Law Commons^™

Where's The Beef? Meat Shortages, Farmer Needs, And Long-Term Recovery Policies In A Pandemic Era, Kim Vu-Dinh

Faculty Scholarship

COVID-19 not only affected every hospital bed in the nation--if not the world; it also affected nearly every dinner table in America and beyond. Supply chain disruptions caused by the pandemic highlighted deep-seated problems with how we get our meat, and how difficult we make it for American farmers to sell to the family next door. Within a few months of the first reported case in the US, hundreds of workers from just two meat-processing plants on American shores became infected with COVID-19, and imports from around the world came to a standstill as factories and shipping companies were forced …

Neuroscience And Behavioral Genetics In Us Criminal Law: An Empirical Analysis, Nita A. Farahany

Faculty Scholarship

The goal of this study was to examine the growing use of neurological and behavioral genetic evidence by criminal defendants in US criminal law. Judicial opinions issued between 2005–12 that discussed the use of neuroscience or behavioral genetics by criminal defendants were identified, coded and analysed. Yet, criminal defendants are increasingly introducing such evidence to challenge defendants’ competency, the effectiveness of defense counsel at trial, and to mitigate punishment.

Hiv/Aids Care And Prevention Infrastructure In The U.S. Deep South, Susan S. Reif, Kristen Sullivan, Elena Wilson, Miriam Berger, Carolyn Mcallaster

Faculty Scholarship

No abstract provided.

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii, Arti K. Rai

Faculty Scholarship

As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings.

In this Article, we provide a fresh diagnosis of, and prescription for, this major public policy problem. We argue that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of FDA …

"And If Your Friends Jumped Off A Bridge, Would You Do It Too?": How Developmental Neuroscience Can Inform Legal Regimes Governing Adolescents, Michael N. Tennison, Amanda C. Pustilnik

Faculty Scholarship

Legal models of adolescent autonomy and responsibility in various domains of law span a spectrum from categorical prohibitions of certain behaviors to recognitions of total adolescent autonomy. The piecemeal approach to the limited decision-making capacity of adolescents lacks an empirical foundation in the differences between adolescent and adult decision-making, leading to counterintuitive and inconsistent legal outcomes. The law limits adolescent autonomy with respect to some decisions that adolescents are perfectly competent to make, and in other areas, the law attributes adult responsibility and imposes adult punishments on adolescents for making decisions that implicate their unique volitional vulnerabilities. As developmental neuroscientists …

Sickeningly Sweet: Analysis And Solutions For Adverse Dietary Consequences Of European Agricultural Law, Emilie K. Aguirre

Faculty Scholarship

Sixty-nine percent of adults in the United States, sixty-four percent in the United Kingdom, and over one-third worldwide are overweight or obese. These staggering figures continue to grow, with accompanying emotional, physical, and economic consequences, both for individuals and society as a whole. The role law plays in facilitating this global trend is significant, and yet puzzlingly, little recognized or understood. The current food system is profoundly structurally flawed: it establishes unhealthy dietary behaviors as the default option for consumers. This Article is the first to examine how agricultural law has facilitated these unhealthier diets for the past fifty years, …

A Closer Look: Deep South Has The Highest Hiv-Related Death Rates In The United States, Susan S. Reif, Donna Safley, Carolyn Mcallaster

Faculty Scholarship

No abstract provided.

Painful Disparities, Painful Realities, Amanda C. Pustilnik

Faculty Scholarship

Legal doctrines and decisional norms treat chronic claims pain differently than other kinds of disability or damages claims because of bias and confusion about whether chronic pain is real. This is law’s painful disparity. Now, breakthrough neuroimaging can make pain visible, shedding light on these mysterious ills. Neuroimaging shows these conditions are, as sufferers have known all along, painfully real. This Article is about where law ought to change because of innovations in structural and functional imaging of the brain in pain. It describes cutting-edge scientific developments and the impact they should make on evidence law and disability law, and, …

Finding Fault?: Exploring Legal Duties To Return Incidental Findings In Genomic Research, Elizabeth R. Pike, Karen H. Rothenberg, Benjamin E. Berkman

Faculty Scholarship

The use of whole genome sequencing in biomedical research is expected to produce dramatic advances in human health. The increasing use of this powerful, data-rich new technology in research, however, will inevitably give rise to incidental findings (IFs), findings with individual health or reproductive significance that are beyond the aims of the particular research, and the related questions of whether and to what extent researchers have an ethical obligation to return IFs. Many have concluded that researchers have an ethical obligation to return some findings in some circumstances, but have provided vague or context-dependent approaches to determining which IFs must …

Redefining Genomic Privacy: Trust And Empowerment, Yaniv Erlich, James B. Williams, David Glazer, Kenneth Yocum, Nita A. Farahany, Maynard Olson, Arvind Narayanan, Lincoln D. Stein, Jan A. Witkowski, Robert C. Kain

Faculty Scholarship

Fulfilling the promise of the genetic revolution requires the analysis of large datasets containing information from thousands to millions of participants. However, sharing human genomic data requires protecting subjects from potential harm. Current models rely on de-identification techniques in which privacy versus data utility becomes a zero-sum game. Instead, we propose the use of trust-enabling techniques to create a solution in which researchers and participants both win. To do so we introduce three principles that facilitate trust in genetic research and outline one possible framework built upon those principles. Our hope is that such trust-centric frameworks provide a sustainable solution …

Diagnostic Patents At The Supreme Court, Arti K. Rai

Faculty Scholarship

No abstract provided.

The Costs Of Changing Our Minds, Nita A. Farahany

Faculty Scholarship

This isn’t quite a draft yet – it’s a concept paper. You’ll see after the first 10 pages a good bit of text in brackets, which are primarily notes for me, but it’ll give you a sense of the content of those sections. I’d like to talk through the concept – the “duty” to mitigate emotional distress damages and how courts have struggled with it, as a foray into a broader dichotomy that I see in a number of areas of law that suggest an implicit value in “cognitive liberty.” This is a smaller version of a broader book project …

Reflections On The Cost Of "Low-Cost" Whole Genome Sequencing: Framing The Health Policy Debate, Timothy Caulfield, Jim Evans, Amy Mcguire, Christopher Mccabe, Tania Bubela, Robert Cook-Deegan, Jennifer Fishman, Stuart Hogarth, Fiona A. Miller, Vardit Ravitsky, Barbara Biesecker, Pascal Borry, Mildred K. Cho, June C. Carroll, Holly Etchegary, Yann Joly, Kazuto Kato, Sandra Soo-Jim Lee, Karen H. Rothenberg, Pamela Sankar, Michael J. Szego, Pilar Ossorio, Daryl Pullman, Francois Rousseau, Wendy J. Ungar, Brenda Wilson

Faculty Scholarship

The cost of whole genome sequencing is dropping rapidly. There has been a great deal of enthusiasm about the potential for this technological advance to transform clinical care. Given the interest and significant investment in genomics, this seems an ideal time to consider what the evidence tells us about potential benefits and harms, particularly in the context of health care policy. The scale and pace of adoption of this powerful new technology should be driven by clinical need, clinical evidence, and a commitment to put patients at the centre of health care policy.

Paved With Good Intentions: Sentencing Alternatives From Neuroscience And The Policy Of Problem-Solving Courts, Emily R. Murphy

Faculty Scholarship

No abstract provided.

Sustainable Production Of Swine: Putting Lipstick On A Pig?, Michelle B. Nowlin

Faculty Scholarship

No abstract provided.

Biomedical Patents At The Supreme Court: A Path Forward, Arti K. Rai

Faculty Scholarship

Although most would argue that software patents pose a bigger challenge, the U.S. Supreme Court has recently focused on biomedical patents. Two of the Court's recent decisions scaling back such patents, Mayo v. Prometheus and AMP v. Myriad, have provoked justifiable anxiety for those concerned about biomedical innovation, particularly in the area of personalized medicine. While acknowledging significant limitations in the Court's reasoning in both cases, this Essay sketches a reading that is consistent with the results and innovation-friendly.

The Nagoya Protocol And Synthetic Biology Research: A Look At The Potential Impacts, Margo A. Bagley, Arti K. Rai

Faculty Scholarship

This report, prepared for the Synthetic Biology Project at the Woodrow Wilson International Center for Scholars, analyzes the 2010 Nagoya Protocol to the Convention on Biological Diversity and how it may affect U.S. researchers working in the field of synthetic biology. The objective of the Protocol is to provide a transparent framework for the acquisition and sharing of genetic resources on fair and equitable terms that facilitate the conservation of biological diversity and associated traditional knowledge. The report finds significant uncertainty surrounding the temporal scope of the Agreement as well as the types of genetic material that will be covered …

Pain As Fact And Heuristic: How Pain Neuroimaging Illuminates Moral Dimensions Of Law, Amanda C. Pustilnik

Faculty Scholarship

Legal statuses, prohibitions, and protections often turn on the presence and degree of physical pain. In legal domains ranging from tort to torture, pain and its degree do important definitional work by delimiting boundaries of lawfulness and of entitlements. The omnipresence of pain in law suggests that the law embodies an intuition about the ontological primacy of pain. Yet, for all the work done by pain as a term in legal texts and practice, it has had a confounding lack of external verifiability. As with other subjective states, we have been able to impute pain’s presence but have not been …

A Neurological Foundation For Freedom, Nita A. Farahany

Faculty Scholarship

No abstract provided.

Unstandard Standardization: The Case Of Biology, Arti K. Rai

Faculty Scholarship

How applicable are the approaches adopted by information and communication technology standards-setting organizations to biological standards? Most engineering-based industries construct products from standard, well understood components. By contrast, despite the early attachment of the moniker “genetic engineering” to biotechnology, standardization in the biological sciences has been relatively rare.

High Crimes, Not Misdemeanors: Deterring The Production Of Unsafe Food, Rena I. Steinzor

Faculty Scholarship

In the fall of 2008, Minnesota public health officials became alarmed by an unusually high number of illnesses and deaths caused by salmonella poisoning. Federal and state regulators and the news media eventually traced the outbreak back to products supplied by the Peanut Corporation of America (PCA). Employees shipped batches that tested positive for salmonella from a plant with a leaking roof, mold growing on ceilings and walls, rodent infestation, filthy processing receptacles, and feathers and feces in the air filtration system. Under an agreement with the Food and Drug Administration (FDA), Georgia state inspectors visited the PCA plant nine …

Nih Guidelines On Human Embryonic Stem Cell Research In Context: Clarity Or Confusion?, Karen H. Rothenberg, Michael R. Ulrich

Faculty Scholarship

No abstract provided.

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 …

Synthetic Biology: Caught Between Property Rights, The Public Domain, And The Commons, Arti K. Rai, James Boyle

Faculty Scholarship

Synthetic biologists aim to make biology a true engineering discipline. In the same way that electrical engineers rely on standard capacitors and resistors, or computer programmers rely on modular blocks of code, synthetic biologists wish to create an array of modular biological parts that can be readily synthesized and mixed together in different combinations. Synthetic biology has already produced important results, including more accurate AIDS tests and the possibility of unlimited supplies of previously scarce drugs for malaria. Proponents hope to use synthetic organisms to produce not only medically relevant chemicals but also a large variety of industrial materials, including …

Synthetic Biology: The Intellectual Property Puzzle, Arti K. Rai, Sapna Kumar

Faculty Scholarship

Synthetic biology, which operates at the intersection of biotechnology and information technology, has the potential to raise, in a particularly acute manner, the intellectual property problems that exist in both fields. A preliminary patent landscape reveals problematic foundational patents that could, if licensed and enforced inappropriately, impede the potential of the technology. The landscape also reveals a proliferation of patents on basic synthetic biology "parts" that could create transaction cost heavy patent thickets. Both foundational patents and patent thickets are likely to be particularly problematic to the extent they read on standards that synthetic biologists would like to establish. Synthetic …

Bad Nature, Bad Nurture, And Testimony Regarding Maoa And Slc6a4 Genotyping In Murder Trials, Nita A. Farahany, William Bernet, Cindy L. Vnencak-Jones, Stephen A. Montgomery

Faculty Scholarship

Recent research—in which subjects were studied longitudinally from childhood until adulthood—has started to clarify how a child’s environment and genetic makeup interact to create a violent adolescent or adult. For example, male subjects who were born with a particular allele of the monoamine oxidase A gene and also were maltreated as children had a much greater likelihood of manifesting violent antisocial behavior as adolescents and adults. Also, individuals who were born with particular alleles of the serotonin transporter gene and also experienced multiple stressful life events were more likely to manifest serious depression and suicidality. This research raises the question …

The Scarlet Gene: Behavioral Genetics, Criminal Law, And Racial And Ethnic Stigma, Karen H. Rothenberg, Alice Wang

Faculty Scholarship

Imagine that a scientist from the state university asks you and your family to participate in a study on a particular gene variant associated with alcoholism. The project focuses on your ethnic group, the Tracy Islanders, who have a higher incidence of alcoholism, as well as a higher incidence of the gene variant, than the general population. You will not be informed whether you have the gene variant, but your participation in the study might help scientists develop drugs to help individuals control their addiction to alcohol. You have a family history of alcoholism, and you are concerned that your …

Broad, Deep And Indirect: The Potential Influence Of Neuroscience In Law, Amanda C. Pustilnik

Faculty Scholarship

No abstract provided.

Behavioural Genetics In Criminal Cases: Past, Present And Future, Nita A. Farahany, William Bernet

Faculty Scholarship

Researchers studying human behavioral genetics have made significant scientific progress in enhancing our understanding of the relative contributions of genetics and the environment in observed variations in human behavior. Quickly outpacing the advances in the science are its applications in the criminal justice system. Already, human behavioral genetics research has been introduced in the U.S. criminal justice system, and its use will only become more prevalent. This essay discusses the recent historical use of behavioral genetics in criminal cases, recent advances in two gene variants of particular interest in the criminal law, MAOA and SLC6A4, the recent expert testimony on …

The Complex Links Between Governance And Biodiversity, C. Barrett, C. Gibson, B. Hoffman, Mathew D. Mccubbins

Faculty Scholarship

We argue that two problems weaken the claims of those who link corruption and the exploitation of natural resources. The first is conceptual. Studies that use national level indicators of corruption fail to note that corruption comes in many forms, at multiple levels, and may or may not affect resource use. Without a clear causal model of the mechanism by which corruption affects resources, one should treat with caution any estimated relationship between corruption and the state of natural resources. The second problem is methodological: Simple models linking corruption measures and natural resource use typically do not account for other …