It was only after this second conviction (over 20 years after the adoption of the Directive) that France brought article 1386-7 into line with the Directive by providing that the seller is liable under the same conditions as the producer unless it refers to its own supplier or producer within three months of the victim’s notification.115 ‘Th e French concept of chains of contracts, very protective of the end purchaser and allowing the supplier to sue the producer at the other end of the chain, eventually broke under the heavy hammering of the Commission and the European Court of Justice.’116

Th e limitations for national law only apply to the producer and the supplier since their legal position is regulated in the Directive. For this reason, the Directive does not affect a national strict liability regime applying to a service provider. A 13-year-old boy suffered burns during surgery carried out in a French hospital. The burns were caused by a defect in the temperature-control mechanism of a heated mattress on which he had been laid. He claimed compensation from the hospital on the basis of a strict liability rule but the hospital argued that this liability regime could no longer apply because of Article 13 of the Directive. In a preliminary ruling, the ECJ held that the liability of a service provider such as a hospital using defective products of which it is not the producer does not fall within the scope of the Directive. Member States are therefore allowed to apply strict liability rules vis-à-vis the provider as long as the victim and the service provider retain the right to sue the producer on the basis of the (implemented) Directive.117

1408 WHEN IS A PRODUCT DEFECTIVE?

1408-1 RELEVANT PROVISIONS

Th e producer shall be liable for damage caused by a defect in his product (Art. 1). This rule raises questions in relation to the notions of producer, damage, causation, defect, and product. The Directive contains definitions of all these notions, except for causation and, since the definitions do not always provide sufficient clarification, the case law of the ECJ and the national courts is of particular importance. In this and the following sections the main issues of the Directive will be examined.

For the purpose of the Directive, ‘product’ means all movables even if incorporated into another movable or into an immovable, including electricity (Art. 2). In several cases throughout the Member States, it was held that blood supplied by a blood bank can be considered to be a product in the sense of this provision.118

115Loi no. 2006-406 of 5 April 2006.

116Olivier Moréteau, ETL 2006, 198.

117ECJ 21 December 2011, C-495/10, nyp (Centre hospitalier universitaire de Besançon v Thomas Dutrueux). Likewise, Member States are allowed to maintain case law that applies the Directive’s liability requirements (damage, defect, and causal link) to damage to an item of property intended for professional use (Section 1409): ECJ 4 June 2009, C-285/08, ECR 2009, I-4733 (Moteur Leroy Somer v Dalkia France).

118A v National Blood Authority [2001] 3 All ER 289, para. 63; Rb. Amsterdam 3 February 1999, NJ 1999, 621 (Scholten v Sanquin Bloedvoorziening); see also Civ. 1re 4 March 2003, D. 2003. IR 866 (X v Établissement

Article 6 provides that a product is defective ‘when it does not provide the safety which a person is entitled to expect, taking all circumstances into account’. The Directive does not make a distinction between different types of defect. In practice, however, a distinction is usually made between manufacturing defects, on the one hand, and design and instruction defects, on the other. Design and instruction defects are shortcomings that are inherent in the product and occur in all products of a specific type, for example side-effects of drugs or an insufficient warning in the directions for use. Manufacturing defects are shortcomings that are not inherent in the product which is the case if the individual product does not meet the standard of the general quality of its specific type—the classic example being the exploding bottle. These shortcomings are mainly, but not solely, caused during the manufacturing or distribution process.119

In relation to manufacturing defects, the Directive provides for a strict liability regime. Consumers do not need to expect that products are defective because of failures in the manufacturing process. As regards design and instruction defects, the situation differs. In such cases, the consumer is not entitled to expect the product to be 100 per cent safe, for example drugs, provided if he has been properly informed about the sideeffects.

Article 6 mentions three circumstances to be taken into account when establishing the defect. It is generally agreed that this enumeration does not have a limitative character.

First, the article mentions the presentation of the product (Art. 6(1)(a)): in this respect, for example, information about the product which is provided by advertising and publicity, and information in an insert or in directions for use. It can be argued that warnings are generally insufficient if it is possible to produce a safer product without additional financial burden and this higher safety level does not affect the benefit of the product (Section 809). This aspect is particularly relevant in assessing the defectiveness of a medicine. One of the dilemmas in this regard is that, if a manufacturer needs to mention all known side-effects, however unlikely or minor they may be, the consumer could become confused and miss the relevant and essential information he needs. For this reason, the French Cour de cassation requires only communication of the reasonably foreseeable risks.120

Second, the court must also take into account the use to which it could reasonably be expected that the product would be put (Art. 6(1)(b)). In other words, what type of (negligent) use might the producer expect from the consumer? The general answer is that the producer must take into consideration that consumers make mistakes and do not always use the product in a safe or even in a proper way. It has to anticipate such

français du sang). See also the French Act 91-1406 of 31 December 1991 pour l’indemnisation des victimes contaminées par le virus de l’immunodéficience humaine, creating a special fund for persons infected with HIV as a result of a blood transfusion; see Van Gerven (2000), 629–630; Le Tourneau (2012), nr 8502–8577.

119See on this distinction, eg, Kötz-Wagner (2010), N 617–640.

120Civ. 1re 8 April 1999, JCP 1999. II. 20721. A different view is taken by the Cour d’Appel Paris 23 September 2004, D. 2005. 1012, on which see Section 1410-2.

infection could not be detected by a test during what has been called ‘the window period’. The court agreed with the claimant that,

taking into account the vital importance of blood products and that in principle there is no alternative, the general public expects and is entitled to expect that blood products in the Netherlands have been 100% HIV-free for some time. The fact that there is a small chance that HIV could be transmitted via a blood transfusion, which the Foundation (defendant) estimates at one in a million, is in the opinion of the Court not general knowledge. It cannot therefore be said that the public does not or cannot be expected to have this expectation.122

A comparable decision can be found in a case decided by the German BGH where the claimant suffered damage when a mineral water bottle exploded. It was established that this explosion resulted from an undetected hairline crack, although the technical and supervisory procedures in the producer’s factory were in accordance with the latest technology, including seven different inspection processes. The BGH concluded:

As the court below rightly held, a product is defective . . . if it does not afford the safety which in all circumstances can justifiably be expected, and consumers expect soda water bottles to be free from faults such as hairline splits and micro fissures which could make them explode. The consumer’s expectation that the bottle be free from faults would not be diminished even if it were technically impossible to identify and remove such faults.123

One may conclude from the foregoing that the expectation of the general public in relation to the safety of the product is not a factual but a normative one. The general public are not entitled to expect the safety the product actually has, which may be 99.9 per cent, but are entitled to expect the safety the product ought to have.

Th is means that the general public are entitled to expect that products are 100 per cent free from manufacturing defects. This is even the case if the public are aware of the risk of, for example, invisible hairline cracks in a bottle which could cause it explode. A different interpretation would lead to a form of Russian roulette124 and to an unfair apportionment of the risks inherent in modern technological manufacturing processes.125

122Rb. Amsterdam 3 February 1999, NJ 1999, 621 (Scholten v Sanquin Bloedvoorziening) (translation from A v National Blood Authority [2001] 3 All ER 289, para. 44(iii). The court considered the blood to be defective but allowed the defendant’s ‘development risks’ defence (Art. 7(e)).

123BGH 9 May 1995, BGHZ 129, 353 = NJW 1995, 2162 = JZ 1995, 1060, on which see Markesinis and Unberath (2002), 584–589 from which the translation is cited.

124Winfield and Jolowicz (2010), para. 10.19 with reference to Richardson v LRC [2000] PIQR 164 (broken condom): a couple used condoms as a means of contraception and after sexual intercourse it appeared that the teat had parted from the body of the condom. The claimant filed claims against LRC alleging that the split of the condom was caused by a weakening of the latex occurring before the condom left the factory, and that the fact of the split itself evidenced the existence of a defect. The court rejected both claims.

125See the second recital in the Preamble to the Directive: ‘Whereas liability without fault on the part of the producer is the sole means of adequately solving the problem, peculiar to our age of increasing technicality, of a fair apportionment of the risks inherent in modern technological production.’