Science and Technology Law Commons^™

Preimplantation Genetic Testing: A Fundamental Right, Julianna S. Swann

William & Mary Journal of Race, Gender, and Social Justice

Unlike many European countries of similar economic, social, scientific, and political advancement, there is virtually no regulation of preimplantation genetic testing in the United States. This Note will explore preimplantation genetic testing and demonstrate that potential parents in the United States have a right to conduct said testing under the umbrella of the fundamental right to privacy. This Note will demonstrate the need for the regulation for preimplantation genetic testing that will comply with the Undue Burden Test set out in Planned Parenthood v. Casey, while acknowledging and supporting the fundamental right of potential parents to conduct testing. This …

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 …

Genetic Duties, Jessica L. Roberts, Alexandra L. Foulkes

William & Mary Law Review

Most of our genetic information does not change, yet the results of our genetic tests might. Labs reclassify genetic variants in response to advances in genetic science. As a result, a person who took a test in 2010 could take the same test with the same lab in 2020 and get a different result. However, no legal duty requires labs or physicians to inform patients when a lab reclassifies a variant, even if the reclassification communicates clinically actionable information. This Article considers the need for such duties and their potential challenges. In so doing, it offers much-needed guidance to physicians …

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.

The Internet Of Bodies, Andrea M. Matwyshyn

William & Mary Law Review

This Article introduces the ongoing progression of the Internet of Things (IoT) into the Internet of Bodies (IoB)—a network of human bodies whose integrity and functionality rely at least in part on the Internet and related technologies, such as artificial intelligence. IoB devices will evidence the same categories of legacy security flaws that have plagued IoT devices. However, unlike most IoT, IoB technologies will directly, physically harm human bodies—a set of harms courts, legislators, and regulators will deem worthy of legal redress. As such, IoB will herald the arrival of (some forms of) corporate software liability and a new legal …

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 …

The Biologics Price Competition And Innovation Act: Is A Generic Market For Biologics Attainable?, Kasey E. Koballa

William & Mary Business Law Review

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated approval pathway for biological therapeutic products shown to be biosimilar to an FDA-approved biological reference product. The BPCIA purported to reduce the price of biologics while promoting innovation. In two recent cases, the Federal Circuit interpreted a key provision of the BPCIA requiring an applicant to provide the reference product sponsor with notice 180 days before marketing the product. The Federal Circuit’s interpretation extends the exclusivity period already provided for the reference product sponsor, deterring innovation and price reduction. Thus, the Supreme Court granted certiorari in one …