Law Commons^™

Segmented Innovation In The Legalization Of Mitochondrial Transfer: Lessons From Australia And The United Kingdom, Myrisha S. Lewis

Faculty Publications

The U.S. is often characterized as a leader in innovation—a home of Nobel Prize‐winning scientists, innovators, and abundant research funding. Yet, in the area of assisted reproduction combined with genetic modification or substitution, what I call “reproductive genetic innovation,” that characterization begins to wane. This Article focuses on the regulation of mitochondrial transfer, a subset of reproductive genetic innovation. While human clinical trials related to mitochondrial transfer go forward in the U.K., the clinical use of the technique remains illegal in the U.S. due to a system of subterranean regulation by the U.S. Food and Drug Administration and a now-recurring …

How Analogizing Socio-Legal Responses To Organ Transplantation Can Further The Legalization Of Reproductive Genetic Innovation, Myrisha S. Lewis

Faculty Publications

The Nobel Foundation emphasized the significance of genetic innovation to society, science, and medicine by awarding the 2020 Nobel Prize in Chemistry to “the CRISPR/Cas9 genetic scissors.” This Article focuses on “reproductive genetic innovation,” a term that includes cytoplasmic transfer, mitochondrial transfer, and germline or heritable gene editing techniques that are all categorized as “experimental” in the United States. These techniques all use in vitro fertilization, a legal and widely available practice. Yet reproductive genetic innovation has resulted in controversy and numerous barriers including a recurring federal budget rider, threats of federal enforcement action, and the unavailability of federal funding. …

Is Germline Gene Editing Exceptional?, Myrisha S. Lewis

Faculty Publications

Advances in gene editing have recently received significant scientific and media attention. Gene editing, especially CRISPR-Cas9, has revived multiple longstanding ethical debates, including debates related to parental autonomy, health disparities, disability perspectives, and racial and economic inequalities. Germline, or heritable, gene editing generates several newer, neglected bioethical debates, including those about the shared human germline and whether there is a "line" that humans should not cross.

This Article addresses several interrelated ethical and legal questions related to germline gene editing. Those questions address why, if at all, germline gene editing needs to be regulated and, if germline gene editing needs …

Fostering States As Laboratories, Myrisha S. Lewis

Popular Media

No abstract provided.

Keeping Ai Under Observation: Anticipated Impacts On Physicians' Standard Of Care, Iria Giuffrida, Taylor Treece

Faculty Publications

As Artificial Intelligence (AI) tools become increasingly present across industries, concerns have started to emerge as to their impact on professional liability. Specifically, for the medical industry--in many ways an inherently "risky" business--hospitals and physicians have begun evaluating the impact of Al tools on their professional malpractice risk. This Essay seeks to address that question, zooming in on how AI may affect physicians' standard of care for medical malpractice claims.

Pay Now, Play Later?: Youth And Adolescent Collision Sports, Vivian E. Hamilton

Faculty Publications

The routine and repeated head impacts experienced by athletes in a range of sports can inflict microscopic brain injuries that accumulate over time, even in the absence of concussion. Indeed, cumulative exposure to head impacts—not number of concussions—is the strongest predictor of sports-related degenerative brain disease in later life. The observable symptoms of disease appear years or decades after initial injury and resemble those of other mental-health conditions such as depression and dementia. The years-long interval between earlier, seemingly minor, head impacts and later brain disease has long obscured the connection between the two.

Risk of injury differs across demographics, …

American Democratic Deficit In Assisted Reproductive Technology Innovation, Myrisha S. Lewis

Faculty Publications

In many areas of innovation, the United States is a leader, but this characterization does not apply to the United States' position in assisted reproductive technology innovation and clinical use. This article uses a political science concept, the idea of the "democratic deficit" to examine the lack of American public discourse on innovations in ART. In doing so, the article focuses on America's missing public consultation in health care innovation. This missing discourse is significant, as political and ethical considerations may impact regulatory decisions. Thus, to the extent that these considerations are influencing the decisions of federal agency employees, namely …

Achieving The Goals Of The Value-Based Purchasing Program: Defining A Standard For External Data Use, Svetlana Makoviy

Student Award Winning Papers

In our society, artificial intelligence technology has permeated through every aspect of human life. By the end of 2019, more than 60 million Americans will use some kind of smartwatch, whether a Fitbit or an Apple Watch as a part of their daily routine. Further, over 58% of people currently use a healthcare-related mobile application, such as MyFitnessPal or Nike+ Running. Health and fitness application usage increased by over 330% in the last three years. Unsurprisingly, healthcare-related data is one of the fastest growing and financially valuable data pools in the country, if not worldwide. The volume of data generated …

Does Va Medicaid Expansion Change The Landscape For Copn?, Megan E. Italiano

Student Award Winning Papers

The Paper will proceed in five parts. Part I will present the history of COPN, both nationally and in Virginia. Next, Part II will detail Virginia’s COPN program and its State Medical Facilities Plan. Part III will discuss the current debate for and against the COPN program. In Part IV, this Paper will discuss the market irregularities that the health care industry faces and how Virginia’s COPN program helps insulate hospitals from these market imbalances. Lastly, Part V will focus on the impact that the Medicaid expansion has on the COPN program, focusing particularly on the effects of the program’s …

Strike Down Obamacare, Says Justice Department, Saikrishna B. Prakash, Neal Devins

Popular Media

No abstract provided.

Brief Of Thirteen Law Professors As Amici Curiae In Support Of The Petitioners, Nathan B. Oman, John D. Adams, Matthew A. Fitzgerald

Briefs

No abstract provided.

Section 8: Looking Ahead: Abortion And The Aca Contraception Mandate, Institute Of Bill Of Rights Law, William & Mary Law School

Supreme Court Preview

No abstract provided.

Brief Of Law Professors Bruce P. Frohnen, Robert P. George, Alan J. Meese, Michael P. Moreland, Nathan B. Oman, Michael Stokes Paulsen, Rodney K. Smith, Steven D. Smith, And O. Carter Snead As Amici Curiae In Support Of The Petitioners, Nathan B. Oman, John D. Adams, Matthew A. Fitzgerald

Briefs

No abstract provided.

Scouting For Approval: Lessons On Medical Device Regulation In An Era Of Crowdfunding From Scanadu’S “Scout”, Colleen Smith

Student Award Winning Papers

This Article will argue that medical device companies should be able to utilize crowdfunding to raise the necessary capital to develop a product. However, because of the risks medical devices pose, any solution that allows medical device companies to employ crowdfunding should ensure the continuing commitment to consumer safety that is at the core of FDA regulation. This Article uses the Scanadu Scout as an example and a staring point for evaluating the use of crowdfunding in the medical device industry. This Article explains how and why Scanadu broke the law when it moved the Scout, an “adulterated or misbranded” …

Section 1: Moot Court: King V. Burwell, Institute Of Bill Of Rights Law, William & Mary Law School

Supreme Court Preview

No abstract provided.

Liberty Without Capacity: Why States Should Ban Adolescent Driving, Vivian E. Hamilton

Faculty Publications

No abstract provided.

Mental Illness And Danger To Self, Cynthia V. Ward

Faculty Publications

No abstract provided.

Section 2: Affordable Care Act, Institute Of Bill Of Rights Law, William & Mary Law School

Supreme Court Preview

No abstract provided.

Party Polarization And Judicial Review: Lessons From The Affordable Care Act, Neal Devins

Faculty Publications

Congress paid nearly no attention to the Constitution when enacting the Affordable Care Act (ACA) in 2010. Legislative hearings and committee reports ignored the Constitution altogether; legislative debates largely did the same. This Essay both highlights Congress’s indifference to the Constitution when enacting the ACA and examines the reasons behind this legislative failure. In particular, this Essay advances three explanations. First, Congress is generally uninterested in “public goods” like constitutional interpretation. Second, the polarization of Democrats and Republicans in Congress further depresses Congress’s interest in thinking about the Constitution; instead, the majority party seeks to limit opportunities for the minority …

Why Congress Did Not Think About The Constitution When Enacting The Affordable Care Act, Neal Devins

Faculty Publications

No abstract provided.

Securing Sovereign State Standing, Katherine Mims Crocker

Faculty Publications

No abstract provided.

How Planned Parenthood V. Casey (Pretty Much) Settled The Abortion Wars, Neal Devins

Faculty Publications

More than twenty-one years after Robert Bork's failed Supreme Court nomination and seventeen years after Planned Parenthood of Southeastern Pennsylvania v. Casey, the rhetoric of abortion politics remains unchanged. Pro-choice interests, for example, argue that states are poised to outlaw abortion and that Roe v. Wade is vulnerable to overruling. In this Essay, I will debunk those claims. First, I will explain how Casey's approval of limited abortion rights reflected an emerging national consensus in 1992. Second, I will explain why the Supreme Court is unlikely to risk political backlash by formally modifying Casey- either by restoring the trimester test …

What Is Urban Health Policy And What's Law Got To Do With It?, Larry I. Palmer

Faculty Publications

No abstract provided.

Preserving A Precious Resource: Rationalizing The Use Of Antibiotics, Eric Kades

Faculty Publications

No abstract provided.

Genetic Health And Eugenics Precedents: A Voice Of Caution, Larry I. Palmer

Faculty Publications

No abstract provided.

Disease Management And Liability In The Human Genome Era, Larry I. Palmer

Faculty Publications

No abstract provided.

The Integrity Of Death: Resolving Dilemmas In Medicine, Larry I. Palmer

Faculty Publications

No abstract provided.

Section 1: Ferguson V. City Of Charleston, Institute Of Bill Of Rights Law, William & Mary Law School

Supreme Court Preview

No abstract provided.

Informed Consent For Neonatal Circumcision: An Ethical And Legal Conundrum, J. Steven Svoboda, Robert S. Van Howe, James G. Dwyer

Faculty Publications

No abstract provided.

Patient Safety, Risk Reduction, And The Law, Larry I. Palmer

Faculty Publications

No abstract provided.