Medical Jurisprudence Commons^™

The Legal Provisions Of The Dna In Light Of Seeking To Ensure Effectiveness In The Determination Of Descent, Bassim Chihab

UAEU Law Journal

The discovery of DNA was a turning point in the legal evidence system, With the pursuit of individuals and States to access the facts and to the inability of traditional evidence to meet the need, Both the legislation and the judiciary have moved towards DNA, as an amazing scientific discovery that provides precise answers to vague questions.

As is the case, developed countries have been credited with discovering and prioritizing DNA, In the Arab countries, and specifically in matters of personal status, there is a keen concern not to harm the family rights system, because they are constants, but on …

Kidney, Money, And The Shī‘Ah Implementation Of The Rule Of Necessity, Zahra Takhshid

Sturm College of Law: Faculty Scholarship

In the U.S., over 43,000 people die every year waiting for a kidney. In Iran, however, monetary incentives have eliminated such a waitlist. Iran is the only country in the world with an unrelated living kidney donor program that has allowed for monetary incentives in the form of an altruistic gift, which has become known as “the Iranian Model.” Nevertheless, the legal details of the system remain vague and scholars both in and outside of Iran continue to debate the nature of the system. Does the Iranian system consider kidneys a commodity? Can you legally buy a kidney in Iran? …

Envisioning The Ftc As A Facilitator Of Blockchain Technology Adoption In The Direct-To-Consumer Genetic Testing Industry, Noah Spector

Vanderbilt Journal of Entertainment & Technology Law

Seemingly overnight, the kingpins of the direct-to-consumer genetic testing (DTC-GT) industry shifted their focus from exploring their customers’ DNA to commodifying it. Companies like Ancestry or 23andMe that were once exclusively known as mere sources of “infotainment” now regularly sell consenting customers’ genetic data to pharmaceutical researchers or use it to develop drugs of their own. To gain these customers’ consent, both firms employ a series of long, complex clickwrap contracts that largely fail to apprise their readers of the potential risks of sharing their genetic data. Nor do these agreements provide any form of compensation to those consumers whose …

Off-Label Use In The Twenty-First Century: Most Myths And Misconceptions Mitigated, 54 Uic J. Marshall L. Rev. 1 (2021), James Beck

UIC Law Review

No abstract provided.

The Reliability Of Statements Made For Medical Diagnosis Or Treatment: A Medical – Legal Analysis Of A Hearsay Exception, 54 Uic L. Rev. 679 (2021), Marc Ginsberg

UIC Law Review

No abstract provided.

Social Justice As A Necessary Guide To Public Health Disaster Response, Stephen S. Hanson

Journal of Health Care Law and Policy

No abstract provided.

"As Long As I'M Me": From Personhood To Personal Identity In Dementia And Decision-Making, James Toomey

Elisabeth Haub School of Law Faculty Publications

As people, especially older people, begin to develop dementia, we confront ethical questions about when and how to intervene in their increasingly compromised decision-making. The prevailing approach in philosophically-inclined bioethics to tackling this challenge has been to develop theories of “decision-making capacity” based on the same characteristics that entitle the decisions of moral persons to respect in general. This Article argues that this way of thinking about the problem has missed the point. Because the disposition of property is an identity-dependent right, what matters in dementia and decision-making is an individual’s personal identity with their prior self, not their moral …

Health Ai For Good Rather Than Evil? The Need For A New Regulatory Framework For Ai-Based Medical Devices, Sara Gerke

Faculty Scholarly Works

Artificial intelligence (AI), especially its subset machine learning, has tremendous potential to improve health care. However, health AI also raises new regulatory challenges. In this Article, I argue that there is a need for a new regulatory framework for AI-based medical devices in the U.S. that ensures that such devices are reasonably safe and effective when placed on the market and will remain so throughout their life cycle. I advocate for U.S. Food and Drug Administration (FDA) and congressional actions. I focus on how the FDA could - with additional statutory authority - regulate AI-based medical devices. I show that …

Big Pharma, Big Problems: Covid-19 Heightens Patent-Antitrust Tension Caused By Reverse Payments, Hannah M. Lasting

Seattle University Law Review

In the wake of COVID-19, pharmaceutical companies rushed to produce vaccinations and continue to work on developing treatments, while the tension caused by reverse payments intensifies between patent and antitrust law. Lawmakers must address this tension, and the current pandemic should serve as a catalyst to prompt reform at the legislative level. By amending the Hatch-Waxman Act, lawmakers can ease the increasing strain between patent and antitrust policy concerns. In 2013, the U.S. Supreme Court attempted to resolve this tension in its landmark decision, F.T.C. v. Actavis, but the tension remains as lower courts struggle to produce a uniform standard …

The Need For A System View To Regulate Artificial Intelligence/Machine Learning-Based Software As Medical Devices, Sara Gerke, Boris Babic, Theodoros Evgeniou, I. Glenn Cohen

Faculty Scholarly Works

Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized treatment plans. However, the emergence of AI/ML in medicine also creates challenges, which regulators must pay attention to. Which medical AI/ML-based products should be reviewed by regulators? What evidence should be required to permit marketing for AI/ML-based software as a medical device (SaMD)? How can we ensure the safety and effectiveness of AI/ML-based SaMD that may change over time as they are applied to new data? The U.S. Food and Drug …

Neither “Post-War” Nor Post-Pregnancy Paranoia: How America’S War On Drugs Continues To Perpetuate Disparate Incarceration Outcomes For Pregnant, Substance-Involved Offenders, Becca S. Zimmerman

Pitzer Senior Theses

This thesis investigates the unique interactions between pregnancy, substance involvement, and race as they relate to the War on Drugs and the hyper-incarceration of women. Using ordinary least square regression analyses and data from the Bureau of Justice Statistics’ 2016 Survey of Prison Inmates, I examine if (and how) pregnancy status, drug use, race, and their interactions influence two length of incarceration outcomes: sentence length and amount of time spent in jail between arrest and imprisonment. The results collectively indicate that pregnancy decreases length of incarceration outcomes for those offenders who are not substance-involved but not evenhandedly -- benefitting white …

Unilateral Burdens And Third-Party Harms: Abortion Conscience Laws As Policy Outliers, Nadia N. Sawicki

Faculty Publications & Other Works

Most conscience laws establish nearly absolute protections for health care providers unwilling to participate in abortion. Providers' rights to refuse-- and relatedly, their immunity from civil liability, employment discrimination, and other adverse consequences--are often unqualified, even in situations where patients are likely to be harmed. These laws impose unilateral burdens on third parties in an effort to protect the rights of conscientious refusers. As such, they are outliers in the universe of federal and state anti-discrimination and religious freedom statutes, all of which strike a more even balance between individual rights and the prevention of harm to third parties. This …

State Peer Review Laws As A Tool To Incentivize Reporting To Medical Boards, Nadia N. Sawicki

Faculty Publications & Other Works

State medical boards have been stymied in their ability to take disciplinary action against physicians who engage in serious misconduct, in part because hospitals and other health care organizations rarely report such misconduct. This Article offers a proposal for incentivizing hospital reporting of physician misconduct, inspired by an existing but flawed model in the federal Health Care Quality Improvement Act. This Article proposes that state legislatures link state medical practice act reporting requirements with state laws establishing an evidentiary privilege for peer review activities.

Playing God: Faulty Decision-Making In Medical Futility Disputes, C. Scott Sergeant

Mitchell Hamline Law Review

No abstract provided.

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

A Malpractice-Based Duty To Disclose The Risk Of Stillbirth: A Response To Lens, Nadia N. Sawicki

Faculty Publications & Other Works

In Medical Paternalism, Stillbirth, & Blindsided Mothers, Lens argues that physicians who fail to disclose the risk of stillbirth to pregnant patients should be liable under the doctrine of informed consent. In this Response, I suggest that courts might be hesitant to expand informed consent in the way Lens proposes. Instead, I offer an alternative avenue for imposing liability, via traditional theories of medical malpractice.

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

Finding Parity Through Preclusion: Novel Mental Health Parity Solutions At The State Level, Ryan D. Kingshill

Dickinson Law Review (2017-Present)

Recently, the federal government has taken numerous steps to promote the equal treatment (also known as parity) of mental and physical health issues. The two most impactful actions are the Mental Health Parity and Addiction Act of 2008 and the Affordable Care Act. These acts focus on the traditional avenue for parity change—insurance regulation. While these acts have improved parity, major gaps in coverage and treatment between mental health/substance use disorder treatment and medical/surgical treatment persist. ERISA Preemption, evasive insurer behavior, lack of enforcement, and lack of consumer education continue to plague patients and healthcare professionals. On its own, federal …

Achieving Better Care In Pennsylvania By Allowing Pharmacists To Practice Pharmacy, Travis Murray

Dickinson Law Review (2017-Present)

Traditionally, state legislatures implemented Prescription Drug Monitoring Programs (“PDMPs”) to assist prescribers, pharmacists, and law enforcement in identifying patients likely to misuse, abuse, or divert controlled substances. PDMP databases contain a catalog of a patient’s recent controlled substances that pharmacies have filled, including the date, location, the quantity of medication filled, and the prescribing health care provider. Prescribers in Pennsylvania have a duty to query the PDMP before prescribing controlled substances in most clinical settings. Pharmacists have a similar duty in Pennsylvania to dispense safe and effective medication therapy to patients and to screen patients for potential signs of misuse, …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

If You Build It, Will They Come? An Empirical Study Of The Voluntary Use Of Mediation And Its Implications, Dwight Golann

Cardozo Journal of Conflict Resolution

A generation ago, American litigants did not often go to mediation voluntarily. Advocates of the process predicted, however, that as lawyers and parties became more familiar with mediation, they would opt to use it more often. But, is this true? Virtually no data exists about how often litigants voluntarily choose to mediate legal disputes, whether use varies in different kinds of cases, and what motivates litigants' decisions whether to mediate or not. This Article presents data about each of these issues and analyzes its meaning.

Social Rights And The Welfare State: A Necessary Relation, Mario Santiago Juarez

Cardozo International & Comparative Law Review

The article argues that the welfare state is indispensable for fulfilling social rights, emphasizing that mere recognition of these rights is insufficient without robust state commitment to public policies and systems. It traces the historical development of social rights from the industrial revolution to modern times, highlighting the role of key reforms and international frameworks. The analysis critiques the limitations of judicial enforcement and advocates for structural policies, such as progressive taxation and full employment, to ensure equitable access to essential services like education, healthcare, and housing.

India's Aadhaar Card - A Violation Of Indian Citizen's Right To Privacy, Sonal Chhugani

Cardozo International & Comparative Law Review

The article examines the implications of India's Aadhaar Card program, arguing that while it may comply with Indian law, it violates the right to privacy under Article 17 of the International Covenant on Civil and Political Rights (ICCPR). The Aadhaar Card, a mandatory biometric identification system, centralizes vast amounts of citizen data, posing significant risks to privacy and security. Despite the Indian Supreme Court's ruling that the program does not violate domestic privacy rights, the article contends that it fails to meet international privacy standards, necessitating reforms to align with global human rights obligations.

Applicability Of International Schemes Of Legal Safeguards In Physician Assisted Suicide To Future United States Policy, Annie M. Bonazzi

Cardozo International & Comparative Law Review

The note argues that the United States can draw from international models, particularly those in Switzerland, Colombia, and Australia, to develop a more cohesive and effective policy on physician-assisted suicide (PAS). By combining existing U.S. state safeguards with international approaches, such as Colombia's panel-based system and Switzerland's nonprofit mechanism, the U.S. could address ethical, legal, and practical challenges more comprehensively.

Information For The Common Good In Mass Torts, Elizabeth Chamblee Burch, Alexandra D. Lahav

Scholarly Works

In recent years, judges have privileged confidentiality over transparency in discovery, especially in large scale multidistrict litigation such as the Opiate litigation. By uncovering the assumptions underlying our current regime, this Article sheds light on the process that got us here as a first step towards re-envisioning the rules governing information in litigation. We investigate an untold history of discovery’s publicity to show that many of our assumptions about what is public and what is private is historically contingent, even accidental. So too are our assumptions about the best way to arrive at truth.

Accordingly, we suggest that courts ought …

Diversity In Mdl Leadership: A Field Guide, Elizabeth Chamblee Burch

Scholarly Works

Multidistrict litigation (MDL) includes some of the most high-profile torts of our day—opioids, talc, RoundUp, to name a few—but the attorneys who spearhead these proceedings often look a lot like they did fifty years ago: predominately white and predominately male.

A debate has emerged over whether attorneys best positioned to fill MDL leadership roles are the grizzled repeat players who appear time and again—and who are largely white, older, and male—or newcomers with fresh ideas and energy who may not always look like their predecessors. And if diversity is important, what kind of diversity matters?

In this short essay, I …

Mdl Revolution, Elizabeth Chamblee Burch, Abbe Gluck

Scholarly Works

Over the past 50 years, multidistrict litigation (MDL) has quietly revolutionized civil procedure. MDLs include the largest tort cases in U.S. history, but without the authority of the class-action rule, MDL judges—who formally have only pretrial jurisdiction over individual cases—have resorted to extraordinary procedural exceptionalism to settle cases on a national scale. Substantive state laws, personal jurisdiction, transparency, impartiality, reviewability, federalism, and adequate representation must all yield if doing so fulfills that one goal.

Somehow, until now, this has remained below the surface to everyone but MDL insiders. Thanks to the sprawling MDL over the opioid crisis—and unprecedented opposition to …

Factors Affecting Access To Administrative Health Data For Research In Canada: A Study Protocol, Cynthia Kendell, Adrian Levy, Geoff Porter, Elaine Gibson, Robin Urquhart

Articles, Book Chapters, & Popular Press

In Canada, most provinces have established administrative health data repositories to facilitate access to these data for research. Anecdotally, researchers have described delays and substantial inter-provincial variations in the timeliness of data access approvals and receipt of data. Currently, the reasons for these delays and variations in timeliness are not well understood. This paper provides a study protocol for (1) identifying the factors affecting access to administrative health data for research within select Canadian provinces, and (2) comparing factors across provinces to assess whether and how they contribute to inter-provincial variations in access to administrative health data for research.

Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross

Articles, Book Chapters, & Popular Press

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

Exploring The Food And Drug Administration’S Review And Approval Of Entresto (Sacubitril/Valsartan), Ashley Eadie, Keith Brunt, Matthew Herder

Articles, Book Chapters, & Popular Press

Federal regulatory agencies such as the United States Food and Drug Administration review pharmacological evidence to ensure the safety and efficacy of new and repurposed pharmaceuticals prior to market approval. The discussions, disagreements and procedural decisions contained within such reviews offer unique insight into a pharmaceutical's strengths, weaknesses and opportunities, yet are often overlooked as a significant source of pharmacological information for research and development. To highlight the value of such resources, we present a case study on Entresto, a first-in-class angiotensin receptor-neprilysin inhibitor for the treatment of heart failure with reduced ejection fraction, and explore the regulatory rationale underlying …