{"title":"Prescription for fairness: a new approach to tort liability of brand-name and generic drug manufacturers.","authors":"Allen Rostron","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.</p>","PeriodicalId":47625,"journal":{"name":"Duke Law Journal","volume":"60 5","pages":"1123-91"},"PeriodicalIF":1.9,"publicationDate":"2011-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29708809","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":"Administrative Law, Filter Failure, and Information Capture","authors":"W. Wagner","doi":"10.15781/T2KW57J84","DOIUrl":"https://doi.org/10.15781/T2KW57J84","url":null,"abstract":"There are no provisions in administrative law for regulating the flow of information coming into or leaving the system, or for ensuring that regulatory participants can keep up with a rising tide of issues, details, and technicalities. Indeed, a number of doctrinal refinements, originally intended to ensure that executive branch decisions are made in the sunlight, inadvertently create incentives for participants to overwhelm the administrative system with complex information, causing much of the decisionmaking processes to remain, for all practical purposes, in the dark. As these agency decisions become increasingly obscure to all but the most well-informed insiders, administrative accountability is undermined as entire sectors of affected parties find they can no longer afford to participate in this expensive system. Pluralistic oversight, productive judicial review, and opportunities for intelligent agency decisionmaking are all put under significant strain in a system that refuses to manage - and indeed tends to encourage - excessive information. This Article first discusses how parties can capture the regulatory process using information that allows them to control or at least dominate regulatory outcomes (the information capture phenomenon). It then traces the problem back to a series of failures by Congress and the courts to require some filtering of the information flowing through the system (filter failure). Rather than filtering information, the incentives tilt in the opposite direction and encourage participants to err on the side of providing too much rather than too little information. Evidence is then offered to show how this uncontrolled and excessive information is taking a toll on the basic objectives of administrative governance. The Article closes with a series of unconventional but relatively straightforward reforms that offer some hope of bringing information capture under control.","PeriodicalId":47625,"journal":{"name":"Duke Law Journal","volume":"59 1","pages":"1321-1432"},"PeriodicalIF":1.9,"publicationDate":"2010-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67097467","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":"Wielding the wand without facing the music: allowing utilization review physicians to trump doctors' orders, but protecting them from legal risk ordinarily attached to the medical degree.","authors":"Katherine L Record","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This Note identifies a discrepancy in the law governing the decisionmaking that directs patient care. Seeking treatment that a third party will pay for, a patient needs not only a physician-prescribed course of treatment but also an insurer's verification that the cost is medically necessary or otherwise covered by the patient's plan. Both of these decisions directly impact the ultimate care delivered to the patient, but are governed by two very different liability regimes. A patient who suffers an adverse outcome may sue his physician in tort, while a patient who suffers from a lack of coverage may generally sue his insurer only under contract. In other words, when a patient suffers from inadequate care, his potential remedies vary considerably depending on whether the physician or the insurer is the defendant. This discrepancy in liability is the consequence of the federal law governing the administration of employer-sponsored health plans, and its extensive preemption of related state law. Many commentators have called for legal reform to address the distortion of managed care liability that results, arguing that managed care liability must be consistent or that wronged beneficiaries must have access to meaningful remedies. This Note argues that the federal law governing managed care organizations is problematic for a different reason and that the first step toward reform may be more elementary than previously suggested. Specifically, it suggests that the law governing insurers' coverage decisions is inconsistent with the law governing treatment recommendations. Patients suffer the same harm from error in both contexts-but because they can recover substantially more from treating physicians, doctors are named as defendants even when the insurers make errors. Further, this Note argues that simply aligning these two standards might offer a gateway to reform.</p>","PeriodicalId":47625,"journal":{"name":"Duke Law Journal","volume":"59 5","pages":"955-1000"},"PeriodicalIF":1.9,"publicationDate":"2010-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28783451","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}
Duke Law JournalPub Date : 2010-01-01DOI: 10.1017/cbo9781107477131.007
R. Ginsburg
{"title":"A Postscript to \"Struck by Stereotype\"","authors":"R. Ginsburg","doi":"10.1017/cbo9781107477131.007","DOIUrl":"https://doi.org/10.1017/cbo9781107477131.007","url":null,"abstract":"Reading the account of Captain Susan Struck’s case, vibrantly told by Neil S. Siegel and Reva B. Siegel, brought me back to the summer of 1972. ACLU Legal Office staff counsel Joel M. Gora and I spent many hours in June and July of that year preparing a petition for certiorari, one we hoped would engage the Court’s attention. In the preceding year, the ACLU had taken on, along with Struck, several other cases challenging the rule, then maintained by all the Armed Forces, requiring pregnant service members to choose between abortion and ouster from the military. But Captain Struck’s case was our frontrunner. We aimed to present the issue of reproductive choice through her eyes and experience. Captain Struck chose birth, but her Government made that choice a mandatory ground for discharge. We filed the petition on July 31, 1972 and were elated that fall, when the Court, on October 24, granted certiorari. From the end of October until December 4, when we filed our brief on the merits, the full presentation of Captain Struck’s case was my principal project. But as if synchronized, the Air Force waived Captain Struck’s discharge on the eve of our submission. It was the right decision for the Air Force, and good news for Captain Struck and other service members caught in the same bind. But an ideal case to argue the sex equality dimension of laws and regulations governing pregnancy and childbirth had slipped from our grasp. Perhaps it is indulgence in wishful thinking, but I remain of this view: Had the Court considered Captain Struck’s case, with the benefit of full briefing and oral argument, a dreadful mistake might have been avoided. After homing in on Captain Struck’s plight, what rational jurist could have declared adverse discrimination based on pregnancy not sex-based discrimination at all!","PeriodicalId":47625,"journal":{"name":"Duke Law Journal","volume":"59 1","pages":"799-800"},"PeriodicalIF":1.9,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1017/cbo9781107477131.007","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"57104490","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 Warp and Woof of Statutory Interpretation: Comparing Supreme Court Approaches in Tax Law and Workplace Law","authors":"Corey Ditslear, J. Brudney","doi":"10.2139/SSRN.1485042","DOIUrl":"https://doi.org/10.2139/SSRN.1485042","url":null,"abstract":"Debates about statutory interpretation - and especially about the role of the canons of construction and legislative history - are generally framed in one-size-fits-all terms. Yet federal judges - including most Supreme Court Justices - have not approached statutory interpretation from a methodologically uniform perspective. This Article presents the first in-depth examination of interpretive approaches taken in two distinct subject areas over an extended period of time. Professors Brudney and Ditslear compare how the Supreme Court has relied on legislative history and the canons of construction when construing tax statutes and workplace statutes from 1969 to 2008. The authors conclude that the Justices tend to rely on legislative history for importantly different reasons in these two fields. The Court regularly invokes committee reports and floor statements in the workplace law area for the traditional role of identifying and elaborating on the legislative bargain that Congress reached. By contrast, the Justices often rely on the legislative history accompanying tax statutes to borrow expertise from key committee actors. The Court’s use of tax legislative history for expertise borrowing purposes relates to the distinctive nature of how tax legislative history is produced, featuring regular cross-party and interbranch cooperation that is virtually unimaginable in the workplace law setting. Although most Justices have appreciated the special character of tax legislative history, Justice Scalia remains steadfast in his unwillingness to do so.With respect to the use of canons, Brudney and Ditslear find that the Court makes comparatively heavier use of the whole act rule and related structural canons in its tax majorities. The authors suggest that the Justices may recognize the Internal Revenue Code to be more of a coherent and self-contained regulatory scheme than the series of workplace law statutes scattered across multiple titles of the U.S. Code. As for substantive canons, the Justices are much more likely to invoke tax-based judicial policy norms than to rely on canons grounded in the specifics of workplace law. The authors contend that the Court’s use of these tax law canons should be viewed as a derivative form of expertise borrowing.Finally, Brudney and Ditslear explore the special role played by Justice Blackmun in the tax area. They demonstrate how Blackmun’s expertise in tax law and his attentiveness to its rich legislative history anchored the Court’s performance for twenty-four years. Since Blackmun’s retirement, the other Justices have been less interested in reviewing tax cases and far less willing to use legislative history when they choose to decide such cases.The evidence that familiar interpretive resources play distinctive roles in the area of tax law contributes to a subtler and richer texture for statutory interpretation than is often captured in scholarly debates. At the same time, the authors’ results also indicate that the C","PeriodicalId":47625,"journal":{"name":"Duke Law Journal","volume":"58 1","pages":"1231-1311"},"PeriodicalIF":1.9,"publicationDate":"2009-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68186167","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":"Remaking the United States Supreme Court in the Courts' of Appeals Image","authors":"C. Guthrie, Tracey E. George","doi":"10.2139/SSRN.1374449","DOIUrl":"https://doi.org/10.2139/SSRN.1374449","url":null,"abstract":"We argue that Congress should remake the United States Supreme Court in the U.S. courts' of appeals image by increasing the size of the Court's membership, authorizing panel decisionmaking, and retaining an en banc procedure for select cases. In doing so, Congress would expand the Court's capacity to decide cases, facilitating enhanced clarity and consistency in the law as well as heightened monitoring of lower courts and the other branches. Remaking the Court in this way would not only expand the Court's decisionmaking capacity but also improve the Court's composition, competence, and functioning.","PeriodicalId":47625,"journal":{"name":"Duke Law Journal","volume":"58 1","pages":"1439-1475"},"PeriodicalIF":1.9,"publicationDate":"2009-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68172485","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":"Abandonment and reconciliation: addressing political and common law objections to fetal homicide laws.","authors":"Douglas S Curran","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Fetal homicide laws criminalize killing a fetus largely to the same extent as killing any other human being. Historically, the common law did not generally recognize feticide as a crime, but this was because of the evidentiary \"born-alive\" rule, not because of the substantive understanding of the term \"human being.\" As medicine and science have advanced, states have become increasingly willing to abandon this evidentiary rule and to criminalize feticide as homicide. Although most states have recognized the crime of fetal homicide, fourteen have not. This is largely the result of two independent obstacles: (judicial) adherence to the born-alive rule and (legislative) concern that fetal homicide laws could erode constitutionally protected reproductive rights. This Note explores a variety of fetal homicide laws that states have adopted, demonstrating that popular opinion has shifted toward recognizing this crime. It then directly confronts the objections that have prevented other states from adopting such laws: it first reviews the literature suggesting that the born-alive rule should be abandoned, as it is an obsolete evidentiary standard; it then argues that constitutionally protected reproductive liberties can be reconciled with, and in fact augmented by, punishing the killing of a fetus as a homicide.</p>","PeriodicalId":47625,"journal":{"name":"Duke Law Journal","volume":"58 6","pages":"1107-42"},"PeriodicalIF":1.9,"publicationDate":"2009-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28100193","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":"Regulation with placebo effects.","authors":"Anup Malani","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>A growing scientific literature supports the existence of placebo effects from a wide range of health interventions and for a range of medical conditions. This Article reviews this literature, examines the implications for law and policy, and suggests future areas for research on placebo effects. In particular, it makes the case for altering the drug approval process to account for, if not credit, placebo effects. It recommends that evidence of placebo effects be permitted as a defense in cases alleging violations of informed consent or false advertising. Finally, it finds that tort law already has doctrines such as joint and several liability to account for placebo effects. Future research on placebo effects should focus on whether awareness of placebo effects can disable these effects and whether subjects can control their own placebo effects.</p>","PeriodicalId":47625,"journal":{"name":"Duke Law Journal","volume":"58 3","pages":"411-72."},"PeriodicalIF":1.9,"publicationDate":"2008-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28100191","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 right's reasons: constitutional conflict and the spread of woman-protective antiabortion argument.","authors":"Reva B Siegel","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":47625,"journal":{"name":"Duke Law Journal","volume":"57 6","pages":"1641-92"},"PeriodicalIF":1.9,"publicationDate":"2008-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27922421","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":"Economic Foundations of Intellectual Property Rights","authors":"J. Stiglitz","doi":"10.7916/D8474M9P","DOIUrl":"https://doi.org/10.7916/D8474M9P","url":null,"abstract":"My work in the economics of innovation began some forty years ago. I realized, as I was beginning my work on the Economics of Information, that knowledge and information are very similar. In fact, you can view information as a particular kind of knowledge, and so the problems that I was analyzing at the time, such as how well the market economy deals with information, corresponded to the question of how well the market economy deals with knowledge. My work showed that the standard paradigm (the neoclassical model, which argued that well-functioning markets solved all economic problems) just did not work when information was imperfect and endogenous (that is, could be affected by what individuals or firms did), and, by extension, when knowledge is endogenous (that is, when technology is changing). Adam Smith’s theory argued that individuals in pursuit of their self-interest (firms in pursuit of maximizing profits) were led as if by an invisible hand to the general well-being of society. One of the important results of my work, developed in a number of my papers, was that the invisible hand often seemed invisible because it was not there.","PeriodicalId":47625,"journal":{"name":"Duke Law Journal","volume":"54 1","pages":"1693-1724"},"PeriodicalIF":1.9,"publicationDate":"2008-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71364624","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}