Off-Label Prescribing by Psychiatrists: What is the Practitioner's Liability?

In psychiatry, the molecules available and the dosages recommended when a drug receives marketing authorization are not always adequate to treat patients with major behavioral disturbances. Off-label prescribing is frequent in this context, with regard to the indications and the dosages given as well as to the drug combinations used. However, if complications or death occur, the practitioner's liability may be engaged. The authors report three deaths attributed to off-label prescribing in psychiatry and which led to charges against the physicians. They review the precautions to be taken when prescribing in such conditions (no other possible treatment, existence of sound scientific evidence, consent obtained from the patient, or their legal representatives except in cases of force majeure) and the physician's liability if adverse events occur that could be attributed to off-label prescribing.     

Fly by Night or Face the Music? Premature Dissolution and the Desirability of Extended Liability

Premature dissolution can be a rational corporate response tothe threat of future liability. Although early dissolution iscostly to a firm, liability may be more so. The way in whichliability rules can exacerbate this extreme form of liabilityavoidance is of interest, since "fly-by-night" firms generateparticularly large social costs. In particular, we explore theconsequences of liability that is extended to the business partnersof an insolvent or absent tortfeasor—a relatively commonlegal response when tortfeasors abandon obligations. Extendedliability can be desirable; however, if extended liability isanticipated, business partners themselves may choose to flyby night. We show how the preferred liability rule, includingno liability, depends on the relative costs of premature dissolutionand future obligations. The analysis also sheds light on a setof interrelated legal issues, such as the role of the trustfund doctrine and state dissolution statutes.     

Strict Liability’s Criminogenic Effect

It is easy to understand the apparent appeal of strict liability to policymakers and legal reformers seeking to reduce crime: if the criminal law can do away with its traditional culpability requirement, it can increase the likelihood of conviction and punishment of those who engage in prohibited conduct or bring about prohibited harm or evil. And such an increase in punishment rate can enhance the crime-control effectiveness of a system built upon general deterrence or incapacitation of the dangerous. Similar arguments support the use of criminal liability for regulatory offenses. Greater punishment rates suggest greater compliance. But this analysis fails to appreciate the crime-control costs of strict liability. By explicitly providing for punishment in the absence of moral blameworthiness, the law undermines its moral credibility with the community and thereby provokes subversion and resistance instead of the cooperation and acquiescence it needs for effective crime control. More importantly, the system’s lost moral credibility undermines the law’s ability to harness the powerful forces of stigmatization, social influence, and internalized norms. Given the serious limitations inherent in the real-world application of general deterrence and preventive detention programs, the most effective crime-control strategy is to build the criminal law’s reputation for being just, which means avoiding the use of strict liability.     

Command Responsibility: Mode of Liability for the Crimes of Subordinates or Separate Offence of the Superior?

The nature of command responsibility is still open to debatein international criminal law: is a superior to be held criminallyresponsible for the crimes committed by his subordinates ‘asan accomplice’, for having participated in the commissionof the crime by omission, or as a perpetrator of a separateoffence of dereliction of duty? This article surveys the post-WW2case law and the first international instruments on this point,and then analyses the jurisprudence of the International CriminalTribunal for the former Yugoslavia (ICTY). The judges appearto have recently adopted a new approach to Article 7(3) ICTYSt.in that the superior is held responsible ‘for failureto prevent or punish with regard to the crimes of the subordinate’and no longer ‘for the crimes of his subordinates’.It is a responsibility ‘sui generis’ indeed, wherethe crime of the subordinate plays a central role in the attributionof responsibility to the superior. It is, therefore, necessaryto carefully consider the relationship between the superior'sfailure to act and the subordinate's crime, both with regardto objective and subjective elements. The same question finallyarises in relation to Article 28 of the Rome Statute, the literalinterpretation of which implies that a superior shall be punishedfor the same crime committed by his subordinates. In order toavoid the risk of holding a person guilty of an offence committedby others in violation of the principle of personal and culpablecriminal responsibility, it is crucial to consider separatelythe different cases of command responsibility, which are basedon distinct objective and subjective requirements.     

Is the European Medical Products Authorisation Regulation Equipped to Cope with the Challenges of Nanomedicines?

This article analyses the emerging European regulatory activities in relation to nanopharmaceuticals. The central question is whether the regulatory responses are appropriate to cope with the regulatory problems nanomedicinal development is posing. The article explores whether the medical product regulations are robust enough, whether there are certain regulatory gaps, and whether the competent bodies have the expertise to evaluate nanomedicinal products when approval is applied for. Based on a social‐constructive approach, the article identifies significant regulatory actors, their ideas on regulatory problems, and preliminary governance responses to them. It finds that the current dynamic regulatory structure appears robust enough to adapt to some of the technological challenges posed by nanomedicines. It concludes that regulators have not yet responded adequately to regulatory gaps related to definitions, classification and specific safety, quality, and efficacy standards that nanopharmaceutical development seems to require. As a consequence of these deficiencies legal certainty, a principle of high priority in European medical regulation policy, cannot be sufficiently provided.     

Is There a Case for Strict Liability?

In this short paper, I shall answer the title’s question first in the context of criminal law and then in the context of tort law. In that latter section, I shall also mention in passing contractual and other forms of civil liability that are strict, although they will not be my principal focus. My conclusions will be that strict liability is never proper as the basis for retributive punishment; that it is a very crude device for achieving deterrence through nonretributive penalties; and that with respect to tort liability, it is best justified as a means of defining insurance categories.     

The Changing Face of Corporate Liability – New Hard Law and the Increasing Influence of Soft Law

The first frameworks defining standards of human rights protection specifically for business enterprises were non-binding “soft law” like the UN Guiding Principles on Business and Human Rights. In recent times, a “hardening” of corporate human rights law has taken place. Several acts of “hard law” have been implemented at a national and EU level. This article provides an overview of the most important ones. The “hard law” provisions differ in their scope: some obligate companies to report on human rights, others stipulate concrete obligations to conduct human rights due diligence. Another way of tackling the issue of human rights compliance has been demonstrated by the prosecution of companies in the United States. While procedural guidelines abstractly stipulate an effective compliance system to be a mitigating factor, the US Department of Justice regularly defines concrete compliance obligations in deferred or non-prosecution agreements. This development could lead to comprehensive liability for negligence due to organisational and monitoring deficiencies. But who defines the standards? This article examines how the changing practice of human rights compliance may have “feedback effects” on hard law, particularly by changing the scale of negligence. Regarding the lack of effectiveness of some due diligence measures, especially in the “certification industry”, it is then asked how legislation may proactively exert influence by defining effective CSR instruments necessary to prevent civil and criminal liability. Using the example of German law, a proposal is made to implement an obligation of human rights due diligence in “hard law” and, simultaneously, set up an independent expert commission that drafts guidelines specifying the necessary measures for different kinds of companies.     

Positive Analysis on the Connotation of Limited Liability——A legal rule of company losses apportion

有限责任既不是公司的法律责任,也不是股东的法律责任,而是一种公司损失的分摊规则.从实证角度分析,有限责任是股东分摊公司“有限损失”的一种制度设计.根据有限责任规则,股东对公司损失实行“定额分摊”,而社会(主要但不限于债权人)则实行“余额分摊”.鉴于公司损失涉及到社会分摊问题,公司不仅是“利益共同体”,也是“损失共同体”,这是公司相关制度刚性设计的基础.     

Can Strict Criminal Liability for Responsible Corporate Officers be Justified by the Duty to Use Extraordinary Care?

The responsible corporate officer (RCO) doctrine is, as a formal matter, an instance of strict criminal liability: the government need not prove the defendant’s mens rea in order to obtain a conviction, and the defendant may not escape conviction by proving lack of mens rea. Formal strict liability is sometimes consistent with retributive principles, especially when the strict liability pertains to the grading of an offense. But is strict liability consistent with retributive principles when it pertains, not to grading, but to whether the defendant has crossed the threshold from noncriminal to criminal conduct? In this essay, I review the two most plausible arguments supporting an affirmative answer in the context of the RCO doctrine. First, perhaps this doctrine reflects a rule-like form of negligence, akin to a rule that prohibits selling alcohol to a minor. Second, perhaps this doctrine expresses a duty to use extraordinary care to prevent a harm. Neither argument is persuasive. The first argument, although valid in some circumstances, fails to explain and justify the RCO doctrine. The second argument, a duty to use extraordinary care, is also inadequate. If “extraordinary care” simply means a flexibly applied negligence standard that considers the burdens and benefits of taking a precaution, it is problematic in premising criminal liability on ordinary negligence. If instead it refers to a higher duty or standard of care, it has many possible forms, such as requiring only a very slight deviation from a permissible or justifiable standard of conduct, placing a “thumb” on the scale of the Learned Hand test, identifying an epistemic standard more demanding than a reasonable person test, or recognizing a standard that is insensitive to individual capacities. However, some of these variations present a gratuitous or incoherent understanding of “negligence,” and none of them sufficiently explain and justify the RCO doctrine.     

Any Other Contribution? Ascribing Liability for Cover-Ups of International Crimes

As the International Criminal Court (the Court or ICC) continues to develop the parameters of the various modes of liability set out in Article 25(3) of the Rome Statute, recent developments raise questions as to whether the Court can consider participation in cover-ups or concealment of crimes as giving rise to individual criminal responsibility. It is only recently that international tribunals, and notably the International Criminal Tribunal for the Former Yugoslavia (ICTY), have turned to consider how international criminal law approaches responsibility for cover-ups or concealment of crimes. In reviewing how and why the ICTY has addressed individual criminal liability for engaging in cover-ups, and in light of the ICC’s Mbarushimana decision, the aim of this paper is to suggest how the ICC might consider such issues in future cases. Having demonstrated the necessity of international criminal law accounting for cover-ups, the paper will discuss how the jurisprudence, in toto, excludes the possibility of holding to account individuals who contribute to the cover up of international crimes, by whatever means, or however grave, unless they were acting on the premise of a prior agreement with the principals. By way of conclusion the paper will suggest that an expansive interpretation of Article 25(3)(d) of the Rome Statute may provide a means of addressing this gap.     

Revisiting Licensed Handgun Carrying: Personal Protection or Interpersonal Liability?

No debate is more sensitive or polemical than the question of ??gun rights?? in the U.S., and licensing private citizens to carry concealed handguns is the most controversial ??right?? of all. The morally charged nature of this controversy is reflected in the disparate results reported by various researchers who analyze the effects of these laws, and also by the especially intense methodological scrutiny that follows published research. A National Science Academy review of existing gun policy research issues methodological recommendations which may help resolve scientifically the question of whether or how ??right to carry?? licensing effects rates of lethal firearm violence. Similar efforts have been published previously, but this study improves upon those earlier efforts by increasing the sample cross-section, by further refining the model specification, and by distinguishing conceptually ??shall issue?? RTC laws from ??may issue?? RTC laws. The results provisionally suggest that the former increases homicide rates whereas the latter decreases them.     

CERCLA Arranger Liability: Town of Islip v. Datre: What Intent is Required?

In Town of Islip v. Datre, the court dismissed a Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) claim based on failure to allege that the defendant knew that the waste it disposed of was hazardous. The court based its decision on language in the Supreme Court's decision in Burlington Northern that indicated that to be liable under CERCLA as one who arranged for disposal, there is a knowledge or intent element. This article questions the Datre decision and argues that the “knowledge” required by the Burlington Northern Court is knowledge that the transaction is a disposal, not knowledge that the waste disposed of is hazardous.     

Does Control Make a Difference? The Moral Foundations of Shareholder Liability for Corporate Wrongs

The doctrine of limited liability, as traditionally understood, prevents shareholders from being held personally liable for corporate wrongs. Several authors have recently argued that the doctrine should be modified to make some or all shareholders individually liable for torts committed by corporations in which they hold shares. This article distinguishes three types of argument that might provide a moral basis for shareholder liability in such cases. I contend that while these arguments support holding at least some shareholders liable for corporate torts, they fail to justify a general regime of unlimited pro rata shareholder liability. The level of control shareholders exercise over a company makes an important difference to their moral duties to compensate victims of corporate wrongdoing.     

When Does an Administrative Order Resolve CERCLA Liability Sufficiently to Trigger a § 113 Contribution Action?

This article discusses how parties who are negotiating administrative agreements with regulatory agencies regarding the remediation of inactive hazardous waste sites can best protect their right to bring a contribution action against other responsible parties. The article discusses the relevant statutory provisions and the case law, much of which holds that parties failed to preserve their contribution rights, and provides advice regarding specific language to include in such agreements.     

Vicarious Liability and Non‐Delegable Duty for Child Abuse in Foster Care: A Step Too Far?

In NA v Nottinghamshire County Council the Court of Appeal held that a local authority is not liable under vicarious liability or for breach of a non‐delegable duty when foster parents sexually or physically abuse a child that it has placed in their care. The note discusses the decision in the light of recent developments in the law. It is argued that the result is unsatisfactory in terms of doctrine and policy. It is further suggested that non‐delegable duty, rather than vicarious liability, offers the most appropriate route for establishing liability.     

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