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Washington and Lee Law Review - Vol. 81

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.

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.

Note

by Bernadette M. Coyle

In an era dominated by efficiency-driven technology, algorithms have seamlessly integrated into every facet of daily life, wielding significant influence over decisions that impact individuals and society at large. Algorithms are deliberately portrayed as impartial and automated in order to maintain their legitimacy. However, this illusion crumbles under scrutiny, revealing the inherent biases and discriminatory tendencies embedded in ostensibly unbiased algorithms. This Note delves into the pervasive issues of discriminatory algorithms, focusing on three key areas of life opportunities: housing, employment, and voting rights. This Note systematically addresses the multifaceted issues arising from discriminatory algorithms, showcasing real-world instances of algorithmic abuse, and proposing comprehensive solutions to enhance transparency and promote fairness and justice.

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