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Volume 114 - Issue 4


Legal Strategies for Reining In “Unconscionable” Prices for Prescription Drugs

Michelle M. Mello,Rebecca E. Wolitz | January 1, 2020

Policy discussions about the affordability of prescription drugs in the United States are infused with the theme that drug prices are unconscionably high. Many of the policy interventions proposed in Congress, the White House, and the states adopt this frame, authorizing regulatory action when prices exceed particular thresholds or otherwise constitute “price gouging” on the part of drug companies. Unsurprisingly, such initiatives have prompted legal challenges by the biopharmaceutical industry. State laws in particular are vulnerable to challenges on a number of grounds. In this Article, we focus on one avenue of challenge that has received little scholarly attention in the context of drug pricing: void-for-vagueness claims under the Due Process Clause. These challenges allege that the law’s definition of “excessive” or “unconscionable” drug prices is so ambiguous as to fail basic requirements of procedural due process.

To better understand how federal and state legislation can be designed to survive vagueness challenges, we review and extract lessons from four adjacent areas of law in which a standard of “excessive” or “unconscionable” price has been operationalized: (1) price gouging laws relating to times of emergency; (2) contract law; (3) consumer lending law; and (4) public utilities rate regulation. We analyze the approaches taken in each field and their potential applicability to the prescription drug context. We conclude that consumer lending law offers the most promising model, particularly if advanced via federal legislation, and offer a series of recommendations for drafting legislation aimed at identifying and curbing excessive drug prices.

Notes and Comments

Decisions in the Dark: Why “Pregnancy Exclusion” Statutes Are Unconstitutional and Unethical

Shea Flanagan | January 1, 2020

Advance health care directives are tools that allow people to state their health care treatment wishes or designate a health care proxy in anticipation of being unable to make those decisions in the future, including preferences to remove life-sustaining medical treatment. However, thirty-six states currently have “pregnancy exclusion” laws that require physicians to void the advance directives of pregnant women receiving life-sustaining treatment. This Note assesses the constitutionality and ethics of state pregnancy exclusion statutes by employing a new five-category typology of current pregnancy exclusion laws. This Note argues that all categories of these statutes violate an individual’s constitutional rights to terminate a pregnancy and to refuse lifesaving medical treatment, and also contends that pregnancy exclusion laws as they currently exist violate basic bioethical principles by restricting the autonomy of patients. To conclude, this Note provides a potential reform to pregnancy exclusion laws that passes constitutional muster and meets today’s ethical standards.

Commandeering, Preemption, and Vehicle Emissions Regulation Post-Murphy v. NCAA

Amelia Raether | January 1, 2020

The Clean Air Act is often heralded as a paragon of cooperative federalism. The Act’s approach to vehicle emissions regulation in particular prescribes a unique partnership between the federal government and the state of California: while all states are bound by federally mandated vehicle emissions requirements, California may set more stringent standards in recognition of its historic role on the leading edge of environmental protection. However, in August 2018, the Environmental Protection Agency proposed not only to roll back the national emissions regulations, but also to revoke California’s ability to set more stringent standards, which include limits on greenhouse gas emissions and zero-emissions vehicle mandates. This revocation, finalized in September 2019, sparked legal challenges and debate on the role of states in environmental protection. The Supreme Court’s recent expansion of the anticommandeering doctrine in Murphy v. National Collegiate Athletic Association may signal increased constraints on federal power over states, which in turn may shed light on the permissibility of the EPA’s action to revoke California’s enhanced regulatory ability. This Note assesses the impact of Murphy on the distinction between permissible preemption and impermissible commandeering of state regulation, then applies that distinction to the vehicle emissions context. Ultimately, this Note argues that Congress and the courts should recognize the value of state involvement in environmental regulation and be wary of discarding the current dual-regulator system for vehicle emissions, owing to both policy and federalism concerns.


Considering a Domestic Terrorism Statute and Its Alternatives

Francesca Laguardia | January 1, 2020

Recent years have seen an increase in right-wing extremist violence within the United States, which has highlighted the disparities in law enforcement’s handling of “international” as opposed to “domestic” terrorism. Public, legal, and law enforcement commenters have begun calling for a “domestic terrorism statute,” arguing that the lack of such a statute is the largest hurdle in prosecuting domestic terrorists. This Essay explains that the primary cause of the disparity in prosecutions between domestic and international terrorists is not a lack of a domestic terrorism statute but rather the lack of a generalized terrorism statute and the failure to designate right-wing organizations as “terrorists.” Law enforcement pursuing international terrorists rely on these designations and material support statutes far more than on any statutes prohibiting terrorist acts, largely because the acts prohibited are so limited that they are rarely useful, even in the international context. But the two options of designating domestic terrorist organizations or creating a broad terrorism statute are highly problematic. This Essay discusses the barriers to prosecuting domestic terrorists as terrorists, including the problems with current terrorism statutes in responding to modern, small scale attacks and the tactics used to prosecute international terrorists. It then explores the problems with broad, generalized terrorism statutes that have been passed at the state level and drafted in Congress, and the problems with simply applying the international framework for terrorist designations to domestic terrorists. Finally, it suggests several alternative options to lessen the disparity between the handling of right-wing and other domestic terrorists, and international terrorists.