Digital Commons Network^™

Eu-Acp Economic Partnership Agreements After Brexit: The (Neglected) Case Of Legitimate Expectations And Fundamental Change Of Circumstances, Regis Y. Simo

The International Lawyer

No abstract provided.

From Protecting Water Quality To Protecting States’ Rights: Fifty Years Of Supreme Court Clean Water Act Statutory Interpretation, Stephen Johnson

SMU Law Review

In 1972, a bipartisan Congress enacted the Clean Water Act “to restore and maintain the chemical, physical, and biological integrity of the Nation’s waters.” Almost fifty years have passed since Congress enacted the law, and during that time, the Supreme Court has played a significant role in the administration and evolution of the law. Since the dawn of the environmental era in the 1970s, the Supreme Court has heard more cases involving the Clean Water Act than any other environmental law. However, the manner in which the Court has analyzed the law has changed substantially over the last half century. …

The Constitutional Basis For Inmate Gender Confirmation Surgery, Bryce Couch

SMU Law Review

Transgender refers to “people whose gender identity, gender expression, or behavior does not conform to what is socioculturally accepted as, and typically associated with, the legal and medical sex to which they were assigned at birth.” Despite representing a small percentage of the U.S. population (0.58%), the transgender community is disproportionately represented in the prison system. Studies suggest that one-in-six transgender people (16%) have been incarcerated in their lifetime, compared to 2.8%–6.6% of the general U.S. population. In total, transgender individuals comprise 0.24% of the U.S. prison and jail population.

Unfortunately, research indicates that the prison system is “ill-prepared to …

United States Army Report And Message Formats, United States Army

United States Army: Field Manuals

United States Army Report and Message Formats, United States Army Field Manual FM 6-99

Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras

Michigan Technology Law Review

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is an essential piece of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Section 101 jurisprudence. It was seen, and litigated, as a case impacting patient rights, access to healthcare, scientific freedom, …

Is There A "Mulatto Escape Hatch" Out Of Racism?: A Reflection On Multiracial Exceptionalism During A Time Of #Blacklivesmatter, Tanya K. Hernandez

Faculty Scholarship

No abstract provided.

Future Sex, I. Bennett Capers

Faculty Scholarship

No abstract provided.

Tsai Today (2021), Southern Methodist University, Dedman School Of Law, Tsai Center For Law, Science And Innovation

Tsai Today

No abstract provided.

Unesco Recommendation On Open Science

Copyright, Fair Use, Scholarly Communication, etc.

1. The aim of this Recommendation is to provide an international framework for open science policy and practice that recognizes disciplinary and regional differences in open science perspectives, takes into account academic freedom, gender-transformative approaches and the specific challenges of scientists and other open science actors in different countries and in particular in developing countries, and contributes to reducing the digital, technological and knowledge divides existing between and within countries.

2. This Recommendation outlines a common definition, shared values, principles and standards for open science at the international level and proposes a set of actions conducive to a fair and …

Proximate Cause Explained: An Essay In Experimental Jurisprudence, Joshua Knobe, Scott J. Shapiro

University of Chicago Law Review

One of the oldest debates in American jurisprudence concerns the concept of “proximate cause.” According to so-called formalists, the legal concept of proximate cause is the same as the ordinary concept of “cause.” The legal question of whether a cause is proximate for the purposes of establishing tort liability, therefore, is an objective matter about the external world determinable by familiar descriptive inquiry. By contrast, legal realists think that issues of proximate causation are disguised normative questions about responsibility. As the realists William Prosser and W. Page Keeton put it, proximate cause is better called “responsible cause.”

Recent work in …

A Class Of One: Multiracial Individuals Under Equal Protection, Desirée D. Mitchell

University of Chicago Law Review

When it comes to recognizing multiracial individuals under the Equal Protection Clause, courts have fallen short. Only rarely do courts explicitly identify multiracial plaintiffs as just that—multiracial. Instead, the majority of courts revert to a “one-drop” rule in which they view plaintiffs as only one part of their self-identified racial composition. In doing so, the unique identities and experiences of multiracial individuals remain unaddressed. This Comment builds off previous scholarship by arguing that courts can and should do better at recognizing multiracial plaintiffs in equal protection cases by using a “class-of-one” framework. Under that doctrine, the Supreme Court has held …

Artificially Intelligent Persons, Nadia Banteka

Scholarly Publications

Artificial Intelligence (AI) entities seriously challenge traditional legal frameworks for attribution and liability because they operate at an increasing distance from their developers and owners, resulting in accountability gaps. Consider a scenario in which a self-driving car causes injury or even death to a human. Who do we hold accountable? We have no clear answer as to who can be sued or prosecuted because we lack a comprehensive legal understanding of AI entities. Many scholars propose as a solution to the accountability problem attaching liability to the direct source of the harm, the Al entity itself, by first granting it …

Addictive Technology And Its Implications For Antitrust Enforcement, James Niels Rosenquist, Fiona M. Scott Morton, Samuel N. Weinstein

North Carolina Law Review

No abstract provided.

Losing Ground: How The Supreme Court's Use Of Easement Law In U.S. Forest Service V. Cowpasture River Preservation Ass'n Thwarts Environmental Justice, William W. Metcalf

North Carolina Law Review

No abstract provided.

Introduction: What Matters For Black Workers After 2020?, Michael Z. Green

Faculty Scholarship

This paper operates as the Introduction to a Symposium that resulted from a Call for Papers discussing the topic of "What Matters for Black Workers after 2020?" to be published in the 25th volume of the Employee Rights and Employment Policy Journal for 2021. This paper briefly discusses the papers in that Symposium publication authored by Jamillah Bowman Williams, Michael Duff, and Henry Chambers that address this topic. I thank Noah Zatz, Marty Malin, Michael Oswalt, Marcia McCormick, and Tristan Kirvan for their dedicated efforts, feedback, and encouragement in completing this Symposium issue for the journal on this very important …

Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross

Articles, Book Chapters, & Popular Press

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

From Sandbox To Pandemic: Agile Reform Of Canadian Drug Regulation, Ipek Eren Vural, Matthew Herder, Janice E. Graham

Articles, Book Chapters, & Popular Press

Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Om- nibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, how- ever, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. …

Exploring The Food And Drug Administration’S Review And Approval Of Entresto (Sacubitril/Valsartan), Ashley Eadie, Keith Brunt, Matthew Herder

Articles, Book Chapters, & Popular Press

Federal regulatory agencies such as the United States Food and Drug Administration review pharmacological evidence to ensure the safety and efficacy of new and repurposed pharmaceuticals prior to market approval. The discussions, disagreements and procedural decisions contained within such reviews offer unique insight into a pharmaceutical's strengths, weaknesses and opportunities, yet are often overlooked as a significant source of pharmacological information for research and development. To highlight the value of such resources, we present a case study on Entresto, a first-in-class angiotensin receptor-neprilysin inhibitor for the treatment of heart failure with reduced ejection fraction, and explore the regulatory rationale underlying …

In The Name Of Public Health: Misoprostol And The New Criminalization Of Abortion In Brazil, Mariana Prandini Assis, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article explores the criminal regulation of misoprostol as a controlled drug in Brazil as a new form of abortion criminalization. A qualitative analysis of Brazilian case law shows how the courts use a public health rhetoric of unsafe abortion to criminalize the distribution of misoprostol in the informal sector. Rather than an invention of the local bench, this judicial rhetoric reflects global public health discourse and policy on unsafe abortion and the double life of misoprostol as both an essential medicine and a controlled drug. In contrast to previous studies, the article shows that abortion criminalization is not the …

Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens

Articles, Book Chapters, & Popular Press

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials …

Optimizing The Data Available Via Health Canada's Clinical Information Portal, Alexander C. Egilman, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast repository of data that have been submitted to support market authorization of drugs and medical devices. Health Canada has released data from more than 160 submissions for drugs, biologics, vaccines and medical devices. The regulator is currently in its third year of a 4-year phase-in schedule to release clinical data proactively from submissions for all new active substances, new clinical indications, generic drugs and higher-risk devices that are approved, withdrawn or rejected. Substantial clinical data submitted by the industry sponsor of the application, …

Federal Legal And Regulatory Developments Relating To The Us Pipeline Industry, Chloe J. Marie, Ross H. Pifer

Faculty Scholarship

The Atlantic Coast Pipeline (“ACP”) was designed as a 600-mile underground, pipeline project transporting natural gas from well sites in West Virginia to end users throughout Virginia and North Carolina. Atlantic Coast Pipeline, LLC (“Atlantic Coast”), the developer of the ACP project, began the extensive process of obtaining the necessary regulatory approvals for this project by initiating a pre-filing process with the Federal Energy Regulatory Commission (“FERC”) in October 2014. In the nearly six years that followed, the project received various permits related to water and air quality as well as other matters from state and federal agencies. At nearly …

Intersections Of Environmental Justice And Sustainable Development: Framing The Issues, Sumudu A. Atapattu, Carmen G. Gonzalez, Sara L. Seck

Articles, Book Chapters, & Popular Press

This chapter proceeds as follows. Section 1.2 describes the evolution of the concept of sustainable development from the 1987 report of the World Commission on Environment and Development (WCED) to the Sustainable Development Goals (SDGs). It discusses contem- porary degrowth and green growth movements, before introducing the relatively novel concept of just sustainabilities, a synthesis of environmental justice and sustainable development. Section 1.3 de!nes environmental justice and discusses its relationship to human rights and the social pillar of sustainable development, reflecting on which dimensions of environmental justice are well reflected in this book and which proved more dif!cult to address. …

The Big Data Regulator, Rebooted: Why And How The Fda Can And Should Disclose Confidential Data On Prescription Drugs And Vaccines, Christopher J. Morten, Amy Kapczynski

Faculty Scholarship

Medicines and vaccines are complex products, and it is often extraordinarily difficult to know whether they help or hurt. The Food and Drug Administration (FDA) holds an enormous reservoir of data that sheds light on that precise question, yet currently releases only a trickle to researchers, doctors, and patients. Recent examples show that data secrecy can be deadly, and existing laws such as the Freedom of Information Act (FOIA) cannot solve the problem. We present here a wealth of new evidence about the urgency of the problem and argue that the FDA must “reboot” its rules to proactively disclose all …

The New Eugenics, Samuel R. Bagenstos

Articles

During the first third of the Twentieth Century, the eugenics movement played a powerful role in the politics, law, and culture of the United States. The fear of “the menace of the feebleminded,” the notion that those with supposedly poor genes “sap the strength of the State,” and other similar ideas drove the enthusiastic implementation of the practices of excluding disabled individuals from the country, incarcerating them in ostensibly beneficent institutions, and sterilizing them. By the 1930s, with the rise of Adolf Hitler in Germany, eugenic ideas had begun to be discredited in American public discourse. And after the Holocaust, …

The Energy Transition And Mining: Reconciling The Growth Of Renewable Energy With The Need For New Mineral Development, Alexandra B. Klass, Allison J. Mitchell

Articles

Under the Paris Agreement, the global governmental signatories embraced the goal to hold global average temperature increase to “well below 2°C above pre-industrial levels” while “pursuing efforts to limit the temperature increase to 1.5°C above pre-industrial levels.” Almost every country in the world signed on to the Paris Agreement, adopting the prevailing science that anthropocentric greenhouse gas emissions would result in rising global temperatures and catastrophic damages from climate change in the absence of immediate action. In pursuit of this goal, the signatories agreed that all member countries would work together to bring greenhouse gas emissions to zero within the …

Advancing Applied Research In Conservation Criminology Through The Evaluation Of Corruption Prevention, Enhancing Compliance, And Reducing Recidivism, Jessica S. Kahler, Joseph W. Rivera, Zachary T. Steele, Pilar Morales-Giner, Christian J. Rivera, Carol F. Ahossin, Ashpreet Kaur, Diane J. Episcopio-Sturgeon

Biological Sciences Faculty Publications

Concomitant with an increase in the global illegal wildlife trade has been a substantial increase in research within traditional conservation-based sciences and conservation and green criminology. While the integration of criminological theories and methods into the wildlife conservation context has advanced our understanding of and practical responses to illegal wildlife trade, there remain discrepancies between the number of empirical vs. conceptual studies and a disproportionate focus on a few select theories, geographical contexts, and taxonomic groups. We present three understudied or novel applications of criminology and criminal justice research within the fields of fisheries, forestry, and wildlife conservation. First, we …

(Im)Mutable Race?, Deepa Das Acevedo

Faculty Articles

Courts rarely question the racial identity claims made by parties litigating employment discrimination disputes. But what if this kind of identity claim is itself at the core of a dispute? A recent cluster of “reverse passing” scandals featured individuals—Rachel Dolezal and Jessica Krug among them—who were born white, yet who were revealed to have lived as members of Black, Indigenous, or Person of Color (BIPOC) communities. These incidents suggest that courts will soon have to make determinations of racial identity as a threshold matter in disputes over employment discrimination and contract termination. More specifically, courts will have to decide whether …

Pandemics, Paid Sick Leaves, And Tax Institutions, Alex Zhang

Faculty Articles

The COVID-19 pandemic is currently ravaging the world, and the United States has been largely unsuccessful at containing the coronavirus. One long-standing policy failure stands out as having exacerbated the pandemic in our country: the lack of a national mandate of paid sick leaves, without which workers face financial and workplace-cultural pressures to attend work while sick, thus spreading the virus to their fellow employees and the public at large.

This Article provides the blueprint for a national, subsidized mandate of paid sick leaves and two additional insights about our tax institutions as mechanisms of effectuating broader societal goals. It …

Thirsty Places, Priya Baskaran

Scholarly Articles in Law Reviews & Journals

The United States, among the wealthiest and most prosperous nations in the world, regularly fails to provide clean, potable water to many of its citizens. Recent water crises occur within communities categorized as Geographically Disadvantaged Spaces ("GDS'), which often encompass urban and rural areas. What is more, people of color and economically vulnerable populations are often located within GDS, disproportionately burdening these groups with the economic and public health consequences of failing water infrastructure. This article provides a novel, comparative analysis of communities lacking potable water in Flint, Michigan, and southern West Virginia. This analysis highlights entrenched structural problems present …