Food and Drug Law Commons^™

Brief Of 11 Narcolepsy Patients, Public Interest Orgnizations, Medical Professionals, And Professors Of Law As Amici Curiae In Support Of Defendants-Appellees, Charles Duan

Amicus Briefs & Court Filings

Amici curiae are patients, organizations, medical professionals, and legal scholars who share a common interest in advancing the law toward better patient health and welfare. New, clinically superior drug products for treating rare diseases and conditions tremendously benefit patients and society, because those products offer choice, competition, and improved patient care. In filing this brief, amici hope to make this Court aware of the broad real-world implications of this case, both for narcolepsy patients and for the public interest generally. Generation Patient is a nonprofit organization that represents young adults with chronic and rare conditions across the United States. Created …

Brief Of 12 Narcolepsy Patients, Public Interest Organizations, Medical Professionals, And Professors Of Law And Medicine As Amici Curiae In Support Of Defendants-Appellees (Amended To Add Further Signatories), Charles Duan

Amicus Briefs & Court Filings

A prior copy of this brief was filed, inadvertently omitting one signatory. This brief has accordingly been amended to correct the error, reflected in the Certificate as to parties and the Appendix.

Brief Of 30 Scholars Of Law, Economics, And Medicine As Amici Curiae In Support Of The Petition, Charles Duan

Amicus Briefs & Court Filings

Amici curiae are scholars of law, economics, and medicine, listed in the Appendix. Their interest is in the proper development of patent law in ways that best promote the interests of innovation access and the public interest.

Let The Sunshine In: Crafting Constitutional Transparency Regulations For Content Moderation, Caitlin Ring Carlson

Seattle University Law Review

In response to public concern about the impact of social media, legislators in some U.S. states have developed laws to regulate the process of content moderation. Many include mandatory transparency and disclosure requirements, some of which courts have already deemed an unconstitutional infringement on social media platforms’ right to free expression. This article explores the parameters for crafting constitutional social media transparency regulations using existing U.S. media policy and insights from recent legal challenges. The resulting analysis identifies content neutral transparency requirements that mandate the disclosure of purely factual, non-controversial information as those most likely to withstand judicial scrutiny. Specifically, …

This Is Not A Game: The Addictive Allure Of Digital Companions, Nizan Geslevich Packin, Karni Chagal-Feferkorn

Seattle University Law Review

Artificial Intelligence (AI) agents have become an inescapable part of modern childhood, reshaping education, leisure activities, entertainment, and social interaction. From AI-powered tutors that adapt to individual learning styles to emotionally responsive chatbots that simulate human companionship, these systems promise unprecedented personalization, cognitive stimulation, and social support. However, these benefits mask significant risks that remain unregulated and inadequately addressed.

Although adults are also susceptible to forming deep emotional bonds with AI companions—often trusting them as if they possessed genuine understanding and empathy—children are particularly vulnerable. Their misplaced trust can more severely distort social development, weaken critical thinking, and foster unhealthy …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Re-Imagining Tomorrow: A Technology, Innovation Law, And Ethics Symposium On Addictive Technology And Children, Margaret Chon

Seattle University Law Review

In this Foreword, Professor Margaret Chon introduces Seattle University's Technology, Innovation Law, and Ethics (TILE) program, the 2024 TILE Symposium, and Dr. Gaia Bernstein’s Unwired: Gaining Control Over Addictive Technologies.

Keynote Address: The Movement To Protect Kids From Addictive Technologies, Gaia Bernstein

Seattle University Law Review

In this keynote address, I describe my personal journey starting with a school outreach program I created in 2017 to address technology overuse among kids. While I initially advocated for self-help methods, I grew to recognize that the tech industry bore responsibility. This realization led me to write Unwired: Gaining Control over Addictive Technologies, which focused on collective action to pressure the tech industry to redesign its addictive products.

I then describe the movement to control addictive technologies and protect kids, which has gained momentum since the end of the pandemic. This movement combines grassroots parent activism with legal-political action. …

Moral Panic Or Public Health Crisis? Lessons From Drugs And Gambling For “Addictive” Design, Matthew B. Lawrence, Haomin (Kevin) Yan

Seattle University Law Review

Alcohol, automobiles, guns, lottery, loot boxes, meat, music, opioid painkillers, processed foods, prop bets, slot machines, television, tobacco, violent video games. Over the last century each of these has been subject to concerns—some might even say “moral panics”—from parents and policymakers about avoidable harms to kids and adults. In some cases we look back with the benefit of hindsight and dismiss those concerns as naïve or moralistic. In others we look back at them as justified or as having come too late to check an expanding industry before it did unfathomable harm while growing so powerful that it became all …

Responding To Digital Addiction, Ned Snow

Seattle University Law Review

In Unwired: Gaining Control over Addictive Technologies, Professor Gaia Bernstein calls our attention to the growing problem of digital addiction. Digital addiction may sound like something out of a science-fiction novel or something that does not raise the same sort of real-life practical concerns as are present in a physical health crisis or an economic decline. But as Bernstein presents the evidence, we learn that the consequences of digital addiction can be just as harmful as a serious disease or a financial depression. Cognitive development disorders, anxiety, emotional depression, social isolation, and other mental health ills can be debilitating—as much …

The Ai Doppelgänger Dilemma: Cloned Voices In The Music Industry, Elizabeth Shields

Seattle University Law Review

With the rise of generative artificial intelligence (AI), there has been an influx of “voice clones”—deep-learning algorithms that create synthetic speech to realistically mimic human voices. Celebrities and, in particular, music artists, have been subjected to the proliferation of AI voice clones on social media platforms like TikTok and streaming platforms such as Spotify. Despite music utilizing AI voice clones having amassed much popularity, this technology can be harmful and highly invasive to musicians whose livelihoods often depend on their distinct voices. While legal scholars have attempted to articulate various rights that could protect a person’s voice, individuals are largely …

State-Powered Acceleration Of Cannabis Economy Growth Engines, Benjamin C. Varadi

Pace Law Review

Small cannabis companies in state-regulated markets have driven extraordinary job creation and economic growth, but now face extinction as consolidation looms. Government intervention can build a future populated with prosperous small business growth engines, while failure to act will magnify economic disparity. This Article proposes state-backed loan guarantees, funded by municipal “cannabonds,” as a novel solution to guide the industry toward a healthier and more diverse economic landscape. This approach offers constitutionally resilient strategies to express explicit preference for local stakeholders and inverts traditional risk metrics to leverage historic institutional lending bias as a force for positive change. In doing …

Hemp And Marijuana: The Necessity Of Lab Testing For Fair Prosecutions, Jessica Aycock

Pace Law Review

This Article examines the evidentiary and ethical challenges prosecutors nationwide face in distinguishing between hemp and marijuana under current federal and state laws. Following the legalization of hemp under the federal 2018 Farm Bill, the legal distinction between hemp and marijuana now hinges on the concentration of delta-9 tetrahydrocannabinol (THC). This distinction requires quantitative lab testing to be established. Without quantitative lab testing, prosecutors cannot accurately determine THC levels, making it challenging, if not impossible, to meet the burden of proof required for marijuana possession convictions. This Article argues that the absence of testing raises evidentiary and ethical concerns that …

Fighting Drugs With Drugs: Medical Mushrooms In Utah’S War On Opioids, Paul Helms

Utah Law Review

In addition to the happy side effect of improving psilocybin’s odds of rescheduling under the proposed new CAMU standard (potentially increasing national psilocybin accessibility for opioid recovery), Senator Escamilla’s S.B. 200 could represent the beginning of a new era for the State of Utah in its battle against opioids. Despite S.B. 200’s failure to pass, the medical application of psilocybin under S.B. 266 (S.B. 200’s spiritual successor) should positively impact several interconnected issues in Utah, including mental illness, addiction, and transiency. However, specific proof of psilocybin’s effectiveness in combatting opioid addiction should be especially persuasive in garnering bipartisan support for …

Washington's Implementation Of Legalized Cannabis: A Model For Other States And The Federal Government, Bruce Turcott, Daniel Shortt

Washington Law Review

This Article examines the process and outcomes of cannabis legalization in Washington State, offering insights for other states and potential federal legalization schemes. It begins with an overview of the campaign that led to the passage of Initiative 502 (I-502), detailing the initiative’s structure, which draws from liquor licensing laws. The Article then explores the establishment of a recreational cannabis market from scratch, focusing on agency structure, federal responses such as the Cole Memorandum, and the state’s regulatory framework aimed at preventing adverse outcomes.

Additionally, this Article highlights Washington’s efforts to promote social equity, emphasizing that I-502 was framed as …

Cannabis In The Clink: An Argument In Favor Of Medical Marijuana For Disabled Inmates, Sophia Dechurch

Journal of Law and Health

In recent decades, medical marijuana programs have become commonplace, and most states in the United States of America are ready to accept marijuana as a natural alternative to treat symptoms of certain conditions such as chronic pain, cancer, mental illness, multiple sclerosis (MS), HIV/AIDS, and substance use disorder; as such, medical marijuana is readily accessible to those who have a qualifying diagnosis – the exception being those who are incarcerated. Although disability, substance abuse, and mental illness are prevalent among those under state supervision, these individuals are effectively prohibited from enjoying the benefits of medical marijuana. This Note will provide …

Race, The Academy, And The Constitution Of The War On Drugs, Jeffrey Bellin, Bennett Capers

Vanderbilt Law School Faculty Publications

The war on drugs is widely viewed as a policy failure. Despite massive government intrusions on personal liberty, drug addiction, overdoses, and drug-related violence have only in- creased since the war was declared in 1971. David Pozen's new book, The Constitution of the War on Drugs, reveals a constitutional failure as well. Pozen chronicles a host of constitutional arguments that American litigants deployed to protect a "right" to use drugs with surprising, if fleeting, suc- cess. Pozen asks what might have been, exploring why the courts backtracked and effectively re- moved the Constitution as a meaningful obstacle to drug prohibitions. …

Brief Of Law Scholars As Amicus Curiae In Support Of Appellees And Affirmance, Charles Duan

Amicus Briefs & Court Filings

Amici are law professors and scholars who focus their scholarship and teaching on intellectual property law, property law, regulatory law, and health law. They write to address the plaintiff, Novartis Pharmaceuticals Corporation (Novartis), contention that the Medicare drug price negotiation program effectuates a taking of personal property in violation of the Fifth Amendment. Amici submit this brief to provide the Court with the historical and legal background necessary to understand two issues: first, the constitutionality of government price negotiations and price regulations; second, the federal government’s use of patents. The amici explain how Courts have historically ruled on these questions, …

Buyer, Beware Of Addiction, Erin E. Meyers, Clayton J. Masterman

Cardozo Law Review

Addictive products kill more than 700,000 people in the United States every year. Despite the large-scale risks that addiction poses, the law requires manufacturers of addictive products to disclose little-to-no information about the risk of addiction—the single most consequential characteristic of a class of products contributing to mass death every year.

While consumers understand that addictive products are, in fact, addictive, they generally do not understand the magnitude of the addiction risks that they face. Metaphorically, consumers understand that they are playing a game of “Russian roulette” when they consume an addictive product—but they play without knowing how many bullets …

The End(S) Of Bankruptcy Exceptionalism: Purdue Pharma And The Problem Of Social Debt, Jonathan C. Lipson, Pamela Foohey

Cardozo Law Review

The Supreme Court’s recent 5-4 decision in the controversial chapter 11 bankruptcy reorganization of opioid-maker Purdue Pharma ends the use of nonconsensual third-party “releases,” which discharge (eliminate) liabilities of nondebtors who may share liability with a corporate debtor. Although the majority opinion is correct that the Bankruptcy Code does not permit this, it failed to recognize the problematic exceptionalism of the lower courts which approved those releases or the “social” qualities of Purdue Pharma’s mass tort liability.

Bankruptcy exceptionalism has been a contested concept since it emerged over fifteen years ago and reflects a willingness to bend the rule of …

The End Of Fda Exceptionalism? Dissecting Deference To The Fda In Drug Disputes, Anjali Deshmukh

Cardozo Law Review

On April 7, 2023, a federal judge issued a nationwide stay on the United States Food and Drug Administration (FDA) approval of the abortifacient medication mifepristone. It was instantly a landmark case, decried as the first time in over one-hundred years that a federal court nullified an FDA drug approval. A few hours later, a second federal district court enjoined FDA restrictions on mifepristone. Two federal courts substantively evaluating FDA drug approval data in one day is unprecedented. It begs the question: will courts overturn FDA drug approvals again?

Conventional wisdom says no. Abortion exceptionalism, the trend of legislatures and …

Public Patent Powers, Laura E. Dolbow

Michigan Law Review

Congress has created multiple structures for agencies to control how patents are used, but that institutional design choice has received little academic attention. This Article provides the first comprehensive survey of existing laws that expressly authorize agencies to control patents. I locate 113 express conditions across 68 laws that expressly authorize executive actors to make some form of decision about patents. These powers, which I refer to as “public patent powers,” allow the government to use patented inventions, to obtain patents, to authorize third parties to use patented inventions, and to regulate how patents are used. Agencies have used many …

The False Promise Of Breaking Patents To Lower Drug Prices, Adam Mossoff

St. John's Law Review

The Biden Administration, congressional leaders, and academic commentators have argued that patents cause high drug prices. They have proposed price controls as a solution. They allege that two federal statutes authorize the government to impose price controls on drug patents to lower drug prices: 28 U.S.C. § 1498 and the Bayh-Dole Act.

Neither § 1498 nor the Bayh-Dole Act authorize price controls on patents. Section 1498 is an eminent domain statute that applies only when a patent is used by and for the federal government, such for the military or by the U.S. Postal Service. The Bayh-Dole Act promotes the …

The Big Cost Of Small Farms, Tammi S. Etheridge

Scholarly Articles

Americans love meat. We celebrate our independence with steaks on the grill, we enjoy our favorite pastime with hot dogs, and we give thanks with turkey. Our love of meat is so ingrained in our culture that, historically, small increases in meat prices have driven the populace to riot. Today, meat prices are rising. Simultaneously, the largest meat processors and packagers are seeing record profits. Consumers, in turn, are outraged. Their emotions are being fueled by politicians who blame rising profits on a pandemic of greed and collusion and then argue that rigid antitrust enforcement is the only solution.

This …

Voting Matters: Materiality Considerations And The Shareholder Vote, Renee M. Jones

Seattle University Law Review

For the shareholder franchise to have meaning, shareholders must have access to relevant information to inform their voting decisions. The securities laws’ disclosure requirements play an essential role in informing the shareholder vote.

This Essay focuses on the question of the materiality of information in the context of shareholder voting. It addresses the question of whether ESG-related information is material, positioning the materiality inquiry within the context of shareholders’ voting decisions. It explores the definition of materiality with a focus on the “reasonable investor” concept embedded within the definition. The Essay argues that the implicit expectations of many commentators that …

Fraud In Feeding Our Future: An Analysis Of “The Largest Pandemic Relief Fraud Scheme Yet”, Alena Johnston

Criminal Law Practitioner

Since the 1930s, the public school system in the United States has provided a distinct place for students to develop, learn, and grow.  Public schools level the playing field for students in academics, allowing them to receive an education at no direct cost. However, students from economically disadvantaged backgrounds continue to face challenges, and their inability to secure nutritious meals can affect their ability to perform academically. In 1946, President Harry Truman signed the National School Lunch Act, forming the first Child Nutrition Program in the United States to remedy the food security issue.

 The program was implemented as “a …

Through A Glass Darkly: How Securities Disclosures Give A Distorted View Of The Economy, Gerald F. Davis

Seattle University Law Review

Our understanding of the American economy often relies on stylized facts derived from mandatory disclosures by listed corporations. Data vendors like Standard & Poor’s vacuum up 10Ks and proxy statements into databases, and scholars distill these into tentative maps. This may have been adequate for a postwar economy centered on asset-heavy manufacturers, but it is increasingly out of step with an information-based economy. Companies listed on the stock market are fewer in number and less representative than they were, light in tangible assets and people, and heavy on IP. Basic facts such as what industry they are in are increasingly …

Beyond Agency Authority: Regulating Sulfur Hexafluoride Under An Enhanced Title Ii Framework Of The Clean Air Act, Matthew Gawley

Fordham Environmental Law Review

This paper explores the critical need for robust Congressional action to regulate sulfur hexafluoride (SF6), a greenhouse gas with a global warming potential more than 20,000 times greater than carbon dioxide. Recent Supreme Court decisions––in West Virginia v. EPA and Loper Bright Enterprises v. Raimondo––to restrict EPA authority and end the Chevron doctrine have curtailed federal environmental agencies’ regulatory authority, shifting the responsibility for addressing major environmental challenges back to Congress. Despite being addressed under Title I of the Clean Air Act (CAA) through the 2022 Inflation Reduction Act (IRA), current SF6 regulations prove grossly inadequate. The utilities industry––the largest …

Abundance And Other Food Fixations, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

Although most people in the United States no longer devote the majority of their time to food production, processing, and distribution, food remains a daily fixation. This Article explores three driving food fixations--abundance, thinness, and health--and situates each against an inverse fear--scarcity, fatness, and illness, respectively. Mapping these threats onto U.S. food policy, this Article examines, among other policy arenas, food waste policy, nutrition and health claim labeling law, and food additive regulations. Across food policy, these fixations feed what this Article calls the “politics of abundance.” This politics helps to insulate the food industry from deeper systemic reform aimed …

Article Iii Standing For Cercla Private Cost Recovery Actions: How The Test's Strained Logic Belies Its Authority, Jonathan M. Palacios

Fordham Environmental Law Review

This Note examines how Article III standing doctrine applies to

private plaintiffs’ cost recovery actions under § 107(a)(4)(B) of the

Comprehensive Environmental Response, Compensation, and

Liability Act. A review of judicial decisions reveals inconsistencies

in the analysis of injury in fact and traceability, and suggests that

current Article III standing doctrine is misaligned with its purported

objectives. In response, this Note proposes a structured framework

for assessing injury in fact and a refined approach to analyzing

traceability that distinguishes between different forms of causal

uncertainty. These doctrinal adjustments should better align case

outcomes with Article III standing doctrine’s constitutional and …