Abbe R. Gluck

Civil Litigation and the Opioid Epidemic: The Role of Courts in a National Health Crisis

The devastating impact of the national opioid epidemic has given rise to hundreds of lawsuits. This article details the extremely broad range of legal claims, compares the opioid cases to other public health litigation efforts, including tobacco, and describes the special mechanism — a multidistrict litigation — through which more than 700 opioid-related cases have been consolidated thus far, with settlement almost certain to follow.

A Legal Victory for Insurance Exchanges

A federal judge has rejected a challenge to the new health insurance exchanges that could have crippled the Affordable Care Act by denying tax subsidies to the 73% of Americans who are expected to purchase their health insurance through a federally run exchange.

Medical-Legal Partnership: Lessons from Five Diverse MLPs in New Haven, Connecticut

This article examines five different Medical-Legal Partnerships (MLPs) associated with Yale Law School in New Haven, Connecticut to illustrate how MLP addresses the social determinants of poor health. These MLPs address varied and distinct health and legal needs of unique patient populations, including: 1) children; 2) immigrants; 3) formerly incarcerated individuals; 4) patients with cancer in palliative care; and 5) veterans. The article charts a research agenda to create the evidence base for quality and evaluation metrics, capacity building, sustainability, and best practices; it also focuses specifically on a research agenda that identifies the value of the lawyers in MLP. Such a focus on the “L” has been lacking and is overdue.

The Supreme Court Ruling in Sandoz v Amgen: A Victory for Follow-on Biologics

In June 2017, the Supreme Court issued its first decision concerning follow-on biologics—lower-cost versions of innovator biologics—ruling 9-0 in Sandoz v Amgen.1 The decision ruled that follow-on biologic companies are not required to share their licensing application with the innovator company and that a required 180day notice to the innovator company before commercial marketing could be given before US Food and Drug Administration (FDA) approval of their product. This handed the nascent follow-on biologics industry a substantial, albeit incomplete victory, which may help reduce prices and improve patient access to biologic therapies.

The New Health Care Federalism on the Ground

This essay, part of a symposium investigating methods of empirically evaluating health policy, focuses on American health care federalism, the relationship between the federal and state governments in the realm of health care policy and regulation. We describe the results of a five year study of the implementation of the Patient Protection and Affordable Care Act (ACA) from 2012-2017. Our study focused on two key pillars of the ACA, which happen to be its most state-centered — expansion of Medicaid and the implementation of health insurance exchanges — and sheds light on federalism in the modern era of nationally-enacted health laws that preserve key roles for state leadership. The full study is detailed in the Stanford Law Review; here, we offer a more accessible snapshot and highlight a key aspect of the research: interviews of approximately twenty high ranking former state and federal officials at the forefront of ACA implementation. The interviews corroborate the study data and substantiate our conclusions about the defining characteristics of the ACA’s implementation from a federalism perspective. Specifically, we found that the ACA’s implementation process has been 1) dynamic; 2) pragmatic; 3) negotiated; and 4) and marked by intrastate politics. We observed waves of engagement and estrangement between states and the federal government, and state decisions to participate in the ACA’s programs have not been binary, in/out choices. Vertical and horizontal negotiation and copying have been near constants. The findings also reveal theoretical and empirical challenges for quantitatively evaluating health care federalism. Does it exist? Is it successful? We found the traditional federalism attributes pop up in inconsistent ways under the ACA and emerge from virtually every structural arrangement of the law. We tried, for instance, to measure how “cooperative” the states were, only to find that concept meaningless. Some states attempted implementation but failed; other states rebelled by refusing to run their own programs at all. The federal government stepped in for both. Were such states equally “cooperative” or “autonomous”? The same challenges occurred for all of the classic federalism metrics. For example, we saw local experimentation emerge from every kind of governance structure under the ACA, including nationalist ones. Our work leads us to a key question: Why choose federalism-oriented health reform models in the first place? In ACA implementation, it sometimes appeared that federalist arrangements did not aim to improve health outcomes but rather reflected “federalism for federalism’s sake”—federalism to advance political or constitutional values, such as reserving power to the states in the interest of sovereignty and balance of power — regardless of the effect on health care coverage, cost, quality, or other measures of health policy success. At other times, it seems federalism was intended as a means to an end — e.g., that state-led health policy is assumed to produce better health outcomes. In the end, we were able to conclude more assuredly that the ACA’s many structural arrangements served state power than that any particular one of those arrangements was more federalist or that any particular one produced better health policy. Clearly, we cannot evaluate federalism — whether it exists, whether it is working, whether it is worth defending — without knowing what it is for in the first place.