Genetic Duties

Genetic Duties' by Jessica L. Roberts and Alexandra Foulkes in William & Mary Law Review (Forthcoming) comments

Our genes don’t change but the results of our genetic tests might. The first is basic biology. The second, a product of the reality that we are still learning about the human genome. A person who took a genetic test in 2010 could take the same test with the same lab in 2020 and get a different result. The law, however, does not reflect this difference. At present, no legal duty requires laboratories or physicians to inform patients when a laboratory reclassifies a genetic variant, even if the reclassification communicates clinically actionable information. This Article considers the need for such duties and their potential challenges. In so doing, we hope to offer much needed guidance to the physicians and the laboratories that may face liability and to the courts that will inevitably hear these cases.

 The authors argue

At present, genetic testing laboratories and physicians have no recognized legal duties to take any action when a VUS gains clinical significance. This Article considers the need for these genetic duties. Failing to inform patients of variant reclassifications can have life-or- death consequences. While we appreciate the gravity of this topic, we also recognize the potential costs that these duties could impose on labs and on doctors. 

Our proposal for imposing genetic duties has three parts: (1) proactive measures, (2) a legal duty to reinterpret, and (3) a legal duty to recontact. First, we encourage laboratories and physicians to act proactively by educating patients about the possibility of variant reclassification and by outlining the steps that they will take to share the updated results. However, when that is not possible, we suggest that courts split the legal duties related to variant reclassification. Drawing from the concept of the cheapest cost avoider, we argue that labs are in the best position to reinterpret genetic test results, whereas ordering physicians are in the best position to contact patients. Our liability framework would therefore impose the duty to reinterpret on the lab and the duty to recontact on the physician. Given the potential impact that legal liability could have on genetic testing and clinical care, we encourage courts to proceed with caution and to make these determinations on a case-by-case basis. Thus, while we advocate recognizing these duties, what constitutes a breach may vary significantly depending on the individual circumstances. 

This Article is novel in at least two ways. One, it is among the first in the legal literature to address the need for potential legal duties related to variant reclassification. Two, it proposes a solution to the cutting-edge question of how to fairly impose those potential duties. As such, it provides an important contribution to the conversation surrounding the variant reclassification and can serve as a valuable resource for lawyers, medical professionals, judges, and scholars alike. 

We discuss the legal implications of variant reclassification in three Parts. Part I gives the relevant scientific background and explores the existing tort doctrines likely to apply to variant reclassification. In Part II, we consider the arguments in favor of genetic duties related to variant reclassification, noting that laboratories are the cheapest cost avoiders with respect to reinterpretation, while the ordering physicians are the cheapest cost avoiders when it comes to recontacting patients. Part III proposes our framework for providing patients with access to updated test results. We begin by urging laboratories and physicians to take action now by developing policies to educate patients and to inform them of variant classifications. In older cases, when these processes would not apply, we argue for bifurcating the duties associated with variant reclassification into (1) a duty to reinterpret and (2) a duty to recontact and imposing those duties on their respective cheapest cost avoiders. We then analyze what would constitute a breach of these novel legal duties using a variety of case studies. We conclude by considering some of the additional hurdles that plaintiffs will face when filing tort claims related to variant reclassification, even with clear, legally recognized genetic duties.

Placentas

The Law of Placenta' by Mathilde Cohen in (2020) 31 Yale Journal of Law and Feminism 337-409 comments

Of the forms of reproductive labor in which legal scholars have been interested, placenta, the organ developed during pregnancy, has been overlooked. As placenta becomes an object of value for a growing number of individuals, researchers, clinicians, biobanks, and biotech companies, among others, its cultural meaning is changing. At the same time, these various constituencies may be at odds. Some postpartum parents and their families want to repossess their placenta for personal use, while third parties use placentas for a variety of research, medical, and commercial purposes. This Article contributes to the scholarship on reproductive justice and agency by asking who should have access to placentas and under what conditions. The Article emphasizes the insufficient protection the law affords pregnant people wishing to decide what happens to their placenta. Generally considered clinical waste under federal and state law, placental tissue is sometimes made inaccessible to its producers on the ground that it is infectious at the same time as it is made available to third parties on the ground that placenta is discarded and de-identified tissue. Less privileged people who lack the ability to shop for obstetric and other pregnancy-related services that allow them to keep their placentas are at a disadvantage in this chain of supply and demand. While calling for further research on the modus operandi of placenta markets and how pregnant people think about them, this Article concludes that lawmakers should take steps to protect decision-making autonomy over placental labor and offers a range of proposals to operationalize this idea.

Trade Secrets

"Naked Price and Pharmaceutical Trade Secret Overreach' by Robin Feldman and Charles Graves in Yale Journal of Law and Technology (Forthcoming) comments

Trade secret has drifted from a quiet backwater doctrine to a pervasive force in intellectual property. As always, the risk of distortion is great when a legal arena is developing and expanding rapidly. Nowhere do the theoretical tensions of trade secret law appear in such stark relief as in the modern pharmaceutical debates, where the heart of the theoretical question involves whether pricing is a proper subject for trade secrecy claims. 

We aim to bring trade secret into greater harmony with broad concepts that reach across all intellectual property regimes. As with other areas of intellectual property law, trade secret law is not a mere contest of private commercial interests. Rather, it embeds substantial dedication to the public interest, reflecting utilitarian balancing of key societal interests. In this context, we develop the concept of “thin” trade secret, looking to the analogous concepts in other intellectual property regimes. Such approaches embody the recogniztion that intellectual property rights are not solid monoliths, presenting an impenetrable wall through which no party but the rights holder may pass. Rather, they are brilliantly nimble and subtle systems, deftly threading their way among various societal goals. 

This article offers the potential of anchoring trade secret more firmly to its theoretical base, as well as bringing trade secret closer to the family of other intellectual property regimes. Although squabbling, chaotic, and somewhat dispersed, all members of this time-honored family can learn from each other, sharing their battle-worn wisdom with the newest, young upstart.

Crimes

'Worth the Effort'? Assessing the Khmer Rouge Tribunal' by Diane Orentlicher comments

 Every international war crimes court has attracted controversy, but none more than the Extraordinary Chambers in the Courts of Cambodia (ECCC). Now in its twilight years, the ECCC has sparked robust debate since the late 1990s, before it was even launched. During negotiations aimed at creating a tribunal to address crimes of the Khmer Rouge, United Nations (UN) officials and others debated whether a court acceptable to Cambodia would be worthy of UN support. Today, the fulcrum of debate is whether the ECCC was ‘worth the effort’ it has required. 

While myriad aspects of the ECCC’s performance are crucial to its legacy, this Article explores one question of overarching importance: whether the court’s performance has justified a central risk the UN assumed when it agreed to support the court — that case selection would be improperly influenced by the Cambodian government. More particularly, it assesses performance against two criteria: How well have safeguards against such interference worked? Are survivors of Khmer Rouge atrocities and other Cambodian citizens satisfied with ECCC justice?

Personalisation

'‘Happy failures’: Experimentation with behaviour-based personalisation in car insurance' by Gert Meyers and Ine Van Hoyweghen in (2020) Big Data and Society comments

Insurance markets have always relied on large amounts of data to assess risks and price their products. New data-driven technologies, including wearable health trackers, smartphone sensors, predictive modelling and Big Data analytics, are challenging these established practices. In tracking insurance clients’ behaviour, these innovations promise the reduction of insurance costs and more accurate pricing through the personalisation of premiums and products. Building on insights from the sociology of markets and Science and Technology Studies (STS), this article investigates the role of economic experimentation in the making of data-driven personalisation markets in insurance. We document a case study of a car insurance experiment, launched by a Belgian direct insurance company in 2016 to set up an experiment of tracking driving style behavioural data of over 5000 participants over a one-year period. Based on interviews and document analysis, we outline how this in vivo experiment was set-up, which interventions and manipulations were imposed to make the experiment successful, and how the study was evaluated by the actors. Using JL Austin’s distinction between happy and unhappy statements, we argue how the experiment, despite its failure not to provide the desired evidence (on the link between driving style behaviour and accident losses), could be considered a ‘happy’ event. We conclude by highlighting the role of economic experiments ‘in the wild’ for the making of future markets of data-driven personalisation.

UDRP and human rights

'Beyond the Governance Gap in International Domain Name Law: Bringing the UDRP in Line with Internationally Recognized Human Rights' by Monika Zalnieriute in (2020) 56(1) Stanford Journal of International Law comments

 This article maps the substantive international human rights implications of the influential Uniform Domain Names Disputes Resolution Policy (“UDRP”). The UDRP is an international legal framework for resolving disputes between trademark owners and domain name holders, created by Internet Corporation for Domain Names and Numbers (“ICANN”)—a multi-stakeholder non-profit corporation, responsible for managing domain names and addresses globally. I sketch out the human rights implications of the substantial aspects of the UDRP from an international perspective because ICANN has recently added a Core Value of respecting “internationally recognized human rights” to its Bylaws, and the UDRP review is underway in 2020. In this article, I analyze the dominant interpretive approaches of UDRP panelists to illustrate how, from an international human rights perspective, the substantive UDRP elements are currently too broad, and lead to problematic outcomes. While international human rights analysis does not automatically generate pinpoint policy prescription, it provides an additional framework to evaluate ICANN’s policies, expanding the focus and range of responses. I argue that a more precise articulation and reflection of the narrow scope and objectives of the UDRP within its substantial elements (including as they are interpreted and applied) is needed if ICANN is to uphold its human rights Core Value and to ensure that the UDRP is interpreted by the panelists as consistently as possible with international human rights principles. I propose several concrete ways to address the problematic substantive aspects of the UDRP from an international human rights perspective. In particular, the upcoming UDRP reform should include:

1) an explicit reaffirmation of the narrow scope and limited objectives of the UDRP; 

2) a clear articulation of the relationship between the UDRP objectives and substantive policy elements; 

3) a reaffirmation of the cumulative nature of the bad faith requirement; 

4) a revision of affirmative defences available to the respondent; 

5) an introduction of an additional defence of an unreasonable delay; 

6) an introduction of a choice-of-law provision; and 

7) a development of “Uniform Consensus View” at ICANN level to increase consistency and reduce the risk of rogue interpretations of the UDRP by panelists. 

Ultimately, I propose “returning” the UDRP to its original, narrower objectives to reduce the UDRP decisions’ potential to encroach upon fundamental human rights.

Health Apps and the GDPR

'Health Apps, their Privacy Policies and the GDPR' by Trix Mulder in (2019) European Journal of Law and Technology comments

 The healthcare sector traditionally processes large amounts of personal data. Nowadays, medical practice increasingly uses information technologies, such as smartphone applicatons (‘apps’) and wearable devices (e.g. smart watches, smart soles), for treatment plans and information collection. It is inherent to these modern technologies that they generate even more personal data. Some of the apps are developed specifcally for the healthcare sector, some are more general (health) apps. Within the European Union (EU), the processing of these personal data is regulated by the General Data Protecton Regulation (GDPR), which entered into force on 25 May 2018. The GDPR provides controllers and processors with obligations and data subjects with rights. This paper analyses the marketing statements of app providers and the privacy policies of the apps in order to determine whether they are in line with each other and with the GDPR.