Health Law and Policy Commons^™

Legal Principles And Seminal Legal Cases In Oocyte Donation, Jody L. Madeira, Susan L. Crockin

Articles by Maurer Faculty

Oocyte donation has played an increasingly important role in assisted reproductive technologies since the early 1980s. Over the past 30 years, unique legal standards have evolved to address issues in the oocyte donation procedure itself as well as the disputes over issues, such as parentage, that inevitably arise with new technologies, particularly for individuals seeking to build nontraditional families. This essay will explore oocyte donation's legal aspects as well as seminal law concerning the procedure, including statutory law (uniform and model provisions and enacted state laws) and selected judicial opinions concerning surrogacy and parentage, testing of oocyte donors, mix-ups of …

Medical Malpractice Cuts Not The Answer, Ruqaiijah A. Yearby

All Faculty Scholarship

Tort reform--legislation that aims to reduce medical malpractice suits --will not cut medical costs and improve health care unless the government addresses the proliferation of unnecessary medical errors that victimize hundreds of thousands of patients every year.

Yearby's research considers how laws enacted to grant equal access to quality health care actually can pose barriers to the disenfranchised, and she is critical of health care reform efforts that do not address the far-reaching problem of medical errors. Finding ways to curb what she calls the "alarming rate of these medical errors," not only will reduce medical malpractice suits, but save …

Avoiding Prolonged Dementia, Norman L. Cantor

Norman Cantor

Health Care Referrals Out Of The Shadows: Recognizing The Looming Threat Of The Texas Patient Solicitation Act And Other Illegal Remuneration Statutes, Trenton Brown

St. Mary's Law Journal

Abstract forthcoming

Informed Consent And The Role Of The Treating Physician, Eric Feldman, Holly Fernandez Lynch, Steven Joffe

All Faculty Scholarship

In the century since Justice Benjamin N. Cardozo famously declared that “[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body,” informed consent has become a central feature of American medical practice. In an increasingly team-based and technology-driven system, however, who is — or ought to be — responsible for obtaining a patient’s consent? Must the treating physician personally provide all the necessary disclosures, or can the consent process, like other aspects of modern medicine, take advantage of specialization and division of labor? Analysis of Shinal v. Toms, …

Crispr/Cas-9 Technologies: A Call For A New Form Of Tort, Kendall Lovell

San Diego International Law Journal

Once relegated to the domains of science fiction, modern day scientists and researchers are poised on the precipice of making genome editing clinically available. Once introduced into a clinical setting the effects of an off-target mutation or germline edit will remain largely unknown until health issues arise later in life or in the following generation. The novelty of the injuries that will arise require a system that is able to balance the interests of physicians with single and multi-generational plaintiffs, while providing a realistic framework for courts to follow. This comment offers a brand-new context that accounts for these needs …

Informing Consent: Medical Malpractice And The Criminalization Of Pregnancy, Laura Beth Cohen

Michigan Law Review

Since the early 1990s, jurisdictions around the country have been using civil child abuse laws to penalize women for using illicit drugs during their pregnancies. Using civil child abuse laws in this way infringes on pregnant women’s civil rights and deters them from seeking prenatal care. Child Protective Services agencies are key players in this system. Women often become entangled with the Child Protective Services system through their health care providers. Providers will drug test pregnant women without first alerting them to the potential negative consequences stemming from a positive drug test. Doing so is a breach of these providers’ …

A Surging Drug Epidemic: Time For Congress To Enact A Mandate On Insurance Companies And Rehabilitation Facilities For Opioid And Opiate Addiction, Alanna Guy

Journal of Law and Health

This Note begins with a discussion of both the national opioid problem as well as the specific epidemic in Ohio as an example of how it has grown within all of the states. Part II discusses the differences between prescription opioids and opiates, how they can be obtained, what effects they have on the human body, and why the government has an interest in this growing problem. Next, this Note explains how and why there was an increase in access and addiction to prescription opioid pain medication. Following this explanation, the steps the government has taken to try to rectify …

Reforming Regenerative Medicine Regulation, Sarah Duranske

Georgia State University Law Review

Regenerative medicine is defined as the branch of medicine that develops methods to regrow, repair, or replace damaged or diseased cells or tissues. It includes a variety of approaches, such as transplanting cells to promote healing, editing genes in cells to attack cancer, and even building organs from biological materials. Regulating regenerative medicine therapies is no easy task. Finding a balance between competing interests–enabling timely access for needy patients while simultaneously ensuring a positive benefit/risk profile and promoting the development of beneficial innovations–is hard enough at any given point in time. But add in constantly advancing scientific knowledge and increasing …

Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa

Ryan B. Stoa

Marijuana legalization is sweeping the nation. Recreational marijuana use is legal in eight states. Medical marijuana use is legal in thirteen states. Only three states maintain an absolute criminal prohibition on marijuana use. Many of these legalization initiatives propose to regulate marijuana in a manner similar to alcohol, and many titles are variations of the "Regulate Marijuana Like Alcohol Act." For political and public health reasons the analogy makes sense, but it also reveals a regulatory blind spot. States may be using alcohol as a model for regulating the distribution, retail, and consumption of marijuana, but marijuana is much more …

Understanding The Sexual Assault Kit Backlog In Pennsylvania, Kallie Crawford, Lyndsie Ferrara

Graduate Student Research Symposium

According to the FBI, to date, there are more than 400,000 untested sexual assault kits nationwide. While this is a huge issue that cannot be solved overnight, continual improvements and changes are needed to reduce and hopefully eliminate the backlog.

This research examines work going on nationwide and aims to better understand the backlog issues specifically in Pennsylvania. Furthermore, the research examines a program utilized by the law enforcement community that garnered necessary resources. First, a comprehensive review of improved practices in proactive jurisdictions of Ohio, Houston, Texas, and Detroit, Michigan was conducted to identify general policies and procedures that …

Modernizing The Emergency Medical Treatment And Labor Act To Harmonize With The Affordable Care Act To Improve Equality, Quality And Cost Of Emergency Care, Katharine A. Van Tassel

Katharine Van Tassel

This Article will propose a very simple, two-step way to modernize EMTALA [Emergency Medical Treatment and Active Labor Act (1986)] to deal with this cascade of problems. This solution converts EMTALA into a powerful tool to enhance equal access to healthcare while at the same time changing EMTALA so that it works in tandem with, instead of against, the efforts of the Affordable Care Act, Medicare and Medicaid to improve healthcare quality, cost and equal access.

This solution also works across systems to resolve the conflict between the tort, licensure and hospital peer review systems that all discourage evidence-based treatment …

Hospital Peer Review Standards And Due Process: Moving From Tort Doctrine Toward Contract Principles Based On Clinical Practice Guidelines, Katharine A. Van Tassel

Katharine Van Tassel

This Article proposes a solution to the problems associated with the current use of vague standards in peer review. This Article will examine the proposal that medical staffs switch from ad hoc judicial decision-making to rule-making. This switch will allow medical staffs to abandon the troublesome practice of applying vague 'standard of care' measures ex post facto. In its stead, express contractual terminology could be adopted, such as 'expectations of performance,' which incorporates specifically chosen and uniquely tailored clinical practice guidelines ('CPGs') directly into the medical staff by-laws. Describing the expectations of physician performance in express contractual terms enables physicians …

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Katharine Van Tassel

This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is …

2018 Legal Update: Npdb Reporting, Retaliation, Physician Well Being, And Medical Staff Litigation, Preparing For A Successful Judicial Review Hearing, Rick D. Barton, Natalie V. Mueller

Center for Health Law Policy and Bioethics

No abstract provided.

Removing Obstacles To A Peaceful Death, Kathy L. Cerminara, Barbara A. Noah

Faculty Scholarship

We all will die, but the American health care system often impedes a peaceful death. Instead of a quiet death at home surrounded by loved ones, many of us suffer through overutilization of sometimes-toxic therapeutic interventions long past the time when those interventions do more good than harm. This article proposes revisions to health professional training and payment policy to eliminate as much as possible physical and existential suffering while progressing through the terminal phase of illness. The solution lies in seamless progression from treatment with integrated palliative care to hospice before death, but provider attitudes and payor practices must …

Interpreting Canada's Medical Assistance In Dying Legislation, Jocelyn Downie, Jennifer A. Chandler

Reports & Public Policy Documents

When the Canadian medical assistance in dying (MAiD) legislation came into force in June 2016, it was widely noted that the meaning of some of its key terms and phrases was unclear. For example, questions were immediately raised about the meaning of “incurable illness, disease, or disability,” “advanced state of irreversible decline in capability,” and “natural death has become reasonably foreseeable.” Interpretation challenges are not uncommon with new legislation. However, in the context of something as significant as access to MAiD and potential criminal liability for getting the meaning of the legislation wrong, these challenges must be confronted by those …

Noa V. Doa: Increasing Medical Diagnostic Patentability After Mayo, Karen Mckenzie

Marquette Intellectual Property Law Review

The medical diagnostics market is expected to reach 65 billion by 2018. In March 2012, in Mayo Collborative Services v. Prometheus Labs, Inc. , ("Mayo") the U.S. Supreme held that the Mayo Clinic (the "Clinic") had not infringed on Prometheus Labs’ (“Prometheus”) diagnostic patent because the Prometheus patent involved ineligible subject matter, and was therefore invalid. Section 101 of the Patent Act defines eligible subject matter an “any new and useful process, machine, manufacture, or composition of matter” as patentable subject matter. Courts have held that Section 101 contains an implicit exception, making laws of nature, natural phenomena, and abstract …

Access To Knowledge And The Global Abortion Policies Database, Joanna Erdman, Brooke Johnson

Articles, Book Chapters, & Popular Press

Research shows that women, healthcare providers, and even policy makers worldwide have limited or inaccurate knowledge of the abortion law and policies in their country. These knowledge gaps sometimes stem from the vague and broad terms of the law, which breed uncertainty and even conflict when unaccompanied by accessible regulation or guidelines. Inconsistency across national law and policy further impedes safe and evidence‐based practice. This lack of transparency creates a crisis of accountability. Those seeking care cannot know their legal entitlements, service providers cannot practice with legal protection, and governments can escape legal responsibility for the adverse effects of their …

A Critique Of Canadian Jurisprudence On The Therapeutic Privilege Exception To Informed Consent, Michael Hadskis

Articles, Book Chapters, & Popular Press

The Supreme Court of Canada’s landmark decisions in Hopp v Lepp and Reibl v Hughes furnished a general analytical framework for informed consent actions that remains fully intact today. This article sets its gaze on a specific aspect of the framework, dubbed “therapeutic privilege,” that permits physicians to deviate from their general duty to disclose material, treatment-related risks to competent patients. Specifically, the privilege allows information about material risks to be withheld or generalized if physicians believe their patients are “unable to cope” with receiving such information. It is argued that the Supreme Court’s terse and vaguely-articulated exception to truth …

An Alternative To Medical Assistance In Dying? The Legal Status Of Voluntary Stopping Eating And Drinking (Vsed), Jocelyn Downie

Articles, Book Chapters, & Popular Press

Medical assistance in dying (MAiD) has received considerable attention from many in the field of bioethics. Philosophers, theologians, lawyers, and clinicians of all sorts have engaged with many challenging aspects of this issue. Public debate, public policy, and the law have been enhanced by the varied disciplinary analyses. With the legalization of MAiD in Canada, some attention is now being turned to issues that have historically been overshadowed by the debate about whether to permit MAiD. One such issue is voluntary stopping eating and drinking (VSED) as an alternative to MAiD. In this paper, I will apply a legal lens …

Access To Knowledge And The Global Abortion Policies Database, Joanna Erdman, Brooke Johnson

Articles, Book Chapters, & Popular Press

Research shows that women, healthcare providers, and even policy makers worldwide have limited or inaccurate knowledge of the abortion law and policies in their country. These knowledge gaps sometimes stem from the vague and broad terms of the law, which breed uncertainty and even conflict when unaccompanied by accessible regulation or guidelines. Inconsistency across national law and policy further impedes safe and evidence‐based practice. This lack of transparency creates a crisis of accountability. Those seeking care cannot know their legal entitlements, service providers cannot practice with legal protection, and governments can escape legal responsibility for the adverse effects of their …

Dignity In Choice: A Terminally Ill Patient's Right To Choose, Cody Bauer

Mitchell Hamline Law Review

No abstract provided.

Baby M Turns 30: The Law And Policy Of Surrogate Motherhood, Eric A. Feldman

All Faculty Scholarship

This article marks the 30th anniversary of the Supreme Court of New Jersey’s Baby M decision by offering a critical analysis of surrogacy policy in the United States. Despite fundamental changes in both science and society since the case was decided, state courts and legislatures remain bitterly divided on the legality of surrogacy. In arguing for a more uniform, permissive legal posture toward surrogacy, the article addresses five central debates in the surrogacy literature.

First, should the legal system accommodate those seeking conception through surrogacy, or should it prohibit such arrangements? Second, if surrogacy is permitted, what steps can be …

The Broken Medicare Appeals System: Failed Regulatory Solutions And The Promise Of Federal Litigation, Greer Donley

Articles

The Medicare Appeals System is broken. For years, the System has been unable to accommodate a growing number of appeals. The result is a backlog so large that even if no new appeals were filed, it would take the System a decade or more to empty. Healthcare providers wait many years for their appeals to be heard before an Administrative Law Judge (ALJ), and because the government recoups providers' Medicare payments while they wait, the delays cause them serious financial harm. Even worse, providers are more likely than not to prevail before the ALJ, proving that the payment should never …

Medical Malpractice And Black-Box Medicine, W. Nicholson Price Ii

Book Chapters

The explosive proliferation of health data has combined with the rapid development of machine-learning algorithms to enable a new form of medicine: “black-box medicine.” In this phenomenon, algorithms troll through tremendous databases of health data to find patterns that can be used to guide care, whether by predicting unknown patient risks, selecting the right drug, suggesting a new use of an old drug, or triaging patients to preserve health resources. These decisions differ from previous data-based decisions because black-box medicine is, by its nature, opaque; that is, the bases for black-box decisions are unknown and unknowable.

Black-box medicine raises a …

Cancer's Ip, Jacob S. Sherkow

Articles & Chapters

The state of publicly funded science is in peril. Instead, new biomedical research efforts — in particular, the recent funding of a “Cancer Moonshot” — have focused on employing public-private partnerships, joint ventures between private industry and public agencies, as being more politically palatable. Yet, public-private partnerships like the Cancer Moonshot center on the production of public goods: scientific information. Using private incentives in this context presents numerous puzzles for both intellectual property law and information policy. This Article examines whether—and to what extent — intellectual property and information policy can be appropriately tailored to the goals of public-private partnerships. …