Liability for defective products
Defence against actions based on Directive 85/374 and its French regime: a product that does not offer the safety that may legitimately be expected, demonstration of the grounds for exemption.
→ Health · Sub-expertise
The liability of manufacturers of health products may be engaged on several grounds: defective product, failure to inform, breach of vigilance obligations. The stakes are legal, financial and reputational, often in the presence of class actions. We defend players in the sector in crisis management and litigation.
→ What we cover
Defence against actions based on Directive 85/374 and its French regime: a product that does not offer the safety that may legitimately be expected, demonstration of the grounds for exemption.
Defence against a claim for failure to inform of risks (package leaflet, communication to professionals), demonstration of the information provided.
Management of class actions or multi-victim proceedings, coordination with insurers, overall defence strategy.
Support in crisis management: analysis of the incident, declaration to the authorities, communication, organisation of the recall, alignment with communication advisers.
Defence in the event of criminal proceedings (endangerment, involuntary injury, deception), alignment with parallel civil and administrative actions.
Mobilisation of product-liability insurance, management of coverage refusals, negotiation with insurers, alignment with subrogated claims.
→ Our approach
01
Rapid mobilisation from the moment of the claim or incident: securing the evidence, analysis of the situation, mobilisation of insurers and experts.
02
Building the defence strategy, alignment with communication and crisis management, anticipation of class actions.
03
Representation before the competent courts (civil, criminal, administrative), management of expert assessments, oral advocacy.
04
Any implementation of the decisions, post-crisis support, updating of processes to prevent new incidents.
→ Who we help
Management of a crisis involving the recall of a health product: declaration to the authorities, organisation of the recall, communication to professionals and the general public, alignment with the insurer.
Defence of a manufacturer facing a class action by patients alleging undisclosed adverse effects: scientific analysis, expert assessment, defence before the civil and criminal courts.
Criminal defence of the executive of a laboratory held personally liable for involuntary injury following adverse effects, aligned with the defence of the company.
Product compliance audit aimed at anticipating risks: analysis of package leaflets, clinical data and vigilance procedures, improvement recommendations.
→ Q&A
Several grounds are possible: liability for defective products (a specific regime), contractual or tortious liability under general law, breach of legal obligations (vigilance, information). The ground chosen by the claimants determines the defence strategy.
Several grounds are provided by law: the product was not put into circulation by the manufacturer, the defect arose after the product was put into circulation, the state of scientific knowledge at the time the product was put into circulation (development risk). Each ground requires rigorous evidence.
An overall strategy combining: scientific analysis of the grievances, medical and statistical expertise, controlled communication, mobilisation of insurers, possible settlement negotiation. Close coordination between the legal, medical and communication advisers is essential.
The authorities (ANSM, ARS) may be informed in parallel with the civil and criminal actions. Coordination is necessary to avoid inconsistencies (declarations, corrective measures). A spontaneous and transparent declaration is generally more favourable than a later discovery.
→ Go further
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