I INTRODUCTION TO THE PRODUCT LIABILITY FRAMEWORK

Before the adoption of the Product Liability Directive No. 85/374/EEC (the Directive), French jurisdictions used to implement general civil liability, whether tortious, based on Article 1240 of the French Civil Code (FCC),2 or contractual, based on Article 1231-13 of the FCC.

The Directive was adopted in the European Union on 25 July 1985 to protect consumers against damages 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 such a 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 FCC.7

Finally, on 19 May 1998,8 France transposed the Directive, and the FCC has 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. It should be noted, however, that in 2002,10 the ECJ ordered the French Republic to amend its existing law, which incorrectly transposed the Directive. The ECJ ruled that the French legislation that 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

II REGULATORY OVERSIGHT

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 Safety 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, the Agency, 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, it should also be noted that in accordance with the EU directives, the conditions for granting a marketing authorisation for medicinal products for human use (for innovated products as well as for 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 Agency (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 such a 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 set out by EU directives,16 and by the PHC under Article L5121-9-2 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, in order to ensure they are in compliance with requirements of safety, quality and efficacy included in the medicinal product master file. It is also relevant to note that, downstream, good distribution practices19 should also be observed. The safety of medicinal products is thus ensured by the ANSM, which has a 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.

III 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 order to make a claim against the producer, the injured person must prove an 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’. There have been several opportunities for defining the content of a ‘defect’ in French case law. It should be noted, for instance, that the fact that certain active ingredients for therapeutic use are dangerous do not characterise de jure the defectiveness of the product.25 Similarly, the defectiveness of a medicinal product cannot be inferred from the simple fact that the medication triggered the damage alleged by the patient,26 or from the fact that the marketing authorisation listed the possible defect as an adverse reaction.27 On the contrary, such a listing provides the consumer or patient ‘the safety that can be legitimately expected from the product’.28

Concerning the causal link between the defect and the damage, at first, the 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;29 however, patients were facing some major difficulties in providing the necessary scientific evidence to prove the causal link between their damages and the defect of the product. Therefore, the actual case law has admitted ‘proof by presumption’, when these presumptions are ‘serious, precise and concordant’. Several elements form the basis of the judges’ assessment, such as the fact that the product, under the acquired scientific data, could be a material cause of the damage, the time between the occurrence of the damage and the medication, and the absence of other causes that could explain the occurrence of the injury to the patient.30

On 22 October 2015, in the Mediator case,31 judges admitted the fulfilment of these three criteria – even if in one case, the medical history of the patient led the Court to partly exclude the liability of the manufacturer. This decision was confirmed by the Court of Appeal of Versailles on 14 April 2016.32

Nevertheless, the Supreme Court remains particularly demanding when it comes to admitting the existence of such presumptions.33

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, precise and concordant presumptions, notwithstanding the absence of scientific proof, as to prove the link of causation.34

The victim could also 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 public action aims to have the criminal offence publicly determined and punished. But, a victim who has been ‘personally’ harmed by the criminal offence and who seeks compensation may start a civil action,35 which may be brought before the same criminal court.36 For example, if the patient dies as a result of the medication, the manufacturer may be sued for manslaughter37 or for an active or passive deceptive product.38

IV LITIGATION

i Forum

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 200239 establishes an autonomous alternative compensation scheme in relation to medicinal liability. The aim is to resolve the difficulties encountered by victims of serious medical accidents, such as iatrogenic disorders,40 or of a defective medicinal product, by allowing them to obtain quick and easy access compensation.

In this regard, the National Compensation for Medical Accidents Office was established in order to compensate victims of therapeutic hazards, medical accidents, iatrogenic diseases and nosocomial infections.

Thus, pursuant to Article L1142-4 et seq. of PHC, the victim of a medical accident may refer to the Commission for Conciliation and Compensation (CCI). Depending on the seriousness of the injury,41 this procedure aims at reaching conciliation or an 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 request and will require any missing documents. When the file is complete, the Commission has a period of six months to issue its opinion.

If the application is deemed admissible, the President of the CCI should appoint an expert or a body of experts, and set a deadline for submission of the expert report. Then, a copy of this report is sent to each party, who is summoned before the CCI and may be assisted or represented by a person of their choice. Following the meeting, the Commission should issue a notice signed by the President and sent to the parties, which is accompanied by documents required for an offer of compensation.

If the parties concerned disagree on the compensation proposed, the case should then be 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 plaintiff42 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 for doing so is given. The assessment of whether a reason is legitimate requires examination in particular of the utility of the measure sought in regard to the further litigation,43 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 them to settle the dispute.44

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.45 In practice, Article 145 of the CPC is frequently used to seek an expert report in order 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 French Civil Code a product is defective ‘when it does not provide all the safety that can be legitimately expected from it’.46

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. The French jurisdictions previously required a direct and certain causal link, but judges now admit ‘proof by presumption’ when these presumptions are ‘serious, precise and concordant’.47 The French courts definitively acknowledge that mere non-concordant presumptions cannot establish the existence of a causal link, no more than a mere possibility of a causal link.48

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, concerning medicinal products, pharmaceutical companies have a strong incentive to provide exhaustive information in the summary of the product characteristics (SPC) 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.49

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 is owing to 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 the time the product was put into circulation 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.50

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 him 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.51

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.52

It should also be borne in mind that pursuant to Article 1245-7 of the FCC, where two or more persons are liable for the same damage, they will be liable jointly and severally,53 without prejudice to the provisions of national law concerning 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 expire 10 years from the date the product was put into circulation, unless the injured person has, in the meantime, brought a case 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 from the day on which the plaintiff became aware, or should reasonably have become aware, of the damage, the defect and the identity of the producer.54

With regard to the coordination of the two expiration periods, it is worth mentioning that the three-year limitation period is included in the 10-year period in which the liability of the manufacturer can be sought.55

However, it follows from the principle of non-retroactivity that, when the defective product 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 Law of 19 May 1998,56 an action for damages is subject to a different period, which is a time limit of 10 years from the consolidation of the damage as it was previously provided under French law.57

In addition, Law No. 2016-41 for the modernisation of our healthcare system set forth that claims brought before the ONIAM are now barred 10 years from the consolidation of the damage.58 The 10-year limitation also applies to claims resulting from a contamination with the hepatitis B or C virus or human T-lymphotropic virus,59 human immunodeficiency virus60 caused by transfusion of blood products or injection of blood derivatives, to actions for compensation for damage directly related to mandatory vaccination61 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.62

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 before 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 the obligations contracted either in France or in foreign countries, with a French citizen. In addition, and more substantially, Article 5 of the EU Regulation No. 44/2001 of 22 December 2000, on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters,63 allows and recognises the French jurisdiction, 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.64

v Expert witnesses

In proceedings before the civil courts, as mentioned in Section IV.ii, supra, Article 145 of the CPC is frequently used by French judges in practice, in order to obtain an expert report that should 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, for instance, could use an expert report compiled by their own experts as part of their defence.

The French criminal courts also permit testimonies or evidence from expert witnesses, including during procedures connected with a crime where a jury is mandatory.

vi Discovery

One of the main differences between the rules of procedural law in common and civil law systems lies in the faculties that correspond both to the parties and to the judicial authority in the application of discovery in finding material evidence. Indeed, in civil law systems, there is no need to apply discovery, given that proceedings tend to be written rather than oral, and therefore there is no tacit or strategic advantage to be gained from applying the element of surprise. Even though a phase similar to that of pretrial (beginning with the allegations or pleading) does exist in civil law systems, the investigative powers offered to the parties are minimal when compared with those corresponding to the parties in common law systems. In this regard, there are no such available discovery methods regarding product liability cases before the French jurisdictions.

vii Apportionment

In situations where several persons are liable for the same damage, the protection of the consumer requires that the injured person should be able to claim full compensation for the damage from any one of them.

A fair apportionment of risk between the injured person and the producer or the distributor implies that the producer should be able to free him or herself from liability if he or she furnishes proof as to 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 cause the damage. The contributory negligence of the injured person may also be taken into account to reduce or disallow such liability.

viii Mass tort actions

As mentioned in Section I, supra, Law No. 2016-41 was enacted on 26 January 2016 and embraces class actions The law entered into force on 26 September 2016.65

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 ANSM66 and liability insurers. Such an action is brought before a civil or administrative court (depending on the defendant) in the name of several plaintiffs in order 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 a case, the court will directly determine within the judgment the criteria to be met in order 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 case of 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.

Such a 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, if the new legislation does not simplify the judicial process for the patients, it will clearly facilitate the expansion of French business litigation with a specialisation of certain French law firms in mass torts as it already exists in the US.67

ix 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 include medical or pharmaceutical expenses, expenses related to requiring assistance from a third person, moral prejudice (pain and suffering,68 compensation for disfigurement and loss of amenity), direct material prejudice (work disability), and indirect material prejudice (revenue loss of subsidies). They also include the damage to goods and property (damage resulting from the destruction or deterioration of goods, economic damages, operating losses, loss of use, loss of profit, expenses caused by the damage to goods, etc.).69

In French civil law, damages are strictly limited to compensation. For this reason, punitive damages are not used since they are deemed to be in contrast with 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 FCC 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 FCC, 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.

V YEAR IN REVIEW

In France, and in particular within the healthcare sector, litigation has increased considerably in the past two years, and should be reinforced by the adoption of the class-action mechanism.

Indeed, since the Mediator case70 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 and authorities have brought several actions, in particular in 2013.

The victims were able to seek remedy either from the manufacturer71 or from the state. Indeed, several judgments rendered by the Administrative Court of Paris in 2014 held that given the legal and material privileges of the ANSM, the absence of the suspension or withdrawal of the medicine’s marketing authorisation should be regarded as a wrongful failure that constitutes a ground for liability on the part of the state.72

Three new judgments of the Administrative Court of Appeal of Paris dated 31 July 201573 have confirmed such a principle: the state – but not the ANSM74 – can be sued before the administrative judge on the ground of a simple negligence, while maintaining a right of action by way of subrogation against the manufacturer. In the Mediator case, questions were also raised about a possible compensation for patients who were simply afraid of developing a valvular disease after the medicine was taken. Unlike the judicial judge,75 it was well-known that the administrative judge has always been reluctant to establish a principle of compensation for the prejudice of anxiety.76 In line with its previous case law, the Council of State recently circumscribed such a possibility of compensation to the existence of three criteria: the awareness of the disease; the seriousness of the risks and the specificity of contaminations by transfusions.77

Such a dissension between the judicial and the administrative judges has been reflected in the Mediator case, where the Administrative Court of Appeal of Paris, in a series of judgments dated 2 July 201578 confirmed by the Council of State on 9 November 201679, chose not to indemnify ‘concerns that could not be legitimately proven’ while the presiding judge of the Court of Nanterre ruled differently.80

Beyond the Poly Implant Prosthesis (PIP) case, and the abnormal level of PIP breast implant ruptures, or the recall of the Ceraver orthopaedic prostheses, the French government and the ANSM contributed to a ‘contraceptive pills scandal’ widely publicised through the media in early 2013. In January 2013, the ANSM suspended the marketing authorisation of Diane 35, and its generic treatments against acne, also prescribed off-label as an oral contraceptive, given the risk of venous or arterial thrombosis. However, the European Commission decided on 15 July 2013 that, contrary to the French Authority’s decision, the risk-benefit balance remained favourable, but that the prescription should be restricted. Following the decision of the European Commission, the ANSM initiated a procedure to inform pharmaceutical laboratories that the marketing authorisation’s suspension had been withdrawn. A similar legal and regulatory imbroglio focused on the third and fourth generation of pills with the same result. However, these regulatory and legal actions have seen litigations before the courts initiated by a large number of patients.

The ANSM, again, in June 2013, issued a general alert on a possible error of the diuretic medicinal product furosemide’s packaging, which was suspected to contain sleeping pills, based on a single report. The Agency decided to recall every batch of the medicinal product as a ‘precautionary measure’ and to stop the corresponding manufacturing lines. This case was given broad media coverage, despite the fact that, after several months, the investigation concluded that it was a possible error on the part of the patient concerned and of the pharmacist involved.

In October 2013, several complaints for manslaughter were filed against a new oral anticoagulant medicinal product, suspected of causing life-threatening bleeding, which is, however, an expected side effect of the medicinal product concerned.

In December 2013, victims of the alleged adverse effects of Gardasil, a vaccine against cervical cancer, have filed complaints for unintentional impairment to physical integrity. The victims claimed that they had contracted severely debilitating diseases in the weeks and months following vaccination without having any medical history.

Very recently, in December 2016, a French class action was initiated against Sanofi before the Tribunal of first instance of Paris, as regards medicinal products based on valproate and derivatives (Dépakine, Micropakine, Dépakote, Dépamide and generics) that may have created malformations and developmental disorders at birth.

Such consequences have become a political issue, to which French public authorities replied by the creation of another compensation fund.81

Beyond the rise in civil and criminal litigations in 2013 and 2016, which can be considered as a key and central new legal fact, particularly within the health sector, the ability to now embrace the class-action mechanism in France will undoubtedly increase the risk of litigation across all the industrial sectors; this should lead companies to adopt renewed and protective behaviours or to reinforce them, in terms, for example, of internal compliance and audit, which will have to duly consider the whole spectrum of regulation in the sector concerned (regulatory obligations, transparency rules or conflict of interests, for example).


Footnotes

1 Christophe Hénin is a partner at Intuity.

2 Article 1240 of the FCC 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 Article 1231-1 of the FCC 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 L5121-8, L5121-10, R5121-5 and R5121-21 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 L5121-9-2 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 Directives 91/356/EEC, as amended by Directive 2003/94/EC and 91/412/EEC, respectively.

19 Ibid.

20 Article L5121-9 of the PHC.

21 Article L5312-1 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, 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.

26 Court of Appeal, Bordeaux, 18 March 2015, No. 13/03029, Société Merck Sharp & Dohme-Chibret.

27 Supreme Court, civ I, 24 January 2006, No. 03-19.534, Société Aventis Pasteur MSD v. Mme X et autres; Tribunal of First Instance, Nîmes, 1 February 2016, No. 14/03320, Laboratoire GlaxoSmithKline, Laboratoire Boehringer, Société Lilly France.

28 Supreme Court, civ I, 24 January 2006, No. 02-16.648, Société les Laboratoires Servier SA v. Mme X et autres – 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.

29 Supreme Court, civ I, 23 September 2003, No. 01-13.063, Laboratoires GSK.

30 Court of Appeal, Versailles, 25 November 2005 No. 04/03953, Laboratoires GSK. 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, Société Sanofi Pasteur MSD.

31 See Section V, infra.

32 Tribunal of First Instance, Nanterre, 22 October 2015, No. 12/07/07723 and No. 13/06176, Société Laboratoires Servier SAS confirmed by Court of Appeal, Versailles, 14 April 2016, No. 15/08232 and No. 15/01593.

33 Supreme Court, 22 January 2009, No. 07-16.449, Laboratoire GlaxoSmithKline; 24 September 2009, No. 08-16.097, Société Aventis Pasteur MSD; 25 November 2010, No. 09-16.556, Société Sanofi Pasteur MSD; 28 April 2011, No. 10-15.289, Laboratoire GlaxoSmithKline; 26 January 2012, No. 10-28.195, Société Sanofi Pasteur MSD; 28 June 2012, No. 11-14.287, Société Sanofi Pasteur MSD; 29 May 2013, No. 12-20.903, Laboratoire GlaxoSmithKline.

34 Supreme Court, 12 November 2015, No. 14-18.118, Société Laboratoires Servier SAS – see also Supreme Court, 22 September 2016, No. 15-20,791, Société Laboratoires Servier SAS, which ruled that since the decision of the ECJ will influence the solution of the appeal before the Supreme Court, it is appropriate to stay the proceedings until such a decision is rendered.

35 Article 2 of the French Code of Criminal Procedure (CCP).

36 Article 3 of the CCP.

37 Article 221-6 of the CCP.

38 Article 213-2 of the Consumer Code. A product should be actively deceptive whenever the allegations, for example, affixed to the leaflet and/or to the immediate or outer packaging do not exactly correspond to the technical or marketing authorisation file. The same product could also be passively deceptive whenever relevant information in order to protect public health is missing.

39 Law of 4 March 2002 No. 2002-303 concerning the patients’ rights and the quality of the national health system.

40 Disorder or adverse effect resulting from the medical treatment, owing to the use of medicinal product or to the intervention of a healthcare professional.

41 Article D1142-1 of the PHC:

the threshold of seriousness is determined by the following criteria:

– the damage must have caused permanent damage to physical and mental integrity above 24%;

– or have resulted in a work disability or temporary functional deficit of at least 6 consecutive months, or 6 months on a non-consecutive 12-month period.

42 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.

43 Tribunal of First Instance, Rouen, Referee’s Order of 6 December 2001, Laboratoire Bayer v. X, Tribunal of First Instance, Toulouse, Referee’s Order of 11 December 2003, Société Aventis Pasteur MSD v. Carine Barbier.

44 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.

45 Court of Appeal, Paris, 26 September 2012 No. 11/23165; Court of Appeal, Paris, 11 October 2012, No. 11/23194.

46 See Section III, supra.

47 See Section III, supra.

48 Supreme Court, civ I, 23 September 2003, Laboratoire GlaxoSmithKline v. Mme Morice; Supreme Court, civ II, 31 March 1983, bull, civ, 1983 II, 89.

49 See, for example, Tribunal of First Instance, Nanterre, 13 February 2014, Leleux v. Zambon France.

50 ECJ, 29 May 1997, Commission of the European Communities v. United Kingdom of Great Britain and Northern Ireland, Case C-300/95.

51 The ‘producer’ might thus have several meanings. Such a terminology obviously refers to the manufacturer but can also include within its scope other actors such as a parallel importer, Supreme Court, civ I, 4 June 2014, Europhyto v. SwissLife Insurance and Axa Belgium, No. 13-13558.

52 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.

53 Supreme Court, civ I, 26 November 2014, Ceramtec v. Wright Medical France, No. 13-18819.

54 Court of Appeal, Grenoble, 27 June 2011, Robveille v. GlaxoSmithKline; Court of Appeal, Toulouse, 24 January 2012, El Hannoui v. GlaxoSmithKline; Court of Appeal, Paris, 4 September 2012, Bitton v. Sanofi-Aventis France; Court of Appeal, Paris, 26 September 2012, MSD France v. Bitton; Court of Appeal, Paris, 11 October 2012, Blouzat v. Sanofi Aventis France; Court of Appeal Lyon, 21 January 2013, Vignes v. SNC Sanofi Pasteur; Court of Appeal, Rennes, 23 January 2013, Raoul v. GlaxoSmithKline; Court of Appeal, Lyon, 12 February 2013, Mazotti v. Expanscience; Tribunal of First Instance, Versailles, 4 April 2013, Devoucoux v. Sanofi Pasteur MSD; Court of Appeal, Versailles, 12 September 2013, Sophie X v. GlaxoSmithKline; Court of Appeal, Reims, 12 November 2013, Vallois v. SAS Carrefour and SAS Unilever France; Court of Appeal, Aix-en-Provence, 16 January 2014, Pierrette X v. SAS Abbott France; Tribunal of First Instance, Nanterre, 13 February 2014, Leleux v. Zambon France; Tribunal of First Instance, Paris, 3 March 2014, Naouri v. GlaxoSmithKline; Court of Appeal, Versailles, 28 May 2014, Saguet v. AstraZeneca; Supreme Court, 18 June 2014, Y v. Expanscience; Tribunal of First Instance, 1 July 2014, Osset v. GlaxoSmithKline; Court of Appeal, Bastia, 3 September 2014, Dayez v. Sanofi Pasteur MSD.

55 Court of Appeal, Versailles, 22 January 2015, No. 13/08038; Court of Appeal, Versailles, 28 May 2014, No. 13/07340; Tribunal of First Instance, Paris, 3 March 2014, No. 12/09780; Tribunal of First Instance, Narbonne, 1 July 2014, No. 13/00352.

56 See Section I, supra.

57 Supreme Court, 15 May 2015, No. 14-13.151 P.

58 Article L1142-28 of the PHC.

59 Article L1221- 14 of the PHC.

60 Article L3122-1 of the PHC.

61 Article L3111-9 of the PHC.

62 Article L3131-4 of the PHC.

63 JOUE, L-12/1, 16 January 2001 – see also, from 1 January 2015, EU Regulation No. 1215/2012 of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, JOUE, L-351/1, 20 December 2012.

64 Article 113-2 and 113-7 of the FCC.

65 Official Journal of the French Republic, 27 September 2016, No. 0225, Text No. 5.

66 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), in the future class action.

67 Taking into due account that Decree No. 2014-1251, 28 October 2014 regarding lawyers’ means of communication allowed lawyers to do advertising through flyers, posters, movies, radio or television; Council of State, 9 November 2015, No. 386296 and No. 384728 stated that such a provision complies with Directive 2006/123/EC.

68 In this regard, the French Supreme Court recently confirmed that a victim can obtain compensation for post-traumatic stress; Supreme Court, Crim, X v. Y, 21 October 2014, No. 13-87669.

69 Damages resulting from injury to the product itself are excluded from product liability, but may be apprehended by the guarantee against hidden defects (Article 1641 et seq. of the FCC). Damages resulting from non-compliance of the good to the intended use are subject to the obligation of conformity (Article L211-1 et seq. of the COC).

70 Out of a total of 8,942 claims addressed to the ONIAM, 1,942 have so far succeeded for the plaintiffs.

71 See Section III, supra. The Tribunal of First Instance of Nanterre compensated the victims of the Mediator on the basis of liability for defective products, Tribunal of First Instance, Nanterre, 22 October 2015, No. 12/07/07723 and No. 13/06176, Société Laboratoires Servier SAS. Although the compensation has been judged derisory (€27,000 and €10,000), Servier filed an appeal against the decision. Court of Appeal of Versailles, on 14 April 2016, No. 15/08232 and No. 15/01593 confirmed the first instance decision.

72 Administrative Court, Paris, 3 July 2014, No. 1312345/6; 7 August 2014, No. 1312469/6; 12 September 2014, No. 1312391/6.

73 Administrative Court of appeal, Paris, 31 July 2015, No. 14PA04082, 14PA04083 and 14PA04146.

74 Article L5322-2 of the PHC, according to which the Director-General of the agency makes, on behalf of the state, the decisions that fall under its scope of competence.

75 The Supreme Court admitted first the compensation for the prejudice of anxiety caused by the exposure to asbestos dust: Supreme Court, 11 May 2010, No. 09-42.241; 3 March 2015, No. 13-20.486.

76 Action relating to asbestos; Council of State, ass., 3 March 2004, No. 241150.

77 Council of State, 27 May 2015, No. 371697.

78 Administrative Court of Appeal, Paris, 2 July 2015, No. 14PA04137, No. 14PA04138, No. 14PA04139, No. 14PA04140, No. 14PA04141, No. 14PA04142, No. 14PA04143 and No. 14PA04156.

79 Council of State, 9 November 2016, No. 393108.

80 Tribunal of First Instance, 28 January 2016, Servier.

81 Article 150 (V) of the French Finance Law for 2017.