In Memoriam: Peter Gerhart: 1945-2021

Tribute to Peter Gerhart

Regulating in Uncertainty: Animating the Public Health Product Safety Net to Capture Consumer Products Regulated by the FDA that Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, and Lab Grown Meat

The past several decades have seen the creation of transformative new technologies that are being used to design innovative consumer product ingredients never seen before in nature. Examples include the use of nanotechnology and genetic modification, and, right around the corner, cloning and lab grown meat. These innovative technologies are harbingers of more pioneering consumer product ingredients to come. The remarkable pace of the development of ground-breaking new technologies means that the population is being steadily exposed to novel ingredients with unknown health risks. Optimally, the Food & Drug Administration ( FDA ) should be regulating these innovative, novel ingredients in consumer products to meet the twin goals of protecting public health while fostering innovation. However, the current litmus test that the FDA is using to trigger regulation to protect public health is focused on hazard. Linking public health protections to the degree of hazard when operating in the area of scientific uncertainty that prevails with most novel technologies is outcome determinative – it means no public health regulatory protection at all. This Article will use nanotechnology as the main example that highlights how a simple change in focus to regulating innovative ingredients based on novelty rather than hazard can achieve the proper balance between protecting public health while encouraging innovation. Novel ingredients should be listed on product ingredient labels to allow for the use of big data strategies to link health impact information collected from electronic health records and social media, to the data generated by the state and federal consumer product reporting systems. Linking these data streams will create a highly sensitive, state-of-the-art product safety surveillance system. This system will work to identify early warnings of product safety problems so that public health officials can proactively mitigate their effects. This focus on novelty and big data strategies will animate what this Article calls the “public health product safety net.” As envisioned by this Article, the public health product safety net is a powerful, interactive network that involves consumers as well as the healthcare system, the state and federal public health protection agencies, and the tort system. Together, these private and public actors can act to ensure consumer safety through: (1) consumer self-protection; (2) appropriate injury treatment by healthcare providers using the correct identification of novel ingredients as causative agents; (3) proper reporting of the injury-causing agents to the state and federal public health protection agencies in charge of the early warning and product recall systems; and, (4) the instrumental use of the tort system to both encourage the proper investment in product safety and to insulate against the overuse and overconsumption of relatively risky products. After walking through how the public health product safety net will operate to achieve the proper balance between public health protection and fostering innovation in the context of nanotech ingredients in consumer products, this Article will show how this safety net will work with other novel technologies used as ingredients in consumer products such as cloned animals, genetically modified plants and animals used for food, cloned animals used for food and lab grown meat. This Article concludes by pointing out that the exploding number and variety of novel ingredients never seen before in nature will be limited only by the ingenuity of engineers and scientists creating these novel ingredients. As such, it is time to put into place a post market surveillance system to protect public health that will work for all of these novel ingredients, regardless of their composition – and that system is the public health product safety net described in this Article

Modernizing the Emergency Medical Treatment & Labor Act to Harmonize with the Affordable Care Act to Improve Equality, Quality and Cost of Emergency Care

The Emergency Medical Treatment and Active Labor Act (EMTALA) is a federal statute passed almost 30 years ago which was designed to ensure equal access to emergency treatment and to halt the practice of “patient dumping.” Patient dumping is a situation where some patients—typically uninsured, disabled, and minority individuals—receive inferior emergency medical care or are denied emergency medical treatment altogether. The goal of EMTALA is to ensure that everyone coming to the emergency room will receive equal care. Unfortunately, despite EMTALA, the practice of patient dumping has continued to this day. The most recent case in the news is the haunting story of a psychiatric hospital, Rawson-Neal in Las Vegas, that purportedly prematurely discharged patients and bussed them out of state. Starting in 2008, the facility allegedly bused nearly 1,500 patients out of state over several years. According to one major class action lawsuit filed in 2013, when patients were placed on a bus, they were given a small amount of food and medication for trips that sometimes lasted for days. They were then told to dial 911 or find a shelter upon their arrival in their new city. One of the allegations in the lawsuit is that hospital officials did not reach out to make arrangements for patient care at these new destinations prior to putting these patients on buses bound for new locations. The news media labeled this practice “Greyhound Therapy.” This practice of patient dumping is of great concern to all patients, but particularly for those in our society who are the most vulnerable—children, many elders, and the physically and mentally disabled—as many of these individuals do not have the ability to engage in self-protection. Of particular concern is that the number of elders with mental disabilities, including dementia and Alzheimer’s, will be growing as our population ages. The dated and flawed EMTALA statute needs to be modernized as it currently negatively impacts the quality and cost of healthcare without any positive trade-off for the equality of healthcare. In fact, there are four ways that EMTALA may actually be having an affirmatively negative impact on equality of care. First, EMTALA encourages the practice of customary treatment choices and discourages the transition to modern day, evidence-based treatment choices. Many customary care treatment choices lead to the provision of unequal, poor quality and costly care. Second, by encouraging customary treatment choices and discouraging the transition to evidence-based treatment choices, EMTALA works against the quality and equality improvement efforts of the Affordable Care Act, Medicare, and Medicaid, and other government programs. Most particularly, EMTALA discourages the adoption of written, evidence-based, emergency protocols that have significant life-saving potential and that ensure equality of care for all. Third, by promoting customary treatment choices, EMTALA perpetuates the use of bias and stereotypes in clinical decision-making. This problem is of particular concern in emergency care. Fourth, by relying on customary care as the exclusive proxy for equality of care, EMTALA renders itself ineffective as an anti-patient dumping tool by facilitating the wide use of procedural tactics to dismiss EMTALA cases before courts can reach the merits. This Article will propose a very simple, two-step way to modernize EMTALA to deal with this cascade of problems. This solution converts EMTALA into a powerful tool to enhance equal access to healthcare while at the same time changing EMTALA so that it works in tandem with, instead of against, the efforts of the Affordable Care Act, Medicare and Medicaid to improve healthcare quality, cost and equal access

Vulnerable Populations and Vaccine Injury Compensation: The Need for Legal Reform

This chapter argues that the potential for vaccine-related harms raises acute concerns for vulnerable populations. These harms have a disparate impact on low-income people, who are disproportionately non-White, and who have limited financial resources to obtain medical care, weather job losses, and pursue injury compensation. When a vaccine is given as a countermeasure during a declared public health emergency (PHE), the problem is acute because of the limited availability of injury compensation

Intellectual Property and Public Health – A White Paper

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions. Led by the moderator, participants at the Forum focused generally on three broad questions. First, are there alternatives to either the patent system or specific patent doctrines that can provide or help provide sufficient incentives for health-related innovation? Second, is health information being used proprietarily and if so, is this type of protection appropriate? Third, does IP conflict with other non-IP values that are important in health and how does or can IP law help resolve these conflicts? This report addresses each of these questions in turn

Intellectual Property and Public Health – A White Paper

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions. Led by the moderator, participants at the Forum focused generally on three broad questions. First, are there alternatives to either the patent system or specific patent doctrines that can provide or help provide sufficient incentives for health-related innovation? Second, is health information being used proprietarily and if so, is this type of protection appropriate? Third, does IP conflict with other non-IP values that are important in health and how does or can IP law help resolve these conflicts? This report addresses each of these questions in turn

Modernizing the Emergency Medical Treatment & Labor Act to Harmonize with the Affordable Care Act to Improve Equality, Quality and Cost of Emergency Care

The Emergency Medical Treatment and Active Labor Act (EMTALA) is a federal statute passed almost 30 years ago which was designed to ensure equal access to emergency treatment and to halt the practice of “patient dumping.” Patient dumping is a situation where some patients—typically uninsured, disabled, and minority individuals—receive inferior emergency medical care or are denied emergency medical treatment altogether. The goal of EMTALA is to ensure that everyone coming to the emergency room will receive equal care. Unfortunately, despite EMTALA, the practice of patient dumping has continued to this day. The most recent case in the news is the haunting story of a psychiatric hospital, Rawson-Neal in Las Vegas, that purportedly prematurely discharged patients and bussed them out of state. Starting in 2008, the facility allegedly bused nearly 1,500 patients out of state over several years. According to one major class action lawsuit filed in 2013, when patients were placed on a bus, they were given a small amount of food and medication for trips that sometimes lasted for days. They were then told to dial 911 or find a shelter upon their arrival in their new city. One of the allegations in the lawsuit is that hospital officials did not reach out to make arrangements for patient care at these new destinations prior to putting these patients on buses bound for new locations. The news media labeled this practice “Greyhound Therapy.” This practice of patient dumping is of great concern to all patients, but particularly for those in our society who are the most vulnerable—children, many elders, and the physically and mentally disabled—as many of these individuals do not have the ability to engage in self-protection. Of particular concern is that the number of elders with mental disabilities, including dementia and Alzheimer’s, will be growing as our population ages. The dated and flawed EMTALA statute needs to be modernized as it currently negatively impacts the quality and cost of healthcare without any positive trade-off for the equality of healthcare. In fact, there are four ways that EMTALA may actually be having an affirmatively negative impact on equality of care. First, EMTALA encourages the practice of customary treatment choices and discourages the transition to modern day, evidence-based treatment choices. Many customary care treatment choices lead to the provision of unequal, poor quality and costly care. Second, by encouraging customary treatment choices and discouraging the transition to evidence-based treatment choices, EMTALA works against the quality and equality improvement efforts of the Affordable Care Act, Medicare, and Medicaid, and other government programs. Most particularly, EMTALA discourages the adoption of written, evidence-based, emergency protocols that have significant life-saving potential and that ensure equality of care for all. Third, by promoting customary treatment choices, EMTALA perpetuates the use of bias and stereotypes in clinical decision-making. This problem is of particular concern in emergency care. Fourth, by relying on customary care as the exclusive proxy for equality of care, EMTALA renders itself ineffective as an anti-patient dumping tool by facilitating the wide use of procedural tactics to dismiss EMTALA cases before courts can reach the merits. This Article will propose a very simple, two-step way to modernize EMTALA to deal with this cascade of problems. This solution converts EMTALA into a powerful tool to enhance equal access to healthcare while at the same time changing EMTALA so that it works in tandem with, instead of against, the efforts of the Affordable Care Act, Medicare and Medicaid to improve healthcare quality, cost and equal access

Using Clinical Practice Guidelines and Knowledge Translation Theory to Cure the Negative Impact of the National Hospital Peer Review Hearing System on Healthcare Quality, Cost, and Access

According to an estimate by the Institute of Medicine made over a decade ago, treatment errors in hospitals alone caused 98,000 deaths yearly. This Institute of Medicine report is proving to be conservative. A recent Consumer Reports investigation came to the conclusion that “[m]ore than 2.25 million Americans will probably die from medical harm this decade…. That’s like wiping out the entire populations of North Dakota, Rhode Island, and Vermont. It’s a manmade disaster.” Thus, it appears that the three major systems in the United States that are designed to improve the quality of patient care — the state medical malpractice and licensure systems and the private hospital peer review hearing system — are all failing at their task. To date, the attention of academics, legislators and lawyers has been on critiquing the medical malpractice and licensure systems, while the far more important hospital peer review hearing system has gone almost unnoticed. In light of the number of patients killed in hospitals each year and the soaring costs of healthcare, it is time to begin a critical review of the hospital peer review hearing system. This Article starts with a history of the growth of hospital peer review and then examines the merits of the rationales that motivated the passage of the Health Care Quality Improvement Act of 1986 (“HCQIA”) that catapulted peer review into the national system that exists today. The Article next explains how the peer review hearing process works and how HCQIA turns private hospitals into small, individual quasi-regulatory agencies. The Article goes on to critique the “bad apple” approach taken by hospital peer review in light of the growing body of empirical research that supports a systems improvement approach to dealing with the problem of medical error. Next, the Article explains how the choice of standards that hospital peer review relies upon to measure physician competence negatively impacts quality and cost. Finally, the Article raises questions regarding the possible negative impact that hospital peer review has on access to healthcare, with a particularly negative potential impact on minority physicians as well as minority and low income patients. This Article proposes that hospital peer review be completely restructured to comport with the current, scientific understandings of the methodologies that best act to prevent medical errors. A new system should be developed that relies on the application of a blend of knowledge translation theory with continuous quality improvement research to integrate evidence-based treatment choices using clinical practice guidelines into physician practice

In Memoriam: Peter Gerhart: 1945-2021

Tribute to Peter Gerhart