commentators in the opioid litigation. Opioid litigation provides a lens through which I explore the role of state and federal courts and the Food and Drug Administration (FDA) in striking the right balance of power. My purpose here is not to resolve the divide among the few courts that have …

Reflections On The Effects Of Federalism On Opioid Policy, Matthew B. Lawrence

Dickinson Law Review (2017-Present)

No abstract provided.

The Pharma Perspective: The Double-Edged Sword Of Direct-To-Consumer Advertising, Ela H. Yalcin

Health Law Outlook

No abstract provided.

Cannabis Legalization In State Legislatures: Public Health Opportunity And Risk, Daniel G. Orenstein, Stanton A. Glantz

Marquette Law Review

Cannabis is widely used in the United States and internationally despite its illicit status, but that illicit status is changing. In the United States, thirty-three states and the District of Columbia have legalized medical cannabis, and eleven states and D.C. have legalized adult use cannabis. A majority of state medical cannabis laws and all but two state adult use laws are the result of citizen ballot initiatives, but state legislatures are beginning to seriously consider adult use legislation. From a public health perspective, cannabis legalization presents a mix of potential risks and benefits, but a legislative approach offers an opportunity …

Money That Costs Too Much: Regulating Financial Incentives, Kristen Underhill

Indiana Law Journal

Money may not corrupt. But should we worry if it corrodes? Legal scholars in a range of fields have expressed concern about “motivational crowding-out,” a process by which offering financial rewards for good behavior may undermine laudable social motivations, like professionalism or civic duty. Disquiet about the motivational impacts of incentives has now extended to health law, employment law, tax, torts, contracts, criminal law, property, and beyond. In some cases, the fear of crowding-out has inspired concrete opposition to innovative policies that marshal incentives to change individual behavior. But to date, our fears about crowding-out have been unfocused and amorphous; …

The Impact Of H.B. 214: A Critical Analysis Of The Texas "Rape Insurance" Bill, Lucie Arvallo

St. Mary's Law Journal

Texas House Bill 214 (H.B. 214) is subject to challenge under the Supreme Court precedent protecting a woman’s right to choose. Passed in 2017, H.B. 214 regulates Texas insurance markets by prohibiting coverage for an elective abortion unless a woman affirmatively opts into such coverage through a separate contract and pays a separate premium. Similar restrictions on insurance coverage for elective abortion in other states have been met with mixed results in the courts. What sets H.B. 214 apart from other regulations of insurance coverage for abortion is that it does not include any exceptions for abortions in cases of …

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 …

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Marquette Intellectual Property Law Review

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

Practice-Based Research Networks Ceding To A Single Institutional Review Board, Jeanette M. Daly, Tabria Weiner Harrod, Kate Judge, Leann C. Michaels, Barcey T. Levy, David L. Hahn, Lyle J. Fagnan, Donald E. Nease Jr.

Journal of Patient-Centered Research and Reviews

Historically, a single research project involving numerous practice-based research networks (PBRNs) required multiple institutional review boards (IRBs) to be involved in approval of the project. However, to avoid redundancies, federal IRB regulations now allow cooperative research projects that involve more than one institution to use reasonable methods of cooperative IRB review and to cede authority for review and oversight of the project to a single lead IRB. Through ceding, a lead IRB has the authority for review and oversight of the project delegated by all participating sites’ IRBs and becomes the IRB of record for the ceded sites. In the …

Too Little Too Late: The Infeasibility Of Osha's Silica Standards In The Oil Industry, Cali M. Franks

St. Mary's Law Journal

Abstract forthcoming

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 …

Too Clever By Half: Commanding The Nonuse Of State Authority To Regulate Health Benefits In The Aca, Michael F. Ryan

University of Massachusetts Law Review

Prior to the enactment of the Patient Protection and Affordable Care Act (ACA), state legislatures routinely passed laws requiring health insurance carriers to cover certain health care services or providers. At the behest of the insurance industry, Congress attempted to use the health reform law as a vehicle to reign in state-specific “mandated benefit” laws. That being said, the ACA does not prevent states from enacting mandated benefit laws; in fact, the statute expressly permits states to enact such laws. Instead, Congress created a significant barrier to continued state-specific regulation of health insurance benefits. Specifically, 42 U.S.C. § 18031(d)(3)(B)(ii) (Section …

Localism, Labels, And Animal Welfare, Samuel R. Wiseman

Northwestern Journal of Law & Social Policy

The law does relatively little to improve the welfare of animals raised for food. In the short term, at least, market-based solutions appear to have more promise as a means of promoting farm animal welfare, as consumers increasingly seek out local and humanely-raised meat and eggs. To aid consumers in identifying these products, certification systems of varying degrees of rigor exist, but even these are of little use to consumers in the restaurant context, which accounts for a large percentage of meat consumption. Patrons see only finished meals, making fraud difficult to detect, and a recent newspaper investigation suggests that …

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 …