The Product Regulation and Liability Review: France
Introduction to the product liability framework
The Directive was adopted in the European Union on 25 July 1985 to protect consumers against damage caused by defective products. It allows injured persons to seek compensation with regard to defective products put into circulation within the internal and single market. Companies are then required to deliver products free from defect or danger to users (i.e., products that offer the level of safety that can reasonably be expected). EU Member States were required to implement the Directive by 30 July 1988. As France failed to transpose the Directive within the time frame imposed, the Commission opened infringement proceedings under former Article 171 of the EC Treaty4 against France, following the 13 January 1993 ruling by the European Court of Justice (ECJ).5
Notwithstanding this default on the part of France, the French jurisdictions decided proprio motu to interpret the existing general civil liability framework in the light of the Directive provisions. In a ruling dated 3 March 1998,6 the French Supreme Court applied the Directive provisions and dismissed the provisions of the French Civil Code (FCC).7
Finally, on 19 May 1998,8 France transposed the Directive and the FCC included an exhaustive set of regulations in this respect: the new Title IV bis, 'Liability for defective products',9 just after the chapter relating to general civil liability rules. In 2002,10 however, the ECJ ordered France to amend its existing law, which incorrectly transposed the Directive. The ECJ ruled that the French legislation, which exposed suppliers and distributors to legal claims on the same basis as producers, was illegal. Again, in 2006,11 the ECJ ordered France to pay a fine because of its failure to take the necessary measures to fully comply with the previous judgment of 2002.12
On 26 January 2016, Law No. 2016-41 for the modernisation of our healthcare system was enacted13 and introduced into French law the class-action mechanism within the healthcare sector. The law entered into force on 26 September 2016 with Decree No. 2016-1249.14
A reform related to contract law, general social insurance schemes and proof of obligations was implemented the same year and ratified in 2018.
In France, the Directorate-General for Competition, Consumer Affairs and Prevention of Fraud is heavily involved in the prevention of accidents occurring in everyday life and has, in this regard, a general competence in dealing with matters of safety of industrial products. It also publishes a list of recall notices of product and several reporting forms of risk products for professionals. There are also several authorities that have specific expertise in certain industrial sectors.
For instance, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) essentially contributes to ensure health and safety in the areas of environment, labour and food. More specifically, it helps to ensure the protection of the health and welfare of animals, the protection of plant health and the assessment of food quality, food safety and nutritional properties. It also has competence over veterinary medicinal products. In its field of competence, ANSES, at the request of other public and administrative authorities, may provide the relevant expertise as well as the scientific and technical support necessary for the development of laws and regulations.
In the health products sector, as a second example, in accordance with the EU directives, the conditions for granting a marketing authorisation for medicinal products for human use (i.e., original products and generics), either nationally or through the European centralised or decentralised procedure, are contained and detailed within the French Public Health Code (PHC).15 In this regard, the French National Agency for Medicines and Health Products Safety (ANSM) plays a key role. Indeed, applications for marketing authorisation are submitted to the ANSM, which scientifically assesses the marketing authorisation file according to scientific criteria regarding quality, safety and efficacy. A new product must provide a benefit–risk ratio at least equivalent to the existing products. The application is thus reviewed by the committees of the ANSM (and in particular by the commission in charge of the initial assessment of the benefit–risk balance of the health products) if a deeper examination and a supplementary peer opinion for the case is required. Three outcomes can arise: a favourable opinion, a request for further information or an unfavourable opinion. Once the marketing authorisation has been granted, manufacturers must comply with a set of rules provided by EU directives,16 and by the PHC under Article L.5121-9-2 et seq.17 The manufacturer of medicinal products for human use must also comply with the good manufacturing practices18 laid down with the intention of providing minimum requirements that a manufacturer must meet while manufacturing these products, to ensure they are in compliance with requirements of safety, quality and efficacy included in the medicinal product master file. Downstream, good distribution practices19 should also be observed. The safety of medicinal products is thus ensured by the ANSM, which has general competence, under certain circumstances, to suspend or withdraw a marketing authorisation20 or to order the recall of any lot or batch of a medicinal product,21 as well as to carry out an inspection on the manufacturing site.
Causes of action
As defined by general French civil liability rules,22 the producer is liable for any loss or damage caused by a defective product23 put into circulation, whether or not the producer has a contract with the injured person. In this respect, the injured person must prove actual damage, a defect of the product and a causal link between the defect and the damage.24
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'.25 There have been several opportunities for defining the content of a 'defect' in French case law. For instance, it is recognised that certain active ingredients for therapeutic use that are considered dangerous do not characterise de jure the defectiveness of the product.26 Similarly, the defectiveness of a medicinal product cannot be inferred from the simple fact that the medicine triggered the damage alleged by the patient,27 or from the fact that the marketing authorisation listed the possible defect as an adverse reaction.28 On the contrary, such a listing provides to the consumer or patient 'the safety that can be legitimately expected from the product'.29
Recent French case law30 recognised that when the adverse reactions are too significant in comparison with the benefits expected, the product should be considered as 'defective', regardless of any reference to these side effects on the leaflet.
Concerning the causal link between the defect and the damage, at first, French jurisdictions required an actual, direct and certain causal link. The certainty of the causal link should be understood as a scientifically proven causal link between the defectiveness of the product and the occurrence of the injury;31 however, patients were facing some major difficulties in providing the necessary scientific evidence. Therefore, the case law has admitted 'proof by presumption', when these presumptions are 'serious, specific and consistent'. The judges' assessment is based on several elements, such as the acquired scientific data on the potential causal link between the product and the damage alleged, and the time between the occurrence of the damage and when the medicine was taken, as well as the absence of other causes that could explain the occurrence of the injury to the patient.32
In the Mediator case,33 judges found these three criteria had been met – even though, in one case, the medical history of the patient led the court to partly exclude the liability of the manufacturer.
Nevertheless, the Supreme Court remains particularly demanding when it comes to admitting the existence of these presumptions.34
The various interpretations of the Supreme Court on the method of proof have recently pushed the jurisdiction, in a case regarding the hepatitis B vaccine, to refer to the ECJ the question of the validity of serious, specific and consistent presumptions as proving the defect in the vaccine and the causal link between the defect and the damage suffered, notwithstanding the absence of scientific proof.35
On 21 June 2017, the ECJ approved the option to rely on these evidentiary rules as long as the burden of proof or the effectiveness of the system of liability introduced by the Directive is not disregarded, and the existence of a causal link is not always considered to be established when certain predetermined causation-related factual evidence is presented.
Since then, the Supreme Court has upheld the rejection by the trial judges of compensation claims from patients attributing their multiple sclerosis to the hepatitis B vaccine.36
The victim is also likely to bring criminal legal proceedings against the manufacturer, either by summoning him or her to appear before the criminal court or by filing a criminal complaint with an application to join in the proceedings. The aim of the public action is to have the criminal offence publicly determined and punished. However, a victim who has been 'personally' harmed by the criminal offence and who seeks compensation may start a civil action,37 which may be brought before the same criminal court.38 For example, if the patient dies because of the medicine, the manufacturer may be sued for manslaughter39 or for an actively or passively deceptive product.40
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 injured person 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 with 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 with 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.
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.59
iv 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.73
v 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.
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.
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.76
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.
Year in review
In France, and in particular within the healthcare sector, litigation has increased considerably in the past five years, and this trend is reinforced by the adoption of the class-action mechanism.
Indeed, since the Mediator case in 2013,85 involving an anti-diabetic medicinal product marketed since 1976, which was prescribed off-label as an appetite suppressant and caused several cases of valvular disease, patients have launched several actions.
Victims have been able to seek a remedy either from the manufacturer86 or from the state.87 However, in 2016 and 2017, it was recognised that the state shall be partly exempted from liability in the event of any fault on the part of the pharmaceutical company Servier, which was under state control at that time;88 it would, in that case, be up to the victims to seek a remedy from the company that is found liable. Recent decisions have considered that victims who have received compensation in non-contentious proceedings have the possibility of seeking state liability before the administrative courts.89
In December 2016, a French class action was initiated against Sanofi before the Paris court of first instance in relation to medicinal products based on valproate and derivatives (Dépakine, Micropakine, Dépakote, Dépamide and generics) that may have produced birth defects and developmental disorders.90
The consequences of this matter have become a political issue and French public authorities have responded by creating another compensation fund.91 In a case of 2019, Sanofi relied on the compliance of its leaflet with the mandatory rules issued by the competent authority at the time the medicine was taken. The Supreme Court referred the case to the trial courts and we are now awaiting the decision that will determine the defectiveness of the product in the light of the company's duty to inform the patients.92
At the beginning of 2017, the Levothyrox case was also placed in the spotlight. Commercialised at the end of March 2017 at the request of the ANSM, the new formula (i.e., change of excipients) of the medicinal product Levothyrox prescribed in the treatment of hypothyroidism and manufactured by Merck was accused of causing many adverse effects, such as cramps, headaches, intense tiredness, dizziness and hair loss.
Beyond the criminal investigation launched by the health division of the Marseille public prosecution service, a class action was filed early 2018 before the District Court of Lyon. On 5 December 2018, the latter dismissed the Levothyrox victims considering there was no fault in respect of the company's duty to inform regarding the leaflet content. The appeal decision should be issued on 9 April 2020.
Decisions of several first instance Courts regarding the unreliability of the serodiagnostic tests used in the detection of LYME disease are expected later this year too.
Finally, an extensive investigation made in November 2018 is now seriously questioning the certification processes and the control of medical implants in Europe, and more particularly in France. According to data gathered from the inventory of material vigilance reports of the ANSM, the number of incidents notified in France, related to these implants, would have doubled in 10 years, with more than 18,000 cases in 2017 and about 158,000 incidents in 10 years. From March 2020, the new EUDAMED database will help to conduct market surveillance on medical devices throughout Europe and include:
- data related to registry of manufacturers, authorised representatives and devices;
- data related to certificates issued, modified, supplemented, suspended, withdrawn or refused according to established procedures; and
- data obtained in accordance with the vigilance procedure on incidents or near-incidents that occur during the use of the medical device.
Aside from the general trend for an increase in civil and criminal litigation, which must now be considered a key and central legal fact (particularly since the Mediator case, and particularly within the health sector), the availability of the class-action mechanism in France is undoubtedly increasing the risk of litigation across all the industrial sectors. This should lead companies to adopt protective behaviours, or to renew and reinforce existing practices (e.g., in terms of internal compliance and audit) and, in doing so, to duly consider the whole spectrum of regulation in their respective sectors, including in relation to regulatory obligations, transparency rules and conflicts of interest.
1 Christophe Hénin is a partner and Julie Vasseur is an associate at Intuity.
2 Based on Article 1240 of the French Civil Code as modified by Ordonnance No. 2016-131 of 10 February 2016: 'Every act whatever of man that causes damage to another obliges him by whose fault it occurred to repair it.'
3 Based on Article 1231-1 of the French Civil Code as modified by Ordonnance No. 2016-131 of 10 February 2016: 'A debtor is condemned, where appropriate, to the payment of damages either on the ground of the non-performance or a delay in performance of an obligation, unless he justifies this on the ground that performance was prevented by force majeure.'
4 Article 171 of the EC Treaty: 'If the Court of Justice finds that a Member State has failed to fulfil an obligation under this Treaty, the State shall be required to take the necessary measures to comply with the judgment of the Court of Justice.'
5 ECJ, 3 January 1993, Commission of the European Communities v. French Republic, Case C-293/91.
6 Supreme Court, civ I, 30 July 1998, Laboratoires Léo v. M. Scovazzo, No. 96-12078.
7 Supreme Court, civ I, 10 December 2014, X v. Royal and Sun Alliance, No. 13-14314 – in this more recent case, the Supreme Court decided to explicitly dismiss Article 1382 of the FCC and to again apply the Directive provisions.
8 Law No. 98-389 of 19 May 1998 on Product Liability.
9 Articles 1245 to 1245-17 of the FCC as modified by Ordonnance No. 2016-131 of 10 February 2016.
10 ECJ, 25 April 2002, Commission of the European Communities v. French Republic, Case C-52/00.
11 ECJ, 14 March 2006, Commission v. France, Case C-177/04.
12 The ECJ, in a ruling of 14 March 2006, Commission v. France, Case C-177/04 stated that: 'by continuing to regard the supplier of a defective product as liable on the same basis as the producer where the producer cannot be identified, even though the supplier has informed the injured person within a reasonable time of the identity of the person who supplied him with the product, the French Republic had not taken all necessary implementing measures set out in the judgment of 25 April 2002.'
13 Official Journal of the French Republic, 27 January 2016, No. 0022, Text No. 1. It is relevant to underline that the French Constitutional Council in its Decision No. 2014-690 DC dated 13 March 2014 decided that the class-action mechanism does not breach any constitutional rules and principles.
14 Official Journal of the French Republic, 27 September 2016, No. 0225, Text No. 5.
15 Articles L.5121-8, L.5121-10, R.5121-5 and R.5121-21 et seq. of the PHC.
16 Directive 2010/84/EU of the European Parliament and of the Council dated 15 December 2010, amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
17 Article L.5121-9-2 of the PHC provides that 'the undertaking or the operator of a medicinal product shall immediately inform the ANSM of the withdrawal or restriction imposed by the competent authority of any country in which the product is marketed, and of any other new information which may affect the assessment of the benefits and risks of the medicinal product or the product concerned. Where appropriate, the ANSM conducts immediate reassessment of the risk-benefit balance of such product and of all products with the same mechanism of action or a similar chemical structure'.
18 Volume 4 of 'The rules governing medicinal products in the European Union' contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directive 91/356/EEC, as amended by Directives 2003/94/EC and 91/412/EEC respectively.
19 ibid., Commission Guideline 2013/C 343/01.
20 Article L.5121-9 of the PHC.
21 Article L.5312-3 of the PHC, concerning the cases mentioned in articles L.5312-1, L.5312-2 and L.5311-1 of the PHC.
22 Article 1245 et seq. of the FCC.
23 On this point, see Court of Appeal, Versailles, 13 October 2016, No. 14/05586, UCB Pharma where for the first time the judge ruled that regardless of the absence of the patient's medical dossier, the evidence of the use of the medicinal product was demonstrated.
24 Article 1245-8 of the FCC.
25 Supreme Court, civ I, 19 June 2019, No. 18-19.239, The liability of a manufacturer for the defect of his product cannot be sought where, at the date of marketing authorisation, the causal link between the side effects and the product was not scientifically proven.
26 Supreme Court, civ I, 5 April 2005, No. 02-11.947 and 02-12.065; see article by Christophe Hénin and Anne-Catherine Maillols, 'La responsabilité des médicaments: à la recherche d'un équilibre entre rigueur et pragmatisme' [Medicinal products liability: looking for a balance between rigour and pragmatism], Les Petites Affiches, 21 June 2005 No. 122 pp. 9–15.
27 Court of Appeal, Bordeaux, 18 March 2015, No. 13/03029.
28 Supreme Court, civ I, 24 January 2006, No. 03-19.534; Court of First Instance, Nîmes, 1 February 2016, No. 14/03320. See also Supreme Court, civ I, 4 July 2019, No. 18-16.809 which considers that the defectiveness of the product cannot be established on the fact that adverse effects were added ex post to the leaflet while such adverse effects were highly unlikely to be linked to the product in such a case.
29 Supreme Court, civ I, 24 January 2006, No. 02-16.648 – see article by Christophe Hénin and Anne-Catherine Maillols, 'La responsabilité du fait des médicaments: nouveautés et exigences' [Medicinal product liability: innovations and requirements], Décideurs, April 2006, No. 74–75, p. 166; in addition, see the decision of the Supreme Court, 27 November 2019, No. 18-16.537.
30 Supreme Court, civ I, 26 September 2018, No. 17-21.271.
31 Supreme Court, civ I, 23 September 2003, No. 01-13.063.
32 Court of Appeal, Versailles, 25 November 2005 No. 04/03953. See also article by Christophe Hénin and Anne-Catherine Maillols, 'La responsabilité du fait des médicaments: de quelques rappels nécessaires sur ses fondements et conditions' [Medicinal product liability: a necessary recall of the conditions and the basis of liability], Les Petites Affiches, 19 May 2006, No. 100, pp. 6–20; Supreme Court, 22 May 2008, No. 05-20.317 and 06-10.967.
33 See Section V. Court of First Instance, Nanterre, 22 October 2015, No. 12/07/07723 and No. 13/06176, confirmed by Court of Appeal, Versailles, 14 April 2016, No. 15/08232; upheld by the Supreme Court on 20 September 2017, No. 16-19643.
34 Supreme Court, 22 January 2009, No. 07-16.449; 24 September 2009, No. 08-16.097; 25 November 2010, No. 09-16.556; 28 April 2011, No. 10-15.289; 26 January 2012, No. 10-28.195; 28 June 2012, No. 11-14.287; 29 May 2013, No. 12-20.903.
35 Supreme Court, 12 November 2015, No. 14-18.118 – see also Supreme Court, 22 September 2016, No. 15-20,791, which ruled that since the decision of the ECJ will influence the judgment of the appeal before the Supreme Court, it is appropriate to stay the proceedings until that decision is rendered.
36 Supreme Court, 20 December 2017, No.15-12.882 and 16-11.267; Supreme Court, 18 October 2017, No.14-18.118. See also the decision of the Supreme Court that rejects causal link between the hepatitis B vaccine and the Catch Syndrome: Supreme Court, 14 November 2018, No. 17-27.980 and 17-28.529.
37 Article 2 of the French Code of Criminal Procedure (CCP).
38 Article 3 of the CCP.
39 Article 221-6 of the CCP.
40 Article 213-2 of the Consumer Code. A product may be considered actively deceptive whenever the indications, for example, affixed to the leaflet or to the immediate or outer packaging do not exactly correspond to the technical or marketing authorisation file. The same product may also be considered passively deceptive if relevant information for the protection of public health is missing.
41 Law of 4 March 2002 No. 2002-303 concerning the patients' rights and the quality of the national health system.
42 Disorders or adverse effects resulting from medical treatment, owing to the use of a medicinal product or to the intervention of a healthcare professional.
43 See the Annual Public Report of the Court of Accounts, February 2017: 'Fifteen years after the enactment of the Law of 4 March 2002, the exercise of such compensation is far removed from the initial objectives and proves to be particularly disappointing, as evidenced by the limited number of beneficiaries.'
44 Victims vaccinated against influenza A virus as part of the vaccination campaign decided by the Orders of the Minister of Health of 4 November 2009 and 13 January 2010.
45 The Amended Finance Act for 2011 of 29 July 2011.
46 Law of 29 December 2016.
47 There are 25 CCI, organised into seven inter-regional divisions.
48 Article D1142-1 of the PHC:
'the threshold of seriousness is determined according to the following criteria:
• the damage must have caused permanent damage of more than 24 per cent to physical and mental integrity;
• or have resulted in a work disability or temporary functional deficit of at least six consecutive months, or six months of a non-consecutive 12-month period'.
49 The actual average processing time was eight and a half months in 2016.
50 Article 1245-8 of the FCC (Article 4 of the Directive), ECJ, 20 November 2014, Novo Nordisk Pharma GmbH v. S, Case No. 310/13.
51 Court of First Instance, Rouen, (interim relief) 6 December 2001; Court of First Instance, Toulouse, (interim relief) 11 December 2003.
52 Supreme Court, com, 17 March 1987, No. 85-11.130; Supreme Court, com, 18 February 1986, No. 84-10.620; Court of Appeal, Paris, 17 December 2003, No. 2003/13837.
53 Court of Appeal, Paris, 26 September 2012 No. 11/23165; Court of Appeal, Paris, 11 October 2012, No. 11/23194.
54 See Section III.
55 See Section III.
56 Supreme Court, civ I, 23 September 2003; Supreme Court, civ II, 31 March 1983, bull, civ, 1983 II, 89.
57 Supreme Court, 22 June 2017, No. 16-19047 and 16-23033.
58 See, for example, Court of First Instance, Nanterre, 13 February 2014.
59 ECJ, 29 May 1997, Commission of the European Communities v. United Kingdom of Great Britain and Northern Ireland, Case C-300/95.
60 The 'producer' might thus have several meanings. This terminology obviously refers to the manufacturer, but it can also include within its scope other actors, such as a parallel importer, Supreme Court, civ I, 4 June 2014, No. 13-13558.
61 See, also, ECJ, 9 February 2006, Declan O'Byrne v. Sanofi Pasteur MSD, Case C-121/04; ECJ, 2 December 2009, Aventis Pasteur v. OB, Case C-358/08.
62 Supreme Court, civ I, 26 November 2014, No. 13-18819.
63 Court of Appeal, Paris, 4 September 2012, No. 11/23170; Court of Appeal, Paris, 26 September 2012, No. 11/23165; Court of Appeal, Reims, 12 November 2013, No. 12/00410.
64 Court of Appeal, Versailles, 22 January 2015, No. 13/08038; Court of Appeal, Versailles, (interim relief) 28 May 2014, No. 13/07340; Court of First Instance, Nanterre, 1 June 2017, No. 14/11657.
65 See Section I; Supreme Court, civ I, 15 May 2015, No 14-13.151.
66 Supreme Court, 15 May 2015, No. 14-13.151 P; 17 January 2018, No. 16-25.817.
67 Article L.1142-28 of the PHC.
68 Article L.1221-14 of the PHC.
69 Article L.3122-1 of the PHC.
70 Article L.3111-9 of the PHC.
71 Article L.3131-4 of the PHC.
72 OJ L 351, 20. December 2012, pp. 1–32.
73 Articles 113-2 and 113-7 of the FCC.
74 Official Journal of the French Republic, 27 September 2016, No. 0225, Text No. 5. Decree No. 2017-888, 6 May 2017 defined the procedural rules applicable before both judicial and administrative judges.
75 It would appear possible to include clinical trials and, as such, medicinal products without marketing authorisation (e.g., the Phase I clinical trial conducted in Rennes in 2016, during which several accidents occurred).
76 Taking into due account that Decree No. 2014-1251, 28 October 2014 regarding lawyers' means of communication allowed lawyers to advertise through flyers, posters, movies, radio or television; Council of State, 9 November 2015, Nos. 386296 and 384728 stated that this provision complies with Directive 2006/123/EC.
77 In this regard, the French Supreme Court recently confirmed that a victim can obtain compensation for post-traumatic stress; Supreme Court, Crim, 21 October 2014, No. 13-87669.
78 Damages resulting from injury to the product itself are excluded from product liability, but may be covered by the guarantee against hidden defects (Article 1641 et seq. of the FCC). Damages resulting from non-compliance of the goods with the intended use are subject to the obligation of conformity (Article L.217-4 et seq. of the French Consumer Code).
79 The Supreme Court first admitted compensation for the prejudice of anxiety caused by exposure to asbestos dust: Supreme Court, 11 May 2010, No. 09-42.241; 3 March 2015, No. 13-20.486.
80 Action relating to asbestos; Council of State, ass., 3 March 2004, No. 241150.
81 Administrative Court of Appeal, Paris, 2 July 2015, Nos. 14PA04137, 14PA04138, 14PA04139, 14PA04140, 14PA04141, 14PA04142, 14PA04143 and 14PA04156. More recently, Administrative Courts of Appeal have again issued decisions along these lines: Administrative Court of Appeal, Paris, 19 November 2019, No. 18PA00180 and 18PA00163.
82 Council of State, 9 November 2016, No. 393108; see also the recent decision of the Administrative Court, Paris, 10 October 2017, No.1312485/6-2.
83 Court of First Instance, 28 January 2016, Nos. 15/01586 and 15/01743, but annulled by the Versailles Court of Appeal, on 27 October 2016, Nos. 16/03382 and 16/03018, because of the existence of a serious challenge raised by Servier regarding the development-risk exemption.
84 Supreme Court, 14 November 2019, No. 18-10794; Supreme Court, 19 June 2019, No. 18-10612.
85 Out of a total of 8,942 claims addressed to the ONIAM, 1,942 have so far succeeded for the plaintiffs.
86 See Section III. The Court of First Instance of Nanterre compensated the Mediator victims on the basis of liability for defective products – the Court of First Instance, Nanterre, 22 October 2015, Nos. 12/07723 and 13/06176. Although the compensation was judged derisory, Servier filed an appeal against the decision. The Court of Appeal of Versailles, on 14 April 2016, Nos. 15/08232 confirmed the first instance decision. The Supreme Court on 20 September 2017, No. 16-19643 upheld the appeal decision.
87 Administrative Court, Paris, 3 July 2014, No. 1312345/6 and 12 September 2014, No. 1312391/6; upheld by the Administrative Court of Appeal, Paris, 31 July 2015, Nos. 14PA04082, 14PA04083 and 14PA04146; also upheld by the Council of State, 9 November 2016, No. 393904.
88 Council of State, 9 November 2016, No. 393902; Administrative Court, Paris, 4 August 2017, Nos. 16PA00157 and 16PA03634: the faults committed by Servier were likely to exonerate the state of 70 per cent of its liability.
89 Council of State, 31 December 2019, No. 420232.
90 Court of Appeal Paris, 14 March 2017, No. 16/17958: declared the action launched by APESAC (the patients' support association) inadmissible for lack of standing.
91 See Section IV.i. Article 150 (V) of the French Finance Law for 2017.
92 Supreme Court, 27 November 2019, No. 18-16-537.