Volume 59, Issue 4

3 posts

No Moral Price: Leveraging Bayh-Dole to Uncover the True Cost of Innovation

By Fabiha Khan

Federal regulators’ inability to access drug-specific research and development (“R&D”) costs constitutes a pressing issue requiring careful scrutiny.  The absence of this data impairs regulatory solutions addressing extreme drug prices and leaves uncontested one of the most effective arguments that the pharmaceutical industry wields to ward off pricing regulation: the purported “chill to innovation.”  Rigorous evaluation of these statistics is essential to determining how to best structure drug prices to facilitate innovation.  This Note presents a novel mechanism for acquiring this crucial information: the Bayh-Dole Act’s “march-in” provision.  This thus-far unused legislative provision endows certain federal agencies with the authority to fact-find.  This Note asserts that the government should leverage this investigative function to obtain drug-specific R&D data, an endeavor that would significantly aid the creation of reasonable pricing benchmarks while sidestepping the risks associated with fully exercising march-in rights.  This Note demonstrates the technical, political, and legal feasibility of this endeavor by analyzing relevant regulations, statutes, case law, and recent political developments.  Americans have been forced to navigate the pharmaceutical realm at an informational handicap for long enough; it is time to level the playing field.

Download Article

Secrecy in the Second Circuit: Protective Orders in Police Misconduct Litigation After Civil Rights Law 50-a

By Charlotte Waldman

Can the public see whether a police officer sued for police misconduct in New York has a record of prior misconduct?  This Note examines access and secrecy surrounding law enforcement misconduct records produced in federal civil rights litigation in New York.  It argues that federal protective orders should respond to increased transparency norms at the state level in order to vindicate the public access interests inherent in liberal disclosure rules.

When New Yorkers injured by police officers file civil rights lawsuits in federal court, discovery sometimes reveals that the defendant officer has a history of misconduct.  Despite the public concerns that this raises, federal courts in New York have historically shielded law enforcement disciplinary records from public disclosure under protective orders, relying on Federal Rule of Civil Procedure 26(c).  In June 2020, however, the New York State Legislature repealed Civil Rights Law 50-a, establishing a state presumption of transparency for law enforcement records under New York’s Freedom of Information Law with the intention of increasing transparency and addressing police brutality.  Since then, federal courts presiding over police misconduct lawsuits have confronted whether their Rule 26(c) determinations to shield disciplinary records under protective orders should account for this change in state FOIL law.

The resulting decisions have been divided in outcome and inconsistent in reasoning.  Courts in the Eastern District of New York have generally imposed higher standards for shielding police misconduct records in light of the state’s new presumption of openness.  But courts in the Southern District of New York have largely refused to consider the 2020 FOIL amendments in evaluating whether Rule 26(c) protection is warranted.  The S.D.N.Y. also declined to reconsider automatic protective orders covering police misconduct records under its 1983 Plan.

This Note argues that the federal protective order inquiry under Rule 26(c) should account for increased transparency in state law—particularly in civil rights litigation, when the records at issue concern state officers sued for violating constitutional rights.  The 2020 repeal of Civil Rights Law 50-a reflects evolving judgments about public accountability, while civil rights litigation implicates a particularly strong public interest in governmental transparency.  New York’s unsettled local landscape since the 2020 state law change presents a novel setting to examine entrenched issues—implicating the tensions between state and federal law, between the presumption of transparency and the reality of access, and between the competing interests of public accountability and private civil discovery.  Ultimately, how federal courts respond to New York’s 2020 shift toward transparency in state law will affect both federal procedural approaches to state decisions about public governance and the long-term impact of the legislature’s efforts to combat police brutality.

Download Article

State Cumulative Environmental Impact Laws: Route to Counteracting Federal Failures in Public Participation?

By Carolina Gittrich

Environmental Justice (EJ) communities across the United States bear a disproportionate burden of industrial facility siting, yet federal law does not equip them with meaningful opportunities to challenge these decisions.  Existing permitting frameworks under primary environmental laws provide affected stakeholders only with formal notice and comment.  There is no requirement for permitting authorities to incorporate this gathered information into the final decision.  This Note argues that state-level cumulative impact legislation provides a path towards procedural justice that can overcome these federal failures.  Drawing on a procedural justice framework, this Note contends that true community participation requires that community input actually shape permitting outcomes.  Using New Jersey’s landmark EJ law as a case study, this Note identifies structural gaps within these existing frameworks and proposes the integration of Community Advisory Groups (CAGs) as an enforceable mechanism for promoting procedural justice.

Part I develops the procedural justice framework and surveys the federal legal architecture governing environmental permitting.  Part II examines how this federal regime leaves EJ communities with participation rights that are both procedurally fragile and substantively weak, using New Jersey’s cumulative impact law to illustrate the promise and persistent limitations of existing reform efforts.  Part III proposes integrating the CAG model into state cumulative impact legislation and addresses the practical and legal challenges of doing so.

Download Article