Juvenile Pariahs

Amy E. Halbrook

Volume 65, Issue 1, 1-56

Under federal and some state laws, juveniles who have been adjudicated delinquent for sex offenses can be required to register on sex offender registries for extended periods or life. In some jurisdictions, lifetime sex offender registration, community notification, and other sex offender restrictions are mandatory.This Article explores whether mandatory lifetime sex offender registration, community notification and other sex offender restrictions violate the Eighth Amendment’s guarantee against cruel and unusual punishment as applied to juveniles. Citing Roper v. Simmons and Graham v. Florida, the United States Supreme Court recently held in Miller v. Alabama that assigning mandatory life-without-parole prison sentences to juveniles violates the Eighth Amendment because a judge must be allowed to consider mitigating circumstances—including a juvenile’s lack of maturity, vulnerability to negative influences, and capacity for change—before imposing a lifetime penalty. With Miller, and before that Graham, the Court extended the definition of the “most severe” punishments to include permanent non-capital punishments applied to juveniles. This reasoning should be applied to mandatory lifetime sex offender registration and related restrictions as applied to juveniles because they are similarly punitive and permanent penalties.

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Captive Markets

Leah A. Plunkett

Volume 65, Issue 1, 57-112

Modern county jails have increasingly adopted policies to bill their inmates for some or all of the costs of their room and board. Statutes authorizing counties to implement these “pay-to-stay” programs are on the books in roughly seventy percent of states, yet the financial mechanism on which these programs typically rely is not well understood. Although the pay-to-stay obligation bears some resemblance to familiar citizen-state financial transactions—such as fines and penalties, restitution, taxes, and fees—it usually belongs to a distinct model that this Article calls the “government-imposed loan.” This Article provides an overview of the landscape of pay-to-stay programs and an articulation of the imposed loan model. The Article also assesses the normative desirability of the imposed loan model, focusing primarily on pay-to-stay programs.The imposed loan structure raises concerns in two primary areas: citizen privacy and governmental services. This model requires citizen-borrowers to disclose personal financial information—some of it with a dubious substantive link to the underlying issue for which a given service was provided—to the government on a long-term basis. It also creates some disincentive for these borrowers to work, thus increasing the likelihood that they will consume governmental services in addition to the one for which the loan was imposed. On balance, it does not appear that the familiar structure of a consumer loan translates well for use in captive markets, such as jail housing or emergency services, where citizens essentially have no choice but to consume services provided by the government through its police powers.

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The Antitrust Implications of Filing “Sham” Citizen Petitions with the FDA

Matthew Avery, William Newsom, and Brian Hahn

Voluem 65, Issue 1, 113-152

The First Amendment protects the right of all citizens to petition the government. The Food and Drug Administration (the “FDA”) has provided a means by which citizens or interested entities can voice their concerns to the FDA by filing a so-called “citizen petition.” However, some brand-name pharmaceutical companies have abused this process by filing baseless petitions with the FDA in an effort to delay generic competition. Such anticompetitive activity is generally protected by the Noerr- Pennington doctrine, which grants antitrust immunity to activity that involves petitioning the government for redress. However, the immunity does not apply to “sham” petitions, the main objective of which is to cause anticompetitive harm through the process, rather than the outcome, of a petition. The citizen petition process has provided a number of examples of likely sham petitions, resulting in delayed generic entry into the market. In some cases, such delay has resulted in billions of dollars in extra profits for brand-name manufacturers submitting “sham” petitions, at the expense of consumers and generic manufacturers.This Article analyzes recent cases in which plaintiffs allege that the citizen petitions aim to delay generic entry, and suggests precautions that practitioners can take in such lawsuits. It proposes a variety of changes to FDA regulations, as well as additions to judicial doctrines, to curb the problems caused by sham petitions. It also serves as a guide to brand-name manufacturers who wish to avoid liability under the “sham” exception. These proposals may become more relevant as the rate of filing citizen petitions grows and more generic drug applications accrue in the FDA’s backlog.

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Evaluating Flexibility in International Patent Law

Sarah R. Wasserman Rajec

Volume 65, Issue 1, 153-211

Global patent law has raced toward harmonization over the past decades. Countries with vastly different industries, values, and levels of development now offer robust patent rights with similar contours through membership in the World Trade Organization and consequent adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”). However, patent law is still far from harmonized among countries or static within countries. Jurisdictions tailor their patent laws to accommodate differences between industries, unforeseen inefficiencies, and diverse views of the costs and benefits associated with offering patent rights to stimulate innovation. Prior scholarly work consists of either doctrinal analyses of relevant governing treaties or utilitarian analyses of the measures’ consistency with an “ideal” level of patent protection. The first perspective sidesteps normative questions by assuming the balance between harmonization and flexibility embodied in TRIPS and provides little guidance for cases in which TRIPS compliance is unclear. The second adopts assumptions that either impose foreign preferences or tacitly accept local preferences embodied in the measure. Any conclusion thus over-privileges background preferences and predetermines a normative conclusion.This Article puts forth a framework for evaluation of a tailoring measure based on whether it meets the justifications for allowing flexibility while accounting for the concerns that favor uniformity and harmonization. The proposed framework looks to the implementing institution and the adequacy of the stakeholder representation to determine the desirability, from a global perspective, of a given mechanism. Rather than offering a strict formula, I suggest that honoring diversity among regimes requires acceptance of measures that are open to criticism from consequentialists but does not preclude critical analysis of the means of development or implementation. Such an analysis allows for a productive evaluation of tailoring measures that honors differences among jurisdictions while properly accounting for the justifications underlying harmonization.

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From Sex for Pleasure to Sex for Parenthood: How the Law Manufactures Mothers

Beth A. Burkstrand-Reid

Volume 65, Issue 1, 211-259

In Sargon Enterprises, Inc. v. University of Southern California, the California Supreme Court decided arguably the most important expert testimony decision that it has rendered in at least two decades. Prior to Sargon, California appeared steadfastly committed to the classic “general acceptance” test, which required judges to assess whether an expert’s theory or technique had gained general acceptance in the relevant fields. In 1993, in Daubert v. Merrell Dow Pharmaceuticals, Inc., the United States Supreme Court announced a new empirical validation test. In the years since 1993, most state courts adopted some version of Daubert, but until Sargon the California Supreme Court had refused to follow the federal lead.Sargon undoubtedly moves California jurisprudence toward the Daubert approach. In Sargon, the court adopted the fundamental perspective of Daubert and embraced key terminology from the Daubert opinion and its progeny. These parallels have prompted some commentators to declare that California is now in the Daubert camp.Although Sargon is a step toward the Daubert approach, it is premature to conclude that Sargon goes that far for at least two reasons. First, even post-Sargon, the California approach may be laxer than the federal approach. In Daubert, Justice Blackmun stated that Federal Rule of Evidence 104(a) governs the trial judge’s admissibility decision, which mandates that the judge probe deeply into the bases for the expert’s opinion, even including assessing credibility. Sargon stops short of explicitly going that far. Second, the California approach may prove to be more demanding than the federal approach. In a footnote, Sargon indicates that the Frye test is still good law in California. If so, then some proponents may face the daunting task of surmounting both hurdles to admissibility.

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Note – The True Man & The Battered Woman: Prospects for Gender Neutral Narratives in Self-Defense Doctrines

Katelyn E. Keegan

Volume 65, Issue 1, 259-283

The recent rise of controversial Stand Your Ground laws has sparked discussions on self-defense law. Comparing the new Stand Your Ground laws with another self- defense doctrine—Battered Women’s Syndrome—it becomes apparent that the law solidifies gender stereotypes by assessing when an individual is justified in using deadly force against an aggressor. “True men” are empowered to use deadly force in public without a duty to retreat, while a battered woman often must provide expert testimony on her psychological condition to prove the reasonableness of her use of deadly force in light of her severe helplessness. At their extremes, both of these doctrines are detrimental to the criminal law and potentially encourage dangerous policy and undesirable public conduct.This Note argues that legal reforms should moderate these extremes and create a more gender-neutral process for proving self-defense claims no matter the theory. While the psychology of juror decisionmaking and the public’s familiarity with the classic narratives likely limit prospects for reform, change is necessary to modernize and equalize self-defense law. Ideally, a new legal framework of individualization for proving self-defense claims can find the middle ground between the empowerment doctrine of true men and the helplessness ideology behind Battered Women’s Syndrome, and will allow the jury to listen to each defendant’s narrative regardless of whether it falls under the traditional paradigm.

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Note – Internalizing the External Costs of Medical Device Preemption

David Chang

Volume 65, Issue 1, 283-309

Medical device preemption is highly controversial because it provides medical device companies with immunity from state tort claims. Congress provided medical device companies with preemption in 1976 because it was concerned that medical device companies were being overwhelmed by the costs of litigation. Congress feared that this was destroying the incentive for medical device companies to develop risky but innovative life-saving devices.Today, the dark side of medical device preemption has come to light. Medical device preemption fails to require medical device companies to account for harms that their products create for society. Medical device companies have been able to externalize the harms caused by their defective products. Many patients harmed by medical devices have been denied the opportunity to sue for redress. Further, medical device companies have been shielded from picking up the costs of their defective products. As a result, American taxpayers have been unfairly forced to pick up the tab.This Note argues that the United States government should force medical device companies to internalize some of the harms created by their products by creating a National Medical Device Injury Compensation Program modeled after the National Vaccine Injury Compensation Program. The government should also create a National Medical Device Insurance Fund. These two programs would force medical device companies to internalize some of the costs of their defective medical devices and provide a remedy for patients harmed by medical devices. Further, these solutions would preserve the life-saving benefits of medical device innovation.

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