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 …

A Genetic Surveillance State: Are We One Buccal Swab Away From A Total Loss Of Genetic Privacy?, Catherine Arcabascio

Faculty Scholarship

No abstract provided.

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 …

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

Articles

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 …

Who Knows What, And When?: A Survey Of The Privacy Policies Proffered By U.S. Direct-To-Consumer Genetic Testing Companies, Christopher Slobogin, James W. Hazel

Vanderbilt Law School Faculty Publications

Direct-to-consumer genetic testing (DTC-GT) companies have proliferated in the past several years. Based on an analysis of genetic material submitted by consumers, these companies offer a wide array of services, ranging from providing information about health and ancestry to identification of surreptitiously-gatheredb iological materials ent in by suspicious spouses. Federal and state laws are ambiguous about the types of disclosures these companies must make about how the genetic information they obtain is collected, used, and shared. In an effort to assist in developing such laws, this Article reports a survey of the privacy policies these companies purport to follow. It …

A Problem Not Yet Manifest: Gaps In Insurance Coverage Of Medical Interventions After Genetic Testing, Christopher Robertson

Faculty Scholarship

In the past decade, the field of genomics has rapidly changed and expanded.1 With these advancements also come new applications of genomics and genetics to clinical medicine. The information gathered from genetic testing and genome sequencing can reveal a great deal about not only an individual's current health, but his/her future health as well.2 This rapid expansion of scientific and medical capacity is accompanied by rapid changes for law and policy making thoughtful regulation essential. The human genome includes many variations, most of which have no known significance. However, some variants can be the cause of important medical conditions, and …

23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely

Other Publications

On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.

Direct-To-Consumer Genetic Testing: Learning From The Past And Looking Toward The Future, Stephanie Bair

Faculty Scholarship

A decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to the consumer and purporting to use genetic information to generate individualized health information. These tests have been subject to only minimal regulation, despite the fact that scientists and policymakers have serious concerns about both the clinical effectiveness of the tests and the safety of releasing certain types of health information to the public without the supervision of a health care professional. Proponents of minimal regulation argue that the tests allow for patient autonomy and privacy of genetic information, …

Mixed Messages: The Intersection Of Prenatal Genetic Testing And Abortion, Rachel Rebouché, Karen Rothenberg

UF Law Faculty Publications

This article, prepared for the 2011 Wiley A. Branton Symposium at Howard Law School, provides a snapshot of how current law and practice generate mixed messages about prenatal genetic testing and abortion. The ability to screen and to test for genetic conditions prenatally is expanding, not only because of technological innovations but also because of increased legal and financial incentives. At the same time that prenatal genetic testing is expanding, abortion – one option pregnant women have after testing – is contracting. Federal and state legislation restricts abortion services, for example, by reducing or prohibiting funding; banning the types or …

Gina's Genotypes, David H. Kaye

Journal Articles

In August 2009, the Board of Trustees of the University of Akron added to the university's employment policy the following proviso: "any applicant may be asked to submit fingerprints or DNA sample for purpose of a federal criminal background check." Although the federal government does not do background checks with DNA, the policy is significant because it highlights a largely unexplored feature of the Genetic Information Nondiscrimination Act of 2008 (GINA). GINA generally prohibits employers from asking for "genetic information." The faculty senate and outside commentators have declared that the Akron policy is "of doubtful legality" because it "appears to …

The Genetic Information Non-Discrimination Act: Protecting Privacy And Ensuring Fairness In Health Insurance And Employment Practices, Melissa Beyer

Louis Jackson National Student Writing Competition

Almost two centuries ago, Thomas Jefferson, one of this country’s foremost scientists and original thinkers, wrote, ‘[L]aws and institutions must go hand in hand with the progress of the human mind. As . . . new discoveries are made [and] new truths disclosed...institutions must advance also, and keep pace with the time.’ In this age of genetic breakthroughs, it is essential that our laws catch up with science. We can’t afford to take one step forward in science but two steps backward in civil rights. Our laws must specify, clearly and unambiguously, how genetic information may be used and how …

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 …

Please, Let's Bury The Junk: The Codis Loci And The Revelation Of Private Information, David H. Kaye

Journal Articles

This Northwestern University Law Review Colloquy paper describes the four possible ways in which genetic loci could possess predictive or diagnostic value with regard to diseases and explains why these mechanisms have not led, and probably cannot lead, to useful screening tests with the Convicted Offender DNA Index System (CODIS) profiles in national, state, and local databases. It then considers the phenotypes and familial relationships that the CODIS STRs can be used to identify. The profiles carry limited information about an individual's race and familial relationships, and the article places the resulting privacy issues in perspective. Finally, the paper comments …

The Reckless Pursuit Of Dominion: A Situational Analysis Of The Nba And Diminishing Player Autonomy, Michael Mccann

Law Faculty Scholarship

This Article examines required genetic testing of NBA players from a situational vantage point, integrating socio-psychological, legal, and ethical analyses. The core argument may be expressed as follows: required genetic testing of NBA players appears consistent with a broader and largely deleterious agenda by the NBA to control players. Since implementation of the rookie wage scale in 1995 through the recent imposition of a paternalistic player dress code, the NBA has increasingly usurped player autonomy. The NBA's capacity to do so largely rests in its adroit manipulation of the situational influences that influence fans and media. For instance, because of …

The Need For A Revitalized Common Law Of The Workplace, William R. Corbett

Journal Articles

No abstract provided.

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

Faculty Scholarship

No abstract provided.

The Wonderful World Of Genetics, George J. Annas

Faculty Scholarship

Review of Future Perfect: Confronting Decisions about Genetics (2001) by Lori B. Andrews

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 …

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

Faculty Scholarship

No abstract provided.

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 …

Commercialization Of Genetic Testing Services: The Fda, Market Forces, And Biological Tarot Cards, Michael J. Malinowski, Robin J.R. Blatt

Journal Articles

No abstract provided.

Sex, Lies, And Genetic Testing: What Are Your Rights To Privacy In Florida?, Jon L. Mills

UF Law Faculty Publications

Individual and human rights in this country have evolved from national movements and national standards. The Fourteenth Amendment's application of rights to the states was a landmark in human rights, guaranteeing all citizens, no matter their state of residence, a baseline of protection. The Federal Constitution was the protector-“states' rights” was the code phrase for discrimination. But in the American crucible of cultural diversity a national standard for “community” may result in the lowest common denominator or a definition based on averaging. Would it not be better when the most individual of rights, privacy, is implicated to define that right …

Genetic Discrimination And Health Insurance: An Urgent Need For Reform, Kathy L. Hudson, Karen H. Rothenberg, Lori B. Andrews, Mary Jo Ellis Kahn, Francis S. Collins

Faculty Scholarship

No abstract provided.

The Good Mother: The Limits Of Reproductive Accountability And Genetic Choice, R. Alta Charo, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.

Coming Into Being: Law, Ethics, And The Practice Of Prenatal Genetic Screening, Michael J. Malinowski

Journal Articles

No abstract provided.

The Law's Response To Reproductive Genetic Testing: Questioning Assumptions About Choice, Causation And Control, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.