HealthLawProf Blog

Milk from Mars. The Challenges of Regulating Lab-Produced (Human) Milk

Mathlide Cohen (University of Connecticut), Dr. Tanya Cassidy (Maynooth University), Milk from Mars. The Challenges of Regulating Lab-Produced (Human) Milk, 77 Food & Drug L. J. (2022):

For over a century, pediatricians, scientists, and industry players have sought to create an infant formula that would be as close as possible to human milk. Until recently, their efforts focused on “humanizing” cow’s milk by making its composition more similar to human milk. But in the past few years, new technologies have led some companies to culture mammary cells or yeast in the lab. The resulting lab-produced components have been claimed to be identical to those found in human milk. One goal behind this new technology is to manufacture an infant formula that is more nutritionally adapted for newborns than conventional breastmilk substitutes. What impact might this new lab-produced milk have on infant feeding and regulation? Will it benefit parents and their children or represent a threat for lactation and donor human milk support? Could it precipitate a new regulatory regime for human milk itself? Given the many unknowns in this area, this Article hypothesizes various outcomes, examining their potential costs and benefits. What is certain, however, is that the legal regime eventually accorded to lab-produced milk will shape not only the products on the market, but also who will get access to them and at what cost.

Revisiting Health Care Fraud in the Biden Administration

Joan H. Krause (University of North Carolina at Chapel Hill), Revisiting Health Care Fraud in the Biden Administration, 15 St. Louis J. Health Law & Pol'y 361 (2022):

Although not one of the Biden administration’s initial priorities, health care fraud inevitably will be a major concern. First, the federal government’s response to the COVID-19 pandemic—including the disbursement of more than $175 billion in provider relief funds and the loosening of traditionally strict rules on Medicare reimbursement for telehealth services—has created new opportunities to divert health care funds for fraudulent purposes. Second, President Joseph Biden took office in the midst of the incomplete transition from volume-based to value-based payment in the federal health care programs, which will allow fraud to flourish in the gaps between multiple reimbursement systems. Third, regardless of these developments, prior forms of fraud are likely to continue. Thus, the Biden administration will have no choice but to devote significant resources to fraud enforcement.

Online Public Health Misinformation, and How to Tame It

Ira Rubinstein (New York University), Tomer Kenneth (New York University), Online Public Health Misinformation, and How to Tame It, Harv. J. Legis. (Forthcoming):

The COVID-19 pandemic was shaped by a corollary infodemic: an abundance of public health misinformation (PHM), primarily online. Studies attest to the pervasive effects of online PHM, creating health hazards for individuals and hindering society’s attempts to confront this and other diseases. Troublingly, online PHM is a multidimensional problem. It involves regulation of speech online, content moderation, public health law, First Amendment issues, and intricate questions in epistemology and misinformation studies, amongst others. This Article features a comprehensive discussion of the problems associated with online PHM, points to shortcoming in existing responses, and advances better solutions.

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Preemption & Gender & Racial (In)equity: Why State Tort Law Is Needed in the Cosmetic Context

Marie Boyd (University of South Carolina),  Preemption & Gender & Racial (In)equity: Why State Tort Law Is Needed in the Cosmetic Context, 102 B.U. L. Rev. 1 (2022): 

Much of the legal scholarship on the preemption of state tort law in the food and drug context and beyond has focused on issues of federalism. While the literature has considered the relationship between state tort law and the regulatory system, it has not generally explored the impact the federal preemption of state tort law may have on women and people of color. Similarly, while the literature has grappled with gender and racial justice issues in the tort system, including in the context of tort reform, it has largely not examined the gender and racial equity issues raised by federal preemption. This Article fills this gap by examining how the federal preemption of state tort law may perpetuate and even compound existing racial and gender inequities in the context of cosmetics. It considers how tort law, coupled with appropriate federal regulatory reform, may help lead to safer cosmetics for all.

Warrantying Health Equity

Heather Payne (Seton Hall University), Jennifer D. Oliva (University of California), Warrantying Health Equity, 70 UCLA L. Rev. (Forthcoming):

The United States is experiencing a significant rise in the prevalence of asthma and other debilitating respiratory and cardiovascular ailments that disproportionately burden low income and marginalized Americans. This is due in large measure to climate change, which is responsible for increasingly devastating air quality events—including wildfires and drought—that trigger these serious health conditions. As a result, it is imperative that we begin to explore potential legal and policy reforms that reign in sources of health-impairing air pollution.

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Patient Access to Health Device Data: Toward a Legal Framework

Charles Duan (Cornell University), Christopher Morten (Columbia University), Patient Access to Health Device Data: Toward a Legal Framework, SSRN (2022):

The connected at-home healthcare device industry is booming. Wearable health trackers alone constituted a $21 billion market in 2020, anticipated to grow to $195 billion by 2027. At-home devices now purportedly make it possible to diagnose and monitor health conditions such as sleep apnea, diabetes, and fertility automatically, immediately, and discreetly. By design, these devices produce a wealth of data that can inform patients of their health status and potentially even recommend life-saving actions.

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