Symposium – From Bench to Society: Law and Ethics at the Frontier of Genomic Technology

Jamie S. King

Volume 64, Issue 6, 1587-1590

Full Article

Symposium – What Real-World Criminal Cases Tell Us About Genetics Evidence

Deborah W. Denno

Volume 64, Issue 6, 1591-1618

Rapid advances in genetic and neuroscience research over the past few decades have fueled a focus on how such information is viewed and used by the criminal justice system. Researchers at the University of Utah recently conducted an unprecedented experimental study indicating that psychopathic criminal offenders are more likely to receive lighter sentences if a judge was aware of genetic and neurobiological explanations for the offender’s psychopathy. This Article contends that the study’s conclusions derive from substantial flaws in the study’s design and methodology. The hypothetical case upon which the study is based captures just one narrow and unrepresentative component of how genetic and neurobiological information operates, and the study suffers from serious omissions that affect the validity and reliability of its results. It is important to call attention to these problems given that the study’s widely publicized findings are likely to bolster inaccurate perceptions regarding the dangers of allowing behavioral genetics evidence in criminal cases. This Article concludes with a detailed discussion of a number of recent criminal cases involving behavioral genetics evidence. Familiarity with such cases may improve the real-world applicability of future experimental studies exploring the influence of genetics evidence on criminal cases.

Full Article

Symposium – Maternal Smoking During Pregnancy and Offspring Health Outcomes: The Role of Epignetic Research in Informal Legal Policy and Practice

Taylor F. Smith, Matthew A. Maccani, and Valerie S. Knopik

Volume 64, Issue 6, 1619-1648

Scientific advances in epidemiology and epigenetics emphasize the importance of prenatal and intergenerational environmental influences and epigenetic regulation in altering vulnerability for later health outcomes. These findings may have wide-ranging legal implications; however, to avoid misapplication, a thorough understanding of the scientific literature and legal precedent is warranted. A growing body of literature suggests that negative health outcomes associated with prenatal smoke exposure may result, in part, from aberrant epigenetic regulation of gene expression. Such findings emphasize the need to reduce rates of prenatal cigarette smoke exposure in order to promote health for both current and future generations. This Article provides a focused overview of research examining the interrelationships between maternal smoking during pregnancy, epigenetic regulation, and vulnerability for later health outcomes. Additionally, this Article discusses legal, ethical, and policy challenges related to reducing smoke exposure during pregnancy.

Full Article

Symposium – Seeking Genomic Knowledge: The Case for Clinical Restraint

Wylie Burke, Susan Brown Trinidad, and Ellen Wright Clayton

Volume 64, Issue 6, 1649-1664

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 will be context-dependent, varying for different patients and clinical settings. This Article argues that a disciplined approach is needed, incorporating research to assess when and how genomic information can improve clinical outcomes, practice guidelines that direct optimal uses of genomic sequencing, and efforts to limit the production of genomic information unrelated to the clinical needs of the patient. Without this approach, genomic testing could add to current uansustainable healthcare costs and prove unaffordable in the long run.

Full Article

Wading Into the Daubert Tide: Sargon Enterprises, Inc. v. University of Southern California

David L. Faigman and Edward J. Imwinkelried

Volume 64, Issue 6, 1665-1696

In Sargon Enterprises, Inc. v. University of Southern California, the California Supreme Court decided arguably the most important expert testimony decision that it has rendered in at least two decades. Prior to Sargon, California appeared steadfastly committed to the classic “general acceptance” test, which required judges to assess whether an expert’s theory or technique had gained general acceptance in the relevant fields. In 1993, in Daubert v. Merrell Dow Pharmaceuticals, Inc., the United States Supreme Court announced a new empirical validation test. In the years since 1993, most state courts adopted some version of Daubert, but until Sargon the California Supreme Court had refused to follow the federal lead.Sargon undoubtedly moves California jurisprudence toward the Daubert approach. In Sargon, the court adopted the fundamental perspective of Daubert and embraced key terminology from the Daubert opinion and its progeny. These parallels have prompted some commentators to declare that California is now in the Daubert camp.

Although Sargon is a step toward the Daubert approach, it is premature to conclude that Sargon goes that far for at least two reasons. First, even post-Sargon, the California approach may be laxer than the federal approach. In Daubert, Justice Blackmun stated that Federal Rule of Evidence 104(a) governs the trial judge’s admissibility decision, which mandates that the judge probe deeply into the bases for the expert’s opinion, even including assessing credibility. Sargon stops short of explicitly going that far. Second, the California approach may prove to be more demanding than the federal approach. In a footnote, Sargon indicates that the Frye test is still good law in California. If so, then some proponents may face the daunting task of surmounting both hurdles to admissibility.

Full Article

The Return of Results in Genetic Testing: Who Owes What to Whom, When, and Why?

Stephanie A. Alessi

Volume 64, Issue 6, 1697-1726

The field of genetic research has revolutionized modern medicine and will continue to do so in the years to come. For the people whose biological materials form the basis for this research, however, the research process may also lead to personal discoveries—namely, it may expose information about their health, genetic predispositions, and other gene-linked characteristics. Researchers who uncover this kind of personal genetic information are likewise confronted with the question of whether they should—or must—provide their subjects with feedback about their results.For subjects and researchers alike, the answer is unclear. Presently, there is little guidance as to these parties’ rights and responsibilities when it comes to the return of genetic results in a research setting. As a result, neither party has a clearly defined understanding of what to expect from the research relationship. This Article draws on recognized ethical and legal foundations to propose that genetic researchers should owe three limited legal duties to their research subjects regarding planning for, acquiring informed consent about, and reporting certain genetic findings. Considering the wide variation among individuals in terms of what genetic information they would like to know, this Article balances concerns for individual autonomy with the right to acquire personal health information, and it weighs those interests against the potential cost to socially beneficial genetic research. In balancing these considerations, this Article’s proposals for a limited set of duties offer a careful step toward clearly defining the rights and responsibilities of genetic researchers and their subjects.

Full Article

Note – Competitive Regulation of Mobile Software Systems: Promoting Innovation Through Reform of Antitrust and Patent Laws

Josh Baskin

Volume 64, Issue 6, 1727-1758

This Note analyzes the current antitrust regulatory framework for high tech, iteratively evolving computer and software systems. This issue has significant implications for the current economy as many modern technology companies base their entire business model on such systems. This Note examines the problems concerning software patents through an analysis of two well-known mobile phone operating systems: Apple’s iOS and Google’s Android.This Note also examines the current regulatory framework that prevents large companies from taking anticompetitive actions to expand their power in fast-moving high tech markets at the expense of smaller competitors—specifically tying, predatory innovation, refusal to deal or license, sham litigation, and overbroad software patents. This Note also proposes several changes to both antitrust and patent laws that will make it more difficult for established market players to prevent new competitors from entering high tech markets, thereby promoting greater openness and innovation. These changes include modernizing sham litigation, reducing the number of patent infringement actions by allowing reverse engineering of software patent and an independent invention defense, and increased scrutiny of the business improvements antitrust defense.

Each of these proposed changes targets the promotion of innovation by enabling the entry of new players into established markets without the threat of expensive litigation constantly undermining the compatibility and efficiency of the products that they attempt to bring to market.

Full Article

Note – Toward Effective Access to Justice in Haiti: Eliminating the Medical Certificate Requirement in Rape Prosecution

Shannon D. Lankenau

Volume 64, Issue 6, 1759-1787

In Haiti, the overwhelming majority of rapes go unpunished. To date, the Haitian government has failed to promulgate a working legal framework in which it can effectively prosecute crimes of sexual violence. Women, in particular, are disproportionately burdened by these inadequacies. This Note explores one of the most problematic aspects of the current legal system: the de facto requirement that a woman obtain a medical certificate to corroborate her claim of rape. Although not mandated by Haitian law, medical certificates are regarded as the foundation of any prosecution because deficient investigations often fail to produce any additional evidence for use at trial and a woman’s own testimony is routinely discredited. By requiring a medical certificate in all rape prosecutions, the Haitian government is reinforcing a deep-seated cultural belief that a woman’s testimony is inherently untrustworthy. Worse yet, victims of sexual violence are deprived of their right to an effective remedy under domestic and international law.This Note suggests that the law should be amended to affirmatively state that a woman’s credible testimony regarding her attack can be legally sufficient to secure a conviction in a rape case, thereby eliminating the de facto medical requirement. Still, enacting legal reform will not be enough. Until Haitian society addresses the root causes of gender discrimination in Haiti, distrust of a woman’s testimony will remain a significant barrier to rape prosecutions.

Full Article