Food and Drug Law Commons^™

Army Commander’S Role—The Judge, Jury, & Prosecutor For The Article 15, Anthony Godwin

Seattle University Law Review

Service members in the armed forces are bound by a different set of rules when compared to other U.S. citizens. Some of the normal safeguards and protections that civilians enjoy are much more restrictive for military service members, and this is generally for a good reason. Such restrictions are partly due to the complex demands and needs of the United States military. Congress and the President have entrusted military commanders with special powers that enable them to handle minor violations of law without needing to go through a full judicial proceeding. Non-judicial punishments (NJP), also known as Article 15s, are …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

A Synthesis Of The Science And Law Relating To Eyewitness Misidentifications And Recommendations For How Police And Courts Can Reduce Wrongful Convictions Based On Them, Henry F. Fradella

Seattle University Law Review

The empirical literature on perception and memory consistently demonstrates the pitfalls of eyewitness identifications. Exoneration data lend external validity to these studies. With the goal of informing law enforcement officers, prosecutors, criminal defense attorneys, judges, and judicial law clerks about what they can do to reduce wrongful convictions based on misidentifications, this Article presents a synthesis of the scientific knowledge relevant to how perception and memory affect the (un)reliability of eyewitness identifications. The Article situates that body of knowledge within the context of leading case law. The Article then summarizes the most current recommendations for how law enforcement personnel should—and …

Nestlé V. Doe: A Death Knell To Corporate Human Rights Accountability?, Phillip Ayers

Seattle University Law Review

The Supreme Court in Nestlé v. Doe held that foreign plaintiffs who claimed to be victims of overseas tortious conduct by corporate defendants had no jurisdiction to sue in federal courts using the Alien Tort Statute. This Comment looks at the history of the Alien Tort Statute, from its inspiration, long dormancy, and recent reinvigoration beginning in the 1980s. The Comment then explores the background of Nestlé and its issues with child slavery in its cocoa supply chain. From there, the Comment analyzes the Nestlé v. Doe decision, and posits an alternative outcome. Finally, this Comment looks for a new …

Blood On The Tracks, Thomas D. Russell

Seattle University Law Review

Streetcars were the greatest American tortfeasors of the early twentieth century, injuring approximately one in 331 urban Americans in 1907. This empirical study presents never-before-assembled data concerning litigation involving streetcar companies in California during the early twentieth century.

This Article demonstrates the methodological folly of relying upon appellate cases to describe the world of trial court litigation. Few cases went to trial. Plaintiffs lost about half their lawsuits. When plaintiffs did win, they won very little money. Regarding the bite taken out of the street railway company, the Superior Court was a flea.

Professor Gary Schwartz and Judge Richard Posner …

Off-Label Speech, David A. Simon

Emory Law Journal

This Article argues that the Food and Drug Administration (“FDA”) should regulate drug manufacturer speech about off-label uses based on the evidentiary support for the relevant use. The more evidence that an off-label use is safe and effective, the less restrictive the regulation should be. The less evidence that an off-label use is safe and effective, the more restrictive the regulation should be. Although intuitive, this is not exactly how current regulation of off-label information works. If the FDA approves a drug, the manufacturer can advertise to doctors and patients for the approved indication. Drug manufacturers cannot, however, promote or …

The President’S Remedy–What The Hydroxychloroquine Story Teaches Us About The Need To Limit Off-Lable Prescribing Powers, Jennifer Bard

Catholic University Law Review

When the history of the first year of the United States Government’s response to the COVID-19 virus is written, there is likely to be mention of the still unexplained vehemence with which then president Donald J. Trump made use of his access to social media to promote seldom used anti-malaria drug, hydroxychloroquine, for both the prevention and treatment of COVID-19 despite the active growing opposition of most of the world’s scientists, including his own government scientists. While the use of drugs developed and approved by the FDA for different purposes to combat new diseases, off-label prescribing, is legal in the …

How Public Health Informed Lawmaking Would Address The Rising Synthetic Opioid Death Toll, Jennifer S. Bard

Brooklyn Law Review

The sharply rising deaths associated with use of synthetic opioids in the United States highlight the failure of a legislative strategy focused on reducing the availability of prescription opioids. However, since synthetic opioids prescribed for pain relief have never been a major contributor to either developing opioid dependence or dying from opioid use, it is not surprising that these measures have not only failed to reduce deaths, but have also caused considerable harm to people in need of pain relief. Yet reversing them and taking a public health approach focused on preventing the most serious harms associated with synthetic opioids …

Learning From South Korea’S Covid-19 Response: Why Centralizing The United States Public Health System Is Essential For Future Pandemic Responses, Meghan Ricci

Seattle Journal of Technology, Environmental, & Innovation Law

The COVID-19 pandemic revealed stark differences in governmental preparedness across the globe. The United States, once thought of as a global leader in public health, had the theoretical skill and efficiency to handle the pandemic but failed to utilize those skills and resources during an actual health crisis. In the spring of 2020, everyone watched the U.S.’s reaction to the unfolding of the COVID-19 pandemic due to its historic placeholder as a global leader and innovator. However, the performance of the U.S. in response to the global pandemic disappointed both global commentators and U.S. citizens. This paper will compare the …

Beyond Compulsory Licensing: Pfizer Shares Its Covid-19 Medicines With The Patent Pool, Chenglin Liu

Faculty Articles

On March 15, 2022, the United States, European Union, India, and South Africa reached an agreement on the waiver of intellectual property rights (IP rights) for COVID-19 vaccines. The waiver agreement has rekindled the debate on the balance between IP rights protection and equitable access to medicines during a public health crisis. India, South Africa, and other developing countries maintain that a waiver was the only way to make vaccines affordable and accessible. Leading pharmaceutical companies argue that the waiver will stifle innovation and make lifesaving medicines less accessible. Both sides have seemingly overlooked Pfizer's voluntary agreement with the Medicines …

Antibody Claims And The Evolution Of The Written Description/Enablement Requirement, S Sean Tu, Christopher M. Holman

Faculty Works

No abstract provided.

Permissive Regulation: A Critical Review Of The Regulatory History Of Buprenorphine Formulations In Canada, Abhimanyu Sud, Meghan Mcgee, Barbara Mintzes, Matthew Herder

Articles, Book Chapters, & Popular Press

Suboxone (buprenorphine-naloxone) is an opioid product approved in the US and Canada for the treatment of opioid use disorder. The drug is considered an important response to the opioid overdose epidemic with consistent calls for wider prescribing and deregulation. The history of Suboxone regulation in Canada has not been critically examined. Part of the rationale for doing so stems from the US regulatory experience, with documented irregularities, or what some have called abuses, that support profit-making by Suboxone's manufacturers. This regulatory analysis allows us to determine how opportunities to address health crises through drug innovation are managed at a federal …

Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck

Brooklyn Law Review

Epidemics have devastated humankind for centuries. Given the simultaneous rise of advanced disease prevention and treatment and the great potential for mass public uptake, it is unsurprising that the U.S. pharmaceutical industry has grown to $775 billion in annual sales revenue. It is clear that the commercialization of important public health measures is not without controversy. Of particular debate is that vaccine and other drug manufacturers monopolize their products and control them through patent laws. Yet there is a strong dichotomy between the importance of patents and the need for public access to innovations. This is not to say that …

Off-Label Use In The Twenty-First Century: Most Myths And Misconceptions Mitigated, 54 Uic J. Marshall L. Rev. 1 (2021), James Beck

UIC Law Review

No abstract provided.

Social Justice As A Necessary Guide To Public Health Disaster Response, Stephen S. Hanson

Journal of Health Care Law and Policy

No abstract provided.

Finding Parity Through Preclusion: Novel Mental Health Parity Solutions At The State Level, Ryan D. Kingshill

Dickinson Law Review (2017-Present)

Recently, the federal government has taken numerous steps to promote the equal treatment (also known as parity) of mental and physical health issues. The two most impactful actions are the Mental Health Parity and Addiction Act of 2008 and the Affordable Care Act. These acts focus on the traditional avenue for parity change—insurance regulation. While these acts have improved parity, major gaps in coverage and treatment between mental health/substance use disorder treatment and medical/surgical treatment persist. ERISA Preemption, evasive insurer behavior, lack of enforcement, and lack of consumer education continue to plague patients and healthcare professionals. On its own, federal …

Big Pharma, Big Problems: Covid-19 Heightens Patent-Antitrust Tension Caused By Reverse Payments, Hannah M. Lasting

Seattle University Law Review

In the wake of COVID-19, pharmaceutical companies rushed to produce vaccinations and continue to work on developing treatments, while the tension caused by reverse payments intensifies between patent and antitrust law. Lawmakers must address this tension, and the current pandemic should serve as a catalyst to prompt reform at the legislative level. By amending the Hatch-Waxman Act, lawmakers can ease the increasing strain between patent and antitrust policy concerns. In 2013, the U.S. Supreme Court attempted to resolve this tension in its landmark decision, F.T.C. v. Actavis, but the tension remains as lower courts struggle to produce a uniform standard …

Neither “Post-War” Nor Post-Pregnancy Paranoia: How America’S War On Drugs Continues To Perpetuate Disparate Incarceration Outcomes For Pregnant, Substance-Involved Offenders, Becca S. Zimmerman

Pitzer Senior Theses

This thesis investigates the unique interactions between pregnancy, substance involvement, and race as they relate to the War on Drugs and the hyper-incarceration of women. Using ordinary least square regression analyses and data from the Bureau of Justice Statistics’ 2016 Survey of Prison Inmates, I examine if (and how) pregnancy status, drug use, race, and their interactions influence two length of incarceration outcomes: sentence length and amount of time spent in jail between arrest and imprisonment. The results collectively indicate that pregnancy decreases length of incarceration outcomes for those offenders who are not substance-involved but not evenhandedly -- benefitting white …

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Achieving Better Care In Pennsylvania By Allowing Pharmacists To Practice Pharmacy, Travis Murray

Dickinson Law Review (2017-Present)

Traditionally, state legislatures implemented Prescription Drug Monitoring Programs (“PDMPs”) to assist prescribers, pharmacists, and law enforcement in identifying patients likely to misuse, abuse, or divert controlled substances. PDMP databases contain a catalog of a patient’s recent controlled substances that pharmacies have filled, including the date, location, the quantity of medication filled, and the prescribing health care provider. Prescribers in Pennsylvania have a duty to query the PDMP before prescribing controlled substances in most clinical settings. Pharmacists have a similar duty in Pennsylvania to dispense safe and effective medication therapy to patients and to screen patients for potential signs of misuse, …

Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross

Articles, Book Chapters, & Popular Press

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

Exploring The Food And Drug Administration’S Review And Approval Of Entresto (Sacubitril/Valsartan), Ashley Eadie, Keith Brunt, Matthew Herder

Articles, Book Chapters, & Popular Press

Federal regulatory agencies such as the United States Food and Drug Administration review pharmacological evidence to ensure the safety and efficacy of new and repurposed pharmaceuticals prior to market approval. The discussions, disagreements and procedural decisions contained within such reviews offer unique insight into a pharmaceutical's strengths, weaknesses and opportunities, yet are often overlooked as a significant source of pharmacological information for research and development. To highlight the value of such resources, we present a case study on Entresto, a first-in-class angiotensin receptor-neprilysin inhibitor for the treatment of heart failure with reduced ejection fraction, and explore the regulatory rationale underlying …

In The Name Of Public Health: Misoprostol And The New Criminalization Of Abortion In Brazil, Mariana Prandini Assis, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article explores the criminal regulation of misoprostol as a controlled drug in Brazil as a new form of abortion criminalization. A qualitative analysis of Brazilian case law shows how the courts use a public health rhetoric of unsafe abortion to criminalize the distribution of misoprostol in the informal sector. Rather than an invention of the local bench, this judicial rhetoric reflects global public health discourse and policy on unsafe abortion and the double life of misoprostol as both an essential medicine and a controlled drug. In contrast to previous studies, the article shows that abortion criminalization is not the …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Patent Eligibility And Investment, David O. Taylor

Cardozo Law Review

Have the Supreme Court's recent patent eligibility cases changed the behavior of venture capital and private equity investment firms, and if so how? This Article provides empirical data about investors' answers to those important questions. Analyzing responses to a survey of475 investors at firms investing in various industries and at various stages of funding, this Article explores how the Court's recent cases have influenced these firms' decisions to invest in companies developing technology. The survey results reveal investors' overwhelming belief that patent eligibility is an important consideration in investment decision making, and that reduced patent eligibility makes it less likely …

Fertility Fraud And Proposal For Florida Legislation, Cheyenne Dunn

Child and Family Law Journal

No abstract provided.

(Almost) No Bad Drugs: Near-Total Products Liability Immunity For Pharmaceuticals Explained, Anita Bernstein

Washington and Lee Law Review

This Article explores four beliefs about supposed pharma-benevolence that appear to be shared by more than the industry, reaching the level almost of conventional wisdom. These figurative pillars help support one-sided results in court. However, each of the pillars on examination turns out at least a bit shaky. This Article puts them forward for review to start a necessary discussion.

The locus of this Article is products liability, where a court concludes that a manufactured object is defective or could be called defective by a factfinder following a trial. Drug manufacturers enjoy near-immunity from this consequence. Modern products liability identifies …

Illegitimate Medical Purpose: Resolving The Fundamental Flaw In Criminal Prosecutions Involving Physicians Charged With Overprescribing Prescription Opioids, Jacob C. Hanley

Duquesne Law Review

No abstract provided.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents