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Nothing Generic About It: Promoting Therapeutic Access by Overcoming Regulatory and Legal Barriers to a Robust Generic Medical Device Market
No full textThis Article addresses a paradox in American healthcare technology: a thriving market for generic drugs but a paucity of generic medical devices. Despite the success of generic pharmaceuticals in reducing healthcare costs, no analogous market exists for generic medical devices. This plays a part in keeping prices high while limiting access to affordable therapies. In this Article, we highlight the regulatory and legal barriers currently impeding the development of a generic medical device market in the United States. We explore differences between generic drugs and generic devices in FDA regulation, products liability, and patentability, all of which contribute to the absence of medical devices in clinical practice. We conclude with recommendations to foster more widespread development of generic medical devices
Risky Business: Holding Hotels Accountable for Sex Trafficking
No full textThe modern-day sex trade is “hidden in plain sight.” Traffickers use and exploit legitimate businesses to engage in and conceal their illegal practices. From nightclubs to travel agencies, massage parlors to car dealerships, a wide variety of industries fail to scrutinize suspicious activity or take adequate precautions, while the most egregious actors actively solicit and benefit from “lucrative” partnerships
The Congressional Bureaucracy
No full textCongress has a bureaucracy.
Legal scholarship, judicial discourse, and doctrine about Congress and statutes have focused almost entirely on elected members of Congress and the ascertainability of their purported intentions about policymaking and statutory language. In recent years, we and others have broadened that perspective, with new scholarship about the on-the-ground realities of the congressional drafting
process-including the essential role that staff plays in that process-and have argued the relevance of those realities for theory and doctrine.
Here we go deeper. This Article goes beyond our previous accounts of partisan committee staff, congressional counsels, and other select staff offices to introduce the broader concept of what we call the congressional bureaucracy. The congressional bureaucracy is the collection of approximately a dozen nonpartisan offices that, while typically unseen by the public and largely ignored by courts and practicing lawyers, provides the specialized expertise that helps make congressional lawmaking possible. In the process, the bureaucracy furthers Congress's own internal separation of powers and safeguards the legislative process from executive and interest-group encroachment
An International Review of Health Technology Assessment Approaches to Prescription Drugs and Their Ethical Principles
No full textHealth technology assessment (HTA) organizations assess the economic value and make recommendations about reimbursement or coverage of prescription drugs and other health care products. The findings are then used by governments or other health insurers to negotiate prices, structure budgets, and decide whether to finance access to a drug or product. HTA is an important tool to control health care costs and determine the distribution of resources in society.
Most high-income countries around the world use HTA as part of a negotiation process to establish drug prices, with the notable exception of the US. While many high-income countries have experienced increases in prescription drug spending in the past decade, due to both increased volume and prices, rising health care costs and prescription drug prices in the US far exceed any other setting. In response, the current US presidential administration and leading Congressional bills seek to rein in spending and excessive drug prices by linking US drug prices to those paid by other countries.4 In 2019, House bill H.R.3 — the Elijah E. Cummings Lower Drug Costs Now Act — proposed pricing some of the most expensive drugs for Medicare and Medicaid Advantage at negotiated prices that may not exceed 120% of the average price in Australia, Canada, France, Germany, Japan, and the UK, each of which uses HTA to negotiate prices for the country. H.R. 3 would also require negotiation for prices below the maximum level taking into consideration costs of drug development and production and information on the comparative effectiveness of the new drug. The methods for this assessment have not been specified yet; other policy proposals may supplant H.R. 3, and so there is an opportunity to learn from the international example and shape the methods based on social and cultural values.
While HTA is an empirical process using economic and clinical evidence to arrive at a cost-effectiveness valuation of a drug, HTA is also fundamentally political; though grounded in evidence and validated modelling methods, the findings and recommendations reflect the political and social values of a country. Though there are objections to HTA as an approach to determining coverage, its use in many countries signals a broad acceptance of a health economics approach to evaluating the value of drugs, so this paper focuses on HTA approaches. There are two key dimensions of every HTA organization that raise potential ethical concerns. The first is how HTA functions to generate the quantitative findings of cost-effectiveness. For example, some HTA bodies may choose to integrate modifications to the economic evaluation methods that change cost or effectiveness thresholds for a particular patient population, such as drugs treating rare diseases. Such adjustments have important implications for patient access
Guests with Guns: Public Support for "No Carry" Defaults on Private Land.
No full textA nationally representative survey of 2000 American adults shows broad support for prohibiting gun-possession on private land without the landowner's explicit permission. Many states have laws which permit concealed weapon carry unless explicitly prohibited by the landowner, but our survey suggests statistically-significant majorities would prefer “no carry” defaults with regard to homeowners, employers, and retailers. While respondents who are Republican, male, or gun owners are more likely to support “carry” defaults, we find that the majoritarian rejection of “carry” defaults does not tend to vary by region or state. However, our survey does find majority support for a default right to possess guns in rented property and on an employer's parking lot. Respondents across all contexts also report substantial ignorance or misinformation about the law. Landowners who don't know or mistakenly believe that concealed carry is, by default, prohibited on their land may be less able to protect themselves by explicitly prohibiting such third-party possession
Mill, acerca de la libertad de expresión.
No full textEn este ensayo el profesor Owen Fiss hace una revision critica de la obra de John Stuart Mill: Sobre la libertad, que presenta una defensa robusta de la libertad individual con base en el reconocimiento de la pluralidad de la condicion humana. De acuerdo con el profesor Fiss, Mill busc expandir la capacidad de cada individuo de crear una vida distintiva para s mismo. A lo largo del texto, el profesor Fiss presenta los componentes centrales de la teor a desarrollada por Mill y los discute en el contexto de diferentes casos de la vida social y pol tica estadounidense. Esta discusion hace patente que Mill entendi la libertad de expresion como parte de un proceso de autoexaminacion que permite a las personas cuestionar las convenciones sociales y postulados ticos dominantes, y expresar libremente su individualidad.
In this essay Professor Owen Fiss makes a critical review of John Stuart Mill’s On Liberty, which presents a robust defense of individual liberty based on the recognition of the plurality of the human condition. According to Professor Fiss, Mill sought to expand each individual's ability to create a distinctive life for himself. Throughout the text, Professor Fiss presents the central components of the theory developed by Mill and discusses them in the context of different cases of American social and political life. This discussion makes it clear that Mill understood freedom of expression as part of a process of self-examination that allows people to question dominant social conventions and ethical postulates, and freely express their individuality
Why Regulate Guns?
No full textIn Second Amendment cases, courts regularly ask how effectively gun laws serve public safety — yet typically discuss public safety narrowly, without considering the many dimensions of that interest gun laws serve. Gun laws protect bodies from bullets —
and Americans’ freedom and confidence to participate in every domain of our shared life, whether to attend school, to shop, to listen to a concert, to gather for prayer, or to assemble in peaceable debate. It is time to take a full accounting of the reasons gun laws are enacted, so that courts review those laws with attention to the many constitutional values Americans vindicate when they regulate guns. Constitutional precedent, much of it authored by sitting conservative justices, directs courts to protect constitutional rights in ways that respect the prerogatives of democratic self-government. Lawyers, health and public health officials, legislators, and citizen advocates can help, by creating a richer record of the government’s reasons for enacting laws that regulate guns.
Observing the wide range of activities gun laws protect is urgent at a time when federal judges are asserting a more active oversight role and the Supreme Court’s new conservative majority seems poised to expand the right to keep and bear arms. In 2008’s District of Columbia v. Heller, the Court first recognized an individual right to keep arms for self-defense in the home, but said nothing explicit about whether that right extends to public places. In 2020, the Court considered but ultimately dismissed another Second Amendment case, New York State Rifle & Pistol Association v. City of New York (NYSRPA), which concerned the transport of guns. And gun rights advocates are pushing hard for recognition of a right to public carry — that is, to bear a gun outside one’s home. Whenever the Court hears another Second Amendment case, it will almost certainly consider the constitutionality of gun regulations designed to keep people safe in public, either through direct restrictions on public carry or
through rules regarding the manufacture, sale, transport, possession, and use of weapons more generally.
This creates a risk: that the Court could begin to extend constitutional protection to the use of guns outside the home without taking account of the full range of reasons why citizens look to their government to regulate guns — as well as the discretion and flexibility government needs to respond to local circumstances and emergency conditions. Whatever framework for reviewing guns laws the Court develops, that framework needs to recognize the many dimensions public life that gun laws protect. But the debate, though robust in so many other ways, has been strangely silent on just this point
The Constitution of Parenthood
No full textThis Article challenges the conventional assumption that the Constitution protects only biological parent-child relationships and makes an affirmative case for constitutional protection for nonbiological parents. Family law in a growing number of states legally recognizes nonbiological parents in a range of families-including nonmarital families, families headed by same-sex couples, and families formed through assisted reproduction. But in some states, nonbiological parents who have not adopted are treated as legal strangers to their children. When these parents turn to the Constitution to assert a liberty interest in their parent-child relationship, they find no relief. Courts conclude that only biological parents possess a right to parental recognition protected by the Due Process Clause. This biological understanding of constitutional parenthood often rests on a reading of Supreme Court precedents from the 1970s and 1980s involving the rights of unmarried fathers and the status of foster parents. This Article revisits those precedents-both to show that they present a more complicated approach to parenthood than conventionally assumed and to make clear the ways in which they are in tension with more recent constitutional commitments. Rather than elaborate a biological approach to parenthood, the Court's decisions on unmarried fathers and foster parents view parenthood as a social practice. Even as these precedents provide useful insights about parenthood's social dimensions, they are outdated. Decided decades ago, these decisions condone forms of inequality that now appear constitutionally suspect. Since they were decided, legal understandings of the family have shifted significantly. The Court itself has contributed to the changing legal landscape through its decisions on the constitutional rights of same-sex couples-who ordinarily include nonbiological parents.
Today, insights, principles, and values observable in constitutional precedents on parenthood and the family point toward a liberty interest in parental recognition that reaches nonbiological parents. To show how, this Article turns to contemporary familylaw
developments. Modern family law takes from constitutional precedents important insights about parenthood and yet updates the meanings and implications of those precedents. Family law's functional turn has featured the vindication of nonbiological parent-child bonds based in part on interpretations of constitutional decisions on unmarried fathers, foster parents, and same-sex couples. In valuing established parent child bonds in marital and nonmarital families, in different-sex and same-sex couples, and
for men and women, family-law authorities have found support in the Court's decisions but have taken those decisions in more inclusive and egalitarian directions. Even as this functional vision of parenthood has arisen as a formal matter in family law, it reflects and extends important constitutional commitments in ways that shed light on the parent child relationships that merit recognition as a matter of due process. Ultimately, constitutional understandings of parenthood may evolve in light of insights from family law. This Article's examination of the law of parenthood contributes to an account of the dialogic relationship between family law and constitutional law-demonstrating how family-law authorities develop approaches to the family that draw on and apply constitutional principles in ways constitutional decisionmakers may eventually adopt
Autonomous Weapon Systems, International Crises, and Anticipatory Self-Defense
No full textAutonomous Weapon Systems (“AWS”) present novel challenges for the laws of war. But the voluminous literature on the use of AWS during war – i.e., under the jus in bello framework – almost entirely ignores the challenges that AWS pose for jus ad bellum. This Note is among the first legal works to systematically analyze the question of when AWS may transition from peace to violence; that is, from crisis to war. Specifically, it asks when an autonomous weapon system may lawfully use force in anticipatory self-defense. This Note argues that with the right rules, AWS may reduce the risk of jus ad bellum violations and dampen escalation, improving compliance with international law and potentially saving lives
Affordable Care Act Entrenchment
No full textThe Affordable Care Act (ACA) is the most challenged-and the most resilient-statute in modern American history. Through and despite hundreds of court challenges, scores of congressional repeal efforts, unexpected state resistance, gutting by the Supreme Court, unprecedented administrative strangulation, and criticism from the beginning that the statute did not go far enough to embrace the principle of universal healthcare, the ACA has changed the way many Americans and the political arena think about healthcare and the entitlement to it.
Over its ten-year lifespan, the ACA went from being the rallying cry of the GOP in 2010, to the center of the Democratic platform in 2018, catapulting universal healthcare to the top of the 2020 Democratic presidential primary agenda. It began as a statute criticized for its practical compromises and its incrementalism-including leaving most insurance in the private market and retaining state control over large swaths of health policy-but those very compromises have, surprisingly, proved key to the ACA's resilience. They have also been instrumental in the ACA's entrenchment of not only its own reforms but also a broader,
emerging principle of a universal right to healthcare. The idea of healthcare for all Americans administered through the federal government was long viewed as political suicide, including as recently as the 2016 presidential election. In an astonishingly fast turnaround, that idea has now been considered and debated by every Democratic presidential hopeful.
The ACA's principles have been codified outside of federal law and into state law, voted on in ballot initiatives, and advocated for on latenight TV. The Supreme Court has treated the ACA differently from other laws. Core features of the ACA-a law that Republicans have sought to repeal scores of times-are now mainstream positions in the Republican Party.
This Article offers a comprehensive account of the ACA's structure, the challenges it survived, and how a law that itself evinces a philosophical ambivalence about the right to government-provided healthcare has nevertheless made that right politically and practically possible for the first time in American history. We examine not only court cases and the political tides but also the statute's governance, implementation, and financing structures to tell a story of entrenchment through multiple modalities-architectural, legal, democratic, political, financial, and expressive-and normative transformation.
Legislation scholars will see in this story themes that echo theoretical concepts of special statutes-statutes whose norms transform the legal landscape beyond the statute itself and change the way we think about fundamental rights. Despite our doubts about the practical payoff of those theories, the concept is a helpful jumping-off point for a more detailed exploration of how the particulars of statutory design can facilitate entrenchment and of the various forms entrenchment can take