France has implemented both Council Directive 85/374/EEC of July 25, 1985, on the approximation of the laws, regulations, and administrative provisions of the Member States concerning liability for defective products (the "PLD") and Directive 2001/95/EC of December 3, 2001, on general product safety (the "GPSD").

French product liability law is profoundly inspired by these European provisions, although French law continues to include several other provisions governing liability for defective products that remain applicable in addition to the PLD and GPSD principles. This chapter will briefly highlight the principal rules specific to French law.


Product liability principles exist under both civil and criminal law.

Civil Liability

Causes of Action

The user of defective goods has several causes of action against the vendor or manufacturer. The user may assert all available causes of action should their conditions be fulfilled.1

Several legal actions may enable the buyer of defective products to obtain the rescission of the sale, a reduction of the sale price, or damages based upon:

  1. Latent defects (vices cachés), Article 1641 et seq. of the French Civil Code;2
  2. Nonconformity defects (défaut de conformité), Articles 1603 and 1604 of the French Civil Code and Article L. 211-4 of the French Consumer Code;3
  3. General civil liability, whether tortious, Article 1382 et seq.4 of the French Civil Code, or contractual, Article 1147 et seq.5 of the French Civil Code; or
  4. Strict liability of the manufacturer of a defective product, Article 1386-1 et seq. of the French Civil Code.

Legal actions based on latent defects and compliance defects apply only in the case of a sales agreement, and there need not be a safety issue. In contrast, the strict liability rules aim to protect persons from a product's lack of safety even in the absence of a contract.

Principles Derived From the PLD

Since May 1998,6 the French Civil Code has included an exhaustive set of regulations that apply when a defective product7 harms an individual.8 Treating them as important general principles, the French legislature inserted this set of rules into the French Civil Code (Title IV bis: Liability for defective products), just after the chapter relating to general civil liability rules (Title IV: Undertakings formed without an agreement).

Pursuant to Article 1386-1 et seq., the producer is liable for any loss or damage caused by a defect in goods put into circulation after May 21, 1998,9 whether or not the producer has a contract with the injured person.

A "producer" is defined under Article 1386-6 as "the manufacturer of a finished product, the producer of a raw material, the manufacturer of a component part, where he acts as a professional." The same article considers a "producer" to be any person acting in a professional context (as opposed to acting for its private use and benefit) "who presents himself as the producer by putting his name, trade mark or other distinguishing feature on the product" or "who imports a product into the European Community for sale, hire, with or without a promise of sale, or any other form of distribution."

In sum, the injured consumer may start a legal action against:

  1. Manufacturers (of finished products or of component parts) and producers of raw materials;
  2. Own-branders – Suppliers who put their names on the products and give the impression that they are the producers;
  3. Importers – Meaning importers into the European Union, not just into the French market.

Pursuant to Article 1386-4 of the French Civil Code and in accordance with the PLD, a product is defective "when it does not provide all the safety that can be legitimately expected from it."10

As required by general French civil liability rules, the injured person must prove actual damage, a defect in the product, and a causal relationship between the defect and the damage.11 Once these elements are proven, the producer shall be held strictly liable for all damage to the injured person, despite the producer's absence of fault or negligence.

The producer can avoid or limit liability if it can prove any of the seven defenses listed under Article 7 of the PLD (transposed in Article 1386-11) or if it can prove the claimant's negligence (Article 1386-13 of the French Civil Code):

  1. The producer did not supply the product;
  2. The state of scientific and technical knowledge at the time it supplied the product did not permit the discovery of the defect;12
  3. The defect was the inevitable consequence of complying with mandatory laws or regulations;
  4. The defect was not in the product at the time it was supplied;
  5. The product was not intended to be sold or distributed in any manner;
  6. In the case of a producer of a component used in another product, the defect was due either to the design of the finished product or to defective specifications given to the component manufacturer by the producer of the finished product; or
  7. The damage was jointly caused by a defect and by the injured person's negligence (or by the negligence of someone under the injured person's control).

Moreover, Article 1386-10 of the Civil Code provides that "the producer may be responsible for the defect even when the product was manufactured in accordance with good engineering practices or existing standards or when the distribution of the product was subject to and obtained an administrative authorization." Recent cases have held that insufficient information regarding the product can make the product defective.

Finally, a strict liability civil action is subject to two statutes of limitation as the PLD provides:

  1. First, the injured person must begin his or her court action within three years of the date of injury or, if later, the date when he or she knew or should have known of the claim against the defendant (see Article 1386-17 of the French Civil Code).
  2. However, the producer cannot be sued 10 years after the product was introduced unless a legal action was started during that period (Article 1386-16 of the French Civil Code).

Warranties and Limited Liability Provisions

A buyer may also benefit from contractual warranties. The French Consumer Code provides that the seller may offer a "commercial warranty" to the buyer in addition to other legal warranties (such as latent defects and product safety) that remain applicable in any case (Articles L. 211-15 and 211-16 of the French Consumer Code).

While as a general rule the producer cannot limit or exclude its liability to the injured person by contract (Article 1386-15 of the French Civil Code), contractual provisions limiting liability between professionals are valid as long as: (i) they relate to damage caused to property not used by the injured party mainly for its own private use (Article 1386-15, paragraph 2, of the French Civil Code); (ii) the defect does not result from an intentional act (or omission) or from the supplier's gross negligence (which French case law defines as negligence of extreme severity bordering on willful misconduct and denoting the unfitness of the defaulting obligor to fulfill its contractual duty13); (iii) the clause limiting liability does not make the core obligations of the defaulting party meaningless—i.e., the maximum amount of the indemnification contractually defined must not be so low that it contradicts the core obligation of the contract;14 and (iv) the contract containing the clause limiting the warranty against hidden defects is concluded between professionals of the "same specialty" (which is narrowly interpreted by case law) and does not involve a consumer.

Brief Description of Civil Proceedings

Civil proceedings begin with a statement of claim (assignation) served on the defendant before French civil courts (Tribunal d'instance, Tribunal de grande instance, or Tribunal de commerce). Proceedings usually last several months. The court may appoint a judicial expert to analyze the product and determine the cause of any defect and injury. In this case, proceedings can then last up to two years.

During civil proceedings, the parties (the plaintiff and the respondent), usually represented by lawyers, exchange various written submissions in which they present their own versions of the events, their legal arguments, and claims. The parties also have to disclose to each other the evidence on which their claims or defenses rely.

In contrast to civil procedure in the U.S., broad pretrial discovery is not available in France. A "fishing expedition" is not permitted, and parties need disclose only the evidence useful to their claims.15 Nevertheless, a party which knows that the other party holds some relevant evidence can ask the court to order the other party (or even third parties) to produce it, subject to a fine for noncompliance (Articles 11 and 145 of the French Code of Civil Procedure). There is no provision in French procedure for the deposition of witnesses or interrogatories.

Once the parties have exchanged all of their evidence and arguments and the case is deemed ready for argument, an oral hearing takes place before the court. While the appearance of witnesses in civil and commercial proceedings remains the exception, when witnesses appear during hearings on the merits, the judge conducts their examination. The court will then render its decision within several weeks or months. The parties may appeal the decision within one month of the date of notification (Article 538 of the French Code of Civil Procedure16). Save when the court has ordered provisional enforcement of the judgment, the appeal is suspensive, and the judgment may not be enforced during the pendency of the appeal.

"Class Actions" Under French Law

Despite the recent debates and bills17 to implement them, class actions still do not exist in France. However, associations or nonprofit organizations can bring some specific types of judicial collective action: (i) actions taken in a collective interest; and (ii) joint representative actions. These collective actions typically take place where product safety is at stake.

Actions taken in collective interest. Under Article L. 421-1 of the French Consumer Code, when a criminal offense has been committed, authorized consumer organizations (associations agrees) may exercise the "rights conferred upon civil parties relating to facts which cause direct or indirect harm to the collective interest of consumers." Article L. 421-7 of the same code allows authorized associations to "join proceedings in civil actions brought by one or more consumers in order to stop illicit acts or request the cancellation of unfair contract terms." These organizations may also initiate a civil action in order to nullify an "illegal or abusive clause from any contract or standard contracts offered to or intended for consumers" under Article L. 421-6.

Associations may claim collective damages and initiate proceedings to stop the allegedly illegal behavior. They aim to protect collective interests rather than the individual interests of consumers. They are not considered to be class actions, because individuals will not receive compensation for individual harm.

Joint representative actions. Joint representative actions enable authorized organizations to bring claims to protect their members' individual interests. Article L. 422-1 of the French Consumer Code provides that:

where several consumers, identified as natural persons, have suffered individual damages caused by the same business act and which have a common origin, any approved association . . . may, if it has been duly authorized by at least two of the consumers concerned, institute legal proceedings to obtain reparation before any court on behalf of these consumers. French law also allows specific associations to represent certain categories of injured persons by bringing representative actions in the fields of the environment,18 stockholders,19 and health.20

Because French law strictly regulates representative actions, they are often criticized as not efficient enough to protect consumers' interests. In order to bring a joint representative action, the authorized association must have the written approval of each claimant, and the claimant may revoke the authorization at any time. Moreover, the organization may not advertise or approach individuals personally to obtain their approval. Because of these hurdles, joint representative actions are used very rarely in France.

Punitive Damages

The notion of punitive damages does not exist under French law. The injured person is entitled only to full reparation of any losses.21

However, an award of punitive damages under a law that permits such damages is not per se contrary to international public policy, according to a recent decision of the French Supreme Court (Cour de cassation). But for such a judgment to be recognized and enforced in France, the punitive damages awarded must be in proportion to the claimant's actual damage.22

In contrast, French courts recognize and award damages for moral prejudice, pain and suffering, and mental fear associated with a defective product.23

Lawyers' Fees

Contingent fees are valid as long as they do not constitute the entire amount of the fees24 charged to the client. The lawyer and client can agree to a potential extra payment in addition to the initial retainer. Under French law, lawyers' fees are usually agreed and calculated in two different ways: either billed by the hour or as a lump sum.

The losing party must pay the adverse party's legal costs (les dépens, meaning all procedural costs incurred with the proceedings, such as cost of service and experts' fees).25 The court will also normally order the losing party to pay the adverse party's lawyer's fees. However, the court typically fixes the amount, and the granted amount rarely corresponds to the amount claimed and actually spent by the winning party.26

Criminal Liability

Corporate Liability

French criminal liability applies not only to individuals, but also to legal business entities and their representatives.27

The criminal liability of legal entities, effective since March 1, 1994, represents one of the principal innovations of French criminal law over the last 20 years.28 Since December 31, 2005,29 all criminal offenses existing under French law can apply to legal entities.30

Criminal liability of individuals is in principle limited to personal liability: "In principle, no criminal proceedings can be initiated, no condemnation to a sentence can be pronounced against a person who has not been the author, or the coauthor or the accomplice of an offense."31 This principle has several exceptions, notably with respect to the entrepreneur (chef d'entreprise). French courts have held on several occasions, without reference to any specific statute, that an entrepreneur can be held criminally liable for its employees' offenses, whether intentional or not. For example, the entrepreneur's liability was upheld in the case of a sale of forged goods by its subordinates.32 The entrepreneur can avoid criminal liability by demonstrating that it lawfully delegated its power to another person.33

If a legal entity is found criminally liable, this does not prevent its legal representative from being held liable as well, but it does not necessarily mean that the representative will also be held criminally liable. In other words, criminal liabilities are not cumulative, and the legal entity can be solely found criminally liable.

Prohibited Acts

Several criminal laws apply to hazardous products:34

Deceit (tromperie as defined under Article L. 213-1, 3°, of the French Consumer Code35):

This offense is intended to punish safety breaches. Indeed, the Code provides that deceit or an attempt to deceive may occur not only with respect to the nature or kind of a product, but also with respect to "the fitness for use, the risks inherent in use of the product, the checks carried out, the operating procedures or precautions to be taken." For example, it is deceit to sell electrical equipment that does not comply with applicable standards or toys bearing labels that falsely state compliance with the standard safety rules.

Penalties are doubled when the deceit allows the use of goods that are dangerous for human or animal health (Article 213-2 of the French Consumer Code).

Involuntary bodily harm (atteintes involontaires à l'intégrité de la personne humaine as defined under Article 222-19 of the French Criminal Code36):

The offense of involuntary bodily harm requires proof of three elements: (i) careless acts or omission; (ii) bodily harm; and (iii) a causal link between the fault and the harm. The bodily harm can be physical or mental (it can be a disease), and the injured person must have had a total incapacity to work. No criminal intent is needed for this offense, and it is sufficient to prove awkwardness, lack of prudence, lack of attention, negligence, or violation of a legal obligation of prudence or security or, when it comes to the aggravating factor of immediate exposure to a risk: (i) a specific act of misconduct that exposed another person to a particularly serious risk of which the perpetrator must have been aware; or (ii) a deliberate violation of a legal obligation (statute or regulation) of prudence or security.

Endangering the lives of others (délit de mise en danger de la vie d'autrui, Article 223-1 of the French Criminal Code37):

This offense requires proof of three elements: (i) a manifestly deliberate violation of a specific obligation of safety or prudence imposed by any statute or regulation; (ii) an immediate risk of death or injury; and (iii) a causal link between the violation and the risk. The element of "manifestly deliberate violation" requires not the intention to injure somebody, but merely the awareness of violating a specific obligation imposed by a statute or regulation.

Failure to help someone in danger (non assistance à personne en danger, Article 223-6, paragraph 2, of the French Criminal Code38):

This offense applies, for instance, in the event that an executive officer or company has not taken all the measures necessary to prevent or stop the expansion of any risk of which the officer or company should have been aware.

Misleading commercial practice (Pratique commerciale trompeuse, Article L. 121-1 of the French Consumer Code, which has recently replaced the offense of publicité trompeuse, i.e., deceptive advertising):

This offense applies when a professional: (i) creates confusion between its product and another product or service; (ii) misleads the consumer by making a false statement about its product concerning its availability, its main characteristics, its price, its after-sale service, the scope of commitment of the advertiser, the identity and quality of the advertiser, or the handling of consumers' complaints; or (iii) omits to state one of the main characteristics of the product. This offense is punished by two years' imprisonment and a €37,500 fine for individuals and a €187,500 fine for legal entities.

Finally, Articles R. 223-1 et seq. of the French Consumer Code punish by fines, the confiscation of the goods, or both, the offense of not complying with a prohibition to sell, suspension of sales, or withdrawal of dangerous products ordered by public authorities.39

Criminal Proceedings

Criminal proceedings involve the commencement of a public action by the government. Such a public action may be commenced either:

  1. At the initiative of the state itself (the public prosecutor), in which case the victim may decide later to join the criminal proceedings; or
  2. At the victim's direct initiative, either by summoning the adverse party to appear before the criminal courts (citation directe40) or by filing a criminal complaint with an application to join in the proceedings (plainte avec constitution de partie civile41).

The public action aims to have the criminal offense publicly determined and punished. Depending upon the nature of the offense, three types of criminal courts have jurisdiction: (a) Tribunal de police, for relatively minor offenses (contraventions); (b) Tribunal correctionnel, for misdemeanors (délits); and (c) Cour d'assises, for felonies (crimes). Criminal courts may order fines, imprisonment, or any other specific sanction as stipulated by the French Criminal Code (Code pénal ), but they will not sua sponte grant damages to the victim of the criminal offense.

A victim who has been "personally" harmed by the criminal offense and who wants compensation may start a civil action (Article 2 of the French Code of Criminal Procedure).42 Pursuant to Article 3 of the Code of Criminal Procedure, this civil action may be brought before the same criminal court. The civil action will not necessarily be suspended until the criminal court has ruled on the existence of the criminal offense.

Depending on the case's complexity, a criminal investigation may be conducted under the control of the examining magistrate (juge d'instruction). The criminal court, composed of three magistrates, presides over the trial. The examining magistrate, who is in charge only of the investigation, cannot participate in the trial.

The criminal trial is divided into four principal phases:

  1. Verification of the parties' identity and factual review of the case;
  2. Motions challenging the legality of the procedure (on grounds such as lack of jurisdiction or nullity of the action);
  3. Examination of the defendant, witnesses, and experts; and
  4. Closing arguments for the plaintiff, the prosecution (requesting a specific sentence or, in exceptional circumstances, acquittal) and, finally, the defendant. The defendant or counsel will always speak last, after the public prosecutor.

Save for a few exceptions, criminal hearings are open to the public. The parties are supposed to appear in person at each hearing but may be represented by their lawyers. Should a party not speak French fluently, the court will provide a translator.

After the closing arguments, the criminal court withdraws to deliberate and then renders its decision to convict or acquit the defendant. However, if the case is complicated and requires further deliberation, the criminal court may inform the parties that it will render its decision later.

A party may appeal the decision within 10 days of the rendering of the judgment.43 But for certain exceptions, the appeal is suspensive, meaning that the judgment is not enforced during the appeal.


The GPSD, transposed under French law, mandates the safety of products. Producers and distributors who "know or ought to know, on the basis of the information in their possession and as professionals, that a product that they have placed on the market poses risks to the consumer that are incompatible with the general safety requirement are required to inform the competent authorities immediately." (Article 5 (3)).

The general safety requirement is broadly defined: "Products and services must, under normal conditions of use or under other circumstances that may reasonably be foreseen by the professional, offer the safety that can legitimately be expected and must not be a danger to public health." (Article L. 221-1 of the French Consumer Code).

Unlike the PLD, which was codified in the French Civil Code, the GPSD is codified in the French Consumer Code. Prior to defining existing legal obligations (2.2), the GPSD first determines which professionals are to enforce its safety obligation under French law (2.1).

Professionals Subject To The General Safety Obligation

Both the producer and the distributor of products are subject to the general safety obligation (as defined under Article L. 221-1 of the French Consumer Code) for the products that they introduce into the market. Both the producer and the distributor have a mutual obligation, in particular, to provide public notification of the risk, as well as a duty to cooperate (Article L. 221-1-4 of the French Consumer Code44).

Scope And Definition Of The Producer's Obligations

The "producer's obligations" are essentially obligations to perform (obligation de faire). The producer is to take "any useful measures" to contribute to compliance with the safety obligation: those actions must be appropriate measures to prevent and mitigate the risk while remaining proportional to the product's danger (Article L. 221-9 of the French Consumer Code).45

In addition to the general safety obligation, Articles L. 221-1-246 and L. 221-1-347 of the French Consumer Code set forth other safety obligations for the producer:

  • Dual obligation to inform: The producer must inform the consumer of the product's risks and the means to assess and avoid them. The producer must provide the consumer with any "useful information." In addition, the producer is obliged to monitor the safety of its product after sale and, in particular, as set forth in the Code, to "remain informed of risks that the products that it markets may present."
  • Organize the monitoring of the products' safety on the market and traceability: The product must be easily identifiable and the producer must be easy to contact in the event of a problem.
  • Initiate the necessary actions: The duty requires withdrawal and recall from the market and the warning of consumers.
  • Notify authorities of the existing risk: Producers and distributors that have marketed unsafe products must notify the relevant public authority immediately.48 Such notification must indicate the measures that have been initiated to prevent the risks.

Until May 1, 2009, notice was to be given to the French competent authority (the Direction Départementale de la Protection des Populations).49 Since then, with respect to nonfood products, the notice must use the European IT application called "business application" created by the European Commission's Directorate-General in charge of consumers. This single form enables simultaneous notification to other national authorities of the Member States in which the product was marketed.50

It is therefore unnecessary to simultaneously inform the DDPP, since that body will be de facto informed through the "business application." Nevertheless, a producer or distributor can still report to the DDPP in case it is not possible to use the "business application" process. Once a national authority has been made aware of a product's safety risk, depending on the extent of the risk incurred, the national authority may be compelled to pass the information to the European Commission through the RAPEX system.51

Despite the duty to notify in the French Consumer Code, French law does not impose any civil or criminal sanctions for failure to do so. Therefore, a producer who marketed or otherwise supplied consumers with a defective or dangerous product in France cannot be liable under civil or criminal laws for failing to notify the competent authorities of an unsafe product. However, the failure to provide notification can be considered an aggravating circumstance in the event that the producer is held liable: for instance, the judge may infer from such breach that the producer was negligent, which may increase its potential liability.

Producers and distributors should act voluntarily to redress the risk of unsafe products on the market. However, should they remain inactive or take insufficient action, the national authorities also may order certain actions:

  • Prohibit or restrict the production, sale, and distribution of products (Article L. 221-3, 1°, of the French Consumer Code);
  • Order the withdrawal or recall of the product from the market (Article L. 221-3, 3°, of the French Consumer Code); or
  • Order temporary emergency measures, such as temporary recall or withdrawal, should there be a serious or immediate risk for consumers (Article L. 221-5 of the French Consumer Code52).


Except for certain regulated professions and in the construction industry, French companies are not obliged to have general civil liability insurance. However, most French companies obtain insurance policies to cover both professional civil liability and risks arising from commercial operations. These insurance policies usually cover personal injury and property damage claims from product liability, subject to specific exclusions. They may also include other costs that may arise, such as product recall costs.


When a U.S. company decides to distribute products in Europe through a subsidiary or independent distributors, it is important for the company to coordinate with its subsidiary or independent distributors for the purpose of monitoring product safety. Coordination is also key for the purpose of notifying the European authorities of any risk identified by the producer or distributor and then acting to remediate and prevent any risk.

A distributor may decide to join a foreign producer in proceedings initiated in France to share liability in case of an unfavorable decision against the distributor. In such case, the producer will also be ordered to pay damages to the injured person or buyer or to indemnify the distributor.

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1 For instance, an action can be based on both latent defects and defective product liability as stipulated under Article 1386-18 of the French Civil Code.

2 "A seller is bound to a warranty on account of the latent defects of the thing sold which render it unfit for the use for which it was intended, or which so impair that use that the buyer would not have acquired it, or would only have given a lesser price for it, had he known of them."

3 "[The seller] has two main obligations, that to deliver and that to warrant the thing which he sells. . . . Delivery is the transfer of the thing sold into the power and possession of the buyer."

4 "Any act whatever of man, which causes damage to another, obliges the one by whose fault it occurred, to compensate it."

5 "A debtor shall be ordered to pay damages, if there is occasion, either by reason of the non-performance of the obligation, or by reason of delay in performing, whenever he does not prove that the non-performance comes from an external cause which may not be ascribed to him, although there is no bad faith on his part."

6 Law No. 98-389 of May 19, 1998, on liability relating to defective products.

7 A "product" is defined under Article 1386-3 of the French Civil Code as "any movable, even though incorporated into an immovable, including the products of the soil, of stock-farming, of hunting and fishing." The same article provides that electricity shall be deemed a product.

8 They apply also to compensation in excess of an amount fixed by decree (currently €500) for damage to property other than the defective product itself.

9 Law No. 98-389 of May 19, 1998, on liability relating to defective products implementing the PLD, entered into force on May 21, 1998, and is codified under Article 1386-1 et seq. of the French Civil Code; before that date, persons injured by defective products could rely on provisions of the French Civil Code (such as, inter alia, Article 1603 et seq. on nonconformity defects, Article 1641 on latent defects, or Article 1382 et seq. on general civil liability). Since May 21, 1998, persons injured by defective products can seek liability on additional grounds.

10 French courts have held that insufficient information regarding the risks associated with the product or its use on labels and product warnings can constitute evidence of a defective product (French Supreme Court, Nov. 7, 2006, no. 05-11.604; French Supreme Court, Jan. 24, 2006, Bull. civ. 2006, I, no. 35).

11 The injured person does not need to explain the origin or nature of the causal relationship (see, e.g., Toulouse Court of Appeal, May 22, 2007, Jurisdata no. 341395, which held that it was sufficient for the injured person to evidence that her car unexpectedly caught fire during normal use of the vehicle).

12 This exception is interpreted extremely strictly, as the Court of Justice of the European Union has specified that the highest level of scientific knowledge must be taken into account. CJEU, May 27, 1997, Dalloz 1998.488, Penneau.

13 A decision of the French Supreme Court (Cour de cassation, chambre commerciale) on June 29, 2010, held that "gross negligence cannot be construed from a simple breach of a contractual obligation, even a core one, but should be based on the severity of the defaulting party's behavior." Decision no. 09-11841.

14 Id.

15 Article 9 of the French Code of Civil Procedure states, "Each party must prove, according to the law, the facts necessary for the success of his claim."

16 Time limits are extended when it comes to foreign defendants. Article 643 of the French Code of Civil Procedure states, "Where the action is brought before a court sitting in the mainland of France, the time-limits for appearances, lodging an appeal, a motion to set aside, a motion for revision and an appeal in cassation will be extended by: 1° One month for persons living in an overseas administrative department or an overseas territory; 2° Two months for persons living in a foreign country."

17 Legislative bills have been submitted in April 2006, February 2007, March 2007, December 2007, September 2009, and October 2009. An "information report" dated May 26, 2010, has been edited by the Senate, proposing class actions in France. The public debate on implementing class actions in France has been recurrent since the 1980s.

18 Article L. 142-3 of the Environment Code.

19 Article L. 452-2 of the Monetary and Financial Code.

20 Article 1114-2 of the French Public Health Code.

21 French case law is constant on this issue: "[T]he reparation of a damage, which must be in full, cannot exceed the amount of the damage." Cass. civ. 1, Nov. 9, 2004, Bull. civ. I, no. 264.

22 Cass. civ. 1, Dec. 1, 2010, Dalloz 2011, no. 6, p. 423.

23 In 10 decisions dated September 12, 2008, the Paris court of appeal held that damages resulting from the fear of having a defective cardiac catheter implanted could be recovered.

24 Article 10 of Law No. 71-1130 of December 31, 1971: Prohibition of "de quota litis" agreements.

25 Article 696 of the French Code of Civil Procedure: "The legal cost will be borne by the losing party, unless the judge, by a reasoned decision, imposes the whole or part of it on another party."

26 Article 700 of the French Code of Civil Procedure: "As provided for under I of Article 75 of the Act n° 91-647 of 10 July 1991, in all proceedings, the judge will order the party obliged to pay for legal costs or, in default, the losing party, to pay to the other party the amount which he will fix on the basis of the sums outlayed [sic] but not included in the legal costs. The judge will take into consideration the rules of equity and the financial condition of the party ordered to pay. He may, even sua sponte, for reasons based on the same considerations, decide that there is no need for such order."

27 In addition, French law provides that persons other than legal representatives of a company may be held criminally liable in the pharmaceutical industry. For instance, Article L. 5124-2 of the French Public Health Code provides that the "responsible pharmacists" are personally responsible for complying with provisions relating to the safety of the medication manufactured and sold by the company.

28 Article 121-2 of the French Criminal Code provides that "legal entities, with the exclusion of the State, are criminally liable, pursuant to the provisions of Articles 121-4 to 121-7, for offenses committed on their behalf, by their organs or representatives."

29 French Law No. 2004-204 of March 9, 2004 (referred to as "law Perben II").

30 Sanctions are more severe when it comes to legal entities: the fines, in particular, are multiplied by five.

31 Droit pénal général - M. Bouloc - Précis Dalloz - Paragraphs 345 et seq. The French Criminal Code itself confirms such principle in its Article 121-1: "No one is criminally liable except for his own conduct," and the French Supreme Court has repeatedly held that "no one is punishable other than by reason of its/his/her personal acts."

32 Crim. March 11, 1959 - Droit pénal général - M. Bouloc - Précis Dalloz - Paragraphs 345 et seq.

33 The French Supreme Court accepts in fact that, "except in the case where law provides differently, the entrepreneur who has not personally participated in the offense, may discharge him/herself from his/her criminal liability if he/she provides the proof that he/she has delegated his/her powers to a person with the necessary competency, authority and means." Crim. March 11, 1993, Bull. crim. no. 112.

34 French criminal courts have discretionary powers to determine which penalty (imprisonment, fine, or both) shall apply. The judge can determine the amount of a fine up to the maximum amount set in French criminal laws, taking into account all circumstances.

35 "Anyone, whether or not they are party to the contract, who may have deceived or attempted to deceive the contractor, by any procedural means whatsoever, even if this is through the intermediary of a third party, shall be punished by two years imprisonment and a € 37,500 fine: . . . even in respect of . . . the fitness for use, the risks inherent in use of the product, the checks carried out, the operating procedures or precautions to be taken."

36 Article 222-19 of the French Criminal Code: "Causing a total incapacity to work in excess of three months to another person by clumsiness, rashness, inattention, negligence or breach of an obligation of safety or prudence imposed by statute or regulations, in the circumstances and according to the distinctions laid down by article 121-3, is punished by two years' imprisonment and a fine of €30,000. "In the event of a deliberate violation of an obligation of safety or prudence imposed by statute or regulation, the penalty incurred is increased to three years' imprisonment and to a fine of €45,000."

37 "The direct exposure of another person to an immediate risk of death or injury likely to cause mutilation or permanent disability by the manifestly deliberate violation of a specific obligation of safety or prudence imposed by any statute or regulation is punished by one year's imprisonment and a fine of €15,000."

38 "Anyone who, being able to prevent by immediate action a felony or a misdemeanour against the bodily integrity of a person, without risk to himself or to third parties, wilfully abstains from doing so, is punished by five years' imprisonment and a fine of €75,000. "The same penalties apply to anyone who wilfully fails to offer assistance to a person in danger which he could himself provide without risk to himself or to third parties, or by initiating rescue operations."

39 Article R. 223-1: "Anyone who, in contravention of the provisions of an order adopted in application of article L. 221-5: Has manufactured, imported, exported, put on the market free of charge or at a fee, a product or a service that is subject to a suspension measure; Has failed to circulate warnings or precautions for use ordered; Has not, in accordance with prescribed conditions of place and time, totally or partially exchanged, modified or reimbursed, the product or service; Has not withdrawn or destroyed the product, will be punished with the fine laid down for petty offences (fifth category). In the event of a repeat offence, the fine laid down for repeat petty offences (fifth category) applies.

"Anyone who, in contravention of the provisions of an order issued by the préfet adopted in application of article L. 221-6, has not respected: Emergency measures prescribed in order to stop the serious or immediate danger presented by the product or service; The detention measure decided upon for products likely to present a serious or immediate danger; Measures to suspend the provision of services; will be punished by the fine laid down for petty offences (fourth category)."

40 Articles 390 et seq. of the French Code of Criminal Procedure.

41 Article 85 of the French Code of Criminal Procedure.

42 Article 4 of the French Criminal Code permits the separate civil action for compensation: "The civil action tending to get compensation for the loss suffered in connection with the offense may also be exercised separately from the public prosecution."

43 Article 498 of the French Code of Criminal Procedure.

44 "Distributors participate in the monitoring of the safety of products on the market . . . with their cooperation to the actions undertaken by producers and by administrative authorities to avoid such risks."

45 "The measures decided upon by virtue of articles L. 221-2 to L. 221-8 must be in proportion to the danger presented by the products and services. These may aim to warn of, or put an end to, the danger with a view to thereby guaranteeing the safety that can legitimately be expected in accordance with France's international commitments."

46 "I. The producer shall provide the consumer with sufficient information to enable him to evaluate the risks inherent in a product during its normal or reasonably foreseeable useful life and to guard against them, when such risks are not immediately apparent to the consumer without adequate forewarning. . . .

"II. The producer shall adopt measures which, in view of the characteristics of the products he supplies, enable him to: a) Keep abreast of the risks which the products he markets may present; b) Implement the actions necessary to contain those risks, including withdrawal from the market, the issuing of adequate and effective warnings to consumers and recalling products sold from consumers.

"Such measures may consist, inter alia, of sample testing or indication on the product or its packaging of instructions for use, the identity and address of the person responsible for marketing, and the product or batch reference. Such indications may be made compulsory by order of the Minister for Consumer Affairs and the other minister(s) concerned."

47 "When a producer or a distributor knows that products intended for consumers which he has put onto the market do not meet the requirements of Article L. 221-1, he shall immediately inform the relevant administrative authorities thereof and indicate the actions he is implementing to guard against risks to consumers.

"The informational requirements are stipulated by order of the Minister for Consumer Affairs and the other ministers concerned. The producer or the distributor cannot avoid his obligation by pleading ignorance of risks which he could not reasonably be unaware of."

48 In France, the competent authority is the Direction Départementale de la Protection des Populations, or the "DDPP," formerly the Directorate- General for Competition Policy, Consumer Affairs and Fraud Control (the "DGCCRF"), as specified in a Recommendation to economic agents in JORF no. 159 of July 10, 2004, p. 12574.

49 As provided by Order of September 9, 2004, "portant application de l'article L. 221-1-3 du code de la consummation," in JORF no. 224 of September 25, 2004, p. 16560.

50 This application form is available online at The Commission has also issued guidelines on how to prepare and submit this notification form. These guidelines are available at (web sites last visited August 10, 2012).

51 RAPEX is the EU rapid alert system for all dangerous consumer products, with the exception of food, pharmaceuticals, and medical devices.

52 "In the event of grave or immediate danger, the Minister for Consumer Affairs and the other minister(s) concerned may, via a joint order and for a period not exceeding one year, suspend the manufacture, importation, exportation and availability of a product, and its general withdrawal or destruction if there is no other means of eliminating the danger, regardless of whether it is provided free of charge or in return for payment. They are also empowered to order the distribution of warnings or precautions for use, and recall of the product for exchange or modification or full or partial reimbursement.

"In the same circumstances, they may also suspend provision of a service.

"Such products and services may be relaunched when they are found to be compliant with the applicable regulations. "The Minister for Consumer Affairs and, where applicable, the other minister(s) concerned, shall hear the professionals concerned without delay and not later than fifteen days after a decision to suspend has been taken. They shall also hear the approved national consumer associations.

"The said orders shall stipulate the conditions under which the costs associated with the safety measures to be taken pursuant to the provisions of the present article shall be borne by the manufacturers, importers, distributors or service providers. "The said orders may be renewed via the same procedure for further periods each not exceeding one year."

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