Law Commons^™

Access To Medicines And Pharmaceutical Patents: Fulfilling The Promise Of Trips Article 31bis, Ezinne Mirian Igbokwe, Andrea Tosato

Fordham Law Review

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has long stood accused of reducing access to medicines for the poorest and most vulnerable nations. Enacted in 1994 as one of the founding pillars of the World Trade Organization, TRIPS has enabled pharmaceutical companies to enforce their patent rights in almost every country, precluding cheaper generics from being distributed, save for very limited exceptions.

But in 2001, TRIPS was amended expressly to address this issue, allowing countries with limited resources to lodge a formal request to obtain patented medicines at a sustainable cost. Generics manufacturers worldwide can answer this …

Interpleader As A Vehicle For Challenging The Constitutionality Of Private Citizen Action Statutes, Delia Parker

Fordham Law Review

The rise of vigilante-esque statutes creates obstacles for litigants seeking to challenge a statute’s constitutionality. State legislatures in Texas and California enacted laws regulating constitutionally protected activity (abortion and firearm possession, respectively) through statutes enforced solely by private actors. The state legislatures cleverly crafted Texas S.B. 8, as well as other copycat statutes, as bounty hunter statutes to block litigants’ usual path to pre-enforcement adjudication—filing a claim against the state to enjoin its actors from enforcing the improper provisions.

The Texas and California state legislatures attempted to forbid constitutionally protected conduct by granting enforcement power to an infinite number of …

Medical Harm Without Negligence, Valerie Gutmann Koch

Fordham Law Review

In December 2019, seven women from one family underwent highly invasive surgeries based on genetic test results that indicated that each were at significant risk of developing cancer by age seventy. Subsequently, after procedures that (among other things) permanently scarred and disfigured their bodies and ended their chances of having biological children, they learned that their particular mutation was not, in fact, pathogenic.

This Article focuses on a previously under-recognized problem: what happens when a patient’s previously classified pathogenic variant is downgraded to uncertain (or even benign) status? Intuitively, it might seem that the genetic testing company, the surgeons, or …

Slowing Down Accelerated Approval: Examining The Role Of Industry Influence, Patient Advocacy Organizations, And Political Pressure On Fda Drug Approval, Stephanie Diu

Fordham Law Review

The U.S. Food and Drug Administration (FDA) has been revered as the gold standard in pharmaceutical safety and efficacy review since the 1960s. More recently, partly in response to the HIV/AIDS epidemic and the pressing need for new treatments, the FDA established an accelerated approval process to hasten the review of new drug applications so that drugs could be approved and brought to market as soon as possible. Although accelerated approval has led to the availability of new treatments for patients with few other options, this Note argues that, today, the FDA grants accelerated approval too hastily and may be …

The "Uncontroversial" Controversy In Compelled Commercial Disclosures, Lauren Fowler

Fordham Law Review

Federal and state administrative agencies increasingly advance public health goals through the use of mandatory disclosures, like warning labels on cigarettes, that are intended to both inform and influence consumer decisions. However, the standard for determining whether these requirements violate a commercial speaker’s First Amendment rights is unsettled. In Zauderer v. Office of Disciplinary Counsel, the U.S. Supreme Court adopted a test that defers to the government’s determination that the compelled disclosure of “factual and uncontroversial information” is justified. Since Zauderer was decided, lower courts have disagreed about the meaning of “uncontroversial.” A recent Supreme Court case, National Institute …

Rape Messaging, Alena Allen

Fordham Law Review

When feminists began advocating for rape reform in the 1970s, the rape message was clear: rape was not a crime to be taken seriously because women lie. After decades of criminal law reform, the legal requirement that a woman vigorously resist a man’s sexual advances to prove that she was raped has largely disappeared from the statute books, and, in theory, rape shield laws make a woman’s prior sexual history irrelevant. Yet, despite what the law dictates, rape law reforms have not had a “trickle-down” effect, where changes in law lead to changes in attitude. Women are still believed to …

Confronting The Ghost: Legal Strategies To Oust Medical Ghostwriters, Deanna Minasi

Fordham Law Review

Articles published in medical journals contribute significantly to public health by disseminating medical information to physicians, thereby influencing prescribing practices. However, the information guiding treatment decisions becomes distorted by selective publishing and medical ghostwriting, which negatively affects overall patient care. Although there is general consensus in the medical community that these practices of publication bias represent a moral failing, the issue is rarely framed as a wrong that necessitates legal consequences. This Note takes the stance that medical ghostwriting constitutes an act prohibited under the Racketeer Influenced and Corrupt Organizations Act (RICO) and argues that physicians fraudulently named as authors …

Leaders And Laggards: Tackling State Legislative Responses To The Youth Sports Concussion Epidemic, Chris Lau

Fordham Law Review

In 2009, state legislatures began to enact concussion safety laws to protect youth athletes suffering from traumatic brain injuries sustained during the course of play. By 2014, all fifty states and the District of Columbia had enacted some form of youth sports concussion legislation. Yet these statutes vary widely across states in terms of the protections offered to youth athletes. This Note provides an analysis of state legislation by classifying all fifty-one statutes among distinct tiers ranging from least to most protective.

History, Governmental Structure, And Politics: Defining The Scope Of Local Board Of Health Power, Pekham Pal

Fordham Law Review

Local boards of health often issue regulations that have broad effects that surpass the borders of the city or county to which they apply. Promulgation of such rules by board of health members appointed by the executive branch implicates separation of powers concerns; because such regulations may so extensively burden a locality’s citizens, it may be more appropriate for elected officials to adopt these regulations. Indeed, local businesses or other interested parties often bring suit challenging local board of health actions. Courts apply different analytical methodologies to review these challenges, which often leads to incongruent local health agency discretion for …