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Duty to Protect: Enhancing the Federal Framework to Prevent Childhood Lead Poisoning and Exposure to Environmental Harm
No full textScientific evidence indisputably demonstrates that lead poisoning causes permanent neurological damage and numerous co-morbidities for children and adults. Exposure to lead hazards irreversibly harms individuals and, left unchecked, can devastate communities into the future. In recognition of these threats, the President's Task Force on Environmental Health Risks and Safety Risks to Children (Task Force) was established by Executive Order in 1997. The original Task Force created the first coordinated federal response to eliminate childhood lead poisoning in the United States and set an ambitious ten-year timeline to achieve its goals of prevention, treatment, research, and progress management
Battling Over Patents: The Impact of Oil States on the Generic Drug Industry
No full textIn the 2018 case of Oil States Energy Services v. Greene’s Energy Group, the U.S. Supreme Court upheld the constitutionality of inter partes review, a non-judicial proceeding for challenging patents that was created by Congress as part of the 2011 Leahy-Smith America Invents Act. By establishing inter partes review, Congress hoped to rebalance patent policy to make it faster and less costly to invalidate erroneously granted patents in all fields of technology. In the pharmaceutical industry, generic drug companies have embraced inter partes review, filing hundreds of challenges in the first five years after its creation, with moderate success. Biologics, which make up a growing class of pharmaceutical products, are sometimes covered by dozens or scores of patents. As more of these complex therapeutics are developed and approved, inter partes review is expected to play an increasingly important role
Innovation Incentives in a Pandemic
No full textThe current pandemic has exposed the skewed nature of innovation incentives in American healthcare. Consider the case of a company that makes a medical device like a ventilator. The demands of its customers shape its incentives to innovate. The end consumers are patients who do not themselves pay for the device, whether they are insured or not (an uninsured patient is likely to receive free care or a large discount). The device maker will not increase sales to these customers by choosing a lower price. Purchase decision-makers are often physicians who are unaware of the price of the device (and regulations in the USA prevent the salesperson from telling the doctor the price, as that would be an inappropriate inducement). What will get the physician’s attention—and can be easily marketed—is additional quality or features of the device. These will also appeal to technicians or skilled nurses who work with the device; they are not responsible for budgets either. The fancy features might involve more convenience in terms of connecting inputs or positioning the patient, a better screen for observing measurements and settings, a greater choice of settings for pressure, oxygen, drug levels, and so forth. The hospital purchasing department may have some input into which device is chosen—and advocate for cost-effective choices—but at the end of the day, if a physician is convinced a device will provide better care, that device is likely to be chosen regardless of price. Therefore, the device manufacturer is incentivized to invent it.
These incremental quality improvements to the device may hold value for patients and caregivers, but the US medical purchasing process often has so many decision makers spending other people’s money that there is no reason to imagine that price is tightly connected to value. A consumer spending her own money on a product she consumes herself, for example, a loaf of bread, sees the nicer bag around the bread and can determine if that is worth a 10 percent price increase. A physician in a hospital is likely to ask if the new feature is an improvement or not, and then want to purchase the device if it has an improvement. Price may not part of that decision. The physician likely does not know how much the device costs, is not spending her own money, and understands that she is not spending her insured patients’ money either. Therefore, the manufacturer markets the improved features to physicians, as do its competitors, and competition takes place almost entirely on the basis of quality. This leads to expensive machines that have high levels of quality without regard for whether the value of those last units of quality is high for everyone, for a minority of patients, or for no patients.
In the absence of disruptive technology, a better device requires higher costs. In the world described above, the device maker only undertakes one kind of innovation: an improved machine at a higher cost. Over time, ventilators go from 10,000, to 25,000. A manufacturer with an idea for how to make a 25,000 ventilator will have no customers. What physician would recommend purchasing the cheaper machine without all the settings and options of the best machine? Consider how different that is from a more functional market such as automobiles. Suppose a new auto maker found a way to make a BMW equivalent car but without the leather seats at half the price. There would likely be a huge demand for that vehicle
Collective Preclusion and Inaccessible Arbitration: Data, Non-Disclosure, and Public Knowledge
No full textWhen courts enforce mandates to arbitrate, jurists describe themselves as respecting the individuals' autonomy to enter into contracts that route claimants to a process that is more user-friendly than adjudication. But those rationales are disjunctive with the practices of providers of goods and services and of employers. These companies neither offer individuals choices about dispute resolution mechanisms nor welcome the exchange of information about experiences with arbitration. Instead, companies impose obligations to arbitrate and set the terms. In addition to the increasingly commonplace bans on joint and collective
actions in any forum, many providers and employers also seek to mandate a cone of silence by instructing individuals not to disclose the content of claims, the use of arbitration, or the outcomes.
But as we document in this Article, during the last decade, very few individuals filed claims, single-file, in arbitration. Given the success in precluding class actions and the rarity of filings, why are market actors seeking to silence the few who do arbitrate? And are such mandates enforceable by courts?
In this Article, we interrupt these silencing provisions through disseminating information about the rules of and use of arbitration. We track efforts to limit information about arbitration, outline the growing body of law on non-disclosure, and analyze the data about consumer use of arbitration. As we recount, some jurists have held non-disclosure obligations unenforceable. Yet many decisions condone their imposition despite the repeat-player advantages that accrue to the clauses' drafters, who have access to information that oneshot participants do not have
Contract's Revenge: The Waiver Society and the Death of Tort
No full textZombie contract has risen from the dead to put a stake through the heart of tort.
A half century ago, leading observers of American law reflected on what they believed was the end of an era. For more than a century, from the 1830s, in what Roscoe Pound called "the formative era" of American law, up at least until the New Deal, significant swaths of the American common law's private law doctrines were distinctively organized around contract. By the middle of the twentieth century, however, the basic structure of the common law's contractual reasoning seemed to be under attack. "[I]t is the
fate of contract," proclaimed leading scholar Grant Gilmore in 1974, "to be swallowed up by tort." Dean William Prosser described with equal confidence an "assault upon the citadel of privity"-the doctrine that had once supported the predominance of contract in the law of products liability; courts, Prosser said, had at last "throw[n] away the crutch" and based their rulings on tort obligations at the expense of contractual liabilities. Gilmore confidently predicted "the death of contract." He and Prosser believed they were watching the advent of an age in which tort's public obligations would dominate where previously the rights and duties of contract law had ruled. Leading torts scholar Greg Keating puts the point bluntly: "[t]ort has
triumphed over contract and property."
History has turned out to be more complicated. Contract has found ways to reassert itself. Public dispute resolution has given way to the private contractual settlement of claims. Increasingly, contract excludes trials altogether. Sometimes it does so in advance, as Margaret Jane Radin, Judith Resnik, and others have shown, through contractual arbitration clauses, which have shunted into private fora the resolution of the publicly imposed obligations on which Gilmore and Prosser focused two generations ago.
Sometimes it does so after the fact in the form of settlement contracts, which now dominate the resolution of civil disputes like never before in the history of the common law.
In this Article, we draw attention to a further way in which contract is wreaking its revenge. Virtually everywhere one goes in contemporary life, there are waivers to be signed: in apartments and housing developments, in daycare centers and nursing homes," in big box stores and birthday party
EARLY TRACES OF KARL POLANYI’S “DISCOVERY OF SOCIETY”: A STUDY OF SIXTEENTH-CENTURY SPIRITUALITY AND CHARITY THROUGH CARAVAGGIO’S PAINTINGS
No full textThrough the lenses of Caravaggio’s life and work, this article studies late sixteenth- and early seventeenth-century social thought and charitable practices. It examines, among others, the theology and social thought of Carlo Borromeo, Filippo Neri and François de Sales, as well as the conduct and rules adopted by a variety of subjects active in the field of social welfare, including hospitals, religious charities, lay confraternities, municipalities and states. Without denying the novelty of late eighteenth and nineteenth-century social thought, the article suggests that the roots of what Karl Polanyi called the “discovery of society”—that is, the idea that evils like sickness and poverty are the consequence of societal flaws, as opposed to one’s moral shortcomings—date back at least to the late sixteenth century, if not earlier. At that time, of course, this ethical view was still embryonic, uncommon and full of contradictions—so much so that it did not translate into significant legislative reforms for another couple of centuries. But the seeds of the subsequent “discovery” were there—scattered in the works of theologians like Juan Luis Vives and artists like Caravaggio
The WTO and Development Policy Space in India
No full textInternational trade law scholarship has offered different approaches for assessing how international trade law impacts domestic policy space for developing nations. However, much of this scholarship has failed to address the realities of how domestic policy implementation affects development policy space. This Article argues for a policy implementation-based approach to assessing development policy space by analyzing India’s response to two recent WTO disputes: India-Solar Cells (2013), and India-Export Related Measures (2018). In the India-Solar Cells dispute, the U.S. challenged India’s inclusion of local content requirements in its National Solar Mission program. In India-Export Related Measures, the U.S. challenged India’s export subsidies programs, including its Special Economic Zones (SEZs) policy. The WTO Appellate Body found that India’s local content requirements in India-Solar Cells violated international trade law norms, while the WTO Panel in India-Export Related Measures will adjudicate on the request for consultations in India-Export Related Measures in 2019. In examining how domestic policy implementation impacts policy space, this Article fills an important gap in the existing literature, which has paid insufficient attention to the domestic policy context of industrial policy in relation to international trade disputes. I argue that key dimensions of industrial policy regimes shape how nations respond to WTO decisions by implementing alternative WTO-compliant policies: the policy goals, tradeoffs and viability of policy alternatives; the nature and size of industrial sectors; and the existence of broader policy transitions. The Article analyzes aspects of policy regimes governing India’s solar industrial policy and SEZ policy, and explores the nature of policy implementation and adaption in response to WTO adjudication in order to fully assess policy space in these sectors. The Article concludes by suggesting the need to look beyond international law norms and WTO dispute resolution to the realities of the domestic policy landscape in order to provide a more complete account of how international trade law impacts development policy space
The Third Space of Puerto Rican Sovereignty: Reimagining Self-Determination Beyond State Sovereignty
No full textThe relationship between Puerto Rico and the United States has long been a story of empire and colonization. From the island's annexation to today, Puerto Ricans have struggled for their right to self-determination. The fiscal control board, housing crisis, austerity measures, Hurricane Maria, and the recent resignation of former governor Ricardo Rossell6 have revived social, economic, and political debates about Puerto Rico's status. This Note illustrates how struggles for self-determination and sovereignty manifest themselves beyond the legal and political realms, inspiringlocal fights for a just recovery in the country. It argues that the third space of Puerto Rican sovereignty exists outside of dominant expressions of citizenship and state sovereignty
Artificial States and the Remapping of the Middle East
No full textThis Article critically examines arguments tracing contemporary crises in the Arab world to the making of the Arab state system a century ago. A series of popular and scholarly articles occasioned by the recent spate of World War I-related centenaries suggest that new boundaries be drawn in the Middle East to produce more stable nation-states. More specifically, a set of authors has advocated for different borders that would avoid ethno-sectarian conflict by designing relatively homogenous smaller states to replace multiethnic, multisectarian states like Iraq and Syria. Such proposals are significant for the underlying presumptions they reflect concerning the relationship between stability and diversity in the Middle East. This Article first offers a historical corrective to the purported artificiality of the current boundaries defining the states in the region. Second, the Article calls into question the legal and political grounds for arguing that more homogenous states would be more stable or better reflect the preferences of the underlying population. The Article concludes by suggesting alternative reforms that might serve the goals of conflict resolution in the Middle East