Daily Archives: February 22, 2024

15 posts

Lenity Before Kisor: Due Process, Agency Deference, and the Interpretation of Ambiguous Penal Regulations

By Thomas Z. Horton

When interpreting ambiguous punitive regulations, lower courts face a choice: either follow the Supreme Court’s instruction in Kisor v. Wilkie and defer to the enforcing agency’s typically more severe interpretation, or rely on the venerable rule of lenity — also endorsed by the Supreme Court — and adopt a less severe interpretation. This choice need not be made. Kisor deference and lenity do not clash when properly applied because these two doctrines operate at different levels of ambiguity. Lenity tips in favor of a defendant when a regulation’s meaning is subject to “reasonable doubt,” whereas agency deference applies only when a regulation is “genuinely ambiguous” — a more searching standard. Lenity, therefore, must apply before agency deference. This order of operations makes sense of both the doctrines and their justifications. Lenity’s constitutional underpinnings — in particular, the due process requirements of “fair notice” and conviction “beyond a reasonable doubt” — take precedence over the lower-order policy rationales behind agency deference.

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The Patent Trap: The Struggle for Competition and Affordability in the Field of Biologic Drugs

Issues Volume 54, Issue 4

By Charlotte Geaghan-Breiner

The biologic drug market in the U.S. suffers from a dearth of competition. Ten years after the passage of the Biologics Price Competition and Innovation Act (BPCIA), competition from biosimilars remains weak, and prices of branded biologics continue to increase at rates that outstrip inflation. This crisis of non-competition has resulted in billions of dollars in lost savings and reduced access to treatment, especially for vulnerable groups. Patent thickets — dense webs of overlapping patents — are one of the main barriers to biosimilar competition. By protecting their products with patent thickets, branded biologic manufacturers are able to deter competition from biosimilars and maintain periods of market exclusivity that far exceed statutory limits. This Note analyzes regulatory gaps in the BPCIA that allow patent thickets to thrive, and recommends both legislative and administrative solutions. Part II assesses the market landscape for biologic drugs in the U.S. and concludes that, of all barriers to biosimilar competition, patent thickets are the most significant. Part III evaluates the BPCIA framework in light of patent thickets and identifies aspects of the statute that allow patent thickets to block biosimilar market entry. Part IV analyzes recent legislative proposals to address the problem of patent thickets, and recommends administrative changes to strike a better balance between innovation and competition in the field of biologics.

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Immigration Court is Out of Sessions: Restoring Nonregulatory Termination to Immigration Judges Post–Matter of S-O-G- & F-D-B-

Issues Volume 54, Issue 4

By Susanna Booth

In 2018, Attorney General Jeff Sessions promulgated three Board of Immigration Appeals (BIA) decisions that sharply curtailed the power of immigration judges (IJs) to manage their own dockets and safeguard the due process rights of immigrant respondents. One such decision, Matter of S-O-G- & F-D-B-, eliminated IJs’ ability to terminate proceedings outside of specific circumstances, removing a traditional tool IJs used to dispense with unnecessary or unconstitutional proceedings.

Yet recent circuit court decisions undergird the conclusion that Matter of S-O-G- & F-D-B-’s reasoning is incorrect. This Note first traces the long history of expanding IJ authority, highlighting IJs’ gradual recognition of a discretionary termination power. After examining the reasoning of S-O-G- & F-D-B-, this Note then argues that, contrary to the Attorney General’s interpretation, IJs do possess the inherent authority to terminate removal proceedings, even outside of circumstances specifically identified by statute. Finally, this Note considers the viability of eventual challenges to S-O-G- & F-D-B- and argues that either executive, legislative, or judicial action is necessary to restore IJs’ power to discretionarily terminate proceedings and protect the rights of immigrant respondents.

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Giving Voice to the Silenced: The POWER Act as a Legislative Remedy to the Fears Facing Undocumented Employees Exercising Their Workplace Rights

Issues Volume 54, Issue 3

By Elie Peltz

Undocumented workers in the United States number nearly eight million and are key contributors to major industries and regional economies across the country. Yet undocumented workers often hesitate to report labor law violations due to the fear of making themselves known to immigration authorities. In recent years, employers have felt emboldened to ignore the labor rights of undocumented workers amidst a political climate marked by anti-immigrant rhetoric and increased government monitoring of immigrants. Although federal, state, and local law all provide criminal and civil remedies for undocumented workers who have experienced workplace violations, these forms of relief do not protect undocumented workers from their greatest fear — deportation. Consequently, many undocumented workers continue to suffer workplace abuse in silence.

This Note explores two complementary federal government reforms to insulate undocumented workers who report workplace abuse from deportation: 1) expansion of the U nonimmigrant status visa program, and 2) restriction of U.S. Immigration and Customs Enforcement’s ability to deport individuals who have pending actions against employers. This Note then analyzes proposed legislation that fixes the shortcomings of these attempts at reform: The Protect Our Workers from Exploitation and Retaliation Act (POWER Act), most recently introduced in Congress in November of 2019. Finally, given enforcement trends that emerged under the Trump Administration, this Note critically assesses the viability of the POWER Act and considers ways to bolster the legislation’s protections for undocumented workers.

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Invisible Victims: Combatting the Consequences of the College Admissions Scandal for Learning-Disabled Students

Issues Volume 54, Issue 3

By Susannah G. Price

In a recent college admissions bribery scheme, a network of wealthy parents paid entrance exam proctors, admissions insiders, and medical providers to rig the system that enables students with disabilities to receive testing accommodations. By purchasing false disability diagnoses, these parents procured testing accommodations and facilitated cheating on standardized tests — all in an effort to gain admission to top-tier universities. As a result, disability rights advocates fear a backlash against students with legitimate needs for disability accommodations in the college admissions process.

The purposes of this Note are to explore the practical consequences of the scandal for students with learning disabilities and to present a legal framework for preserving disability rights. This Note proposes: (1) adopting a purposive statutory interpretation of the Americans with Disabilities Act (ADA) as amended in 2008 to ensure that the rights of learning-disabled students are not violated; and (2) implementing this interpretation through legislative and regulatory amendments as well as judicial construction. The Note begins with a summary of the college admissions scandal and its exploitation of disability accommodations. Part II examines the legislative framework and case law that govern testing accommodations, including the ADA and its 2008 amendments (ADAAA). Part III outlines the trend of treating prior receipt of accommodations as a quasi-prerequisite for future accommodations, and how this trend discriminates against disabled students with recent diagnoses. Part III also details how the emphasis on prior receipt of accommodations is contrary to the purpose of the ADAAA and proposes adopting a purposive statutory and regulatory interpretation to ensure that first-time applicants for accommodations are not unduly penalized. Part IV identifies concrete methods to implement this interpretation and adequately safeguard the rights of learning-disabled students, including legislative amendment of 42 U.S.C. § 12102, regulatory amendment of 28 C.F.R. § 36.309, and corresponding judicial construction.

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Ill-Advised, Ill-Prescribed: A Remedy for the Alarming Usage of Psychotropic Drugs Among Migrant Children Held in U.S. Detention Facilities

Issues Volume 54, Issue 3

By Ilana Gomez

In recent years, many U.S. detention facilities have faced intense scrutiny for failing to comply with the 1997 Flores Settlement Agreement — a binding agreement that outlines national standards for the detention and release of migrant minors. Among other Flores Settlement violations, a 2018 class-action lawsuit revealed that a detention facility in Texas was unlawfully administering psychotropic medications to migrant minors under its supervision. The class members in Flores v. Sessions alleged receiving psychotropic drugs without parental or legally authorized consent, in addition to experiencing abusive medical practices. In response, the U.S. District Court in Flores v. Sessions ordered that the detention facility follow Texas child welfare laws and regulations when administering psychotropic medications to detained minors.

After the Flores v. Sessions order, detention facilities across the country have looked to their respective state child welfare laws and policies for instruction on how to authorize psychotropic medications to detained migrant minors. At present, state laws and policies governing consent and assent to psychotropic treatment vary across jurisdictions and are not tailored to the needs of migrant minors detained separately from their families. Of concern is the lack of guidance on who should consent for a migrant minor when their parent or legal guardian is not available; and the lack of procedure on how and when to obtain consent and assent from migrant youth. To address these outstanding issues, this Note proposes a national consent and assent framework for minors undergoing psychotropic treatments at U.S. detention facilities. By incorporating Loretta Kopelman’s “Best Interests Standard,” this framework will help facilitate the administration of psychotropic drugs in a manner that respects the health, safety, and rights of migrant youth.

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Back to Good: Restoring the National Emergencies Act

Issues Volume 54, Issue 3

By Samuel Weitzman

As amended after the Supreme Court’s decision in Immigration & Nationality Services v. Chadha, the National Emergencies Act (NEA) vests the President with crisis powers that cannot be terminated or taken away even by majorities in both Houses of Congress. President Donald Trump’s 2019 declaration of a “national emergency” at the southern border of the United States as a pretext to secure funding for his border wall with Mexico threw into sharp relief the perils and shortcomings of this imbalanced arrangement. This Note argues first that the President lacks any inherent emergency powers; any such powers that might exist belong to Congress and are within Congress’ discretion to delegate to the President. In turn, this Note contends that the post-Chadha change to the emergency termination procedure undermined the statute’s basic efficacy in service of formalist constitutional theory. Under a revisionist, functionalist reading of Chadha, the original emergency termination procedure was constitutionally permissible as a political legislative veto. Alternatively, the recently proposed ARTICLE ONE Act would help to return the NEA to its original role of constraining executive use of emergency authorities.

Predicated Predictions: How Federal Judges Predict Changes in State Law

Issues Volume 54, Issue 2

By Connor Clerkin

Erie v. Tompkins requires federal courts to apply state substantive law in diversity suits. In determining the content of the relevant state law, federal judges tend to rely on decisions made by the highest court of the relevant state. Yet decisions subsequent to Erie required federal judges to do more than mechanically apply prior state law decisions; rather, these judges predict how the highest court of the state would rule on the legal issue at that time, thus reducing the possibility of divergent outcomes due to forum. This rule results in the occasional federal court prediction that, if faced with a given legal issue, a state’s highest court would deviate from its previous decisions.

The purpose of this Note is to collect and analyze those cases in which federal judges predict deviations from established state law. This Note compiles and analyzes each case in which a federal court has predicted a change in state law and follows up with the subsequent state high court decision that either verified or rejected that prediction. This Note then categorizes and tallies the various analytical methods used by federal judges in making their decisions, with a table of cases and their utilized methods collected in Appendix I. First, this Note reviews the mid-century Supreme Court decisions that led to the modern predictive method and demonstrates how each federal Circuit Court utilizes that method. Next, this Note discusses problems with the predictive method addressed by scholarship and illustrated with examples from the collected cases. Finally, this Note analyzes the cases in which federal courts predict deviations from established state law and suggests that to improve the verification rate of their predictions of change, federal courts should predict such a divergence only when capable of making certain kinds of arguments.

Remedying Public-Sector Algorithmic Harms: The Case for Local and State Regulation via Independent Agency

Issues Volume 54, Issue 2

By Noah Bunnell

Algorithms increasingly play a central role in the provision of public benefits, offering government entities previously unimaginable ways of optimizing public services, but they also pose risks of error, bias, and opacity in government decision-making. At present, many publicly-deployed algorithms are created by private companies and sold to government agencies. Given robust protections for trade secrets in the courts and feeble state open records laws, such algorithms, even those with fundamental flaws or biases, may escape regulatory scrutiny. If state and local governments are to avail themselves of the benefits of algorithmic governance without triggering its potential harms, they will need to act quickly to design regulatory systems that are flexible enough to respond to continual innovation yet durable enough to withstand regulatory capture. This Note proposes a novel regulatory solution in the form of a new, independent agency at the state or local level — an Algorithmic Transparency Commission — devoted to the regulation of publicly-deployed algorithms. By establishing such an agency, tailored to the needs of each jurisdiction, state and local governments can continue to enhance their efficiency and safeguard companies’ proprietary information, while also fostering a greater degree of algorithmic transparency, accountability, and fairness.

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SALT, Subsidies, and Subnational Spending

Issues Volume 54, Issue 2

By Alak Mehta

Historically, the Internal Revenue Code has permitted itemizing taxpayers to deduct state and local tax (SALT) payments on their federal tax returns. While this SALT deduction has been adjusted and refined over the years, it has been a mainstay of the federal tax code. As of December 2017, taxpayers were entitled to deduct the full amount of state and local property tax payments, as well as their choice of either state and local income taxes or sales taxes. The Tax Cuts and Jobs Act of 2017 (TCJA) dramatically altered this provision by setting a $10,000 limit on the amount a taxpayer may deduct from her federal taxable income to account for all state and local tax payments. This $10,000 cap on SALT deductibility is scheduled to expire on December 31, 2025, by which point Congress will likely readdress this issue.

This Note proposes that the next iteration of the SALT deduction scheme should allow for full deductibility of state taxes, while retaining a cap on the deductibility of local taxes. This distinction between the treatment of state and local taxes would reflect the relative advantages of public administration at the state level. State-level funding and provision of public services strikes the optimal balance between the competing goals of local administration and redistributive spending. Instituting full state tax deductibility would incentivize a shift in the funding and provision of redistributive federal programs to the state level, and would further the goals of state autonomy and policy innovation. Moreover, reducing or eliminating local tax deductibility would increase the internal policy consistency of the Internal Revenue Code, mitigate the regressive nature of the SALT deduction, and help reduce residential income segregation.

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Molecule Size Doesn’t Matter: The Case for Harmonizing Antitrust Treatment of Pay-for-Delay Agreements

Issues Volume 54, Issue 2

By Morgan Marmaro

With notoriously the most-expensive drug prices in the world, the United States has failed to use all of the tools in its shed to combat the unending upwards trend. One such important tool is U.S. antitrust law that targets companies that improperly charge monopoly and supracompetitive prices long past their original patent’s expiration. Some companies have found a way to game the regulatory approval system by suing would-be generic competitors and then, under the guise of settlement, paying them to delay their market entry — allowing a brand drug manufacturer to maintain their monopoly prices and continue raking in large profits. The Actavis Supreme Court found these agreements involving reverse payments — also known as pay-for-delay — can violate antitrust laws even in light of the existing patents. This Note argues that in an ongoing case, In re Humira that examines reverse payments between biologic drug companies, the district court was right to engage in an Actavis analysis but did so improperly. In re Humira provides a prime opportunity to strengthen and clarify U.S. jurisprudence on reverse payments and market allocations to reduce ambiguity in an evolving pharmaceutical sphere: biologics and biosimilars. This Note further argues that to harmonize the antitrust treatment of pharmaceuticals — small molecule and biologic — both clear judicial standards and legislation are needed.

This Note proceeds in four parts. Part II discusses various forms of antitrust abuses that arise in the pharmaceutical sphere and that often accompany reverse payment agreements. It follows with the relevant legal and regulatory backgrounds of small and large molecule drugs. Part III then considers the consequences of lax antitrust scrutiny on pharmaceuticals and finishes with an in-depth examination of the In re Humira litigation. Lastly, Part IV proposes a two-fold solution, legal and legislative, to the problems posed by Actavis’s lack of legal clarity. Ultimately, the purpose of this Note is to demonstrate that the way a drug is manufactured, approved, or allowed to compete does not alter the application of antitrust law seeking to rid the market of collusive agreements between rivals.

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Bend and Snap: Adding Flexibility to the Carpenter Inquiry

Issues Volume 54, Issue 1

By Sherwin Nam

The Supreme Court’s decision in Carpenter v. United States, which requires law enforcement to obtain warrants to access historical cell-site location information, raises new questions about the application of the Fourth Amendment to biometric technologies, such as facial recognition technology (FRT) and voice recognition technology (VRT). While “no single rubric definitively resolves which expectations of privacy are entitled to protection,” this Note seeks to demonstrate that current applications of the rubric offered in Carpenter — considering voluntariness, invasiveness, comprehensiveness, ease of data collection, and retrospectivity — are inadequately flexible. To safeguard the private and intimate details that ongoing “seismic shifts in digital technology” continue to reveal, the courts need a bolder, more robust framework for Fourth Amendment protection. Using FRT and VRT as illustrative examples, this Note argues that analyses of reasonable expectations of privacy involving biometric technologies should recognize the right to anonymity as an integral part of the Carpenter inquiry.

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Commercial Free Speech Constraints on Data Privacy Statutes After Sorrell v. IMS Health

Issues Volume 54, Issue 1

By Bastian Shah

Collection and use of big data drive the modern information economy. While big data can produce valuable innovations, it also comes with perils for consumers. In particular, consumers have little ability to protect their privacy online and are unnerved by the hyper-targeted advertising to which they are subjected. In response to these concerns, American states have begun enacting general data privacy laws similar to those passed in Europe. At the same time, the United States Supreme Court has grown wary of laws attempting to restrict companies from distributing and using data for advertising purposes. For instance, in Sorrell v. IMS Health, the Court found that a Vermont statute aimed at preventing targeted advertising by pharmaceutical manufacturers violated the commercial free speech doctrine. Since Sorrell, the constitutionality of data privacy statutes has been ambiguous.

This Note argues that data privacy laws that empower consumers to meaningfully protect their privacy by opting out of unwanted data collection do not violate the commercial free speech doctrine. Part II defines data privacy and summarizes the objectives current data privacy laws seek to achieve. Part III analyzes commercial speech jurisprudence before and after Sorrell and discusses the effect of Sorrell on commercial free speech jurisprudence and data privacy law. Part IV argues that government interest in empowering consumers by giving them meaningful choices in their online privacy is important enough to survive scrutiny under the post-Sorrell commercial free speech paradigm.

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A Critique of Consumer Advocacy Against the Restatement of the Law of Consumer Contracts

Issues Volume 54, Issue 1

By David Berman

In May 2019, the American Law Institute proposed adopting a Restatement of the Law of Consumer Contracts. In it, the Restatement’s Reporters suggested a “grand bargain,” which removed the requirement that consumers meaningfully assent to contractual terms and compensated for this by adding teeth to ex post remedies already available to consumers. The proposed Restatement drew immense criticism from consumer advocates, who argued both that meaningful assent was not disappearing in the common law, and that the ex post remedies did not go far enough to cure consumer harms. In the wake of this critique, the draft was shelved for further consideration.

This Note argues that consumer advocates’ approach to critiquing the Restatement is misguided. Contrary to the position of consumer advocates, the Reporters were fundamentally correct in identifying the gradual demise of assent as a reality in consumer contracts. However, this Note acknowledges that ex post review procedures, such as the application of the unconscionability doctrine, are inadequate mechanisms for redressing consumer harm.

Instead, this Note argues that consumer groups are better served by focusing on ex ante regulation of contract design, which would ensure that consumers are presented with fair contracts. This Note suggests that consumer advocates should focus their attention on the adoption of more rigorous Unfair and Deceptive Acts & Practices statutes on the state level. Provided that the right combination of prohibited terms, administrative updating mechanisms, and enforcement provisions are included, such state-level regulation would better protect consumers from unfair adhesive contracts.

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Out of Sight, Out of Mind: Rural Special Education and the Limitations of the IDEA

Issues Volume 54, Issue 1

By Lydia Turnage

In 1975, the Individuals with Disabilities Education Act (IDEA) established a substantive right to “free appropriate public education” (FAPE) for children with special needs. Since that time, the right to FAPE has primarily been defined by — and enforced through — the IDEA’s robust set of procedural safeguards and avenues for private enforcement. However, the Act’s emphasis on procedure over substance has prevented the realization of meaningful educational programming for a significant number of special needs students. This Note illustrates the fundamental tension between the IDEA’s substantive and procedural goals by contrasting the legislative and judicial vision of the IDEA with the current state of special education in rural public schools.

Part II gives a general overview of frameworks for policy implementation. Part III provides a background in the evolution of special education law, with a focus on the role that courts have played in the development of special education policy. Part IV argues against the IDEA’s proceduralist approach by demonstrating how this approach fails to account for the challenges faced by rural students at every stage of the special education process, including eligibility for special education, the formulation and enforcement of individualized education plans, and the provision of feasible alternatives to students’ initial public school placement. Finally, Part V argues that the current framework for the provision of special education should be modified to include more effective means for enforcing students’ rights and should incorporate the “inclusive schools” approach, which allows for a more substantive, collaborative, and holistic approach to providing FAPE.

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