defect is a key element in the whole system and, therefore, they rightly hold that, pursuant to Art. 5 LRPD, the defect must be regularly proven by the claimant and that this rebuttable presumption of the defect introduced by Art. 3.2 LRPD is exceptional.23

The divide between defects for lack of utility and defects for lack of safety has not generally posed great problems so far. It must be admitted that it is not always easy to draw a clear-cut distinction between (a) products that are defective because they are unsafe and, in our case, do not meet the consumers’ expectations test, and (b) products that are defective because they do not meet the utility expectations of the particular contracting consumer, according to what had been expressly or tacitly agreed in a contract. However, if the defect, as many decisions hold, is a key element of the whole system, it is worth striving for clarity on this point.

There are some decisions which, if they ever reach the Supreme Court, will require a clear rectifying statement. This is the case of SAP Valencia 16.9.2002 [AC 2002\1657], where the claimant had purchased an irrigation engine from a supplier who, in turn, had obtained it from the manufacturer. The engine did not work properly, and it had to be repaired and some of its parts replaced. No personal injury occurred. No damage to other property arose and not even damage to the engine itself took place. Nevertheless, the Court considered, verbatim, that the case was a clear case of a manufacturing defect and held the manufacturer liable for all expenses in accordance with the provisions of the Product Liability Act

(emphasis added).

Likewise, in SAP Cordoba´ 30.7.2003 [AC 2003\1142], a taxi driver suffered some malfunction in the taxi which caused the vehicle to be off the road for seventeen days while it was still under the guarantee period. The Court had no hesitation in wrongly interpreting half a dozen provisions of the Product Liability Act, held the seller, Opel Spain, liable pursuant to the Product Liability Act (emphasis added) and ordered a damages award of €1,359 for the seventeen days during which the taxi-driver could not use the car.

The legal concept of ‘manufacturer’: back door for the supplier?

Before the Product Liability Act came into force, Art. 26 LGDCU permitted the victim of a defective product to file a claim against the

23See, among many others, SSAP Tarragona 18.7.1998 [AC 1998\1546]; Zaragoza 27.9.1999 [AC 1999\1661]; Cordoba´ 30.10.2000 [AC 2000\2097] and Albacete 9.3.2000 [AC 2000\ 1145].

manufacturer, the importer and the supplier, together or individually, without establishing any order of priority. The idea that, according to the Product Liability Act, the victim would normally sue the manufacturer, in certain cases only the importer, and exceptionally, i.e. in the cases expressly established by the rules transposing the Directive, the supplier is not always properly understood by victims and courts. So for instance, in SAP Badajoz 8.4.1999 [AC 1999\674], referring to the damage caused by the explosion of a butane gas cylinder due to a leak in the cylinder that was attributable to a manufacturing defect, the Court of Appeal had no problem finding the supplier jointly and severally liable with the manufacturer and its insurance company.

This decision does not accord with the Product Liability Act. However, it must be pointed out that the Spanish Act contains a provision (the Sole Additional Provision of the Act), which can give rise to liability for the supplier well beyond the provisions of the Directive. This provision sets forth that ‘[t]he supplier of a defective product shall be responsible, as if he were the manufacturer, when he has supplied the product with knowledge of the existence of the defect. In this case, the supplier may bring a claim for recovery against the manufacturer or importer.’ Although it is very likely that this provision was meant to hold liable those suppliers who had supplied defective products with intent, courts seem to have turned this liability of the supplier into liability for fault.

So, for instance, in SAP Barcelona 19.4.2002 [JUR 2002\184459], where the victim suffered a personal injury as the result of being knocked by the hydraulic tube of an industrial machine, the court holds the supplier liable, according to the Sole Additional Provision of the LRPD, arguing that, since he was an expert in that sort of product, he should have detected the defect. By contrast, SAP Caceres´ 21.6.2002 [JUR 2002\226019], where a toy that had been purchased inside a sealed box was defective, the court stated that the supplier could not have known of the defect when he received the product and, therefore, he could not be held liable according to this Additional Provision.

On this point it might be useful to remind Spanish courts that the European Court of Justice in Commission of the European Communities v French Republic,24 dealing with the French transposition of the Directive which in Art. 1386–7 Code Civile equated the supplier with the producer,

24Judgment of the Court (Fifth Chamber) of 25 April 2002. Commission of the European Communities v French Republic. Failure by a Member State to fulfil its obligations – Directive 85/374/EEC – Product liability – Incorrect transposition. Case C–52/00. European Court reports 2002 page I–03827.

declared that ‘[s]ince the Community legislature had competence to harmonise the laws of the Member States in the field of product liability, it was also competent to determine the person who was to bear that liability and the conditions under which that person was to be sued’.25

Defences, in particular, the full development-risks defence for public bodies

It is very likely that the defence that has been most commonly invoked by the defendants is the one referring to the fact ‘[t]hat, given the circumstances of the case, it can be presumed that the defect did not exist at the time the product was put into circulation’ (Art. 6.1 (b) LRPD). This is likely to be so because, according to its wording (‘it can be presumed that the defect did not exist’), the Article does not seem to require full proof of the non-existence of the defect. Nevertheless in SAP Santa Cruz de Tenerife 19.4.2002 [AC 2002\898], dealing with cuts to the tongue of a victim who drank beer from a bottle which contained pieces of broken glass, the court rejects this defence out of lack of proof. The manufacturer had argued that it was impossible for these pieces of glass to have entered the bottle before it was put into circulation. The court held that it had been established that the bottle contained pieces of glass and that the manufacturer had not proven sufficiently that they had entered the bottle afterwards. SAP Cantabria 19.6.2002 [JUR 2002\212110] decided in a similar way with regard to the damage caused by an elevating platform that broke.

With regard to the development risk defence it is worth mentioning that in spite of the fact that Art. 6.1 (e) LRPD provides that ‘[t]he manufacturer or the importer shall not be liable if they prove: (e) That the scientific and technical knowledge existing at the time the product was put into circulation did not allow for appraisal of the defect’, Art. 6.3 LPRD provides that this defence cannot be invoked ‘[i]n the case of medicines, foods or food products for human consumption . . .’ (emphasis added).26

25ECJ Decision, para. 39.

26Spanish bibliography on this topic is extensive. Among many others see Pablo Salvador Coderch and Josep Sole´ Feliu, Brujos y aprendices. Los riesgos de desarrollo en la responsabilidad de producto (Madrid: Marcial Pons, 1999); Mar´ıa Paz Garc´ıa Rubio, ‘Los riesgos de desarrollo en la responsabilidad por danos˜ causados por productos defectuosos. Su impacto en el Derecho espanol’,˜ Actualidad Civil 35 (1998): 853–70; Jose´ Lu´ıs Ingles´ Buceta, ‘Riesgos del desarrollo y accesibilidad: la Sentencia del Tribunal de Justicia de las Comunidades Europeas de 29 de mayo de 1997, con un apostrofe´ sobre el nuevo Art´ıculo

According to the Spanish provisions, ‘medicines’ includes both prescription and over-the-counter medicines. The reference ‘for human consumption’ applies to medicines, in order to exclude medicines for animals, since according to the Spanish rules ‘medicines’ are both for human consumption and for animals.27 Foods and food products also exclude animal food, which is in accord with the Spanish regulations on food and food products.28

The liability of public bodies, by contrast, is governed by a different Act (Legal Regime of Public Administrations and General Administrative Procedure Act 1992 [hereafter, LRJAP]).29 In its original wording Art. 141.1 LRJAP provided that recoverable damage was only the damage stemming from harm that the person who has suffered it ‘does not have the legal duty to endure’. Although it was considered that the public bodies could exonerate for force majeure, a series of decisions issued in the early nineties, dealing with the tort liability of public healthcare centres for the damage caused by blood transfusions infected with HIV, considered that this was not a case of force majeure and held the public healthcare centres liable.30

In 1999, the 1992 Act was amended by Ley 4/1999, of 23.1.1999.31 Fearing a second wave of litigation, in this case with regard to HIV, and arguing that the concept of force majeure needed ‘fine-tuning’, the following paragraph was added to Art. 141.1 LRJAP:

141.1 de la LRJAP-PAC’, Derecho de los Negocios, October (1999: 15–28; Javier Lete Achirica, ‘Los riesgos de desarrollo en materia de responsabilidad por los danos˜ causados por los productos defectuosos. Comentario a la sentencia del Tribunal de Justicia de las Comunidades Europeas de 29 de mayo de 1997’, Actualidad Civil 28 (1998): 685–93 and Elena Vicente Domingo, ‘Responsabilidad por producto defectuoso, responsabilidad objetiva, riesgos del desarrollo y valoracion´ de los danos’,˜ La Ley 5034 (13 April 2000).

27See Arts. 6 and 8 Ley 25/1990, 20 December, del medicamento (BOE n◦ 306, 22.12.1990).

28See Art. 1.02.01 C´odigo alimentario espa˜nol (Decreto 2484/1967, de 21 de setiembre (BOE n◦ 248 to 253, of 17 to 23.10.1967, amended by RD 1353/1983, de 27 de abril, BOE n◦ 126 27.05.1983)).

29Ley 30/1992, de 26 de noviembre, de R´egimen Jur´ıdico de las Administraciones P´ublicas y del Procedimiento Administrativo Com´un (BOE num. 285, 27.11.1992 [correccion´ de errores BOE num. 311, 28.12.1993 and num. 23, 27.1.1993]).

30So SSTS 4a 5.6.1991 [RJ 1991\5131], 4a 10.6.1996 [RJ 1996\5007], STSJ Cataluna,˜ Social, 9.12.1992 [AS 1992\6357]. However, 1997 marks a turning point in the opinion of the courts, and decisions progressively begin to accept the force majeure defence (see, for instance, SSTS 4a, 22.12.1997 [RJ 1998\737], 4a 3.12.1999 [RJ 1999\9349], 4a 5.4.2000 [RJ 2000\3284], 4a 9.10.2000 [RJ 2000\9420]).

31Act Amending the Legal Regime of Public Administrations and Common Administrative Procedure Act (Ley 4/1999, de 13 de enero, de modificaci´on de la Ley 30/1992, de 26 de noviembre, de R´egimen Jur´ıdico de las Administraciones P´ublicas y del Procedimiento Administrativo Com´un [BOE num. 12, 14.1.1999]).

[T]he damage resulting from the facts or circumstances which could not have been foreseen or avoided according to the state of scientific or technical knowledge existing when the damage occurred shall not be recoverable, without detriment to the social benefits that the law may provide for these cases.

It must be stressed that the development risk defence that public bodies can invoke refers to all sort of products, not just blood transfusions or blood products and, accordingly, public bodies can be exonerated from liability in all cases of development risks.

This difference of treatment between private and public producers has given rise to an intense debate. Some legal writers have declared that this amendment does not give rise to any objections.32 Others have contended that this provision is unconstitutional, and therefore that it could be challenged before the Constitutional Court by any First Instance or Appellate Court that has to apply it and entertains doubts about its constitutionality (the so-called cuesti´on de inconstitucionalidad ).33 The grounds are as follows: Art. 106.2 of the Spanish Constitution provides: ‘Private individuals, under the terms established by the law, shall have the right to be indemnified for any harm they suffer in any of their property and rights, except in the cases of force majeure, whenever such harm is the result of the functioning of the public services’ [emphasis added].

The Constitution allows exoneration from liability of public bodies only in the case of force majeure and, in spite of the reasons given for amending Art. 141.1 LRJAP and introducing a full defence in all cases of development risks, development risks are not, strictly speaking, a case of force majeure (they are closer to ‘caso fortuito’, a fortuitous event close to a force majeure which is internal to the activity of the person causing the harm and which could have been avoided if it could have been foreseen).34

Other legal writers argue that this duplicity of rules introduces a duality of legal regimes which will be a disincentive for research by public bodies

32See Fernando Pantaleon´ Prieto, ‘Como´ repensar la responsabilidad civil extracontractual (tambien´ la de las administraciones publicas)’,´ in Juan Antonio Moreno Mart´ınez (Coord.),

Perfiles de la responsabilidad civil en el nuevo milenio (Madrid: Dykinson, 2000), pp. 439–65, at p. 462.

33See Jesus´ Jordano Fraga, ‘La reforma del art´ıculo 141, Apartado 1, de la Ley 30/1992, de 26 de noviembre, o el inicio de la demolicion´ del sistema de responsabilidad objetiva de las administraciones publicas’,´ Revista de Administraci´on P´ublica 149 (May–August 1999): 321–36, at 333 and 336.

34In this sense, see Jordano Fraga, ‘La reforma del art´ıculo 141’: 333–4.

manufacturing products35 or that foreign manufacturers supplying their products to Spain will prefer to supply them to public bodies.36 These arguments point out possible negative effects of the duality of regimes but say nothing about their legality or conformity with other legal rules in force.

Recently, another legal writer has pointed out that this duality of regimes infringes on the rights of the patients of public hospitals (and I would add, of all citizens who use medicines, food and food products which had defects that scientific and technical knowledge could not have detected) and that it also infringes on the equality of the legal position of public bodies and private manufacturers acting in the same market.37

However, it must be pointed out that with regard to the interpretation of the principle of equality contained in Art. 14 CE38 the Spanish Constitutional Court has been quite restrictive. In the decision STC 181/2000, of 29 June, regarding the constitutionality of the legal tariffication scheme for traffic accidents, the Constitutional Court has held that not treating victims equally in different cases of liability does not give rise to an infringement of the equality principle. Moreover, as the legal liability regime established for public bodies applies in exactly the same way to all citizens, following the Constitutional Court, discrimination cannot take place.

On this point I would like to stress two arguments that, I think, can be put forward in order to claim that the provision dealing with the development risks defence of public bodies infringes the Directive.

First, this provision refers to the state of scientific or technical knowledge ‘existing when the damage occurred’. By contrast, Art. 7(e) Directive sets forth that ‘[t]he producer shall not be liable as a result of this Directive if he proves: 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’ (emphasis added).

In the case Commission v France,39 decided on 25 April 2002, the European Court of Justice has held that ‘[w]ith regard to the arguments based

35Salvador Coderch, ‘Prologo’,´ in Salvador and Sole,´ Brujos y aprendices, p. 15.

36Ingles,´ ‘Riesgos del desarrollo y accesibilidad’: 15–28, at 24.

37In this sense, Seuba Torreblanca, Sangre contaminada, responsabilidad civil y ayudas publicas,´ cit., p. 312 et seq.

38Article 14 [Equality]: ‘Spaniards are equal before the law, without any discrimination for reasons of birth, race, sex, religion, opinion, or any other personal or social condition or circumstance.’

39Case C-52/00. European Court reports 2002, p. I–03827, point 47.

on Article 15 of the Directive, it should be noted that whilst that provision enables the Member States to remove the exemption from liability provided for in Article 7(e) thereof, it does not authorise them to alter the conditions under which that exemption is applied ’ (emphasis added). A key element of the architecture of the Directive is the moment when the product was put into circulation. The domestic legislation can take the exemption of liability dealing with the development risks defence as it is . . . or leave it. But it cannot start changing its key elements.

Secondly, let us imagine, however, that the State amends Art. 141.1. LRJAP and refers the relevant moment to the moment when the product was put into circulation, thus bringing the wording of this provision in line with the wording of the Directive.

It is likely that in this case the objection that could be raised would go much further, since the Product Liability Directive does not establish any distinction between public law regimes and private law regimes. To give an example: tort liability of private persons is governed in Spain by the provisions of the Civil Code and by specific statutes (for instance, nuclear energy, air traffic, consumer protection Acts, etc.). These Acts do not apply to public bodies, which are governed by the already mentioned Ley 30/1992 as amended in 1999.

Liability of public bodies, even when they act as private individuals, will always be governed by this Act (cf. Art. 144 LRJAP), and therefore it will exclude the application of all other rules. Does this mean that the Product Liability Act implementing the Directive can be also excluded? Rather I would say that it cannot be excluded because the norm implementing the Directive binds both private persons and public bodies. In this sense the European Court of Justice has decided cases in which the rules implementing the Directive have been applied to public bodies.40 Moreover, although it is true that the existence of a Directive cannot alter the internal or domestic distribution of legislative powers, and therefore it is possible for a regional Act (provided that the region involved has legislative power) and a State Act to implement the same Directive, it is at least arguable that the State can implement a Directive twice, i.e. make one implementation for private individuals and another for public bodies.

40Although it was not a case related to the development risk defence, in the Judgment of the Court (Fifth Chamber) of 10 May 2001, Henning Veedfald v Århus Amtskommune, Reference for a preliminary ruling: Højesteret – Denmark. Approximation of laws – Directive 85/374/EEC – Liability for defective products – Exemption from liability – Conditions. Case C-203/99, the European Court of Justice applied the Danish norms implementing the Directive to a public body.