WOLF SAUTER, Dutch Healthcare Authority, Tilburg Law and Economics Center (TILEC)
Email: wsauter@nza.nl

This paper provides a discussion of the Commission's July 2008 proposal for a Directive on the application of patients' rights in cross-border healthcare (the proposed patient mobility Directive). It does so against the background of an overview of the preceding patient mobility case law of the European Court of Justice that is based on the freedom to provide services of Article 49 EC, from Kohll and Decker in 1998 to Watts in 2006. The findings are that the proposed patient mobility Directive is not a full codification of the case law as it leaves out certain guarantees developed by the Court, while it adds some new elements of harmonisation. The Court had in principle accepted public interest justifications for prior authorisation requirements with respect to hospital treatment and focused on developing substantive and procedural guarantees of patients' rights such as the criteria for "undue delay", in which case authorization for treatment abroad must be granted. The Commission takes a different approach, by both requiring Member States to actually demonstrate the need for a prior authorization regime and at the same time itself providing evidence that this is in most cases unlikely to be warranted. Because the criteria for "undue delay" would no longer be used to determine when authorizations must be granted there will be no clear EU standard to apply if any authorisation requirements survive. The main innovation of the proposal are new patients' rights to accountability and transparency which apply not just to mobile patients but to all patients in each Member State. This represents a first step from negative integration (liberalisation) to positive integration (harmonisation). Moreover transparency and accountability will generate pressure for further change, not just in relation to the cross-border provision of services, but more broadly across the healthcare sector.

JAMES M. ANDERSON, RAND Corporation, University of Pittsburgh
Email: jmanderson2@gmail.com

Settlement agreements that require a plaintiff not to disclose or publicize any information about her claim are both common and controversial. Under some conditions, however, a mass tort defendant will rationally choose to discourage such secrecy. A defendant can use publicity to act as a commitment device akin to a most-favored-nation agreement to increase its bargaining power with plaintiffs. The paper uses the real world example of Bayer's cerivastatin litigation as a case study to illustrate this theory in practice and to explore the public policy implications of this finding.

NICOLETTE M. PRIAULX, University of Wales System - Cardiff Law School
Email: priaulxn@cardiff.ac.uk

In a recent paper, Chris Bruce (2008) comments that "Nicolette Priaulx, using legal reasoning argued that the British courts' ruling in [the wrongful birth] cases have been inconsistent and unsupportable. This paper takes the contrary view, arguing that the court's behaviour can be explained using economic reasoning."

Insofar as Bruce's fascinating paper raises a much broader range of issues of interest to me, it is this passage which captures my particular attention. In light of my earlier contribution to the Journal of Legal Economics (hereafter, "JLE"), which provides a lengthy critique of the recent developments in the wrongful conception/birth case law in the UK, in this note I seek to explore what I consider to be critical and problematic aspects of the law and economics approach to these wrongful birth cases, as forwarded by Chris Bruce; in doing so, I restrict my response to the following interrelated questions:

(1) Why is it that Professor Bruce and I should find ourselves so profoundly in disagreement as to the British courts' management of these wrongful birth cases? What lies at the heart of this disagreement?

(2) Should there really be a "disagreement" at all, if, as is it commonly claimed, that economists employ the "positive scientific" approach to investigate the rationale underlying the development of the common law?

(3) Why do I find an economic analysis of the wrongful birth cases unconvincing? How could it convince me?

KIMBERLY MUTCHERSON, Rutgers School of Law-Camden
Email: mutchers@CAMDEN.RUTGERS.EDU

The article focuses on pre-implantation genetic diagnosis ("PGD"), a technology that allows health care providers and potential parents to screen embryos for a range of characteristics prior to implanting them in a woman's uterus. Many potential parents use the technology to screen out life-threatening diseases, but many have expressed concerns about the technology's potential use to screen for benign characteristics such as sex. Recognizing the potential for future regulation, this article focuses on three major topics 1) the potential for legal regulation of pre-implantation genetic diagnosis; 2) the relationship between such future regulation and the existing legal landscape attendant to parenting, procreation, and pregnancy; 3) and the specific consequences for women of legal incursion into PGD decision-making.

The article begins by describing the medical landscape relevant to modern pregnancies in the United States. I then discuss the myriad ways in which existing law impacts procreative and parental decision-making and the ways in which the public nature of procreation and pregnancy make it a time ripe for regulation that is deeper and more intimate than is often the case when the law regulates non-pregnant bodies. The article describes motherhood, unlike fatherhood, as deeply contested territory in which many women struggle to conform to their own definitions of good motherhood and avoid the dreaded label of bad mother. It also describes how the law participates in a process of naming some women as bad mothers and questioning and at times denying their right to parent. Ultimately, this portion of the article emphasizes the disparate gender impact of much reproductive regulation and focuses on the vagaries of restrictive abortion regulation to highlight the link between how states have chosen to regulate abortion and future attempts to regulate PGD.

In the next section, the article imagines and contemplates the constitutionality of future state regulation of PGD, specifically a potential ban on the technology or limiting its use to disease prevention. I conclude that some forms of regulation would likely pass constitutional muster. Finally, the article imagines the consequences of future PGD legislation for women and explains how many legislative choices, including bans or limitations on the use of PGD, will negatively impact many women in part by continuing attempts to delineate categories of good and bad motherhood. The article concludes that regulation of PGD is an idea that should not yet be put into practice.

MARGARET GILHOOLEY, Seton Hall University - School of Law
Email: gilhooma@shu.edu

The extent to which FDA decisions can preempt tort liability for prescription drugs is a critical issue that the Supreme Court will address this term in Wyeth v. Levine. The agency has issued a Preemption Policy that favors preemption when a drug manufacturer consults with the agency about a risk. Wyeth has unusual factors since the label warned of the risk from the method that led to the injury, and the plaintiff's expert testified that the label should not have allowed the method at all.

The most important and difficult preemption question is the liability for new risks that are found from use after the drug is on the market. This paper will examine the factors that can limit the scope of the Wyeth decision. Instead of having a broad rule recognizing preemption generally, the determination should focus on matters that the agency has specifically addressed based on current and accurate information. Moreover, the consultations between the drug company and the agency about the need for warnings for emerging risks need to be based on means that ensure "fairness and deliberation."