Introduction to the product liability framework
The Directive was adopted in the European Union on 25 July 1985 to protect consumers against damage caused by defective products. It allows injured persons to seek compensation with regard to defective products put into circulation within the internal and single market. Companies are then required to deliver products free from defect or danger to users (i.e., products that offer the level of safety that can reasonably be expected). EU Member States were required to implement the Directive by 30 July 1988. As France failed to transpose the Directive within the time frame imposed, the Commission opened infringement proceedings under former Article 171 of the EC Treaty4 against France, following the 13 January 1993 ruling by the European Court of Justice (ECJ).5
Notwithstanding this default on the part of France, the French jurisdictions decided proprio motu to interpret the existing general civil liability framework in the light of the Directive provisions. In a ruling dated 3 March 1998,6 the French Supreme Court applied the Directive provisions and dismissed the provisions of the French Civil Code (FCC).7
Finally, on 19 May 1998,8 France transposed the Directive and the FCC included an exhaustive set of regulations in this respect: the new Title IV bis, 'Liability for defective products',9 just after the chapter relating to general civil liability rules. In 2002,10 however, the ECJ ordered France to amend its existing law, which incorrectly transposed the Directive. The ECJ ruled that the French legislation, which exposed suppliers and distributors to legal claims on the same basis as producers, was illegal. Again, in 2006,11 the ECJ ordered France to pay a fine because of its failure to take the necessary measures to fully comply with the previous judgment of 2002.12
On 26 January 2016, Law No. 2016-41 for the modernisation of our healthcare system was enacted13 and introduced into French law the class-action mechanism within the healthcare sector. The law entered into force on 26 September 2016 with Decree No. 2016-1249.14
A reform related to contract law, general social insurance schemes and proof of obligations was implemented the same year and ratified in 2018.
In France, the Directorate-General for Competition, Consumer Affairs and Prevention of Fraud is heavily involved in the prevention of accidents occurring in everyday life and has, in this regard, a general competence in dealing with matters of safety of industrial products. It also publishes a list of recall notices of product and several reporting forms of risk products for professionals. There are also several authorities that have specific expertise in certain industrial sectors.
For instance, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) essentially contributes to ensure health and safety in the areas of environment, labour and food. More specifically, it helps to ensure the protection of the health and welfare of animals, the protection of plant health and the assessment of food quality, food safety and nutritional properties. It also has competence over veterinary medicinal products. In its field of competence, ANSES, at the request of other public and administrative authorities, may provide the relevant expertise as well as the scientific and technical support necessary for the development of laws and regulations.
In the health products sector, as a second example, in accordance with the EU directives, the conditions for granting a marketing authorisation for medicinal products for human use (i.e., original products and generics), either nationally or through the European centralised or decentralised procedure, are contained and detailed within the French Public Health Code (PHC).15 In this regard, the French National Agency for Medicines and Health Products Safety (ANSM) plays a key role. Indeed, applications for marketing authorisation are submitted to the ANSM, which scientifically assesses the marketing authorisation file according to scientific criteria regarding quality, safety and efficacy. A new product must provide a benefit–risk ratio at least equivalent to the existing products. The application is thus reviewed by the committees of the ANSM (and in particular by the commission in charge of the initial assessment of the benefit–risk balance of the health products) if a deeper examination and a supplementary peer opinion for the case is required. Three outcomes can arise: a favourable opinion, a request for further information or an unfavourable opinion. Once the marketing authorisation has been granted, manufacturers must comply with a set of rules provided by EU directives,16 and by the PHC under Article L.5121-9-2 et seq.17 The manufacturer of medicinal products for human use must also comply with the good manufacturing practices18 laid down with the intention of providing minimum requirements that a manufacturer must meet while manufacturing these products, to ensure they are in compliance with requirements of safety, quality and efficacy included in the medicinal product master file. Downstream, good distribution practices19 should also be observed. The safety of medicinal products is thus ensured by the ANSM, which has general competence, under certain circumstances, to suspend or withdraw a marketing authorisation20 or to order the recall of any lot or batch of a medicinal product,21 as well as to carry out an inspection on the manufacturing site.