Law Commons^™

Direct-To-Consumer Genetic Testing, Ellen W. Clayton, Et Al.

Vanderbilt Law School Faculty Publications

Direct-to-consumer genetic testing is marketed as a tool to uncover ancestry and kin. Recent studies of actual and potential users have demonstrated that individuals’ responses to the use of these tests for these purposes are complex, with privacy, disruptive consequences, potential for misuse, and secondary use by law enforcement cited as potential concerns. We conducted six focus groups with a diverse sample of participants (n = 62) who were aware of but had not used direct-to-consumer genetic tests, in an effort to understand more about what people considering these tests think about the potential value, risks, and benefits of such …

Reimagining Disability: The Screening Of Donor Gametes And Embryos In Ivf, Isabel Karpin, Roxanne Mykitiuk

Articles & Book Chapters

In this article,we examine how disability is figured in the imaginaries that are given shape by the reproductive projects and parental desires facilitated by the bio-medical techniques and practices of assisted reproductive technologies (ARTs) that involve selection and screening for disability. We investigate how some users of ARTs understand and deploy these imaginaries in ways that are both concordant with and resistant to the understanding of disability embedded within the broader sociotechnical and social imaginaries. It is through users’ deliberations, choices, responses, and expectations that we come to understand how these imaginaries are perpetuated and resisted, and how maintaining them …

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 …

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 …

23anddiverseme: Using Genetic Ancestry Tests To Establish Minority Status, Robert Karl

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Marquette Intellectual Property Law Review

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

What Genetic Testing Teaches About Long-Term Predictive Health Analytics Regulation, Sharona Hoffman

Faculty Publications

The ever-growing phenomenon of predictive health analytics is generating significant excitement, hope for improved health outcomes, and potential for new revenues. Researchers are developing algorithms to predict suicide, heart disease, stroke, diabetes, cognitive decline, future opioid abuse, and other ailments. The researchers include not only medical experts, but also commercial enterprises such as Facebook and LexisNexis, who may profit from the work considerably. This Article focuses on long-term disease predictions (predictions regarding future illnesses), which have received surprisingly little attention in the legal and ethical literature. It compares the robust academic and policy debates and legal interventions that followed the …

Needles, Haystacks, And Next-Generation Genetic Sequencing, Teneille R. Brown

Utah Law Faculty Scholarship

Genetic testing is becoming more frequent and the results more complex. Not infrequently, genetic testing conducted for one purpose reveals information about other features of the genome that may be of clinical significance. These unintended findings have been referred to as “incidental” or “secondary” findings. In 2013, the American College of Medical Genetics (“ACMG”) recommended that clinical laboratories inform people if their genetic analyses indicate that they have certain secondary mutations. These mutations were selected because they probably cause a serious disease, which is treatable, and may go undetected. The ACMG’s recommendations galvanized critical responses by the genetics and ethics …

Wrongful Birth; Preconception Torts; Duty To Inform Of Genetic Risks; Becker V. Schwartz, Gail White Sweeney

Akron Law Review

Both pairs of parents sued on their own behalfs for (1) the expenses incurred in the care and treatment of the infants and for (2) the mental distress caused them by the birth of a defective child. They also sought damages on behalf of the children for (3) wrongful life. The Court of Appeals acknowledged the first claim as valid, but dismissed the second and third. It dismissed the claims for damages for emotional distress on the precedent of its 1977 decision in Howard v. Lecher and upon the difficulty of ascertaining the value of mitigated damages prescribed by Restatement …

23andme Inc.: Patent Law And Lifestyle Genetics, Matthew Rimmer

Matthew Rimmer

The venture, 23andMe Inc., raises a host of issues in respect of patent law, policy, and practice in respect of lifestyle genetics and personalised medicine. The company observes: ‘We recognize that the availability of personal genetic information raises important issues at the nexus of ethics, law, and public policy’. 23andMe Inc. has tested the boundaries of patent law, with its patent applications, which cut across information technology, medicine, and biotechnology. The company’s research raises fundamental issues about patentability, especially in light of the litigation in Bilski v. Kappos, Mayo Collaborative Services v. Prometheus Laboratories Inc. and Association for Molecular Pathology …

Judging Genes: Implications Of The Second Generation Of Genetic Tests In The Courtroom, Diane E. Hoffmann, Karen H. Rothenberg

Diane Hoffmann

The use of DNA tests for identification has revolutionized court proceedings in criminal and paternity cases. Now, requests by litigants to admit or compel a second generation of genetic tests – tests to confirm or predict genetic diseases and conditions – threaten to affect judicial decision-making in many more contexts. Unlike DNA tests for identification, these second generation tests may provide highly personal health and behavioral information about individuals and their relatives and will pose new challenges for trial court judges. This article reports on an original empirical study of how judges analyze these requests and uses the study results …

There Will Be Blood ... Testing: The Intersection Of Professional Sports And The Genetic Information Nondiscrimination Act Of 2008, Jesse A. Bland

Vanderbilt Journal of Entertainment & Technology Law

Genetic testing, professional baseball, and employment discrimination seldom intersect. This Note changes that. Thanks to scientific breakthroughs in genetic research over the past half-century, genetic testing is a powerful tool for producing rich, individualized information. Progress comes at a price, however. As genetic testing has advanced and become more prevalent, so too has the potential misuse of genetic information. A recently enacted federal law--the Genetic Information Nondiscrimination Act of 2008 (GINA)--seeks to eliminate one such threat by prohibiting the improper use of genetic information in employment decisions. While the law gained congressional momentum after tales of abuse in blue-collar industries, …

Judging Genes: Implications Of The Second Generation Of Genetic Tests In The Courtroom, Diane E. Hoffmann, Karen H. Rothenberg

Karen H. Rothenberg

The use of DNA tests for identification has revolutionized court proceedings in criminal and paternity cases. Now, requests by litigants to admit or compel a second generation of genetic tests – tests to confirm or predict genetic diseases and conditions – threaten to affect judicial decision-making in many more contexts. Unlike DNA tests for identification, these second generation tests may provide highly personal health and behavioral information about individuals and their relatives and will pose new challenges for trial court judges. This article reports on an original empirical study of how judges analyze these requests and uses the study results …

Social Implications Of Genetic Testing, Karen H. Rothenberg

Karen H. Rothenberg

This paper examines the social implications of predictive genetic testing and its impact on the insurance industry. Although the Human Genome Project has the potential to improve the health of our nation, it also may serve as a means of highlighting genetic differences among individuals and ethnic groups. Thus, if we are to reach the full promise of the Project, society must address the public's fears of genetic discrimination in insurance and employment context. Following an analysis of state and federal legislation on genetic privacy and discrimination, the paper concludes with a challenge to the insurance industry to work with …

Judging Genes: Implications Of The Second Generation Of Genetic Tests In The Courtroom, Diane E. Hoffmann, Karen H. Rothenberg

Faculty Scholarship

The use of DNA tests for identification has revolutionized court proceedings in criminal and paternity cases. Now, requests by litigants to admit or compel a second generation of genetic tests – tests to confirm or predict genetic diseases and conditions – threaten to affect judicial decision-making in many more contexts. Unlike DNA tests for identification, these second generation tests may provide highly personal health and behavioral information about individuals and their relatives and will pose new challenges for trial court judges. This article reports on an original empirical study of how judges analyze these requests and uses the study results …

Judging Genes: Implications Of The Second Generation Of Genetic Tests Inthe Courtroom, Diane E. Hoffmann, Karen H. Rothenberg

Maryland Law Review

No abstract provided.

Note: Exclusive Licensing Of Dna Diagnostics: Is There A Negative Effect On Quantity And Quality Of Healthcare Delivery That Compels Nih Rulemaking?, Edward Weck

William Mitchell Law Review

This comment surveys the costs of deoxyribonucleic acid (DNA) diagnostic tests and argues in favor of non-exclusive licensing as a means to provide broad access to affordable DNA diagnostic testing. Part II provides background information on genetic testing, patenting genes as applied to genetic testing, the Bayh-Dole Act, and technology transfer. In addition, Part II summarizes academic commentary regarding the implications of exclusive licensing for biotechnology. Scholars propose a number of solutions, including expanding the experimental use exception. Part III details proposed rulemaking for DNA diagnostics. Part IV reviews anecdotal examples of genetic testing for breast cancer, hereditary hemochromatosis, and …

Direct-To-Consumer Genetic Tests, Government Oversight, And The First Amendment: What The Government Can (And Can't) Do To Protect The Public's Health, Gail H. Javitt, Erica Stanley, Kathy Hudson

Oklahoma Law Review

No abstract provided.

Predatory Paternity Establishment: A Critical Analysis Of The Acknowledgment Of Paternity Process In Texas., Anne Greenwood

St. Mary's Law Journal

Child support programs across the nation are struggling to achieve even meager recovery of the financial support children need from their parents. Obtaining child support payments from men who are not fathers and who unknowingly signed their rights away is not a sound long-term policy. States must ensure that children are supported and their custodial mothers receive assistance from non-custodial fathers. Logically, the law should only compel a man to support a child he fathered. If a man chooses to assume not only the financial obligation but also the relationship which belongs to the biological father; then such agreement must …

Reproductive Genetics 1991-2002: A Selected Annotated Legal Bibliography Of Genetic Testing, Gene Transfer And Reproductive Cloning, Gail H. Javitt

Journal of Health Care Law and Policy

No abstract provided.

Index To The Bibliography

Journal of Health Care Law and Policy

No abstract provided.

Before It's Too Late- Addressing Fear Of Genetic Information, Karen H. Rothenberg, Sharon F. Terry

Faculty Scholarship

No abstract provided.

Your Dna Is Your Resume: How Inadequate Protection Of Genetic Information Perpetuates Employment Discrimination

Washington and Lee Journal of Civil Rights and Social Justice

No abstract provided.

Science Fact Or Science Fiction? The Implications Of Court-Ordered Genetic Testing Under Rule 35, Anthony S. Niedwiecki

Publications

This article proposes an analysis for courts to follow when faced with a Rule 35 motion to compel a party to undergo genetic testing or any other procedure that tests for a specific medical condition.

Part I explains the analysis courts generally conduct for a Rule 35 motion. Generally, courts make a factual inquiry into whether there is a need for the procedure and whether the examinee has placed his or her physical or mental condition in controversy. Rarely have courts examined the risks associated with ordering an examination. When courts do examine the risks, they continue to show a …

Adverse Impact Of Predisposition Testing On Major Life Activities: Lessons From Brca 1/2testing, Katherine A. Schneider

Journal of Health Care Law and Policy

No abstract provided.

Social, Legal, And Ethical Issues, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.

Searching For The Holy Grail: The Human Genome Project And Its Implications , Allison Morse

Journal of Law and Health

This Paper will explore the ethical considerations of the reductionist paradigm that the Human Genome Project represents, and analyze how this paradigm affects our political institutions, our family relationships, and even our identity. Part Two will provide the scientific background for a discussion of the Human Genome Project. It will begin by defining two competing theoretical constructs scientists use when exploring biological phenomenon: reductionism and organism. This Part will then offer a rudimentary explanation of how genes function. Yet even this rudimentary explanation illustrates the complexity involved in the functioning of genes, leaving the reductionist notions of genes as the …

Testing For Genetic Traits: The Need For A New Legal Doctrine Of Informed Consent , Elizabeth B. Cooper

Faculty Scholarship

Innovative medical technology has made it possible to test whether you are at increased risk for certain types of cancer. The mere processing of a vial of blood can reveal whether you have a genetic predisposition to develop breast, ovarian, or prostate cancer, or other life-threatening conditions. The Human Genome Project, an international endeavor seeking to map our genetic structures, has facilitated this increasing ability to test for genetic flaws. It is expected that as the human genetic map is filled in, and as flaws in our fundamental building blocks are identified, there will be a concomitant drive to test …

Social Implications Of Genetic Testing, Karen H. Rothenberg

Faculty Scholarship

This paper examines the social implications of predictive genetic testing and its impact on the insurance industry. Although the Human Genome Project has the potential to improve the health of our nation, it also may serve as a means of highlighting genetic differences among individuals and ethnic groups. Thus, if we are to reach the full promise of the Project, society must address the public's fears of genetic discrimination in insurance and employment context. Following an analysis of state and federal legislation on genetic privacy and discrimination, the paper concludes with a challenge to the insurance industry to work with …

What Should The Law Say About Disclosure Of Genetic Information To Relatives?, Ellen Wright Clayton

Journal of Health Care Law and Policy

No abstract provided.