Similar Journals
![]() |
Washington and Lee Law Review
Number of Followers: 2 ![]() ISSN (Print) 0043-0463 Published by Washington and Lee University ![]() |
- FDA Overreach: Is Your Pet’s Health a “Major Question”
to You'
Authors: Ross C. Reggio
Abstract: Pharmacy compounding of drugs for companion animals and humans is as old as time. For hundreds of years, pharmacists created these drugs using active pharmaceutical ingredients, otherwise known as bulk drug substances, to address the medical needs of these patients. Congress recognized this longstanding practice when it enacted the Food, Drug, and Cosmetic Act (“FDCA”), with lawmakers then noting that while pharmacists, physicians, and veterinarians were already highly regulated by the states, mass-producing drug manufacturers were not regulated. The FDCA would regulate such manufacturers.Thereafter, pharmacy compounding from bulk drug substances continued for decades after the FDCA’s enactment and without any attempted interference by the Food and Drug Administration (“FDA”). But, approximately fifty years after Congress enacted the FDCA, the FDA began to change its tune. The FDA’s policy guides first proclaimed such compounding to be illegal under the FDCA in relation to human drugs. Congress pushed back and, in 1997, created the Food and Drug Administration Modernization Act (“FDAMA”), which expressly permits pharmacy compounding from bulk drug substances for human use. Despite this congressional statement, the FDA persisted in its position that using bulk drug substances to compound drugs for companion animals is illegal per se. Its latest 2022 policy guide adheres to this position, stating that the FDA, “in its discretion,” will permit such compounding only in limited, delineated circumstances. But in that same year, the Supreme Court officially recognized the “major questions doctrine,” which attempts to rein in overzealous agency assertions of power beyond that which Congress likely granted. In West Virginia v. EPA, the Court announced that, when faced with dramatic claims of agency authority that have political or economic significance, are novel or unprecedented, or impact traditionally state-regulated areas, the Court will look for a “clear statement” from Congress that it delegated such authority to the agency.This Note analyzes the legality of the FDA’s 2022 policy guide for pharmacy compounding from bulk drug substances for companion, nonfood animals. For several reasons, the “major questions doctrine” should apply to curtail the FDA’s claimed authority. The FDA’s position ignores centuries of history, several FDCA textual provisions, the FDA’s own inconsistent policy positions, and traditional state regulation over pharmacy and medical practices. And, at bottom, the FDA’s policy jeopardizes companion animals’ medical needs and runs counter to the FDCA’s mission. If the FDA’s 2022 policy guide is allowed to stand, it will have a substantial and unnecessary negative impact on the health and wellbeing of nonfood companion animals—who, for many of us, are beloved members of our families.
PubDate: Fri, 07 Jun 2024 14:02:44 PDT
- Supporting Healthy Futures: Capitalizing on Medicaid’s EPSDT Medical
Necessity Standard
Authors: Teressa Colhoun
Abstract: Youth mental health is in crisis. Children report increased rates of suicidal ideology, depression, and anxiety. Diagnosis rates soar. Pediatric mental health care remains difficult to access. When services are accessible, they are costly—often sending families into medical debt.This Note discusses Medicaid’s Early and Periodic Screening, Diagnostic, and Treatment (“EPSDT”) benefit. Specifically, it studies the EPSDT benefit’s creation, structure, and administration. This Note focuses on the context in which the EPSDT benefit operates, particularly how health care financing models impact benefit administration. It suggests that the EPSDT benefit has the capacity to address crucial gaps in pediatric mental health care. However, this Note summarizes key issues in the benefit’s current administration. Specifically, it articulates how EPSDT’s medical necessity standard is manipulated by states to deny coverage to children, despite their providers’ opinion that such treatment is necessary. It further discusses inconsistencies that exist when courts are asked to apply the EPSDT benefit’s medical necessity standard in coverage determination challenges.This Note ultimately advocates for consistency and predictability in medical necessity standards, so that children receive coverage for crucial health care services. It urges three possible solutions to address the EPSDT benefit’s current shortcomings: First, it suggests federalizing a definition for medical necessity. Next, it advocates for the establishment of a consistent burden shifting framework to apply in courts where coverage determinations are being challenged on the basis of medical necessity. Finally, it proposes the implementation of a specialized patient advocacy model. Ultimately, these solutions share a common goal: to capitalize on the potential of the EPSDT benefit’s broad promise to cover medically necessary services so that children can access much needed care, particularly given the ongoing youth mental health crisis.
PubDate: Fri, 07 Jun 2024 14:02:42 PDT
- Piercing the Procedural Veil of Qualified Immunity: From the Guardians of
Civil Rights to the Guardians of States’ Rights
Authors: Leo Yu
Abstract: Scholars have found that, despite a split on the burden of proof for qualified immunity, courts agreed that defendants must bear the burden of pleading to raise qualified immunity as a defense. This Article is the first to find that, over the past decade, this established consensus has been disrupted, culminating in a fresh circuit split.This Article investigates twelve Federal Courts of Appeals’ qualified immunity rulings on 42 U.S.C. § 1983 and finds that six have required plaintiffs to anticipate defendants’ qualified immunity arguments at the pleading stage, essentially treating the negating of qualified immunity as an element of § 1983. This Article criticizes this approach, as it distorts the rule-of-law value of the Federal Rules of Civil Procedure, and it cannot be reconciled with the statutory text and the original intent of the forty-second Congress in enacting the Civil Rights Act of 1871.This new circuit split should not be understood as merely a procedural split regarding the pleading burden. Courts often take advantage of procedural law’s elusive nature and use it as a veil to shield judicial activism. This circuit split is another example. Behind the veil of the pleading allocation is a clear policy agenda: anti-civil rights and unconditionally pro-law enforcement.Yet, one subtle, albeit salient, theoretical strand remains underexplored: the undertones of states’ rights embedded within the contemporary qualified immunity jurisprudence. Both the Rehnquist and Roberts Courts exhibited a predilection for interpreting the objective knowledge test in a manner favorable to law enforcement, leading to a predicament the Reconstruction Congress once grappled with: the enforceability of a federal right today often hinges upon a state actor’s acknowledgment of that right. Such an outcome, far from being serendipitous, resonates with the Court’s overt pro-states’ rights disposition on many civil rights matters. Thus, the contemporary qualified immunity jurisprudence reflects a departure from the vision of the Reconstruction Congress, which envisioned federal courts as guardians of civil rights. The prevailing sentiment of the Court suggests a reimagining of a new role for federal courts: guardians of states’ rights.
PubDate: Fri, 07 Jun 2024 14:02:39 PDT
- Illegal Contracts and Agreements: A New Standard for Prostitution and
Marijuana Agreements
Authors: Doug Rendleman
Abstract: Agreements exchanging sex for money and those involving marijuana may encounter illegality defenses in court. Granting a legal remedy for breach of an agreement that exchanges seriously illegal consideration would lower the court’s public standing and endanger its legitimacy. On the other hand, the spectacle of a buyer claiming its own illegality to escape paying its seller troubles courts.Lord Mansfield stated the illegality defense in Holman v. Johnson: “No Court will lend its aid to a man who founds his cause of action upon an immoral or an illegal act.” Yet he rejected the illegality defense in that case on the ground that the plaintiff’s contract to sell tea that the buyer planned to smuggle into England was complete before the crime occurred.Difficult illegality decisions arise when the illegality is not serious, as in this Article’s sex and marijuana topics. This Article rejects fixed rules for illegality disputes and favors judicial discretion guided through standards. The standards include the seriousness of the illegality and preventing unjust enrichment leading to restitution. Applying the standards to the Article’s first example leads to potential recovery for an unpaid sex worker. The Article also approves recovery of contractual damages for many marijuana transactions that are illegal under federal law but legal under state law.
PubDate: Fri, 07 Jun 2024 14:02:36 PDT
- Civil Means to Criminal Ends
Authors: Kathryn Ramsey Mason
Abstract: The divide between the civil and criminal legal systems is one of the most fundamental distinctions in American law. There are laws, however, that do not fit clearly into either category and the Supreme Court’s jurisprudence on how to categorize these statutes has been murky. Crime-free rental housing ordinances, which encourage or coerce private landlords into evicting tenants for a single incident of criminal activity that does not need to result in a conviction, are an example of the laws that occupy this middle ground. Local legislatures designate these laws as civil statutes and use them as a means to accomplish one of the same ends as the criminal legal system—the removal of undesirable people from the community—but without the need to comply with the more stringent constitutional rights and protections that criminal defendants are entitled to. Tenants facing eviction under crime-free rental housing ordinances must confront allegations of criminal activity without the protections of the Fourth Amendment exclusionary rule, the Sixth Amendment right to counsel, or the expectation that the criminal activity be proven beyond a reasonable doubt. This Article argues that, given the severe consequences that individuals and communities suffer as a result of eviction, including the racial justice implications, legislatures and courts should consider designating evictions under crime-free rental housing ordinances as quasi-criminal matters, thereby ensuring better protection of tenants’ constitutional rights.
PubDate: Fri, 07 Jun 2024 14:02:33 PDT
- Disclosure, Greenwashing, and the Future of ESG Litigation
Authors: Barbara Ballan et al.
Abstract: The Environmental, Social, and Governance (“ESG”) disclosure movement is expanding both voluntarily, as businesses choose to disclose this information, and mandatorily, as government agencies impose disclosure requirements. As ESG disclosure expands, so do the litigation risks. “Greenwashing” refers to presenting false or misleading environmental or sustainability (i.e., “green”) qualities of products, services, or practices. Businesses may greenwash consumers as well as investors with false and misleading ESG disclosures in advertising, securities filings, or other public statements activating greenwashing litigation from investors and consumers. This Article addresses (1) the laws and regulations that cover consumer and securities greenwashing litigation, (2) how these forms of greenwashing litigation are evolving, and (3) the synergistic relationships that do, and should, exist between these forms of litigation.
PubDate: Fri, 07 Jun 2024 14:02:30 PDT
- Restorative Constitutionalism
Authors: David E. Landau et al.
Abstract: Cass Sunstein and other scholars have distinguished between two forms of constitutionalism: preservative constitutionalism, which looks to maintain the status quo, and transformative constitutionalism, which aims to transcend a flawed constitutional history and achieve a better future. In this Article, we introduce a third, undertheorized mode of constitutionalism, which we call restorative. Restorative constitutionalism seeks a return to a lost, more authentic constitutional past, whether real or imagined. Restorative discourse in modern United States constitutionalism is dominated by conservative calls for originalist judicial interpretation. But originalism is only one subset of restoration, and indeed restorative discourse has been present at many moments in U.S. history, including in both the Trump and Biden administrations. We survey examples of restorative constitutionalism both inside and outside the United States and show that it is a powerful and varied mode of change that can facilitate popular and elite consensus and repair damage wrought by anti-democratic political actors. Restoration is not without risks: it may restrict the horizons of constitutional imagination and be abused for authoritarian ends. Nonetheless, progressives would be well-served by engaging with restorative constitutional discourse, rather than treating it as a trap and allowing it to be monopolized by conservative constitutionalists.
PubDate: Fri, 07 Jun 2024 14:02:27 PDT
- Comment: Protecting Childhood Independence and the Families Who Embrace It
Authors: David Pimentel
Abstract: The legal problem of how to give parents flexibility and how to give children independence cuts to the core of some of our most sacred values: (1) how we raise our kids in this society, (2) the degree to which parents are free to raise their children as they see fit, and (3) the extent to which the state gets to substitute its own judgment for that of parents. Incursions into the family, and disruptions of family security and integrity, should be the exception rather than the rule. Schick-Malone joins a small group of legal scholars who are not content to stand by and watch while families are disrupted and parents are forced to infantilize their children for fear of legal consequences. Her contribution to the discussion and debate in this area is most welcome, as it highlights the problem and raises awareness of the need for better solutions and better approaches.
PubDate: Mon, 29 Apr 2024 08:09:43 PDT
- Letting the Kids Run Wild: Free-Range Parenting and the (De)Regulation of
Child Protective Services
Authors: Fenja R. Schick-Malone
Abstract: Families in the United States suffer from a removal epidemic. The child welfare framework allows unnecessary and harmful intervention into family and parenting matters, traditionally left to the discretion of the parent. Many states allow Child Protective Services (“CPS”) to investigate, intervene, and permanently separate a child from their parents for innocuous activities such as letting the child play outside unattended. This especially affects low-income and minority families.To prevent CPS from unnecessarily intervening in a family’s decision to let their children engage in independent, unsupervised activities, Utah passed a “free-range” parenting act (“Act”) in 2018. The Act explicitly excludes independent, age-appropriate activities from the definition of neglect. This Act has remained largely unexamined: whether the passage of the free-range parenting law has resulted in a decrease of non-supervision cases referred to and substantiated by CPS is unclear. It is also unclear whether free-range parenting laws are a viable solution to the issue of unnecessary and harmful state intervention, in general.This Note explores whether the free-range parenting law passed in Utah in 2018 has led to any discernible reduction in non-supervision cases and removals. Since the statistical analysis has significant limitations, the Note then takes a more general approach in examining whether these laws address the causes of unnecessary state intervention. The Note finds that many free-range parenting laws fail to address larger issues in the child welfare system and tend to mainly benefit middle-class and high-income families. A solution will likely require a concerted effort by all three branches of the government. It is imperative that efforts to pass free-range parenting laws are not abandoned but rather utilized for bigger and more equitable change.
PubDate: Mon, 29 Apr 2024 08:09:40 PDT
- Comment: Court ADR Analytics
Authors: Benjamin G. Davis
Abstract: For the reasons in my comments below, Jordan Hicks’s note entitled Judicial-ish Efficiency: An Analysis of Alternative Dispute Resolution Programs in Delaware Superior Court is a tour de force. Its content and methodology suggest a fresh approach to thinking about court-annexed Alternative Dispute Resolution (“ADR”) in general and court-annexed mandatory nonbinding arbitration programs in particular. The meticulous analysis of three different eras (1978–2008, 2008–2018, and 2018–present) of the program, with a focus on judicial efficiency (speed, failure rate, and prejudicial concerns), provides an important template for how this work might be expanded to look at programs in other courts in different jurisdictions. Whether this approach can be incorporated in the analysis of ADR efficacy on a broader level is the topic of this comment.
PubDate: Mon, 29 Apr 2024 08:09:37 PDT
- Judicial-ish Efficiency: An Analysis of Alternative Dispute Resolution
Programs in Delaware Superior Court
Authors: Jordan Hicks
Abstract: Since the late twentieth century, federal and state jurisdictions across the United States have explored the use of Alternative Dispute Resolution (“ADR”) programs to resolve legal disputes. ADR programs provide extrajudicial mechanisms through which parties can resolve their disputes without the delay and expense of a traditional judicial proceeding. Courts and practitioners alike have lauded ADR programs. For litigators, ADR programs are a way to deliver outcomes to clients quickly and efficiently. For courts, ADR programs are a way to remove cases from overcrowded dockets.While ADR is generally considered to be speedier and more cost-efficient than a trial, little empirical research has been done to determine which sorts of ADR programs deliver the greatest returns. An examination of the last four decades of ADR programs in Delaware Superior Court may provide just this insight.Since 1978, the Delaware judiciary has enacted, repealed, and amended three similar, but distinct, iterations of an ADR program in Delaware Superior Court. Because all three iterations were enacted in the same court system, the Delaware ADR program is a microcosm in which different characteristics of ADR programs may be compared against each other. This objective comparison reveals which iteration of the ADR program has proven most efficient for Delaware, and may provide valuable insights for legislators and rule-makers who seek to design efficient ADR programs in jurisdictions across the United States.
PubDate: Mon, 29 Apr 2024 08:09:34 PDT
- Mandatory Sentences as Strict Liability
Authors: William W. Berry III
Abstract: Strict liability crimes—crimes that do not require a criminal intent—are outliers in the world of criminal law. Disregarding criminal intent risks treating the blameworthy the same as the blameless.In a different galaxy far, far away, mandatory sentences—sentences automatically imposed upon a criminal conviction—are unconstitutional in certain contexts for the exact same reason. Mandatory death sentences risk treating those who do not deserve death the same as those that might.Two completely separate contexts, two parallel rules of law. Yet courts and commentators have failed to see the similarities between these two worlds, leaving an analytical black hole. Indeed, equity in criminal sentencing may depend upon recognizing the connections between these parallel universes.This Article aims to fill this analytic gap, proposing a rethinking of mandatory sentences in light of the way criminal law treats strict liability crimes. Specifically, the Article argues that courts should reconceptualize mandatory sentences as a type of strict liability. To that end, it proposes a series of possible statutory and constitutional limits on mandatory sentences.
PubDate: Mon, 29 Apr 2024 08:09:32 PDT
- Decisionmaking in Patent Cases at the Federal Circuit
Authors: Jason Reinecke
Abstract: This Article provides the results of an empirical study assessing the impact of panel composition in patent cases at the Federal Circuit. The dataset includes 2675 three-judge panel-level final written decisions and Rule 36 summary affirmances issued by the Federal Circuit between January 1, 2014 and May 31, 2021. The study informs the longstanding debate concerning whether the Federal Circuit is succeeding as a court with nationwide jurisdiction in patent cases and provides insight into judicial decisionmaking more broadly. And several results show that many of the worst fears that commentators have about the Federal Circuit appear overstated or untrue.For example, the results show that, in the aggregate, patent-related ideology plays a role in voting and decisionmaking at the Federal Circuit—that is, some judges are more likely to vote in a pro-patentee direction than others. This patent ideology is not explained by political affiliation, nor is it significantly explained by the judges’ prior patent-related experience. The former observation undercuts the assumption made by scholars that if political affiliation does not predict voting in an area of law, then that area of law must either be clear and binding, or there must be a near-consensus about the appropriate principles.The results also indicate that decisionmaking at the Federal Circuit is influenced by panel effects, which refer to changes in judges’ voting patterns based on the preferences of the other judges on the panel. The study exemplifies how prevalent panel effects can be in an area of law, considering they persist in patent cases at the Federal Circuit despite several reasons to believe panel effects may not exist.This study also compares decisionmaking in precedential, nonprecedential, and summarily affirmed cases and finds that voting and decisionmaking is most influenced by patent ideology in precedential cases. Prior studies of judicial decisionmaking in other circuits typically focus exclusively on precedential cases, and thus must be interpreted in view of that limitation.Furthermore, according to the results, judges do not appear to use summary affirmances as a tool to systematically bury cases opposing their patent ideology. To the contrary, decisionmaking in summarily affirmed cases is largely, if not entirely, independent of patent ideology. And judges are not more likely to summarily affirm cases coming out against their patent ideology, when considered as a fraction of the total number of opportunities to issue a summary affirmance.The results also show that judges tend to write a disproportionate share of opinions favoring their patent ideology. As a result, there is greater risk than previously recognized that the law will develop to reflect the idiosyncratic preferences of a few judges and that opinions will be written ideologically.
PubDate: Mon, 29 Apr 2024 08:09:29 PDT
- The Violence of Free Speech and Press Metaphors
Authors: Erin C. Carroll
Abstract: Today, our free speech marketplace is often overwhelming, confusing, and even dangerous. Threats, misdirection, and lies abound. Online firestorms lead to offline violence. This Article argues that the way we conceptualize free speech and the free press are partly to blame: our metaphors are hurting us.The primary metaphor courts have used for a century to describe free speech—the marketplace of ideas—has been linked to violence since its inception. Originating in a case about espionage and revolution, in a dissent written by Oliver Wendell Holmes, a thrice-injured Civil War veteran, the marketplace has been described as a space where competition and force order the rungs on a ladder climbing toward truth. Power and violence are at home in the speech marketplace. Perhaps unsurprisingly then, these same characteristics animate the defining metaphor for a key free speech institution: the press is a “watchdog.” In First Amendment law, the press’s role is to attack government for its misdeeds.As linguists have shown, metaphors are not simply rhetorical icing. They shape human understanding and behavior—sometimes in dangerous ways. The marketplace and watchdog metaphors have this power, and with it they have helped to create a speech environment where violence can feel routine.No easy fix exists for the violence in our public sphere. But new metaphors could help us reconceptualize the ways we communicate. This Article explains how and provides examples of just what types of metaphors might work.
PubDate: Mon, 29 Apr 2024 08:09:26 PDT
- Progressive Facade: How Bail Reforms Expose the Limitations of the
Progressive Prosecutor Movement
Authors: Sarah Gottlieb
Abstract: Progressive prosecutors have been acclaimed as the new hope for change in the criminal legal system. Advocates and scholars touting progressive prosecution believe that progressive prosecutors will use their power and discretion to address systemic racism and end mass incarceration. Just as this hope has arisen, however, so have concerns that meaningful change cannot be enacted within the criminal system by the very actors whose job it is to incarcerate. This Article highlights these concerns by looking at the bail reforms enacted by four different progressive prosecutors and analyzes the initial promises made, the actions taken to reform and eliminate monetary bail, and the resulting impacts on pretrial incarceration rates and existing racial disparities. This analysis shows how these prosecutors failed to deliver on their promises of reduced incarceration and more equitable treatment in the criminal system, and examines why these efforts often resulted in a shift to more conservative rhetoric and refocused efforts to incarcerate. Finally, this Article will use bail reform to show why progressive prosecutors are not a reliable method for transforming the criminal legal system due to their lack of transparency and accountability, role as political and adversarial actors, and lack of power to dismantle the carceral state.
PubDate: Mon, 29 Apr 2024 08:09:23 PDT
- Resistance Proceduralism: A Prologue to Theorizing Procedural
Subordination
Authors: Portia Pedro
Abstract: 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.
PubDate: Tue, 20 Feb 2024 16:50:23 PST