Product Liability in Italy

The Directive 85/374/EEC on Product Liability is more than thirty years old and was adopted in a completely different context from the current one, in a pre-digital age.It is very important to understand how it has since been applied in the EU member states and how this application has changed over the years. In order to systematically analyze the Italian case law interpreting the notion of defectiveness of a product, the paper distinguish different categories: 1) case law on damages foreseeable and avoidable; 2) case law on damages unforeseeable and unavoidable; 3) case law on damages statistically foreseeable in advance, though unavoidable. The paper discusses in particular the application of a risk/benefit analysis that exempts the producer from his liability in some cases

Vaccini Covid e sospensione dei brevetti, tra etica e lotta al virus

L'autrice espone le ragioni di ordine giuridico, economico e sanitario che giustificherebbero la sospensione del privilegio brevettuale accordato ai produttori del vaccino anti-covid

IL VACCINO ANTI COVID-19. LA NORMATIVA SPECIALE E IL MECCANISMO DI DISTRIBUZIONE DEI RISCHI E DEI BENEFICI

La legislazione d\u2019urgenza, adottata per fronteggiare la pandemia, \ue8 andata ad innestarsi su un complesso sistema normativo stratificatosi nel tempo e caratterizzato da una costante tensione tra due esigenze contrapposte: da un lato garantire l\u2019accesso al farmaco al fine di tute-lare il bene fondamentale della salute; dall\u2019altro lato consentire lo sfruttamento esclusivo della propriet\ue0 intellettuale sul farmaco al fine di incentivare l\u2019innovazione e la ricerca nel settore (sul presupposto che i costi per la ricerca e l\u2019innovazione siano stati affrontati dallo stesso titolare del diritto di propriet\ue0 intellettuale). Contemporanea-mente al riconoscimento del diritto di propriet\ue0 intellettuale sui farma-ci, sono stati predisposti dei correttivi idonei a proteggere l\u2019interesse generale per l\u2019ipotesi di abuso nell\u2019esercizio del diritto da parte del ti-tolare o anche solo allo scopo di potenziarne le capacit\ue0 produttive qualora esse siano insufficienti a sopperire al bisogno urgente del farmaco. Tutti i sistemi giuridici prevedono l\u2019espropriazione per pub-blica utilit\ue0, la concessione di licenze obbligatorie, l\u2019imposizione auto-ritativa del prezzo di vendita. Nessuno di questi strumenti \ue8 stato sin qui utilizzato nel caso del vaccino contro il Covid19. Nello stesso tem-po i produttori dei vaccini contro il Covid19 beneficiano ovunque, per legge o per contratto, di una esenzione della loro responsabilit\ue0 civile per il rischio di danni cagionati dagli effetti collaterali negativi dei vaccini. Conseguentemente gli Stati si attrezzano con i fondi pubblici di compensazione al fine di far fronte alle esigenze di equit\ue0 e di soli-dariet\ue0 sociale a favore delle eventuali vittime. La scissione tra priva-tizzazione dei profitti e socializzazione del rischio, in assenza di corret-tivi, genera ineguaglianze sociali e, in ultima analisi, tradisce i princi-pi fondanti dell\u2019economia liberale prima ancora che le norme di rife-rimento. The emergency legislation, enacted to deal with the pandemic, has been grafted onto a complex system that has built up over time and is charac-terized by a constant tension between two opposing needs: on the one hand, to insure access to pharmaceutical products in order to protect the fundamental right to health; on the other hand, to allow the exclusive ex-ploitation of intellectual property on pharmaceuticals in order to incentiv-ize innovation and research in the sector (on the assumption that the costs for research and innovation have been faced by the owner of the intellectual property right himself) . At the same time as the recognition of the intellectual property right on pharmaceuticals, corrective measures have been settled to protect the general interest for the eventuality of abuse in the exercise of the right by the owner or for the purpose of strengthen his production capacities whenever they are insufficient to meet the urgent need for the pharmaceutical product. All legal systems provide for expropriation for public utility, compulsory licenses, compulso-ry sale prices. None of these tools have so far been used in the case of the Covid19 vaccine. At the same time, the producers of Covid19 vac-cines benefit everywhere, by law or by contract, from an exemption from their civil liability for the risk of damage caused by the negative side ef-fects of vaccines. Consequently, the States equip themselves with public compensation funds in order to meet the needs of equity and social soli-darity in favor of any victims. The split between the privatization of profits and the socialization of risk, in the absence of corrections, generates so-cial inequalities and, ultimately, betrays the founding principles of the lib-eral economy even before the reference norms

Projets de législation européenne sur la responsabilité pour les dommages causé par l'intelligence artificielle. A' la recherche d'un équilibre entre les interets des consommateurs, des multinationales et des PME.

Depuis 2017, le Parlement européen et la Commission ont commencé à échanger une série d'actes visant à exhorter l'adoption d'un dispositif législatif qui régit de manière uniforme les critères d'attribution de la responsabilité pour les dommages causés par l'intelligence artificielle. L'intention exprimée par les institutions européennes est de stimuler le marché de l'IA en attirant les investissements publics et privés dans le secteur, sans négliger la nécessité d'une protection spécifique des start-ups et des PME. Afin d'inspirer confiance aux acteurs du marché, la nécessité d'assurer la sécurité juridique par l'adoption d'une législation uniforme est décriée. C'est ainsi que la question de la responsabilité pour les dommages causés par l'I.A. devient centrale du point de vue des choix politiques (que les institutions européennes déguisent sous l'apparence de technicités juridiques). Le sujet rappelle évidemment la réglementation de la responsabilité pour les dommages causés par des produits défectueux, déjà prévue par la directive n° 374/85/CEE, dont la révision est attendue pour la fin de cette année. En l'état actuel des choses, la Commission n'a pas encore pris position sur la question débattue de savoir si les règles générales de la responsabilité du fait des produits doivent être complétées par des règles ad hoc sur les dommages causés par l'I.A.. Avec sa résolution du 20 octobre 2020, le Parlement européen va jusqu'à l'extrême limite de ses pouvoirs en élaborant un projet de règlement sur la responsabilité du fait des produits pour les dommages causés par les I.A., dont l'adoption est recommandée à la Commission. Cette étude expose certains des points critiques soulevés par le règlement ad hoc envisagé par le Parlement européen et analyse l'éventuelle mise en place d'un mécanisme général d'attribution de la responsabilité pour les dommages causés par les produits défectueux. L'opinion défendue par l'auteur est qu'un régime de responsabilité générale doté d'efficacité (et donc exerçant une fonction dissuasive) permet non seulement de réglementer les activités des acteurs du marché, mais aussi d'alléger les obligations de conformité que la réglementation ex ante impose au détriment notamment des moyennes ou petites entreprises et des start-ups qui souhaitent entrer sur le marché de l'innovation technologique

Procurement of Covid-19 vaccines: why were legal liabilities transferred to the public sector?

he recent release of the Covid-19 vaccine supply contract between the European Commission and Astra Zeneca has caused a political and media storm about vaccine production logistics and supply issues. A lesser noticed but controversial issue revealed by the contract is that of where ultimate liabilities should lie, which has potentially far-reaching consequences for the public purse. Many commercial contracts include so-called indemnity clauses hereby one party contractually agrees to cover liabilities incurred by the other. The European Commission accepted in Article 14 of the agreement an extremely broad indemnity of the manufacturer covering almost any and every defect imaginable whether that be the vaccine’s inherent characteristics, manufacturing / distribution, and storage issues, labelling errors or even problems due to administration of the vaccine. This is a potentially significant burden to place on the state, and ultimately taxpayers

COMPARING NO-FAULT COMPENSATION SYSTEMS FOR VACCINE INJURY

The policy responses to redressing serious adverse reactions caused by vaccines are many and varied. Scholars have identified three broad options for responding to the need for support of those who have been subject to vaccine injury. The first is a minimalist approach that entails injured persons bearing the costs associated with their injuries with assistance provided solely by means of standard social welfare and health benefits provided by the state. Second, compensation may be sought through legal proceedings brought against those responsible for producing, or in certain cases distributing, the vaccines in question. Third, compensation may be sought from a dedicated compensation scheme outside the normal litigation system, generally premised upon no-fault liability. The discussion in this Article focuses on the latter schemes, which are generally government-created and specifically respond to vaccine injuries. The advantages of such a mechanism over the other options, which entail either patients bearing the costs themselves or seeking compensation though litigation against private sector, have been widely discussed, and we will also examine the broader rationales below

The threat of collective redress in product liability cases

The European Commission Recommendation on Collective Redress (2013/396/EU) establishes a framework to ensure a coherent horizontal approach to collective litigation in the EU context without harmonising national systems. The Commission clearly aims at distinguishing collective redress in Europe from the North American class action approach. The book explores the need for mass litigation mechanisms in Europe from a series of interdisciplinary perspectives (law and economics, behavioural sciences, and sociological and judicial perspectives). It also analyses the current collective redress landscape in Europe in light of the Commission Recommendation; this includes an assessment of national collective redress mechanisms; views from oversees on the present and future of collective litigation in Europe; commentary on various specific areas of collective redress including competition law, product liability and consumer protection; and the options for and relevance of collective ADR mechanisms

THE AMBIGUOUS CONCEPT OF PRODUCT DEFECTIVENESS AND THE BUSINESS RISK: DIFFERENT APPROACHES OF EUROPEAN AND US COURTS COMPARING THE PRODUCER’S AND USER’S BEHAVIOUR

Abstract The European directive on product liability defines as defective a product that “does not provide the safety which a person is entitled to expect”. In the last years, European national courts have given a number of diverse interpretations of such a broadly and ambiguous defined provision. For an analytical comparison among court decisions, I suggest to distinguish between (1) risk of damages that were foreseeable and avoidable at the time when the product was put into circulation, (2) risk of damages that were unforeseeable and unavoidable, and (3) risk of damages that were statistically foreseeable yet unavoidable. As regards the first category, the Italian Corte di Cassazione has pointed out that the legal provision implies a comparison between the conduct of the victim and that of the producer in order to assess which one of two was in the best position to avoid this risk of damage. Therefore the mechanism of apportionment of the risk is not different from the one implied by a fault liability rule. It is interesting to note that the third American Restatement on torts does not make any reference to the user’s behavior in its black letter on product defectiveness. The analysis shows how this different approach impacts on judicial decision-making. With respect to the second category, the development risk defense clause (expressly provided for by the directive) produces the effect of leaving the victim uncompensated, despite the fact that the European lawmaker has declared his intention to place a liability without fault upon the producer. The problem arises with the third category, because the directive has not envisaged a specific rule for those damages that were statistically foreseeable yet unavoidable, such as the manufacturing defects. On the contrary, Italian law makes explicit that a product “is defective if it does not provide the safety normally provided by other products in the same series”. Under this rule (that is one of the application of a more broad doctrine on business risk) the producer is deemed strictly liable for those damages that, even though unavoidable, were manageable as quantifiable in advance. The question is whether this doctrine could be applied also to those design defects actually foreseen by the producer. Following the business risk doctrine the producer should be held strictly liable as he had accepted the risk in full awareness, having taken it into account in his cost/benefit analysis. However, according to those European courts that do apply the risk/utility test (such as the German courts), the producer is insulated from liability if the cost of an alternative design overweighed the foreseeable risk of damage