Product liability is an automatic liability (art. 1245 et seq. Civ.). In such a regime, based on causality independently of any fault, the question of the causes of exemption is major, since it is the only way to escape the automatism of responsibility. “Development risk” constitutes the most notable cause of exemption. Article 1245-10, 4° of the Civil Code, repeating the terms of the 1985 European directive, provides that the producer will escape liability for safety defects if he proves that “the state of scientific and technical knowledge, at the time when it put the product into circulation, did not make it possible to detect the existence of the defect“. The stated aim has been not to discourage innovation.
Too routine case law?
In a judgment of December 6, 2023 (no. 22-23.383), which is another episode in the Médiator drug case, the Court of Cassation recently said that personal knowledge by the producer of the defect in its product excludes the benefit from the exemption for development risk. The patient who sought compensation had argued that the withdrawal from the market by the health authorities in Switzerland of this medicine in 1998, then in Spain and Italy in 2003, revealed that the producer knew of the existence of the safety defect at the time. where its product had been prescribed in France, between 2006 and 2009. The Court’s decision is not a surprise, if we consider in particular its precedent from 2017 (no. 16-19.643) on a similar question regarding the same product.
The new directive on product liability should be an opportunity to give this cause of exemption the consideration it deserves
The solution seems logical, since the idea of development risk presupposes imperfect knowledge of the exact effects that the characteristics of the product will have and this is no longer the case when one was already aware of safety problems. Furthermore, we must consider, as the German Federal Court of Justice said in its 1968 decision which was the first to recognize the exonerating effects of the development risk, that the manufacturer can only benefit from the exemption if he respected his monitoring obligation. Beyond the case, we should take stock of this cause of exoneration which, however worthy of interest it may be, has never had the wind in its sails. It is practically never used in France (one exception: Civ. 1re, May 5, 2021 no. 19-25.102), and the European Court of Justice recommended a rather restrictive design in 1997 (no. C-300/95 , § 29).
We hardly find, in jurisprudence, the in concreto assessment which should separate things by fully integrating, in the search for responsibility, the complexity of the data corresponding to the latest state of science and its applications. We find with a little too easily the slope of systematic protection of victims (despite the existence of generalized social protection for attacks on the person), independently of the precautions that the promoter of an innovative product has could take.
The opportunity created by the new European directive
A new EU directive on product liability will be adopted, since on March 12 Parliament approved the latest version of the text. Member States will have 24 months to transpose it. The main aim was to understand, among the products in question, software and its updates, as well as digital services resulting from artificial intelligence. It is enough to imagine how AI applications in the field of health or intelligent home systems will spread to understand the interest, for end users, of seeing the liability rules as of right extended to these innovative applications. With such an expansion, there is no doubt that the subject of development risk will gain increased importance.
Its definition has been revised, and Article 11, 1 (e) states that the manufacturer will not be liable for damage caused by a defective product if it proves “as the objective state of scientific and technical knowledge at the time of placing the product on the market or putting it into service or during the period during which the product was under the control of the manufacturer [cf. art. 4, 5, a] did not detect the defect“. This more detailed text, but also the nature of the new products resulting from information technologies, will raise more questions of interpretation. Let us hope that this will encourage the development of a casuistry capable of arbitrating between the reasonable protection of victims and the preservation of innovation in Europe, while it is increasingly falling behind the United States and China. The practical effect that is more or less favorable to innovation will also depend on the way in which it is implemented. applied the presumption of Article 10, intended to make it easier for victims when they face “to excessive difficulties“to prove the safety defect or the causal link with the damage suffered,”particularly due to technical or scientific complexity“.
Finally, let us recall that under French positive law, exemption for development risk is excluded for human body products (Civil Code, art. 1245-11). This illogical solution, adopted to react to the political scandal of contaminated blood, should be abandoned (arg. art. 3 of the new directive). This was not the opinion of the French authorities, as shown by the 2017 Chancellery project on civil liability (see art. 1298-1 of the project), not to mention a questionable decision of the Constitutional Council (No. 2023-1036 QPC). We will therefore get rid of an irrational and discouraging solution for a now major part of the activity, since the designers of biological drugs (those resulting from biotechnologies), who have become in particular the spearheads in the fight against cancer , do not benefit from the exemption for development risk, even though the subject of contaminated blood had nothing to do with such applications. All in all, the appearance of the new texts could be an opportunity to give the exemption for development risk the consideration it deserves.
ABOUT THE AUTHOR
François Xavier Testu, associate professor of law, is an associate lawyer at the Court (STH2 firm, Paris).
