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.

Minors, Paternalism and Privacy

'Children’s Privacy: The Role of Parental Control and Consent' by Jelena Gligorijevic in (2019) 19(2) Human Rights Law Review 201-229 comments

 Protecting children’s informational privacy has never been more difficult. To what extent does it depend upon parental control and consent, and how is this factor incorporated into the law seeking to protect children’s informational privacy? This paper addresses these questions, considering the relevant jurisprudence of English courts, in particular under the tort of misuse of private information, and the relevant jurisprudence of the European Court of Human Rights under Article 8 of the European Convention on Human Rights. This paper argues that the jurisprudence of both courts’ informational privacy cases reveals a doctrine that prioritizes parental control and consent, above the harm of intrusion to the child. This risks laying a legal terrain that does not accommodate the protection and vindication of children’s informational privacy rights when they conflict with the wishes of, or are not actively protected by, that child’s parents.

'Children’s Capacities and Paternalism' by Samantha Godwin in (2020) Journal of Ethics comments

Paternalism is widely viewed as presumptively justifiable for children but morally problematic for adults. The standard explanation for this distinction is that children lack capacities relevant to the justifiability of paternalism. I argue that this explanation is more difficult to defend than typically assumed. If paternalism is often justified when needed to keep children safe from the negative consequences of their poor choices, then when adults make choices leading to the same negative consequences, what makes paternalism less justified? It seems true that ordinary adults have capacities enabling them to promote their interests in ways most children lack. This can explain why paternalism is more often justified towards children than adults. What is not explained, however, is why paternalism would be justifiable for children, but not adults, when neither possess the relevant interest-promoting capacities – exactly the cases when paternalism towards adults might be considered. I argue that this dilemma undercuts capacities-based explanations for the belief that childhood is distinctively relevant for the permissibility of paternalism. I then address defenses of both consequentialist and deontological versions of the capacities-based explanation. Absent this capacities-based explanation, I argue that the intuition that less demanding justificatory standards apply to paternalism when directed at children than when directed towards adults presents unresolved problems for egalitarians.

Gligorijević's 'Privacy at the Intersection of Public Law and Private Law' [2019] Public Law 563 comments

 To demonstrate that any common law system can adequately and legitimately protect informational privacy through a private law action influenced by public law, this paper argues that: tort law can accommodate privacy protection, and the English action is appropriately labelled a ‘tort’; the English tort does not depend upon the Human Rights Act 1998 (HRA), allowing other common law jurisdictions to choose to adopt aspects of that tort; and the public law tool of proportionality can determine privacy tort outcomes in a way that ensures credible legal protection of the fundamental right to privacy in the private sphere, without unjustifiably encroaching upon other rights.

Yet another dimension

After the bleakness of the practice critiqued by Wigney J I have turned for amusement to World Futures, the journal published by Taylor and Francis that - as noted elsewhere in this blog - recurrently features deliciously pious accounts about dowsing, astral travel, pan psychic gratitude, distance healing, two-way communication with the dead and other pseudoscience. The journal is ERA ranked, which says something rather sad about quality assurance in parts of Australian academia.

In my opinion this month's treat is 'Hacking the Akashic Records: The Next Domain for Military Intelligence Operations?' by Jeff Levin in (2020) 76(2) World Futures: The Journal of New Paradigm Research 102-117.

Levin comments

This paper outlines a hypothetical six-dimension doctrine for military intelligence-gathering in the Akashic domain. The Akashic records are described by esotericists and mystics as a permanent record of all thoughts, feelings, and actions, stored in a kind of cosmic memory bank outside of space and time. Psychics, clairvoyants, and other intuitives purport to read the records, suggesting that development of an operational strategy for accessing such information may be possible. Command oversight, however, would present significant moral challenges, as “hacking” into this information would be a personally intrusive invasion of privacy with serious repercussions for the operators and state sponsors.

Levin goes on to state

Not so long ago, cyber/information was introduced as a new paradigm for a military accustomed to a four-dimension land-sea-air-space doctrine. Accordingly, cyber would seem to be the ultimate domain of warfare operations. After transitioning from the physical planet (land and sea) to the atmosphere (air) and beyond (space), the virtual information domain (cyber) must presumably be the final frontier. This five-dimension doctrine has been operational for a quarter of a century (see Fogelman, 1995), and is a cutting edge of the U.S. military’s strategic plans moving forward (Card and Rogers, 2012; Department of Defense, 2015). But, according to the publications cited above, perhaps it is time to consider a sixth domain of operations. 

We simply can't have too many dimensions.

In the present paper, material is presented which cautiously reviews the possibility of a post-cyber domain for intelligence operations, founded on the esoteric concept of the Akashic records—a repository of information and sensory/thought impressions “located” in the nonphysical realms akin to Jung’s collective unconscious—thus moving quite beyond the present five-dimension doctrine. A new doctrine, made operational, would draw on human resources that would seem to surpass current consensus definitions of human capabilities, and would interface with (meta-)physical realities that would seem to surpass current consensus definitions of physical reality. An Akashic domain for military intelligence would thus represent a substantial expansion of the concept of battlespace to include a “dimension” that is located, apparently, outside of space—and time—as conventionally understood.

After a quick stop that cites authorities such as Madame Blavatsky and Ervin Lazslo - alas, no citation of peers such as the Comte de St Germain, Cagliostro, Lobsang Rampa, Aleister Crowley or Obi-Wan Kenobi - we are presented with -

Unlike much of conventional remote reviewing, Akashic readings may be more suited to reading the mind and consciousness of enemy targets and clairvoyantly viewing the future behavior and collective action of such individuals. The targets would not be military installations, geographic or geological features, or other natural or man-made structures, but rather the psyche and life course of persons of interest. The operational objectives would involve understanding targets’ presumptions and motivations and discerning their likely decision-making calculus and future (and past) actions. Engaging in such readings and tasking subordinates to do so would, for sure, be considerably more complex than conventional behavioral profiling, involving a much more invasive probe of the personal space of one’s targets. Such tasking may potentially present moral red flags cautioning against the use and misuse of information gleaned from Akashic readings that were intended for strategic and tactical purposes (more on this later).

That is only partly redeemed by -

The past history of military and intelligence explorations into the world of psi and psychotronic technologies suggests that restoration of R and D funds may be a tall order, especially in the present political environment, unless such funding would originate in off-the-books or black-budget sources. At one time, according to Charles Tart, “a lot of research money was spent …. but it has all pretty much disappeared” (Tart, 2002, p. 33). The present author is not qualified to opine whether the odds of its restoration are growing higher or lower. 

I will risk a guess - we won't be spending a lot of money on astral travel or reading the akashic tea leaves to offset flight cancellations attributable to COVID-19.

Undeterred, Levin states -

Once engaged, hacking the Akashic domain would seem to cross a line that is sacrosanct, setting in motion retributive cosmic or spiritual forces from which there may be no turning back, in the sense of a karmic backlash. ... 

Because the Akashic realm is said to exist outside of the physical universe, ops that seek to breach the target space presumably cannot be prevented or defended against by naturalistic means, that is by any three-dimensional, physical, mechanical technology. Akashic hacking thus would not require technology, strictly speaking, but rather a developed paranormal or spiritual gift that enables one to “read” this substrate of reality. Another consideration: the Akashic realm may be accessible through the dream state (Krippner, 2006). As noted, this does not really involve hacking, as the term is generally understood. Information is presumably available to anyone with the requisite skillset and karmic balance sheet to enable accessing the Akashic records, through whatever conscious, subconscious, or unconscious means.

Habeas Corpus and compliance with Federal Court orders

The Minister for Home Affairs, responsible for an ongoing erosion of civil liberties, has a tendency to channel Gollum in Lord of the Rings, assuming that he will get what he seeks on the basis of "I wants it" and "I wants it, I wants it now". Judicial concern with his approach is evident in Minister for Immigration, Citizenship, Migrant Services and Multicultural Affairs v PDWL [2020] FCA 394.

Wigney J politely offers a suite of condemnations of the Minister's disregard for tribunals, courts and the law. His Honour states

[57] The conduct of the Minister in this case, on just about any view, has been disgraceful. Putting aside the fact that PDWL remains in detention, despite having been granted a visa on 11 March 2020, that is, six days prior to the hearing of these applications, the Minister appears to have willingly and flagrantly failed to comply with the orders made by Perry J on 12 March 2020. 

[58] Putting aside the Minister’s undoubted ability to waive any privilege if he wished to do so, I have little doubt that an explanation could have been given for the continuing detention of PDWL which did not involve the disclosure of any privileged information. The reasons for the continuing detention could have been explained by an officer who was not a solicitor and the explanation could undoubtedly have been given without exposing any legal advice that may have supported that explanation. It may perhaps be inferred that the only explanation that the Minister had for the continuing detention of PDWL was that he, or someone in his Department, thought that the Tribunal’s decision was wrong. It would appear, however, that either no officer in the Minister’s Department was prepared to depose to that fact, or the Minister was simply prepared to ignore the clear terms of Perry J’s order. 

[62] The Minister sought to characterise PDWL’s application for a writ in the nature of habeas corpus as an application “in relation to a migration decision”. That was said to be because some hypothetical officer somewhere in the Commonwealth must have made a decision to detain the first respondent under subs 189(1) of the Migration Act. The Minister did not adduce any evidence that any officer had in fact turned his or her mind to subs 189(1) of the Act at any time after the Tribunal’s decision, or that any officer had in fact made a decision under subs 189(1) of the Act. One wonders why, if there was in fact such an officer, he or she did not swear an affidavit in compliance with the orders made by Perry J on 12 March 2020. 

[63] In any event, the Minister’s characterisation of PDWL’s application for habeas corpus as being a review of a hypothetical decision by the hypothetical officer to detain PDWL under subs 189(1) of the Migration Act has no merit and is rejected. ... 

[77] The Minister’s contention that the Court does not have jurisdiction to entertain PDWL’s application has no merit and is rejected. That is so whether it be considered to be an application for a writ of habeas corpus, an action in the nature of habeas corpus, an action for injunctive relief against an officer of the Commonwealth, or an action in respect of a matter arising under the Migration Act. Either way, the Court has jurisdiction to entertain such an application under s 39B of the Judiciary Act and power to make an order releasing a person from detention under s 23 of the Federal Court Act. The Court’s jurisdiction to entertain such an action is not affected in any way by s 476A of the Migration Act because it is not an action in relation to a migration decision. 

[82]    First, the Tribunal’s decision is not a nullity until the Court sets it aside and declares that it is a nullity. It may, of course, be readily accepted that if that occurs, the decision is then treated as having been a nullity at all times; that is, it is treated as if the decision was never made: cf. Minister for Immigration and Multicultural Affairs v Bhardwaj (2002) 209 CLR 597 at 612-613, 618, 643-647. That may no doubt have other implications. But it does not mean that the Tribunal’s decision can reasonably be considered to be a nullity by some hypothetical officer of the Minister’s Department simply because he or she thinks that the Court might eventually, or even will eventually, declare it to be so. 

[83] The decision has not yet been set aside or declared by the Court to be a nullity. While the Minister may have reasonable arguments as to why the Court should, at some stage in the future, declare it to be a nullity, that has not yet occurred. The Minister, or officers in his Department, cannot simply ignore, or decide to give no effect to, a decision of the Tribunal simply because they do like it or believe it is wrong.