Product Liability

The legal regimes under which consumers who are injured by a defective product can bring a claim for compensation are as follows:

• Strict liability for defective products: Articles 1245 and following of the Civil Code apply where a product does not provide the safety which a person is entitled to expect, considering notably:
• • the presentation of the product;
  • the use that can reasonably be expected of it; and
  • the time when it was placed on the market (Article 1245-3).
• The rules laid down in these articles are based on strict liability, meaning that no fault, negligence or breach of contract is required to condemn the manufacturer.
• Tort liability: This can be sought by any claimant where compensation is claimed for damage that does not result from the manufacturer’s breach of a contractual obligation. The other regime that exists links liability to “things that are in one’s custody” – that is, a thing that a party has the power to use, manage and control (Article 1242).
• Contractual liability: This can be based on a breach of contractual provisions but also on statutory warranty against hidden defects. With regard to a breach of contractual provisions, the manufacturer’s contractual liability is established when three conditions are met:
• • a breach of contract;
  • a loss; and
  • a causal link between the two (Article 1231-1).
• Such claims are commonly brought by a writ of summons from the victim against the manufacturer.

Unlike product safety which is governed by several regulations depending on the sector (see question 15), the product liability regime is unified and is always based on the general regimes set out in question 1.1.

Yes, the French courts are generally considered to be claimant friendly and, more generally, sympathetic to weaker parties (eg, consumers, employees).

Yes. See question 2.2.

France has implemented a collective redress mechanism which focused on specific sectors but was (and is still) likely to legislatively expand together with the types of issues that may be raised against companies. This is how a “class action” for consumer claims was first created in 2014, together with competition-related class actions (‘follow-on actions’), before specific class action schemes were introduced for discrimination, health and cosmetics, environmental and data privacy-related issues. All mechanisms are opt-in actions. In order to bring a group action, at least two individuals placed in a similar situation must request an approved consumer association or entity to take the case to court and represent the group. Depending on the type of mechanism at stake (eg, consumer or health), there are specific associations that can launch such claims. The court will first rule on the merits of the case and on the liability of the defendant. If damages are awarded, the non-profit association will be responsible for:

• managing the group;
• collecting the necessary information; and
• distributing the individual damages with the court’s approval.

A pending reform which is being discussed aims to open up:

• the types of claims that can be brought through collective redress; and
• the types of claimants for such claims.

In February 2024, the reform went through a second reading in the National Assembly.

Today, mass litigation is more common in France – that is, a significant number of individual claims filed by the same counsel before the same court.

Liability rests with the producer of the finished product, the raw materials or a component of the finished product, depending on which part is purported to be defective. Article 1245-5 of the Civil Code defines the ‘producer’ as a person or entity that:

• places its name or brand on the product; or
• imports the product into the European Union.

If the producer is unknown, the claimant may act against the sellers or importers, but they will be excluded once the producer is known. If a judgment is entered against the seller or the importer, it may bring a claim against the producer for reimbursement. Joint and several liability is possible where a defective product is incorporated in another product.

In civil matters, such as product liability cases, both national and EU laws make the defendant’s domicile in the French territory the primary criterion of jurisdiction of the French courts (Article 42 of the Code of Civil Procedure). This principle applies equally to domestic and cross-border cases, provided that there is no applicable provision or jurisdiction clause agreed upon between the contracting parties that would preclude it.

The jurisdiction of the French courts may also result from the location of the claimant’s domicile within the French territory. Article R631-3 of the Consumer Code allows a consumer to bring an action before either:

• the court of the place where he or she resided at the time of the conclusion of the contract; or
• the court of the place where he or she resided at the time of the event giving rise to the damage.

Similarly, Article 18 of EU Regulation 1215/2012 states that, in matters relating to contracts concluded by consumers, the consumer may bring proceedings against the other contracting party “either in the courts of the Member State in which that party is domiciled or, regardless of the domicile of the other party, in the courts for the place where the consumer is domiciled”. Therefore, based on these provisions, a consumer domiciled in France is free to bring proceedings before the French courts against a professional manufacturer/distributor/seller domiciled in another EU member state or in a third jurisdiction.

The most common grounds are:

• strict liability for defective products (Articles 1245 and following of the Civil Code); and
• liability on the grounds of the statutory warranty for hidden defects (see question 1.1).

The supply of defective products can sometimes qualify as a breach of the safety obligation incumbent on the product’s producer, which can constitute a criminal offence depending on the seriousness of the consequences of the supply. It may constitute manslaughter or unintentional injury if death or injury results for the victim.

However, it is mainly the offences of deceit, fraud, falsification, misleading commercial practices that will apply.

Pursuant to Article 1245-3 of the Civil Code, a product is ‘defective’ where it does not offer the level of safety that a person could legitimately expect.

Various factors must be taken into account when assessing the defect, such as:

• the presentation of the product;
• its reasonable use; and
• the date on which it was placed on the market.

‘Product presentation’ refers to the information provided by the manufacturer or supplier about the product. The lack of safety may therefore result from insufficient information on the potential of the product, without it necessarily being affected by an internal defect (French Supreme Court, 9 December 2020, Case 19-17.724). Article 1245-9 of the Civil Code provides that there can be a defect even if the product was manufactured in compliance with applicable standards or was granted an authorisation to be placed on the market by the competent authorities.

Under Article 1245-8 of the Civil Code, the burden of proof lies with the claimant, who must prove:

• the damage;
• the defect; and
• the causation between the two.

That said, in practice, the French courts tend to shift the burden of proof to the manufacturer. The latter often must demonstrate, where it cannot prove a flagrant misuse of the product by the claimant, that its product is compliant with the relevant regulations and is safe in order to answer the claimant’s claim.

The burden of proof also lies with the manufacturer for mass-produced products. If one item in a batch is alleged to be defective, the manufacturer must prove the absence of a serial defect.

More generally, in most product liability cases giving rise to preliminary expert proceedings, whereby a court-appointed expert tries to determine the origin of the damage, manufacturers tend to make a greater effort to demonstrate the lack of defect – in particular, by:

• commissioning tests;
• filing technical documents; and
• providing explanations.

These efforts are necessary as the French courts tend to be favourable to claimants by giving credit to evidence that does not prove an adequate causal link or equivalence of causes (the two theories of causation that co-exist under French law), but which are in fact presumptions. However, manufacturers can rely on an established line of case law according to which the mere involvement of a product in the occurrence of damage is not sufficient to establish a defect within the meaning of Article 1245-3 of the Civil Code.

As per the proof of the defect (see question 4.2), the burden of proof of causal link lies, in principle, with the claimant and then shifts to the defendant whenever the defendant invokes a limitation of liability.

In practice, the French courts tend to shift the burden of proof to the manufacturer. A recent decision established an irrebuttable presumption of hidden defects on the part of the professional seller regarding buyers who do not have the same skills (Case 22-11.621). Accordingly, the manufacturer often ends up having to demonstrate, where it cannot prove flagrant misuse of the product by the claimant, that its product is compliant with the relevant regulations and is safe in order to answer the claimant’s claim that the product is, for instance, affected by a hidden defect. This generally happens within the scope of expert proceedings, conducted by an expert appointed by the French courts to independently investigate the origin of an incident involving a product.

Apart from the defect and the causal link, the plaintiff must also prove the existence and the extent of all damages claimed for. These damages should ideally be substantiated by an expert, bearing in mind that the expert’s opinion may be challenged by the other party, especially where it is private and not adversarial.

The criterion of the claimant’s knowledge is key when it comes to determining whether a claim is time barred. Articles 1245-15 and 1245-16 of the Civil Code provide for a double limitation period for products placed on the market after the entry into force of the Law of 19 May 1998, which implemented the EU Product Liability Directive (85/374/EEC):

• The claim must be brought within three years of the date on which the claimant was aware or ought to have been aware of:
• • the defect;
  • the damage; and
  • the identity of the manufacturer; and
• In the absence of a fault of the producer, no action can be taken 10 years after the product was placed on the market

Article 1245-10 of the Civil Code allows for five defences:

• The product was not placed on the market;
• The defect did not exist when the product was placed on the market or the defect arose afterwards;
• The product was not intended for sale or distribution;
• The state of technical or scientific knowledge at the time the product was placed on the market did not allow the existence of the defect to be detected (the development risk defence); or
• The defect is due to the product’s compliance with mandatory regulatory or legislative requirements.

Other defences are also available – in particular, where the claimant is at fault or where his or her negligence contributed to the damage, in which case the manufacturer’s liability can be reduced or excluded (Article 1245-12 of the Civil Code).

As in force majeure cases, the manufacturer’s liability can be totally excluded only if it can prove that the claimant’s fault was unforeseeable (meaning that the event could not reasonably have been foreseen at the time of the conclusion of the contract) and irresistible/unavoidable (meaning that the effects of the event could not be avoided by appropriate measures).

Besides, the manufacturer’s liability towards the claimant is not reduced where the act or omission of a third party contributed to the damage (Article 1245-13 of the Civil Code).

Finally, the manufacturer of components benefits from additional defences. It will not be held liable if it can establish that the defect is attributable to:

• the design of the product into which the part was incorporated; or
• the instructions given by the manufacturer of that finished product.

Clauses intended to exclude or limit liability for defective products are prohibited. However, for damage caused to goods that were not used by the victim primarily for his or her own private use or consumption, clauses stipulated between professionals are valid (Article 1245-14 of the Civil Code).

Liability may be reduced or excluded, depending on the facts of the case, if the damage was caused:

• jointly by a defect in the product and a fault of the claimant, or the fault of a third party under the claimant’s responsibility (eg, minor children or employees); or
• exclusively by a fault of the claimant or the person under its responsibility.

As in force majeure cases, the manufacturer’s liability can be totally excluded only if the manufacturer can prove that the claimant’s fault was unforeseeable (meaning that the event could not reasonably have been foreseen at the time of the conclusion of the contract) and irresistible/unavoidable (meaning that the effects of the event could not be avoided by appropriate measures). However, it is not possible to limit or exclude liability for the acts of third parties that jointly caused the damage but are not related to the claimant. That said, the manufacturer can bring a claim for damages against the third party whose actions caused the damage (Articles 1245-11 and 1245-12 of the Civil Code).

Product liability cases brought by consumers against companies are typically handled by the civil or commercial courts (at the claimant’s choice).

Consumers ordinarily bring their claims before a civil court. Civil courts generally rule with three judges, with exceptions depending on the subject matter of the case. Civil court judges are career judges who, after law school, are trained in a dedicated school for judges in France.

If a claim is brought by a professional, the commercial courts have jurisdiction to hear it. The commercial courts are composed of a panel of three judges, although cases may be heard by only one judge. Commercial court judges are not career judges but professionals who have been elected by their peers within professional unions. However, there are career judges at the appellate level.

There are no juries in the French legal system, except in criminal proceedings relating to the most serious criminal offences. If an authority considers that a product is not compliant, the case will likely be analysed by the criminal courts, which have jurisdiction to rule not only on cases where there has been a personal injury due to the use of a product, but also where deceit or misleading commercial practices are involved. If the criminal courts are seized, claimants can seek compensation before the criminal courts, which will rule on both the criminal liability and civil compensation. This type of case is not heard by a jury.

There are no juries in the French legal system, except in criminal proceedings relating to the most serious criminal offences.

It is not possible under French law to circumvent the rules determining the forum (eg, whether the claim is brought before the commercial courts, the civil courts or the administrative courts). These rules are mandatory and are determined based on the nature of the dispute.

Jurisdiction clauses can be stipulated, but only between parties that are classified as merchants. These clauses are null and void against non-merchants (Article 48 of the Code of Procedure).

Consumers have the choice of bringing an action before either:

• the court of the place where they resided at the time of the conclusion of the contract; or
• the court of the place where they resided at the time of the event giving rise to the damage (Article R631-3 of the Consumer Code).

A product liability suit is generally introduced by filing two writs of summons:

• one to have an expert appointed by the court to investigate the technical aspects of the case and determine the root cause of the issue; and
• a second one on the merits (which will be stayed until the expert proceedings are over).

These writs of summons must:

• contain a certain number of mandatory details; and
• specify the legal grounds invoked against the opposing party.

These writs of summons must be served to the opposing party through a bailiff, who must inform it that a lawsuit has been brought against it and that it must appear at the date and time indicated in the summons.

Following the serving of the writs of summons, the defendant will file submissions in response. Both parties successively have the opportunity to respond and file submissions in response, the number of which will vary depending on the complexity of the case. The case will not be heard until the judge decides it is ready for hearing.

The timeframe of the proceedings will mainly depend on the complexity of the case. Such proceedings generally take at least a year to be heard, which may be doubled if an expert is appointed.

Since 1 October 2023, a preliminary attempt at conciliation is required for certain claims to be admissible in court, such as claims with a value of less than €5,000. The plaintiff thus must provide evidence of this conciliation attempt in the writ of summons.

Since the 2020/21 reform of French civil procedure, it is also mandatory to:

• schedule with the court clerk the date of the first hearing prior to serving the summons; and
• indicate this date in the writ of summons.

In civil matters, such as product liability cases, both national and EU laws make the defendant’s domicile in the French territory the primary criterion for the jurisdiction of the French courts (Article 42 of the Code of Civil Procedure). This principle applies equally to domestic and cross-border cases, provided that no applicable provision or jurisdiction clause agreed upon between the contracting parties precludes it.

The jurisdiction of the French courts may also result from the location of the claimant’s domicile within the French territory. Article R631-3 of the Consumer Code allows the consumer to bring an action before either:

• the court of the place where he or she resided at the time of the conclusion of the contract; or
• the court of the place where he or she resided at the time of the event giving rise to the damage.

Similarly, Article 18 of EU Regulation 1215/2012 states that in matters relating to contracts concluded by consumers, the consumer may bring proceedings against the other party “either in the courts of the member state in which that party is domiciled or, regardless of the domicile of the other party, in the courts of the place where the consumer is domiciled”.

The applicable law will be mainly determined based on the Hague Convention of 2 October 1973 on the Law Applicable to Products Liability, which designates in principle the law of the place where the damage occurred (Article 4).

There are no provisions for security for costs under French law. This is theoretically possible but is never used in practice in France.

There are no procedures for disclosure/discovery of documents under French civil law.

Parties are free to select the documents they wish to disclose during the proceedings.

They can, however, request the production of evidence that has not been disclosed by the other party or that is in the possession of a third party, but only under very strict conditions. Parties can request preliminary inquiries prior to the proceedings on the merits “if there is a legitimate reason to preserve or to establish … evidence of facts upon which the outcome of the dispute depends” (Article 145 of the Code of Civil Procedure). If the conditions are met, the court may order investigative measures to gather evidence. The requesting party must properly identify the document sought, as so-called ‘fishing expeditions’ are not allowed (Articles 138 and 139 of the Code of Civil Procedure).

Legal advice provided by lawyers to clients and their communications are protected by lawyers’ professional secrecy, as defined by Article 66-5 of Law 71-1130 of 31 December 1971. This encompasses:

• legal opinions;
• communications between lawyers and clients;
• meeting notes; and
• all case-related documents.

Under the National Rules of Procedure of the French Bar Council, lawyer-client communications are protected as a matter of public order. Lawyers are prohibited from disclosing any information contrary to professional secrecy, except in specific legal circumstances.

In civil litigation, documents and communications between lawyers and clients are generally protected by secrecy and cannot be disclosed to third parties or used as evidence without the client’s consent. However, clients are not bound by professional secrecy and can use such communications or documents in their defence.

In application of Article 226-13 of the Criminal Code, all professionals (eg, lawyers, judges, doctors, journalists) are prohibited from disclosing confidential information obtained in their professional capacity.

However, in-house counsel at companies are not protected by privilege, so their communications (except those with their lawyers) will not be covered by professional secrecy.

There are no procedures for disclosure/discovery of documents under French civil law as there would be in common law jurisdictions (see question 8.1).

Should a party ask the judge to order the production of an evidence (in the context of the request described in question 8.1, which can be brought only under very strict conditions), the defendant can argue that this evidence is not useful to the resolution of the dispute and is confidential/protected by privilege. In practice, the judge will balance the interests at stake against the importance of the breach of confidentiality in deciding whether to order the production of evidence.

All evidence is permissible under French law, on condition that it is lawful. This prohibits in principle the production of evidence obtained against a person without his or her knowledge (eg, by recording a phone conversation). In such circumstances, the judge will carry out a proportionality assessment of the infringement of the rights of the individual against whom the evidence is being administered.

The probative force of the evidence is determined by the sovereign interpretation of the judges, but is also classified by the Civil Code according to the type of document – for example:

• deed established by a ministerial officer;
• private deed;
• bailiff’s findings;
• written or oral testimonies; and
• “beginnings of proof by writings” ("imperfect" type of evidence, which can be taken into account by the Judge but cannot itself constitute the proof of what is alleged and must be supported by other evidence).

During the proceedings, evidence is most often presented in writing, in the form of exhibits accompanying the submissions. It is extremely unusual to have witnesses or experts questioned during trial.

Generally, the court appoints experts to assist it in considering technical issues. In addition, the testimony of expert witnesses can be produced before the French courts to prove facts such as the step(s)/cause(s) that gave rise to an incident linked to a product. However, judges have full discretion as to whether to give credit to this type of testimony and in practice, the weight of such evidence is light.

What is much more common in product liability litigation is the appointment by the French courts of a judicial expert prior to the trial (through summary proceedings), or even during the trial. During expert operations conducted by the court-appointed expert, each party can be assisted by its own expert. The parties can choose an expert:

• who is listed by the French courts of appeal or the Supreme Court as being knowledgeable in a specific area; or
• who is not on such a list, bearing in mind that an unlisted expert’s opinion may be considered less convincing than that of a listed expert.

The party-appointed expert will file written reports and statements with the judicial expert during the expert operations, which will then become evidence in the case.

Product liability suits are often determined by the expert proceedings and this type of evidence is most likely to influence the opinion of the judge.

In France, court proceedings are public in product liability matters, with no possibility to keep them confidential.

Usually, product liability suits start with a request by the claimant for the appointment of an expert by the court to investigate the root cause and technical issues of the matter. After the expert submits his or her final report, such proceedings are over.

The claimant or any other party can then decide to file a claim on the merits to obtain compensation. This is done through summons. There is then an exchange of submissions between the parties before the case is heard by the court – unless the parties have decided to stick with written submissions. Following the hearing, the court can take several weeks or months to issue its decision, depending on its workload and the complexity of the case. Two levels of appeals are at the disposal of the parties following the first judgment.

The timeframe for the proceeding will mainly depend on the complexity of the case. In our experience, expert proceedings can last around five years. Afterwards, a first decision can be obtained within two or three years. Appellate proceedings will add around 18 months. An appeal lodged before the Supreme Court can take a further year.

Conciliation and mediation are increasingly encouraged by the French courts.

Since 1 October 2023, a preliminary attempt at conciliation has been required for certain claims to be admissible in court, such as claims with a value below €5,000. The plaintiff thus must provide evidence of this conciliation attempt in the writ of summons.

French law provides for compensatory monetary damages.

The damages awarded in product liability disputes are generally economic damages but can also extend to non-economic damages such as moral damages. In cases of personal injury, the claimant is entitled to claim for a wide range of damages as set out in medico-legal rating scales (eg, see the so-called Mornet Report), which encompass the following, among others:

• pecuniary losses before and after stabilisation;
• functional impairment;
• pain and suffering; and
• aesthetic loss.

Punitive damages are not permitted under French law.

The judge will mainly rely on the expert opinion in deciding on the quantum of damages to award. In terms of personal injury, the Dintilhac Nomenclature, created in 2006 by medical researchers, is the basis for compensation for all areas of injury.

The courts also tend to take into account precedents and case law to ensure consistency in their decisions.

The parties can appeal a first-instance decision on all legal and factual grounds, and thereafter can appeal to the Supreme Court on legal grounds only.

The successful party can recover all procedural costs listed in Article 695 of the Code of Civil Procedure, such as court-appointed experts’ fees, witnesses’ expenses and service fees (Article 696 of the French Code of Civil Procedure).

Any other legal costs incurred by a party, such as legal fees, fall under the scope of Article 700 of the Code of Civil Procedure, which states that the court will order the party bearing the court costs – or, failing that, the losing party – to pay to the other a sum determined by the court corresponding to the costs incurred that are not included in the procedural costs. The losing party will not have to reimburse the full amount spent by the winning party.

See question 13.1.

If the claim is withdrawn, each party will bear its own costs and fees, unless the parties agree otherwise within the scope of the agreement they enter into.

No, except for the expert fees if the court has appointed an expert to assist it.

The court will assess, on a case-by-case basis, what amount it would be fair to grant, taking into account equity or the economic position of the paying party and the amount of damages granted.

Legal aid in France is available under very stringent conditions. Two conditions must be met:

• The claimant’s legal fees must not be fully covered by insurance; and
• His or her reference tax income and the value of his or her assets must not exceed the legal limits.

Under the professional ethics rules for lawyers, success fees that equate to all legal fees are prohibited. However, it is possible for the client to agree to a success fee in addition to the regular legal fees depending on the services provided or the outcome of the case.

Third-party funding is not prohibited in France, but it is not yet common practice. For lawyers, the main difficulty relates to professional responsibility rules, which provide that:

• payment must come exclusively from the client; and
• confidential information about the case may not be shared by the lawyer with persons who are not the client.

• The EU Product Liability Directive (85/374/EEC) establishes strict liability for defective products. This has been transposed into the Civil Code at Articles 1245 to 1245-17. Under the Product Liability Directive, manufacturers, distributors and retailers may be found liable where a defect in their products has caused damages, even in the absence of any fault.
• Consumer law contributes in large part to the regulation and safety of products which are placed on the French market, as it provides for a general safety obligation. The General Product Safety Directive (2001/95/EC) was transposed into the Consumer Code and provides a right to safety for consumers (Article L421-3). Under Article L411-1 of the Consumer Code, products must comply with all safety regulations from the first time they are placed on the market.
• Tort law is also relevant, making a manufacturer, distributor, importer or retailer liable if a product causes damage to a consumer. Tort liability is a non-contractual liability that can be sought by consumers even if no contractual provision has been breached or if there is no contract.
• Contract law, sales law and statutory warranties also play a role in the regulation of product safety.
• Criminal law can, under certain circumstances, be applied against the manufacturers, distributors, importers or retailers of products in the event of bodily injury or a failure to comply with a specific regulation.

Every product manufactured, distributed, imported or sold in France must comply with:

• the general guarantee of conformity; and
• the general safety obligation.

Additionally, certain categories of products are specifically regulated, such as:

• automobiles;
• chemicals;
• food;
• electronic devices;
• medicines;
• cosmetics; and
• weapons.

The Directorate General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) is the authority in charge of regulating the largest number of products, including:

• cosmetics;
• toys;
• food;
• chemicals; and
• books.

To carry out its mission, the DGCCRF has 23 regional directorate offices and 101 departmental directorate offices, in addition to its central administration located in Paris.

The DGCCRF notably has the power to:

• carry out extensive investigations;
• request the provision of documents (Article l. 512-8 of the Consumer Code);
• seize products (Article l. 512-51 of the Consumer Code) ;
• issue injunctions;
• access manufacturing and storage sites (Article l. 512-5 of the Consumer Code);
• impose financial penalties; and
• order the withdrawal of non-compliant products from the French market.

It is therefore in the interests of all manufacturers, distributors and retailers to cooperate with the DGCCRF when their products are being investigated and before placing these products on the French market to ensure compliance with local regulations.

Other authorities have similar powers over other specific types of products – for example:

• food products of animal origin are regulated by the Directorate General for Food;
• vehicles are regulated by the Directorate General for Energy and Climate;
• health products are regulated by the French National Agency for the Safety of Medicines and Health Products;
• radio equipment is regulated by the French National Frequency Agency; and
• nuclear activities are regulated by the French Nuclear Safety Authority.

The various authorities that are competent to enforce the regulations related to product safety have the power to:

• issue injunctions;
• impose financial penalties;
• order the withdrawal or recall of non-compliant products from the French market; and
• publish their decisions.

If the necessary procedures for withdrawal or recall of a product are not taken despite being aware of a risk to human health:

• company owners or executives could be liable for:
• • a maximum prison sentence of five years; and
  • a fine of up to €600,000; and
• companies could be fined:
• • up to €3 million; or
  • up to a maximum of 10% of the average annual turnover for the last three years (Article L452-5 of the Consumer Code).

Consumers can also obtain compensation for injuries and damages sustained due to a product defect.

If the court holds the defendant company liable for misleading commercial practices, it can impose a penalty of up to €1.5 million.

If the benefits obtained from the misleading commercial practice exceed the initial penalty of €1.5 million, this penalty can be increased to:

• 10% of the defendant’s average annual turnover in the last three years; or
• 50% of the expenses incurred in carrying out the advertising of misleading commercial practice. This can be increased to 80% in the event of a misleading environmental claim.

A company owner or executive could face a penalty of up to €300,000 and a two-year prison sentence.

A product recall is one of the corrective measures that a producer or distributor can implement when it discovers that a product which it has placed on the market may pose a risk to health or safety. Therefore, a recall may be carried out even if the product complies with the applicable regulations.

French law does not specify when a product recall is required or the criteria that companies should apply when deciding whether to conduct a product recall. The law provides only that a recall can be conducted at any time if a product does not meet the applicable safety requirements (Article L423-3 of the Consumer Code). The recalling entity must therefore assess whether the risk is serious enough to initiate a recall action. In this context, the General Product Safety Directive states that a product recall must “take place as a last resort, when other actions would not be sufficient to prevent the risks involved” (Article 5.1). In practice, when a product recall is imposed by a public authority, the authority conducts the risk assessment.

The general rule is that a product recall may be triggered when the manufacturer or distributor identifies, or has reason to believe, that the product does not meet general product safety requirements (Article L423-3 of the Consumer Code). In this case, the manufacturer or distributor can choose to implement a voluntary product recall (among other measures) (Article 5.1 of the General Product Safety Directive).

On becoming aware that a product it has placed on the market may present a risk to consumers, a producer or distributor must:

• take the necessary action to prevent risks to consumers; and
• immediately inform the competent administrative authorities (Article L423-3 of the Consumer Code.)

The producer or distributor must:

• for non-food products, send a notice through the Product Safety Business Alert Gateway of the European Commission. If the notifier is unable to do so, it must send the notification form and traceability form available on the website of the Directorate General for Competition Policy, Consumer Affairs and Fraud Control; and
• for food products, send a notice, including traceability forms, directly to the Departmental Directorate for the Protection of Populations of the French territorial department where the notifier is established.

For motor vehicles, the economic operator must send a recall campaign notification form to the Directorate General for Energy and Climate.

If the necessary procedures for withdrawal or recall of a product are not taken despite being aware of a risk to human health, the following penalties can apply:

• Company owners or executives could be liable for:
• • a maximum prison sentence of five years; and
  • a fine of up to €600,000.
• The company could be fined:
• • up to €3 million; or
  • up to a maximum of 10% of the average annual turnover for the last three years (Article L452-5 of the Consumer Code).

Recall measures must include notification to consumers and product buyers.

The only obligation to consumers is to publish a notice on the Rappel Conso website, which provides information on all ongoing product recalls, except for those relating to medicines and medical devices. To advertise a recall on RappelConso, the recalling entity must complete a form containing certain required information on the product and the company. The responsible person is free to include any additional information on the recall process.

In any case, the professional is obliged to communicate only the information of which it is aware, or of which it could not reasonably be unaware, at the time of submitting the information on the platform (Article 2, Ministerial Order of 20 January 2021).

Producers and distributors are also free to organise voluntary recall advertising campaigns. These can take various forms – for example:

• in-store displays;
• communications with consumers who have purchased the product;
• announcements in the press or on the radio; and
• television advertising.

Voluntary recall advertising campaigns can:

• help to ensure that a recall is effective; and
• limit exposure to liability arising from unsafe products.

The temporary withdrawal of a product until the necessary measures have been taken by the manufacturer is another corrective measure that a producer or distributor can implement when it discovers that a product it has placed on the market may pose a risk to health or safety.

The best practices are to carry out an effective product recall programme covering two aspects:

• preparation for potential safety issues and product recalls; and
• crisis management in the event of safety issues and product recalls.

A producer should take measures to ensure it keeps abreast of the risks posed by its product, to be able to prevent and mitigate these risks. This may involve conducting internal audits, tests and surveys. The producer may also wish to indicate on the product or its packaging information enabling consumers to identify the product in the event of a recall, such as:

• the identity and address of the producer; and
• the product reference and batch number (Article L423-2 of the Consumer Code).

When initiating a product recall, a producer should set up a crisis unit, which will be responsible for managing relations with:

• the competent authorities (eg, submitting declarations to the authorities and publishing information on the Rappel Conso website);
• customers;
• commercial partners; and
• the media.

The producer may also wish to inform consumers of a recall:

• through its distributors;
• in the media; or
• by displaying messages at the places where its products are sold.

The producer should have the necessary resources in place to contact consumers who are in possession of the product.

The recalling entity should also keep documents regarding actions taken during the recall process.

Suppling defective products is not a criminal offence in itself under French law. It can, however, constitute a breach of the safety obligation incumbent on the product’s manufacturer, which can qualify as a criminal offence depending on the seriousness of the consequences of the supply. It can also constitute deceit or misleading commercial practices which are criminal offences.

(a) Which parties can be held responsible?

All the parties that took part in the infringement may be held liable depending on the facts of the case:

• the manufacturer;
• importers;
• distributors; and
• all economic operators in the chain of production.

The company and its representatives can both be prosecuted.

(b) Can individual officers or employees be held responsible?

Individual officers or employees can be held liable if they are found to have personally taken part in the offences.

(c) What is the basis for liability?

Supplying defective products and breaching the safety obligation incumbent on the manufacturer may constitute manslaughter or unintentional injury if death or injury results for the victim.

However, it is mainly the offences of deceit, fraud, falsification and misleading commercial practices that will apply.

(d) What penalties can be imposed?

A large range of penalties can be imposed depending on the criminal offence.

For instance, misleading commercial practices are punishable under Article 132-2 of the Consumer Code by a maximum of:

• two years’ imprisonment (where the offence is committed by an individual for his or her own benefit); and
• a fine of up to €300,000 (€1.5 million for businesses), which can be increased to:
• • 10% of the annual turnover over the last three years; or
  • 50% of the expenses incurred in carrying out the advertising or practice constituting the offence.

Deceit or falsification can result in:

• a fine of up to €300,000 (€1.5 million for businesses);
• a prison sentence of up to two years (Article L451-1-1 of the Consumer Code); and
• a fine of €750,000 (€3.75 million for businesses) and seven years’ imprisonment if the falsified substance is harmful to human or animal health for food products (Article L451-2 of the Consumer Code).

Manslaughter is punishable by up to five years’ imprisonment and a €75,000 fine (€375,000 for businesses); while homicide is punishable up to 30 years’ imprisonment (Articles 221-6 and 221-1 of the Criminal Code).

A notable example is the Mediator case. Mediator was a drug prescribed as an antidiabetic but widely used as an appetite suppressant. It was withdrawn from the market in 2009 due to its association with serious heart problems.

In this case, criminal proceedings were brought against Servier, the pharmaceutical company which manufactured and marketed Mediator. The charges included:

• aggravated deception;
• fraud; and
• involuntary manslaughter and injury.

Several Servier executives, including the company’s founder, as well as officials from the French Agency for the Safety of Health Products, were indicted. It was found that at least 500 people had died of heart valve problems after taking this drug.

On 20 December 2023, the Paris Court of Appel ruled that Servier was guilty of fraud and several charges by supplying the drug when knowing it was potentially harmful. Among other convictions, Servier was convicted to pay:

• €415.6 million to French social security services (on top of the approximately €200 million in compensation already paid to the victims); and
• criminal fines of close to €9 million.

Former chief executive officer Jean-Philippe Seta was convicted to four years of suspended prison sentence (with one year of house arrest) and a fine of €89,000.

On 15 November 2023, the French Supreme Court recognised the possibility for victims who suffered heart damage as a result of taking Mediator (see question 17.2) to bring an action on the grounds of tort law, despite the fact that they were time barred from bringing an action on the basis of the strict defective product liability statutory regime.

The Versailles Court of Appeal dismissed all the victims’ claims, ruling that the manufacturer’s wilful negligence in knowing that Mediator was defective but deliberately keeping the product in circulation did not constitute a fault separate from the product’s safety defect. The Versailles Court of Appeal therefore held that the statutory regime of liability for defective products was applicable in this case, but that the plaintiffs’ action was time barred.

The French Supreme Court overturned this position, pointing out that it follows from Article 1245-17 of the Civil Code – which transposed the EU Product Liability Directive into French law – that the regime established by the directive does not exclude the application of other contractual or non-contractual liability regimes based on different grounds, such as the warranty for latent defects or fault.

These decisions therefore confirm the admission of a combination of legal grounds and hold that tort law may still be engaged notwithstanding the defectiveness of a product where a separate fault is established – in this case, the fact that the manufacturer had kept on the market a product known to present a risk (French Supreme Court, 15 November 2023, Cases 22-21.174, 22-21-178, 22-21.179, 22-21.180).

The rise in regulations relating to the environmental impact of products and manufacturing process is certainly affecting product liability litigation. We have observed an increase in the number of investigations carried out by the DGCCRF into environmental-related claims, product reparability and similar issues, with the aim of characterising misleading commercial practices or planned obsolescence, which are criminal offences in France.

The exponential growth and influence of artificial intelligence (AI) will also have an impact on product liability litigation, especially as:

• the Proposed Directive on Liability for Defective Products will address the issue of damage stemming from AI systems; and
• a specific regulation on AI is also expected.

Currently, the next anticipated ground-breaking regulations regarding product safety are the Proposed Directive on Liability for Defective Products and the General Product Safety Regulation (2023/988) which will enter into force on 13 December 2024. Discussions will again take place on what ‘safety’ means when it comes to complex and connected products, for instance.

The most important tips are as follows:

• Stay fully up to speed with French and EU regulations regarding safety, labelling, packaging and all regulatory obligations; and organise internally to be able to make necessary adjustments quickly when new provision enters in force.
• Proactively implement testing and quality control measures throughout the manufacturing process to detect and rectify potential safety issues early on. French authorities and notably the Directorate General for Competition Policy, Consumer Affairs and Fraud Control will take into consideration any voluntary steps taken.
• Implement an effective product recall programme (see question 16.5) in case the product faces safety issues.

The main sticking point is the need to deal with certain national measures specific to France that have not been standardised at the EU level and the tendency of French regulators to go it alone and enforce certain regulations in a specific way which differs from that across the rest of Europe. We have recently seen examples of this regarding:

• the enforcement of specific absorption rates regulations by the National Frequency Agency; and
• the enactment of a law and decree (the Studer Law) imposing parental control functionalities on all electronic devices.