Supremacía del derecho federal sobre el Common Law en materia de requisitos de seguridad y eficacia terapéutica de productos sanitarios. Comentario a Riegel v. Medtronic, Inc. [552 U.S.__ (2008); February 20, 2008]

En Riegel v. Medtronic Inc. (552 U.S.__2008; February 20, 2008), el Sr. Riegel tuvo que ser sometido a un by-pass como consecuencia de la rotura del catéter, fabricado por Medtronic, con el que su médico le practicaba una angioplastia. A pesar de que el catéter había obtenido la autorización de comercialización de la FDA y cumplía los requisitos de seguridad previstos por el sistema regulatorio federal, el Sr. Riegel y su mujer interpusieron una acción de daños contra Medtronic –y no contra el médico- conforme a las reglas de responsabilidad civil objetiva y por negligencia del Common Law neoyorquino. Sin embargo, el Tribunal Supremo federal de los EE.UU., en ponencia del Magistrado Antonin Gregory Scalia, votó, por mayoría de ocho magistrados, rechazar el recurso de la Sra. Riegel y confirmar la sentencia de segunda instancia, desestimatoria de la demanda, porque consideró que la regla de primacía del derecho regulatorio federal sobre seguridad de productos sanitarios [Medical Device Amendments de 1976, 21 U.S.C. Artículo 360k(a)] excluye la aplicabilidad no sólo del derecho regulatorio estatal sobre seguridad de productos sanitarios, sino también del Common Law sobre responsabilidad civil del fabricante.

Prescription in the proposal for a common european sales law

The rules on prescription in Part VIII, Chapter 18, of the Proposal for a Common European Sales Law (CESL) follow the provisions of the Principles of European Contract Law (PECL) and the Draft Common Frame of Reference (DCFR), which, in general, have deserved favourable comments. Yet, a number of rules contained in those texts have been omitted. It is necessary to ascertain whether the CESL rules only apply to provisions on rights and claims resulting from sales or related services contracts, or whether they are also applicable to any other contractual right or claim and also to rights or claims of non-contractual origin. One of the most problematic issues concerns general prescription periods: firstly, because there are two general periods, a short one and a long one, without any specification about the claims or rights covered by each one of them; secondly, because neither period is suitable in case of non-conformity. There are also some interpretation problems due to missing, ambiguous or defective definitions. The systematic approach demands clarification too.

Cuestiones sobre el contrato de servicios diseñado en el Marco Común de Referencia

La reciente publicación del draft del Common Frame of Reference invita a reflexionar sobre la figura del contrato de servicios, tal como ha sido desarrollada por el Study Group on a European Civil Code, y respecto de la que encontramos verdaderas innovaciones en comparación con la teoría tradicional que aún mantienen nuestra doctrina y jurisprudencia. El objeto del trabajo es exponer algunas de las soluciones que propone el derecho contractual europeo, e incidir en la posibilidad y conveniencia de su aplicación en nuestro país, con vistas a la oportuna elaboración de la tan esperada regulación civil sobre el contrato de servicios.

Proposta d’un text articulat sobre teoria general del contracte per al Llibre sisè del Codi Civil de Catalunya

El treball que es presenta conté un text articulat sobre la part de teoria general del contracte (arts. 612-1 i següents) del llibre sisè del Codi Civil de Catalunya. El procés de codificació civil que es viu a Catalunya justifica aquest treball, que podria ser útil per a elaboració del llibre sisè del CCCat dedicat a les obligacions i els contractes. El treball consta d’una proposta de text articulat, amb el seus respectius comentaris a cada article. Es tracta del capítol segon del títol primer del llibre sisè, i es divideix en les següents seccions: 1) El contracte, els seus elements essencials, i la seva eficàcia; 2) La formació del contracte; 3) La interpretació del contracte; i 4) La ineficàcia del contracte, que inclou l’anàlisi dels vicis del consentiment. El treball ha pres com a referència les principals propostes d’harmonització del dret contractual (Principis Unidroit [PICC], Principis de Dret Contractual Europeu [PECL], Marc Comú de Referència [DCFR], i l’Instrument Opcional sobre Compravenda Europea [CESL] i la regulació dels codis més moderns (entre ells, el del Quebec, l’Holandès, el Portuguès o l’Italià) i les seves propostes de reforma (el projecte Terrè a França, i la Propuesta de Modificación del Código Civil Español en materia de obligaciones y contratos). En la proposta presentada s’incorporen institucions no regulades en el Codi civil espanyol actualment vigent a Catalunya en la seva condició de dret supletori, i s’omplen algunes llacunes d’aquest cos legal. Es poden citar, entre elles, les clàusules abusives dels contractes, el canvi en les circumstàncies essencials del contracte, el contracte per a persona per designar, la responsabilitat per culpa in contrahendo, les cartes d’intencions, el règim de l’oferta i l’acceptació del contracte, els contractes preparatoris, els drets de preferència, la possibilitat d’anul·lació del contracte per concessió d’un avantatge injust a alguna de les parts, i el règim dels contractes en frau de creditors.

Steady-state global optimization of metabolic non-linear dynamic models through recasting into power-law canonical models

Background: Design of newly engineered microbial strains for biotechnological purposes would greatly benefit from the development of realistic mathematical models for the processes to be optimized. Such models can then be analyzed and, with the development and application of appropriate optimization techniques, one could identify the modifications that need to be made to the organism in order to achieve the desired biotechnological goal. As appropriate models to perform such an analysis are necessarily non-linear and typically non-convex, finding their global optimum is a challenging task. Canonical modeling techniques, such as Generalized Mass Action (GMA) models based on the power-law formalism, offer a possible solution to this problem because they have a mathematical structure that enables the development of specific algorithms for global optimization. Results: Based on the GMA canonical representation, we have developed in previous works a highly efficient optimization algorithm and a set of related strategies for understanding the evolution of adaptive responses in cellular metabolism. Here, we explore the possibility of recasting kinetic non-linear models into an equivalent GMA model, so that global optimization on the recast GMA model can be performed. With this technique, optimization is greatly facilitated and the results are transposable to the original non-linear problem. This procedure is straightforward for a particular class of non-linear models known as Saturable and Cooperative (SC) models that extend the power-law formalism to deal with saturation and cooperativity. Conclusions: Our results show that recasting non-linear kinetic models into GMA models is indeed an appropriate strategy that helps overcoming some of the numerical difficulties that arise during the global optimization task.

Children in the welfare state. A social investment approach

Children occupy centre-stage in any new welfare equilibrium. Failure to support families may produce either of two undesirable scenarios. We shall see a society without children if motherhood remains incompatible with work. A new family policy needs to recognize that children are a collective asset and that the cost of having children is rising. The double challenge is to eliminate the constraints on having children in the first place, and to ensure that the children we have are ensured optimal opportunities. The simple reason why a new social contract is called for is that fertility and child quality combine both private utility and societal gains. And like no other epoch in the past, the societal gains are mounting all-the-while that families’ ability to produce these social gains is weakening.In the following 1 analyze the twin challenges of fertility and child development. I then examine which kind of policy mix will ensure both the socially desired level of fertility and investment in our children? The task is to identify a Paretian optimum that will maximize efficiency gains and social equity simultaneously.

The short arm of the law: judicial institutions and local governance in Brazil

This paper estimates the effect of judicial institutions on governance at the local level in Brazil. Our estimation strategy exploits a unique institutional feature of state judiciary branches which assigns prosecutors and judges to the most populous among contiguous counties forming a judiciary district. As a result of this assignment mechanism there are counties with nearly identical populations, some with and some without local judicial presence, which we exploit to impute counterfactual outcomes. Conditional on observable county characteristics, offenses per civil servant are about 35% lower in counties that have a local seat of the state judiciary. The lower incidence of infractions stems mostly from fewer violations of financial management regulations by local administrators, fewer instances of problems in project execution and project managment, fewer cases of non-existent or ineffective civil society oversight and fewer cases of improper handling of remittances to local residents.

Common law and civil law as pro-market adaptations

We argue that in the development of the Western legal system, cognitive departures are themain determinant of the optimal degree of judicial rule-making. Judicial discretion, seen here as the main distinguishing feature between both legal systems, is introduced in civil law jurisdictions to protect, rather than to limit, freedom of contract against potential judicial backlash. Such protection was unnecessary in common law countries, where free-market relations enjoyed safer judicial ground mainly due to their relatively gradual evolution, their reliance on practitioners as judges, and the earlier development of institutional checks and balances that supported private property rights. In our framework, differences in costs and benefits associated with self-interest and lack of information require a cognitive failure to be active.

Market institutions and judicial rulemaking

Assuming that the degree of discretion granted to judges was the main distinguishing feature between common and civil law until the 19th century, we argue that constraining judicial discretion was instrumental in protecting freedom of contract and developing the market order in civil law. We test this hypothesis by analyzing the history of Western law. In England, a unique institutional balance between the Crown and the Parliament guaranteed private property and prompted the gradual evolution towards a legal framework that facilitated market relationships, a process that was supported by the English judiciary. On the Continent, however, legal constraints on the market were suppressed in a top-down fashion by the founders of the liberal state, often against the will of the incumbent judiciary. Constraining judicial discretion there was essential for enforcing freedom of contract and establishing the legal order of the market economy. In line with this evidence, our selection hypothesis casts doubts on the normative interpretation of empirical results that proclaim the superiority of one legal system over another, disregarding the local conditions and institutional interdependencies on which each legal system was grounded.

The second law of thermodynamics and the global climate system : A review of the maximum entropy production principle

The long-term mean properties of the global climate system and those of turbulent fluid systems are reviewed from a thermodynamic viewpoint. Two general expressions are derived for a rate of entropy production due to thermal and viscous dissipation (turbulent dissipation) in a fluid system. It is shown with these expressions that maximum entropy production in the Earth s climate system suggested by Paltridge, as well as maximum transport properties of heat or momentum in a turbulent system suggested by Malkus and Busse, correspond to a state in which the rate of entropy production due to the turbulent dissipation is at a maximum. Entropy production due to absorption of solar radiation in the climate system is found to be irrelevant to the maximized properties associated with turbulence. The hypothesis of maximum entropy production also seems to be applicable to the planetary atmospheres of Mars and Titan and perhaps to mantle convection. Lorenz s conjecture on maximum generation of available potential energy is shown to be akin to this hypothesis with a few minor approximations. A possible mechanism by which turbulent fluid systems adjust themselves to the states of maximum entropy production is presented as a selffeedback mechanism for the generation of available potential energy. These results tend to support the hypothesis of maximum entropy production that underlies a wide variety of nonlinear fluid systems, including our planet as well as other planets and stars

Studying Avalanches in the ground-state of the two-dimensional random field Ising model driven by an external field

We study the exact ground state of the two-dimensional random-field Ising model as a function of both the external applied field B and the standard deviation ¿ of the Gaussian random-field distribution. The equilibrium evolution of the magnetization consists in a sequence of discrete jumps. These are very similar to the avalanche behavior found in the out-of-equilibrium version of the same model with local relaxation dynamics. We compare the statistical distributions of magnetization jumps and find that both exhibit power-law behavior for the same value of ¿. The corresponding exponents are compared.