Lost in the cacophony surrounding the debate about high drug prices is the fundamental principle that pharmaceutical innovation will not occur without the prospect of outsized returns enabled through market exclusivity. Biopharmaceutical patents are currently under siege, subject to challenge both in inter partes review ("IPR") proceedings and in Hatch-Waxman actions. These twin assaults threaten to eliminate the incentives necessary for biotechnological innovation--particularly for discoveries made upstream in the innovation pipeline--thus imperiling the development of new drug therapies. But a fascinating solution has emerged: invoking tribal immunity to shield pharmaceutical patents from IPR before the Patent Trial and Appeal Board ("PTAB"). This serves two critically important objectives: promoting tribal self-sufficiency, and encouraging investment in life-saving and life-improving new drugs. Contractual partnerships between Native American tribes and pharmaceutical companies not only provide the tribes with a steady stream of royalty revenue, but also insulate biopharmaceutical patents from challenge in IPR proceedings through the invocation of long-established principles of tribal sovereign immunity. This Note is the first piece of scholarship to comprehensively analyze, and advocate for, the right to invoke tribal sovereign immunity in IPR proceedings.

Bacteriophages, or "phages," are a category of highly adept and adaptable viruses that can infect and kill bacteria. With concerns over the burgeoning antibiotic-resistance crisis looming in recent years, scientists and policymakers have expressed a growing interest in developing novel treatments for bacterial infections that utilize bacteriophages. Because of the great expense associated with bringing a new drug to market, patents are usually considered the gold standard for incentivizing research and development in the pharmaceutical field. Absent such strong protection for a developer’s front end investment, pharmaceutical development remains financially risky and unattractive. Unfortunately, recent Supreme Court jurisprudence analyzing patentable subject matter under 35 U.S.C. subsection 101 has cast doubt on whether phage therapeutics would be eligible for strong patent protection. In order for the promise of phage therapeutics to become a reality, alternative protections or incentives are likely necessary. Such a framework would likely include trade secrecy, regulatory exclusivities, research support, alternative payment models, or some combination thereof.

Three widely discussed explanations of the punitive carceral state are racism, harsh drug laws, and prosecutorial overreach. These three narratives, however, only partially explain how our correctional system expanded to its current overcrowded state. Neglected in our discussion of mass incarceration is our largely forgotten history of the long-term, wholesale institutionalization of the disabled. This form of mass detention, motivated by a continuing application of eugenics and persistent class-based discrimination, is an important part of our history of imprisonment, one that has shaped key contours of our current supersized correctional system. Only by fully exploring this forgotten narrative of long-term detention and isolation will policy makers be able to understand, diagnose, and solve the crisis of mass incarceration.

In the United States, women are routinely forced to undergo cesarean sections, episiotomies, and the use of forceps, despite their desire to attempt natural vaginal delivery. Yet, the current American legal system does little to provide redress for women coerced to undergo certain medical procedures during childbirth. Courts and physicians alike are prepared to override a woman's choice of childbirth procedure if they believe this choice poses risks to the fetus, and both give little value to the woman's right to bodily autonomy. This Note proposes a solution for addressing the problem of coerced medical procedures during childbirth by importing a framework created in Venezuela and Argentina that characterizes this issue as "obstetric violence." First, this Note contains an overview of the shortcomings of the existing American legal framework to address the problem. Second, it explains the advantages of the obstetric violence framework and argues that its adoption in the United States would address many of the failures of the existing system. And third, this Note introduces a few legislative and litigation strategies that can be used to implement this framework in the United States and briefly addresses some of the challenges these strategies may pose.

Over the past forty years, the Food and Drug Administration (FDA) has successfully restricted consumers' access to home-testing applications based on the notion that it should protect individuals from their own reactions to test results. In the 1970s, the FDA briefly denied women access to home pregnancy tests that were identical to those used in laboratories. In the late 1980s and early 1990s, it relied on concerns about consumer responses to HIV status results to justify a categorical ban on applications for HIV home-testing technology. More recently, it placed burdensome restrictions on direct-to-consumer (DTC) genetic testing companies, such as 23andMe, based on fears that consumers would make irrational medical decisions after receiving genetic variant results. Although the FDA has the statutory authority to ensure the "safety and effectiveness" of medical devices, it has expansively interpreted the term "safety" to encompass considerations of how consumers might use test results provided by purely informative devices. This Note argues that courts should not give the FDA deference on its broad interpretation of safety" in restricting home-testing devices. It documents the evolution of the expertise-based rationale for judicial deference, noting that courts typically provide scientific agencies, including the FDA, "super deference" because of the complicated nature of their work. Ultimately, courts should not defer to the FDA's interpretation of "safety" because it did not use its scientific expertise when it considered how consumers might react to HIV home-testing and DTC genetic testing results. Further, the FDA should not have the authority to make decisions based on its view of "safety" because it should not have the power to make value judgments for consumers about whether they should seek their personal medical information.

Direct primary care is a promising, market-based alternative to the fee-for-service payment structure that shapes doctor–patient relationships in America. Instead of billing patients and insurers service by service, direct primary care doctors charge their patients a periodic, prenegotiated fee in exchange for providing a wide range of healthcare services and increased availability compared to traditional practices. This “subscription” model is intended to eliminate the administrative burdens associated with insurer interaction, which, in theory, allows doctors to spend more time with their patients and less time doing paperwork. Direct practices have become increasingly popular since Congress passed the Affordable Care Act (ACA). This growth has been driven by legislation in several states that resolves a number of legal questions that slowed the model’s growth and by the ACA’s recognition of the model as a permissible way to cover primary care in "approved" health plans. Yet legal scholars have hardly focused on direct primary care. Given the model’s growth, however, the time is ripe for a more focused legal inquiry. This Note begins that inquiry. After tracing the model’s evolution and its core components, this Note substantively examines the laws in states that regulate direct practices and analyzes how those laws address a number of potential policy concerns. It then analyzes direct primary care’s broader role in the contemporary American healthcare marketplace. Based upon that analysis, this Note concludes that direct primary care is a beneficial innovation that harmonizes well with a cooperative-federalism-based healthcare policy model.

Public health experts agree that sexual violence constitutes a significant public health issue. Yet criminal law dominates rape law almost completely, with public health law playing at best a small supporting role. Recent civil law developments, such as university disciplinary proceedings, similarly fixate on how best to find and penalize perpetrators. As a result, rape law continues to spin its wheels in the same arguments and obstacles. This Article argues that, without broader cultural changes, criminal law faces a double bind: rape laws will either be ineffective or neglect the importance of individual culpability. Public health law provides more promising terrain for rape prevention because it is a strong legal framework that can engage the complex causes of rape, including the social norms that promote sexual aggression. While criminal law can only punish bad behavior, public health interventions can use the more effective prevention strategy of promoting positive behaviors and relationships. They can also address the myriad sexual behaviors and social determinants that increase the risk of rape but are outside the scope of criminal law. Perhaps most importantly, public health law relies on evidence-based interventions and the expertise of public health authorities to ensure that laws and policies are effective. Transforming rape law in this way provides a framework for legal feminism to undertake the unmet challenge of "theorizing yes," that is, moving beyond how to protect women’s right to refuse sex and toward promoting and exploring positive models of sex. Criminal law is simply incapable of meeting this challenge because it concerns only what sex should not be. A public health framework can give the law a richer role in addressing the full spectrum of sexual attitudes and behaviors.

The news has been peppered with tragic stories of individuals with disabilities who have been killed or injured following police encounters. In the aftermath of these incidents, as injured parties seek accountability, a question looms: Can arrest proceedings violate the Americans with Disabilities Act? The ADA was enacted to prohibit disability discrimination. The law had an ambitious agenda, supported by broad statutory authority, to ensure equality in all areas of public life for individuals with disabilities. But while the ADA has fostered integration into many aspects of modern life, one area remains deeply contested: arrests. If Congress envisioned that Americans with disabilities would enjoy lives free from discrimination, excluding arrests from ADA coverage undermines the law’s broad promise of protection. In 2015, a Supreme Court opinion raised but failed to resolve this very issue, leaving an important question unanswered. This Note examines whether arrest proceedings must comply with the ADA and argues that they should. It then proposes comprehensive disability training as a tool to aid ADA compliance and avoid discriminatory arrest proceedings.

Clinical research faces a reproducibility crisis. Many recent clinical and preclinical studies appear to be irreproducible--their results cannot be verified by outside researchers. This is problematic for not only scientific reasons but also legal ones: patents grounded in irreproducible research appear to fail their constitutional bargain of property rights in exchange for working disclosures of inventions. The culprit is likely patent law’s doctrine of enablement. Although the doctrine requires patents to enable others to make and use their claimed inventions, current difficulties in applying the doctrine hamper or even actively dissuade reproducible data in patents. This Article assesses the difficulties in reconciling these basic goals of scientific research and patent law. More concretely, it provides several examples of irreproducibility in patents on blockbuster drugs--Prempro, Xigris, Plavix, and Avastin--and discusses some of the social costs of the misalignment between good clinical practice and patent doctrine. Ultimately, this analysis illuminates several current debates concerning innovation policy. It strongly suggests that a proper conception of enablement should take into account after-arising evidence. It also sheds light on the true purpose--and limits--of patent disclosure. And lastly, it untangles the doctrines of enablement and utility.

The physician-patient relationship rests on a bedrock of trust. Without trust, patients--and for that matter, physicians--are less willing to divulge information critical to providing accurate medical diagnoses and treatments. The state of Florida seemingly ignored this when its legislature, with support from the National Rifle Association and other pro-gun advocates, enacted the Firearm Owners Privacy Act (FOPA), a statute that restricts physicians from questioning their patients about firearm ownership. In Wollschlaeger v. Governor of Florida, the United States Court of Appeals for the Eleventh Circuit held that FOPA did not regulate physician speech but, instead, regulated physician conduct. As such, the law was exempted from First Amendment scrutiny. But almost one year to the day after publishing its first Wollschlaeger opinion, the Eleventh Circuit sua sponte vacated its original opinion and substituted in its place a brand new opinion--one holding that FOPA was subject to First Amendment scrutiny, but nonetheless passed constitutional muster. This Note uses the diverging Wollschlaeger opinions as a vehicle to analyze the First Amendment's coverage and protection of physician speech. Specifically, it argues that an uninhibited line of communication is required to protect the trust necessary for an effective physician-patient relationship. This logical underpinning leads to the conclusion that the First Amendment presumptively covers physician speech and, furthermore, that physician speech should be subject to intermediate scrutiny--a level of scrutiny that FOPA cannot meet.

Children have a constitutional right to bodily integrity. Courts do not hesitate to vindicate that right when children are abused by state actors. Moreover, in at least some cases, a child's right to bodily integrity applies within the family, giving the child the right to avoid unwanted physical intrusions regardless of the parents' wishes. Nonetheless, the scope of this right vis-à-vis the parents is unclear; the extent to which it applies beyond the narrow context of abortion and contraception has been almost entirely unexplored and untheorized. This Article is the first in the legal literature to analyze the constitutional right of minors to bodily integrity within the family by spanning traditionally disparate doctrinal categories such as abortion rights; corporal punishment; medical decisionmaking; and nontherapeutic physical interventions such as tattooing, piercing, and circumcision. However, the constitutional right of minors to bodily integrity raises complex philosophical questions concerning the proper relationship between family and state, as well as difficult doctrinal and theoretical issues concerning the ever-murky idea of state action. This Article canvasses those issues with the ultimate goal of delineating a constitutional right of bodily security and autonomy for children.

The Americans with Disabilities Act explicitly excludes "compulsive gambling" from its definition of disability, thus denying gambling addicts protection from employer discrimination based on their disorder. Since the enactment of the ADA, however, scientific understandings of gambling disorder have evolved to view the condition as an addiction, rather than as a compulsion or impulse-control disorder. This move is mirrored in the DSM-5's reclassification of gambling disorder under the category of "substance-related and other addictive disorders." This Note contends that gambling disorder would qualify as a "disability" under the ADA, were it not for the disorder's current statutory exclusion. This Note therefore recommends that the ADA be amended to bring gambling disorder within its coverage. Such a change would not only reflect recent developments in the field of addiction psychology, but would also further the ADA's underlying purpose--to protect individuals with disabilities from workplace discrimination.

For more than a quarter century, public discourse has pushed the nuclear-power industry in the direction of heavier regulation and greater scrutiny, effectively halting construction of new reactors. By focusing on contemporary fear of significant accidents, such discourse begs the question of what the nation's court system would actually do should a major nuclear incident cause radiation-induced cancers. Congress's attempt to answer that question is the Price-Anderson Act, a broad statute addressing claims by the victims of a major nuclear accident. Lower courts interpreting the Act have repeatedly encountered a major stumbling block: it declares that judges must apply the antediluvian preponderance-of-the-evidence logic of state tort law, even though radiation science insists that the causes of radiation-induced cancers are more complex. After a major nuclear accident, the Act's paradoxically outdated rules for adjudicating "causation" would make post-incident compensation unworkable. This Note urges that nuclear-power-plant liability should not turn on eighteenth-century tort law. Drawing on modern scientific conclusions regarding the invariably "statistical" nature of cancer, this Note suggests a unitary federal standard for the Price-Anderson Act--that a defendant be deemed to have "caused" a plaintiff's injury in direct proportion to the increased risk of harm the defendant has imposed. This "proportional liability" rule would not only fairly evaluate the costs borne by injured plaintiffs and protect a reawakening nuclear industry from the prospect of bank-breaking litigation, but would prove workable with only minor changes to the Price-Anderson Act's standards of "injury" and "fault."

Choice can be an extraordinary benefit or an immense burden. In some contexts, people choose not to choose, or would do so if they were asked. In part because of limitations of "bandwidth," and in part because of awareness of their own lack of information and potential biases, people sometimes want other people to choose for them. For example, many people prefer not to make choices about their health or retirement plans; they want to delegate those choices to a private or public institution that they trust (and may well be willing to pay a considerable amount to those who are willing to accept such delegations). This point suggests that however well accepted, the line between active choosing and paternalism is often illusory. When private or public institutions override people's desire not to choose and insist on active choosing, they may well be behaving paternalistically, through a form of choice-requiring paternalism. Active choosing can be seen as a form of libertarian paternalism, and a frequently attractive one, if people are permitted to opt out of choosing in favor of a default (and in that sense permitted not to choose); it is a form of nonlibertarian paternalism insofar as people are required to choose. For both ordinary people and private or public institutions, the ultimate judgment in favor of active choosing, or in favor of choosing not to choose, depends largely on the costs of decisions and the costs of errors.

The pharmaceutical industry relies on innovation. However, many innovative firms are cutting their research and development investments and seeing their new product pipelines dry up, due in part to a lack of sufficient patent protection. This Note identifies two major factors that have caused this inadequacy in patent protection. First, pharmaceutical patents are challenged early and often by generic manufacturers, as encouraged by the 1984 Hatch-Waxman Act. Second, the scope of pharmaceutical-patents is sometimes unduly restrained due to limited application of the doctrine of equivalents. Consequently, pharmaceutical patents, especially drug-product patents, are easily designed around and cannot offer the protection necessary for innovative firms to recoup their developmental costs. This Note argues for a wider application of means-plus-function clauses in pharmaceutical patents as a potential cure for this problem. Means-plus-function claims, although authorized by Congress in the 1952 Patent Act, have not been explored much in the pharmaceutical context. This Note argues that this claiming strategy is not only appropriate but also particularly effective for pharmaceutical patents. Means-plus-function claims would give drug-product patents adequate scope even with the limited use of the doctrine of equivalents and thus would provide the protection necessary for innovative firms to withstand frequent attacks by generic manufacturers. Finally, this Note examines issues anticipated with applying means-plus-function claims to pharmaceutical patents and proposes possible solutions.

Concerns about the alleged harmful effects of gene patents--including hindered research and innovation and impeded patient access to high-quality genetic diagnostic tests--have resulted in overreactions from the public and throughout the legal profession. These overreactions are exemplified by Association for Molecular Pathology v. U.S. Patent and Trademark Office, a 2010 case in the Southern District of New York that held that isolated DNA is unpatentable subject matter under 35 U.S.C. § 101. The problem with these responses is that they fail to adequately consider the role that gene patents and patents on similar biomolecules play in facilitating investment in the costly and risky developmental processes required to transform the underlying inventions into marketable products. Accordingly, a more precisely refined solution is advisable. This Note proposes a narrowly tailored set of solutions to address the concerns about gene patents without destroying the incentives for companies to create and commercialize inventions derived from these and similar patents.

Professional cycling has suffered from a number of doping scandals. The sport's governing bodies have responded by implementing an aggressive new antidoping program known as the biological passport. Cycling's biological passport marks a departure from traditional antidoping efforts, which have focused on directly detecting prohibited substances in a cyclist's system. Instead, the biological passport tracks biological variables in a cyclist's blood and urine over time, monitoring for fluctuations that are thought to indirectly reveal the effects of doping. Although this method of indirect detection is promising, it also raises serious legal and scientific concerns. Since its introduction, the cycling community has debated the reliability of indirect biological-passport evidence and the clarity, consistency, and transparency of its use in proving doping violations. Such uncertainty undermines the legitimacy of finding cyclists guilty of doping based on this indirect evidence alone. Antidoping authorities should address these important concerns before continuing to pursue doping sanctions against cyclists solely on the basis of their biological passports.

Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.

In this Essay, we examine a case in which the organizational and logistical demands of a novel form of organ exchange (the nonsimultaneous, extended, altruistic donor (NEAD) chain) do not map cleanly onto standard cultural schemas for either market or gift exchange, resulting in sociological ambiguity and legal uncertainty. In some ways, a NEAD chain resembles a form of generalized exchange, an ancient and widespread instance of the norm of reciprocity that can be thought of simply as the obligation to “pay it forward” rather than the obligation to reciprocate directly with the original giver. At the same time, a NEAD chain resembles a string of promises and commitments to deliver something in exchange for some valuable consideration--that is, a series of contracts. Neither of these salient "social imaginaries" of exchange--gift giving or formal contract--perfectly meets the practical demands of the NEAD system. As a result, neither contract nor generalized exchange drives the practice of NEAD chains. Rather, the majority of actual exchanges still resemble a simpler form of exchange: direct, simultaneous exchange between parties with no time delay or opportunity to back out. If NEAD chains are to reach their full promise for large-scale, nonsimultaneous organ transfer, legal uncertainties and sociological ambiguities must be finessed, both in the practices of the coordinating agencies and in the minds of NEAD-chain participants. This might happen either through the further elaboration of gift-like language and practices, or through a creative use of the cultural form and motivational vocabulary, but not necessarily the legal and institutional machinery, of contract.

Pursuant to federal statutes and to laws in all fifty states, the United States government has assembled a database containing the DNA profiles of over eleven million citizens. Without judicial authorization, the government searches each of these profiles one-hundred thousand times every day, seeking to link database subjects to crimes they are not suspected of committing. Yet, courts and scholars that have addressed DNA databasing have focused their attention almost exclusively on the constitutionality of the government's seizure of the biological samples from which the profiles are generated. This Note fills a gap in the scholarship by examining the Fourth Amendment problems that arise when the government searches its vast DNA database. This Note argues that each attempt to match two DNA profiles constitutes a Fourth Amendment search because each attempted match infringes upon database subjects' expectations of privacy in their biological relationships and physical movements. The Note further argues that database searches are unreasonable as they are currently conducted, and it suggests an adaptation of computer-search procedures to remedy the constitutional deficiency.

One of the most controversial administrative actions in recent years is the U.S. Department of Education's campaign against sexual assault on college campuses. Using its authority under Title IX of the Education Amendments of 1972 (mandating nondiscrimination on the basis of sex in all educational programs and activities receiving federal funds), the Department's Office for Civil Rights (OCR) has launched an enforcement effort that critics denounce as aggressive, manipulative, and corrosive of individual liberties. Missing from the commentary is a historically informed understanding of why this administrative campaign unfolded as it did. This Article offers crucial context by reminding readers that freedom from sexual violence was once celebrated as a national civil right--upon the enactment of the Violence Against Women Act of 1994--but then lost that status in a 5-4 decision by the U.S. Supreme Court. OCR's recent campaign reflects a legal and political landscape in which at least some potential victims of sexual violence had come to feel rightfully connected to the institutions of the federal government, and then became righteously outraged by the endurance of such violence in their communities. OCR's campaign also reflects the unique role of federal administrative agencies in this landscape. Thanks to the power of the purse and the conditions that Congress has attached to funding streams, agencies enjoy a powerful form of jurisdiction over particular spaces and institutions. Attempts to harness this jurisdiction in service of aspirational rights claims should not surprise us; indeed, we should expect such efforts to continue. Building on this insight, the Article concludes with a research agenda for other scholars seeking to understand and evaluate OCR’s handiwork.