General climate and recent developments

State of legal development

In general terms, how developed are the product regulation and liability laws in your jurisdiction?

French product regulation and liability legislation is extensive, offering a wider scope than the EU directives from which they are derived: when transposing the EU Product Liability Directive (85/374/EC) into an exhaustive set of regulations under Article 1245 and following of the Civil Code, the French legislature extended the liability to relationships with businesses rather than limit it to relationships with consumers only. Similarly, Article L421-3 of the French Consumer Code provides for a very large general safety obligation that applies to products as well as services, and aims at protecting any individual.

Recent developments

Have there been any notable recent developments in relation to product liability law and product safety law in your jurisdiction, including any regulatory changes and case law?

Although relevant statute law has not been amended recently, there is an abundance of case law, in particular in the sector of pharmaceutical and chemical products. Recent decisions of the Court of Cassation provided clarifications as to the nature and scope of the product liability regime set out by the Product Liability Directive.

In Decision 15-25.651 (July 7 2017), the Court of Cassation held that the French courts have a duty to verify whether a claim brought before them falls within the scope of product liability legislation, even if the claimant has not invoked such legislation, as it derives from EU public policy rules.

The court also upheld a decision of the European Court of Justice (Case C-621/15) concerning acceptable evidence to prove product defect and the causal link between the product defect and the damage, in cases where a vaccine allegedly caused serious diseases. Presumptive evidence of the defect and the causal link is admitted, provided that the presumptions are serious, precise and concordant. In addition, both the defect and the causal link must be demonstrated; the mere presence of evidence does not induce an automatic presumption (Decisions 14-18.118 and 15-20.791, October 18 2017).

Lastly, a reform of the French civil liability regime is currently under discussion. Any amendments should remain in the spirit of the Product Liability Directive.

Legal framework

Legislation

What primary and secondary legislation governs product safety and liability in your jurisdiction?

Product safety and liability rules are governed by EU directives and national primary and secondary legislation.

The EU legal framework consists of the EU Product Liability Directive (85/374) and the General Product Safety Directive (2001/95).

The national product liability regime is provided for in Articles 1245 and following of the French Civil Code, which implemented the Product Liability Directive in French law – with the particularity that this regime is available for disputes between professionals and not only for consumers disputes. Product safety rules derived from the General Product Safety Directive can be found in the French Consumer Code, under Articles L411-1 and following (legal warranty of conformity) and L421-1 and following (safety requirements).

Further, the Ministerial Order of September 9 2004 lays down detailed rules for the application of Article L423-3 of the French Consumer Code, providing for the obligation to notify the competent authorities of any safety risk. The order is supplemented by a notice to economic operators on the notification obligation and measures taken to prevent those risks (NOR: EFIC1203531V, February 11 2012).

Regulatory and enforcement authorities

Which government authorities regulate and enforce product safety and liability laws in your jurisdiction, and what is the extent of their powers?

The minister in charge of consumer affairs is competent to regulate and enforce product safety and liability laws in France. Pursuant to Article L521-17 of the Consumer Code, the minister in charge of consumer affairs can temporarily suspend the sale of a product and order its withdrawal from the market when the ‘professional’ (ie, the producer or distributor in France) does not voluntarily take corrective action, and in case of serious or immediate danger. The minister is also empowered to order the publications of warnings or precautions for use, and the recall of the product. Article L521-18 of the Consumer Code provides for further powers, in particular to order a technical inspection of the product.

The Directorate General for Competition Policy, Consumer Affairs and Fraud Control has general competence in dealing with matters of safety of industrial products as stated by Articles L511-3 and L511-11 of the Consumer Code. Pursuant to Articles L511-1 and following of the Consumer Code, agents from the Directorate General for Competition Policy, Consumer Affairs and Fraud Control may exercise powers of inquiry and control. Moreover, the Directorate General has the power to enforce measures if there is evidence of infringements, according to Article L521-1 of the Consumer Code.

Article L511-22 of the code lists other agents that may ascertain safety infringements during the performance of their official duties.

Liability

Product defects

How is a ‘product defect’ defined in your jurisdiction?

Article 1245-3 of the Civil Code states that a product is defective if it does not provide the safety that a person is entitled to expect. To determine the safety that a person is entitled to expect, the courts will take into consideration all circumstances and, in particular:

  • the presentation of the product;
  • the use that can be reasonably expected to make of it; and
  • the time when the product was put into circulation.

A product may not be considered defective for the sole reason that a better product is subsequently put into circulation.

Causation and burden of proof

How is causation of loss or damage established in relation to product liability claims and where does the burden of proof lie? Can this burden be shifted in any way?

According to Article 1245 of the Civil Code, a producer is strictly liable for the damages caused by a defect of its product, whether it was contractually bound to the claimant or not. Under this regime, the claimant does not have to establish negligence or wrongdoing from the producer; it must nevertheless establish the existence of a safety defect.

In order to make a claim against the producer, the claimant must then prove an actual damage, a defect of the product and the causal link between the defect and the damage (Article 1245-8 of the Civil Code). Regarding the causal link, French case law has admitted ‘proof by presumption’, when these presumptions are "serious, precise and concordant".

In this regard, the European Court of Justice held recently that, in the absence of certain and irrefutable evidence, proof of both product defect and a causal link between the defect and the damage suffered may be demonstrated by serious, specific and consistent evidence. The temporal proximity between the vaccination and the occurrence of a disease, the lack of personal and familial history of the person vaccinated and the existence of a significant number of reported cases of the disease occurring following vaccinations may, where applicable, constitute sufficient evidence to make out such proof (Case C-621/15, June 21 2017).

Legal bases for claims

On what legal bases can a product liability claim be brought?

The liability for defective product is a specific regime based on Articles 1245 and following of the Civil Code.

However, the liability for defective products is not exclusive, and the claimant may opt between the product liability regime and the rules of contractual or extra-contractual liability (depending on whether or not there is a contractual link), or on the basis of a special liability regime. The producer remains liable for the consequences of its fault or for the fault of persons for whom it is responsible (Article 1245-17 of the Civil Code).

In the case of damage caused by a defective product, the claimant can bring a claim based on one of the following grounds:

  • defective product liability (Articles 1245 and following of the Civil Code);
  • contractual or extra-contractual liability (Articles 1103 and 1240 of the Civil Code); or
  • warranty for ‘hidden defects’ (Article 1641 of the Civil Code).

Criminal liability

Can a defendant be held criminally liable for defective products?

A producer, as a natural person, can be held criminally liable when a defective product causes or could have caused bodily harm:

  • If death occurs, the defendant can be held criminally liable for involuntary manslaughter (Article 221-6 of the Criminal Code), punished by three years' imprisonment and a fine of €45,000;
  • In any other case, the defendant can be held criminally liable for involuntary offences against the physical integrity of the person (Articles 222-19 and 222-20 of the Criminal Code); and
  • The defendant may also face charges for endangering someone 's life or safety (Article 223-1 of the Criminal Code).

A producer, as a legal entity, can also be held criminally liable for such offences when the acts are committed on its behalf by a member or representative of the corporation (Article 121-2 of the Criminal Code; for manslaughter see Article 221-7 of the Criminal Code and for involuntary offences against the physical integrity of the person, see Article 222-21 of the Criminal Code). Where the legal entity is found liable, fines are multiplied by five (Article 131-38 of the Criminal Code).

Liable parties

Which parties can be held liable for defective products?

The producer, any person acting in a professional capacity as a producer and, on a secondary level, the seller or distributor can be found liable.

 

The term ‘producer’ encompasses the manufacturer of a finished product, the producer of a raw material and the manufacturer of a component (Article 1245-5 of the Civil Code). Additionally, any person acting in a professional capacity is considered a producer when:

  • he or she presents him or herself as the producer by affixing his or her name, trademark or other distinguishing sign on the product; or
  • he or she imports a product into the European Union to sell or lease it (with or without a promise of sale) or to carry out any other form of distribution (Article 1245-5 of the Civil Code).

 

According to Article 1245-6 of the Civil Code, if the producer cannot be identified, the seller, the lessor (with the exception of a financial lessor or a lessor similar to a financial lessor) or any other professional supplier is liable for the defect in the safety of the product in the same conditions as a producer, unless it names its own supplier or producer within three months of receiving notice of the request from the claimant.

 

The recourse of the supplier against the producer is subject to the same rules as those applicable to the claim brought by the immediate victim of the defect. However, the action must be filed within one year of the date of summons.

 

Limitation of liability

Can liability be excluded or mitigated in any way?

Any clauses limiting or exonerating the producer from liability in the contracts between a professional and a consumer are forbidden and considered null and void. However, as regards damages caused to things that are not used by the claimant mainly for his or her own private use or consumption, such clauses stipulated between professionals are valid (Article 1245-14 of the Civil Code).

‘Professionals’ (as defined by the law in this context) can also mitigate their liability by adjusting the rules on the burden of proof (Article 1356 of the Civil Code).

Litigation

Procedure

What is the procedure for filing a product liability claim before the courts in your jurisdiction?

Product liability claims are subject to common civil proceedings rules. If the claimant is a consumer, it may bring a claim either before civil or commercial courts. Conversely, if the claimant is a ‘professional’ in the sense of the law, commercial courts will have sole jurisdiction.

The process to file a claim is similar before civil and commercial courts: unless the claim is urgent, the claimant should first initiate amicable discussions with the producer and potential co-defendants. If the discussions fail, the claimant should serve the producer with a writ of summons through a bailiff. Once properly served, the writ is filed at the court docket. Such filing initiates proceedings.

Interlocutory motions

Can the court issue interlocutory orders or judgments in product liability cases? If so, what rules and procedures apply?

Yes. Interlocutory orders may be issued through autonomous fast-track summary proceedings, or as part of ongoing proceedings on the merits (Articles 771, 808 and following, 872 and following). Such judgment may order the defendant to pay a provision (interlocutory payment) to the claimant, to the extent that liability is not seriously challengeable. This is rarely the case in product liability cases, though, because the producer's liability is rarely blatant and requires investigations to be substantiated.

The judge may also issue discovery mechanisms through interlocutory orders, as described in the section below.

Pre-trial disclosure

What pre-trial disclosure/discovery mechanisms are available in product liability cases, if any?

There is no equivalent in France to the US discovery or UK disclosure mechanisms. In civil courts, the claimant has the burden to disclose the pieces of evidence supporting its claim from the beginning of the proceedings. The defendant discloses at a later stage, together with its reply brief, the pieces of evidence supporting its defence. The claimant may request the civil or commercial court judge to order investigation measures prior to initiating a trial, or during the pre-trial phase (Article 145 of the Code of Civil Procedure). Two sets of measures are usually ordered:

  • expert appraisals, in order to assess the existence of a defect, the medical situation of the claimant or the losses; and
  • seizures of documents, data or products necessary to evidence a safety defect.

Seizures are usually requested and ordered ex parte.

Evidence standards

What evidence is accepted to support claims in product liability cases? What formalities apply to evidence submission?

Before civil courts, only written evidence is admissible, whereas before commercial courts, any type of evidence is admissible. Only ‘fair’ evidence is admitted before both courts – evidence that was stolen or recordings made without the defendant’s knowledge are not admissible.

Circumstantial evidence may be admitted to the extent that it results from "serious and corroborating clues".

Evidence is to be spontaneously submitted by each party that refers to it in its submissions. It may be submitted in writing or in electronic form (including sound or video files).

Unlike US or UK courts, French civil and commercial courts do not hear the parties' experts during trials. Consequently, the courts often order technical expertise reports as a preliminary step to assess the technical aspects of the claim (see below).

Expert evidence

Under what circumstances will the court appoint an expert to assist it in examining the merits of the case? What rules and procedures apply?

Experts are usually appointed at the request of the claimant, through pre-trial disclosure proceedings.

Experts will be appointed where further evidence or technical knowledge is needed for the judge to rule on the claim.

If the claimant has already initiated an action on the merits, any party may request the pre-trial judge (civil court) or reporting judge (commercial court) to order an expert appraisal. Alternatively, the court may decide to appoint an expert on its own, if it finds that it needs technical advice. Before appointing an expert, the judge needs to follow due process principles and gather each party's comments.

Experts are appointed through pre-trial orders that can be appealed.

Can the parties rely on expert witness testimony to support their claims? If so, what rules and procedures apply?

Yes. However, French civil and commercial courts rarely rely on witness testimonies.

Testimonies are submitted in written form, and should mention the identity of the witness, as well as a statement that he/she is aware that it will be used before courts. Oral testimonies are possible, at the court's request, but rarely ordered.

Where parties provide conflicting expert testimonies, the court may appoint an ‘independent’ expert to clear the contradictions, under the conditions described above.

Class actions

Are class actions or any other collective proceedings available for product liability claims in your jurisdiction? If so, what is the procedure for their formation and what benefits do they afford claimants? Are class actions formed on an opt-in or an opt-out basis?

Two specific class actions may be triggered in product liability claims: a consumers class action, which aims at compensating only material losses suffered by consumers (Articles L623-1 and following of the Consumer Code), and a healthcare class action, which aims at compensating losses resulting from health products (Articles L1143-1 and following of the Public Healthcare Code).

Both types of action can be initiated only by certain consumers associations or healthcare system users associations on an opt-in basis. The class action regime is twofold: the first phase is when the association initiates proceedings against a producer to assess its potential liability and determine the relevant class. The second step is the opt-in phase, during which, after the publication of the ruling on the producer's liability, the victims will be asked to opt in in order to have their damages assessed, and then compensated.

Appeals

What rules and procedures govern appeals of court decisions?

Common civil procedure rules govern appeals of court decisions: decisions on the merits can be appealed within one month of their notification, whereas summary decisions can be appealed within 15 days of their notification. Appellate decisions may also be appealed before the Court of Cassation, but only to review points of law, not facts.

Statute of limitations

What is the statute of limitations for filing product liability claims?

The statute of limitations is three years from the date when the claimant knew the extent of the damage, the defect and the identity of the producer (Article 1245-16 of the Civil Code).

Any claim is barred 10 years after the date when the product was released on the market, except where the producer committed a wrongdoing in connection to the defect (Article 1245-15 of the Civil Code).

Timeframe

What is the typical duration of proceedings in product liability cases?

It greatly varies on the complexity of the case, especially with regards to expert investigations aimed at identifying the defect and causal link.

Simple cases can take two years at first instance, while more complex ones can take up to 10 years.

Costs, fees and funding

Can the successful party to the litigation recover court and attorneys’ fees and any other related expenses from the losing party? If so, what rules and procedures apply?

Parties to civil and commercial proceedings may request compensation for their legal costs; however, the compensation is awarded at the court's discretion, and French courts tend to award limited lump sums (that do not correspond to the actual fees spent), in the range of €5,000 to €20,000. Therefore, actual legal costs are not usually recovered, even for winning parties.

What rules and restrictions (if any) govern contingency fee arrangements?

Contingency fee arrangements are allowed by French lawyers' ethics rules, to the extent that they are associated with another fee arrangement, which does not depend on the outcome of the trial. Full contingency fee arrangements are prohibited.

Is third-party litigation funding permitted in your jurisdiction? If so, do any rules or restrictions apply?

There is no specific rule governing litigation funding – it is allowed in principle, although not really used in product liability cases.

Is legal aid (ie, public funding) available to claimants in product liability cases? If so, what rules, restrictions and procedures apply?

Legal aid is awarded based on the claimant's revenues (or lack thereof), and may be available in product liability cases. Requests for legal aid are administered by the Legal Aid Office.

Settlement

What rules and procedures govern the settlement of product liability cases?

Settlements are possible at any stage of the proceedings, and are subject to one main requirement: parties must agree to mutual concessions. A valid settlement has an effect similar to res judicata. The settlement is usually signed out of court, unless one of the parties is a protected person, in which case the settlement must by homologated by the court.

How common are settlements in product liability cases?

Producers will generally try and settle product liability cases. However, settlements are usually confidential, so there is no clear data on how often cases are settled.

Alternative dispute resolution

Are any alternative dispute resolution (ADR) methods required or advised before or in lieu of proceeding with litigation?

As a general requirement, and unless the claim is urgent, claimants must try and settle the case amicably before filing a claim.

French courts are increasingly encouraging parties to resort to conciliation or mediation, at any stage of the proceedings. However, conciliation or mediation is always subject to the agreement of all parties.

The laws that provide for consumer class actions and healthcare class actions have also implemented specific collective mediations aimed at settling consumers and healthcare class actions.

How commonly is ADR used in relation to product liability cases in your jurisdiction?

There is little, if any, data on the use of ADR in product liability cases, in particular because conciliation and mediation are confidential by law.

However, in the authors’ experience ADR is an efficient tool to resolve product liability disputes.

Defences

Available defences

What defences are available to defendants in product liability cases?

The limitation period for a product liability claim is three years from the date that the claimant knew or ought to have known of the damage, the defect and the identity of the producer (Article 1245-16 of the Civil Code). The general statute of limitations for making a claim or invoking a right is five years (Article 2224 of the Civil Code).

Under Article 1245-10 of the Civil Code, the producer is strictly liable for any loss or damage caused by a defective product unless it proves that:

  • it did not put the product into circulation;
  • given the circumstances, it is likely that the defect that caused the damage did not exist at the time the product was put into circulation or that this defect appeared subsequently;
  • the product was not meant to be sold or for any other form of distribution;
  • the state of scientific and technical knowledge, at the time the producer put the product into circulation, was not such as to enable anyone to detect the existence of the defect, except where the damage was caused by an element of the human body or by products derived therefrom; or
  • the defect is due to compliance with mandatory legislation or regulation.

The producer of a component part is not liable if it can prove that the defect is imputable either to the design of the product in which the component was incorporated or to the instructions given by the producer of that product.

The liability of the producer may be reduced or suppressed if, taking into account all the circumstances, the damage was caused both by a defect in the product and by the fault of the claimant or of a person for whom the claimant is responsible (Article 1245-12 of the Civil Code).

By contrast, the producer cannot limit its liability by invoking a third party's contribution to the occurrence of the damage (Article 1245-13 of the Civil Code).

Lastly, another legal defence may consist in contesting the causal link between the damage and the defect of the product, with the support of scientific literature related to, say, the occurrence of the disease at issue. This literature can help prove that the product, under the acquired scientific data, could not be a cause of the damage suffered.

Preliminary actions

What preliminary procedural mechanisms are available to defendants, if any?

No specific preliminary procedural mechanisms are available to defendants. They are subject to the common civil proceedings rules.

Before civil courts, defendants can make a plea of non-admissibility (Article 122 of the Code of Civil Procedure), which consists of getting the adversary's claim declared inadmissible without entering into the merits of the case, for lack of a right of action including not being the proper party, lack of interest, statute of limitations, fixed time-limit or res judicata.

The defendants can also raise other procedural arguments such as lack of jurisdiction (Articles 75 and following of the Code of Civil Procedure) or preliminary objections (Articles 73 and 74 of the Code of Civil Procedure). These arguments must be raised simultaneously and before any defence on the merits (in limite litis).

Remedies

Damages

What types of damages may be awarded in product liability cases? What rules and standards govern their calculation? Are damages capped?

In France, civil law aims at compensating. Compensation aims at putting the claimant in the situation it would have been in had the damage not occurred. The general rule is that the person found liable for the damage has to compensate the claimant for its ‘whole but sole’ loss.

Any person whose body was injured may claim a compensation for the injury suffered when the causal link between the defect of the product and the damage has been demonstrated.

The damages potentially recoverable mainly concern the impairment of physical integrity (death or injury) and all the resulting damages, whether or not they have economic consequences. Damages can include:

  • medical or pharmaceutical expenses;
  • expenses related to requiring assistance from a third person;
  • moral prejudice (pain and suffering, compensation for disfigurement and loss of amenity);
  • direct material prejudice (work disability); and
  • indirect material prejudice (revenue loss of subsidies).

They also include the damage to goods and property (damage resulting from the destruction or deterioration of goods, economic damages, operating losses, loss of use, loss of profit, expenses caused by the damage to goods, etc).

When caused to an item of property other than the defective product itself, any damage greater than €500 (as fixed by Decree 2005-113 of February 11 2005) is compensated.

Are punitive damages allowed?

No, French law prohibits punitive damages.

The French courts can refuse the exequatur of a foreign judgment when the damages awarded are manifestly disproportionate to the prejudice suffered "if the principle of a punitive damages award is not, in itself, contrary to mandatory law, it is otherwise when the amount allocated is disproportionate in view of the damage suffered and the breaches of his contractual obligations by the debtor" (Cass 1re civ, December 1 2010, n09-13.303).

Other remedies

Are any other remedies available?

Other remedies are not regulated by product liability legislation, but subjects to common civil rules. In case of damage to property, the claimant can claim for compensatory damages necessary for the repair or replacement of the damaged property. If an interchangeable property is destroyed, the compensation shall consist in the same or identical property or the amount of the purchase price or costs of repair.

Product recalls

General requirements

Are there any statutory criteria under which a product must be recalled or other corrective action be taken?

A product must be recalled or other corrective action be taken where it poses a risk that is incompatible with the general safety requirement defined by Article L421-3 of the French Consumer Code and based on the General Product Safety Directive (2001/95/EC).

The conformity of the product with the general safety requirement is assessed with reference to specific national health and safety requirements, national standards transposing EU standards and national voluntary regulations applicable to the product, as well as other reference material such as codes of good practice and the state of the art and technology. Article 2(b) of the General Product Safety Directive sets out further criteria that can be taken into account when assessing the risk, such as the characteristics and presentation (notice of use) of the product.

Notification

What rules and procedures govern notification of the product recall to government authorities and the public?

The notification procedure to government authorities is governed by Article L423-3 of the French Consumer Code, a ministerial order dated September 9 2004, the General Product Safety Directive and the Guidelines for the Notification of Dangerous Consumer Products to the Competent Authorities of the Member States by Producers and Distributors in accordance with Article 5(3) of Directive 2001/91/EC (Business Guidelines). The notification shall be submitted online through the European Business Application at https://webgate.ec.europa.eu/gpsd-ba, except for food products for which the notification is submitted directly to the competent authority of the French department where the company is established. The competent authorities are the Directorate General for Competition, Consumer Affairs and Prevention of Fraud for non-food products and the departmental direction of the directorate general concerned for food products. The Directorate General publishes a recall notice on its website to inform the public.

Repairs, replacements and refunds

What rules and procedures govern repairs, replacements and refunds for defective products?

The French product liability legislation (Articles 1245 and following of the Civil Code) does not regulate repairs, replacements and refunds for ‘defective products’, defined as products that do not offer the safety that can legitimately be expected.

However, under Article L217-1 and following of the Consumer Code, the buyer is entitled to demand that the product be conform to the contract of sale and shall choose between repair and replacement of the product in the event of lack of conformity. If neither repair nor replacement of the product is possible, the consumer may also return the product and obtain a refund. The limitation period of the statutory warranty of conformity is two years.

Article 1604 of the Civil Code provides for a similar warranty of conformity, which is not limited to B to C situations. The limitation period is of five years.

Lastly, there is a statutory warranty against ‘hidden defects’ pursuant to Article 1641 of the Civil Code where the product is unsuitable for standard use (in abstracto). The buyer shall choose between returning the product and obtaining a refund, and keeping the product with a price reduction. The limitation period is two years.

Non-compliance

What penalties apply for non-compliance with the legal provisions governing product recalls?

A number of criminal fines are set out in Articles R451-1 and following of the Consumer Code. In particular, Article R452-2 sets out a fine for the default of notification of the corrective actions taken to the authorities and Article R532-1 for non-compliance with a ministerial order issued under Article L521-17 of the Consumer Code (€1,500 in each case, multiplied by five when applied to a company – ie, €7,500).