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The Marketplace of Ideas is in Chaos. Chaos Theory Would Like a Word
Full text linkThe marketplace of ideas is the Supreme Court’s dominant tool for rationalizing expansive First Amendment safeguards. The model, however, is fundamentally flawed. Enlightenment-based assumptions about truth and human rationality that justices installed into the theory’s foundations have been criticized by scholars and, in the era of powerful algorithms and generative AI, are becoming even more suspect. The space is in a state of chaos. Perhaps chaos theory can help. The theory provides a lens through which to revise marketplace theory and therefore re-examine First Amendment free-expression rationales. Chaos theory identifies that Enlightenment-era positivistic, reductionist thinking fails to account for variables and does not allow for linear outcomes. A chaos-infused marketplace accounts for human diversity and revises truth assumptions
Public Health Product Hops
Full text linkPharmaceutical product hops are anticompetitive maneuvers that often represent a last-ditch effort by brand manufacturers to preserve market share in the face of generic competition. An integral part of product life cycle management strategies, product hops may offer marginal benefits to patients but can substantially increase costs to payers and patients alike. Yet industry advocates maintain that this is essential follow-on research and development, resulting in the development of novel products that would otherwise never reach the market.
Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they furthered important public health interests? Sometimes product hops arise due to safety concerns raised by FDA or pressure from other public health agencies. For instance, a push from Congress and the EPA to remove chlorofluorocarbons from all consumer and industrial products resulted in a switch from chlorofluorocarbon to hydrofluoroalkane propellants in respiratory inhalers. In another instance, concerns about the opioid crisis fueled the development of abuse-deterrent formulations of opioids as part of a public health response to the crisis. Despite the public health motivations driving each scenario, I find that some public benefit may have been achieved, but at substantial expense to both payers and patients.
I explore the potential benefits of a “public health product hop” in more detail using the recent push to approve over-the-counter versions of intranasal naloxone as a case study. I develop a framework for rewarding product hops that provide a meaningful and quantifiable public health benefit. In these instances, I argue for time-limited patent incentives that more equitably reward manufacturers for advancing important public health-goals while ending regulatory incentives for purely profit-driven product hops
Upholding Longstanding Prohibitions on Firearm Possession Under Bruen
Full text linkThe Supreme Court’s decision in New York State Rifle & Pistol Association, Inc. v. Bruen has cast doubt on the constitutionality of federal firearms possession laws, such as the prohibition on felons possessing guns. This piece examines how one federal district court upheld a federal restriction on felon gun possession in the recent wake of the Bruen decision. In this article, Mitchell Gordon especially focuses on the historical facts and analysis that are now required under Bruen in order to uphold a governmental restriction on Second Amendment rights.https://scholarship.law.slu.edu/lawjournalonline/1117/thumbnail.jp
The Supreme Court, Question-Selection, Legitimacy, and Reform: Three Theorems and One Suggestion
Full text linkInefficacy of the Transparency in Coverage Final Rule in Promoting Cost-Effective Choices
Full text linkThe Transparency in Coverage Final Rule requires health plans to provide beneficiaries with financial information such as estimates of their personalized cost-sharing liabilities for items and services offered by different providers, the plan’s negotiated in-network rates with these providers, and the plan’s allowed out-of-network amounts. The Final Rule is designed to enhance consumers’ access to pricing information under their health plan so they have the ability to make well-informed and cost-effective decisions regarding their health care. However, empirical evidence suggests that the Final Rule will not effectuate its intended purpose. Many consumers lack the high level of health insurance comprehension required to interpret and understand this information, and an overabundance of technical information provided to consumers overcrowds their decision environment, resulting in consumers feeling overwhelmed with their choice set. Together, a lack of health insurance comprehension and an overcrowded decision environment lead to information overload among consumers, preventing them from using this financial information to make cost-effective health care choices. To carry out the Final Rule’s intended purpose, the rule should be interpreted to require health plans to format this pricing information using symbolic designations and standardized graphics as well as to provide personalized assistance to consumers upon disclosure. This formatting and personalized assistance will mitigate the effects of information overload and empower consumers to use this financial information to make cost-conscious health care decisions
Prioritizing Patients or Impropriety?: Why the 8th Circuit’s Cairns Decision sets a Dangerous Precedent Jeopardizing Patient Protection and Government Investment in Federal Programs
Full text linkIn July 2022, the 8th Circuit established a stricter causation standard for plaintiffs alleging a False Claims Act claim through a violation of the Anti-Kickback Statute in United States ex rel. Cairns v. D.S. Medical LLC. The requirement that a plaintiff demonstrate but-for causation stands in stark contrast to the 3rd Circuit’s “at least one claim standard.” In this article, Nicole Beachboard addresses how the 8th Circuit’s decision enforces an onerous burden on the plaintiff, undermines statutory authority, and facilitates defendant misconduct.https://scholarship.law.slu.edu/lawjournalonline/1115/thumbnail.jp