Digital Commons Network^™

Amgen V. Sanofi: The Supreme Court Takes Up The Enablement Requirement In The Context Of Therapeutic Monoclonal Antibodies, Christopher M. Holman

Faculty Works

No abstract provided.

Ai And The Regulatory Paradigm Shift At The Fda, Catherine M. Sharkey, Kevin M. K. Fodouop

Duke Law Journal Online

No abstract provided.

Conceiving Consistency: Giving Birth To A Uniform "Best Interests Of The Child" Standard, Victoria L. Pepe

Hofstra Law Review

The article address the lack of consistency surrounding the best interests of the child (BIOTC) standard as it has been used in child legal custody adversarial proceedings. It mentions lack of consistency surrounding the BIOTC standard as it has been used in child legal custody adversarial proceedings. It also mentions need to incorporate child welfare data from across the U.S., legal scholarship, and case law to determine which state factors or tests.

Litigation, Referendum Or Legislation? The Road To Becoming The First In Asia To Institutionalize Same-Sex Marriage, Tzu-Chiang Huang

Michigan Journal of Gender & Law

In the pursuit of same-sex marriage, advocates in each country evaluate the appropriate decision-making process for addressing this highly disputed issue—litigation, legislation, or referendum. The choice may be partially based on the institutional advantages of each approach, but more importantly, the choice is also conditioned by the legal and political context of each country, such as the authority of the court, the framing of public opinion, and the dynamics between movement and countermovement. Uniquely, all three decision-making processes are involved in the course of the institutionalization of same-sex marriage in Taiwan. This Article, focusing on the experience in Taiwan, examines …

Bostock And Textualism: A Response To Berman And Krishnamurthi, Andrew Koppelman

Notre Dame Law Review Reflection

The Bostock Court adopted an argument I’ve been making for years, and that I pressed upon it in an amicus brief: that discrimina-tion against gay people is necessarily sex discrimination. I defended Justice Neil Gorsuch’s opinion for the Court in my article, Bostock, LGBT Discrimination, and the Subtractive Moves, which catalogues various common but unsuccessful strategies for evading the force of the sex discrimination argument. That piece, originally drafted before the Supreme Court’s decision as a critique of arguments by Court of Appeals judges, was easy to revise and update. The dissenters, Justices Samuel Alito (joined by Clarence …

The Cost Of Survival For Insulin-Dependent Diabetics, Nikol Nesterenko

UC Law Journal

Insulin, an injectable drug discovered about 100 years ago that now costs less than $5 to manufacture, is currently sold between $300 and $500 in the United States. The continuously growing price forces many insulin-dependent diabetics to forego their lifesaving medication, which can result in death. Although insulin manufacturers are a significant cause of insulin unaffordability in this country, pharmacy benefit managers (PBMs), such as CVS Caremark, OptumRx, and Express Scripts, are essential in the insulin market and pressure insulin manufacturers to provide higher rebates, leading to higher prices for consumers.

Some states have addressed this issue by passing legislation …

Federal Food Safety Framework: Where Does Seaweed Fit In?, Catherine M. Janasie

Journal of Food Law & Policy

When one mentions seaweed as food, what do you think of? The dried nori used to wrap your sushi roll or perhaps the seaweed salad on the side? In fact, seaweed has many uses, including as both a food source in its own right and as a food additive. While the seaweed market has been dominated by East Asian countries, seaweed is cultivated in about 50 countries, and the U.S. seaweed industry is steadily growing. The global seaweed industry is currently worth about $6 billion annually. Food products for human consumption account for about 85% of this value.

Following The Framework: Intentional Genomic Alterations In Animals, Sarah Copper

Journal of Food Law & Policy

Intentional genomic alterations in animals or genetically engineered animals have existed in their modern form since the 1980s. However, the introduction of these animals into our food supply has been a more recent development. The federal government has taken steps in an attempt to regulate these products in a streamlined and efficient manner but has faced criticism in their approach. While the Food and Drug Administration (“FDA”) is currently responsible for the regulation of intentional genomic alterations (“IGAs”) in animals, there is significant effort behind transferring that oversight to the United States Department of Agriculture (“USDA”). However, in the meantime, …

Medical Harm Without Negligence, Valerie Gutmann Koch

Fordham Law Review

In December 2019, seven women from one family underwent highly invasive surgeries based on genetic test results that indicated that each were at significant risk of developing cancer by age seventy. Subsequently, after procedures that (among other things) permanently scarred and disfigured their bodies and ended their chances of having biological children, they learned that their particular mutation was not, in fact, pathogenic.

This Article focuses on a previously under-recognized problem: what happens when a patient’s previously classified pathogenic variant is downgraded to uncertain (or even benign) status? Intuitively, it might seem that the genetic testing company, the surgeons, or …

Say It Ain’T Roe: Dobbs And Reason Bans Are Trojan Horses For The Down Syndrome Community, Calvin Lee

Minnesota Law Review Vols. 106:2 onward (2021-present)

In recent times, one of the most in vogue methods for curtailing abortion rights has been through the enactment of “reason bans,” statutes precluding abortions if the procedure is being sought due to the sex, race, or potential genetic abnormality of the fetus. This note_comment focuses on the contemporary litigation and discourse concerning reason bans’ genetic abnormality prong. In the immediate lead-up to the Supreme Court’s ruling in Dobbs, several reason ban statutes faced facial challenges in federal court, with the plaintiffs alleging that the statutes violated Casey’s undue burden standard by imposing categorical prohibitions on pre-viability abortions. Reason ban …

Civil Rights Law—Preserving Female Athletics: Arkansas’S Fairness In Women’S Sports Act, Chandler Little Bray

University of Arkansas at Little Rock Law Review

No abstract provided.

When Uncle Sam Spills: A State Regulator’S Guide To Enforcement Actions Against The Federal Government Under The Clean Water Act, Ian M. Staeheli

Washington Law Review

The U.S. government is one of the largest polluters on the planet. With over 700 domestic military bases and countless more federal facilities and vessels operating within state borders, there exists an enormous potential for spills and discharges of pollutants into state waters. The regulatory burden for enforcing environmental laws against the federal government falls on the Environmental Protection Agency and state regulators. But enforcing laws and regulations against the federal government and its progeny is a daunting regulatory task.

Other scholarship addresses some of the vexing peculiarities involved when regulating Uncle Sam. Those works discuss the “confusing mess” that …

Forensic Linguistics: Science Or Fiction?, Abigail Shim

UC Law Journal

The history of linguistics is meager and splintered due to the subject’s interdisciplinary nature. In the postwar era, the discipline attempted to revive as a scientific one, spearheaded by Noam Chomsky and his theory of generative grammar. Linguistics consequently broke away from the predominant structuralist approach of the nineteenth century, returning to rationalist roots. But with the rise of computer technology, Chomsky’s critiques of empirical, applicational linguistic approaches have lost their force. As academic linguistics splinters off again, loses its scientific edge, and regroups with the humanities, linguistics applied in the forensic context may implicate more questions than it answers, …

Indoctrination By Elimination: Why Banning Critical Race Theory In Public Schools Is Unconstitutional, Emma Postel

William & Mary Bill of Rights Journal

This Note argues that Texas public school students’ First Amendment Rights have been violated by the passage of Senate Bill 3 (SB 3), which bans the teaching of Critical Race Theory (CRT) in K–12 public schools. The First Amendment is violated here because (1) students have a First Amendment right to speech, and this law bans protected speech; (2) students have a right to receive information, and this ban prevents them from receiving information; and (3) schools are meant to be the marketplace of ideas for students and banning CRT amounts to unconstitutional viewpoint discrimination. This Note does not suggest …

Debiasing Criminal Justice, Sandra Guerra Thompson, Nicole Bremner Cásarez

William & Mary Bill of Rights Journal

The killing of George Floyd by police officers in Minnesota inspired a summer of protests in 2020, followed by a call for racial reckoning and a professed commitment to reform criminal justice. Many have condemned the “systemic racism” reflected in countless demographic measures. From killings of unarmed men by the police at the front end of the criminal justice system to incarceration rates at the back end, the statistics show stark disparities along racial lines. These disparities are held up as evidence of racial bias in the system.

Statements about racial bias may be intended as an indictment of a …

Domestic Relations, Charles V. Crowe

Mercer Law Review

This Article addresses noteworthy appellate decisions and legislative updates relevant to Georgia domestic relations law during the Survey period from June 1, 2021 through May 31, 2022.

The Fathers' Veto And Fatherhood As Property, Yvonne Lindgren

North Carolina Law Review

No abstract provided.

Developing The Who's Pandemic Treaty To Facilitate Global Solidarity And International Accountability, Sonam K. Shah

North Carolina Law Review

No abstract provided.

Conflicts Between Ghg Accounting Methodologies In The Steel Industry, John Biberman, Perrine Toledano, Baihui Lei, Max Lulavy, Rohini Ram Mohan

Columbia Center on Sustainable Investment

Accurate, verifiable, and comparable greenhouse gas (GHG) emissions data throughout supply chains in the materials sector are necessary to drive decarbonization. This is particularly the case for the steel supply chain, a major source of GHG emissions with untapped potential for reduction. However, emissions accounting methods used by the steel industry suffer from gaps and misalignment, resulting in significant differences in reported GHG emissions. The result is a patchwork reporting landscape vulnerable to manipulation and miscommunication, generating little actionable data for policymakers, producers, customers, and investors. These shortcomings highlight the need for a harmonized carbon accounting framework for the steel …

The Exoskeleton Of Environmental Law: Why The Breadth, Depth, And Longevity Of Environmental Law Matters For Judicial Review, Sanne H. Knudsen

Utah Law Review

Environmental law is pragmatic, inevitable, and intentional. In the aggregate, the numerous federal environmental statutes are not simply a patchwork of ad hoc responses or momentary political breakthroughs to isolated public health problems and resource concerns. Together, they are a group of repeated, legislatively-backed commitments to embrace selfrestraint for self-preservation.

Self-restraint and discipline are the essence of environmental law. Indeed, if one studies the patterns and repeated choices in environmental law’s many statutory texts, one can start to appreciate environmental law’s indispensable role in society: it serves as an enduring “exoskeleton,” a sort of protective armor created over time to …

Wills, Trusts, Guardianships, And Fiduciary Administration, Mary F. Radford

Mercer Law Review

This Article discusses significant cases decided by the Georgia Court of Appeals during the period of June 1, 2021 through May 31, 2022, and significant Georgia legislation enacted in that same period relating to Georgia probate and trust law, guardianship, and estate planning.

Sex Trait Discrimination: Intersex People And Title Vii After Bostock V. Clayton County, Sam Parry

Washington Law Review

Title VII of the Civil Rights Act of 1964 protects employees from workplace discrimination and harassment on account of sex. Courts have historically failed to extend Title VII protections to LGBTQ+ people. However, in 2020, the U.S. Supreme Court decision in Bostock v. Clayton County changed this. Bostock explicitly extended Title VII’s protections against workplace discrimination to “homosexual” and “transgender” people, reasoning that it is impossible to discriminate against an employee for being gay or transgender without taking the employee’s sex into account. While Bostock is a win for LGBTQ+ rights, the opinion leaves several questions unanswered. The reasoning in …

Traumatic Ulcerative Granuloma Mimicking Squamous Cell Carcinoma In Oral Lichen Planus, David I. Tindle Dds, Ms, Dabom

The Journal of the Michigan Dental Association

Background: Oral lichen planus is an immune mediated mucosal disorder affecting up to 2% of the population. Dysplasia has been known to develop in 0.1% to 1% of patients with lichen planus. This necessitates close surveillance for the development of atypical lesions.

Case: Described is the case of a 68-year-old female patient with oral lichen planus who developed a non-healing ulceration on her right lateral tongue. Out of concern for neoplasia, a biopsy was performed. Histopathologic report indicated features consistent with traumatic ulcerative granuloma. The lesion did not return.

Conclusions: Oral lichen planus is a common mucosal disease. Although uncommon, …

Would You Make It To The Future? Teaching Race In An Assisted Reproductive Technologies And The Law Classroom, Sonia Gipson Rankin

Faculty Scholarship

Would you make it to the future? For the last five years, I have started my Assisted Reproductive Technology (ART) lecture in Family Law with this question. Students take the query seriously. They ponder their lived experiences such as home training, medical history, education, financial well-being, personality traits, work ethic, and social graces when determining if they would be the “model DNA” someone might select in a future society. The good-natured jokes about being nearsighted, having a pitiful jump shot, and wearing orthodontic headgear turn reflective when someone raises the question: would someone in the future select my race? In …

Driving-Decision Making Of Autonomous Vehicle According To Queensland Overtaking Traffic Rules, Hanif Bhuiyan, Guido Governatori, Avishkar Mahajan, Andry Rakotonirainy, Meng Weng (Huang Mingrong) Wong

Centre for Computational Law (2022-2025)

Making a driving decision according to traffic rules is a challenging task for improving the safety of Autonomous Vehicles (AVs). Traffic rules often contain open texture expressions and exceptions, which makes it hard for AVs to follow them. This paper introduces a Defeasible Deontic Logic (DDL) baseddriving decision-making methodology for AVs. We use DDL to formalize traffic rules and facilitate automated reasoning. DDL is used to effectively handle rule exceptions and resolve open texture expressions in rules. Furthermore, we supplement the information provided by the traffic rules by an ontology for AV driving behaviour and environment information. This methodology performs …

Traffic Rule Formalization For Autonomous Vehicle, Hanif Bhuiyan, Guido Governatori, Andry Rakotonirainy, Meng Weng Wong, Avishkar Mahajan

Centre for Computational Law (2022-2025)

This study devised and implemented a Defeasible Deontic Logic (DDL)-based formalization approach for translating traffic rules into a machine-computable (M/C) format and thus solving rule issues: rule vagueness (open texture expressions) and exceptions in rules. The resulting M/C format of traffic rules can be utilized for automatic traffic rule reasoning to assist the Autonomous Vehicle (AV) in making legal decisions. The method incorporates the components and behaviour of regulations based on the rule's obligation, prohibition, and permission activities.

The need for the encoding methodology is motivated by the desire for automated reasoning over Autonomous Vehicle information involving traffic rules.

A …

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 …

Virtual Art And Non-Fungible Tokens, Lawrence J. Trautman

Hofstra Law Review

Fueled in part by the wealth recently created from digital currencies, major art dealers such as Christie's and Sotheby's have embraced the sale of non-fungible tokens attached to unique digital works of art. What are non-fungible tokens, how is this related to the blockchain, and what do we know about this rapidly evolving market for digital art? It appears that digital art can be added to the growing list of uses for blockchain technology now becoming a part of modern life. This Article proceeds in seven Parts. First is a discussion about the new and explosive market for digital art. …

Education Administration In Federal Indian Law: Learning From A Colonial Project Turned Tool Of Liberation, Ariel Liberman, Douglas L. Waters Jr.

American Indian Law Journal

While statistics tend to focus on the difficulties facing tribal education, this article endeavors to look at the matter with fresh eyes. The federal administrative paradigm governing tribal schools has gone from a tool of cultural genocide to a mechanism for empowerment. A survey of recent governmental reforms demonstrates an embrace of the diversity of Indigenous communities, an interest in empowering students through learning, and an acknowledgement of a history of active disenfranchisement. This is ever-evolving federal-tribal relationship shows the administrative state’s capacity for dealing with greatly nuanced community needs and for tailor-making reforms to achieve concrete goals, even if …

Africana Legal Studies: A New Theoretical Approach To Law & Protocol, Angi Porter

Michigan Journal of Race and Law

“African people have produced the same general types of institutions for understanding and ordering their worlds as every other group of human beings. Though this should be obvious, the fact that we must go to great lengths to recognize and then demonstrate it speaks to the potent and invisible effect of the enslavement and colonization of African people over the last 500 years.” – Greg Carr