Medical Jurisprudence Commons^™

Need For Harmonized Terminology In Cryopreservation To Support Reproducibility, Regulation, And Translation, Susan Wolf, Lakshya Gangwar, Lowell Wolfe, Nikolas Zuchowicz, Irina Filz Von Reiterdank, Srivasupradha Ramesh, Bat-Erdene Namsrai, Joseph Kangas, Joseph Sushil Rao, Matthew Powell-Palm, Timothy L. Pruett, John C. Bischof, Korkut Uygun

Articles

As cryopreservation technologies continue to develop, the need for harmonized terminology across the multitude of disciplines where cryopreservation is applied is becoming increasingly acute. Terminology in cryopreservation remains inconsistent, leading to confusion and barriers to progress. Applications of cryopreservation in medicine, food, agriculture, and conservation remain limited by this lack of consensus. Inconsistent terminology contributes to ethical, legal, and societal issues in translating and integrating new cryopreservation technologies. Here we identify the problem with examples of cryopreservation terminology that demand harmonization. We describe the need for terminological consistency by providing examples of effective terminology harmonization projects in related fields. We …

Monitoring, Oversight, And Learning In Medical Ai, W. Nicholson Price Ii

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When medical AI errs, it often goes unnoticed. If there’s a specific patient injury, and the link to AI is obvious, that problem might be reported to the Food and Drug Administration (FDA), but not always. And many other types of problems, like worse performance on specific groups or ineffective integration into health system workflows, simply don’t fall within the contours of regularized reporting. Even if they are noticed by the health system—far from a given—there’s no obvious way to share that information more broadly. Against this backdrop, there are justified calls for better oversight and reporting. But there’s the …

Revoluntionizing Brain Research Using Portable Mri In Field Settings: Public Perspectives On The Ethical And Legal Challenges, Molly K. Madzelan, Frances Lawrenz, Susan Wolf, Francis X. Shen

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Introduction

New, highly portable MRI (pMRI) technology promises to revolutionize brain research by facilitating field-based studies that can expand research to new settings beyond the traditional MRI suite in a medical center. At this early stage of development, understanding public knowledge and attitudes about pMRI research is crucial.

Objective In this article we present the first empirical study of the general public’s willingness to participate in pMRI research, and their perceptions of expected benefits and concerns.

Methods & Results

We conducted a nationally representative online survey (N = 2,001) administered Aug. 15-31, 2022. We found that respondents were overwhelmingly willing …

Clinicians In The Loop Of Medical Ai, W. Nicholson Price Ii

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As medical AI begins to mature as a health-care tool, the task of governance grows increasingly important. Ensuring that medical AI works, works where it’s used, and works for the patient in the moment is a challenging, multifaceted task. Some of this governance can be centralized—in review by FDA or by national accreditation labs, for instance. Some must be local, performed by the hospital or health system about to use the product in their own, unique environment. But a large amount of governance is left to the individual provider in the room, the human in the loop who presumably knows …

Do Specialized Medical Llms Demand A Radically New Approach Under The Eu's Medical Device Regulation, Hannah Louise Smith, W. Nicholson Price Ii

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We examine the arguments made by Onitiu and colleagues concerning the need to adopt a “backward-walking logic” to manage the risks arising from the use of Large Language Models (LLMs) adapted for a medical purpose. We examine what lessons can be learned from existing multi-use technologies and applied to specialized LLMs, notwithstanding their novelty, and explore the appropriate respective roles of device providers and regulators within the ecosystem of technological oversight.

We Don't Talk About Insurance (No, No, No!), Anthony J. Sebok

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Kenneth S. Abraham and Catherine M. Sharkey's The Glaring Gap in Tort Theory has a dramatic title. The article, which is about the unheralded and unappreciated role that liability insurance plays in tort, promises to make good on two claims-first, that the major (or a major) "missing piece" in modern tort scholarship is liability insurance, and second, once this missing piece is identified, it is impossible to ever see tort law the same way again.

Navigating The Conundrum Of Mandatory Reporting Under The Pocso Act: Implications For Medical Professionals, Nanditta Batra

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To address the under reporting of sexual offences against children, the Protection of Children from Sexual Offences (POCSO) Act, 2012, makes reporting of such offences mandatory. The duty to report such offences has been extended to healthcare professionals. The inclusion of healthcare professionals within mandatory reporting, however, strikes at the very foundation of the doctor-patient relationship based on trust and confidentiality and conflicts with the patient confidentiality safeguards of the Mental Healthcare Act, 2017. It also has unintended public health consequences, such as denial of medical termination of pregnancy due to fear of prosecution under POCSO. An urgent reassessment of …

National Medical Commission Act, 2019: The Need For Parity, Ov Nandimath, S. Suhas, Y. Malik, B.C. Malathesh

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The National Medical Commission (NMC) has replaced the erstwhile Medical Council of India with the intention of bringing about positive reforms in medical education and enforcing ethical standards in the practice of medicine in India. The NMC Act of 2019, under clauses 3 and 4 of Section 30, details the procedure of grievance redressal. However, these clauses in their current form empower doctors and patients unequally. While the Act empowers an aggrieved medical professional to approach the relevant appellate fora under the NMC, it is silent on a similar opportunity for an aggrieved patient or caregiver to appeal against the …

Trade Transparency: A Call For Surfacing Unseen Deals, Kathleen Claussen

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For many years, the executive branch has concluded foreign commercial agreements with trading partners pursuant to delegated authority from Congress. The deals govern the contours of a wide range of U.S. inbound and outbound trade: from food safety rules for imported products to procedures and specifications of exported goods, to name two. The problem is that often no one-apart from the executive branch negotiators- knows what these deals contain. A lack of transparency rules has inhibited the publication of and reporting to Congress of these unseen deals. Dozens if not hundreds of foreign commercial deals are unseen in two ways: …

Courts Beyond Judging, Michael C. Pollack

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Across all fifty states, a woefully understudied institution of government is responsible for a broad range of administrative, legislative, law enforcement, and judicial functions. That important institution is the state courts. While the literature has examined the federal courts and federal judges from innumerable angles, study of the state courts as institutions of state government — and not merely as sources of doctrine and resolvers of disputes — has languished. This Article remedies that oversight by drawing attention for the first time to the wide array of roles state courts serve, and by evaluating the suitability of both the allocation …

Feigned Consensus: Usurping The Law In Shaken Baby Syndrome/Abusive Head Trauma Prosecutions, Keith A. Findley, D. Michael Risinger, Patrick D. Barnes, Julie A. Mack, David A. Moran, Barry C. Scheck, Thomas L. Bohan

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Few medico-legal matters have generated as much controversy--both in the medical literature and in the courtroom--as Shaken Baby Syndrome (SBS), now known more broadly as Abusive Head Trauma (AHT). The controversies are of enormous significance in the law because child abuse pediatricians claim, on the basis of a few non-specific medical findings supported by a weak and methodologically flawed research base, to be able to “diagnose” child abuse, and thereby to provide all of the evidence necessary to satisfy all of the legal elements for criminal prosecution (or removal of children from their parents). It is a matter, therefore, in …

Deploying Mindfulness To Gain Cognitive Advantage: Considerations For Military Effectiveness And Well-Being, Amishi P. Jha, Scott L. Rogers, Eric Schoomaker, Edward Cardon

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Mindfulness involves paying attention to present moment experience without discursive commentary or emotional reactivity. Mindfulness training (MT) programs aim to promote this mental mode via introduction to specific mindfulness exercises, related in-class discussion, and ongoing engagement in mindfulness exercises. MT is being increasingly offered to high-demand, high-stress military/uniformed and civilian cohorts with a wide array of reported benefits. Herein, we begin by discussing recent theoretical models regarding MT’s mechanisms of action from a cognitive training/cognitive neuroscience perspective, which propose that MT engages and strengthens three key processes [e.g., 1]. These are: 1) attentional orienting, which is the ability to select …

When Ais Outperform Doctors: Confronting The Challenges Of A Tort-Induced Over-Reliance On Machine Learning, A. Michael Froomkin, Ian Kerr, Joelle Pineau

Articles

Someday, perhaps soon, diagnostics generated by machine learning (ML) will have demonstrably better success rates than those generated by human doctors. What will the dominance of ML diagnostics mean for medical malpractice law, for the future of medical service provision, for the demand for certain kinds of doctors, and in the long run for the quality of medical diagnostics itself?

This Article argues that once ML diagnosticians, such as those based on neural networks, are shown to be superior, existing medical malpractice law will require superior ML-generated medical diagnostics as the standard of care in clinical settings. Further, unless implemented …

How Neuroscience Technology Is Changing Our Understanding Of Brain Injury, Vegetative States And The Law, Glenn R. Butterton

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The author examines clinical studies that use neuroscience technology to study patients in Vegetative States. The studies indicate that some of the patients are, in fact, conscious. The author suggests that this finding is a matter of considerable practical importance for the drafting and execution of end-of-life protocols such as Advance Directives and Living Wills. He recommends that statutes, and other guidance used by patients, caregivers, medical institutions, family members and others to draft and interpret such Directives and Wills, be revised or amended to take account of these results.

Conviction Integrity Units Revisited, Barry Scheck

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“Conviction Integrity Unit” has become a brand name that has good public relations value for an elected official. But what does it really mean? Is it just a fashion accessory, a flashy but empty appellation intended to convey the idea that the office is extremely serious about correcting wrongful convictions and holding its own members accountable for errors or acts of misconduct, but really is not? Is conviction integrity nothing more than a passing fad, a nebulous slogan without real meaning that is good for propaganda purposes, but will not bring about any serious change in the way business is …

Success And Failure In Adr: A Dialogue Between Partners, Lela P. Love, Joseph B. Stulberg

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Love and Stulberg critically discuss policy, scholarly, and practice developments in four areas of program development in the area historically referenced as alternative dispute resolution (ADR): the range of process options; the impact of court procedures on ADR program development and practice; the nature of ADR scholarship and training; and the general public's receptiveness to or rejection of the normative principles that structure ADR collaborative processes. Their concluding remarks suggest that the promise of ADR, particularly of the mediation process, remains inspiring to many, even if its effective implementation remains uneven.

Shaken Baby Syndrome, Abusive Head Trauma, And Actual Innocence: Getting It Right, Keith A. Findley, Patrick D. Barnes, David A. Moran, Waney Squier

Articles

In the past decade, the existence of shaken baby syndrome (SBS) has been called into serious question by biomechanical studies, the medical and legal literature, and the media. As a result of these questions, SBS has been renamed abusive head trauma (AHT). This is, however, primarily a terminological shift: like SBS, AHT refers to the two-part hypothesis that one can reliably diagnose shaking or abuse from three internal findings (subdural hemorrhage, retinal hemorrhage, and encephalopathy) and that one can identify the perpetrator based on the onset of symptoms. Over the past decade, we have learned that this hypothesis fits poorly …

Malpractice Suits And Physician Apologies In Cancer Care, Eugene Chung, Jill R. Horwitz, John A.E. Pottow, Reshma Jagsi

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Conside the following case: The patient is a 44-year-old woman who presents for radiation treatment of an isolated locoregional recurrence of breat cancer in her chest wall, 3 years after undergoing masectomy. At the time of diagnosis, she had T2N2M0 disease, with four of 15 lymph nodes involved with tumor. She received a masectomy with negative margins and appropriate chemotherapy, but none of her physicians talked to her about postmasectomy radiation therapy, which would clearly have been indicated to reduce her risk of locoregional failure and would have been expected to improve her likelihood of survival. She asks the radiation …

The Multiple Common Law Roots Of Charitable Immunity: An Essay In Honor Of Richard Epstein's Contributions To Tort Law, Jill R. Horwitz

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Professor Epstein has long promoted replacing tort-based malpractice law with a new regime based on contracts. In Mortal Peril, he grounded his normative arguments in favor of such a shift in the positive, doctrinal history of charitable immunity law. In this essay, in three parts, I critique Professor Epstein’s suggestion that a faulty set of interpretations in charitable immunity law led to our current reliance on tort for malpractice claims. First, I offer an alternative interpretation to Professor Epstein’s claim that one group of 19th and early 20th century cases demonstrates a misguided effort to protect donor wishes. Rather, I …

The Paternalistic Ideology Of Erisa And Unforgiving Courts: Restoring Balance Through A Grand Bargain, Edward A. Zelinsky

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No abstract provided.

The Use Of Litigation Screenings In Mass Torts: A Formula For Fraud?, Lester Brickman

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The article critically examines the pervasive abuse of litigation screenings in mass tort cases, revealing a system driven by financial exploitation where medical evaluations are manipulated to generate lawsuits. These screenings, often designed to produce false positives, undermine the integrity of the legal system by creating a flood of specious claims. The analysis highlights how lawyers, doctors, and screening companies exploit legal loopholes and financial incentives, leading to billions of dollars in settlements and eroding public trust in the civil justice system.

Jesting Pilate, Carl E. Schneider

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I have two goals this month. First, to examine a case that's in the news. Second, to counsel skepticism in reading news accounts of cases. Recently, I was talking with an admirable scholar. He said that transplant surgeons sometimes kill potential donors to obtain their organs efficiently. He added, "This isn't just an urban legend - there's a real case in California." A little research turned up California v. Roozrokh. A little Googling found stories from several reputable news sources. Their headlines indeed intimated that a transplant surgeon had tried to kill a patient to get transplantable organs. CNN.com: …

The Standard Of Care For Health Providers In Idaho, Monique C. Lillard

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No abstract provided.

Can Glucksberg Survive Lawrence? Another Look At The End Of Life And Personal Autonomy, Yale Kamisar

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In Washington v. Glucksberg, the Court declined to find a right to physician-assisted suicide ("PAS") in the Constitution. Not a single Justice dissented. One would expect such a ruling to be quite secure. But Lawrence v. Texas, holding that a state cannot make consensual homosexual conduct a crime, is not easy to reconcile with Glucksberg. Lawrence certainly takes a much more expansive view of substantive due process than did Glucksberg. It is conceivable that the five Justices who made up the Lawrence majority-all of whom still sit on the Court-might overrule Glucksberg. For various reasons, …

Midstream Mediator Evaluations And Informed Consent, John W. Cooley, Lela P. Love

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No abstract provided.

Drugged, Carl E. Schneider

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The Supreme Court's recent decision in Gonzales v. Oregon, like its decision last year in Gonzales v. Raich (the "medical marijuana" case), again raises questions about the bioethical consequences of the Controlled Substances Act. When, in 1970, Congress passed that act, it placed problematic drugs in one of five "schedules," and it authorized the U.S. attorney general to add or subtract drugs from the schedules. Drugs in schedule II have both a medical use and a high potential for abuse. Doctors may prescribe such drugs if they "obtain from the Attorney General a registration issued in accordance with the …

Liability, Regulation And Policy In Surgical Innovation: The Cutting Edge Of Research And Therapy, Anna C. Mastroianni

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This article examines the implications of the foregoing competing claims from a U.S. legal perspective, focusing particularly on how the legal system addresses patient safety concerns and autonomous decision-making of surgeons in the context of surgical innovation. The lack of oversight and the risks borne by patients during surgeons' development and subsequent refinement of a novel procedure must be balanced with the need to encourage medical progress through the development of improved techniques designed to benefit the health of current and future patients. This article argues that current reliance on the medical malpractice system and the federal regulatory system of …

The Intersection Of Evaluation Be Mediators And Informed Consent: Warning The Unwary, Lela P. Love, John W. Cooley

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No abstract provided.

Sports Medicine Conflicts: Team Physicians Vs. Athlete-Patients, Steve P. Calandrillo

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Team physicians for professional sports franchises face a conflict of interest created by the competing loyalties they owe to the team that employs them and to the athlete-patient they must treat. Marketing agreements under which physicians pay significant sums of money to be designated as the team's "official healthcare provider" exacerbate this conflict. These marketing arrangements call into question the independent judgment of team physicians and cause players to question the quality of care they receive.

This paper explores several solutions to the growing conflicts between athletes and team doctors with the goal of enhancing players' trust in the medical …

Making Lawyers Compete, Lester Brickman

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The article argues that the market for contingent-fee-financed tort litigation is not price competitive, primarily due to uniform contingency fees charged by lawyers regardless of case-specific factors such as risk or effort required. This lack of competition leads to excessive costs for claimants and contributes to the expansion of tort liability. The author contends that the legal profession maintains this system through various barriers, including ethical rules and entry restrictions, which prevent competitive market forces from functioning effectively.