Health Law and Policy Commons^™

A New Framework For Drug Pricing Law And Policy, Rachel E. Sachs

Indiana Law Journal

Scholars and policymakers have expressed concern about the impact of high prescription drug costs on patients and healthcare budgets. This Article presents a new theoretical framework for evaluating both the problem to be addressed by drug pricing reforms as well as the efficacy of potential solutions. In seeking to solve “the drug pricing problem,” our legal system has given primacy to competition rather than regulation to drive down drug prices. This Article disaggregates the broader concept of drug competition into four steps, each of which must be addressed and each of which elevates different institutional actors to key roles. In …

When Death Is Not Binary, Teneille R. Brown

Indiana Law Journal

There are few dichotomies more recognized than the one between life and death. Given the many legal rights that pivot on this distinction, one would think that the law has exceptionally clear standards for diagnosing death. It may surprise you then to learn that the line between legal life and death is no longer so obvious. That is, in a growing number of cases, there is now disagreement about whether someone is legally dead or alive. This is due to two things: the development of medical devices that can breathe for patients with severe brain injuries, and neuroimaging technology that …

True Man, Captive Mother: Abortion As A Fundamental Self-Defense Right, Nicholle Vandy

Indiana Journal of Law and Social Equality

Abortion healthcare has faced significant challenges since the Supreme Court held in Dobbs v. Jackson Women’s Health Organization that there exists no constitutional right to abortion. Contrastingly, the right to bear arms, grounded in the right to self-defense, has strong constitutional protections, as highlighted in New York State Rifle & Pistol Association v. Bruen. The extension of the right to self-defense is exemplified by the proliferation of Stand Your Ground laws in numerous states.

This Comment examines the growing tension between self-defense doctrine, particularly through Stand Your Ground laws, and the increasing criminalization of abortion in various states. It …

The Law’S Failure To Protect Our Drinking Water From Pfas, Emily Levine

Indiana Law Journal

How did per- and polyfluoroalkyl substances (PFAS), the forever chemicals known to harm human health and appear in most Americans’ blood, spread so widely in drinking water? Why didn’t someone with the power and knowledge to stop this crisis step in sooner? Simply imposing limits on PFAS levels in public water systems is the bare minimum to protect American drinking water—a necessary step but only the starting point of a long path toward creating a regulatory framework that can withstand the whims of changing presidential administrations and political influences.

     It is too easy for the EPA Administrator, either out of …

Fred H. Cate Appointed To 23andme Research Institute Privacy Advisory Board, Maurer School Of Law - Indiana University

Keep Up With the Latest News from the Law School (blog)

Indiana University Maurer School of Law Distinguished Professor Fred H. Cate, one of the nation’s foremost authorities on information privacy and security law, has been appointed as an inaugural member to the newly formed Privacy Advisory Board of the 23andMe Research Institute, a leading nonprofit medical research organization focused on advancing genetic and health discoveries.

The appointment cements the Law School’s position as a global leader at the intersection of law, data governance, and privacy.

Vandy Earns Top Prize In Auwcl National Health Law Writing Competition, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

Nicholle Vandy, a rising 3L from Knox, Ind., has become the first Indiana University Maurer School of Law student to earn top honors at the American University Washington College of Law National Health Writing Competition.

Vandy’s paper, “True Man, Captive Mother: Abortion as a Fundamental Self-Defense Right,” was named the winning entry of the 10th annual competition, which encourages law students from across the country to write scholarly papers on current topics of interest relevant to health, food, and/or drug law.

Regulating Healthcare Coverage Algorithms, Jennifer D. Oliva

Indiana Law Journal

American healthcare facilities and providers increasingly rely on algorithmic tools to support clinical decision-making, standards of care, and institutional practices related to patient diagnosis and treatment. This development has been characterized as both “promising” and “peril[ous].” Healthcare algorithms are intended to improve and standardize healthcare decision-making, but they also are capable of exacerbating bias and discrimination and, thus, contributing to the delivery of inequitable care for already disadvantaged groups.

The Chemical Straightjacket: Institutional Over-Use Of Psychotropic Drugs On Children In Lieu Of Therapeutic Community Mental Health Services, Marisa Leib-Neri

Indiana Journal of Law and Social Equality

This Article argues that the abysmal state of children’s mental health in America is in part due to an overreliance on and over prescription of psychotropic drugs inside psychiatric residential institutions in lieu of community based mental health services. This overreliance on residential institutions and psychotropic drugs has allowed a new form of chemical restraint to flourish—the chemical straitjacket. This Article uses the medication lists of twelve children in seven different North Carolina psychiatric residential treatment facilities to demonstrate how the chemical straitjacket operates: the prescription of drugs not approved for pediatric populations, counter to evidence-based practices for particular diagnoses, …

A Bloody Mess: Why Blood Plasma Donation Centers Are Not Public Accommodations Subject To Title Iii Of The Americans With Disabilities Act, Kevin D. Marshall

Indiana Journal of Law and Social Equality

No abstract provided.

Prescribing A Balance: Sustaining Environmental Health With Pharmaceutical Interest In Puerto Rico, Derek Warzel

Indiana Law Journal

Puerto Rico, often referred to as the “Medical Cabinet of the U.S.A.,” is a hub for pharmaceutical manufacturing, contributing significantly to the American medical supply chain and Puerto Rico’s economy. However, decades of industrial activity, compounded by climate events like Hurricane Maria, have led to severe environmental damage, particularly through groundwater contamination and damaged Superfund sites. This Note examines the historical intersection of economic incentives and environmental neglect in Puerto Rico, focusing on the pharmaceutical industry’s impact. By critically analyzing the Superfund program and proposing reforms, this Note advocates for a balanced approach: introducing proactive environmental protections and financial incentives …

Oliva Elected To American Law Institute, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

Jenn Oliva, Professor of Law and Val Nolan Faculty Fellow, has been elected to the American Law Institute, the organization announced yesterday (Oct. 4).

She becomes the 18th member of the Indiana University Maurer School of Law faculty to earn the prestigious recognition.

“This is a tremendous honor for Professor Oliva and we are proud to have her on our faculty,” said Indiana Law Dean Christiana Ochoa, who holds an ex officio role with the ALI. “Since Jenn joined us in 2023 she’s quickly become an invaluable member of the Maurer community and we’re thrilled to see her recognized.”

Legal, Policy, And Environmental Scholars Discuss Global Food Systems At Indiana Law Symposium, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

The Indiana University Maurer School of Law and its Indiana Journal of Global Legal Studies are hosting scholars from around the country Friday and Saturday (Jan. 19-20) for an interdisciplinary discussion on one of the world’s most prevalent problems—food insecurity.

Data from the World Bank estimate more than 780 million people around the world suffered from chronic hunger in 2022. As climate change affects agricultural production and water accessibility, the problem could worsen in coming years.

“A Fragile Framework: How Global Food Systems Intersect with the International Legal Order, the Environment, and the World’s Populations” will bring together legal, policy, …

Medical Research Without Consent? It's Like Deja Vu All Over Again, Lois Shepherd, Donna Chen

Indiana Law Journal

When patients seek medical care, they trust their physician to offer treatments that are in their best medical interests and to engage them in a shared decision-making process to determine the best way forward. But today, in hospitals and doctors’ offices around the country, physicians also place patients in research studies that randomly assign them to a standard of care treatment, sometimes without the patients’ knowledge or consent. In such studies, patients may receive a treatment that results in worse outcomes for them, some of which can be serious and permanent. What’s more, there are reasons to be concerned that …

The Federal Pregnant Workers Fairness Act: Statutory Requirements, Regulations, And Need (Especially In Post-Dobbs America), Deborah Widiss

Articles by Maurer Faculty

The federal Pregnant Workers Fairness Act, enacted in December 2022, is landmark legislation that will help ensure workers can stay healthy through a pregnancy. It responds to the reality that pregnant workers may need small changes at work, such as permission to sit periodically, carry a water bottle, relief from heavy lifting, or reduced exposure to potentially dangerous chemicals. Workers may also need schedule modifications or leave for prenatal appointments, childbirth, or post-partum recovery, or accommodations to address medical conditions related to pregnancy or childbirth.

Previously, federal sex discrimination law and federal disability law sometimes required employers to provide such …

Meet Our New Faculty: Jenn Oliva, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

Professor Jenn Oliva joined Indiana Law earlier this summer as a professor of law and as Val Nolan Faculty Fellow. Prior to joining the IU Maurer Law faculty, Professor Oliva served as Professor of Law and Co-Director of the UCSF/UC Law Consortium on Law, Science & Health Policy at the University of California College of Law, San Francisco. She has also served as Associate Dean for Faculty Research & Development and Director of the Center for Health & Pharmaceutical Law at Seton Hall University School of Law where she was selected as the law school’s 2021 Professor of the Year …

Rethinking The Civil Protection Of Patients From Misleading Pharmaceutical Marketing Under Saudi Law, Muflih Saud Almughyirah

Maurer Theses and Dissertations

The effect of pharmaceutical marketing on individuals is a universal concern. It can influence patients' health and wealth. Patients, as well as their prescribing medical doctors, have been targeted by such marketing through different means. Many patients are unaware of their position as the most vulnerable party in this context and how these promotional strategies affect their physicians' decisions. When pharmaceutical marketing includes false, misleading, or otherwise negligent statements, patients become potential victims. This research addresses patients' civil protection from misleading pharmaceutical marketing under Saudi law. The study addresses four crucial aspects of patient protection: (i) ex-ante government regulations, (ii) …

Trust The Science But Do Your Research: A Comment On The Unfortunate Revival Of The Progressive Case For The Administrative State, Mark Tushnet

Indiana Law Journal

This Article offers a critique of one Progressive argument for the administrative state, that it would base policies on what disinterested scientific inquiries showed would best advance the public good and flexibly respond to rapidly changing technological, economic, and social conditions. The critique draws on recent scholarship in the field of Science and Technology Studies, which argues that what counts as a scientific fact is the product of complex social, political, and other processes. The critique is deployed in an analysis of the responses of the U.S. Centers for Disease Control and Food and Drug Administration to some important aspects …

Domestic Emergency Pretexts, Amy L. Stein

Indiana Law Journal

Whereas emergencies used to be the exception to the rule, they now seem to be the norm. Wildfires, hurricanes, flooding, and contagious diseases dominate our daily lives. Although these are not the traditional types of military emergencies of our past, these non-wartime emergencies can trigger some of the same emergency powers. And with their use comes some of the same concerns about abuses of such emergency powers. Much ink has been spilled analyzing the tradeoffs associated with necessary emergency powers and frequent abuses in the context of foreign threats—resulting in reduced privacy, civil liberties, and freedoms.

This Article is not …

Big Data, Big Gap: Working Towards A Hipaa Framework That Covers Big Data, Ryan Mueller

Indiana Law Journal

One lasting impact of the Health Insurance Portability and Accountability Act (HIPAA) is the privacy protections it provides for our sensitive health information. In the era of Big Data, however, much of our health information exists outside the traditional doctor-patient dynamic. From wearable technology, to mobile applications, to social media and internet browsing, Big Data organizations collect swaths of data that shed light on sensitive health information. Big Data organizations largely fall outside of HIPAA’s current framework because of the stringent requirements for when the HIPAA protections apply, namely that the data must be held by a covered entity, and …

Due Diligence In A Pandemic: State Accountability For Covid-19 Under International Law, Andrea Cocchini, Gonzalo Villalta Puig

Indiana Journal of Global Legal Studies

The coronavirus disease 2019 pandemic has tested the response capacity of the international community. This article analyses the due diligence principle and the various international legal instruments that restate it in an assessment of the possible actions that states could have taken to avoid or, at least, contain the initial outbreak of the pandemic.

Dau-Schmidt: Scotus Vaccine Ruling Raises As Many Questions As It Resolves, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

No abstract provided.

Worth A Shot: Encouraging Vaccine Uptake Through "Empathy", Jody L. Madeira

Articles by Maurer Faculty

Pro- and anti-vaccine organizations and individuals have frequently invoked empathy as a strategy for increasing uptake of COVID-19 precautions, including vaccinations. On one hand, vaccine supporters deployed empathy to defuse conflict, prioritize safeguarding the collective welfare, and avoid government mandates. On the other hand, vaccine opponents used empathy to emphasize the alleged individual effects of pandemic precautions, mobilize public voices, and stress the importance of medical freedom in policy-making contexts.

This Article first defines empathy and reviews empathy scholarship, paying particular attention to its relationship with narrative and the contexts where empathy can be difficult or dangerous. It then applies …

The Limits Of Regulation By Insurance, Kenneth S. Abraham, Daniel Benjamin Schwarcz

Indiana Law Journal

Insurance is an enormously powerful and beneficial method of spreading risk and compensating for loss. But even insurance has its limits. A new and misleading aspiration for insurance—that it also can and often does substitute for or significantly complement health and safety regulation—is increasingly in vogue. This vision starts from the uncontroversial recognition that insurers typically adopt measures designed to counteract “moral hazard,” the tendency of insurance to blunt policyholders’ incentives to take care. But proponents of this vision go on to contend that the risk-reducing potential of insurance is significantly more extensive than is traditionally imagined, because insurers are …

The Next Pandemic Might Be A Petdemic, Hillary Greene

Indiana Law Journal

A new scientific study shows that COVID-19 can be transmitted from cats to humans. Luckily, this channel of transmission seems extremely rare, at least thus far. But next time—and there will be a next time—we may not be so fortunate. This Article addresses this underappreciated risk of what I term a “petdemic”—a pandemic or epidemic that involves significant disease transmission between pets and humans. With nearly 70% of U.S. households owning pets, a petdemic could be catastrophic. One of our go-to responses for even perceived petdemics, honed over the last century, is to slaughter our pets. This pioneering Article proposes …

Delusions, Moral Incapacity, And The Case For Moral Wrongfulness, Lea Johnston

Indiana Law Journal

Responsibility is a legal—not medical—construct. However, science can be useful in exposing faulty assumptions underlying current doctrine or practice, illuminating changes in practice or evidentiary standards to better effectuate the law’s animating purpose, and even suggesting updates to legal standards to account for modern understandings of functionalities of concern. This Article uses the science of delusions to assess the law regarding, and practice of establishing, criminal irresponsibility for defendants with psychosis. Over the last two decades, researchers from the cognitive sciences have compiled strong evidence that a host of cognitive and emotional impairments contribute to the origin and maintenance of …

Stealing Organs?, Benjamin Mcmichael

Indiana Law Journal

Every nine minutes, a new person joins a waitlist for an organ transplant, and every day, seventeen people die waiting for an organ that will never come. Because the need for organ transplants far outstrips the number of available organs, the policies and rules governing organ allocation in the United States are critically important and highly contentious. Recently, proponents of a new allocation system—one focused more on sharing organs across the nation instead of allocating organs primarily to local transplant candidates—have gained ground. Bolstered by two separate lawsuits in the past five years, advocates of greater national sharing have succeeded …

Calling The Shots: Balancing Parental And Child Rights In The Age Of Anti-Vax, Mahrukh Badar

Indiana Journal of Global Legal Studies

Vaccinations have become a contentious issue in recent times. Although there has always been opposition to vaccines, the internet has made it possible for pseudoscience and false information to spread like never before. This has led to alarming declines in vaccine confidence and adherence rates globally. High-income countries have seen the sharpest drop in vaccine confidence rates. Factors such as the complacency effect and religious objections likely explain this decline. Most countries have attempted to raise vaccine confidence levels by enacting laws that make vaccinations for children compulsory, with strict penalties for parents who refuse to comply. In addition to …

Unilateral Burdens And Third-Party Harms: Abortion Conscience Laws As Policy Outliers, Nadia Sawicki

Indiana Law Journal

Most conscience laws establish nearly absolute protections for health care providers unwilling to participate in abortion. Providers’ rights to refuse—and relatedly, their immunity from civil liability, employment discrimination, and other adverse consequences—are often unqualified, even in situations where patients are likely to be harmed. These laws impose unilateral burdens on third parties in an effort to protect the rights of conscientious refusers. As such, they are outliers in the universe of federal and state anti-discrimination and religious freedom statutes, all of which strike a more even balance between individual rights and the prevention of harm to third parties. This Article …

Second Thoughts On Fda's Covid-Era Mental Health App Policy, Michael Mattioli

Articles by Maurer Faculty

As the coronavirus pandemic swept across the globe in April 2020, the US Food and Drug Administration (FDA) made an unusual decision. The agency announced that it would relax its enforcement of compliance rules for “digital therapeutics”—smartphone apps designed to address mental health disorders. The measure was a response to widely reported upticks in symptoms of anxiety, depression, and substance abuse brought on by the pandemic. As an added benefit, the agency explained, digital therapeutics could promote social distancing by removing patients’ need to visit health care providers.

This essay explores the possible lasting effects of the FDA’s temporary suspension …

Tort Immunity In The Pandemic, Betsy J. Grey, Samantha Orwoll

Indiana Law Journal

The Covid-19 pandemic set off a public health emergency that quickly brought doctors and other health care providers to the front line, while shuttering businesses throughout the United States. In response to the emergency, the federal and state governments rapidly created broad protections from tort liability for health care providers. To encourage businesses to reopen, some states have also provided liability protection for businesses from personal injury suits brought by patrons and employees. Congress is considering similar protections for businesses as it contemplates further aid packages. Some industries, like nursing homes and universities, are lobbying for specific immunity. This Essay …