Zika, Pregnancy, and the Law

The public health emergency surrounding the spread of the Zika virus has resurrected and brought into sharp relief some of the most vexing questions surrounding the relationship between pregnancy and law: the appropriate circumstances, if any, in which fetal tissue research is permissible; when and how the government may sponsor statements intended to influence reproductive decisions; and how to balance the health and rights of both women and their unborn children when health threats target both

Health Data and Privacy in the Digital Era

In 2010, the social networking site Facebook launched a platform allowing private companies to request users’ permission to access personal data. Few users were aware of the platform, which was integrated into Facebook’s terms of service. In 2014, Cambridge Analytica, a UK-based political consulting firm, developed a data-harvesting app. That app prompted Facebook users to provide psychological profiles, including responses such as “I get upset easily” and “I have frequent mood-swings” as part of a “research project.” The Facebook platform allowed users to share their friends’ data as well, enabling Cambridge Analytica to access tens of millions of personal profiles, identifying voters’ political preferences. The controversy revealed risks to identifiable health data posed by social media and web services companies’ practices. After the Cambridge Analytica controversy, Facebook suspended a project that aimed to link data about users’ medical conditions with information about their social networks. Individuals often reveal detailed, sensitive health information online. Through wearable devices, social media posts, traceable web searches, and online patient communities, users generate large volumes of health data. Although some individuals participate in online patient forums and wellness information sharing apps under their own names, others participate via pseudonyms, assuming their privacy is preserved. Many users believe their data will be shared only with those they designate

Efficient Contracting between Foreign Investors and Host States: Evidence from Stabilization Clauses

Bilateral investment treaties are agreements between sovereign states that give broad protections to investors and investments made within the jurisdiction of the other state. The prevailing view in the academy and practice is that developing countries sign bilateral investment treaties in order to reassure investors from developed states that their investments will be safe from changes in domestic law. Without these “credible commitments,” investors would be deterred from making investments, depriving developing countries of foreign capital. This Article disputes that view by demonstrating that foreign investors and host states effectively contract around the risk of changes in the law. This Article applies transaction cost economic theory to the most comprehensive empirical study of stabilization clauses (provisions intended to manage post-investment changes in domestic law) recently conducted under the auspices of the World Bank\u27s International Finance Corporation. The analysis shows that investors and states demonstrate principles of efficient contracting even without the protections of bilateral investment treaties (BITs). This finding adds to current research focusing on the “credible commitment” story. The Article concludes that (1) BITs can be explained as instruments developed and developing states use in their competition for markets and capital and (2) differences in the reasons states execute BITs raise significant doubts about conclusions drawn based on aggregate phenomena

The Hague Convention on the Civil Aspects of International Child Abduction and the Latent Domestic Relations Exception to Federal Question Jurisdiction

This article explores the discrepancy in the law of federal jurisdiction as it has developed under the Hague Child Abduction Convention. In contrast to return claims where the remedy is discrete, finite, and closely tied to fundamental international obligations under the treaty, orders to enforce access rights are, or would be, amorphous, ongoing, and subject to other administrative structures codified in the convention as well as, in the U.S. system, adding responsibilities for federal judges more generally associated with those undertaken by state judges. Even in the one federal appellate decision that explicitly acknowledged a judicially enforceable right to ensure access, the court fashioned the remedy toward return, ultimately rendering that part of the decision dicta. In any case, federal courts have overwhelmingly rejected jurisdiction over access claims, emphasizing state courts\u27 role in making child custody determinations and alternative treaty mechanisms like cooperation between executive branch officials. Ultimately, this article argues that there is little if any support in the language of the Hague Child Abduction Convention or in its implementing statute, the International Child Abduction Remedies Act, to justify federal courts\u27 refusal to hear access claims. Rather, the rationales adopted by federal courts in allocating access cases to state courts resurrects a long-standing problem in the law of federal jurisdiction: Is the exception to federal jurisdiction for matters relating to divorce, maintenance, and child custody based on courts\u27 interpretation of jurisdictional statutes or did Article III\u27s jurisdictional grant to cases or controversies always exclude matters traditionally handled by ecclesiastical courts in 1787 Britain? While this article takes no position on that problem directly, it does suggest that federal courts have appropriated to themselves authority to determine jurisdiction based on their own assessment of state courts\u27 competencies, what is called here a latent domestic relations exception to federal question jurisdiction

Jerusalem in the Courts and on the Ground

This Article analyzes presidential speeches and the pleadings of the U.S. Government in response to a lawsuit by Jerusalem-born U.S. citizen Menachem Zivotofsky seeking to have Israel listed in his U.S. passport rather than Jerusalem as U.S. law now requires. The picture that emerges is one of a growing flexibility in U.S. policy toward Israel/Palestine in general and Jerusalem in particular. That flexibility moves away from adherence to two states (and impliedly two capitals in Jerusalem) to one emphasizing various kinds of democracy that may characterize a future Israeli state. Part I of this Article provides a brief summary of Jerusalem in the history of the Israeli/Palestinian conflict as well as U.S. law and policy toward Jerusalem. Part II provides a brief overview of the scholarly disagreement over how and under what circumstances the United States develops its foreign policy preferences focusing on interpretations of international law. Contesting the widespread view that foreign policy positions and interpretations of international law are traceable to responsible bureaucracies who act with a clear path to their desired outcome, Part II argues that U.S. foreign policy and legal positions are subject to intermittent but nevertheless influential legal pressures-what Rebecca Ingber describes as interpretation catalysts -that regularly force the United States to frame or re-frame foreign policy preferences. These catalysts include both presidential speeches and litigation over foreign policy positions. Part II analyzes two of these framing events: Presidential speeches from Clinton to Obama and pleadings filed in the long-running dispute between Menachem Zivotofsky and the U.S. Government over the designation in his passport. That litigation is, in effect, the latest round in the dispute between Congress and the President over Jerusalem\u27s status under U.S. law. Part III applies insights from the analysis in Part II to current trends in the movement for Palestinian self-determination. Those trends demonstrate a shift in ideology from self-determination as a form of sovereignty under international law to self-determination as civil rights and equality with Israeli citizens. As a result of these movements, I ultimately argue that U.S. policy is shifting in preparation for the window to two-states closing, if it has not closed already

The Drug Repurposing Ecosystem: Intellectual Property Incentives, Market Exclusivity, and the Future of New Medicines

The pharmaceutical industry is in a state of fundamental transition. New drug approvals have slowed, patents on blockbuster drugs are expiring, and costs associated with developing new drugs are escalating and yielding fewer viable drug candidates. As a result, pharmaceutical firms have turned to a number of alternative strategies for growth. One of these strategies is drug repurposing -finding new ways to deploy approved drugs or abandoned clinical candidates in new disease areas. Despite the efficiency advantages of repurposing drugs, there is broad agreement that there is insufficient repurposing activity because of numerous intellectual property protection and market failures. This Article examines the system that surrounds drug repurposing, including serendipitous discovery, the application of big data methods to prioritize promising repurposing candidates, the unorthodoxly regulated off-label prescription practices of providers, and related prohibitions on pharmaceutical firms\u27 off-label marketing. The Article argues that there is a complex ecosystem in place and that additional or disruptive IP or market exclusivity incentives may harm as much as help in promoting repurposing activity. To illustrate this threat, the Article traces the trajectory of metformin, a common diabetes drug that shows promise for conditions ranging from polycystic ovary syndrome to breast cancer. From the initial reasons for Bristol-Myers Squibb to refuse to invest in promising alternative uses, to the institutions, researchers, and regulators who identified possibilities for metformin treatment, this Article aims to map the role of intellectual property protection, market exclusivity, and search for capital that led to metformin\u27s ascent as a repurposed drug. The Article contributes a concrete understanding to an important problem in pharmaceutical law and policy, one for which scholars have quickly suggested more powerful patent and market exclusivity protection when doing so may undermine the very processes now leading to effective alternative uses for existing drugs

International Intellectual Property Shelters

The battle over the reach and strength of international protections for intellectual property rights is one of the critical flashpoints between wealthy and low-income countries: those protections are perceived to obstruct access to essential medicines, thwart regulatory efforts to promote individual and population health, and undermine traditional forms of agriculture and food production. While scholars have thoroughly tracked the bilateral and multilateral trade and investment treaties responsible for the expansion of international intellectual property rights worldwide, they have paid significantly less attention to the strength and form that opposition to international intellectual property expansion has taken. This Article examines the proliferation of international legal agreements that carve out special areas of intellectual property for treatment that differs from protections extended under international trade and investment rules and argues that they should be reconceived as a unified body of international economic law. Responding to demands from low- and middle-income countries that benefits from intellectual property protections be more equitably shared, these international intellectual property shelters include the Doha Declaration on the TRiPS Agreement and Public Health, the World Health Organization’s Pandemic Influenza Preparedness Standard Manual Transfer Agreements, the Framework Convention on Tobacco Control, the International Treaty on Plant Genetic Resources for Food and Agriculture, and the proposed Medical Research and Innovation Treaty This Article analyzes the circumstances that give rise to international intellectual property shelters and the aspects of intellectual property rights they attempt to regulate. While these shelters are advocated as safeguards for areas of global public welfare, such as food security and population health, they tend to arise in areas in which a small number of knowledge-intensive firms dominate global markets. International intellectual property shelters should therefore be understood as forms of supranational regulation of those firms

Against Fiduciary Utopianism: The Regulation of Physician Conflicts of Interest and Standards of Care

This Article critically examines calls by scholars, legislators, and regulators advocating the imposition of fiduciary duties upon a broad range of actors including judges, jurors, agencies, parents, friends, and even entire countries. The Article examines the physician-patient relationship—an archetypal and frequently cited relationship in which fiduciary duties, administered by courts, are asserted to work well. It argues that some of the most significant problems fiduciary duties are used to address like asymmetry of information, conflicts of interest, and professional conduct have not only been handled badly by courts, but have actually found more effective resolution through legislative fact-finding, acknowledgment of the complexity of medical practice, and ultimately regulatory solutions aimed at sources of conflicts of interest and specific circumstances in which claims for medical malpractice arise. Behind many of these initiatives are physicians themselves—who experience the sources of potential conflicts and endeavor to create self-regulatory and legislative solutions to them. In contrast, court-administered fiduciary duties are often marginalized as judicially manageable claims related to the duties of loyalty and the duty of care converge, litigants focus on settlement, and the high expectations held for fiduciaries are rarely enforced. The Article concludes that not only may imposing more fiduciary duties on more relationships not generate the benefits many scholars suggest, but that doing so will stymie more targeted and effective solutions to problems that occur in trust relationships

The Patient Protection and Affordable Care Act of 2010: Rulemaking the Shadow of Incentive-Based Regulation

While legislators, scholars and mainstream observers are focused on the intense debates surrounding the constitutionality of the Patient Protection and Affordable Care Act’s individual mandate, the Department of Health and Human Services and other agencies are proceeding apace in promulgating rules to implement the law’s other requirements. Congress’s substantial delegation of administrative authority to HHS and other agencies will provide a second key area for constitutional challenges after the U.S. Supreme Court resolves the initial lawsuits based on the individual mandate. Between facial constitutional challenges to the Affordable Care Act and lawsuits based on defects in agency rules or the rule making process lies the significant discretionary area in which the Secretary of HHS, and others, will make the most important implementation decisions. This Article provides agencies guidance for shaping the rules that Congress clearly intended them to adopt and implement, but which courts are less likely to scrutinize. This article argues that (1) Congress demonstrated a strong intent for private enforcement of the Affordable Care Act’s provisions (especially those expanding Medicare and Medicaid benefits and eligibility); (2) Congress concurrently included enhancements for private enforcement of governmental payments programs in the Fraud Enforcement and Recovery Act and the Dodd-Frank Wall Street Reform and Consumer Protection Act; and, therefore, (3) administrative agencies should structure rules to facilitate private enforcement

The Comity of Empagran: The Supreme Court Decides that Foreign Competition Regulation Limits American Antitrust Jurisdiction over International Cartels

The equivocal language of the 1982 Foreign Trade Antitrust Improvements Act ( FTAIA ) has led to several disputes concerning when victims of international price-fixing can bring suit under U.S. antitrust law. Recently, the U.S. Supreme Court ruled in E Hoffmann-La Roche, Ltd. v. Empagran S.A. ( Empagran ) that the doctrine of comity among nations limited the reach of U.S. anti-trust law over foreign plaintiffs who claim injury in nations where other competition regulations exist. This article argues that Empagran misapplies the doctrine of comity. Part II traces the history of the FTAIA, which was passed to define the limits on participation by American businesses in anticompetitive conduct overseas. Part III narrates the factual and procedural history of Empagran. Part IV contrasts the Fifth and Second Circuits\u27 interpretations of the FTAIA. In Part V, the Recent Development analyzes the Supreme Court\u27s ruling in Empagran, and Part VI outlines the procedurally questionable application of the comity among nations doctrine