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Medical Device Regulation: Going from Bad to Worse...or Better?
No full textThe Elena and Miles Zaremski Law Medicine Forum presents: Medical Device Regulation: Going from Bad to Worse...or Better? with George Horvath
Innovations in medical device technology hold the potential to improve health outcomes across the populace. But these same innovations can inflict widespread harm; by some estimates, medical devices caused 1.7 million injuries and 83,000 deaths between 2008 and 2017. Hence, we need for a regulatory system that ensures safety while simultaneously permitting—or ideally, fostering—innovation. Over the past half-century, Congress and the FDA have created a unique and complex regulatory system that seeks to achieve these goals. But according to many critics, this system is far too lax, allowing devices to reach the market without an adequate assessment of safety; others maintain that FDA regulation is stifling innovation and depriving patients of valuable technology.
This talk will focus on some of the perennial shortcomings of medical device regulation, on how the regulatory framework might be altered to achieve its goals, and, in an era of changing administrative priorities and limited agency resources, on how we might begin to move forward
Mosaic Theory of Litigation
No full textIn this second installment of the Steven S. Kaufman Family Anatomy of a Trial Lecture Series, litigator John K. Villa—described by The American Lawyer as “the lawyers’ lawyer”, by Chambers as “the ultimate lawyers’ lawyer” and by the Financial Times as “the lawyer that law firms turn to in a spot of bother” offers his thoughts on the theory and tools to create a winning factual mosaic. He draws upon his experience having spent three years of his life on his feet in courtrooms and representing the best law firms in America. He was deeply involved in the Enron case, the Madoff litigation and many if not most of the major cases against lawyers for the past 35 plus years.
With few exceptions, Villa maintains, there is no single objective narrative that explains the many facts that will emerge in a complicated case—only competing story lines each attempting to be the most persuasive. Great trial lawyers don’t recite or argue facts; they first present a logical story or framework drawn from the facts that resonates with the factfinder. Once the fact-finder sees, internalizes and accepts the outline of the lawyer’s mosaic, then every fact that later emerges is placed like a tile into that mosaic. In essence, trial is a competition between lawyers to win first the heart and then the mind of the factfinder through the power of narrative.
In this presentation, Villa will share the concrete steps attorneys should consider at the outset of litigation to construct a persuasive trial narrative. He will demonstrate how to apply this mosaic approach across essential stages of trial practice: from the use of pretrial evidentiary motions, the thoughtful use of depositions, and the key to direct and cross-examination. There will be special emphasis on bench trials and arbitrations as an increasing portion of business disputes now are resolved without juries.
Finally, Villa’s experience in defending the great law firms of America gives him a unique insight into related issues which he will discuss – why even skilled trial lawyers get sued for malpractice and a handful of steps that a lawyer can take to reduce dramatically the risk of such malpractice claims.
A networking reception will follow the lecture
Appeal No. 1042: Empire Fluid Solutions, LLC v. Division of Oil & Gas Resources Management
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Uncovering Spain\u27s Lost Victims: Can the Continuing Crimes Doctrine Expand the Jurisdiction of the International Criminal Court?
Full text linkThroughout Spain’s transition years (1975-1985), the country has maintained an “agreement to forget” and consequently failed to prosecute any perpetrators of crimes during the Franco dictatorship. This Note examines Franco-era forced disappearances in Spain and argues that the ICC has ratione temporis jurisdiction to investigate and prosecute perpetrators under the application of the continuing crimes doctrine, which is consistent with the principle of nullum crimen sine lege. (Abstract from author.
Sacrifice Zone: Conciliating Racial Discrimination in Louisiana\u27s Cancer Alley Under the International Convention on the Elimination of All Forms of Racial Discrimination
Full text linkIn June 2023, the Environmental Protection Agency (EPA) abandoned its civil rights investigation into racially discriminatory practices by Louisiana state agencies in Cancer Alley. It did so after issuing initial findings which indicated those agencies had operated in a racially discriminatory manner, subjecting predominately Black communities to adverse health outcomes resulting from air pollution. This action is one in a long line of violations by the United States of its obligations under the International Convention on the Elimination of All Forms of Racial Discrimination (ICERD) in Cancer Alley. In light of U.S. inaction in Cancer Alley, other parties to ICERD have the opportunity to and should challenge these violations under ICERD’s recently activated dispute settlement procedure. (Abstract from author.
White Paper on the Need to Strengthen International Humanitarian Law to Address the Challenges of 21st Century Warfare
Full text linkOn the seventy-fifth anniversary of the Geneva Conventions, thirty leading experts in the field of IHL from around the world gathered at Case Western Reserve University School of Law in Cleveland, Ohio, on September 26, 2024, to discuss whether there is a need to strengthen IHL to address the challenges of 21st century warfare, and how that could best be accomplished. The experts participated in three follow-up meetings over Zoom on October 31, November 7, and November 14, 2024. The participating experts are listed at the end of this document. The experts participated in their personal capacity; the views expressed in this White Paper do not necessarily reflect those of their university, firm, agency, or organization. Further, the Chatham House Rule governed the sessions, and this White Paper summarizes the substance of the discussion but does not indicate the specific position taken by any of the participants. (p. 8
Breaking The Boomerang: Judicial Oversight and the Fourth Amendment When the War Comes Home
No full textThe Renewed (and Wild) Race in Corporate Law with Eric Talley
No full textFor much of the last century, Delaware reigned supreme in corporate law. Nearly two-thirds of all public companies—and countless private ones—chose to incorporate there, facing little competition from other jurisdictions. In the process, Delaware became the epicenter of high-stakes legal battles, attracting the world’s largest companies and most influential legal minds. Its dominance seemed self-perpetuating, reinforced by network effects, an extensive body of case law, and sheer institutional inertia. Yet today, that dominance is under challenge. Over the past year, a chorus of voices—some anxious, others eager—has suggested that Delaware stands on the precipice of losing its hegemony. Other states, sensing an opening, are making moves to reshape their corporate law landscapes in ways that range from strategic to seemingly haphazard. The result? A renewed and unpredictable contest for influence in corporate governance. What has brought about this moment of upheaval? And why now? Most importantly, how should practitioners, scholars, and policymakers navigate this shifting terrain
Climate Liberalism and Decarbonization
Full text linkExisting climate policy goals require dramatic and rapid reductions in greenhouse gas emissions. Achieving such reductions within the desired time frame is a tremendous challenge, particularly through conventional regulatory approaches. The conventional approach to environmental problems is to treat such problems as “market failures” that can be corrected by government intervention, such as through regulation. Such approaches are constrained by various sources of government failure that are exacerbated by the scale and scope of the problem. The knowledge problem, administrative transaction costs, and limits on regulatory throughput capacity all hamper the use of traditional regulatory tools to address the problem of climate change. An alternative approach to environmental problems views such problems not as “market failures” but as a failure to have markets in relevant contexts. This approach counsels looking for ways to extend market institutions to cover environmental resources and encourage decentralized, spontaneous responses to price signals as a means of encouraging environmentally desirable behavior. Such approaches have been successful at helping to address many environmental concerns and at encouraging net dematerialization in advanced market economies. These experiences offer lessons for how to more effectively encourage decarbonization and address climate change. Among other things, they suggest a greater emphasis on the conditions that foster innovation and a greater reliance on fiscal tools than on regulatory interventions.
This Essay was prepared for the 2024 Iowa Law Review Symposium, “The Economic Implications of Climate Change.
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