Product Liability Directive (Directive 85/374/EEC)
- INTRODUCTION
STRICT LIABILITY: Directive 85/374/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, as amended by Directive 1999/34/EC (“the Directive”) creates a strict liability regime for the benefit of the person injured by a defective product. Under this Directive, it makes absolutely no difference whether the person legally responsible is at fault for the defective product. In other words, the injured party is relieved of the obligation to prove negligence. All he has to prove is the existence of a defect in the product, the damage caused to it, and the causal link between the two. Of course, in accordance with Article 13 of the Directive, any rights of the injured party arising from any contractual term or other rule of law are not affected by the existence of a right to compensation granted to him by the Directive. The Directive establishes a liability regime only for the issues it regulates.
SCOPE: Most European Directives aimed at protecting consumers apply where the purchaser of the goods is a consumer. The Directive, however, differs in this respect. The main differences with the Directives aimed at protecting consumers are that: First, for a person to have an enforceable right under the Directive, it is not necessary for him or her to be the purchaser of the defective product. Second, it is not required that either he or the purchaser acts as a consumer. Anyone who suffers damage from the defective product (both the purchaser and third parties) has a right to compensation. Hence the Directive refers to “injured party” and not to “buyer” or “consumer”. Thirdly, for the application of the Directive it does not matter whether the defective product itself is a consumer good since the damage it causes is damage to property of the injured party which is normally intended and used for private or consumer use. Damage to the defective product itself is excluded.
Precisely because damage caused by a defective product will usually be damage to consumer goods, in practice the Directive applies mainly where the injured party was acting as a consumer when purchasing the damaged goods. As mentioned above, the main exceptions are cases where the damage caused by the defective product is death or injury or damage to immovable property normally intended and used primarily for private use.
- DEFINITION OF DEFECTIVE PRODUCT
Article 6(1) of Directive 85/373/EEC defines a defective product as follows:
«a product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including a) the presentation of the product· b) the use to which it could reasonably be expected that the product would be put· c) the time when the product was put into circulation. »
SAFETY LEVEL EXPECTED: The sixth recital of the Directive states that the level of safety must be what the public at large has a right to expect. Where, for example, the product is hot coffee, the public at large expects that if it is spilled on someone, it will cause minor burns and not third-degree burns. This level may differ from the level of security that the claimant himself actually expects. In Richardson v LRC Products Ltd a woman used a condom but during intercourse it broke resulting in her becoming pregnant. Although the Court accepted her testimony that she expected that the condom would not break, it dismissed her claim, stating that the level of safety that the public at large was entitled to expect from the condom was lower than what she expected. The decision maker of the level of safety the public at large is entitled to expect is the Court.
ACCEPTANCE OF DEFECT: Where the defect or the possibility of the existence of the defect is not known to the public at large, it is obviously not accepted by them. On the contrary, if it is known to the public at large, then the use of the product in itself implies acceptance of the defect or the possibility of its existence, as the case may be. Thus, in the Richardson case (above) it was decided that the public at large accepted the likelihood of a condom breaking during intercourse. Similarly, it is accepted by the public at large that a contraceptive pill is likely to cause cardiovascular disease if this is a known side effect or that the possibility of toxic shock syndrome is an accepted risk among women who use tampons.
According to the definitions in Directive 85/373/EEC, a product «means all movables, with the exception of primary agricultural products and game, even though incorporated into another movable or into an immovable.» It is also very important that electricity is also considered as a product, but services are not included, such as for example incorrect information contained in newspapers – even if the newspaper itself is a product. Also, as mentioned above, it is important that the definition of goods also includes goods that are incorporated into immovable property – contrary to the general principle of the law of sale of goods that such goods are considered to be appurtenances to land.
Under the Directive, a product is considered safe when it does not cause damage.
BURDEN OF PROOF: It is important to stress that the burden of proving that a product does not provide safety rests with the claimant. This is not always easy since often the nature of the product is so complex that the lack of safety can only be proven by expert testimony. It should be noted that, although the consumer must prove that there is a defect in the product, he is not required to specify what that defect is. Thus, if he simply proves that there is a defect in the electronics of his car without specifying it, he will succeed.
- CIRCUMSTANCES TAKEN INTO ACCOUNT
Whether a product is considered defective is always judged in relation to the level of safety that the public at large is entitled to expect. According to the Article 6(1) a product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including:
«a) the presentation of the product·
b) the use to which it could reasonably be expected that the product would be put · and
c) the time when the product was put into circulation. »
ALL INCIDENTS: The phrase «taking all circumstances into account » in Article 6(1) of the Directive means that the above circumstances are the most important, but not the only ones. The phrase «all the circumstances» means all the relevant circumstances. However, the Defendant cannot claim as a relevant circumstance the difficulty of avoiding the defect in the product at issue, as this would be contrary to the strict liability regime created by the Directive.
AVAILABILITY OF SAFER PRODUCTS: The existence of other similar products at the time the contested product is put into circulation which are safer than the contested product may be taken into account in deciding whether the contested product is defective. However, where such safer products are put on the market after the contested product, this does not in itself render the contested product defective.
EXISTENCE OF STANDARDS: Where there are formal quality standards, e.g. ISO standards, this is taken into account when considering whether a product is considered to provide safety. However, it should be noted that non-compliance with these does not always result in a product being considered as not providing safety – particularly where quality standards are not legally binding. In Tesco Stores v Connor Frederick Pollock a thirteen-month-old infant opened a bottle of dishwasher powder which he swallowed, resulting in him being poisoned. The action was brought against the manufacturer of the bottle on the basis that whilst the bottle was supposed to have a child-resistant lid, it was nevertheless easily opened. The testimony showed that the cap was the kind that had to be pushed and then turned to open, but it required significantly less force than similar caps that met the British Standard (“British Standard”) of caps. However, although less force was required than for similar lids meeting the British Standard lid, because this particular lid required more force than an ordinary lid, and more force than could be expected to be exerted by a thirteen month old infant, the English Court of Appeal dismissed the plaintiff’s appeal. The Court of Appeal stated that the public at large was entitled to expect that the lid would be more difficult to open than an ordinary lid and nothing more.
It is submitted that where official standards are binding on the producer, then non-compliance with them is in itself sufficient for the product to be considered as not providing safety.
Α. MANNER IN WHICH AND PURPOSES FOR WHICH IT WAS PUT INTO CIRCULATION
METHOD: The way a product is put on the market affects the level of safety it provides. For example, when a particular product is placed on the market with other products it may be safe, whereas if it is placed on the market alone it may not provide the same high level of safety.
PURPOSE: The purpose for which a product is placed on the market has a very strong influence on the level of safety expected from it. If, for example, the purpose is to keep a patient alive, the level of safety expected is so enhanced that the concept of defectiveness includes the possibility of a defect occurring in the future. In the Boston Scientific Medizintechnik. case involving medical devices, namely cardiac pacemakers and implantable automatic defibrillators, it was established by the manufacturer that some products of the same group or production series as those implanted in the plaintiffs’ bodies could potentially malfunction in the future. However, the products themselves implanted in the plaintiffs’ bodies (‘the products at issue’) were not found to be so.
The fact that only some products from the same group or range of products as the contested products might have been defective in the future did not prevent it from being decided that all products of that group or range, including the contested products, were defective. The Court emphasised that, taking into account the purpose of these products and the vulnerable situation of the patients using them, their users are entitled to have particularly high safety requirements. It also stressed that any defect in these products would have an unusually high likelihood of harm to users. In these circumstances, it decided that even without proof of a defect in the products at issue, it could automatically be concluded that all products in the group or range of products were defective. Although this decision may at first sight appear to be strict, it should nevertheless not be surprising as it is essentially limited to its facts, since it concerned products which present a particularity with regard to the damage they would cause to their users if the defect were to manifest itself.
PURPOSE TO USE FUNCTION: It should be noted that the safety of a product is not judged in abstracto. It is the use made of the product in relation to the purpose for which it was placed on the market that is taken into account.
EXAMPLE: A, a teenager, bought toothpaste from P. The next day at school A hears that any toothpaste can be used to treat acne. So when he gets home, he smears the toothpaste on parts of his face where he had acne. The next day, he wakes up with severe dermatitis resulting in the need for expensive dermatological treatment. Since the purpose for which the toothpaste was marketed is not to treat acne, the toothpaste is not considered defective.
Β. PROVISION OF INSTRUCTIONS, WARNINGS OR STATEMENTS RELATING TO POSSESION, USE OR CONSUMPTION
In Iman Abouzaid v Mothercare (UK) Ltd the claimant was helping his mother fit a cover to his little brother’s pram when an elastic strap was thrown off and a metal buckle at one end of the strap hit him in the eye injuring him. The English Court of Appeal ruled that the product was defective as its design allowed the risk to be created which actually materialized. The Court emphasized that the product was sold with a design that allowed the creation of a risk without instructing the user of the product not to stand in such a position so that the chances of the risk materializing were reduced. Thus, the public at large was entitled to expect a high level of safety, especially in view of the serious consequences of an eye injury.
LOSS OF INSTRUCTIONS OR WARNINGS: In Worsley v Tambrands Limited the Claimant bought a tampon whose packaging stated that the tampon was associated with a particular condition and so users had to carefully read the leaflet inside the packaging. The Claimant lost the amulet. When she contracted the condition, she argued to the Court that the warnings about the use of the product were incomplete and therefore the product was defective. Her claim was rejected as the product was accompanied by adequate warnings for its use and the fact that she lost them could not be a basis for the producer’s liability.
C. PERIOD OF RELEASE FOR CONSUMPTION
A product is considered to be put into circulation when its producer, in the course of his business, makes it available for supply to others.
(i) PRODUCER
For the concept of “producer” see Section 3.1 below.
(ii) WHEN IT ENTERS INTO CIRCULATION
In the O’Byrne it was said that:
«…a product must be considered to have been put into circulation … when it has left the production process carried out by the producer and has entered a process of commercial circulation in the course of which it is offered, as such, to the public».
DIRECT SALE: On the basis of the above assumption, a product is therefore considered to be put into circulation when it leaves the production phase and enters “commercial circulation”. When the product is sold directly by the producer, it is considered to enter into commercial circulation when it becomes available to the buyer. This applies irrespective of whether the product has left the producer’s sphere of control. Thus, where a product can only be used within the producer’s premises, it is considered to have entered into circulation when it is used by the purchaser on those premises.
CHAIN OF DISTRIBUTION: As far as distribution chain cases are concerned, if a part of the distribution chain is closely linked to the producer, e.g. a subsidiary of the producer, then, in order to establish whether the product has passed from production to distribution, it is necessary to examine whether this part is also involved in the production process. In considering this issue, it is irrelevant whether it is a separate legal entity from the producer. What matters is whether the two entities are engaged in different production activities or whether one acts as a distributor for the other. In the first case, both entities are considered to be jointly the ‘producer‘ and therefore the delivery of the product from one entity to the other does not result in the product being considered to have been put into circulation. On the contrary, in the second case, once the product is given by the producing entity to the distributing entity, the product is considered to be put into circulation.
- SAFETY OF NON-STANDART PRODUCTS
Where a product is produced as part of a product range or produced in a production line of products which are standardised, there is a possibility that due to a manufacturing error it may differ from the rest of the products in the range or production line. In this case, this product is considered to be non-standard. In the English authority A v National Blood Authority Judge Burton held that in order to determine whether the product in question is standardised it must be considered firstly whether the product differs from other products on the production line and secondly (assuming that it does differ) whether the difference is due to a manufacturing error. In the latter case, the product is considered to be non-standard. In all other cases, it is considered to be standardised (including, obviously, the case where the product does not differ from the others).
The fact that a product is non-standard does not automatically mean that it is considered defective. Based on the above decision, by far the most important factor to be taken into account for the purposes of the Directive to be considered defective is the acceptance of the manufacturing defect by the public at large compared to other similar products on the market. In other words, whether the public at large accepts the manufacturing defect and, despite its existence, is willing to use the (non-standard) product. In contrast to standardised products where knowledge of the possibility of a defect by the public at large always implies social acceptance, he same is not true for non-standardised products. In the case of non-standard products, the manufacturing defect may be known but not socially acceptable (e.g. because it significantly reduces the safety of the product). Obviously, however, if the possibility of a defect is not known to the public at large, it is impossible for it to be socially acceptable.
EXAMPLE: A, who is allergic to nuts, buys a sweet from P. The packaging of the sweet states in bold letters that the sweet may contain traces of nuts. After consuming the sweets, A develops allergies and needs treatment. This sweet is a non-standard product precisely because it contains traces of nuts (unlike the vast majority of P’s sweets). Since the public at large is aware of the risk of the sweet being defective, the question is whether they accept it. It is argued that in this case the manufacturing error is acceptable and thus the product is not considered defective.
- PERSONS RESPONSIBLE
GENERAL: The person liable under the Directive is regulated by Articles 3(1), 3(2) and Recital 2 of the Directive which, in addition to the liability of the producer, also regulate which of the professionals involved in the processes of manufacture and marketing of the product is liable. These are the importer and any supplier of the product involved at any stage in the distribution chain. The above-mentioned persons are mentioned in the legislation in a restrictive way and are liable as if they were the producer.
SERVICE PROVIDER: It should be noted that a service provider who uses a defective product supplied by another person as part of the services provided cannot be considered either a producer or a supplier of the product. The logic is that the Directive does not regulate the liability of such persons and the service provider is not part of the chain of manufacture and placing on the market of the product in question, as long as he does not buy it for resale. As a result, if a person is damaged by a product which was used in the context of services provided to him, he does not enjoy the protection of the Directive and thus, in addition to being unable to establish strict liability against his contractor, he cannot even compel him to disclose the identity of his producer or supplier.
THE PRODUCER IS PRIMARILY RESPONSIBLE: Based on Article 1 of the Directive:
“The producer shall be liable for damage caused by a defect in his product”
Therefore, where the injured party proves that he has suffered damage caused by a defective product, the producer of the product is the primarily responsible for the defect.
CONCEPT OF PRODUCER: Under the Directive, the producer of the product is considered to be:
“…the manufacturer of a finished product, the producer of any raw material or the manufacturer of a component and any person who, by putting his name, trademark or other distinguishing feature on the product presents himself as its producer.·”
INVOLVEMENT OF VARIOUS PERSONS: It is not always clear who the producer is. This is particularly the case where various legal or natural persons are involved in the production and/or distribution of the product. In such a case, only those persons involved up to the moment the product is considered to have been put into circulation are considered to be producers. As described above, a product is considered to be put into circulation when it leaves production and enters into commercial circulation.
Where the Claimant is aware of the existence of a parent company and a subsidiary and cannot know which of the two companies took the decision to put the product into circulation, it is advisable to bring an action against both to avoid the issue of limitation, on the one hand, and to force the Defendant companies to disclose which of the two took the decision, on the other hand.
ELECTRICITY: According to Decision C 691/21, an electricity distribution system operator is considered to be a “producer” since it transforms the voltage level of electricity for the purpose of distributing it to the final customer.
AFFIXATION OF A TRADEMARK AND OTHER DISTINCTIVE SIGN: It should be noted that in relation to the requirement in the Directive that a person who has affixed his name, trademark or any other distinctive sign to the product be regarded as the producer, this is self-explanatory and, in accordance with judgment C-264/21:
“…there is no requirement that the person who has affixed or allowed his name, trademark or other distinctive sign to the product must also appear in some other way as the producer of the product in order to be considered a ‘producer’.”
IMPORTER: Under Article 3(2) of the Directive «any person who imports into the Community a product for sale, hire, leasing or any form of distribution in the course of his business is liable as if he were the producer of the product. It is noted that the importation of products is not limited to products imported from other Member States (“MS”) of the European Union, but also extends to products imported from third countries.
SUPPLIER: Similarly, Article 3(3) imposes liability on any person who has supplied a product to another person where it is impossible to determine the identity of the producer and the supplier has failed to inform the injured party within a reasonable time of the identity of the producer or the person who supplied the product.
It is clear that the above article covers cases where the injured party is unable to verify the identity of the producer. In such a case the injured party should within a reasonable time after the damage has been caused ask the supplier to disclose the identity of the producer. If the injured party fails to request such disclosure in accordance with the requirements of this Article, the injured party shall be precluded from taking action against the supplier. However, the injured party’s right to take action against the producer and/or importer shall remain intact.
The Directive gives the right to know the identity of the previous supplier or producer, not only to the injured party but also to any supplier of the product. In any event, where that right is exercised, the mere denial by the recipient of the request that he is not the producer does not constitute sufficient fulfilment of his obligation to disclose the identity of the producer or his own supplier. Indeed, the protection of the injured party has been extended by the European Court of Justice to impose a positive obligation on a supplier sued to disclose to the claimant, on his own initiative and with diligence, the identity of his supplier or producer.
- JOINT AND SEVERAL LIABILITY
There are cases where more than one person may be liable under the Directive. Therefore, where two or more persons are liable, Article 5 of the Directive states that their liability is always joint and several. This Article will be particularly useful to importers who cannot avoid liability to the injured party in any way.
- DAMAGE
According to Article 9 of the Directive, damage means:
“a) damage caused by death or personal injury·
- b) damage to, or destruction of, any item of property other than the defective product itself, with a lower threshold of 500 EUR, provided that the item of property:
- i) is of a type ordinarily intended for private use or consumption, and
- ii) was used by the injured person mainly for his own private use or consumption.”
SPECIFIC DAMAGES: In the Boston Scientific Medizintechnik case it was said that recoverable damages include all costs necessary to eliminate the harmful effects of the defect. In the two cases at issue, the company that manufactured cardiac pacemakers and implantable automatic defibrillators found defects in these products. In relation to the pacemakers, it recommended that doctors should consider changing them, which would involve surgery. In relation to defibrillators, he recommended that doctors simply turn off their magnetic switch. The Court of Justice of the European Communities ruled that the injured parties were entitled to all the relevant costs necessary to remedy in each case the defect and its harmful consequences. That is, if the surgical removal of the defibrillators and replacement with new ones was unnecessary because simply turning off the switch would have been sufficient to eliminate all the harmful effects of the defect, then the costs of future surgery would not be recoverable.
GENERAL DAMAGES: As regards non-material damage, the 9th recital of the Directive refers to it as “pretium doloris [pain and suffering] or other non-material damage“. The compensation of such damages is left entirely to the MS and is thus governed exclusively by the general principles of MS law.
Damage to property intended for professional use is not covered by the Directive. The same applies to any damage caused by a nuclear accident, which is covered by international conventions ratified by the Member States and to products put into circulation before 30/07/1985. Furthermore, under Article 9(b) of the Directive, no compensation is awarded for damage to the defective product itself.
Based on the above article, it is clear that under the Directive, the following two losses are not recoverable. Firstly, damage to the defective product itself and secondly, damage caused to a product by a defective product which was part of it at the time it was supplied to the Claimant.
EXAMPLE: A buys from P an expensive mobile phone which is sold with a removable battery. Due to a defect in the battery, the mobile phone is destroyed. The damage to the phone is not recoverable since under section 9(b) the battery (defective product) was part of the phone (product) at the time the claimant acquired it.
Finally, under Article 9(b), no damages are awarded for damage to property where the amount of damages would not exceed €500. For the purposes of calculating this amount, interest shall not be taken into account. This limitation, however, does not deprive the injured party of the right to take legal action on the basis of general principles of law for breach of contract or negligence.
It is important to note that the minimum damage of €500 is a requirement only in respect of property damage. Conversely, there is no such limitation for loss due to death or personal injury. Thus, if the injured party due to an injury claims compensation for medical expenses below €500, he or she is entitled to compensation.
- LIMITATION OF LIABILITY
- LIMITATION OF LIABILITY EXCLUDED
ACT OR OMISSION OF A THIRD PARTY: Based on Article 8(1) of the Directive, “the liability of the producer shall not be reduced when the damage is caused both by a defect in product and by the act or omission of a third party.” This means that, where there is concurrent liability between a third party and a person liable under the Directive, the latter person will be liable in full, i.e. for all the damage suffered by the injured party. The liability of the third party, on the other hand, is not determined on the basis of the Directive but on the basis of the general principles of civil law and the principles of contributory negligence. It should be noted that the person liable under the Directive retains any rights against the third party (e.g. for contribution).
CONTRACTUAL CLAUSES: Furthermore, under Article 12 of the Directive, liability imposed under the Directive may not be limited or excluded against the injured party by a limitation or exclusion clause.
- POSSIBILITY OF LIMITATION OF LIABILITY
The only way to limit or eliminate a person’s liability under the Directive is essentially the contributory negligence of the injured party or anyone acting under his or her responsibility. This is provided for in Article 8(2) of the Directive, which states that the liability of any person may be reduced or even eliminated where the damage is caused both by the defective product and by the fault of the injured party.
- CAUSATION
As mentioned above, according to Article 4 of the Directive, the injured party must prove that his damage is the result of the defect in the product. The causal link between the defect and the damage may be proved either directly or by excluding any other possibility that may have caused the damage, until the defect in the product remains the only possible cause of the damage (provided that the defect in the product is of such a nature that it may have caused the damage).
- DEFENCES
Article 7 of the Directive provides some defences to the producer. These are exhaustively listed and exempt the producer from any liability; they must therefore be interpreted restrictively by the courts. The defences are the following:
- DID NOT PLACE THE PRODUCT INTO CIRCULATION
Article 7(a) states that it is a defence to the producer if he proves that “he did not put the product into circulation.” This defence takes two forms. The first is where the Defendant alleges that the product was not put into circulation at all. As we have seen, however, a product is deemed to have been put into circulation by its use even if it is only used within the producer’s premises. In Veedfald case, a medical liquid was manufactured in the pharmacy of a hospital for use on a patient who was being treated at another hospital. Both hospitals were owned by the same organisation which claimed that due to these circumstances, the liquid did not leave its sphere of control and thus had to be considered not to have been put into circulation. The Court of Justice of the European Communities rejected the argument, holding that the product was put into circulation. The reason for this was that the product could only be used within the producer’s premises. The second form of this defence is where the Defendant admits that the product was put into circulation but claims that this was done by another person and not by him. For the same reason, it is a defence where the defective product is used against the will of the manufacturer, e.g. before the manufacturing process has been completed.
- SUBSEQUENT APPEARANCE OF A DEFECT
Under Article 7(b) it is a defence where the producer proves that “having regard to the circumstances, it is probable that the defect which caused the damage did not exist at the time when the product was put into circulation by him or that this defect came into being afterwards.” It is noted that the phrase “came into being afterwards” implies that the defect came into existence later and does not include cases of latent defects, i.e. defects which existed from the outset but which appeared later. In Piper v JRI Manufacturing Limited the manufacturer of a hip prosthesis proved that when it put the product into circulation, that is, when it was delivered to the hospital where it was incorporated into the Claimant’s body, it was not defective. The manufacturer proved that it followed inspection and quality control procedures that would have identified the defect if it existed before it was delivered to the hospital. Thus, it proved the defence of the English provision corresponding to Article 7(b) of the Directive. The Court pointed out that all that was required for the manufacturer to establish this defence was that the product was not defective when it was put into circulation. It did not require the manufacturer to prove how the defect was subsequently caused, nor exactly when it was caused.
- CONSTRUCTION FOR A PURPOSE OTHER THAN ECONOMIC OR PROFESSIONAL
Article 7(c) provides that it is a defence for any person to prove that “the product was neither manufactured by him for sale or any form of distribution for economic purpose nor manufactured or distributed by him in the course of his business”
Where the manufacturer of the defective product manufactured it for any reason other than for a disinterested activity, he is deemed to have manufactured it for an economic and commercial purpose. Thus, in the Veedfald case it was immaterial that the defective medical fluid was manufactured by a public hospital and was intended for a patient who did not have to pay for it.
- COMPLIANCE WITH LEGISLATION
Article 7(d) of the Directive states that it is a defence for the Supplier if it proves that “the defect is due to compliance of the product with mandatory regulations issued by the public authorities”. It is submitted that, the same applies where the producer has complied with mandatory safety standards.
- LACK OF SCIENTIFIC OR TECHNICAL KNOWLEDGE WHEN THE PRODUCT WAS PLACED ON THE MARKET
Article 7(e) states that it is a defence if it is shown that “the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered”. This defence is known as the (“development risks defence”). Indeed, it is the only one of the defences provided that the MSs could decide not to apply.
C-300/95 clarified what is meant by the phrase “scientific and technical knowledge at the time the product was placed on the market”. The Court of Justice of the European Communities said that this phrase does not only mean the practice and safety standards used in the industrial sector of the producer. According to the Court, the phrase includes the highest objective level of scientific and technical knowledge at the time the product in question was put on the market. The producer is presumed to have such knowledge, provided that it was available at the time the product was put on the market. The Court of Justice of the European Communities has in this judgment significantly limited the scope of this defence, since it can only succeed where the producer proves that even the highest level of knowledge would not have allowed the defect to be detected. On the other hand, however, the addition by the Court of Justice of the European Communities of the requirement that such knowledge be available, works in the opposite direction. For example, if there was a very high-level of knowledge which was the result of research which had not yet been published, then it would not be considered available, thus effectively reducing the burden of proof which the producer would have to bear in order to succeed in his defence.
The question then arises: what scientific and technical knowledge is considered to be available? There is no clear answer to this question. In Case C-300/95, for example, the Advocate General of the European Union, in paragraph 23 of his opinion, expressed the view that a Manchurian scientific review is not included in the information available (as long as it is not published in European countries). In the English Authority A v National Blood Authority however, Judge Burton J held that even a Manchurian scientific review can be considered available if the allegedly defective product is a product for which Manchuria is famous.
PROBABILITY OF A DEFECT OCCURRING: The fact that the producer knew or could have discovered the existence of a likelihood of the defect is sufficient to deprive him of the right to invoke that defence. This is the case where, for example, one of the products in a particular range is defective and the producer knows about it and continues to put the products in that range into circulation. In A v National Blood Authority where the producer knew that for each container of blood there was a possibility of hepatitis C, it raised this defence saying that there was no test which proved the existence of hepatitis. Judge Burton J held that the defence, could not succeed where the manufacturer knew that there was a likelihood of the defect occurring, even if the existence of the defect itself could not be established when the product was put on the market. His reasoning was that the phrase “existence of a defect” in the Act was not limited to the existence of a defect in the particular product at issue but also included the risk of the defect occurring. Consequently, he decided that the provision of the Directive provides a defence only for defects that are actually unknown to the producer.
Although the wording of the Directive does not support Burton J’s decision in so far as it states that it is a defence that the fact that the defect could not be established (and not the probability of its occurrence) is a defence, the subsequent judgment of the European Court of Justice in Joined Cases C-503/13 and C-504/13 appears to support the above reasoning to some extent. It was decided that in some cases, even if only the probability of a defect in a product of the same group or range as the contested product is proven, this may be sufficient to consider the contested product as defective. It should be recalled, however, that the principle set out in Joined Cases C-503/13 and C-504/13 is not always applicable, but only in specific cases where the potential damage is very serious (e.g., to human health).
PHARMACEUTICAL PRODUCTS: The developing risks defence effectively exempts pharmaceutical manufacturers from any liability under the Directive, since usually, any defects in medicines appear either at the trial stage (when the medicine is not put on the market for this reason) or after a long period of time. In the latter case, it is very easy for the manufacturer to prove that he could not detect the defect when he put the medicinal product into circulation.
- DEADLINES
Article 10(1) of the Directive sets out the time limits within which the Member States must set time limits for bringing a claim for damages for loss suffered by the claimant as a result of a defective product.
- THREE YEARS FROM THE DATE OF THE FINDING OF DAMAGE, DEFECT AND IDENTITY OF PRODUCER
Article 10(1) provides for the right of action of any person who is injured by a defective product:
“Member States shall provide in their legislation that a limitation period of three years shall apply to proceedings for the recovery of damages as provided for in this Directive. The limitation period shall begin 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.”
The three-year period begins when the injured party becomes aware or could reasonably have become aware of (1) the damage, (2) the defect and (3) the identity of the producer.
- TEN YEARS SINCE THE CIRCULATION OF THE PRODUCT
Under Article 11 the injured party’s right to claim damages
“is extinguished upon the expiry of a period of 10 years from the date on which the producer put into circulation the actual product which caused the damage, unless the injured person has in the meantime instituted proceedings against the producer.”
PUT INTO CIRCULATION: A product is considered to be put into circulation when it leaves production and enters into commercial circulation. This question is important in order to determine when the limitation period starts to run. This issue has been dealt with above in Section 2.2.1. D.
REPLACEMENT OF THE DEFENDANT: Where the injured party brings an action against a company that is mistakenly held to be the producer but discovers the identity of the actual producer after the ten-year period has expired, the question arises: can it substitute the defendant company in the pending action with the actual producer? In Aventis Pasteur , the European Court of Justice clarified that the replacement of the defendant after the expiry of the ten-year period circumvents the time limit and affects the legal certainty promoted by the Directive as well as the reasonable expectation of the actual producer that after the expiry of the time limit he will be relieved of any liability. The European Court of Justice also emphasised that subjective elements such as the injured party’s mistaken impression that the defendant was the producer or his intention to sue the actual producer can in no way be taken into account. Thus, it decided that after the ten-year period had elapsed, the wrong defendant could not be replaced by the real producer. There is the following exception to the above principle: In Aventis Pasteur it was clarified that in cases where the wrong defendant is a wholly owned subsidiary of the actual producer, then the national court must decide on the facts of the case whether it was in fact the parent company that put the product at issue on the market. If that is the case, then the national court may decide that the parent company can substitute its defendant subsidiary even after the time limit has expired.
In any case, as the European Court of Justice itself stated, the issues arising from the expiry of the time limit where the wrong person is initially sued as a producer are only of an academic nature, since under normal circumstances the injured party will only take action against the “wrong” person where the latter is a supplier who fails to inform him of the identity of his own supplier or the actual producer. As we have seen above, in this case the provisions of Article 3(3) of the Directive are triggered and the injured party’s claim is therefore considered to be in conformity with the law.
By George Charalambous and Evripides Hadjinestoros
