Health Law and Policy Commons^™

Amending The Ryan Haight Act: Elevating Telemedicine Law To New Heights, Dillon Vaughn

Texas A&M Law Review

The Ryan Haight Act has established excessive restrictions on controlled substance prescribing through telemedicine by first requiring an in-person exam. If the Act is not amended, many individuals in need of medication will go without proper medical care. While other agencies and states have made moves to expand telehealth, the DEA has dragged its feet on making any significant changes. This Comment argues that the federal government should amend the Ryan Haight Act, allowing telemedicine providers to prescribe controlled substances without an in-person exam. This amendment would focus on the standard of care while requiring stringent documentation by physicians who …

Ivf Errors - Is This Only The Tip Of The Iceberg?, Jody L. Madeira, Steven R. Lindheim Md, Mark P. Trolice

Articles by Maurer Faculty

ART errors are fortunately a rare occurrence. but humans are fallible and mistakes are inevitable. As social media sensationalizes these events, we, as infertility specialists, must be vigilant in reviewing existing risk management systems and consider other options to minimize/eliminate these events. ART programs should work to emphasize honesty and transparency to improve quality of care.

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 …

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

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: …

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

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Under Kemp’S Eye: Analyzing The Constitutionality Of The Heartbeat Restriction In Georgia’S Life Act And Its Potential Impact On Abortion Law, Brittney A. Sizemore

Mercer Law Review

The current state of women’s right to bodily autonomy in the United States has eerily begun to resemble that of the dystopian society depicted in The Handmaid’s Tale. While abortion rates have steadily declined over the last decade, the attempts by state legislatures to restrict or completely take away women’s right to abortion have exponentially increased. In the first six months of 2019 alone, five states passed laws placing restrictions on abortion. These restrictions range from limiting the time frame in which a woman may obtain an abortion to when a fetal heartbeat has been detected—normally around six weeks—to a …

Competency To Decide For Another, Elyn R. Saks

Health Matrix: The Journal of Law-Medicine

Our topic is competency of a Substitute Decisionmaker (SubDM) to make a decision about medical treatment for another who is incompetent himself (the “ward”). While there is Competency to Decide for Another considerable literature on competency to decide for oneself, there is very little on competency to decide for another. Some studies look at a range of things that a SubDM needs to do —for example, seek information on what the ward has said—but there is none on how well a person must understand the relevant issues to be a competent SubDM.

The Paradoxes Of Defensive Medicine, Michael J. Saks, Stephan Landsman

Health Matrix: The Journal of Law-Medicine

For decades, “defensive medicine” has been the leading argument driving reforms of medical malpractice laws throughout the United States. Defensive medicine is the presumed practice of administering excessive tests and treatments as a stratagem for reducing healthcare providers’ risk of malpractice liability, despite the absence of any expected benefit for the patient. The practice is widely believed to exist throughout American healthcare as a response to fears of malpractice litigation, and thought to be enormously wasteful of healthcare dollars. In consequence, it has become a justification for law reforms insulating the healthcare industry from tort liability. These claims are promoted …

The Promise And Failures Of Children's Medicaid And The Role Of Medical-Legal Partnerships As Monitors And Advocates, L. Kate Mitchell

Health Matrix: The Journal of Law-Medicine

For decades we have known that access to early and preventive diagnosis and treatment can dramatically alter the course of a child’s life. Because of this knowledge, immediately after Congress enacted Medicaid, it created the Early and Periodic Screening, Diagnostic and Treatment, or EPSDT, program. EPSDT requires broad, holistic, and preventive care to correct or ameliorate health defects identified in Medicaid-eligible children. This coverage currently extends to 2 out of 5 children in the United States, and 47 percent of children with special health care needs. Because of the broad parameters of coverage mandated by EPSDT, Medicaid-eligible children should receive …

The Off-Label Loophole In The Psychopharmacologic Setting: Prescription Of Antipsychotic Drugs In The Nonpsychotic Patient Population, Lisa E. Smilan

Health Matrix: The Journal of Law-Medicine

U.S. physicians have wide discretion in treating patients with off-label medications. Many consider off-label prescription essential in our country’s health care system, and it is wholly supported by FDA and federal courts. Assumptions about physicians’ expertise, judgments, and commitments to beneficence and nonmaleficence undergird laissez-faire policies that allow and support physicians’ novel and innovate uses of FDA-approved drugs for purposes and populations not studied in original, strictly regulated clinical trials. Though sometimes beneficial, off-label prescribing, which flourishes in privatepractice psychiatry, often harms scores of psychiatric patients. Frequently, potential harms are insufficiently disclosed to patients. In the public health sector, officials …

Why The United States Is Failing New Mothers And How It Can Counteract Its Rapidly Climbing Maternal Mortality Rate, Khouloude Abboud

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Medicalization And The New Civil Rights, Craig Konnoth

Publications

In the last several decades, individuals have advanced civil rights claims that rely on the language of medicine. This Article is the first to define and defend these “medical civil rights” as a unified phenomenon.

Individuals have increasingly used the language of medicine to seek rights and benefits, often for conditions that would not have been cognizable even a few years ago. For example, litigants have claimed that discrimination against transgender individuals constitutes illegal disability discrimination. Others have argued that their fatigue constitutes chronic fatigue syndrome (which was, until recently, a novel and contested diagnosis) to obtain Social Security disability …

Where No One Can Hear You Scream: Regulating The Commercial Space Industry To Ensure Human Safety, Kurt Harris

Health Matrix: The Journal of Law-Medicine

Outstanding Note of the Year (2019)

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 …

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, …

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.

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/.

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 …

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 …

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

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.