Duke Law Journal最新文献

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 consumerswould 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 Noteargues 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 expertisewhen 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–patientrelationships 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’srecognition 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 instates 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 moreeffective 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 legalfeminism 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.