Just compensation: a no-fault proposal for research-related injuries

Biomedical research, no matter how well designed and ethically conducted, carries uncertainties and exposes participants to risk of injury. Research injuries can range from the relatively minor to those that result in hospitalization, permanent disability, or even death. Participants might also suffer a range of economic harms related to their injuries. Unlike the vast majority of developed countries, which have implemented no-fault compensation systems, the United States continues to rely on the tort system to compensate injured research participants—an approach that is no longer morally defensible. Despite decades of US advisory panels advocating for no-fault compensation, little progress has been made. Accordingly, this article proposes a novel and necessary no-fault compensation system, grounded in the ethical notion of compensatory justice. This first-of-its-kind concrete proposal aims to treat like cases alike, offer fair compensation, and disburse compensation with maximum efficiency and minimum administrative cost. It also harmonizes national and international approaches—an increasingly important goal as research becomes more globalized, multi-site trials grow in number, and institutions and sponsors in the United States move to single-IRB review.     

域外医疗损害无过失补偿制度研究

如何实现医疗损害的合理分担和对医疗损害被害人的充分救济,是世界各国普遍面临的难题。新西兰、瑞典、美国和法国等国家都较为重视对医疗损害被害人的补偿,先后建立了契合本国实际的、各具特色的医疗损害无过失补偿制度,并以立法和修法的形式实现制度的确立与变革。     

Bad medicine: prescription drugs, preemption, and the potential for a no-fault fix

For decades, federal regulation of pharmaceutical drugs and medical devices has worked hand in hand with state tort claims to protect the health and safety of the American public. Now, a new trend toward preemption endangers this scheme. In recent years, the Supreme Court has given increasing deference to agency assertions about their preemptive authority and has found preemption in an increasing number of cases. In the process, the Supreme Court has preempted claims for medical device injuries and left claims for pharmaceutical harms in a precarious position. The elimination of common law claims for drug and device harms will leave holes in the FDA's regulatory scheme, endangering the health and safety of Americans. It will also prevent ordinary Americans from seeking compensation for their injuries--even those injuries caused by manufacturer malfeasance. This Article proposes that Congress create a no-fault compensation scheme for drugs and medical devices to close these gaps. Such a scheme could be both practical and politically possible, satisfying manufacturers, tort reformers, patients, and plaintiffs' lawyers alike.     

民法典离婚损害赔偿制度法律适用的疑难问题

离婚损害赔偿在性质上属离异损害赔偿,与夫妻间侵权责任彼此独立但存在一定的交叉。《民法典》第1091条新增"其他重大过错"的范围应以是否严重违反家庭义务或家庭伦理,以至于威胁到共同生活的可能性作为判断标准。重大过错行为与离婚之间因果关系的认定应采推定原则。离婚赔偿范围仅指因离婚造成的精神损害,而不包括财产损害;离婚精神损害赔偿金数额的确定应将与婚姻家庭有关的特殊因素纳入考量范畴。为避免双重赔偿与过度惩罚,在司法实践中,应注意离婚损害赔偿制度与离婚财产分割之照顾无过错方原则以及夫妻间侵权责任制度的协调适用。     

Ethical issues in international biomedical research: an overview

Human subjects research has been the focus of numerous controversies over the years. The dilemma lies between the potential harm to individuals who participate in research and the knowledge to be gained from the research study that might benefit society. When research is conducted in developing countries by researchers and sponsors from the United States and other industrialized countries, differences in history, culture, politics, wealth, and power between the countries give rise to unique challenges. In this Article, the author identifies several ethical issues to be considered when research is conducted in developing countries and provides the legal and ethical framework for their resolution.     

论过度医疗侵权责任及其法律救济

过度医疗侵权责任是过度医疗侵权行为中患者合法权益救济与过度医疗侵权行为法律规制的核心问题。《侵权责任法》第63条法律适用中最大障碍性因素,是法律意义上的过度医疗如何界定与过度医疗侵权责任构成明晰问题。对过度医疗内涵法律界定与过度医疗侵权责任构成分析,应综合侵权行为一般本质、医疗侵权行为特殊本质以及过度医疗行为性质及其固有属性来进行。过度医疗侵权应适用过错推定责任进行归责,并应适用全面赔偿原则。过度医疗中由于医师履行告知义务的违法性与患者知情同意侵权行为产生竞合,在过度医疗侵权法律救济中,两种诉由皆可适用。应对《侵权责任法》第63条进行立法扩充解释,对过度医疗及认定标准进一步作出司法解释。     

Navigating the Legal System After a Motor Vehicle Collision

More often than not, individuals involved in motor vehicle collisions (MVCs) do not sustain physical injuries. When individuals are involved in serious, injury-causing MVCs, the consequences may be devastating. Injured persons sometimes elect to pursue legal action to address the medical costs incurred and earning losses experienced in association with their injuries and the resulting impairments in function. This article presents a comprehensive review of the requirements of MVC-related litigation and the laws that govern this process, with emphasis placed on Ontario law in effect at the time of writing. Information considered germane to the decision to pursue legal action is reviewed, including the likely settlement amount, length of the legal process, costs associated with legal services and fee agreements that govern remuneration paid to the lawyer. Also described are no-fault regime and civil lawsuit, the two avenues of compensation that injured persons can pursue in an effort to recover losses and obtain the assistance they need to recover from their MVC-related injuries.     

Legal considerations of sleep deprivation among resident physicians

Medical training in the United States often takes the form of a grueling endurance test in which patients are often those most at risk. This Article discusses sleep deprivation among resident physicians in the United States with an eye towards resolving the problem through legal channels. It analyzes the effects of sleep deprivation on resident physicians, with subsequent discussion of the implications for patient care and medical training. Next, it makes comparisons to medical training in other developed nations, as well as regulations that exist in the airline and trucking industries, where public safety is a principal concern. Furthermore, this Article discusses proposals to mend the dilemmas created by sleep-deprived resident physicians through statutory and regulatory reform, deterrence by way of tort law, and unionization or collective bargaining.     

《民法典》环境侵权惩罚性赔偿制度之功能剖辨

《民法典》侵权责任编第1232条规定的环境侵权惩罚性赔偿制度,是一项新增制度.从内在机理审视,惩罚主义理论或功利主义理论均难以为环境侵权惩罚性赔偿制度的"惩罚"功能提供理论支撑.从规则体系审视,若赋予该制度"惩罚"功能,则错置了侵权责任的保护客体,混同了生态环境保护中私法机制与公法机制,忽视了"环境损害"救济法律机制体...     

新自由主义对美英国家刑事法制的影响及反思

从一国或地区的政治经济体制来理解其刑事法制,可以以相对宏观的视角把握其刑事法制脉络。美国刑事法制自20世纪70年代以来发生了深刻变化,从刑事法制基本观念到具体实践都渗透强烈的报应主义色彩,而隐藏其后则是新自由主义思潮。美国刑事法制的转变也影响着英国等国家。对这一思潮进行研究,一方面可以对这些国家刑事法制过去半个世纪发展脉络进行整体把握,另一方面也为分析研究这些国家刑事法制提供了一个更具批判性的视角。     

Economic origins of the no-fault divorce revolution

Richard Posner argues that late twentieth-century divorce-law reform rendered marital relationships in the United States increasingly contractual in nature. Chief among such reforms was the no-fault divorce revolution: the widespread switch in states’ legal regimes from fault-based, mutual-consent divorce to no-fault based, unilateral divorce, which swept across America in the 1970s. While a growing literature considers the no-fault divorce revolution’s effects on divorce rates, almost no work considers its causes. Taking Posner’s observation as its starting point, this paper develops testable hypotheses relating to the potential origins of no-fault divorce reforms in the US.     

Limiting Liability for Automobile Accidents: Are No-Fault Tort Thresholds Effective?

"No-fault" automobile insurance plans are designed to supplant the tort system by requiring motorists to purchase no-fault insurance and allowing victims to file liability insurance claims and tort suits only if their injuries exceed a legislated "tort threshold." While thresholds vary among states, many are satisfied if the victim incurs medical expenses as low as a few hundred dollars. Using insurance claims data, we estimate the effectiveness of several states' thresholds. We find that tort thresholds are surprisingly effective: modest tort thresholds reduce the number of successful tort claimants by half, and the strictest thresholds may exclude nine-tenths of potential claimants. Moreover, we find little evidence of claimants "padding" their claims to exceed the dollar thresholds.     

工伤补偿制度:起源、问题与解决

社会化的工伤保险制度系因应工业社会中频发的工伤而产生,在一些国家是工伤补偿以禁止劳动者对雇主请求民事侵权赔偿为前提的,除第三人侵权情形外,我国亦是如此.但工伤补偿和民事侵权赔偿的差异,导致了两个方面的问题:劳动者无法获得充分赔偿和雇主对安全问题的懈怠,这要求工伤补偿与民事侵权赔偿之间的制度衔接.工伤补偿制度仅应适用于无过错责任,在雇主存在过错的情况下,应赋予劳动者独立的民事侵权责任求偿权,确立过错责任和无过错责任之间补充的关系.     

论生态环境损害的补偿体系

生态环境损害有其特殊性,这种特殊性使得传统侵权制度的功能受到限制,中国有必要借鉴西方国家的制度,针对生态环境损害建立一个综合性的补偿体系。     

医疗损害责任评析

《侵权责任法》中关于医疗损害侵权责任的规定,明确了过错责任原则。过错判断标准,强调了“说明义务”和“知情同意”,提出有限度适用无过错责任原则,对规范医疗损害赔偿具有积极意义。同时对司法鉴定工作也提出了新的要求。需要司法鉴定行业积极应对。     

The jury is still in: Florida's Birth-Related Neurological Injury Compensation Plan after a decade

Florida's Birth-Related Neurological Injury Compensation Plan (NICA) is the most significant experiment with compensation for medical injury yet undertaken in the United States. As NICA enters its second decade of operation, maintaining the scheme's jurisdictional integrity has emerged as a key challenge for policy makers in Florida. We explore the relationship that has emerged between NICA and the tort system as competing avenues for families to obtain compensation for severe birth-related neurological injury. By linking NICA claims data with data on malpractice claims filed in Florida, we found a lively persistence of "bad baby" litigation despite NICA's implementation. Many families pursued claims in both fora. An explanation for these results can be traced to key features of the plan's design--primarily, the way in which "exclusive" jurisdiction over injuries is determined and the restrictive nature of the compensation criteria used. Our findings may help efforts to consolidate NICA's role in injury compensation and inform future design of alternative compensation systems.     

海上人身损害赔偿案件连带责任的法律适用

因船舶碰撞造成海上人身损害属于典型的共同侵权行为。如受害方仅向造成碰撞事故的一方侵权人提出赔偿请求,法院是否应当追加另一方侵权人为共同被告?根据《关于审理人身损害赔偿案件适用法律若干问题的解释》第5条规定,在共同侵权诉讼中,法院应将没有被起诉的侵权人追加进来。但作为民法的特别法,《中华人民共和国海商法》对有关人身损害赔偿的规定,应较一般法律规定优先适用。因此,受害方仅向造成碰撞事故的一方侵权人提出赔偿请求的,法院不追加未被起诉的其他共同侵权人的做法,符合《中华人民共和国海商法》有关规定及"不告不理"的司法原则。