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Trudo Lemmens - One of the best experts on this subject based on the ideXlab platform.
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Legal Remedies for medical ghostwriting imposing fraud liability on guest authors of ghostwritten articles
PLOS Medicine, 2011Co-Authors: Simon Stern, Trudo LemmensAbstract:There are persistent concerns about the influence of the pharmaceutical and device industries on the medical literature, and particularly on the reporting of clinical trials, which can include the distortion of the true evidence base of medical interventions and overestimation of the clinical benefit of a drug used to treat patients [1]. An especially problematic issue involves the industry practice of publishing studies prepared by hired medical writers but signed by academic “guest authors” who are invited to add their names without fulfilling authorship criteria. In this case, “guest authorship” is accompanied by “ghostwriting,” which occurs when a published article fails to acknowledge the original writer or writers' contributions [2]–[4]. Ghostwriting can also occur when an academic research group uses a professional writer to draft an article based on data generated by the group. When the research group retains control of the data and the final analysis, however, there is less of a concern about possible bias in the reporting of the results, and the appropriate remedy in that case is to report explicitly the role and contribution of the medical writer in the article. Here, we concentrate on ghostwriting and guest authorship in industry-controlled research, where several examples have revealed the use of ghostwriters to insert concealed marketing messages favourable to a company's product, and the recruitment of academics as “guest” authors despite not fulfilling authorship criteria [5]–[9]. Commentators have condemned the practice as unethical and unacceptable and have discussed the harms resulting from this form of medical ghostwriting, recommending that journal submissions be policed more aggressively and that the “guest authors” be suitably sanctioned by journals, academic institutions, and regulatory agencies [1]–[14]. However, these recommendations have not yet been widely embraced by the academic institutions, medical journals, and medical licensing organizations that would seem to have the most at stake in curbing this practice. Here, we discuss some of the reasons for this lack of response and suggest that the law may offer a solution, given these other institutions' failure to impose sanctions.
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Legal Remedies for medical ghostwriting imposing fraud liability on guest authors of ghostwritten articles
2011Co-Authors: Simon Stern, Trudo LemmensAbstract:Ghostwriting and guest authorship of medical journal articles raise serious ethical and Legal concerns, bearing on the integrity of medical research and evidence used in Legal disputes. Ghostwriting involves undisclosed authorship, usually by medical communications agencies or a pharmaceutical sponsor of the published research; guest authorship involves taking authorial credit for the published work without making a substantial contribution to it. Commentators have objected to these practices because of concerns involving bias in ghostwritten clinical trial reports and review articles. We also note the effects of ghostwritten articles on questions involving the Legal admissibility of scientific evidence. Efforts to curb ghostwriting practices, undertaken by medical journals, academic institutions, and professional disciplinary bodies, have thus far had little success and show little promise. These organizations have had difficulty adopting and enforcing effective sanctions, for specific reasons relating to the interests and competencies of each kind of organization. Because of those shortcomings, a useful deterrent in curbing the practice may be achieved through the imposition of Legal liability on the ‘guest authors’ who lend their names to ghostwritten articles. We explore the doctrinal grounds on which such articles might be characterized as fraudulent. A guest author’s claim for credit of an article written by someone else constitutes Legal fraud, and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO). The same fraud could support claims of “fraud on the court” against a pharmaceutical company that has used ghostwritten articles in litigation. This doctrine has been used by the U.S. Supreme Court to impose sanctions on the authors and corporate sponsors of a ghostwritten article. We discuss the potential penalties associated with each of these varieties of fraud.
Robin Kundis Craig - One of the best experts on this subject based on the ideXlab platform.
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Legal Remedies for deep marine oil spills and long term ecological resilience a match made in hell
Social Science Research Network, 2011Co-Authors: Robin Kundis CraigAbstract:The Deepwater Horizon oil spill that lasted from April to September 2010 was not only the worst oil spill disaster in United States history but also the first to occur at great depth. Drilling at depth multiplies the risks and complications of offshore oil extraction. It also, as this Article explores, makes natural resource damages a decisively inadequate remedy for the damages done to the Gulf of Mexico’s ecosystems, especially the poorly understood but highly productive ecosystems that exist almost a mile below the surface. This Article argues that our current natural resource damages regimes for oil spills depend too heavily on an assumption that ocean areas like the Gulf are stably resilient, able to absorb and recover from an incessant series of environmental insults, ranging from widespread loss of wetlands to nutrient pollution and a dead zone to overfishing to continual releases of oil. By acknowledging that disasters like the Deepwater Horizon oil spill could push ecosystems across regime-shifting thresholds into new states, resilience thinking better captures the inherent and unavoidable risks that exploitative activities in the Gulf actually pose to the socio-ecological systems that depend on its continued productive functioning. As a result, resilience thinking can also suggest new and more comprehensive ways of thinking about oil spill liability that might bring about the reformations in offshore oil drilling regulation that many commentators seek.
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Legal Remedies for deep marine oil spills and long term ecological resilience a match made in hell
BYU Law Review, 2011Co-Authors: Robin Kundis CraigAbstract:ABSTRACT The Deepwater Horizon oil spill that lasted from April to September 2010 was not only the worst oil spill disaster in United States history, but also the first to occur at great depth. Drilling at great depth multiplies the risks and complications of offshore oil extraction. It also, as this Article explores, makes natural resource damages a decisively inadequate remedy for the injuries done to the Gulf of Mexico's (the "Gulf") ecosystems, especially the poorly understood but highly productive ecosystems that exist almost a mile below the surface. This Article argues that our current natural resource damages regimes for oil spills depend too heavily on an assumption that ocean areas like the Gulf are stably resilient, able to absorb and recover from an incessant series of environmental insults ranging from widespread loss of wetlands to nutrient pollution and a dead zone to overfishing to continual releases of oil. By acknowledging that disasters like the Deepwater Horizon oil spill could push ecosystems across regimeshifting thresholds into new states, resilience thinking better captures the inherent and unavoidable risks that exploitative activities in the Gulf actually pose to the socio-ecological systems that depend on its continued productive functioning. As a result, resilience thinking can also suggest new and more comprehensive ways of thinking about oil spill liability that might bring about the reformations in offshore oil drilling regulation that many commentators seek. I. INTRODUCTION The Deepwater Horizon oil rig was huge, weighing in at 33,000 tons and supporting four decks of working space and an oil derrick that rose another twenty stories above the platform.1 It cost $350 million to build2 and had arrived at the Macondo lease site on January 31, 2010, to drill the Macondo well for British Petroleum ("BP").3 Less than three months later, "BP and the Macondo well were almost six weeks behind schedule and more than $58 million over budget."4 The commercial pressures BP faced as a result of these cost overruns likely led it to take shortcuts, and these shortcuts probably help to explain why, on the night of April 20, 2010, the Macondo well blew out. The well's explosion engulfed the Deepwater Horizon in flames, requiring abandonment of the rig,5 and killed eleven crew members.6 The rig itself sank into the depths of the Gulf of Mexico (the "GuIf) two days later, on April 22- Earth Day.7 In the aftermath of this human tragedy, concerns about the environment began to grow. Immediate attempts to trigger the rig's "blowout preventer" failed,8 and "[b]y mid-afternoon on April 23, [remotely operated] vehicles discovered that oil was leaking from the end of the riser, where it had broken off from the Deepwater Horizon when the rig sank."9 A second leak was discovered the next day, leading to the Unified Command's announcement "that the riser was leaking oil at a rate of 1000 barrels per day."10 The background of this estimate remains unclear, although the estimate itself appears to have come from BP.11 A few days later, a National Oceanic and Atmospheric Administration ("NOAA") scientist estimated that the well was releasing about 5000 barrels of oil a day, although, given the uncertainties involved in the estimation because of the depth of the leak, he also noted that the flow could have been as much as 10,000 barrels per day.12 Immediate environmental consequences included surface oil slicks, fishery closures,13 contaminated beaches,14 oiled wildlife,15 and increasing reports of health problems among spill workers.16 Oil spill responders sprayed dispersants on the surface oil for twelve weeks,17 releasing far more of these toxic chemicals into the environment than had been used (even then, controversially) after the 1989 Exxon Valdez oil spill in Prince William Sound, Alaska.18 In response to that 1989 oil spill, responders sprayed a total of about 5500 gallons of dispersant, compared to 141,358 gallons sprayed on the Gulf spill during the week of April 27 to May 3, and another 168,988 gallons the following week. …
Mark L Hatzenbuehler - One of the best experts on this subject based on the ideXlab platform.
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Legal Remedies to address stigma based health inequalities in the united states opportunities and challenges
Social Science Research Network, 2019Co-Authors: Valarie Blake, Mark L HatzenbuehlerAbstract:Stigma is an established driver of population-level health outcomes. Antidiscrimination laws can generate or alleviate stigma and, thus, are a critical component in the study of improving population health. Currently, antidiscrimination laws are often underenforced and are sometimes conceptualized by courts and lawmakers in ways that are too narrow to fully reach all forms of stigma and all individuals who are stigmatized. To remedy these limitations, we propose the creation of a new population-level surveillance system of antidiscrimination law and its enforcement, a central body to enforce antidiscrimination laws, as well as a collaborative research initiative to enhance the study of the linkages between health and antidiscrimination law in the future.
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Legal Remedies to address stigma based health inequalities in the united states challenges and opportunities
Milbank Quarterly, 2019Co-Authors: Valarie Blake, Mark L HatzenbuehlerAbstract:Policy Points Stigma is an established driver of population-level health outcomes. Antidiscrimination laws can generate or alleviate stigma and, thus, are a critical component in the study of improving population health. Currently, antidiscrimination laws are often underenforced and are sometimes conceptualized by courts and lawmakers in ways that are too narrow to fully reach all forms of stigma and all individuals who are stigmatized. To remedy these limitations, we propose the creation of a new population-level surveillance system of antidiscrimination law and its enforcement, a central body to enforce antidiscrimination laws, as well as a collaborative research initiative to enhance the study of the linkages between health and antidiscrimination law in the future. Context Stigma is conceptualized as a fundamental cause of population health inequalities. Antidiscrimination law is one important lever that can influence stigma-based health inequities, and yet several challenges currently limit the law's potential to address them. Methods To determine whether antidiscrimination law adequately addresses stigma, we compared antidiscrimination law for its applicability to the domains and statuses where stigma is experienced according to the social science literature. To further examine whether law is a sufficient remedy for stigma, we reviewed law literature and government sources for the adequacy of antidiscrimination law enforcement. We also reviewed the law literature for critiques of antidiscrimination law, which revealed conceptual limits of antidiscrimination law that we applied to the context of stigma. Findings In this article, we explored the importance of antidiscrimination law in addressing the population-level health consequences of stigma and found two key challenges-conceptualization and enforcement-that currently limit its potential. We identified several practical solutions to make antidiscrimination law a more available tool to tackle the health inequities caused by stigma, including (1) the development of a new surveillance system for antidiscrimination laws and their enforcement, (2) an interdisciplinary working group to study the impact of antidiscrimination laws on health, and (3) a central agency tasked with monitoring enforcement of antidiscrimination laws. Conclusions Antidiscrimination law requires better tailoring based on the evidence of who is affected by stigma, as well as where and how stigma occurs, or it will be a poor tool for remedying stigma, regardless of its level of enforcement. Further interdisciplinary research is needed to identify the ways in which law can be crafted into a better tool for redressing the health harms of stigma and to delimit clearer boundaries for when law is and is not the appropriate remedy for these stigma-induced inequities.
Simon Stern - One of the best experts on this subject based on the ideXlab platform.
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Legal Remedies for medical ghostwriting imposing fraud liability on guest authors of ghostwritten articles
PLOS Medicine, 2011Co-Authors: Simon Stern, Trudo LemmensAbstract:There are persistent concerns about the influence of the pharmaceutical and device industries on the medical literature, and particularly on the reporting of clinical trials, which can include the distortion of the true evidence base of medical interventions and overestimation of the clinical benefit of a drug used to treat patients [1]. An especially problematic issue involves the industry practice of publishing studies prepared by hired medical writers but signed by academic “guest authors” who are invited to add their names without fulfilling authorship criteria. In this case, “guest authorship” is accompanied by “ghostwriting,” which occurs when a published article fails to acknowledge the original writer or writers' contributions [2]–[4]. Ghostwriting can also occur when an academic research group uses a professional writer to draft an article based on data generated by the group. When the research group retains control of the data and the final analysis, however, there is less of a concern about possible bias in the reporting of the results, and the appropriate remedy in that case is to report explicitly the role and contribution of the medical writer in the article. Here, we concentrate on ghostwriting and guest authorship in industry-controlled research, where several examples have revealed the use of ghostwriters to insert concealed marketing messages favourable to a company's product, and the recruitment of academics as “guest” authors despite not fulfilling authorship criteria [5]–[9]. Commentators have condemned the practice as unethical and unacceptable and have discussed the harms resulting from this form of medical ghostwriting, recommending that journal submissions be policed more aggressively and that the “guest authors” be suitably sanctioned by journals, academic institutions, and regulatory agencies [1]–[14]. However, these recommendations have not yet been widely embraced by the academic institutions, medical journals, and medical licensing organizations that would seem to have the most at stake in curbing this practice. Here, we discuss some of the reasons for this lack of response and suggest that the law may offer a solution, given these other institutions' failure to impose sanctions.
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Legal Remedies for medical ghostwriting imposing fraud liability on guest authors of ghostwritten articles
2011Co-Authors: Simon Stern, Trudo LemmensAbstract:Ghostwriting and guest authorship of medical journal articles raise serious ethical and Legal concerns, bearing on the integrity of medical research and evidence used in Legal disputes. Ghostwriting involves undisclosed authorship, usually by medical communications agencies or a pharmaceutical sponsor of the published research; guest authorship involves taking authorial credit for the published work without making a substantial contribution to it. Commentators have objected to these practices because of concerns involving bias in ghostwritten clinical trial reports and review articles. We also note the effects of ghostwritten articles on questions involving the Legal admissibility of scientific evidence. Efforts to curb ghostwriting practices, undertaken by medical journals, academic institutions, and professional disciplinary bodies, have thus far had little success and show little promise. These organizations have had difficulty adopting and enforcing effective sanctions, for specific reasons relating to the interests and competencies of each kind of organization. Because of those shortcomings, a useful deterrent in curbing the practice may be achieved through the imposition of Legal liability on the ‘guest authors’ who lend their names to ghostwritten articles. We explore the doctrinal grounds on which such articles might be characterized as fraudulent. A guest author’s claim for credit of an article written by someone else constitutes Legal fraud, and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO). The same fraud could support claims of “fraud on the court” against a pharmaceutical company that has used ghostwritten articles in litigation. This doctrine has been used by the U.S. Supreme Court to impose sanctions on the authors and corporate sponsors of a ghostwritten article. We discuss the potential penalties associated with each of these varieties of fraud.
Leigh T Anenson - One of the best experts on this subject based on the ideXlab platform.
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limiting Legal Remedies an analysis of unclean hands
Social Science Research Network, 2010Co-Authors: Leigh T AnensonAbstract:This article analyzes the extension of the equitable defense of unclean hands to damages actions across federal and state jurisdictions in order to unify this fragmented area of law. The doctrine of “clean hands” (unclean hands) justifies dismissal of a lawsuit where the opposing party has engaged in ilLegal, unethical or unconscionable conduct relating to the case. The defense potentially applies to all claims, statutory and common law. It is one of a few equitable defenses, however, that courts have traditionally limited to lawsuits seeking equitable Remedies (i.e. injunctions, specific performance). Thirty years ago, certain courts began recognizing unclean hands in lawsuits requesting Legal Remedies (i.e. monetary damages). Despite the divisive decisions on its applicability, there has been surprisingly little examination of the defense in damages actions until my recent research. (Anenson 2008; Anenson 2010 in press) This article extends those analyses by providing a fuller explanation of unclean hands by looking at the defense’s doctrinal underpinnings. It describes the arguments over the Legal status of unclean hands and evaluates those justifications in an effort to aid courts in their application of the defense in the future. The study and insight regarding the reception of unclean hands into the most prevalent form of relief in the US also contributes to the worldwide fusion debate (“fusion wars”) concerning the role of equity in Legal actions.
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limiting Legal Remedies an analysis of unclean hands
Kentucky Law Journal, 2010Co-Authors: Leigh T AnensonAbstract:1 Associate Professor, University of Maryland Robert H. Smith School of Business; Of Counsel, Reminger Co., L.P.A. This article was the recipient of the Outstanding Paper Award at the 2009 Annual Conference of the Pacific Southwest Academy of Legal Studies in Business. The author is grateful for the support and comments of the members and attendees of the conference. Thanks also to Abe Herzberg, Julie Manning Magid, Gideon Mark, Kevin Marshall, Don Mayer, Tom Rutledge, Paul von Nessen, and Eric Yordy for their reviews and critiques. This Article was written as part of my doctoral thesis in conjunction with fulfilling the writing requirement for a Doctor of Philosophy at Monash University. Research for the paper was supported by the 2009 Smith School Summer Research Award. 2 Zechariah Chafee, Jr., Coming into Equity with Clean Hands, 47 Mich. L. Rev. 877, 878 (1949) [hereinafter Chafee I]. 3 See T. Leigh Anenson, Treating Equity Like Law: A Post–Merger Justification of Unclean Hands, 45 Am. Bus. L.J. 455, 459 (2008) (“Despite its containment mainly to actions in equity, cases considering the doctrine during the present century already tally in the thousands.” (citation omitted)); see infra note 10 and accompanying text. 4 T. Leigh Anenson, The Role of Equity in Employment Noncompetition Cases, 42 Am. Bus. L.J. 1, 51–52 (2005) [hereinafter Anenson, Role of Equity] (citations omitted) (explaining that unclean hands is broader in application than the defenses of equitable estoppel and waiver); see also T. Leigh Anenson, Beyond Chafee: A Process–Based Theory of Unclean Hands, 47 Am. Bus. L.J. 509, 566–72 (2010) [hereinafter Anenson, Process–Based Theory of Unclean Hands] (comparing unclean hands to estoppel as well as to the Legal doctrines of in pari delicto and fraud on the court). 5 Anenson, supra note 3, at 466 n.63 (“Unclean hands is considerably newer than most equitable doctrines.”); see also Zechariah Chafee, Jr., Some Problems of Equity 2 (1950) (unclean hands “is a rather recent growth”); Id. at 5 (describing unclean hands as “a child beside some other maxims . . . mature in Shakespeare’s day” (citation omitted)). Chief Baron Eyre of the English Court of Exchequer (which had equity powers) adopted the doctrine in Dering v. Earl of Winchelsea, (1787) 29 Eng. Rep. 1184 (Ch.) 1186; 1 Cox Eq. Cas. 318, 319–20.
