Law Commons^™

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 …

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 …

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, …

"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 …

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 …

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. …

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 …

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 …

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 …

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. …

An Empirical Assessment Of Early Offer Reform For Medical Malpractice, W. Kip Viscusi, Wesley A. Magat, Joel Huber

Vanderbilt Law School Faculty Publications

The early offer reform proposal for medical malpractice provides an option for claimants to receive prompt payment of all their net economic losses and reasonable attorney fees. Using a large sample of closed individual medical malpractice claims from Texas supplemented by data from Florida, this article provides an empirical assessment of the consequences of the early offer reform. Noneconomic damages make up about two-thirds of paid claim amounts. The minimum payment amount for serious injuries will affect the magnitude of insurer savings and claimant compensation. Payments to claimants will be expedited by 2 years by the early offer reform, and …

An Empirical Assessment Of Early Offer Reform For Medical Malpractice, Joni Hersch, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

The early offer reform proposal for medical malpractice provides an option for claimants to receive prompt payment of all their net economic losses and reasonable attorney fees. Using a large sample of closed individual medical malpractice claims from Texas supplemented by data from Florida, this article provides an empirical assessment of the consequences of the early offer reform. Noneconomic damages make up about two-thirds of paid claim amounts. The minimum payment amount for serious injuries will affect the magnitude of insurer savings and claimant compensation. Payments to claimants will be expedited by 2 years by the early offer reform, and …

Mental Disorder As An Exemption From The Death Penalty: The Aba-Irr Task Force Recommendations, Christopher Slobogin

Vanderbilt Law School Faculty Publications

The Task Force on Mental Disability and the Death Penalty (Task Force) established by the Individual Rights and Responsibilities Section of the American Bar Association (ABA-IRR) has proposed that the ABA adopt three recommendations concerning the role of mental disability in capital cases. The first two recommendations call for a prohibition on execution of offenders whose mental disorder rendered them less culpable at the time of the offense, and the third would prohibit execution of those whose mental disability currently renders them incompetent to pursue appeals or to be executed. This Article discusses the first two, culpability-related, recommendations. With respect …

Damages: Using A Case Study To Teach Law, Lawyering, And Dispute Resolution, Chris Guthrie

Vanderbilt Law School Faculty Publications

Seven law school faculty members and one practicing attorney recently developed and taught a wholly new kind of law course based on an already published case study, Damages: One Family's Legal Struggles in the World of Medicine, by Barry Werth, an investigative reporter who spent several years researching to write the book. Damages, an in-depth account of a medical malpractice case, presents the perspectives of the injured family, the defendant physician, the lawyers, and the three mediators. In this Symposium Introduction, the authors provide a summary of Werth's book, explain why they decided to create a course based on his …

Development Of An Early Identification And Response Model Of Malpractice Prevention, Ellen Wright Clayton, Gerald B. Hickson, James W. Pichert, Charles F. Federspiel

Vanderbilt Law School Faculty Publications

The dramatic rise in the incidence of malpractice claims over the past thirty years has revealed several problems with the U.S. system of medical dispute resolution. First, the sudden and unexpected increase in claims has created an insurance crisis wherein various medical specialists have had difficulty obtaining affordable insurance coverage. One such crisis occurred in Florida in the mid-1980's, when an inability of many physicians to procure medical malpractice coverage caused some to limit or curtail their practice. This resulted in access problems for the public. This phenomenon has disproportionately befallen physicians practicing obstetric medicine. Second, besides contributing to periodic …

Medical Malpractice Insurance In The Wake Of Liability Reform, W. Kip Viscusi, Patricia Born

Vanderbilt Law School Faculty Publications

This article examines the effect of the liability reforms on medical malpractice insurance over the 1984-91 period. This is the first study to use data by firm and by state for every firm writing medical malpractice insurance over that time period. The liability reforms increased insurance profitability (that is, decreased the loss ratios), where the main mechanism of influence was through decreasing losses. The quantile regression estimates imply that the greatest effects of liability reform are on the most unprofitable firms and that the effect is not uniform across the entire market. This pattern is consistent with the other principal …

The National Implications Of Liability Reforms For General Liability And Medical Malpractice Insurance, W. Kip Viscusi, Patricia Born

Vanderbilt Law School Faculty Publications

The stabilization of the insurance market may lead to lower prices for products and for medical care, but will also generally lead to lower values of tort awards as well. If the social objective was simply to reduce losses, then that objective could be achieved by abolishing tort liability altogether. Our societal concerns are clearly much broader. In the absence of a more detailed assessment of the desirability of the reforms and their effect on injured parties, it would be premature to conclude that reform efforts that were successful in enhancing insurance market profitability should be judged a success from …

Screening And Treatment Of Newborns, Ellen Wright Clayton

Vanderbilt Law School Faculty Publications

With the advent of new genetic technologies and the Human Genome Initiative, interest in the problems posed by genetic diagnostics in general, and by genetic screening in particular, has surfaced. Many recent works focus on the problems posed by the "new genetics" in the contexts of prenatal diagnosis, carrier detection, employment, and insurance. In the midst of all this discussion, the routine testing of newborns for genetic disorders seems relatively uncomplicated and has, in fact, become "a part of common practice and accepted public policy with little thought having been given to the implications." The relative lack of concern about …

Treatment Of The Mentally Disabled: Rethinking The Community-First Idea, Christopher Slobogin

Vanderbilt Law School Faculty Publications

In the past several decades the treatment, habilitation and education of the mentally disabled has been heavily influenced by what could be called the "community-first" movement. This movement which encompasses such developments as deinstitutionalization, the least restrictive alternative doctrine, normalization, mainstreaming,and outpatient commitment-is based on the idea that, in caring for the mentally disabled, we should favor placement in the community rather than in institutions segregated from mainstream populations. The community-first idea is not unanimously supported. But Congress, many courts, and countless advocacy groups composed of lawyers, mental health professionals and laypeople have rallied behind the community first standard as …

"New And Improved" Estimates Of Qualification Discrimination, Joni Hersch, Joe A. Stone

Vanderbilt Law School Faculty Publications

The early offer reform proposal for medical malpractice provides an option for claimants to receive prompt payment of all their net economic Losses and reasonable attorney fees. Using a Large sample of closed individual medical malpractice claims from Texas supplemented by data from Florida, this article provides an empirical assessment of the consequences of the early offer reform. Noneconomic damages make up about two-thirds of paid claim amounts. The minimum payment amount for serious injuries will affect the magnitude of insurer savings and claimant compensation. Payments to claimants will be expedited by 2 years by the early offer reform, and …

Father And Mother Know Best: Defining The Liability Of Physicians For Inadequate Genetic Counseling, Ellen Wright Clayton

Vanderbilt Law School Faculty Publications

Although genetic disorders have been recognized for centuries, recent advances in the study of human genetics often permit accurate determination of the risk that parents will have genetically defective children.' When this information is available either before conception or during pregnancy, prospective parents may choose to prevent the birth of such defective children through contraception or abortion. Recently, courts have been called on to define the circumstances in which either the parents or the children should receive tort damages when parents are denied opportunities to prevent the birth of defective children because of their physicians' negligent failure to detect or …