Medical Jurisprudence Commons^™

Mixed-Up Origins: The Case For A Gestational Presumption In Embryo Mix-Ups, Betsy A. Sugar (J.D. Candidate)

Vanderbilt Law Review

Embryo mix-ups-instances in which fertility clinics mistakenly implant one couple with another couple's embryo confound courts' determinations of who, between the two couples, are the legal parents. Lax regulation of the fertility industry permitted this relatively new injury to develop, and it has led to morally and legally fraught questions of parenthood and personal autonomy. This Note reviews parentage doctrines, beginning with a discussion of the martial presumption; it also tracks how courts have traditionally responded to parentage questions that fertility medicine has generated, including embryo division in divorce and parentage in surrogacy contracts. It then analyzes potential approaches to …

Education And Electronic Medical Records And Genomics Network, Challenges And Lessons Learned From A Large-Scale Clinical Trial Using Polygenic Risk Scores, Ellen Wright Clayton, John J. Connolly, Et Al.

Vanderbilt Law School Faculty Publications

Polygenic risk scores (PRS) have potential to improve health care by identifying individuals that have elevated risk for common complex conditions. Use of PRS in clinical practice, however, requires careful assessment of the needs and capabilities of patients, providers, and health care systems. The electronic Medical Records and Genomics (eMERGE) network is conducting a collaborative study which will return PRS to 25,000 pediatric and adult participants. All participants will receive a risk report, potentially classifying them as high risk (∼2-10% per condition) for 1 or more of 10 conditions based on PRS. The study population is enriched by participants from …

The Public Perception Of The #Geneeditedbabies Event Across Multiple Social Media Platforms: Observational Study, Ellen W. Clayton, Congning Ni, Et Al.

Vanderbilt Law School Faculty Publications

In November 2018, a Chinese researcher reported that his team had applied clustered regularly interspaced palindromic repeats or associated protein 9 to delete the gene C-C chemokine receptor type 5 from embryos and claimed that the 2 newborns would have lifetime immunity from HIV infection, an event referred to as #GeneEditedBabies on social media platforms. Although this event stirred a worldwide debate on ethical and legal issues regarding clinical trials with embryonic gene sequences, the focus has mainly been on academics and professionals. However, how the public, especially stratified by geographic region and culture, reacted to these issues is not …

Defending Henrietta Lacks: Justification Of Ownership Rights In Separated Human Body Parts, Arseny Shevelev, Georgy Shevelev

Vanderbilt Journal of Transnational Law

Since the time of Moore v. Regents of the University of California, it has become a well-established and widespread view that a person, when their separated body parts are misappropriated, is forced to limit themselves to fiduciary and other non-proprietary claims against those who violate the bodily inviolability of their separated parts. Now, with the filing of a lawsuit in defense of the rights in body parts of the victim of racial discrimination, Henrietta Lacks, the judicial system has an opportunity to justify itself by adopting a different perception of rights in human body parts. This Article focuses on the …

Isscr Guidelines For The Transfer Of Human Pluripotent Stem Cells, Ellen W. Clayton, I Hyun, Et. Al.

Vanderbilt Law School Faculty Publications

The newly revised 2021 ISSCR Guidelines for Stem Cell Research and Clinical Translation includes scientific and ethical guidance for the transfer of human pluripotent stem cells and their direct derivatives into animal models. In this white paper, the ISSCR subcommittee that drafted these guidelines for research involving the use of nonhuman embryos and postnatal animals explains and summarizes their recommendations.

The newly revised ISSCR Guidelines for Stem Cell Research and Clinical Translation includes scientific and ethical guidance for the transfer of human pluripotent stem cells and their direct derivatives into animal models (ISSCR, 2021). We are the members of the …

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 …

Protecting Research Data Of Publicly Revealing Participants, Ellen Clayton, B. A. Malin, Kyle J. Mckibbin

Vanderbilt Law School Faculty Publications

Biomedical researchers collect large amounts of personal data about individuals, which are frequently shared with repositories and an array of users. Typically, research data holders implement measures to protect participants’ identities and unique attributes from unauthorized disclosure. These measures, however, can be less effective if people disclose their participation in a research study, which they may do for many reasons. Even so, the people who provide these data for research often understandably expect that their privacy will be protected. We discuss the particular challenges posed by self-disclosure and identify various steps that researchers should take to protect data in these …

What Results Should Be Returned From Opportunistic Screening In Translational Research?, Colin M.E. Halverson, Sarah H. Jones, Laurie Novak, Christopher Simpson, Digna R. Velez Edwards, Sifang K. Zhao, Ellen W. Clayton

Vanderbilt Law School Faculty Publications

Increasingly, patients without clinical indications are undergoing genomic tests. The purpose of this study was to assess their appreciation and comprehension of their test results and their clinicians’ reactions. We conducted 675 surveys with participants from the Vanderbilt Electronic Medical Records and Genomics (eMERGE) cohort. We interviewed 36 participants: 19 had received positive results, and 17 were self-identified racial minorities. Eleven clinicians who had patients who had participated in eMERGE were interviewed. A further 21 of these clinicians completed surveys. Participants spontaneously admitted to understanding little or none of the information returned to them from the eMERGE study. However, they …

Encomium For Karen Rothenberg, Ellen W. Clayton

Vanderbilt Law School Faculty Publications

Karen is also a zealous advocate in the very best sense of the word. After Struewing's article appeared, she wrote an editorial that appeared in multiple newspapers arguing that women with these variants should not lose their insurance. She became deeply involved in the National Action Plan for Breast Cancer, a powerful grass roots organization. Additionally, she became involved at the National Institutes of Health and addressed, often in leadership roles, such issues to develop strategies to prevent genetic discrimination for individuals with variants that increased the risk of developing cancer, to create tools to obtain meaningful informed consent for …

Unjust Timing Limitations In Genetic Malpractice, Ellen W. Clayton, Gary Marchant, Bonnie Leroy, Lauren Clatch

Vanderbilt Law School Faculty Publications

As genomic data are increasingly being collected and applied in clinical care, physicians, laboratories, and other health care providers are more frequently being sued for alleged medical malpractice or negligence. Because the genetic underpinnings of an existing or future health condition may not be immediately apparent, such cases sometimes raise unique timing issues involving the applicable statute of limitations, statute of repose, or statutory notification requirements. Although these timing limitations on when a lawsuit can be brought have important policy rationales and justifications, such as helping to protect providers from open-ended liability, their application to genetic liability cases may sometimes …

The Law Of Genetic Privacy: Applications, Implications, And Limitations, Ellen Wright Clayton, Barbara J. Evans, James W. Hazel, Mark A. Rothstein

Vanderbilt Law School Faculty Publications

Recent advances in technology have significantly improved the accuracy of genetic testing and analysis, and substantially reduced its cost, resulting in a dramatic increase in the amount of genetic information generated, analysed, shared, and stored by diverse individuals and entities. Given the diversity of actors and their interests, coupled with the wide variety of ways genetic data are held, it has been difficult to develop broadly applicable legal principles for genetic privacy. This article examines the current landscape of genetic privacy to identify the roles that the law does or should play, with a focus on federal statutes and regulations, …

The Waiting Game: How States Can Solve The Organ-Donation Crisis, Meredith M. Havekost

Vanderbilt Law Review

Thousands of patients in the United States live in limbo every day waiting for a lifesaving organ transplant, and the gap between the number of people who need a transplant and the number of available organs widens every year. Every state currently allows individuals to unilaterally indicate their intent to donate their organs upon death, but in practice, family members are frequently allowed to override the express intentions of decedents. In addition, the current U.S. "opt-in" system fails to reach its full potential because many eligible decedents never express their desires to become or not to become organ donors, and …

"Sorry" Is Never Enough: How State Apology Laws Fail To Reduce Medical Malpractice Liability Risk, W. Kip Viscusi, Benjamin J. Mcmichael, R. Lawrence Van Horn

Vanderbilt Law School Faculty Publications

Based on case studies indicating that apologies from physicians to patients can promote healing, understanding, and dispute resolution, 38 states have sought to reduce litigation and medical malpractice liability by enacting apology laws. Apology laws facilitate apologies by making them inadmissible in subsequent malpractice trials.

The underlying assumption regarding the potential efficacy of these laws is that, after receiving an apology, patients will be less likely to pursue a malpractice claim and will be more likely to settle those claims that are filed. However, once a patient has been made aware that the physician has committed a medical error, the …

Medical Malpractice Reform: What Works And What Doesn't, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

Concerns with medical malpractice liability costs have been a principal factor leading states to adopt a series of tort liability reforms. Medical malpractice premiums have been declining, creating less of a cost-based impetus for additional reforms. The most consistent empirical evidence indicating statistically significant effects of medical malpractice reforms has been for caps on non-economic damages. Damages caps reduce insurance losses and foster insurer profitability, consistent with the objective of caps. The impacts of caps are greatest for insurance companies that otherwise would have experienced the greatest losses in the state. However, caps may reduce payouts to plaintiffs, potentially reducing …

A Taste Of Their Own Medicine: Examining The Admissibility Of Experts' Prior Malpractice Under The Federal Rules Of Evidence, Neil Henson

Vanderbilt Law Review

Medical malpractice litigation is challenging for both plaintiffs and defendants. The intersection of legal issues with complex medical theories creates a dispute focused on expert witnesses, which leads to greater litigation expenses and cumbersome legal proceedings.' As one scholar observed, "medical malpractice has proven to be ... an unpleasant quagmire of unending skirmishes and full-scale engagements spread across a shifting battlefield." That analogy is fitting considering the stakes of a medical malpractice case-the injured patient's emotional, physical, and financial well-being may be contingent on a successful outcome, while the doctor may perceive even the threat of litigation as detrimental to …

Insurance Coverage Policies For Pharmacogenomic And Multi-Gene Testing For Cancer, Ellen Wright Clayton, Christine Y. Lu, Stephanie Loomer, Et Al.

Vanderbilt Law School Faculty Publications

Abstract: Insurance coverage policies are a major determinant of patient access to genomic tests. The objective of this study was to examine differences in coverage policies for guideline-recommended pharmacogenomic tests that inform cancer treatment. We analyzed coverage policies from eight Medicare contractors and 10 private payers for 23 biomarkers (e.g., HER2 and EGFR) and multi-gene tests. We extracted policy coverage and criteria, prior authorization requirements, and an evidence basis for coverage. We reviewed professional society guidelines and their recommendations for use of pharmacogenomic tests. Coverage for KRAS, EGFR, and BRAF tests were common across Medicare contractors and private payers, but …

Instrumental And Transformative Medical Technology, Nicole Huberfeld Professor Of Law

Vanderbilt Journal of Entertainment & Technology Law

This Article considers how medical technologies impact universality in health care. The universality principle, as embodied in the Patient Protection and Affordable Care Act (ACA), eliminated widespread discriminatory practices and provided financial assistance to those otherwise unable to become insured--a democratizing federal act that was intended to stabilize health care policy nationwide. This Article posits that medical technology, as with all of medicine, can be universalizing or exclusionary and that this status roughly correlates to its being "instrumental technology" or "transformative technology." Instrumental technology acts as a tool of medicine and often serves an existing aspect of health care; in …

Preemption Of State Law Claims Involving Medical Devices: Why Increasing Liability For Manufacturers Is A Perilous But Pivotal Proposition, Neil M. Issar

Vanderbilt Journal of Entertainment & Technology Law

A circuit split regarding the preemptive scope of the Medical Device Amendments of 1976 (MDA) has widened over the past several years. The split encompasses both the circumstances under which the MDA implicitly preempts state law claims and the scope of the MDA's express preemption provision. Manufacturers of medical devices regulated by the Food and Drug Administration (FDA) enjoyed many years of favorable rulings on the issue of federal preemption and deference to the primacy of FDA jurisdiction on monitoring or enforcement actions. However, the circuit split is reshaping the litigation landscape, and injured plaintiffs may rely on certain Circuit …

Uncovering The Silent Victims Of The American Medical Liability System, Joanna Shepherd

Vanderbilt Law Review

A frequently overlooked problem with the current medical liability system is the vast number of medical errors that go uncompensated. Although studies indicate that 1% of hospital patients are victims of medical negligence, fewer than 2% of these injured patients file claims. In this Article, I explain that many victims of medical malpractice do not file claims because they are unable to find attorneys willing to take their cases. I conducted the first national survey of attorneys to explore medical malpractice victims' access to the civil justice system. The results from the survey indicate that the economic reality of litigation …

Can I Be Sued For That? Liability Risk And The Disclosure Of Clinically Significant Genetic Research Findings, Ellen Wright Clayton, Amy L. Mcguire, Et Al.

Vanderbilt Law School Faculty Publications

Genomic researchers increasingly are faced with difficult decisions about whether, under what circumstances, and how to return research results and significant incidental findings to study participants. Many have argued that there is an ethical—maybe even a legal—obligation to disclose significant findings under some circumstances. At the international level, over the last decade there has begun to emerge a clear legal obligation to return significant findings discovered during the course of research. However, there is no explicit legal duty to disclose in the United States. This creates legal uncertainty that may lead to unmanaged variation in practice and poor quality care. …

Seeking Genomic Knowledge: The Case For Clinical Restraint, Ellen Wright Clayton, Wylie Burke, Susan Brown Trinidad

Vanderbilt Law School Faculty Publications

Genome sequencing technology provides new and promising tests for clinical practice, including whole genome sequencing, which measures an individual's complete DNA sequence, and whole exome sequencing, which measures the DNA for all genes coding for proteins. These technologies make it possible to test for multiple genes in a single test, which increases the efficiency of genetic testing. However, they can also produce large amounts of information that cannot be interpreted or is of limited clinical utility. This additional information could be distracting for patients and clinicians, and contribute to unnecessary healthcare costs. The potential for genomic sequencing to improve care …

Late Fathers' Later Children: Reconceiving The Limits Of Survivor's Benefits In Response To Death-Defying Reproductive Technology, Jeffrey W. Sheehan

Vanderbilt Journal of Entertainment & Technology Law

When Congress instructed the Social Security Administration to begin paying a social insurance benefit to "widows and orphans" in the 1930s, it simplified the process of determining an applicant's relationship to an insured decedent in two significant ways: First, Congress ordered the agency to honor the intestate laws of each state when determining whether an applicant was actually the child of a decedent, and second, it ordered the agency to treat any child who could qualify as an intestate heir as if that child actually depended on the parent financially at the time of the parent's death. Three-quarters of a …

Preemption Under The Controlled Substances Act, Robert A. Mikos

Vanderbilt Law School Faculty Publications

States are conducting increasingly bold experiments with their marijuana laws, but questions linger over their authority to deviate from the federal Controlled Substances Act. The CSA bans marijuana outright, and commentators have assumed that Congress sought to preempt all state laws that might somehow conflict with the CSA. Under the preemption rule now in vogue, state marijuana reforms are preempted if they either require someone to violate the CSA or, more controversially, if they pose an obstacle to Congress’s objective of eradicating marijuana. Seeking to avoid such conflicts, government officials have scuttled a number of important state marijuana reforms. This …

Three And Out: The Nfl's Concussion Liability And How Players Can Tackle The Problem, Jeremy P. Gove

Vanderbilt Journal of Entertainment & Technology Law

In 1952, the New England Journal of Medicine published a study stating that a player should not continue playing professional football after suffering three concussions. As players continue to get bigger, faster, and stronger, the number of concussions has increased. In response to this problem, the National Football League (NFL) commissioned a study run by scientists and NFL team doctors to determine the long-term effects of concussions. That committee determined that no long-term repercussions exist after experiencing a concussion while playing NFL football. Despite the scientific community's critiques of the study, the NFL used the committee's findings to create the …

Electronic Medical Records: A Prescription For Increased Medical Malpractice Liability?, Blake Carter

Vanderbilt Journal of Entertainment & Technology Law

The cost and quality of health care is and most likely will continue to be one of the most important issues that the United States faces in the coming decade. Although no powerful antidote exists to cure this industry of all of its ailments, one potential suggestion to treat some of the symptoms is the introduction of electronic medical records (EMRs).

Members of the medical community, patients, and even politicians all agree that EMRs offer promising opportunities to improve the overall quality of health care. However, lost in the discussion of these opportunities, is a consideration of the potential side …

Over The Counter But Under The Radar: Direct-To-Consumer Genetics Tests And Fda Regulation Of Medical Devices, Lauren B. Solberg

Vanderbilt Journal of Entertainment & Technology Law

Direct-to-consumer genetic tests are laboratory-developed tests that are marketed and sold directly to consumers. They typically do not require a prescription or any other involvement from a consumer's health care provider. Consumers order these tests online and return a specimen, usually a saliva sample, directly to the laboratory. The results are mailed directly to the consumer, and no health care provider or insurance company need ever learn the contents of these results. The FDA does not currently regulate direct-to-consumer genetic tests, though tests for hundreds of different diseases are readily available to the public.

The FDA's approach to regulating genetic …

Tissue Tug-Of-War: A Comparison Of International And U.S. Perspectives On The Regulation Of Human Tissue Banks, Lisa C. Edwards

Vanderbilt Journal of Transnational Law

Every day in the United States and around the world, patients and research participants at hospitals and doctors' offices give biological samples, whether in the form of surgically removed cancer tissue or a routine blood sample. Many of these patients are entirely unaware that their tissues were not thrown out as hazardous waste, and instead used by scientists for the development of new drugs and therapies. The courts in the United States in Moore v. Regents of the University of California, Greenberg v. Miami Children's Hospital Research Institute, and most recently Washington University v. Catalona have determined that a patient …

Recognizing Our Dangerous Gifts: Applying The Social Model To Individuals With Mental Illness, Rachel Anderson-Watts

Vanderbilt Law School Faculty Publications

Our society and laws allow a space for a multitude of identities and forms of expression. Many kinds of differences are legally protected in various ways, such as differences in race, religion, and gender. Sometimes protection takes the form of requiring social institutions to adapt to the unique needs of certain individuals or groups. Rights for disabled individuals, as exemplified by the Americans with Disabilities Act, rest on the principle that impairment disables because the world is structured around an incompatible model of human ability; not because of a fundamental deficit within the individual. This conception, termed the social model …

Assessing The Market For Human Reproductive Tissue Alienability: Why Can We Sell Our Eggs But Not Our Livers?, Brenda Reddix-Smalls

Vanderbilt Journal of Entertainment & Technology Law

Currently, an unregulated marketplace for assisted reproductive technology exists in the United States. For some people suffering from infertility, the ability to purchase human reproductive tissue, eggs, and sperm yields a maximum benefit when examined in a market context. Buyers, sellers, supply and demand, and technological advances all operate in a robust marketplace to provide the infertile with a supply of human eggs for reproduction with minimum state and federal regulatory control. Conversely, the buying and selling of all other human organs and tissues is prohibited in the United States by several federal statutes. The National Organ Transplant Act (NOTA) …

The Failure Of Breast Cancer Informed Consent Statutes, Rachael Anderson-Watts

Vanderbilt Law School Faculty Publications

Informed consent is a common law concept rooted in the idea that "[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body."' Its aim is to ensure that each patient gets the information she needs to meaningfully consent to medical procedures. Coming of age in the 1970s alongside other important rights movements, informed consent purported to solve medicine's paternalism: doctors too often dictating treatments rather than discussing options. Combating medical paternalism seems a worthwhile goal, given abuses in the past century, but moreover to improve everyday physician-patient encounters. …