"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.     

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.     

Capital punishment in Poland: The debate continues

Throughout its modern history, Poland has not escaped controversies surrounding the use of the death penalty. Tracing the historical development of laws dealing with the issue demonstrates an evolution influenced by various legal, political, social, philosophical, and international factors, leading up to the current absence of the penalty from the Polish legal system. The debate in society revolves around some stereotypical views held by different social groups. One of the biggest challenges is how to reconcile those views with empirical evidence, especially on issues like the deterrent effect of capital punishment. The authors describe the death penalty debate in Poland from these perspectives and take a retentionist position with regard to some selected crimes. As long as there are individuals willing to take other people's lives in a premeditated and deliberate manner demonstrating callous contempt for another person's existence, death remains the only punishment satisfying a sense of social justice and upholding the value of human life.     

澳大利亚联邦法院对专家证据的采纳

I. Introduction
The opinion evidence of experts is an exception to the general rule that witnesses can only give evidence of that which they have seen or heard and may not give evidence of inferences which arise from their observations and from that which they have heard.