In France, product liability claims are usually brought before civil and criminal courts. However, alternative procedures do exist in certain cases. For example, within the healthcare sector, the Law of 4 March 200241 establishes an autonomous alternative compensation scheme in relation to medical liability. The aim is to resolve the difficulties encountered by victims of serious medical accidents such as iatrogenic disorders,42 by allowing them to obtain quick and easy access to compensation.
In this regard, the National Office for Compensation of Medical Accidents (ONIAM) was established to compensate victims of therapeutic hazards, medical accidents, iatrogenic diseases and nosocomial infections.43 This has been further extended, specifically to victims of medical accidents resulting from health emergency measures44 or compulsory vaccinations, contaminated blood products, benfluorex45 (active principle of the medicinal product Mediator) and, more recently, sodium valproate and derivatives.46
This being said, pursuant to Article L.1142-4 et seq. of the PHC, the victim of a medical accident, iatrogenic disease or nosocomial infection may refer his or her case to the competent commission for conciliation and compensation (CCI).47 Depending on the seriousness of the injury,48 this procedure aims at reaching conciliation or amicable settlement. The procedure of conciliation applies to an injury whose seriousness is below the damage threshold considered as serious, whereas the procedure of amicable settlement applies when the injury is above the threshold of seriousness.
The president of the CCI acknowledges receipt of the application and requests any missing documents. When the file is complete, the CCI theoretically has a period of six months to issue its opinion.49
If the application is deemed admissible, the president of the CCI appoints an expert, or a body of experts, and sets a deadline for submission of the expert report. A copy of this report is then sent to each party; in turn, the parties are summoned before the CCI and may be assisted or represented by a person of their choice. Following the meeting, the CCI issues a notice signed by the president and sent to the parties, and which is accompanied by documents required for any eventual offer of compensation.
If the parties concerned disagree on the compensation proposed, the case is then brought before the regular courts.ii Burden of proof
It is particularly obvious that questions and procedural issues relating to the burden of proof, which falls on the plaintiff,50 are seen by the different parties to be of real practical significance.
Pursuant to Article 145 of the French Code of Civil Procedure (CPC), it is possible, prior to any trial, to obtain the necessary and relevant information, to establish proof of the facts or request the admissible investigation measures – including upon request.
The plaintiff may ask the judge to appoint an expert to draft an expert's report, on the condition that a legitimate reason is given for doing so. The assessment of whether a reason is legitimate requires examination in particular of the utility of the measure sought with regard to the further litigation,51 and the relevance of the investigations requested.
Conversely, such a measure will be refused if it is considered 'unnecessary'. Thus, the judges refuse to order an expert to issue a report when they consider that there is sufficient evidence to rule or when the measure sought is not likely to enable settlement of the dispute.52
Furthermore, on the basis of established practice and case law, judges consider that if the action based on the future litigation is time-barred, there is no legitimate reason to order the measures sought on the basis of Article 145 of the CPC.53 In practice, Article 145 of the CPC is frequently used to seek an expert report to clearly establish the existence of the damage and its extent.
Concerning the burden of proof in regard to the defect of the product, pursuant to Article 1245-3 of the FCC, a product is defective 'when it does not provide all the safety that can be legitimately expected from it'.54
Article 1245-3 also provides that the safety of a product, which can be legitimately expected, has to be assessed through all the circumstances concerned, including the presentation of the product, the reasonably expected use of the product and the time when the product was put into circulation. A product should not be considered defective for the sole reason that a better product has been subsequently put into circulation.
The burden of proof in relation to the causal link between the damage and the defect of the product concerns the certainty of the causal link. As mentioned above, the French jurisdictions previously required a direct and certain causal link, but judges now admit 'proof by presumption' when these presumptions are 'serious, specific and consistent'.55 French courts definitively acknowledge that inconsistent presumptions alone cannot establish the existence of a causal link any more than the mere possibility of a causal link.56 One judgment even recognised that while the plaintiffs in the Distilbene case were relieved of the normal burden of proof relating to the intake of the medicine by their mother (owing to the age of the facts), they were nevertheless required to prove the causal link between the active principle57 and the alleged damage.iii Defences
As mentioned above, 'the safety that can be legitimately expected from the product' is notably assessed in the light of the product's presentation. Indeed, this information will influence the legitimate expectation of the user about the safety of the product and must therefore be regarded as inseparable from the product in the assessment of the defectiveness. In this respect, the more information provided to consumers, the lower the chances of characterising the defect of the product. Therefore, as regards medicinal products, pharmaceutical companies have a strong incentive to provide exhaustive information in the summary of the product characteristics and in the package leaflet.
Another legal defence may consist in contesting the causal link between the damage and the defect of the product, with the support of the world scientific literature related to the occurrence of the disease. This literature can help prove that the product, under the acquired scientific data, could not be a cause of the damage suffered.58
Moreover, Article 1245-10 of the FCC provides several grounds of exoneration for the manufacturer. The producer or the distributor cannot be found liable if he or she proves that he or she did not put the product into circulation, or that the product was neither manufactured by him or her for sale or any form of distribution. He or she can also argue that the defect results from compliance of the product with mandatory regulations issued by the public authorities.
Finally, the manufacturer can also prove, alternatively or in addition, that the defect that caused the damage did not exist at the time the product was put into circulation, or that the state of scientific and technical knowledge at that time did not allow the manufacturer to discover or identify the defect concerned.
The ECJ clarified that the state of scientific and technical knowledge must be examined through an objective assessment of the most advanced level of knowledge, regardless of the industrial sector concerned.59iv Personal jurisdiction
Article 1245-5 of the FCC provides that a producer of a finished product should be defined as the producer of any raw material or of any component part and any other person who, by attaching his or her name, trademark or other distinguishing feature on the product presents himself or herself as the producer.
Without prejudice to the liability of the producer, any person who imports into the European Union a product for sale, hire, leasing or any form of distribution in the course of his or her business is deemed to be a producer and should be responsible as a producer.60
In addition, where the producer of the product cannot be identified, each supplier of the product is treated as a producer unless he or she informs the injured person of the identity of the producer or of the person who supplied him or her with the product within three months of the date the victim notified the claim.61
Pursuant to Article 1245-7 of the FCC, where two or more persons are liable for the same damage, they must be jointly and severally liable,62 without prejudice to the provisions of national law as regards the rights of contribution or recourse.
In this respect, Article 1245-15 of the FCC provides that the rights conferred upon the injured person against the producer shall be extinguished upon the expiry of a 10-year period from the date on which the product was put into circulation, unless the injured person has, in the meantime, instituted proceedings against the producer.
Moreover, Article 1245-16 adds that a limitation period of three years applies to proceedings for the recovery of damages. The limitation period begins to run the day the plaintiff becomes aware, or should reasonably have become aware, of the damage, the defect and the identity of the producer.63 With regard to the coordination of these two time lines, the three-year limitation period is included within the 10-year period during which the liability of the manufacturer can be sought.64
However, it follows from the principle of non-retroactivity that this rule does not apply to defective products that entered into circulation after the expiry of the time limit for the transposition of the Directive, but prior to the entry into force of the implementation of Law of 19 May 1998.65 In such cases, actions for damages are subject to a different rule, which is a time limit of 10 years from the establishment of the damage as provided under French law.66
In addition, Law No. 2016-41 for the modernisation of our healthcare system stated that claims brought before the ONIAM are now barred after 10 years from the establishment of the damage.67 The 10-year rule also applies to claims resulting from a contamination with the hepatitis B or C virus or human T-lymphotropic virus,68 and human immunodeficiency virus69 caused by transfusion of blood products or injection of blood derivatives, to actions for compensation for damage directly related to mandatory vaccination70 and those resulting from the intervention, in exceptional circumstances, of a professional, an institution, a service or an organisation outside the scope of its activity of prevention, diagnosis or treatment.71
Where the product is manufactured in a foreign country and sold in the French jurisdiction, this sale within the French territory is sufficient to expose the manufacturer or producer to liability in the French jurisdictions. Indeed, Article 14 of the FCC states that the foreign party may be summoned to appear before the French courts for the enforcement of obligations contracted, either in France or in foreign countries, with a French citizen. In addition, and more substantially, Article 7 of EU Regulation 1215/2012 of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters72 allows and recognises the French jurisdiction within the EU, especially when the damage is suffered in France.
French criminal law is also applicable to offences committed within the French jurisdiction. A criminal offence should be deemed to be committed within the French territory as long as one of the facts constituting the offence concerned is located within France. French criminal law is also applicable whenever the victim is of French nationality at the time of the offence, regardless of whether the crime was committed by a French national or a foreign national, and even if the offence took place outside the French jurisdiction.73v Expert witnesses
In proceedings before the civil courts, as mentioned in Section IV.ii, Article 145 of the CPC is frequently used by French judges in practice, to obtain an expert report to identify the damage, its extent and the existence of a causal link between the damage suffered and the alleged defect of the product.
Both parties are permitted to retain industry or subject-matter experts as a part of their defence. The victim can present an expert from his or her insurer, for example, while pharmaceutical companies could use an expert report compiled by their own experts as part of their defence.
The French criminal courts also permit testimony or evidence from expert witnesses, including during proceedings connected with a crime where a jury is mandatory.vi Discovery
One of the main differences between the rules of procedure in common law and civil law systems lies in the application of discovery in obtaining material evidence, for both the parties and the judicial authorities. Indeed, in civil law systems, there is no need to apply discovery, given that proceedings tend to be written rather than oral. There is, therefore, no tacit or strategic advantage to be gained from applying the element of surprise. Although a phase similar to pretrial (beginning with the allegations or pleading) does exist in civil law systems, the investigative powers offered to the parties are minimal compared to those of the parties in common law systems. In this regard, there are no discovery methods, as such, available in product liability cases in French jurisdictions.vii Apportionment
In situations where several persons are liable for the same damage, the principle of the protection of the consumer requires the possibility of obtaining full compensation for the damage from any one of those persons.
A fair apportionment of risk between the injured person and the producer or the distributor implies that the producer should be able to free himself or herself from liability if he or she furnishes proof of the existence of certain exonerating circumstances. Therefore, the liability of the producer remains unaffected or may be reduced by acts or omissions of other persons having contributed to causing the damage. The contributory negligence of the injured person may also be taken into account to reduce or disallow the producer's liability.viii Mass tort actions
As mentioned in Section I, Law No. 2016-41 was enacted on 26 January 2016 and embraces class actions. The law entered into force on 26 September 2016.74
The French class action model enables an accredited association, for the defence of users of the French health system, to sue manufacturers, suppliers or providers using health products that fall within the sphere of competence of the ANSM75 and liability insurers. Such an action is brought before a civil or administrative court (depending on the defendant) in the name of several plaintiffs to obtain compensation for the damage suffered by individual consumers placed in a similar or identical situation. The law applies to any breach of a legal or contractual obligation that caused physical injuries.
In such cases, the court will directly determine within the judgment the criteria to be met to join the group, as well as the publicity measures to be implemented. After the exhaustion of domestic remedies, the publicity measures will be implemented. The deadline to join the group (late opt-in system) will be determined by the judge (between six months and five years) and the claim for compensation will be directly addressed to the defendant.
In the case of a refusal or improper offer to compensate, the members of the class action will have to introduce an individual legal action before the initial judge. This will considerably delay the final decision.
This procedure does not seem well-adapted to the health sector, as cases will obviously not be handled in a timely and efficient manner. Indeed, the time to settle a complex case is expected to exceed 10 years.
However, even if the new legislation does not simplify the judicial process for patients, it will clearly facilitate the expansion of French business litigation with a specialisation by certain French law firms in mass torts, as in the United States.76ix Damages
The damages potentially recoverable against the manufacturer for product liability mainly concern the impairment of physical integrity (death or injury), and all the resulting damages, whether or not they have economic consequences. Damages can extend to medical or pharmaceutical expenses, expenses related to requiring assistance from a third person, moral prejudice (pain and suffering,77 compensation for disfigurement and loss of amenity), direct material prejudice (work disability) and indirect material prejudice (revenue loss of subsidies). They also include damage to goods and property (damage resulting from the destruction or deterioration of goods, economic damage, operating losses, loss of use, loss of profit, expenses caused by damage to goods, etc.).78
Recently, questions have been raised about possible compensation for patients afraid of developing a certain disease after having taken a medicine. It is well known that administrative judges (unlike judicial judges)79 have always been reluctant to establish a principle of compensation for the prejudice of anxiety.80
This dissension between judicial and administrative judges has been reflected in the Mediator case, in which the Administrative Court of Appeal of Paris, in a series of judgments dated 2 July 2015,81 confirmed by the Council of State on 9 November 2016,82 chose not to indemnify 'concerns that could not be legitimately proven', while the interim relief judge took the opportunity to rule differently.83 Within the context of diethylstilboestrol, the Supreme Judicial Court ruled that the anxiety injury is an autonomous injury that is different from the physical injury and independent from the proof of causal link.84
In French civil law, damages are strictly limited to compensation. For this reason, punitive damages are not used since they are deemed to be contrary to the principle of compensation, which has been promoted as a fundamental and mandatory principle governing the civil liability system.
However, there may be criminal penalties in certain circumstances. For example, if a victim of a defective product dies, as mentioned above, the manufacturer may be sued for manslaughter.
As an example, the maximum penalty for manslaughter, pursuant to Article 221-6 of the French Criminal Code is three years' imprisonment as well as a €45,000 fine. If a prudential obligation has been voluntarily breached, the maximum penalty increases to five years' imprisonment and a €75,000 fine. Pursuant to Article 222-19 of the Criminal Code, the maximum penalty for unintentional impairment to physical integrity is two years' imprisonment as well as a €30,000 fine. If a prudential obligation has been voluntarily breached, the maximum penalty increases to three years' imprisonment and a €45,000 fine.