Written commercial agreement

Significant imbalance

Sudden termination of established relationships

Competition investigation – French law

Civil competition action

French competition law

Competition investigation – European law

European competition law

Vertical restraints

Distribution law

Liability for defective products

Consumer law

Prohibition of measures having equivalent effect

European business law

Corruption

Compliance

Economic law

Shareholders' agreements

Removal of company directors

Abuse of voting rights

Companies

Action for infringement (counterfeiting)

Rights conferred by the trademark

Patentability

Industrial property

Commercial rent review

Renewal of the commercial lease

Despecialization (change of use)

Commercial leases

Reform of contract law

Reform of the law of special contracts

Preliminary sales agreement

Obligation to deliver goods in conformity

Classification of the contract for services (contrat d'entreprise)

Effects of the agency agreement with respect to third parties

Business contracts

Ongoing contracts

Recovery claims

Court-approved transfer plan

Bankruptcy proceedings

Personal data breaches

White collar crime

Commercial law

500 Questions - Business Law

Directive No 85/374 is repealed with effect from 9 December 2026; however, it continues to apply to products placed on the market or put into service before this date.
Directive No 2024/2853, which applies to products placed on the market or put into service after 9 December 2026 (Art. 2(1)), which is a maximum harmonization directive, aims to enhance the level of protection of consumers' health a …

What will Directive No 2024/2853 of 23 October 2024 change in Directive No 85/374 of 25 July 1985?

Article 1245-17, para. 1, of the Civil Code provides that the victim of damage resulting from a defective product may avail themselves of the rights derived from contractual or non-contractual liability law or a special liability regime. However, this possibility must be interpreted restrictively .

The Court of Justice clarified that the reference to the rights that a victim of damage may invoke under contractual or non-contractual liability should be interpreted as the ability to apply liability regimes based on different grounds, such as the warranty against hidden defects or fault. Similarly, Union law does not oppose the application of special liability regimes when they are limited to a specific production sector or when the damage does not fall within the scope of the Directive .

Even though the general system governing liability for defective products not intended for business/commercial use, nor used for such use, does not exclude the application of other liability regimes, whether contractual or non-contractual, which are based on different grounds than a product's lack of safety, when a power surge in the electricity distribution network is invoked as the cause of damages, that is, a lack of safety in electricity, a product within the meaning of Articles 1245 et seq. of the Civil Code, the liability of the electricity supplier can only be sought on the basis of these provisions.

CA Colmar, 3 May 2019, LawLex201900000609JBJ.

Directive No 85/374 does not preclude a Member State from adopting or  maintaining a general system of product liability allowing compensation  for damage to an item of property intended for professional use, where  such damage does not fall within its scope of application.

ECJ, Case C-285/08 Moteurs Leroy Somer, Judgment of 4 June 2009, LawLex201100000469JBJ.

How does liability for defective products interact with other liability regimes?

The general system of liability for defective products excludes the application of other contractual or non-contractual liability regimes under ordinary law, such as liability for things, based on the defect of a product that does not offer the safety one can legitimately expect, except for fault-based liability and the warranty against hidden defects . Therefore, the rules governing liability for defective products precludes the enforcement of the producer's civil liability, including when it sanctions the violation of the general safety obligation provided for in Article L. 421-3 of the Consumer Code . Similarly, when the victim highlights a fault that is not distinct from the lack of safety of the disputed product, their action can only succeed based on Articles 1245 et seq. of the former Civil Code, and not on Article L. 217-4 of the Consumer Code for lack of conformity.

However, the claimant may take action against the manufacturer under the ordinary liability regime if the specific liability regime of Articles 1245 et seq. of the Civil Code is not applicable. The Court of Cassation indeed considers that the victim of damage attributed to a defective product may take action for liability against the producer based on Article 1240 of the Civil Code, if they establish that their damage results from a fault committed by the producer, such as keeping the product in circulation despite knowing its defect or failing in their duty of care regarding the uses presented by the product. 

The implementation of a producer's liability pursuant to Articles 1245 et seq. of the Civil Code does not exclude the buyer's right to simultaneously seek the seller's liability based on the warranty against hidden defects.

CA Rennes, 28 October 2020, LawLex201800000141JBJ.

The buyer cannot bring an action against the intermediary seller for breach of their safety obligation, since, following the entry into force of the regulation on liability for defective products, they can only base their action on the defect of the product on Articles 1245-1 of the Civil Code, which primarily target producers.

CA Amiens, 5 October 2017, LawLex201700001654JBJ.

Pursuant to Article 1245-17 of the Civil Code, the regime of liability for defective products does not affect the rights that a victim of damage may invoke under contractual or non-contractual liability law or a special liability regime, so that the victim may seek compensation based on Article 1240 if they establish that their damage results from a fault committed by the producer, such as keeping the product in circulation despite knowing its defect or failing in their duty of care regarding the risks presented by the product.

Cass. civ., 15 November 2023, LawLex202300013620JBJ.

When does contractual or tort liability apply?

Article 1245-5 of the Civil Code states that “producers (...) are not considered to be persons whose liability may be sought on the basis of Articles 1792 to 1792-6 and 1646-1”. The liability of the builder thus takes precedence over the regime resulting from the Product Liability Directive. Liability for defective products applies to defective equipment not classified as “elements that may entail joint liability” (EPERS - Éléments Pouvant Entraîner la Responsabilité Solidaire du fabricant) within the meaning of Article 1792-4 of the Civil Code, which establishes for the benefit of the project owner a joint liability of the manufacturer or importer of prefabricated elements .

Finally, in terms of medical liability, Article L. 1142-1, I, para. 1, of the Public Health Code establishes, for healthcare professionals and institutions, a fault-based liability concerning the performance of prevention, diagnosis, or treatment acts, and strict liability that exempts the victim from proving a fault by the professional if the damage results from a defect in a health product . When a healthcare institution has compensated a patient for damages caused by the use of a defective health product, it may seek recourse against the producer of that product based on Articles 1245 et seq. of the Civil Code or tort-based liability; when based on the provisions relating to liability for defective products, the recourse action can only be exercised within ten years from the date the product was put into circulation, unless the victim has initiated an action within this period.

A defective boiler chosen from a catalog and produced in series, not for the specific needs of the dwelling in question, does not constitute an element that could entail the joint liability (EPERS) of the manufacturer or importer of prefabricated elements justifying the application of Article 1792-4 of the Civil Code.

CA Rennes, 18 May 2017, LawLex201700001044JBJ.

The liability of a doctor is not automatically incurred due to a defect in a health product they implant in their patient, based on Articles 1245-6 of the Civil Code and L. 1142-1, I, 1, para. 1, of the Public Health Code, except in cases where the producer could not be identified and where the healthcare professional or the healthcare establishment did not designate their own supplier or the producer within the allotted time.

Cass. 1re civ., 26 February 2020, LawLex202000000301JBJ.

When do other special liability regimes apply?

The incorrect transposition of Directive No 85-374 by the Law of 19 May 1998 not only led the French legislator to repeatedly amend the liability system resulting from thiat law but also caused difficulties in its application over time.

Article 13 of the Directive prohibits Member States from maintaining a liability regime for defective products different from that provided for by the Directive.

To define the scope of application over time, it is necessary to distinguish according to the date the products are put on the market:

for products placed on the market before the expiration date of the transposition period (30 July 1988) and a fortiori before the notification of the directive, ordinary law is applicable since no special liability regime for defective products existed or was to exist under Union law prior to this date ;

for products placed on the market after the entry into force of the transposition law of 19 May 1998 (21 May 1998), the special liability regime for defective products is applicable, to the exclusion of ordinary law ;

for products placed on the market after 30 July 1988 and before 21 May 1998, ordinary law applies, interpreted “in the light of the directive” by the courts .

Since the disputed products were put into circulation in February 1985, that is, before the notification of Directive No 85-374, there is no need to interpret national law in light of it.

Cass. 1re civ., 24 January 2006, LawLex200600001142JBJ.

The liability of the manufacturer and the seller of the disputed harrow must be sought on the basis of Article 1386-1 (now Art. 1245) of the Civil Code, since it was put into circulation after the entry into force of the law on liability for defective products.

CA Pau, 11 April 2014, LawLex201400000748JBJ.

In the event of bodily injury or aggravation of damage resulting from a defective product put into circulation after the expiration of the transposition period of the directive, but before the effective date of the law of 19 May 1998, domestic law must be interpreted in light of the directive so that, regarding the starting point of the limitation period for the liability action, the date of knowledge of the damage must be understood as that of its consolidation.

Cass. 1re civ., 15 June 2016, LawLex201600001109JBJ.

What is the temporal scope of liability for defective products?

The regime established by Articles 1245 et seq. of the Civil Code covers a very broad scope.

The “product,” within the meaning of Article 1245-2 of the Civil Code, is in principle a “movable good, even if it is incorporated into an immovable.” Thus, while under Article 1245-5, immovables by nature are excluded from the scope of liability for defective products, immovables by destination are included.

The products of the soil are also concerned—and as such, water and gas—but also livestock products , hunting and fishing products, as well as electricity .

Health products (medicines, cosmetic products, medical devices, etc.) are also subject to the provisions relating to liability for defective products. Human body elements or products derived from it fall under this category but benefit from a specific regime, as the producer cannot invoke the development risk to exempt themselves from liability.

Farm animals are products that may be defective within the meaning of Article [1245-2, former Article 1386-3] of the Civil Code.

CA Saint-Denis de la Réunion, 11 October 2013, LawLex201600000571JBJ.

Electricity being a product within the meaning of Article [1245-2, former Article 1386-3] of the Civil Code, it is legitimate to rely on a continuous supply of electricity capable of operating the oxygenation system of a fish farm uninterruptedly, so that the company EDF is strictly liable when the malfunction of its network has led to poor electricity supply, causing the death of the fish raised by the complainant.

CA Rennes, 4 June 2010, LawLex201200001829JBJ.

Which products fall under liability for defective products?

Article 1245-3 of the Civil Code defines a “defective product” as one “that does not provide the safety which one is entitled to expect.” According to the courts, a product is defective when it is likely to harm the health, physical or mental integrity of individuals, or cause the destruction or deterioration of property. The defectiveness of the product within the meaning of Article 1245-3 of the Civil Code must be distinguished from the product's dangerousness. The potentially dangerous nature of a product does not establish its defect. A product may also present an intrinsic danger, such as electricity, without being defective under this text. To be deemed defective, the product must present an abnormally serious danger .

The defect of the product refers to the concept of safety, which is assessed in light of all circumstances, including the presentation of the product, its use, and its circulation. According to case law, a product does not offer the safety one can legitimately expect when there is an internal, manufacturing, or design defect , but the defect of a product may also consist of a lack of information or presentation. Indeed, the defectiveness may result from the absence or insufficiency of information, or from the lack of warning against the dangers presented by the product .

The term defect (défaut) is ambiguous as it refers both to the defectiveness of the product implicating the producer's liability (Art. 1245 Civil Code) and to the latent defect for which the seller is responsible, rendering the item unfit for its intended use (Article 1641 of the Civil Code). In reality, a latent defect refers to the defect of the item that makes it unfit for its intended use, while the implementation of the producer's liability assumes a defect inherent in the product's manufacture that compromises the user's safety. When the internal defect of a product causes bodily or material damage, independent of the damage caused to the defective product itself, the victim may cumulatively invoke the manufacturer's liability for the defective product and the warranty against latent defects .

The defect of the product is also not to be confused with the lack of conformity of the product. Indeed, case law does not recognize the victim's right to act cumulatively on the basis of Articles 1245 et seq. of the Civil Code and Article 1603. The lack of conformity only allows the buyer to hold the producer liable on the basis of Articles 1245 et seq. of the Civil Code when the product has harmed the safety of a person or property other than the product itself .

A buoyancy compensator vest is defective if it does not fulfill its normally expected function of ensuring the diver's buoyancy at the surface.

CA Bastia, 9 March 2011, LawLex201900001296JBJ.

The design defect of a refrigerator, presenting a risk of short-circuit likely to release sufficient energy to ignite surrounding combustible materials, constitutes a defect within the meaning of Article [1245-3, former Article 1386-4] of the Civil Code.

CA Pau, 11 October 2011, LawLex201200001565JBJ.

A product is defective when its labeling does not comply with regulations by failing to indicate either the risks associated with its inhalation or the necessity of wearing respiratory protective equipment for certain tasks.

Cass. 1re civ., 21 October 2020, LawLex202000002749JBJ.

The provisions relating to the producer's liability for their defective product do not affect the rights of the victim of damage to invoke contractual or non-contractual liability, including the warranty against hidden defects.

CA Orléans, 23 June 2005, LawLex200600001119JBJ.

Products packaged from a batch of contaminated cumin, which have a pesticide content far exceeding the food compliance limit, do not offer the safety that the consumer can legitimately expect.

CA Nîmes, 26 May 2021, LawLex200300004008JBJ.

What is a defect within the meaning of Article 1245-3 of the Civil Code?

Under Article 1245-8 of the Civil Code, the claimant must prove the defect . The proof of an internal defect in the product causing the damage, which is particularly difficult to provide, especially in the case of a fire, has led to some jurisprudential confusion. Some courts have held that a product that suddenly catches fire under ordinary conditions of use is defective, without the claimant having to demonstrate the exact nature of this defect and its origin . Others have accepted the existence of negative evidence, in the absence of other explanations . Still others, reversing the burden of proof, have considered that a fire that spontaneously ignites within a device characterizes the defectiveness under Article 1245-3 of the Civil Code, unless the manufacturer proves that the fire originated from an external element or that the defect arose after it was put into circulation .

However, the Court of Cassation has called upon the trial courts to adopt a stricter approach, holding, on the basis of Article 1245-8, that a victim’s claim must be dismissed where the expert, while expressing a qualified opinion on the process that led to the fire in the case, identifies the point of origin of the fire but provides no evidence establishing the existence of a specific .

On the other hand, in the medical field, when it comes to demonstrating the defectiveness of vaccines causing the development of certain diseases, the Court of Cassation allows the use of presumptions, which it previously only authorized in the context of establishing the causal link between the defect and the damage. To do this, it referred a preliminary question to the Court of Justice to determine whether Article 4 of Directive No 85-374 does not oppose, in the area of pharmaceutical laboratories' liability for the vaccines they produce, a method of proof whereby the trial court, in exercising its sovereign power of assessment, may consider that the factual elements invoked by the claimant constitute serious, precise, and consistent presumptions, capable of proving the defect of the vaccine and the existence of a causal link between it and the disease, notwithstanding the finding that medical research does not establish a link between the vaccination and the occurrence of the disease. The latter responded affirmatively, provided that national courts ensure that the concrete application they make of such a probative regime neither disregards the burden of proof nor undermines the effectiveness of the liability regime established by this directive .

Some trial courts allow the use of presumptions outside the medical sphere: in the absence of certain proof from scientific data, the claimant may rely on serious, precise, and consistent indications to establish proof of the product's defectiveness and the causal link between this defectiveness and the damage, even if it is not a health product .

Finally, according to the Court of Justice, the finding of a potential defect in medical products that belong to the same group or come from the same production series allows such a product to be classified as defective without the need to find said defect in the product itself. This solution, adopted regarding pacemakers and implantable automatic defibrillators, is justified given the life-threatening risk in the event of a defective device: the patient can legitimately expect a failure rate of the implanted device close to zero. However, its scope seems to be limited, for this same reason, to the medical sector.

Advice: Challenge the of lack of safety claim.  

Not only does the burden of proof regarding the product’s defect rest with the claimant, who must identify the defect precisely, but the claimant must also demonstrate that the safety defect falls short of the level of safety that could reasonably be expected. If this is not demonstrated, the claim will be dismissed.

The victim who does not demonstrate that the deformation of the fork of the disputed Vélib (shared public bicyle - Paris) occurred during the use that can reasonably be expected of this device, nor, consequently, that this Vélib, intact and operational at the start of the rental, did not offer normal safety, must be dismissed from their action for liability due to defective products.

CA Paris, 26 June 2017, LawLex201700001175JBJ.

A vehicle that, under ordinary conditions of use, suddenly catches fire is considered defective, without the claimant having to prove the exact nature of this defect and its origin.

CA Toulouse, 22 May 2007, LawLex201200001857JBJ.

Insofar as no misuse of the soldering pen can be attributed to the victim, the only possible explanation for the accident being necessarily internal to the device, whether it involves a release of the gas contained in the cartridge or a manufacturing defect thereof, the producer's liability is engaged under Articles [1245, former Article 1386-1] et seq. of the Civil Code.

CA Paris, 25 June 2013, LawLex201600000570JBJ.

The fire that spontaneously broke out within a dishwasher, as it originated in the upper panel of the appliance, characterizes the defectiveness within the meaning of the Article of the Civil Code, so that the manufacturer who fails to prove that the fire originated from an external element or that the defect arose after it was put into circulation, is strictly liable for the damages caused by the defectiveness of its product. CA Aix-en-Provence, 17 April 2014, LawLex201600000560JBJ.

A court of appeal cannot hold the producer liable on the grounds that the control and regulation box of the cold rooms is the cause of the fire, even when it is not possible to determine whether the fire is linked to an original defect in the device or to the intervention of the installer.

Cass. 1re civ., 27 June 2018, LawLex201800001000JBJ.

Article 4 of Directive No 85/374 does not preclude a national evidentiary system under which, when a court ruling on the merits of an action involving the  liability of the producer of a vaccine due to an alleged defect in that  vaccine, in the exercise of its exclusive jurisdiction to appraise the  facts, may consider that, notwithstanding the finding that medical  research neither establishes nor rules out the existence of a link  between the administering of the vaccine and the occurrence of the  victim's disease, certain factual evidence relied on by the applicant  constitutes serious, specific and consistent evidence enabling it to  conclude that there is a defect in the vaccine and that there is a  causal link between that defect and that disease.

CJEU, Case C-621/15 N.W, L.W and C.W, Judgment  of  21 June 2017, LawLex201700001080JBJ.

There are serious, precise, and consistent presumptions of the defective nature of the tempered glass composing a desk, and therefore of said desk, when the tempered glass panel on top of it, regardless of the scientific cause, did not simply crack but spontaneously exploded, a phenomenon that is inherently dangerous and likely to compromise the physical safety of individuals.

CA Douai, 5 September 2019, LawLex201900001063JBJ.

How is the defect proven?

While Article 9 of the Directive provides for the compensation of damage caused to something other than the defective product itself, subject to a deductible of 500 euros, the transposition law of 19 May 1998 did not impose any limitation on the compensation for bodily injury. Declared non-compliant with the directive by the Court of Justice in a judgment of 25 April 2002, the former Article 1386-2 of the Civil Code, now Article 1245-1, which did not include the 500-euro deductible referred to in Article 9 of Directive No 85/374, was therefore amended. Now, in accordance with Article 9 of the directive, Article 1245-1 provides that liability for defective products applies to the compensation for damage resulting from personal injury, as well as “to the compensation for damage exceeding an amount determined by decree, resulting from damage to property other than the defective product itself.” However, the threshold of 500 euros, set by Decree No 2005-113 of 11 February 2005, applies only to damage caused to property, and not to bodily injury for which the principle of full compensation prevails .

In accordance with Article 9 of the Directive, Article 1245-1, para. 2, expressly excludes damage resulting from harm to the defective product itself, and the losses arising from this harm .

In contrast, contrary to the directive which, in its Article 9, only targets damage to goods that are of a type normally intended for private use or consumption and have been used by the victim primarily for their private use or consumption, and which provides, in its Article 7, that the producer is not liable if they prove that “the product was neither manufactured nor distributed in the course of their professional activity,” French law does not distinguish whether the victim has the status of a professional. Furthermore, Article 1245-14, in fine, recognizes the validity of contractual stipulations that limit the compensation for damage caused to goods not used by the victim primarily for their private use or consumption. When questioned for a preliminary ruling by the Court of Cassation on the compatibility of these provisions with Union law, the Court of Justice held that the directive does not preclude a Member State from adopting or maintaining a liability regime for defective products that allows for the compensation for damage caused to goods intended for professional use, as long as such damage does not fall within its scope .

Article 1245-14, para. 1, prohibits in principle clauses that exclude or limit the producer's liability for their defective product while recognizing the validity of clauses stipulated between businesses for damage caused to goods that are not used by the victim primarily for their private use or consumption.

Finally, even though Article 9 of the Directive does not prejudice national provisions relating to non-material damage, Article 1245-1 does not mention compensation for this type of damage. Since there is no need to distinguish where the law does not, the French courts accept compensation for non-material damage based on Articles 1245 et seq. of the Civil Code, in the presence of material or bodily damage caused by a safety defect .

Advice: Argue that there is no damage under Article 1245-1 of the Civil Code.

Very often, claimants allege damage related to the product itself. However, according to Article 1245-1 of the Civil Code, the provisions of Articles 1245 et seq. of the Civil Code apply to the compensation for damage resulting from harm to a person or to property other than the defective product itself. Consequently, liability for defective products does not apply to the compensation for damage resulting from harm to the defective product itself.

A Member State cannot restrict the  damage resulting from death or personal injury, or the damage caused to an item or consisting in the destruction of an item when the latter exceeds EUR 500 , without undermining the effectiveness of Directive No 85/374.

ECJ, Case C-203/99 Henning Veedfald, Judgment of 10 May 2001, LawLex200900001108JBJ.

The loss of business and the absence of provision of a replacement machine resulting from the damage to the disputed agricultural machine are not compensable on the basis of liability for defective products.

Cass. 1re civ., 9 December 2020, LawLex202000003675JBJ.

The producer may be required to compensate for non-material damage that may be caused by damage to property, as long as, excluding the damage suffered by the defective product itself, Article 1245-1 of the Civil Code makes no distinction between reparable property damages.

CA Chambéry, 7 March 2017, LawLex201700000600JBJ.

What damage is compensable?

Article 1245-8 of the Civil Code requires the claimant to prove the existence of a causal link between the damage and the defect of the product. The proof can be provided by any means, through expert reports or the system of presumptions. The trial court has full discretion to assess the causal relationship between the defect and the damage based on the evidence submitted to them, provided that they do not rely on hypothetical grounds .

The mere involvement of the product in causing the damage is insufficient to establish the causal link. The courts generally require a direct and certain link .

In the medical field, particularly in the case of vaccine injections, proving a direct and certain causality between the product defect and the damage is not always easy to establish. When a link between the drug intake and the onset of the disease is scientifically recognized, the courts may, according to the Court of Cassation, rely on a body of evidence to establish the causal link .

On the other hand, scientific uncertainty has raised doubts among the judges. Some courts have concluded an impossibility to establish the causal link while others have adopted a more flexible approach, presuming its existence from circumstances such as the victim's family history or the concurrence between vaccination and the onset of the disease .

The Court of Cassation therefore referred a preliminary question to the Court of Justice regarding the possible methods of administering proof of the causal link in the context of the liability of pharmaceutical laboratories. According to the Court of Justice, when medical research neither establishes nor refutes the existence of a causal link between the administration of a vaccine and the occurrence of a disease, Union law does not oppose an evidentiary system that does not require the victim to produce certain and irrefutable evidence of the existence of the defect and the causal link between it and the damage incurred, but which allows the court, if necessary, to conclude that such existence is proven based on a body of serious, precise, and consistent indicia presented by the claimant, such as the proximity between the time of administration of a vaccine and the occurrence of a disease, the absence of personal and family medical history related to this disease, or the existence of a significant number of recorded cases of the occurrence of this disease following such administrations. Conversely, a probative regime based on presumptions cannot be admitted, whereby, when medical research neither establishes nor refutes the existence of a link between the administration of the vaccine and the occurrence of the disease affecting the victim, the existence of a causal link between the defect attributed to a vaccine and the damage suffered by the victim is always considered established when certain predetermined factual indicators of causality are met .

The Court of Cassation has since aligned itself with the position of the Court of Justice .

Advice: Argue absence of a causal link or the existence of an exonerating fact.

These defenses are more limited and more complex to implement but can apply in certain cases (absence of causal link, absence of release or defect at the time of release, fault of the victim; under certain conditions, defect related to mandatory standards or development risk).

The court cannot hold the producer liable based on hypothetical reasons that are inadequate to establish the existence of a causal link between the product defect and the damage.

Cass. civ. 2e, 9 July 2009, LawLex201200001776JBJ.

A product whose presentation allowed its users to expect an aesthetic improvement effect without real risks of serious side effects, as they were indicated as theoretical, whereas it emerges from the medical expert's report that its injection is the direct and certain cause of the granulomas that appeared on the victim's face, engages the manufacturer's liability.

CA Paris, 27 February 2015, LawLex201600000624JBJ.

It should be considered that the causal link between the defect of the medication and the damage suffered is sufficiently established, as a link between its ingestion and the onset of Lyell's syndrome is scientifically recognized, the victim developed this toxic effect within the usual timeframe observed between the administration of the product and the occurrence of the disorder, and its cessation coincided with the discontinuation of the medication, and it is not established that there was any prescription error, predisposition of the patient to this syndrome, or association with other medications.

Cass. 1re civ., 5 April 2005, LawLex200500006006JBJ.

Due to the absence of scientific consensus recognizing a certain causal link between the hepatitis B vaccine and multiple sclerosis, or a statistically significant association likely to attribute this pathology to the vaccine in a highly probable or even plausible manner, the sole data from the victim's personal history (temporal concordance between the onset of disease symptoms and vaccination, absence of risk factors, absence of other explanations for the disease) cannot be considered as serious, precise, and consistent presumptions in favor of attributing the pathology that appeared to the administered vaccine.

CA Paris, 2 June 2006, LawLex200600002451JBJ.

In the absence of certain scientific proof of a relationship between vaccination and the onset of multiple sclerosis, a possible causal link, in view of the reported cases, the victim's family history, and the concomitance between the vaccination and the onset of the disease, may suffice to conclude that the disputed vaccine played a precipitating or triggering role in the disease.

CA Versailles, 2 May 2001, LawLex200300004419JBJ.

In the absence of scientific consensus on the etiology of multiple sclerosis and in favor of the existence of a causal link between this disease and hepatitis B vaccination, it should be considered that the absence of personal and family risk factors and possible other causes of the disease in the victim, the rarity of the occurrence of multiple sclerosis in children, and the criterion of temporal proximity between the onset of the first symptoms and the vaccination of the person concerned, as sovereignly assessed by the trial courts, do not constitute serious, precise, and consistent presumptions capable of attributing the occurrence of the disease to the vaccination.

Cass. 1re civ., 20 December 2017, LawLex201800000005JBJ.

Union law does not preclude an evidentiary system which, where medical  research neither establishes nor rules out the existence of a causal  link between the administering of a vaccine and the occurrence of a  disease, does not require the victim to produce certain and irrefutable  proof of the existence of the defect and of the causal link between the  latter and the damage incurred, but which authorizes the court, where  appropriate to conclude that such existence is proven on the basis of a  body of serious, precise and concordant evidence invoked by the  plaintiff, such as the proximity in time between the administration of a  vaccine and the occurrence of a disease, the lack of any personal or  family medical history in relation to this disease, or the existence of a  significant number of recorded cases of the occurrence of this disease  following such administrations.

CJEU, Case C-621/15 N.W, L.W and C.W v Sanofi, Judgment of 21 June 2017, LawLex201700001080JBJ.

How is the causal link between the damage and the defect proved?

The producer is any person who “acting in professional capacity, the manufacturer of a finished product, the producer of a raw material, the manufacturer of a component part” (Article 1245-5, para. 1, of the Civil Code).

It is also “any person acting in a professional capacity who presents themselves as a producer by affixing their name, brand, or another distinctive sign to the product” . The Court of Cassation considers that it is not necessary to distinguish whether this labeling is voluntary or imposed by the legislation of the Member State in which the product is marketed. According to the Court of Justice, the concept of producer referred to in Article 3(1) of Directive No 85/374 does not require that the person who affixed their distinctive sign, whoever they may be, or who authorized this affixing, also presents themselves as the producer of the product in any other way. Furthermore, when one of the links in the distribution chain is closely related to the producer, constituting a subsidiary, it is necessary to determine whether the links between the producer and the other entity are so close that the concept of producer also includes the latter, regardless of the legal form of the companies involved .

The importer is also considered a producer. An importer, within the meaning of Article 1245-5, 2 of the Civil Code, is the person who imports a product into the European Union for the purpose of sale, lease, with or without a promise of sale, or any other form of distribution. The importation of products outside the Union does not constitute a production activity within the meaning of this text .

The company that affixed its trademark on the blowtorch that caused the damage must thus be regarded as a “producer” within the meaning of Article 1245-5 of the Civil Code, even if it is not responsible for the product's entry into Europe or if it is not the manufacturer.

CA Paris, 21 June 2011, LawLex201200001926JBJ.

When an action is brought based on Directive No 85-374 against a company mistakenly considered to be the producer of a product, while in reality, it was manufactured by another company, it is up to national law to set the conditions under which the substitution of one party for another may occur in the context of such an action, respecting the ratione personae scope of the directive.

ECJ, Case C-127/04 O'Byrne, Judgment of 9 February 2006, LawLex200900000473JBJ.

The company that imported a piece of furniture into New Caledonia cannot therefore be equated with a producer within the meaning of Article 1245-5, 2° of the Civil Code.

CA Nouméa, 7 June 2012, LawLex201500001719JBJ.

Who is a producer or equivalent?

Pursuant to Article 1245-7 of the Civil Code, which incorporates Article 5 of Directive No 85/374, the producer of the component part and the one who carried out its incorporation are jointly and severally liable in the event of damage caused by the defect of a product incorporated into another .

These provisions do not limit the rights of the victim, as the latter may direct their action against either of the producers concerned, with the one declared responsible having the right to seek recourse against the other.

The trial court interprets the concept of incorporation strictly since the joint and several liability of the producers can only be pronounced in that specific case.

However, a producer cannot escape liability by invoking Article 1245-7 of the Civil Code applicable in the event of damage caused by a defect in a product incorporated into another, as the joint liability of the producer of the component part and the one who carried out the incorporation can only be understood in relation to third parties. According to the Court of Cassation, the determination of their respective contribution to the debt does not fall within the scope of the directive, nor Article 1245-10 of the Civil Code, but rather ordinary law, which provides that the contribution to the debt, in the absence of fault, is divided equally among the co-debtors. Furthermore, the manufacturer who carried out the incorporation is not entitled to exercise against the manufacturer of a component part the recourse provided for in Article 1245-6 of the Civil Code, reserved for the supplier whose subsidiary liability is engaged in the absence of identification of the producer .

The company having manufactured the buoyancy compensator vest, which is characterized as the producer of the finished product, and the subcontractor manufacturer of the hose, which is the producer of the incorporated product, must be declared jointly liable on the basis of Article 1386-8 (now Article 1245-7) of the Civil Code, since the entire diving equipment (buoyancy compensator, inflator, and hose) must be considered as having been defective.

CA Bastia, 9 March 2011, LawLex201200001565JBJ.

The application of Article [1245-7, former Article 1386-8] of the Civil Code should be set aside in the case of damage caused to Reblochons by milk contaminated with bacteria, as cheese is obtained by processing milk and not by incorporating milk into another product.

CA Chambéry, 27 October 2009, LawLex201200001849JBJ.

The recourse action of the manufacturer of a product subject to incorporation against the third-party undertaking that manufactures certain components cannot therefore be based on Article 1245-6 of the Civil Code, reserved for the supplier whose strict liability has been engaged due to the failure to identify the producer.

CA Toulouse, 9 December 2019, LawLex201900001572JBJ.

Who is liable in the case of products subject to incorporation?

Article 1245-6 of the Civil Code states that if the producer cannot be identified, the supplier is liable for the product's lack of safety, unless they designate their own supplier or the producer within three months from the date the victim's claim was notified to them. The intermediary supplier of a product cannot therefore be directly liable for its defects towards the victim and downstream suppliers in the distribution chain .

Article 1245-6 specifies that the supplier may be, in particular, the seller or the lessor of the product. However, the lessor under a finance lease is not considered a supplier.

The courts strictly interpret the current Article 1245-6 and regularly emphasize the subsidiary nature of the supplier's liability: the claimant is only admissible to pursue the supplier when the producer cannot be identified, particularly when the absence of marking does not allow the manufacturer to be traced and the chain of manufacturers, distributors, and contractors does not ensure traceability. It also follows from this subsidiarity that the victim who chooses to sue the seller of the incriminated product must be dismissed, and conversely, the supplier can be exonerated, as long as the producer of the defective product is known .

Being vested with the victim’s rights, it also has, where it has been held liable, a right of recourse under warranty against the producer. Article 1245-6, para. 2, subjects its action to the same regime as that of the direct victim of the defect, except that the supplier must act within one year from the date of service of the writ of summons, as opposed to three years for the victim, running from the date on which the latter knew or ought to have known of the damage, the defect, and the identity of the produce .

Advice: Argue the inadmissibility of the claim against the non-producing supplier.

Under Article 1245-6 of the Civil Code, if the producer cannot be identified, the seller is responsible for the product's lack of safety, unless they designate their own supplier or the producer within three months from the notification of the victim's claim. The supplier's liability is only provided for when the producer cannot be identified. If the producer's identity is known, claims made against mere resellers are inadmissible, without the reseller having to substitute for the identified or defaulting producer. The reseller will designate their supplier and the manufacturer as soon as possible.

The intermediary supplier of a product cannot be equated with the producer, within the meaning of Directive No 85-374 on liability for defective products, and thus cannot be held directly liable for its defects towards the victim and downstream suppliers in the distribution chain.

ECJ, Case C-327/05, Ministero dello Sviluppo economico et Autorità per la vigilanza sui contratti pubblici di lavori, servizi e forniture, Judgment of 5 July 2007, LawLex201300001798JBJ.

The supplier is not required to substitute for the identified but defaulting producer, as its liability is only secondary.

CA Metz, 23 June 2015, LawLex201600000555JBJ.

The recourse of intermediaries situated between the manufacturer of the defective product and the consumer, whose liability is engaged on the basis of Articles and following of the Civil Code, must be exercised within one year from the summons.

CA Limoges, 25 February 2010, LawLex201200001689JBJ.

Under what circumstances can a supplier be held liable?

The state of scientific and technical knowledge at the time the product was put into circulation, which would not have allowed the detection of the defect or “development risk,” constitutes one of the grounds for exemption that the producer can invoke to be relieved of liability under Article 1245-10 of the Civil Code. However, Article 1245-11 of the Civil Code excludes the possibility for the producer to invoke the development risk to be relieved of liability when the damage was caused by a component of the human body or by products derived from it.

According to the Court of Justice, the state of scientific and technical knowledge prevailing at the date the product referred to in Article 7(e) of the Directive is put into circulation must be understood as the most advanced state of science and not merely the practice or safety standards in use in the industrial sector in which the producer operates.

This knowledge is not limited to what the producer concerned was or could have been concretely or subjectively informed about, but includes the objective state of scientific and technical knowledge that the producer is presumed to be informed of, provided it was accessible at the time the product was put into circulation .

500 Questions - Business Law

241. What will Directive No 2024/2853 of 23 October 2024 change in Directive No 85/374 of 25 July 1985?

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241. What will Directive No 2024/2853 of 23 October 2024 change in Directive No 85/374 of 25 July 1985?

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