ABSTRACT: As in many countries throughout the world, Canada is struggling to address the legal and ethical challenges created by the emerging genetic testing technologies. Though Canada currently has little "genetic testing" jurisprudence and no formal regulations, there has been a significant amount of policy discussion. Moreover, there are reasons to believe that genetic malpractice cases may become more common. Canada's distinctive socio-political environment-marked by our mix of American individualism and a European deference to community interests-will ensure that this emerging legal framework will have a unique Canadian tenor.
CITATION: Timothy Caulfield, Genetic Testing, Liability, and Regulatory Policy: The Canadian Situation, 41 Jurimetrics J. 7-21 (2000).
ABSTRACT : This article explores the extent to which completion of maps of the human genome, coupled with the introduction of technology that will accelerate the identification of gene and protein function, have introduced immeasurable potential to advance life science and health care through genetic profiling. In light of definitional uncertainly, the regulatory and legal environment surrounding predictive genetic testing threatens to impede clinical utilization of genetic profiling technologies that could significantly improve human health. Especially given that genetic testing technologies have been stigmatized in the public and medical community, they must enter the marketplace with a regulatory framework that assures safety, efficacy, and market responsibility.
CITATION: Michael J. Malinowski, Separating Predictive Genetic Testing from Snake Oil: Regulation, Liabilities, and Lost Opportunities, 41 Jurimetrics 23-52 (2000).
ABSTRACT : The Secretary's Advisory Committee on Genetic Testing recently recommended that FDA be involved in the regulation of all new genetic tests. This culminates a long effort to end a double standard under which the FDA regulates genetic tests marketed as "kits" but not those marketed as clinical laboratory services. For kits, FDA requires data on the accuracy of predictions or diagnoses of disease. Yet, for tests marketed as services, the FDA applies no such requirement. Using existing policies for classifying medical devices, FDA could readily implement the committee's recommendation, assuring that data on clinical validity are available to assist decision making.
CITATION: Neil A. Holtzman, FDA and the Regulation of Genetic Tests, 41 Jurimetrics J. 53-62 (2000).
ABSTRACT : Calls for FDA to regulate genetic testing are possibly premature. The concerns that animate the desire for closer regulation lie generally beyond FDA expertise and experience, and to the extent they involve medical judgments, they invite the agency to enter an arena-the practice of medicine-which it has historically declined to regulate. Further, FDA's current statutory authority does not fit well the activities that trouble the advocates for reform.
CITATION: Richard A. Merrill, Genetic Testing: A Role for FDA?, 41 Jurimetrics J. 63-66 (2000).
ABSTRACT : The tort system generally treats plaintiffs as indistinguishable black boxes, entitled to compensation when a defendant's wrongful act or defective product causes some manifest disease or injury. This paradigm is likely to change dramatically with recent advances in genetic and related technologies. By peering inside the individual plaintiff to identify cellular and molecular markers that indicate both the status and etiology of pre-symptomatic disease processes, it will be possible to differentiate among individuals with respect to susceptibility and predispositions. This article surveys potential, and in some cases existing, uses of such biomarkers in toxic injury litigation and assesses the doctrinal, procedural, policy, and normative issues they present.
CITATION: Gary E. Marchant, Genetic Susceptibility and Biomarkers in Toxic Injury Litigation, 41 Jurimetrics 67-109 (2000).
ABSTRACT : Sensitivity and specificity are two important and relatively fixed characteristics of any clinical test. Arguably, a test's predictive values (positive and negative) are even more important, especially for screening. Unless care is taken at the design stage, the majority of test results in screening programs may be false positives, because the predictive values change dramatically based on the background frequency of the disease. These concepts are illustrated with a hypothetical, periodic disease surveillance program mandated by the court following a community exposure to a toxic agent.
CITATION: Ralph R. Cook, The Importance of Test Validity and Predictive Value to Screening Programs, 41 Jurimetrics J. 111-120 (2000).
ABSTRACT : The evolution of predictive genetic testing is best described as a shift from the detection of rare, highly penetrant "disease genes" to the detection of more common, less predictive genetic susceptibilities to disease and sensitivities to environmental agents. This paper describes how a better understanding of gene-environment interactions will cast new light on familiar bioethical issues and present a number of unique ethical and social challenges. Three topics are examined in detail: the protection of research participants in environmental genomics, how a better understanding of gene-environment interactions could impact socially identifiable groups, and potential shifts in social priorities and assignments of responsibility for health based on our knowledge of genetic sensitivities to environmental agents. Clarifying these emerging areas of concern, many of which have not received adequate attention in the existing bioethics literature and legal scholarship, is critical to ensuring that the benefits of predictive genetic testing are not overshadowed by unintended misuses.
CITATION: Richard R. Sharp, The Evolution of Predictive Genetic Testing: Deciphering Gene-Environment Interactions, 41 Jurimetrics J. 145-163 (2001).
ABSTRACT : The Environmental Genome Program intends to identify "susceptibility genes" that would indicate if a person is more vulnerable to cancer or other disease as a result of exposure to certain chemicals in the workplace, the environment, foods, or other products. Research findings and the capability to test persons for such genes are likely to impugn and challenge health policies and regulatory programs that do not take genetic susceptibility into account when conferring health benefits and restricting chemical exposures. This article focuses on the Occupational Safety and Health Administration (OSHA) and discusses four options available to this agency for protecting genetically susceptible workers and the issues involved in designing and implementing each option. The options involve amending each workplace chemical standard to incorporate genetic testing in a medically supervised program akin to OSHA's Lead Standard, generic revision of all standards so they are sufficiently stringent to protect susceptible workers, requiring information dissemination to prompt management and workforce initiatives, and incorporating genetic susceptibility in holding employers accountable to OSHA's "general duty clause."
CITATION: Michael Baram, Genetic Testing for Susceptibility to Disease from Exposure to Toxic Chemicals: Implications for Public and Worker Health Policies, 41 Jurimetrics J. 165-176 (2001).
ABSTRACT: Biomarkers have the potential to make the connections between exposures and adverse health outcomes clearer, more specific to particular individuals and groups, and more quantitative. As a general matter, biomarker information and other data on individual variability in susceptibility are relevant for risk management assessments of both overall economic efficiency issues and equity or fairness issues. Equity concerns can be particularly important. As people who are at greatest risk are identified within particular groups, they are better able to mobilize social resources for their protection. There are, however, formidable obstacles to using susceptibility information in regulatory decision making. To articulate practical and quantitative risk management standards, decision makers need to address ambiguities in policies toward control of uncertain and variable risks that have persisted in the face of advancing scientific information and risk assessment techniques. Clarification of such ambiguities may come from the relative openness of the U.S. regulatory system, which fosters public articulation and both legislative and judicial review of the technical and policy bases of regulatory decisions.
CITATION: Dale Hattis and Sue Swedis, Uses of Biomarkers for Genetic Susceptibility and Exposure in the Regulatory Context, 41 Jurimetrics J. 177-194 (2001).
ABSTRACT: The concept of relative risk has been of increasing interest in establishing causation in toxic tort suits. Specifically, courts are asking whether epidemiological data demonstrating a relative risk greater than 2 is required to meet the standard for proof ("more likely than not") or to admit an expert's opinion of causation in toxic tort cases. This article analyzes 31 such cases. Although the frequency of judicial opinions referring to relative risk greater than 2 is increasing, courts disagree as to the use of 2 as a bright-line test. These cases also provide information about judicial understanding of epidemiology and toxicology in providing a scientific basis for legal decisions.
CITATION: Russellyn S. Carruth and Bernard D. Goldstein, Relative Risk Greater than Two in Proof of Causation in Toxic Tort Litigation, 41 Jurimetrics J. 195-209 (2000).
ABSTRACT: Rapid increases in the ability to identify disease genes and disease susceptibility genes and the expanding field of toxicogenomics suggest that genetic testing could become an important part of causal proof in toxic injury litigation. This article examines the implications of genetic testing for disease genes or susceptibility genes in establishing or excluding a genetic cause for the plaintiff's injury, particularly in light of the commonly posited theory that genetics and toxic exposures are alternative causes of injury. It discusses both the mechanistic and statistical implications of additive and synergistic models of combined action of toxic and genetic causes and concludes that genetic testing for disease susceptibility will be probative only where there is statistical or mechanistic information on the combined effects of the genetic susceptibility and toxin.
CITATION: Susan R. Poulter, Genetic Testing in Toxic Injury Litigation: The Path to Scientific Certainty or Blind Alley?, 41 Jurimetrics J. 211-238 (2001).
ABSTRACT: Most genetic testing is currently conducted by test manufacturers, in-house. In-house testing is not subject to liability for product defects because it is considered a service, not a product. However, changes in the regulatory climate and increasing demand for genetic tests will likely result in increasing numbers of genetic tests being sold for use by others, as kit products.
The author argues that genetic test kits should be subject to negligence liability and to liability for product defects, including manufacturing, design and instruction or warning defects. The special rules for medical products that essentially exempt them from design-defect liability should not apply to genetic test kits because (1) genetic tests are not unavoidably unsafe; (2) as with other durable goods, alternative safer designs for genetic test kits may exist or be feasible; (3) genetic tests may not be regulated to the same extent as prescription drugs; and (4) the public cannot rely on physicians as effective gatekeepers for determining the safe and appropriate use of genetic tests, because physicians' training in genetics is inadequate.
CITATION: Pilar N. Ossorio, Product Liability for Predictive Genetic Tests, 41 Jurimetrics J. 239-260 (2000).
ABSTRACT: The place of the rational actor model in the analysis of individual and social behavior relevant to law remains unresolved. In recent years, scholars have sought frameworks to explain (a) disjunctions between seemingly rational behavior and seemingly irrational behavior, (b) the origins of and influences on law-relevant preferences, and (c) the nonrandom development of norms. This essay explains two components of an evolutionary framework that can encompass all three. They are, respectively, time-shifted rationality and the law of law's leverage.
CITATION: Owen D. Jones, The Evolution of Irrationality, 41 Jurimetrics J. 289-318 (2001).
ABSTRACT: Legal scholars interested in the behavior of citizens subject to the law's dictates have long relied on economic analysis to inform their normative analysis of legal problems. In recent years they have begun using insights provided by behavioral economics and evolutionary psychology as well. This article presents a framework for understanding how these disciplines individually and together can inform legal scholarship. First, the article distinguishes between motivational theories of behavior (that underlie both traditional law-and-economics analysis and evolutionary psychology) and empirical observation (exemplified by experimental social sciences such as behavioral economics) and contends that neither approach is alone sufficient to inform sound legal policy. Second, the article presents a model of how motivational theory and empirical observation can be combined to create a more useful multi-disciplinary approach to the study of law-relevant behavior and provides an example of how the model can be used.
CITATION: Russell Korobkin, A Multi-Disciplinary Approach to Legal Scholarship: Economics, Behavioral Economics, and Evolutionary Psychology, 41 Jurimetrics J. 319- 336 (2001).
ABSTRACT: Humans evolved in small communities, but now must make political decisions in vastly larger societies. Our evolved decision mechanisms have had to adapt to this change. Economists and psychologists disagree on the amount of human rationality, but consideration of evolutionary forces can help resolve this argument. For evolved reasons, humans pay excessive attention to factors involving identifiable individuals. There are other factors that influence decision making and that are based on evolution in small societies.
CITATION: Paul H. Rubin, How Humans Make Political Decisions, 41 Jurimetrics J. 337-356 (2001).
ABSTRACT: Recent developments in the neurosciences have produced profound insights into brain function and human behavior. There is a hope that neuroscientific studies may conclusively resolve questions about a criminal offender's diminished responsibility. However, neuroscience will never be able to answer conclusively legal questions of individual culpability for criminal actions. The very concept of legal responsibility derives from a particular model of human behavior that neuroscience does not share. Hence, neuroscience will remain mute on the issue of legal responsibility.
CITATION: Jacob R. Waldbauer and Michael S. Gazzaniga, The Divergence of Neuroscience and Law, 41 Jurimetrics J. 357-364 (2001).
ABSTRACT: In recent years, some legal scholars have argued that legal scholarship could benefit from a greater reliance on theories of human behavior that arise from biological evolution. These scholars contend that reliance on biological evolution would successfully combine the rigor of economics with the scientific aspects of psychology. Complex legal systems, however, are uniquely human. Law has always been the product of cognitive processes that are unique to humans and that developed as a response to an environment that no longer exists. Consequently, the evolutionary development of the cognitive mechanisms upon which law depends cannot be rigorously modeled or studied empirically.
CITATION: Jeffrey J. Rachlinski, Is Evolutionary Analysis of Law Science or Storytelling?, 41 Jurimetrics J. 365-370 (2001).
ABSTRACT: Human behavior originates in the human brain, an organ with an evolutionary history. Because that history has shaped the brain's psychological capacities and predispositions over evolutionary time, it continues to influence patterns in human behaviors. Integrating this life science perspective with existing social science perspectives can deepen our understanding of the multiple causes of behaviors relevant to law. Deepened understanding can, in turn, help us to better effect those behavioral changes we hope to achieve with the tools of law.
CITATION: Owen D. Jones, Science and Human Behavior: A Reply, 41 Jurimetrics J. 371-378 (2001).
ABSTRACT: Evolutionary theory can be helpful in understanding the law and determining what it should be. There are two ways in which the evolutionary perspective differs from an economic perspective on law. Not only does the evolutionary approach shift our attention from the world today to the environment of evolutionary adaptation, it shifts our focus from rational individuals to rational genes and from rational behaviors to rational design of mental architecture. Finally, the law of law's leverage makes predictions about the relative elasticities of demand for all sorts of behaviors, including those that did and did not exist in the environment of evolutionary adaptation.
CITATION: Jeffrey Evans Stake, Can Evolutionary Science Contribute to Discussions of Law?, 41 Jurimetrics J. 379-384 (2001).
ABSTRACT: This article begins by reviewing the history of the Frye general acceptance test for the admissibility of scientific evidence, from its origins in 1923 to its demise in federal court in Daubert v. Merrell Dow Pharmaceuticals, Inc., in 1993. This section focuses especially on how the Frye rule, which for decades applied almost exclusively in criminal cases, came to be the focal point of the controversy over the admissibility of scientific evidence in toxic tort cases in the early 1990s. Next, the article discusses the development of the Frye test since 1993. Despite Daubert, Frye has remained the plurality rule in state courts. Following the lead of federal courts operating under Daubert's broad gatekeeper mandate, Frye jurisdictions are increasingly applying the general acceptance test to scientific evidence in civil cases, especially toxic tort cases. However, Frye jurisdictions are divided regarding whether the general acceptance test applies primarily to the expert's general methodologies or must be applied to the expert's conclusions. Recently, several courts have followed the Supreme Court's lead in General Elec. Co. v. Joiner. Instead of focusing on the methodologies-conclusions distinction, these courts have scrutinized experts' reasoning process. Meanwhile, most Frye jurisdictions do not apply the general acceptance test to nonscientific evidence, although some Frye courts apply a Kumho Tire-like reliability test to such evidence. This article concludes that case law under Frye is slowly converging with Daubert jurisprudence. Rather than allowing this process to continue haphazardly and inconsistently, state legislatures should enact state versions of new Federal Rule of Evidence 702, which explicitly adopts Daubert and its progeny.
CITATION: David E. Bernstein, Frye, Frye, Again: The Past, Present, and Future of the General Acceptance Test, 41 Jurimetrics J. 385-407 (2001).
ABSTRACT : The prevailing tools of legal scholarship have focused the study of law on questions of doctrine. Recent developments in cognitive neuroscience allow us to explore a different kind of problem: how people think when they apply law. First we must update the accepted model of cognition, replacing the unified Cartesian approach with a multi-capacity, "modular" view of the human mind. Such an approach suggests that the classic, apparently intractable, arguments between positive-law and natural-law adherents may reflect the workings of two separate mental capacities for judging human actions-the application of word-based rules on the one hand and of unarticulated understandings of justice on the other. This hypothesis need not remain just a plausible assertion. The techniques of functional neuroimaging provide an experimental means of testing it. A series of brain-scanning experiments could reveal whether there are significant differences in the brain regions employed in using legal rules and moral intuition to judge human behavior, in the process helping us understand the neurological basis of the distinction between natural and positive law.
CITATION: Oliver R. Goodenough, Mapping Cortical Areas Associated with Legal Reasoning and Moral Intuition, 41 Jurimetrics J. 429-442 (2001).
ABSTRACT : Computers, databases, and the Internet have made personal information readily available. All states have enacted criminal laws to protect against abuses of accessing or using such data. This article traces the history of privacy as it pertains to personal information and explores the criminal laws against invasion of privacy.
CITATION: Jordan M. Blanke, Criminal Invasion of Privacy: A Survey of Computer Crimes, 41 Jurimetrics J. 443-463 (2001).
ABSTRACT : Using a random sample of web servers, this article examines the prevalence of various forms of on-line content, including adult content. We found adult content accounts for 2.1 percent of information on the World Wide Web, substantially less than commercial, educational, personal, or organizational content. Additionally, we examined the age-verification measures and business practices of adult web sites. Currently 73.8 percent of these sites provide access to adult content on their index page without age verification. We further assessed the prevalence of site ratings, disclaimers, and privacy policies, as well as the use of services that verify age through a credit card and "mousetraps," technical devices designed to prevent users from leaving the site. We present our results in these areas and discuss their policy implications.
CITATION: Daniel Orr and Josephine Ferrigno-Stack, Childproofing on the World Wide Web: A Survey of Adult Webservers, 41 Jurimetrics J. 465-475 (2001).
ABSTRACT : The objectives of the Convention on Biological Diversity (CBD) are "the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources . . . ." The CBD states that access is provided on the basis of "prior informed consent" and under "mutually agreed terms." Only countries that are "countries of origin" are empowered to give this consent and agree to terms. The definition of "countries of origin," however, lacks clarity and scientific rigor as applied to domesticated and cultivated species. Agricultural biodiversity is the product of innovation, whether in farmer-selected crop varieties or the latest biotechnologically produced gene construct. How such innovations and associated technologies will be protected and derivative benefits apportioned has been the subject of controversy for centuries. The CBD aimed, in part, to address this question. The particular strategy employed by the CBD, however, is not likely to be successful, given the difficulties that will surely be encountered in identifying "countries of origin" for plant genetic resources for food and agriculture.
CITATION: Cary Fowler, Protecting Farmer Innovation: The Convention on Biological Diversity and the Question of Origin, 41 Jurimetrics J. 477-488 (2001).
ABSTRACT : This article explores the effects of standards of proof on verdict error rates, particularly errors related to the identity of the offender. It focuses on the number of offenders set free per innocent person erroneously convicted and the overall error rate. By combining available data on conviction rates with assumptions about the percentage of accused persons who actually committed the crimes, the effects of various procedural changes on errors in ascertaining guilt can be estimated. These include the effect of (1) raising or lowering the standard of proof required for conviction; and (2) the prosecutor's tradeoff between the number and accuracy of convictions. The accuracy of convictions increases as the prosecutor spends more time on each case and seeks fewer sentencing concessions. Effects of other changes also are considered, including the effects of improvements in forensic analysis, the effects of alternative investigative profiling rules on errors in pre-arrest decision making, and jury size and voting rules. Some interventions shift errors from false acquittals to false convictions or vice versa; others reduce or increase both types of errors.
CITATION: Brian Forst, Toward an Understanding of the Effect of Changes in Standards of Proof on Errors of Justice, 41 Jurimetrics J.489-504 (2001).
