{"title":"Dirty dancing--the FDA stumbles with the Chevron two-step: a response to professor Noah.","authors":"Gary Lawson","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":51518,"journal":{"name":"Cornell Law Review","volume":"93 5","pages":"927-38"},"PeriodicalIF":2.5,"publicationDate":"2008-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27527766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Losing deference in the FDA's second century: judicial review, politics, and a diminished legacy of expertise.","authors":"James T O'Reilly","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":51518,"journal":{"name":"Cornell Law Review","volume":"93 5","pages":"939-80"},"PeriodicalIF":2.5,"publicationDate":"2008-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27527767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Drug review \"behind the curtain\": a response to Professor Struve.","authors":"James T O'Reilly","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":51518,"journal":{"name":"Cornell Law Review","volume":"93 5","pages":"1075-90"},"PeriodicalIF":2.5,"publicationDate":"2008-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27527773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This Article explores the evolution and interaction of the legal and cultural categories "food" and "drug" from the late nineteenth century to the present. The federal statutory definitions of "food" and "drug" have always been ambiguous and plastic, providing the FDA with significant regulatory flexibility. Nevertheless, the agency is not necessarily free to interpret the definitions however it chooses. "Food" and "drug" are not only product classes defined by food and drug law, but also fundamental cultural concepts. This Article demonstrates that the FDA, as well as Congress and the courts, have operated within a constraining cultural matrix that has limited their freedom to impose their preferred understandings of these categories on American society. Nonetheless, history also provides ample evidence that lawmakers possess substantial power to mold the legal categories of "food" and "drug" so as to advance desired policies. One explanation for this regulatory flexibility in the face of deep-seated cultural conceptions is the indeterminate nature of the extralegal notions of "food" and "drug." The terms, as commonly understood, embrace nebulous, overlapping, and constantly evolving realms. Moreover, the relationship between culture and law is not a one-way street with respect to these categories. Although the regulatory apparatus has always had to take into account the extralegal understandings of "food" and "drug," the law in turn has exerted significant influence over their meaning in broader culture.
{"title":"Food, drugs, and droods: a historical consideration of definitions and categories in American food and drug law.","authors":"Lewis A Grossman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This Article explores the evolution and interaction of the legal and cultural categories \"food\" and \"drug\" from the late nineteenth century to the present. The federal statutory definitions of \"food\" and \"drug\" have always been ambiguous and plastic, providing the FDA with significant regulatory flexibility. Nevertheless, the agency is not necessarily free to interpret the definitions however it chooses. \"Food\" and \"drug\" are not only product classes defined by food and drug law, but also fundamental cultural concepts. This Article demonstrates that the FDA, as well as Congress and the courts, have operated within a constraining cultural matrix that has limited their freedom to impose their preferred understandings of these categories on American society. Nonetheless, history also provides ample evidence that lawmakers possess substantial power to mold the legal categories of \"food\" and \"drug\" so as to advance desired policies. One explanation for this regulatory flexibility in the face of deep-seated cultural conceptions is the indeterminate nature of the extralegal notions of \"food\" and \"drug.\" The terms, as commonly understood, embrace nebulous, overlapping, and constantly evolving realms. Moreover, the relationship between culture and law is not a one-way street with respect to these categories. Although the regulatory apparatus has always had to take into account the extralegal understandings of \"food\" and \"drug,\" the law in turn has exerted significant influence over their meaning in broader culture.</p>","PeriodicalId":51518,"journal":{"name":"Cornell Law Review","volume":"93 5","pages":"1091-148"},"PeriodicalIF":2.5,"publicationDate":"2008-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27529275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The little agency that could (act with indifference to constitutional and statutory strictures).","authors":"Lars Noah","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":51518,"journal":{"name":"Cornell Law Review","volume":"93 5","pages":"901-26"},"PeriodicalIF":2.5,"publicationDate":"2008-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27527765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Greater and lesser powers of tort reform: the primary jurisdiction doctrine and state-law claims concerning FDA-approved products.","authors":"Catherine T Struve","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":51518,"journal":{"name":"Cornell Law Review","volume":"93 5","pages":"1039-74"},"PeriodicalIF":2.5,"publicationDate":"2008-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27527772","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The FDA and deference lost: a self-inflicted wound or the product of a wounded agency? A response to Professor O'Reilly.","authors":"David C Vladeck","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":51518,"journal":{"name":"Cornell Law Review","volume":"93 5","pages":"981-1002"},"PeriodicalIF":2.5,"publicationDate":"2008-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27527769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
"It's a Wonderful Life," the title of Frank Capra's classic 1946 movie, seems to encapsulate a fundamental all-American conviction. Unsurprisingly, several courts and jurists have applied the movie-title maxim as the ultimate retort to one of the most intriguing questions in modern tort discourse: Is it possible to say that a severely disabled child has been harmed by the mere fact of being born? Wrongful life claimants answer in the affirmative, whereas Capra's aphorism makes a compelling counter-argument. In my opinion, the contrasting views represent equally legitimate subjective beliefs rather than objective truths, so neither may ever prevail. Without a satisfactory solution from conventional wisdom, the life-as-injury debate may be the Gordian knot of tort law. The purpose of this Article is to cut, rather than untie, the knot: Allow the child to recover without challenging or validating the deep-seated perception of life. Part I shows that hostility to liability in tort for wrongful life is almost universal, crossing lands and seas. Part II argues that this demurral is ultimately rooted in the absence of one of the central components of the cause of action. A tort action must fail because of the inability--both logical and practical--to establish "harm" under the traditional definition of this term. Part III opines that because the Gordian knot of tort law cannot be untied, it must be cut altogether. We must replace the traditional tort framework, which gives rise to an insoluble problem, with a more promising contractual framework inspired by the celebrated case of Hawkins v. McGee. In my view, the child may base an action on the claim that the defendant promised the parents that the child would be born without a certain defect and that the promise went unfulfilled. In formal terms, the child is an intended third party beneficiary of the contract between the parents and the consultant in which the latter warranted birth without a particular disability. The warranty of the future child's physical integrity and health, an integral and inseparable part of the contract, should form the basis of the child's cause of action.
弗兰克·卡普拉(Frank Capra) 1946年的经典电影《生活多美好》(It's a Wonderful Life)的片名,似乎概括了一种基本的美国信念。毫不奇怪,一些法院和法学家将电影标题的格言作为现代侵权话语中最有趣的问题之一的终极反驳:是否有可能说一个严重残疾的孩子仅仅因为出生的事实就受到了伤害?错误的生命索赔者的回答是肯定的,而卡普拉的格言则提出了一个令人信服的反论点。在我看来,这两种截然不同的观点代表了同样合理的主观信念,而不是客观真理,因此两种观点都不可能占上风。从传统的观点来看,没有一个令人满意的解决方案,生命即伤害的争论可能是侵权法的死结。这篇文章的目的是切断而不是解开这个结:允许孩子在不挑战或验证对生活的根深蒂固的看法的情况下恢复过来。第一部分表明,对过错生命侵权责任的敌意几乎是普遍存在的,跨越了陆地和海洋。第二部分认为,这种异议的最终根源在于缺乏诉因的一个核心组成部分。侵权行为必须失败,因为在逻辑上和实践上都无法根据这一术语的传统定义确立“损害”。第三部分认为,由于侵权法的“死结”无法解开,因此必须彻底斩断。我们必须用受著名的Hawkins诉McGee案启发的更具前景的合同框架来取代传统的侵权框架,因为它会产生一个无法解决的问题。在我看来,孩子可以根据被告向父母承诺孩子出生时不会有某种缺陷,而这一承诺没有兑现的主张提起诉讼。在正式情况下,儿童是父母和顾问之间的合同的预定第三方受益人,后者在合同中保证没有特别残疾的出生。对未来儿童身体完整和健康的保证是合同不可分割的组成部分,应构成儿童诉因的基础。
{"title":"It's a wonderful life: is it possible to say that a severely disabled child has been harmed by the mere fact of being born?","authors":"Ronen Perry","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>\"It's a Wonderful Life,\" the title of Frank Capra's classic 1946 movie, seems to encapsulate a fundamental all-American conviction. Unsurprisingly, several courts and jurists have applied the movie-title maxim as the ultimate retort to one of the most intriguing questions in modern tort discourse: Is it possible to say that a severely disabled child has been harmed by the mere fact of being born? Wrongful life claimants answer in the affirmative, whereas Capra's aphorism makes a compelling counter-argument. In my opinion, the contrasting views represent equally legitimate subjective beliefs rather than objective truths, so neither may ever prevail. Without a satisfactory solution from conventional wisdom, the life-as-injury debate may be the Gordian knot of tort law. The purpose of this Article is to cut, rather than untie, the knot: Allow the child to recover without challenging or validating the deep-seated perception of life. Part I shows that hostility to liability in tort for wrongful life is almost universal, crossing lands and seas. Part II argues that this demurral is ultimately rooted in the absence of one of the central components of the cause of action. A tort action must fail because of the inability--both logical and practical--to establish \"harm\" under the traditional definition of this term. Part III opines that because the Gordian knot of tort law cannot be untied, it must be cut altogether. We must replace the traditional tort framework, which gives rise to an insoluble problem, with a more promising contractual framework inspired by the celebrated case of Hawkins v. McGee. In my view, the child may base an action on the claim that the defendant promised the parents that the child would be born without a certain defect and that the promise went unfulfilled. In formal terms, the child is an intended third party beneficiary of the contract between the parents and the consultant in which the latter warranted birth without a particular disability. The warranty of the future child's physical integrity and health, an integral and inseparable part of the contract, should form the basis of the child's cause of action.</p>","PeriodicalId":51518,"journal":{"name":"Cornell Law Review","volume":"93 2","pages":"329-400"},"PeriodicalIF":2.5,"publicationDate":"2007-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27333452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This article uses unique data from over 300 criminal trials in four large counties to study the relations between the existence of a prior criminal record and defendants testifying at trial, between testifying at trial and juries' learning about a criminal record, and between juries' learning about a criminal record and their decisions to convict or acquit. Sixty percent of defendants without criminal records testified compared to 45 percent with criminal records. For testifying defendants with criminal records, juries learned of those records in about half the cases. Juries rarely learned about criminal records unless defendants testified. After controlling for evidentiary strength and other factors, statistically significant associations exist (1) between the existence of a criminal record and the decision to testify at trial, (2) between the defendant testifying at trial and the jury learning about the defendant's prior record, and (3) in cases with weak evidence, between the jury learning of a criminal record and conviction. For cases with strong evidence against defendants, learning of criminal records is not strongly associated with conviction rates. Juries appear to rely on criminal records to convict when other evidence in the case normally would not support conviction. Use of prior record evidence may therefore lead to erroneous convictions. Prosecutors and judges should consider the increased likelihood of erroneous conviction based on use of prior convictions in decisions to prosecute and in evidentiary rulings.
{"title":"Taking a Stand on Taking the Stand: The Effect of a Prior Criminal Record on the Decision to Testify and On Trial Outcomes","authors":"T. Eisenberg, V. Hans","doi":"10.2139/SSRN.998529","DOIUrl":"https://doi.org/10.2139/SSRN.998529","url":null,"abstract":"This article uses unique data from over 300 criminal trials in four large counties to study the relations between the existence of a prior criminal record and defendants testifying at trial, between testifying at trial and juries' learning about a criminal record, and between juries' learning about a criminal record and their decisions to convict or acquit. Sixty percent of defendants without criminal records testified compared to 45 percent with criminal records. For testifying defendants with criminal records, juries learned of those records in about half the cases. Juries rarely learned about criminal records unless defendants testified. After controlling for evidentiary strength and other factors, statistically significant associations exist (1) between the existence of a criminal record and the decision to testify at trial, (2) between the defendant testifying at trial and the jury learning about the defendant's prior record, and (3) in cases with weak evidence, between the jury learning of a criminal record and conviction. For cases with strong evidence against defendants, learning of criminal records is not strongly associated with conviction rates. Juries appear to rely on criminal records to convict when other evidence in the case normally would not support conviction. Use of prior record evidence may therefore lead to erroneous convictions. Prosecutors and judges should consider the increased likelihood of erroneous conviction based on use of prior convictions in decisions to prosecute and in evidentiary rulings.","PeriodicalId":51518,"journal":{"name":"Cornell Law Review","volume":"94 1","pages":"1353"},"PeriodicalIF":2.5,"publicationDate":"2007-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67936580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}