Defective health products, liability of users, healthcare professionals, faultless liability, European framework, Public Health Code, Article L. 1142-1, Council of State, Cour de cassation, Court of Justice of the European Union, CJUE, Directive 85/374/CEE, product liability, medical devices, healthcare facilities, hospitals, manufacturers, suppliers, contractual liability, non-contractual liability, victim compensation, medical accidents, jurisprudence, jurisprudential controversies, strict liability, no-fault liability, European directive, Civil Code, Articles 1245, Rennes University Hospital, Besançon University Hospital, defective prosthesis, defective heating mattress, tibial prosthesis, packaging defect, manufacturer liability, supplier liability, healthcare law, medical liability, patient rights, compensation regime, non-negligent medical accidents
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Abstract
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Abstract
The European framework excludes user liability for defective health products, but national judicial frameworks remain divided. Healthcare professionals are liable only in case of fault, unless they act as producers or distributors.
Extract
[...] The Conseil d'État's ruling of 25 May 2022 confirmed that hospitals are liable without fault for the consequences of defective products they use (document 10). In contrast, the Cour de cassation, in its ruling of 26 February 2020, reaffirmed the need to establish a fault to engage the liability of a healthcare professional. In this case concerning a defective hip prosthesis, the Court rejected the idea of faultless liability of doctors, specifying that their liability was subsidiary and conditional on the identification of the responsible producer (document 6). [...]
[...] This distinction was confirmed by the Cour de cassation in its judgment of July which rejected the liability of a surgeon who had used a defective prosthesis, in the absence of proof of fault on his part (document 9). In addition, decisions such as that of the Conseil d'État in 2012 show that doctors do not fall under the strict liability regime defined by the directive, except in very limited cases (document 2). However, for public hospitals, faultless liability has been recognized in several cases, including damages caused by defective products used in care. [...]
[...] Les mécanismes de recours et d'indemnisation pour les dommages causés La protection et l'indemnisation des victimes ne peut pas être assurée sans un recours ou des recours effectifs A. Le recours contre le producteur ou le fournisseur When a defective health product causes damage, the victim may hold the manufacturer liable in accordance with Articles 1245 and following of the Civil Code. Article L. 1245-15 sets a ten-year prescription period from the product's release onto the market, unless an action is brought within this timeframe (document 4). In addition, Article L. [...]
[...] What is the responsibility of users towards defective health products and what remedies do victims have? Defective Health Products: The User's Responsibility In 2000, a hospitalized teenager at the Besançon University Hospital suffered severe burns caused by a defective heating mattress (document 7). More recently, in 2023, a defective tibial prosthesis was implanted in a patient at the Rennes University Hospital (document 5). These incidents are not isolated: in France, thousands of similar cases are reported each year, highlighting the complexity of shared responsibilities between manufacturers, healthcare professionals, and hospital establishments (documents 6 and 7). [...]
[...] Despite these guarantees, victims may encounter practical difficulties, particularly in cases where it is impossible to identify the responsible manufacturer. Article L. 1245-6 then transfers responsibility to the supplier or seller of the product, who can then turn against the manufacturer within a one-year deadline from the action taken against them (document 15). Similarly, when a healthcare facility compensates a patient due to a defective product, it may bring a counterclaim against the product manufacturer. This action is based on Articles 1245-15 and 1245-17 of the Civil Code. [...]
