When the Problem Is the Solution: Evaluating the Intersection Between the U Visa “Helpfulness” Requirement and No-Drop Prosecution Policies

Diane Mickelson *

When Congress introduced the U visa in 2000, it intended to create a program that not only protected immigrant victims of domestic violence from deportation, but also strengthened law enforcement’s ability to investigate crimes and encouraged victims to report the abuse. Traditionally, immigrant victims are particularly vulnerable to domestic violence and have been provided with few options to leave the relationship without risking their immigration status. However, while the U visa provides immigration protections to broad categories of victims, it contains a unique “helpfulness” requirement that compels victims to continually cooperate with law enforcement in order to receive the necessary certification. This requirement alone is not contradictory to the goals of the U visa, but particular problems arise in jurisdictions with no-drop prosecution policies. No-drop prosecution policies remove the ability of victims to request that their cases be dropped and the discretion of prosecutors to drop cases unless there is a clear lack of evidence. In these jurisdictions, if immigrant victims cease cooperation, they lose their eligibility to receive a U visa. However, where sufficient evidence exists, the case will continue to be tried and could result in the victim’s deportation along with her abuser. Therefore, to further the goals of the U visa, I recommend adopting the evidence-based standard of no-drop prosecution policies for the certification requirement in place of the current cooperation-based standard.

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   *      J.D. Candidate 2020, University of Richmond School of Law; B.S., 2013, Furman University. I would like to thank Professor Margaret Ivey for her invaluable guidance and support throughout the writing process. I would also like to thank the University of Richmond Law Review staff and editors for helping prepare this article for publication. Lastly, I would like to thank my family for their input and support

Access Before Evidence and the Price of the FDA’s New Drug Authorities

Erika Lietzan *

Sometimes drug innovation seems to happen in reverse. Patients enjoy a treatment for years even though the treatment has not been approved by the FDA or proven safe and effective to the FDA’s standards. (Sometimes this happens because the FDA has declined to take enforcement action.) The agency encourages companies to perform the work necessary to satisfy the United States “gold standard” for new drug approval, however, by promising exclusivity in the marketplace. When a company does this work, at considerable expense, the results are predictable. The new drug is expensive, and patients and payers (and sometimes policymakers) are outraged. To them, it seems like nothing more than a sudden and significant price increase in a drug that was already widely available. 

This reverse sequence happens regularly. Doctors all over the country prescribe medicines for a variety of ailments, not realizing the medicines are supposed to be approved by the FDA—but have not been. Every time a company finally does the research that the FDA requires and enjoys the reward of exclusivity in the marketplace, the public cries foul. Today doctors administer fecal microbiota therapy, using an unapproved stool preparation that has been shipped by a company in Massachusetts. But companies are studying new drugs based on the principle. A recent New York Times article described the looming controversy, quoting doctors and patients who seem to question whether the new drug approval process will be worth its cost.

These scenarios force us to confront basic questions about the cost and the benefit of the new drug framework. This article examines the new drug authorities with fresh eyes, with the added benefit of these unusual scenarios where in a sense the gatekeeping mechanism has failed. Its principal insights are that, in addition to ensuring the production of high quality evidence about treatments in the marketplace, the new drug authorities: (1) ensure the disclosure—and provide a mechanism for close regulation of the disclosure—of that information, and (2) give federal regulators a leash on new drugs, and the companies who market them, through the life cycle of those drugs. It explores the costs of error and delay associated with new drug approval and alternatives that some scholars and policymakers have proposed, ultimately arguing that—though aspects may need tweaking—the new drug approval paradigm is worthwhile.

But these access-before-evidence scenarios bring home the point that the new drug approval standard does not, itself, ensure high quality innovation is performed. Something else must provide the encouragement. It concludes that those who object to temporary exclusivity for new medicines that complete the approval process (and the high prices they make possible for a while) must ask themselves whether they value the new drug framework (including good evidence) as much as they thought.

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        *    Associate Professor of Law, University of Missouri School of Law. In June 2015, Diane Hoffmann and coinvestigators from the University of Maryland Baltimore received a grant from the National Institute for Allergy and Infectious Diseases to study legal and regulatory aspects of microbiota transplantation. The author served on an expert working group convened to advise the investigators from December 2015 through February 2018. This project was supported by the Joe Covington Faculty Research Fellowship and the William F. Sutter Faculty Research Fellowship Fund. The author is grateful for feedback from audience members at the sixth annual fall conference of Scalia Law School’s Center for the Protection of Intellectual Property (IP for the Next Generation of Technology, in October 2018) and for the opportunity to discuss this project at a symposium hosted by Mizzou Law’s Center for Intellectual Property & Entrepreneurship (Protecting the Public While Fostering Innovation and Entrepreneurship: First Principles for Optimal Regulation in February 2019). Krista Carver, Joseph Gabriel, Brook Gotberg, Thomas Lambert, and Patricia Zettler provided helpful comments. Henry Adams (University of Missouri School of Law Class of 2020) and Alec Larsen (Class of 2019) provided research assistance.

 

Silence of the Liberals: When Supreme Court Justices Fail to Speak Up for LGBT Rights

David S. Cohen *

In 1985, Justice Brennan did something that had never been done before and has, surprisingly, never been done again—penned a separate opinion from the Court’s left vigorously arguing for the protection of gay rights under the Constitution. Since then, even though the Court has repeatedly protected gay rights, none of the Court’s liberal Justices have said a word on the topic. Rather, the liberal Justices have ceded the territory on the issue of the Constitution and gay rights almost entirely to Justice Kennedy’s notoriously flowery but somewhat vacuous statements about the issue, as well as the pointed and often homophobic critiques of the Court’s more conservative Justices.

This liberal silence has been costly. Court developments around gay rights have been one of many factors contributing to the drastic change in this country with respect to accepting gay people and treating them more equally. Concurring opinions could have been a part of this judicial influence, both in society and in lower court doctrine, but the liberal Justices have opted to remain silent. By doing so, they have lost an opportunity to use separate opinions to influence the trajectory of the law on gay and trans rights, solidify the societal and legal gains that may be threatened by Justice Kennedy’s departure from the Court, clarify Justice Kennedy’s vague analysis, and counter the stereotypes and bigotry of the dissenting opinions.

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*   Professor of Law, Drexel University Thomas R. Kline School of Law. Thank you to Professor Leonore Carpenter for her valuable feedback on this article, as well as to Sarah Varney and Alice Thornewill for excellent research assistance.

 

 

Improving Lawyers’ Health by Addressing the Impact of Adverse Childhood Experiences

Karen Oehme *

Nat Stern **

Although the legal profession has recognized the importance of improving attorneys’ mental health, it has largely ignored recent social and scientific research on how adverse childhood experiences (“ACEs”) can harm attorneys’ long-term well-being. This article reviews the science of ACEs and argues that law schools and the legal profession should educate law students and attorneys about the impact of prior trauma on behavioral health. Without such education, law schools and the legal system are missing a crucial opportunity to help lawyers prevent and alleviate the maladaptive coping mechanisms that are associated with ACEs. Until such knowledge is widespread, many lawyers will be plagued by their own trauma histories—to the detriment of individuals, families, communities, and the legal system.

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       *     Director, Institute for Family Violence Studies, and Distinguished University Scholar, Florida State University.

     **     John and Ashley E. Frost Professor of Law, Florida State University College of Law.

Making the Invisible Visible: Exploring Implicit Bias, Judicial Diversity, and the Bench Trial

Melissa L. Breger *

All people harbor implicit biases—which by definition, are not always consciously recognized. Although trial judges are specifically trained to compartmentalize and shield their decisions from their own biases, implicit biases nonetheless seep into judicial decision making. This article explores various strategies to decrease implicit bias in bench trials. Questions are then raised about whether a judge who has faced bias personally would be more amenable and more open to curbing implicit bias professionally. Ultimately, does diversifying the trial court judiciary minimize implicit bias, while also creating a varied, multidimensional judicial voice comprised of multiple perspectives? This article will explore this potential interplay between diversifying the trial court judiciary and reducing implicit bias, while urging future quantitative research.

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*  Professor of Law, Albany Law School. J.D., 1994, University of Michigan Law School; B.S., 1991, University of Illinois at Urbana-Champaign. Thank you to Judge Rachel Kretser who invited me to present a very early iteration of this article in March 2017 during a conference entitled, Balancing the Scales of Justice: The Impact of Judicial Diversity after the screening of the Pioneering Women Judges documentary. Thank you to the audience at Boston University’s Diversity & Law Association for inviting me to present this paper in April 2017. I am grateful for the feedback on earlier drafts by Professors Deseriee Kennedy, Jean Sternlight, Christine Sgarlata Chung, and Beverly Moran. Many thanks for the excellent research assistance of Ashley Milosevic, Nicole Finn, Konstandina Tampasis, and Robert Franklin.

 

Intellectual Property and Human Rights 2.0

Peter K. Yu *

Written in celebration of the seventieth anniversary of the Universal Declaration of Human Rights, this article calls for greater methodological engagement to refine existing human rights approaches to intellectual property and to devise new approaches to advance the promotion and protection of human rights in the intellectual property area. This article begins by briefly recapturing the past two decades of scholarship on intellectual property and human rights. It documents the progress scholars have made in this intersectional area. The article then draws on the latest research on human rights methods and methodology to explore whether and how we can take the academic discourse to the next level. It highlights three dominant research methods that have been used in this intersectional area: comparative methods, quantitative assessments, and contextual analyses. The second half of this article identifies the contributions a robust discourse on intellectual property and human rights can make to the future development of the intellectual property regime, the human rights regime, and the interface between these two regimes. Responding to critics and skeptics in the intellectual property field, the article concludes by explaining why human rights discussions in the intellectual property area will provide important benefits to the future development of the intellectual property regime, especially in relation to developing countries.

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        *    Copyright © 2019 Peter K. Yu. Professor of Law, Professor of Communication, and Director, Center for Law and Intellectual Property, Texas A&M University. This article benefited from discussions with the participants of a number of events at which the author explored issues at the intersection of intellectual property and human rights, including the Annual Meeting of the Norwegian Copyright Society in Oslo, Norway, the Third Business and Human Rights Scholars Conference at Santa Clara University School of Law, the “Global Genes, Local Concerns” Symposium at the University of Copenhagen in Denmark, a workshop organized by the International Centre for Trade and Sustainable Development in Geneva, Switzerland, the 4th International Intellectual Property Scholars Roundtable at Duke University Law School, the International Law Weekend 2014 at Fordham University School of Law, the Workshop on “Patent Regimes and the Right to Science and Culture” at Yale Law School, and the “Intellectual Property and Human Rights” Conference at American University Washington College of Law. The author is grateful to the participants of these events for their valuable comments and suggestions

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