CORNELL LAW REVIEW

Cross-Market Mergers in Healthcare: Adapting Antitrust Regulation to Address a Growing Concern
Lopatka TJ
Unquantified Benefits and the Problem of Regulation Under Uncertainty
Masur JS and Posner EA
"Unique Identities and Vulnerabilities": the Case for Transgender Identity as a Basis for Asylum
Wayne AL
Reanalyzing reverse payment settlements: a solution to the patentee's dilemma
Wang Z
Circumvention tourism
Cohen G
Under what circumstances should a citizen be able to avoid the penalties set by the citizen's home country's criminal law by going abroad to engage in the same activity where it is not criminally prohibited? Should we view the ability to engage in prohibited activities by traveling outside of the nation state as a way of accommodating cultural or political differences within our polity? These are general questions regarding the power and theory of extraterritorial application of domestic criminal law. In this Article, I examine the issues through a close exploration of one setting that urgently presents them: medical tourism. Medical tourism is a term used to describe the travel of patients who are citizens and residents of one country, the "home country," to another country, the "destination country," for medical treatment. This Article is the first to comprehensively examine a subcategory of medical tourism that I call "circumvention tourism," which involves patients who travel abroad for services that are legal in the patient's destination country but illegal in the patient's home country--that is, travel to circumvent domestic prohibitions on accessing certain medical services. The four examples of this phenomenon that I dwell on are circumvention medical tourism for female genital cutting (FGC), abortion, reproductive technology usage, and assisted suicide. I will briefly discuss the "can" question: assuming that a domestic prohibition on access to one of these services is lawful, as a matter of international law, is the home country forbidden, permitted, or mandated to extend its existing criminal prohibition extraterritorially to home country citizens who travel abroad to circumvent the home country's prohibition? Most of the Article, though, is devoted to the "ought" question: assuming that the domestic prohibition is viewed as normatively well-grounded, under what circumstances should the home country extend its existing criminal prohibition extraterritorially to its citizens who travel abroad to circumvent the prohibition? I show that, contrary to much of current practice, in most instances, home countries should seek to extend extraterritorially their criminal prohibitions on FGC, abortion, assisted suicide, and, to a lesser extent, reproductive technology use to their citizens who travel abroad to circumvent the prohibition. I also discuss the ways in which my analysis of these prohibitions can serve as scaffolding for a more general theory of circumvention tourism.
Judging sex
Tuerkheimer D
This Article explores the curious jurisprudence of sexual patterns and how it constructs female sexuality. In modern rape law, the "unchaste character inference" expressly prohibited by the rape shield endures. Though the boundaries that circumscribe appropriate sexual conduct have shifted over time, courts persist in making normative judgments about women's sexuality. Cloaked in the legitimizing rhetoric of sexual patterns, retrograde notions of deviancy are substituting for rational deliberation on the question of consent. As rape shield law enters its fourth decade, it continues to defy reason, both in application and in theory. The proposed evidentiary approach promises to improve judicial decision making in rape cases, while reorienting the law toward the female sexual subject and the contingency of her consent.
Pain as a fact and heuristic: how pain neuroimaging illuminates moral dimensions of law
Pustilnik AC
In legal domains ranging from tort to torture, pain and its degree do important definitional work by delimiting boundaries of lawfulness and of entitlements. Yet, for all the work done by pain as a term in legal texts and practice, it has a confounding lack of external verifiability. Now, neuroimaging is rendering pain and myriad other subjective states at least partly ascertainable. This emerging ability to ascertain and quantify subjective states is prompting a "hedonic" or a "subjectivist" turn in legal scholarship, which has sparked a vigorous debate as to whether the quantification of subjective states might affect legal theory and practice. Subjectivists contend that much values-talk in law has been a necessary but poor substitute for quantitative determinations of subjective states--determinations that will be possible in the law's "experiential future." This Article argues the converse: that pain discourse in law frequently is a heuristic for values. Drawing on interviews and laboratory visits with neuroimaging researchers, this Article shows current and in-principle limitations of pain quantification through neuroimaging. It then presents case studies on torture-murder, torture, the death penalty, and abortion to show the largely heuristic role of pain discourse in law. Introducing the theory of "embodied morality," the Article describes how moral conceptions of rights and duties are informed by human physicality and constrained by the limits of empathic identification. Pain neuroimaging helps reveal this dual factual and heuristic nature of pain in the law, and thus itself points to the translational work required for neuroimaging to influence, much less transform, legal practice and doctrine.
Autism, insurance, and the idea: providing a comprehensive legal framework
Holland CD
Can bad science be good evidence? Neuroscience, lie detection, and beyond
Schauer F
Invisible and involuntary: female genital mutilation as a basis for asylum
Harivandi ZE
As the tide turns: the changing HIV/AIDS epidemic and the criminalization of HIV exposure
McArthur JB
Mandatory reassignment under the ADA: the circuit split and need for a socio-political understanding of disability
Dorsey NA
Food, drugs, and droods: a historical consideration of definitions and categories in American food and drug law
Grossman LA
This Article explores the evolution and interaction of the legal and cultural categories "food" and "drug" from the late nineteenth century to the present. The federal statutory definitions of "food" and "drug" have always been ambiguous and plastic, providing the FDA with significant regulatory flexibility. Nevertheless, the agency is not necessarily free to interpret the definitions however it chooses. "Food" and "drug" are not only product classes defined by food and drug law, but also fundamental cultural concepts. This Article demonstrates that the FDA, as well as Congress and the courts, have operated within a constraining cultural matrix that has limited their freedom to impose their preferred understandings of these categories on American society. Nonetheless, history also provides ample evidence that lawmakers possess substantial power to mold the legal categories of "food" and "drug" so as to advance desired policies. One explanation for this regulatory flexibility in the face of deep-seated cultural conceptions is the indeterminate nature of the extralegal notions of "food" and "drug." The terms, as commonly understood, embrace nebulous, overlapping, and constantly evolving realms. Moreover, the relationship between culture and law is not a one-way street with respect to these categories. Although the regulatory apparatus has always had to take into account the extralegal understandings of "food" and "drug," the law in turn has exerted significant influence over their meaning in broader culture.
Drug review "behind the curtain": a response to Professor Struve
O'Reilly JT
Order Without Intellectual Property Law: Open Science in Influenza
Kapczynski A
Today, intellectual property (IP) scholars accept that IP as an approach to information production has serious limits. But what lies beyond IP? A new literature on "intellectual production without IP" (or "IP without IP") has emerged to explore this question, but its examples and explanations have yet to convince skeptics. This Article reorients this new literature via a study of a hard case: a global influenza virus-sharing network that has for decades produced critically important information goods, at significant expense, and in a loose-knit group--all without recourse to IP. I analyze the Network as an example of "open science," a mode of information production that differs strikingly from conventional IP, and yet that successfully produces important scientific goods in response to social need. The theory and example developed here refute the most powerful criticisms of the emerging "IP without IP" literature, and provide a stronger foundation for this important new field. Even where capital costs are high, creation without IP can be reasonably effective in social terms, if it can link sources of funding to reputational and evaluative feedback loops like those that characterize open science. It can also be sustained over time, even by loose-knit groups and where the stakes are high, because organizations and other forms of law can help to stabilize cooperation. I also show that contract law is well suited to modes of information production that rely upon a "supply side" rather than "demand side" model. In its most important instances, "order without IP" is not order without governance, nor order without law. Recognizing this can help us better ground this new field, and better study and support forms of knowledge production that deserve our attention, and that sometimes sustain our very lives.
The Maternal Dilemma
Rimalt N
The Family and Medical Leave Act (FMLA) aims to protect the right to be free from gender-based discrimination in the workplace . . . . By creating an across-the-board, routine employment benefit for all eligible employees, Congress sought to ensure that family-care leave would no longer be stigmatized as an inordinate drain on the workplace caused by female employees, and that employers could not evade leave obligations simply by hiring men. "By setting a minimum standard of family leave for all eligible employees, irrespective of gender, the FMLA attacks the formerly state-sanctioned stereotype that all women are responsible for family caregiving, thereby reducing employers’ incentives to engage in discrimination by basing hiring and promotion decisions on stereotypes."
Asylum at Last?: Matter of A-R-C-G-'S Impact on Domestic Violence Victims Seeking Asylum
Bachmair JK
Assembled Products: The Key to More Effective Competition And Antitrust Oversight in Health Care
Sage WM
This Article argues that recent calls for antitrust enforcement to protect health insurers from hospital and physician consolidation are incomplete. The principal obstacle to effective competition in health care is not that one or the other party has too much bargaining power, but that they have been buying and selling the wrong things. Vigorous antitrust enforcement will benefit health care consumers only if it accounts for the competitive distortions caused by the sector's long history of government regulation. Because of regulation, what pass for products in health care are typically small process steps and isolated components that can be assigned a billing code, even if they do little to help patients. Instead of further entrenching weakly competitive parties engaged in artificial commerce, antitrust enforcers and regulators should work together to promote the sale of fully assembled products and services that can be warranted to consumers for performance and safety. As better products emerge through innovation and market entry, competition may finally succeed at lowering medical costs, increasing access to treatment, and improving quality of care.
Sharing, samples, and generics: an antitrust framework
Carrier MA
Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management programs known as Risk Evaluation and Mitigation Strategies ("REMS"). Pursuant to legislation enacted in 2007, the FDA requires REMS when a drug's risks (such as death or injury) outweigh its rewards. Brands have used this regime, intended to bring drugs to the market, to block generic competition. Regulations such as the federal Hatch-Waxman Act and state substitution laws foster widespread generic competition. But these regimes can only be effectuated through generic entry. And that entry can take place only if a generic can use a brand's sample to show that its product is equivalent. More than 100 generic firms have complained that they have not been able to access needed samples. One study of 40 drugs subject to restricted access programs found that generics' inability to enter cost more than $5 billion a year. Brand firms have contended that antitrust law does not compel them to deal with their competitors and have highlighted concerns related to safety and product liability in justifying their refusals. This Article rebuts these claims. It highlights the importance of samples in the regulatory regime and the FDA's inability to address the issue. It shows how a sharing requirement in this setting is consistent with Supreme Court caselaw. And it demonstrates that the brands' behavior fails the defendant-friendly "no economic sense" test because the conduct literally makes no sense other than by harming generics. Brands' denial of samples offers a textbook case of monopolization. In the universe of pharmaceutical antitrust behavior, other conduct--such as "pay for delay" settlements between brands and generics and "product hopping" from one drug to a slightly modified version--has received the lion's share of attention. But sample denials are overdue for antitrust scrutiny. This Article fills this gap. Given the failure of Congress and the FDA to remedy the issue, antitrust can play a crucial role in ensuring generic access to samples, affirming a linchpin of the pharmaceutical regime.
Visual gut punch: persuasion, emotion, and the constitutional meaning of graphic disclosure
Goodman EP
The ability of government to "nudge" with information mandates, or merely to inform consumers of risks, is circumscribed by First Amendment interests that have been poorly articulated. New graphic cigarette warning labels supplied courts with the first opportunity to assess the informational interests attending novel forms of product disclosures. The D.C. Circuit enjoined them as unconstitutional, compelled by a narrative that the graphic labels converted government from objective informer to ideological persuader, shouting its warning to manipulate consumer decisions. This interpretation will leave little room for graphic disclosure and is already being used to challenge textual disclosure requirements (such as county-of-origin labeling) as unconstitutional. Graphic warning and the increasing reliance on regulation-by-disclosure present new free speech quandaries related to consumer autonomy, state normativity, and speaker liberty. This Article examines the distinct goals of product disclosure requirements and how those goals may serve to vindicate, or to frustrate, listener interests. I argue that many disclosures, and especially warnings, are necessarily both normative and informative, expressing value along with fact. It is not the existence of a norm that raises constitutional concern but rather the insistence on a controversial norm. Turning to the means of disclosure, this Article examines how emotional and graphic communication might change the constitutional calculus. Using autonomy theory and the communications research on speech processing, I conclude that disclosures do not bypass reason simply by reaching for the heart. If large graphic labels are unconstitutional, it will be because of undue burden on the speaker, not because they are emotionally powerful. This Article makes the following distinct contributions to the compelled commercial speech literature: critiques the leading precedent, Zauderer v. Office of Disciplinary Counsel, from a consumer autonomy standpoint; brings to bear empirical communications research on questions of facticity and rationality in emotional and graphic communications; and teases apart and distinguishes among various free speech dangers and contributions of commercial disclosure mandates with a view towards informing policy, law, and research.
Stricken: the Need for Positive Statutory Law to Prevent Discriminatory Peremptory Strikes of Disabled Jurors
Benson J