Medical Jurisprudence Commons^™

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 …

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: …

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 …

Encomium For Karen Rothenberg, Ellen W. Clayton

Vanderbilt Law School Faculty Publications

Karen is also a zealous advocate in the very best sense of the word. After Struewing's article appeared, she wrote an editorial that appeared in multiple newspapers arguing that women with these variants should not lose their insurance. She became deeply involved in the National Action Plan for Breast Cancer, a powerful grass roots organization. Additionally, she became involved at the National Institutes of Health and addressed, often in leadership roles, such issues to develop strategies to prevent genetic discrimination for individuals with variants that increased the risk of developing cancer, to create tools to obtain meaningful informed consent for …

Unjust Timing Limitations In Genetic Malpractice, Ellen W. Clayton, Gary Marchant, Bonnie Leroy, Lauren Clatch

Vanderbilt Law School Faculty Publications

As genomic data are increasingly being collected and applied in clinical care, physicians, laboratories, and other health care providers are more frequently being sued for alleged medical malpractice or negligence. Because the genetic underpinnings of an existing or future health condition may not be immediately apparent, such cases sometimes raise unique timing issues involving the applicable statute of limitations, statute of repose, or statutory notification requirements. Although these timing limitations on when a lawsuit can be brought have important policy rationales and justifications, such as helping to protect providers from open-ended liability, their application to genetic liability cases may sometimes …

Key Expert Stakeholder Perceptions Of The Law Of Genomics: Identified Problems And Potential Solutions, Lauren E. Clatch

Law Faculty Publications

The law on human genomics in the United States is currently in transition and under debate. The rapid evolution of the science, burgeoning clinical research, and growing clinical application pose serious challenges for federal and state law. Newer genomic assays, such as gene panels, whole exome and whole genome sequencing that can assess many or all of a patient’s genetic variants are different from former genetic assays that consist of assessing for variants in specific genes that indicate risk for medical conditions and for single-gene Mendelian disorders. Overall, single-gene genetic testing has primarily been used for risk prediction, disease diagnosis, …

Medical Civil Rights As A Site Of Activism: A Reply To Critics, Craig Konnoth

Publications

See Craig Konnoth, Medicalization and the New Civil Rights, 72 Stan. L. Rev. 1165 (2020).

See also Rabia Belt & Doron Dorfman, Response, Reweighing Medical Civil Rights, 72 Stan. L. Rev. Online 176 (2020), https://www.stanfordlawreview.org/online/reweighing-medical-civil-rights/; Allison K. Hoffman, Response, How Medicalization of Civil Rights Could Disappoint, 72 Stan. L. Rev. Online 165 (2020), https://www.stanfordlawreview.org/online/how-medicalization-of-civil-rights-could-disappoint/.

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

Association Between State Policies Using Medicaid Exclusions To Sanction Noncompliance With Welfare Work Requirements And Medicaid Participation Among Low-Income Adults, Atheendar S. Venkataramani, Elizabeth F. Bair, Erica Dixon, Kristin A. Linn, William J. Ferrell, Kevin G. Volpp, Kristen Underhill

Faculty Scholarship

Twenty states have pursued community engagement requirements (ie, work requirements) as a condition for Medicaid eligibility among adults considered able-bodied. Work requirements seek to improve health by incentivizing work, but may result in coverage losses.

The impact of work requirements on Medicaid coverage may extend beyond qualifying beneficiaries, by increasing confusion around benefit rules or deterring individuals from applying for coverage. However, the spillover effects of work requirements on individuals not directly subject to them are difficult to study because these programs have only recently been implemented. To examine this possibility, we studied Temporary Assistance for Needy Families (TANF), the …

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, …

How Much Do Expert Opinions Matter? An Empirical Investigation Of Selection Bias, Adversarial Bias, And Judicial Deference In Chinese Medical, Chunyan Ding

Brooklyn Journal of International Law

This article investigates the nature of the operation and the role of expert opinions in Chinese medical negligence litigation, drawing on content analysis of 3,619 medical negligence cases and an in-depth survey of judges with experience of adjudicating medical negligence cases. It offers three major findings: first, that both parties to medical negligence disputes show significant selection bias of medical opinions, as do courts when selecting court-appointed experts; second, expert opinions in medical negligence litigation demonstrate substantial adversarial bias; third, courts display very strong judicial deference to expert opinions in determining medical negligence liability. This article fills the methodological gap …

Pharmaceutical Drug Pricing: The Internet As A Solution For This Health Issue Turned Financial Issue, Thomas P. Kelly

Brooklyn Journal of Corporate, Financial & Commercial Law

Over the course of five decades, American annual expenditure on pharmaceutical drugs has increased by more than $350 billion. This drastic increase has led many patients to struggle to afford their necessary, and potentially life-saving, medications. Today’s high pharmaceutical prices are largely due to the fact that name-brand drug manufacturers have few restrictions on how much they can charge for their products. Additionally, name-brand manufacturers are able to monopolize the manufacture of their drugs because patent laws prevent other manufacturers from using the formula of these drugs for two decades. To combat these high prices, this Note proposes a partnership …

Parens Patriae And Parental Rights: When Should The State Override Parental Medical Decisions?, Elchanan G. Stern

Journal of Law and Health

Alfie Evans was a terminally ill British child whose parents, clinging to hope, were desperately trying to save his life. Hospital authorities disagreed and petitioned the court to enjoin the parents from removing him and taking him elsewhere for treatment. The court stepped in and compelled the hospital to discontinue life support and claimed that further treatment was not in the child’s best interest. This note discusses the heartbreaking stories of Alfie and two other children whose parents’ medical decisions on their behalf were overridden by the court. It argues that courts should never decide that death is in a …

Protecting Health Information In Utero: A Radical Proposal, Luke Isaac Haqq

Journal of Law and Policy

This Article introduces an underappreciated space in which protected health information (“PHI”) remains largely unprotected, a fact that will become only more problematic as clinical medicine increasingly turns to genomics. The past decade has seen significant advances in the prevention of birth defects, especially with the introduction of clinical preconception, prenatal, and neonatal genomic sequencing. Parental access to the results of embryonic and fetal clinical sequencing is critical to reproductive autonomy; results can provide parents with important considerations in determining whether to seek or avoid conception, as well as in deciding whether to carry a pregnancy to term. The information …

Combatting The Opioid Epidemic In Texas By Holding Big Pharma Manufacturers Liable, Katherine Spiser

St. Mary's Law Journal

Abstract forthcoming

The Road To Provider Status: Legislative Obstacles And Precursors, Todd A. Tucker Jr., Sarah Turley, Kaila Bollinger, Lara Long, Jenelle Sobotka, Amy Fanous

Pharmacy and Wellness Review

No abstract provided.

Prescription Drug Abuse: What Are We Doing About It?, Heather Helsel, Thomas Otroba, Juliana Zschoche, Brandon Haas

Pharmacy and Wellness Review

No abstract provided.

Genetic Predispositions To Opioid Addiction, Legislative Action And Implications To Pharmacy Practice, Adam N. Trimble, David N. Jones, Courtney L. Salvino, Michael M. Milks, David Kisor

Pharmacy and Wellness Review

Prescription pain-relievers can be powerfully effective agents in the treatment of moderate to severe pain; however, these drugs are also strongly associated with drug abuse and addiction. In the brain, opioid analgesics bind to various receptors in the mesocorticolimbic dopaminergic pathways, which play a multifaceted interaction of role in reward. Several specific single nucleotide polymorphisms (SNPs) have been identified as potential genetic factors that increase an individual's risk for addiction; however, confounding studies and lack of large trials prohibit definitive conclusions from being drawn. As a result of genetic testing, federal and state laws have been enacted to protect individuals …