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Washington and Lee Law Review - kovens

Note

by John Gilmore

Since the 1950’s, scientists have built novel technologies to screen for genetic diseases and other biological irregularities. Recently, researchers have developed a method called “liquid biopsy” (as opposed to a standard tissue biopsy) that uses a liquid sample (e.g., blood) to non‑invasively spot biomarkers indicating different types of cancers in the patient’s body. While the U.S. Food and Drug Administration (FDA) has fully cleared a small number of liquid biopsy tests under its rigorous and expensive review process, most biotech companies have instead followed a less restrictive regulatory path through the Centers for Medicare and Medicaid Services (CMS), which label the devices as “laboratory-developed tests” (LDTs).

Despite Congress’ initial passage of LDT designation in the 1980’s, LDT regulation remains akin to the “Wild West,” with ongoing questions about which agency is actually in charge of LDTs. While FDA initially claimed regulatory control over LDTs, it has (until recently) left discretion to CMS. Therefore, some unscrupulous companies have tried to abuse the gray regulatory area by marketing potentially misleading scientific claims about their LDTs, comparing them to FDA‑approved tests. Competitors with fully‑approved tests are furious and have sued under federal Lanham Act claims. Because of Congress’ repeated failures to pass a law addressing these claims and modernize the regulatory path for all in-vitro diagnostic tests, the FDA has proposed its own rules amending its regulatory authority to reign in most diagnostic tests.

This Note therefore suggests a multi-faceted approach to address the issue of regulating LDTs and their potentially misleading claims by (1) revising failed Congressional bills to allow regulatory and industry compromise, (2) applying certain circuit court decisions on Lanham Act claims to questionable facts in a company’s advertisements, and (3) narrowly expand the FDA’s regulatory power to all liquid biopsy tests before gradually expanding to all LDTs. Although LDTs may benefit the healthcare sector by offering novel tools to identify rare diseases, the federal government must develop an approach that both protects private parties and the general public and balances the need for research and development of life‑saving diagnostic tests.

Article

by Marsha Griggs

Answerable only to the courts that have the sole authority to grant or withhold the right to practice law, lawyers operate under a system of self-regulation. The self-regulated legal profession staunchly resists external interference from the legislative and administrative branches of government. Yet, with the same fervor that the legal profession defies non-judicial oversight, it has subordinated itself to the controlling influence of a private interest. By outsourcing the mechanisms that dictate admission to the bar, the legal profession has all but surrendered control of the most crucial component of its gatekeeping function to an unregulated industry that profits at the expense of those seeking entry.

The judicial outsourcing of the bar exam has privatized bar admission in ways that can be detrimental to the goal of public protection and damaging to those seeking licensure. The manner in which state courts have fostered privatized bar admission brings into question whether the delegation of judicial power is consistent with Constitutional prerogatives. This Article applies the lenses of multiple political-economic theories to the normative framework of attorney self-regulation and bar admission. In so doing, it seeks to identify justifications for outsourcing an exclusive judicial power that is essential to the goals of self-regulation. This Article ultimately questions whether the legal profession has surrendered, or will soon lose, the ability to regulate itself. The Article concludes with multiple recommendations to reverse the directional flow of power in attorney licensure in a manner that will yield more transparency and public accountability.

Article

by Sheldon Bernard Lyke

Over the past forty years, affirmative action advocates have participated in a defensive campaign where they have admitted that affirmative action is a form of justified discrimination. This Article finds this a dangerous strategy because it allows for the practice of misguided beliefs about race and remedies for racism. When schools fail to fight the pernicious perception that affirmative action is a racial preference, they allow the bulk of society to participate in the belief that there are no other remedial justifications for affirmative action—like remedying an institution’s history of discrimination, or curing a school’s present and ongoing discrimination by accounting for bias in admissions measures like grades, standardized testing, and letters of recommendation which are the products of racial bias. Given this fact, affirmative action is neither a racial preference nor a form of “benign” racial discrimination. Instead, affirmative action acts as a corrective function.

This Article argues that the Supreme Court’s dismantling of affirmative action in Students for Fair Admissions v. Harvard (“SFFA v. Harvard”) was not solely the work of conservatives. Advocates of affirmative action implemented an over forty-year, weak affirmative defense strategy that centered diversity and treated race conscious remedies as a form of preferential treatment. This Article discusses how portions of the SFFA decision that are critical of the diversity rationale align with principles of racial equality. Additionally, this Article discusses equality, the critiques of the diversity rationale, and calls for advocates of affirmative action to abandon diversity in the wake of SFFA.

Article

by Courtlyn G. Roser-Jones

Regulatory efforts to curb wage theft are failing. And for good reason: these laws generally empower individual workers to pursue their rights when employers neglect to pay them what they are owed and deter employers with substantial penalties. But the vast majority of workers do not take formal action against their employers. So, when the penalties for committing wage theft are almost entirely triggered by claims workers do not bring, they do not deter employer behavior. Instead, because the likelihood of being penalized at all is so low, some employers make profit-maximizing decisions to commit wage theft on a large scale. In addition to being against the law, these practices impose substantial costs on taxpayers and distort the competitive labor market, as law-abiding employers struggle to compete with others who cut costs by underpaying workers.

This Article explores government contracting initiatives at the state and local level as a supplemental tool for deterring wage theft. In addition to deterring unlawful behavior, conditioning government contracts and other public business relationships on recipients’ past and continued compliance with existent wage payment laws ensure that public funds are not used to subsidize wage theft’s public harm. Furthermore, publicly labeling wage-theft offenders as ill-fit government partners or providers of public goods and services challenges industry practices that have normalized this one particular kind of property “theft.”

While contract-based initiatives are an increasingly popular government tool for promoting certain workplace activities, these initiatives are specifically well suited for promoting wage-payment obligations and addressing the economic and logistical shortcomings of existing anti-wage-theft laws. Rather than relying on individual worker complaints to spur the enforcement process, contract-based initiatives make self-enforcement and rigorous disclosure obligations the price tag for lucrative public works and publicly subsidized opportunities. And because the potential penalty (or cost) of committing wage theft is contract ineligibility, contract-based initiatives turn employers’ cost-benefit analyses inside out. Instead of using low enforcement rates and predictable penalties to determine whether wage theft is likely the most profitable course of action, conscious employers must make these decisions with an added cost variable—the potential loss of public business opportunities. As the movement towards privatization marches on into new services and industries, more employers than ever should assess these costs as too high to risk having to pay.

Article

by Portia Pedro

Several legal scholars have discussed the role of slavery within their own family histories and a growing number of scholars are exploring the successes and strategies of lawyers and Black litigants in freedom suits and other litigation in the United States antebellum South. I build on these literatures with a focus on procedure. In this Article, I analyze procedures involved in a few of my ancestral and personal experiences. Some of the experiences with process involved litigation to be free from slavery while other experiences did not explicitly involve any law. But they all involved process.

Engaging in this practice—marshaling procedure to increase justice for marginalized groups and to decrease procedural subordination and white supremacy—is a form of what I am calling resistance proceduralism. I draw from engagement with procedures, such as requirements to file a lawsuit or for bonds and securities, in my ancestors’ freedom suits—lawsuits fighting for their freedom from slavery—to query whether some marginalized litigants, and even people who were enslaved at the time, may have engaged in resistance proceduralism.

Development

by Stewart E. Sterk

Real property owners across the country have been targeted by scammers who prepare deeds purporting to convey title to property the scammers do not own. Sometimes, the true owners are entirely unaware of these bogus transfers. In other instances, the scammers use misrepresentation to induce unsophisticated owners to sign documents they do not understand.

Property doctrine protects owners against forgery and fraud—the primary vehicles scammers use in their efforts to transfer title. Owners enjoy protection not only against the scammers themselves, but generally against unsuspecting purchasers to whom the scammers transfer purported title.

Recovery of title, however, involves costs and delays that are difficult to bear, especially for victims without significant resources—often the favorite targets of scammers. Legislators have proposed a variety of reforms to make unauthorized transfers more difficult. Most of the proposed reforms, however, would do little to ease the financial burden on victims. Victims cannot generally rely on title insurance because the standard title insurance policy does not protect the insured against title defects that arise after issuance of the policy. Requiring title insurers to cover post-policy forgery and fraud would ease the burden on victims without significantly increasing costs to title insurers.

Development

by Carol T. Li, Matthew E.K. Hall, and Veronica Root Martinez

In late 2017, the #MeToo movement swept through the United States as individuals from all backgrounds and walks of life revealed their experiences with sexual abuse and sexual harassment. After the #MeToo movement, many scholars, advocates, and policymakers posited that the watershed moment would prompt changes in the ways in which sexual harassment cases were handled. This Article examines the impact the #MeToo movement has had on judicial decisionmaking. Our hypothesis is that the #MeToo movement’s increase in public awareness and political attention to experiences of sexual misconduct should lead to more pro-claimant voting in federal courts at the district and courts of appeals levels.

For district courts, we find that the probability of a pro-employee ruling in a district court increased drastically after November 1, 2017. However, while pro-employee rulings increased in district courts during the #MeToo era, pro-employee rulings decreased in circuit courts during this time period. Our findings suggest that the #MeToo movement—an extralegal social movement—impacted legal rulings that occurred in its wake before district courts but courts of appeals were more restrained in their reaction to the movement. Importantly, the law and legal standards in place during the time period of our study did not meaningfully change. In short, the #MeToo movement had a statistically significant impact on rulings from district court judges.

Development

by Gary Myers

The Supreme Court’s recent decision in Andy Warhol Foundation for the Visual Arts, Inc. v. Goldsmith clarifies the scope of transformative use and the role of these uses in the fair use analysis. This important case has implications for a fair use analysis of artificial intelligence. This article evaluates the interaction between copyright law’s fair use doctrine and typical sources and uses for artificial intelligence. In other words, the article will assess whether or not the use of copyrighted material to “train” AI programs—AI inputs—and the products of AI programs—AI outputs—are likely to found to be transformative in light of the Warhol framework. This article assesses the potential fair use analysis for generative AI applications in light of Warhol’s analytical framework. The central question in Warhol is the scope of transformative use versus a use that is derivative and which supplants a market for the original copyrighted work. Whether the use of copyrighted material to “train” AI programs and the products of AI programs are likely to found to be transformative in light of the Warhol framework is an intensely factual inquiry. This article concludes that the use of copyrighted material as inputs for training AI programs is — by itself—likely to be found to be a transformative fair use in most circumstances. The more difficult question is how AI outputs are analyzed. Fair use is necessarily a case-by-case inquiry. In light of cases like Warhol and Google v. Oracle, the analysis will turn on a series of considerations that are identified in this article. It is likely that the fair use question will be litigated frequently in the context of AI outputs, which can involve myriad factual scenarios.

Note

by Simon Ciccarillo

Across the United States, a countless number of people rely on groundwater for basic necessities such as eating, drinking, agriculture, and energy-creation. At the same time, overuse combined with increasingly dry conditions throughout the country, tied to the increasingly unpredictable and devastating impacts of climate change, threaten this fundamental building block of society. Nowhere is this problem more pernicious than the American Southwest. The Colorado River Basin has always been the epicenter of water disputes between communities and states. Bad policies, unhelpful federal actions, and sluggish Supreme Court decisions stop the painful but necessary steps to address the increasingly dire water shortage. At the center of this crisis are two opposing camps that stand to gain or lose much. California, with the weight of history is on one side, while Arizona and Nevada, often disadvantaged, occupy the other. Yet these underdog states may have a way to escape the unjust outcomes that have hounded them to this point. If Arizona and Nevada choose, recent Supreme Court decisions provide the ammunition needed to finally create a fair and equitable distribution of water in the Southwest, and break California’s oppressive control over the lion’s share of Colorado River Basin water.

Note

by Tom Boss

Municipalities have been trying for decades to hold energy companies accountable for their role in the climate change crisis. In an effort to prevent suits, these companies are pushing the novel legal theory that federal common law provides a basis for jurisdiction in federal court over these claims. Once in federal court, the defendants argue that the very federal common law that served as the basis for removal has been displaced by the Clean Air and Clean Water Acts. This would then justify dismissal of the entire case for failure to state a claim. Luckily for the plaintiffs, nearly all the Courts of Appeals have rejected this theory, finding that removal on federal common law grounds is improper and remanding to state courts. But herein lies the problem. On remand, nothing stops the state courts from adopting the defendants’ theory. Essentially, the defendants are permitted to relitigate their preemption argument after a federal court holds that federal law does not apply.

This Note argues for the adoption of a new rule of preclusion that would apply in these cases. Where a federal court determines that federal law does not cover the claims, that judgment should have issue preclusive effect in a subsequent state court proceeding on an ordinary preemption defense. This is because a finding of no jurisdiction by a federal court necessarily entails a finding that federal law does not cover, and thus preempt, the state law claims. This rule would serve to simultaneously preserve the balance of federalism, keeping state claims in state courts and allowing only federal claims in federal courts, as well as preventing dismissals on inconsistent judgments. This rule would also preserve a fundamental notion of justice in the American legal system; it would allow the climate tort plaintiffs to finally have their day in court.

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