Law Commons^™

Fda’S Efforts To Tame The 'Wild West' Of Regenerative Medicine, Christopher M. Holman

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Stem cell-based regenerative therapies hold the potential to address a host of health concerns, particularly congenital, age-related, and trauma-induced injuries, and diseases involving organ and tissue degeneration, conditions that have proven refractory to conventional drug-based approaches. For the time being, however, there is little in the way of solid evidence supporting the safety and efficacy of most cell-based therapeutic approaches (with the notable exception of hematopoietic stem cells used to treat diseases of the blood and immune system). This Holman Report begins with an overview of the current uncertain regulatory status of regenerative medicine in the U.S., including several draft …

Producing Better Mileage: Advancing The Design And Usefulness Of Hybrid Vehicles For Social Business Ventures, John E. Tyler, Evan Absher, Kathleen Garman, Anthony J. Luppino

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Since 2008 approximately half of the states in the U.S. have enacted statutes permitting “hybrid” business forms that blend aspects of traditional for-profit ventures with characteristics normally associated with traditional non-profit entities. This article analyzes theoretical, academic, practical, legal, and regulatory questions regarding the extent to which the existing hybrids are suited to achieving social purposes objectives, including in comparison to modified traditional forms of business organization. Finding the current fleet of hybrids an innovative, useful start, but with need to evolve, this article proposes statutory language (set forth in a detailed appendix, and summarized in the article text), and …

Testimony Before The Financial Crisis Inquiry Commission, Miami, Florida September 21, 2010, William K. Black

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"Control frauds" are seemingly legitimate entities controlled by persons that use them as a fraud "weapon." (The person that controls the firm is typically the CEO, so that term is used in this testimony.) A single control fraud can cause greater losses than all other forms of property crime combined. Neo-classical economic theory, methodology, and praxis combine to optimize criminogenic environments that hyper-inflate financial bubbles and produce recurrent, intensifying financial crises. A criminogenic environment is one that creates such perverse incentives that it leads to widespread crime. Financial control frauds’ "weapon of choice" is accounting. Neoclassical theory, which dominates law …

Wall St. Fraud And Fiduciary Responsibilities: Can Jail Time Serve As An Adequate Deterrent For Willful Violations?, William K. Black

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The answer to the question posed by the title of this hearing is: only prison sentences can deter the violations that caused the debacle. We should, however, never rely solely on prosecutions to constrain crimes. The criminal justice system needs to work with regulation not only to make regulation more effective, but also to prevent “private market discipline” from becoming a “criminogenic” oxymoron. To understand the vital role that the criminal justice system must play if we are to avoid the recurrent, intensifying financial crises that have beset this and many other nations for nearly three decades we must begin …

Echo Epidemics: Control Frauds Generate White-Collar Street Crime Waves, William K. Black

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“Control fraud” drove the crisis. Control fraud occurs when those that control a seemingly legitimate entity use it as a “weapon” to defraud. In finance, accounting is the “weapon of choice.” Regulators, criminologists, and criminologists have documented the pervasive role of control fraud in causing the second phase of the S&L debacle. That crisis was followed by the accounting control frauds of Enron and its ilk.

Top economists, criminologists, and the S&L regulators agreed that lenders engaged in accounting control fraud optimize through a four-part recipe that is a “sure thing” – it produces guaranteed, record (fictional) near-term profits and …

Insurance Law Between Business Law And Consumer Law, Jeffrey E. Thomas

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The U.S. legal system has multiple and complex regulatory regimes for insurance which combine statutes, administrative regulations and common law rules. Regulation of insurance is predominantly done by the fifty states, and this increases the system’s complexity. The regulatory regimes generally divide the industry, the subject of regulation, from the consumers, which are to be protected, without regard for the status or sophistication of the insurance consumer. This article focuses on the role of insurance law and regulation within the legal system, and in particular the divide between business or commercial insurance and that provided for consumers, more commonly known …

Control Frauds As Financial Super-Predators: How 'Pathogens' Make Financial Markets Inefficient, William K. Black

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White-collar criminology scholarship shows that “accounting control frauds” (frauds led by the CEO) use accounting fraud to deceive (or suborn) sophisticated financial market participants. Large control frauds cause greater financial losses than all other forms of property crimes combined. Weak regulation, supervision and ethics produce epidemics of control fraud that cause systemic economic damage. As with the natural world, these financial super predators act like pathogens that take over a firm and act as a “vector” to cause even greater damage. Control fraud theory poses a major challenge to the efficient markets hypothesis and the resulting praxis that devalues financial …