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FDA After Loper Bright
No full textThis Article illustrates that Loper Bright may empower the U.S. Food and Drug Administration in unexpected ways. Loper Bright, which overruled the Chevron decision from 1984, tells us that a court should determine the meaning of all statutory provisions for itself — rather than deferring to the views of the federal agencies that implement those provisions. This Article grapples with the effect of the decision at FDA — one of the most important federal agencies, affecting the life of every person in the United States and regulating about a quarter of all consumer spending in the country, i.e., over $4 trillion annually. It makes three novel and potentially surprising claims, as follows.First, the Chevron doctrine meant less to FDA than conventional wisdom supposes. Empirical studies of litigation during the Chevron years — one published by the author and one published by a different team — show that FDA often lost cases at “step one” of Chevron, after reviewing courts decided the agency’s statute clearly answered the question differently than the agency had. This Article also offers the first review of litigation against FDA in the decade before Chevron, finding that the agency generally prevailed in cases involving statutory interpretation even without Chevron in play. Indeed, with one possible exception, no case would have clearly come out differently after Chevron, i.e., none that FDA lost and that it unquestionably would have won after 1984.Second, if Loper Bright and the formalist principles ascendant in the judiciary are understood properly, FDA should now win many cases that it would have won previously on the basis of Chevron deference. But the reasoning will be different. In many of these instances, the agency was not really interpreting its statute. Instead, it was engaged in policymaking. If FDA policymaking was authorized by Congress, judicial review — even after Loper Bright — remains deferential. Thus, some territory that agency defenders fear was lost with elimination of the Chevron framework will be regained if the agency persuades courts of its statutory authority to make discretionary calls. Scouring FDA’s statute for evidence of this authorization has not been a priority in the past, but this Article shows that the search may be surprisingly fruitful.Finally, de novo review may yield new and surprising results, but not in the cases that people expect. The defeats should not stem from judicial interpretation of ambiguous statutory provisions as to which those courts would previously have deferred to FDA. Again, many of those agency actions should today be understood as policymaking. Instead, the surprises will come when courts review actual interpretations that have not been challenged previously. Some of FDA’s statutory interpretations are half a century old, or older, and experts in the field have simply internalized them, without realizing that federal judges coming to the issues cold will see things very differently. That said, regulated parties may decline to upset the apple cart. And the Court’s increasingly formalist Article III standing jurisprudence may limit the others who would seek to do so.Scholars and others writing in health law and policy were almost uniformly alarmed by the Loper Bright certiorari grant and have continued to express concern that the decision will hamstring FDA. These concerns were overblown. FDA may be surprisingly resilient. This Article is meant to illustrate how it could defend itself and also offer ideas for other agencies that face challenge in the new era
RPS Coach is Biased - And Proud of It
No full textThis short essay explores the concept of bias in artificial intelligence tools used in dispute resolution. Biases are not necessarily flaws to be avoided, but inevitable and potentially constructive features of these tools. They reflect values and design choices that AI developers should disclose.
There are both market and ethical imperatives for AI tools to disclose their features and embedded values. As developers compete for users, people will want to know what they’re getting. Disclosure helps users understand the effects of assumptions, priorities, and frameworks built into a tool’s design, and thus should be treated as a core ethical principle.
As an illustration, the essay focuses on RPS Coach – a custom AI tool grounded in Real Practice Systems (RPS) Theory based on the author’s publications. It outlines the structure of RPS Coach’s knowledge base and the instructions that shape its responses, which are designed to support good decision-making by mediators, lawyers, parties, and educators. Coach encourages users to tailor dispute resolution processes based on multiple case-specific factors, rather than simply follow any one model. It reflects a practice systems perspective that favors professional growth over tactics and adaptation over scripts
What Shall Be Orthodox in Polarized Times: Overview and Response to Commentators
No full textlf there is any fixed star in our constitutional constellation, it is that no official, high or petty, can prescribe what shall be orthodox in politics, nationalism, religion, or other matters of opinion or force citizens to confess by word or act their faith therein. Justice Robert Jackson wrote this celebrated passage in his majority opinion in West Virginia State Board of Education v. Barnette (1943), which protected the First Amendment right of Jehovah\u27s Witness children not to participate in a compulsory flag salute in public schools. ln recent years, protests against imposed orthodoxy-usually invoking Barnette-have occurred in a growing number of contexts, often when conservatives resist governmental promotion of public values concerned with equality. Many controversies, like Barnette, concern schools: conflicts over how best to teach U.S. history, civics, and patriotism, and whether state restrictions and mandates on teaching about race, gender, or sexual orientation are unconstitutional. Barnette also features in conservative challenges to state antidiscrimination laws. The children in Barnette, members of a persecuted religious minority, have become the symbol of today\u27s religious and social conservatives, who contend their unpopular dissenting beliefs are threatened by the compelled orthodoxy of hostile majorities
Viability as Abortion-Rights Orthodoxy
No full textBorrowing a quotation from Justice Jackson\u27s influential opinion in West Virginia Board of Education v. Barnette, Professors Linda McClain and James Fleming have named their ambitious and illuminating new book What Shall Be Orthodox in Polarized Times. As Justice Jackson wrote in applying the First Amendment to protect school children with familial objections to a required flag salute: lf there is any fixed star in our constitutional constellation, it is that no official, high or petty, can prescribe what shall be orthodox in politics, nationalism, religion, or other matters of opinion or force citizens to confess by word or act their faith therein. Although Justice Jackson takes aim at government prescribed orthodoxy and Professors McClain and Fleming understandably center such concerns, this essay for the symposium on their book takes a broader look at orthodoxy. As l show, orthodoxies can form in subtle ways without government prescription, and official speech-although not itself subject to the First Amendment-can sometimes shape them
Removing “Black Marks”: How States Can Preserve Wrongful Birth Suits Without Reliance on “Eugenic” Rhetoric
No full text“[L]ebensunwertes Leben—Life Unworthy of Life.” Those words, used by the National Socialist (Nazi) Party in Germany to describe people with genetic disorders, ring throughout world history as a moral indictment of the Nazi German state and all those who collaborated with it. Unfortunately, Germany was not alone in its designation of some people as unworthy of life; the United States has also, throughout its history, given the same designation to portions of its population. From Japanese-Americans during the Second World War to people with disabilities in the era of eugenics, the American government has frequently singled out those whom it believes to be undeserving of full constitutional rights. When American courts ratified such actions, legal commentators rightly described these decisions as “black mark[s]” on the entirety of American jurisprudence
Revolutionizing the System: Designing a Safe Order of Protection Mediation Program
Full text linkConsider a situation where an African American man, Tony, residing in a rural southern jurisdiction, holds an order of protection against his partner, John, who is also an African American man. Furthermore, the presiding judge, an elderly white man, was known for denying orders of protection even when sought by white women, which creates an atmosphere where seeking court intervention might result in embarrassment and judgment for the client. This embarrassment and judgment stems from the stereotypes that mostly people who have engaged in criminal behavior belong in court; additionally, survivors experience shame about why they are appearing before a judge. Moreover, the alleged abuser is also averse to the order of protection, particularly with the specific details surrounding the situation. With its assurance of confidentiality, the appeal of mediation assumes a central role in these situations
Suicide’s Shadow: The Evolution of a Ghost Crime
Full text linkLaw treats suicide as malfeasance—a display of mental illness and, worse, a ghost crime that has never left us. While states no longer criminally punish suicide, they detain and force mental-health treatment on many who attempt it, or indicate they might attempt it, and threaten criminal sanctions against those who aid or encourage it. For these and other reasons, the suicide label functions not merely as a description of an event but as a censure. A lengthy, legal history, fueled originally by religion but then tempered by pragmatism, led to these circumstances and can largely rationalize relevant legal doctrines and practices as they currently operate. Yet a countervailing view of consensually hastened deaths as often acceptable has powered a continuing movement for reform. It is possible to envision in the distant future the culmination of this effort in the acceptance of suicide as a right or privilege. However, the movement in its present stages has sought to elide rather than directly challenge law’s suicide prohibition. Success has come most notably through legislated suicide exemptions in several states that authorize doctors to prescribe for certain terminally ill patients a lethal dose of medicine that the patient can self-administer. More states will likely follow what has already begun. But if the exemption movement is not to stall with terminally ill patients who self-administer prescribed medicine, what is the immediate path forward? This Article distinguishes between advances that can be achieved without defying the negative conceptions of suicide that currently prevail and other advances that would begin to seriously undermine law’s anti-suicide regime. In the former category are exemptions that cover consensually hastened deaths that are plausibly called natural and other exemptions for deaths that, with changes to official reporting practices, can at least be characterized as not suicide (or homicide). Yet this Article concludes that there is no apparent inflection point along the way that can define an area of potentially permanent stasis. Law’s anti-suicide system may well continue evolving through the distant future until suicide becomes a right or privileg
Looking Forward, Reflecting Back: The Promise of Dispute Resolution to Reform the Criminal Legal System
No full textThe criminal legal system in the United States is plagued by serious and systemic problems. There have been countless efforts at reform over the last many decades that have included changes in what is a crime, how crimes are punished, how prosecutors do their job, and changes in policing. Yet, despite these efforts, problems such as mass incarceration remain deeply embedded. It is easy to be swept up in pessimism when discussing the criminal legal system. Change is hard, at best incremental, and we seem to be in the beginning of an era of backlash against recent reforms. This is despite the widespread use of dispute resolution processes which are often looked to as processes that can contribute to meaningful change. Why have these processes and reforms had such limited impacts