Medical Jurisprudence Commons^™

What Is The Trade-Off: Are New Trade Deals Worth The Changes To Pharmaceutical Patents?, Kaitlyn Carter

Marquette Intellectual Property Law Review

None.

Cruzan’S Legacy In Autonomy, Kathy Cerminara

Faculty Scholarship

No abstract provided.

Patents, Information, And Innovation, Brenda M. Simon

Faculty Scholarship

Inventors and commercialization partners often rely on patents to facilitate the exchange of sensitive information. Most scholarship in this area has focused on the areas of software and biotechnology. To provide a richer description of the role of patents in the innovative process, this project evaluates the existing literature and sets forth examples drawn from a series of interviews with professionals from the largely-overlooked medical device industry. The limited analysis of the medical device industry has focused on the largest few dozen firms—as publicly-traded entities, a great deal of data about them is readily available. Small medical device companies are …

A Commitment To The Whole Athlete: Embracing The Role Of Cannabinoids In Collegiate Athletics, Kelli Rodriguez Currie

Seattle University Law Review

Cannabinoids can be a highly effective way for athletes to combat various kinds of pain associated with intense training. Derivatives of cannabis, such as marijuana, have been used for centuries as a form of pain relief. Part I of this Article discusses how cannabinoids are used in sports medicine. Part II discusses the different approaches to marijuana and cannabidiol use across sports leagues. Part III highlights the inconsistencies between the NCAA’s approach to testing for substance abuse and its investment in student-athletes’ well-being. Part IV discusses how the NCAA must focus on student-athlete health. Finally, Part V concludes that the …

In Memory Of Professor James E. Bond, Janet Ainsworth

Seattle University Law Review

Janet Ainsworth, Professor of Law at Seattle University School of Law: In Memory of Professor James E. Bond.

Of Mosquitoes And "Moral Convictions" In The Age Of Zika: How The Trump Administration's Gutting Of The Affordable Care Act's Contraceptive Mandate Jeopardizes Women's And Children's Health, Linda C. Fentiman

Health Matrix: The Journal of Law-Medicine

The Trump Administration’s efforts to undo the contraceptive mandate, a key component of the Affordable Care Act (ACA), threaten a major public health emergency, as well as the rule of law and separation of powers. The Trump Administration’s Rules greatly expand the grounds for exemption from the contraceptive mandate: they allow even publicly traded corporations to assert religious beliefs as a ground for exemption and exempt all employers except publicly traded corporations from compliance with the contraceptive mandate if they hold “moral convictions” in opposition to contraception. By denying women access to effective, affordable contraception, these Rules increase the odds …

Medical Aid In Dying By Telehealth, Konstantin Tretyakov

Health Matrix: The Journal of Law-Medicine

Medical aid in dying is a form of medical treatment recognized in several states and the District of Columbia and available to adult residents of those states who are competent and suffer from a terminal disease. Timely access to it is critical for qualifying patients. The article explores the possibility of facilitating access to medical aid in dying via telehealth—a method of providing health care remotely by means of electronic communication. Specifically, I analyze the feasibility of medical aid in dying by telehealth from clinical and legal perspectives. I also examine a relevant normative issue of the nature of in-person …

Say “No” To Discrimination, “Yes” To Accommodation: Why States Should Prohibit Discrimination Of Workers Who Use Cannabis For Medical Purposes, Anne Marie Lofaso, Lakyn D. Cecil

Seattle University Law Review

This Article addresses the question of how the law should treat medical cannabis in the employment context. Using Colorado as a primary example, we argue that states such as Colorado should amend their constitutions and legislate to provide employment protections for employees who are registered medical cannabis cardholders or registered caregivers.

Part I briefly traces the legal regulation of cannabis from an unregulated medicine known as cannabis to a highly regulated illicit substance known as marijuana under the Controlled Substances Act. Our travail through this history reveals, unsurprisingly, an increasing demonization of cannabis throughout the twentieth century. That socio-legal demonization …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

On Trust, Law, And Expecting The Worst, Elizabeth F. Emens

Faculty Scholarship

This Review has three parts. Part I aims to convey something of the breadth and interest of Hasday’s fascinating new book, foregrounding the role of gender and beginning to touch the subject of trust. Part II delves briefly but widely into the theme of trust, which pervades the book and invites further examination. Part III presents a framework that combines affective trust and epistemic curiosity and applies this framework to illuminate and sort Hasday’s proposals for reform; to critique a recent, dramatic change in the evidentiary treatment of marital confidences; and to devise a novel approach to prenuptial agreements. Throughout, …

Video Advance Directives: Growth And Benefits Of Audiovisual Recording, Thaddeus Pope

Faculty Scholarship

The key question in Cruzan v. Director, Missouri Department of Health was one of substantiation and evidence: how can the incapacitated patient’s surrogate decision maker prove that the health care decisions she makes on the patient’s behalf are the same health care decisions that the patient would have made for herself? Answering this question, the Court observed that an advance directive would constitute adequate proof because an advance directive constitutes clear and convincing evidence of a patient’s wishes.

Today, clinicians and policymakers no longer focus on the constitutional question of how much evidence state law may require from a patient’s …

On The Road Again: Revisiting State Laws That Unreasonably Restrict Drivers With Epilepsy And Burden The Physicians Who Treat Them, Katrina E. Luffy

Loyola University Chicago Law Journal

When a driver with epilepsy experiences a seizure behind the wheel, she is more likely than not to cause an accident. Consequently, all fifty states and the District of Columbia have statutes, regulations, and policies governing drivers with epilepsy and the physicians who treat them. Although these laws aim to protect the states' interest in public safety, many of them are premised on the inaccurate assumption that drivers with epilepsy have higher crash rates than the general population. They provide blanket restrictions for a highly individualized disorder and ignore evidence that drivers with other disorders or diseases should be of …

Minding The Gaps In Regulation Of Do-It-Yourself Biotechnology, Barbara J. Evans

UF Law Faculty Publications

This Symposium confronts the reality that genetic technologies – not just genetic tests, but tools for altering plant, animal, and human genomes – are rapidly becoming and indeed already are consumer technologies. People can experiment with and apply these technologies in disintermediated formats, potentially without the involvement of national research funding agencies, professional scientists, physicians, genetic counselors, regulators, and traditional medical product manufacturers. The framework of 20th -century medical product and practice regulations assigned each of these parties a role in promoting ethical, safe, and effective biomedical research and health care. Do-it-yourself biotechnology (DIYbio), which includes direct-to-consumer (DTC) and do-it-yourself …

Disagreements Within The Us Food And Drug Administration Regarding Approval Of Novel Therapeutic Agents, 2011-2015, Andrea Macgregor, Audrey D. Zhang, Joshua D. Wallach, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Thirty days after a novel therapeutic agent, a new molecular entity, or original biologic is approved, the US Food and Drug Administration (FDA) must publicly disclose its approval package, including scientific reviews completed by FDA disciplines (eg, pharmacology, statistical, and medical reviewers) and any available assessments by agency leadership.1 Although reports of internal disagreement have surfaced,2 it is unclear how often such disagreements occur. Disagreements document differing points of view or engaged discussion and may, thus, capture important scientific debates or signal challenging decisions within the agency. We sought to determine the frequency of disagreements within the FDA regarding approval …

Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens

Articles, Book Chapters, & Popular Press

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials …

Transparency Too Little, Too Late? Why And How Health Canada Should Make Clinical Data And Regulatory Decision-Making Open To Scrutiny In The Face Of Covid-19, Sterling Edmonds, Andrea Macgregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, Matthew Herder

Articles, Book Chapters, & Popular Press

Hard-won gains in the transparency of therapeutic product data in recent years1 have occurred alongside growing reliance by regulators upon expedited review processes.2 The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality.3 The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the …

Assisted Dying And Evidence-Based Law-Making: A Critical Analysis Of An Article’S Role In New Zealand’S Referendum, Ben White, Lindy Willmott, Jocelyn Downie, Andrew Geddis, Colin Gavaghan

Articles, Book Chapters, & Popular Press

Aim: To critically analyse the reliability of an article which claims to be evidence that the End of Life Choice Act 2019 provides a “potential hotspot for family, community and social discord that may not be easily remedied” should the legislation receive public support in New Zealand’s September 2020 referendum.

Method: The subject article was reviewed multiple times by all authors and critiqued against three criteria: a reliability pyramid developed to weigh evidence about assisted dying; principles that guide the conduct of social science research; and the use of reliable and current social science literature to support factual claims.

Results: …

Germany’S Digital Health Reforms In The Covid-19 Era: Lessons And Opportunities For Other Countries, Sara Gerke, Ariel D. Stern, Timo Minssen

Faculty Scholarly Works

Reimbursement is a key challenge for many new digital health solutions, whose importance and value have been highlighted and expanded by the current COVID-19 pandemic. Germany’s new Digital Healthcare Act (Digitale–Versorgung–Gesetz or DVG) entitles all individuals covered by statutory health insurance to reimbursement for certain digital health applications (i.e., insurers will pay for their use). Since Germany, like the United States (US), is a multi-payer health care system, the new Act provides a particularly interesting case study for US policymakers. We first provide an overview of the new German DVG and outline the landscape for reimbursement of digital health solutions …

23anddiverseme: Using Genetic Ancestry Tests To Establish Minority Status, Robert Karl

Health Matrix: The Journal of Law-Medicine

No abstract provided.

The Conscience Defense To Malpractice, Nadia N. Sawicki

Faculty Publications & Other Works

This Article presents the first empirical study of state conscience laws that establish explicit procedural protections for medical providers who refuse to participate in providing reproductive health services, including abortion, sterilization, contraception, and emergency contraception.

Scholarship and public debate about law's role in protecting health care providers' conscience rights typically focus on who should be protected, what actions should be protected, and whether there should be any limitations on the exercise of conscience rights. This study, conducted in accordance with best methodological practices from the social sciences for policy surveillance and legal mapping, is the first to provide concrete data …