美国"无声"的侵权法改革——以产品责任法中的联邦法优先为视角

美国联邦政府机构近几年通过行政法规及导言的方式对美国产品安全标准和产品缺陷判断标准设定各种规则,使消费者通过诉讼获得赔偿屡屡受挫.这被学者们称为"无声的侵权法改革".奥巴马政府上台后对联邦政府机构的这些做法进行了限制,并主张将保护消费者人身安全和健康的权利还给州法院和立法机关.由此,工业界通过政府机构进行的"无声"的侵权法改革受到挫败.     

"Insuring" the continued solvency of pharmaceutical companies in the face of product liability class actions

Costly product liability lawsuits continue to plague the pharmaceutical industry, and insurance to cover these losses is severely inadequate. Furthermore, questionable regulation of drugs exists once a pharmaceutical has passed FDA approval. This article describes a plan that uses a capitalistic, rather than a governmental, approach to solve both the insurance and the quality control problems. Although the proposed plan has never been used to insure pharmaceutical companies, different permutations of it have been used to insure other litigation-prone industries. Success from the proposed insurance entity results from the combined knowledge of scientists and actuaries to provide both protection from product liability lawsuits for the pharmaceutical industry and enhanced post-market surveillance of pharmaceuticals.     

Medical devices; preemption of state product liability claims--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations regarding preemption of State and local requirements applicable to medical devices. This action is being taken to clarify and codify the agency's longstanding position that available legal remedies, including State common law tort claims, generally are not preempted under the Federal Food, Drug, and Cosmetic Act (the act).     

Medical devices; preemption of state product liability claims--FDA. Withdrawal of proposed rule

The Food and Drug Administration (FDA) is announcing that it is withdrawing a proposed rule that published in the Federal Register of December 12, 1997 (62 FR 65384), relating to medical device preemption of State product liability claims. FDA is making this withdrawal because of concerns that have been raised regarding the interplay between the FDA Modernization Act of 1997 (FDAMA) and the proposed rule.     

Legislating for corporate criminal liability in Finland: 22-year long debate revisited

The criminal liability of corporations has been the subject of long debates in many countries. This article scrutinizes the 22-year long genesis of corporate criminal liability legislation in Finland. We are interested in unveiling the turns of the law-making process, and in investigating the struggle between various interest groups from a socio-historical perspective. The research data consist of legislative documents such as committee memorandums and written opinions, and the method of inquiry is content analysis. Our study reveals that the core issue of the process became whether jurisprudential principles should be changed in accordance with societal change or whether they are essentially immutable. The Act of Corporate Criminal Liability took effect in 1995, but its coverage was weakened by imposing discretionary sentencing and leaving employment offences outside of its purview. The initial aim and the very justification of the law—to place liability where it belongs—was achieved only in principle. Furthermore, the final outcome of the 1995 law served to actually prevent corporate misconducts from being processed as crimes.     

Researcher liability for negligence in human subject research: informed consent and researcher malpractice actions

Two sets of federal regulations, the "Common Rule" and Food and Drug Administration (FDA) regulations, govern human subject research that is either federally-funded or involves FDA regulated products. These regulations require, inter alia, that: (1) researchers obtain informed consent from human subjects, and (2) that an Institutional Review Board (IRB) independently review and approve the research protocol. Although the federal regulations do not provide an express cause of action against researchers, research subjects should be able to bring informed consent and malpractice actions against researchers by establishing a duty of care and standard of care. Researchers owe human subjects a duty of care analogous to the special relationship between physicians and patients. The federal regulations should provide the minimum standard of care for informed consent in human subject research, and complying with them should be a partial defense. In contrast, expert testimony should establish the standard of care for researcher malpractice, and IRB approval should be a partial defense.     

The genesis of liability in ancient law

This article considers the emergence and evolution of punitiveand compensatory remedies in ancient law. I describe how ancientpractices of retaliation gradually evolved, through four generalphases, into rules requiring victim's compensation. I suggestthat the Biblical lex talionis ('eye for an eye...life for alife') and similar rules that emerged in other ancient legalsystems triggered an important change in the ancient law ofwrongs, marking the end of a system of retaliatory justice andthe emergence of a system based on victim's compensation. Thepaper addresses four related questions. (1) Why was a singlelimit of 1:1 to talionic penalties introduced across all categoriesof wrongdoing, replacing older customary practices that haddifferent multipliers according to the circumstances of thecase? (2) In the presence of imperfect enforcement, did the1:1 limit to retaliation result in underdeterrence? (3) Whydid the practices of literal talionis rapidly fall into disuseafter written formalization? (4) Where the kofer and blood-moneypayments made under a threat of literal retaliation likely togenerate overextraction from the wrongdoer and excessive deterrence?     

Police civil liability: An analysis of section 1983 actions in the Eastern and Southern districts of New York

This article examines the Section 1983 civil damage remedy and the Bivens-type action — the direct claim of the victim of official wrongdoing to obtain compensation for the denial of his or her Fourth Amendment rights. Using court records of cases filed under this statute from 1983 to 1987 in the Eastern and Southern districts of New York, the study determined: (1) the nature and volume of damages awarded by the courts in Section 1983/Bivens actions, (2) the differences in the amount of damages recovered from bench trials, jury trials, and settlements, (3) the parties involved in Section 1983 suits, (4) the trials and settlements, and (5) the time and resources spent by the parties and the courts on these cases. The analysis of the data was used to gauge the impact of these suits on individual police and police administrators.