Medical Jurisprudence Commons^™

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 …

Torts: Just Walk Away: How An Overbroad Foreseeability Of Harm Standard Could Kill “Curbside Consultations” — Warren V. Dinter, 926 N.W.2d 370 (Minn. 2019), Erika Miller

Mitchell Hamline Law Review

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.

The Importance Of Doctor Liability In Medical Malpractice Law: China Versus The United States, Vincent R. Johnson

St. Mary's Journal on Legal Malpractice & Ethics

Medical malpractice law in China does not work. Disappointed patients and their families, or the gangs they hire, frequently resort to physical violence, beating up doctors and disrupting hospital activities in order to extort settlements. This happens because Chinese law has failed to provide viable remedies to many victims of medical malpractice.

This dysfunctional situation (medical chaos or yinao) has persisted for more than two decades. Today, parents in China discourage their children from attending medical school because practicing medicine is too dangerous.

Reforming Chinese medical malpractice law will be difficult. Many factors contribute to the public’s lack of confidence …

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 …

The Injustice Of New York’S Notice Of Claim Limitations In Medical Malpractice Actions, Jessica Simon

NYLS Law Review

No abstract provided.

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)

The Current Application Of The Myriad And Mayo/Alice Rulings On Patent Eligibility: Inconsistent Results And Contradistinguishing Biotechnology Products, Skye Cho

Cardozo Arts & Entertainment Law Journal

The note examines the inconsistent application of the patent eligibility framework under Section 101 of the Patent Act, particularly in biotechnology. It argues that despite efforts by the USPTO to clarify the framework through memos and examples, courts have applied it inconsistently, leading to discrimination against biotechnology products. The analysis focuses on key Supreme Court decisions, such as Myriad Genetics and Mayo, and their impact on the patent eligibility of biotechnological innovations. The note highlights the need for clearer guidance to ensure consistent outcomes and fair treatment of biotechnological inventions.

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 …

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/.

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, …

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 …