C-203/99

OPINION OF MR COLOMER — CASE C-203/99

OPINION OF ADVOCATE GENERAL RUIZ-JARABO COLOMER delivered on 14 December 2000 1

1. A reference has been made to the Court kidney's blood vessels was commenced by of Justice under Article 234 EC by the mean of a perfusion fluid in order to clean Højesteret (Danish Supreme Court) for a the kidney of blood and to cool and preliminary ruling on five questions regard- stabilise the organ. The fluid consisted of ing the interpretation of Directive a basic fluid, produced in the dispensary of 85/374/EEC 2 concerning liability for Århus hospital, to which the operating staff defective products ('Directive 85/374'). at Skejby hospital added a glucose solution, magnesium chloride, heparin and papaver- ine designed to increase the fluid's stabilis- ing effect on the cell tissue while the kidney was without a blood supply. These sub- stances were also prepared in the dispens- ary of Århus hospital. I — The facts of the main proceedings

The surgeons taking part in the operation stated that over the course of twenty years the perfusion fluid had been used in II — The questions referred for a approximately one thousand transplant preliminary ruling operations, without complications having arisen. After the operation, a test was conducted, in which a fresh portion of perfusion fluid was prepared. Following 4. The appellant appealed against that mixing, the fluid was completely clear but judgment to the Højesteret, which, prior after three or four minutes it also crystal- to ruling on the substantive issue, decided lised and a deposit formed. The laboratory to stay the proceedings and to refer five of the Sundhedsstyrelse (Health Ministry) questions to the Court of Justice for a carried out an analysis of the preparations preliminary ruling, explaining that the used to produce the perfusion fluid and an matters it raised centred on whether the analysis of the mixed perfusion fluid con- provisions of Lov No 371 om Produktans- taining the deposit but was unable to var (Law on Product Liability), which provide an unequivocal explanation as to transposed Directive 85/374 into Danish why the precipitation had occurred in the law, created an obligation to pay compens- fluid. ation.

3. Mr Veedfald commenced proceedings before the Vestre Landsret (Western 5. The five questions are as follows: Regional Court), seeking a ruling that the Århus Regional Authority was liable for the failure of the transplant operation and an order that the authority should pay com- pensation for that failure. During the course of those proceedings, questions were '(1) Must Article 7(a) of Council Directive addressed to the Retslægeråd (Medical 85/374/EEC of 25 July 1985 be con- Legal Council), but neither the answers strued as meaning that a defective provided nor the evidence adduced in product is not put into circulation if support of Mr Veedfald's claim enabled the producer of the defective product, the actual cause of the precipitation which in the course of providing a specific occurred in the perfusion fluid to be medical service, produces and uses the explained. product on a human organ which, at

I - 3574

VEEDFALD

ceedings within the period prescribed for producer for damage caused by the defecti- that purpose by Article 20 of the EC veness of his products, since the existing Statute of the Court of Justice. divergences may distort competition, affect the free movement of goods within the common market and entail a differing degree of protection of consumers against damage caused by a defective product to their health or property; that liability with- At the hearing, which took place on out fault on the part of the producer is the 16 November 2000, oral argument was sole means of adequately solving the prob- presented by the representatives of Mr lem, peculiar to our age of increasing Veedfald, the Århus Amtskommune, the technicality, of a fair apportionment of French Government, the Irish Government the risks inherent in modern technological and the Commission. production; and that liability without fault should only apply to movables which have been industrially produced.

I - 3575

OPINION OF MR COLOMER — CASE C-203/99

damage caused by death or by personal movables which have been manufactured injuries and damage to, or destruction of, industrially. However, I deduce from the any item of property other than the defect- summary of the facts set out in the order ive product itself. Under Article 7(a) and for reference that the perfusion fluid used (c), a producer will not be liable if he on the kidney, consisting of a o base fluid proves that he did not put the product into prepared in the dispensary of Århus hos- circulation, or that the product was not pital and of other substances which were manufactured by him for sale or any form added by the operating staff at Skejby of distribution for economic purpose nor hospital, is a single preparation which is manufactured or distributed by him in the specially made up each time it is required course of his business. for use in a transplant operation. In those circumstances, I must conclude that this was not an industrially produced product.

11. At the hearing, I asked the parties to comment on the applicability of Directive 14. Second, even if the preparation in 85/374 to the circumstances giving rise to question is a movable, in other words a the main proceedings and it emerged that 'product', and each of the hospitals could views differed. "While the appellant, the be deemed to be the 'producer', given the French Government and the Commission such broad definitions of these terms in were unreservedly of the view that the Directive 85/374, regard must always be directive does apply, the respondent re- had to the fact that underlying the entire gional authority and the Irish Government scheme of the directive is the idea of a expressed the opposite view. product being 'put into circulation' by the producer, an activity which the directive does not define.

technical knowledge was not such as to principle of liability on the part of the enable the existence of the defect to be supplier of a service in the case of a fault discovered. Lastly, under Article 11, the committed by him, making no distinction limitation period within which an injured as to the supplier's public or private status, person is entitled to commence proceedings provided that it was rendered by a profes- claiming liability on the part of the pro- sional operator. It should be pointed out ducer is ten years from the date on which that the services covered by this proposal the product was put into circulation. did not coincide with those envisaged by Articles 49 EC and 50 EC, since it included any transaction carried out in an independ- ent manner, whether or not in return for payment, which did not have as its direct and exclusive object the manufacture of movable property or the transfer of rights The perfusion fluid in this case was pre- in rem or intellectual property rights.

15. There is also a third reason for my would have extended to damage caused by view, which reinforces the arguments use of a product manufactured by the said advanced above. It is common knowledge that in November 1990 the Commission submitted a Proposal for a Directive to the 6 — Izquierdo Peris, J.J., in '1995-1999: L'évolution de la directive 85/374/CEE relative à la responsabilité du fait Council, the aim of which was to harmon- des produits défectueuex. Le Livre vert de la Commission ise the laws of the Member States relating européenne,' Revue européenne tle droit de laconsomma- lion, 1999, pp. 241 et seq, points out the existence of to the liability of suppliers of services. 5The Community initiatives relating to civil liability.

As can, therefore, cither purchase the fluid or prepare it indicated in its Consumer Policy Action Plan for 1999- themselves using the basic constituents. 2001, the Commission intends to examine the need to reinforce the safety of services. On the basis of this analysis, 5 — Proposal for a Council Directive on the liability of suppliers the Commission will propose initiatives that will address of services, COM(90) 482 final; OJ 1991 C 12, p. 8. both service safety and the liability of service providers'.

supplier with the aim of using it exclusively not requested an interpretation of Directive in the course of his business. 92/59 and that the proposal for the amend- ment of the directive has not yet been adopted. However, both examples appear to indicate that, in the Commission's mind, products which are manufactured by a professional for use in the course of his 16. My conviction in this regard is bol- business and which are not intended to be stered still further by the fact that products made available to the public are incidental used exclusively in the course of a trade or to the supply of services and that, as such, business were excluded from the scope of any damage which they might cause must Directive 92/59/EEC on general product be dealt with in conjunction with the safety. 8 Moreover, the Proposal for a provision of the service. Directive amending Directive 92/59, recently drafted by the Commission, 9the aim of which is to establish within the framework of the Community a general obligation of safety for all products placed on the market or made available to con- 17. It is therefore my opinion that Directive sumers by other means, 10 is not intended to 85/374 is not applicable to a situation such cover services. The ninth recital in the as the one at issue in the proceedings before preamble to the proposed directive states the national court which had referred these that the directive does not govern services questions. but that, in order to ensure that the consumer protection aims in question are achieved, the provisions of the directive also cover products supplied to or made available to consumers for their use in the context of the provision of a service. The safety of the equipment used by the suppli- 18. It follows from this conclusion that, in ers of services themselves in the course of the absence of a directive governing liabil- their business is not covered by the pro- ity for defective services, there is no posed directive since this is to be examined Community legislation on which consum- in relation to the safety of the service ers may rely where they suffer damage rendered. caused by a product produced by a profes- sional operator for use in the course of his business, a situation which is to be la- mented.

riaily manufactured and which, in general, 20. I therefore propose that the Court reply are intended for circulation in the market, to the Højesteret that, as Community law applies to such cases. stands at present, Directive 85/374 does not apply to cases of liability for defective services, which include damage caused by a professional operator as a result of his using, in the course of his business, a product which he himself prepared and which is intended for use solely within his organisation, since this liability has not yet 19. I am also aware of the case-law of the been regulated by the Community legisla- Court, according to which it is, by virtue of ture. the division of functions provided for by Article 234 EC, for the national court, whose responsibility it is to rule on the substantive issue, to apply the rules of Community law to a specific case. 1 1The Court has also held that, where a reference for a preliminary ruling concerns the inter- pretation of a provision of Community law, However, in the event that the Court does the Court delivers its ruling without, in not share my view, I shall now examine the principle, having to look into the circum- questions referred for a preliminary ruling. stances in which a national court was prompted to submit the questions and envisages applying the provision of Com- munity law which it has asked the Court to interpret. 12

V — Examination of the questions referred for a preliminary ruling

Nevertheless, the task of interpretation assigned to the Court by Article 234 EC is designed to ensure a uniform application of Community law throughout the Member States and to prevent the erroneous applica- tion of Community law provisions to A — The first question matters that they are not intended to govern.

22. The parties which have submitted observations in these proceedings differ as to the reply to be given to this question. It follows that Article 7(a) of Directive The appellant in the main proceedings, 85/374 must be construed as meaning that together with the French, Austrian and where a professional operator produces a United Kingdom governments and the preparation, for use in the course of his Commission, take the view that the perfu- business and within his organisation (as sion fluid is a product which was put into may be the case with a shampoo used by a circulation because the person who made hairdresser or an oil used by a masseur), he the product also used it. By contrast, the cannot avoid liability if the preparation respondent Danish authority and the causes damage to his clients, by arguing Danish and Irish Governments argue that that he did not put it into circulation. use of a fluid prepared by medical staff employed at a publicly funded hospital and intended for use as an accessary element in a surgical operation, cannot be regarded as putting a product into circulation within the meaning of Article 7(a) of Directive 85/374.

B — The second question

23. In the event that the Court should take the view that Directive 85/374 applies to products prepared by a professional opera- tor for use exclusively in the course of his business, I would propose that it hold that the product's mere use must mean that it 24. By its next question, the Højesteret has been put into circulation. This is the wishes to know whether, under Article 7(c) only meaning that accords with the aim of of Directive 85/374, a public hospital is the directive, since products prepared in exempt from liability for preparations these circumstances are naturally intended which it produces and uses in the course

25. The appellant in the main proceedings argues that the product was prepared in the 27. The reply to the second question must course of a business and that, in Denmark, therefore be that a public hospital is not although patients are not required to pay exempt from liability under Directive for medical treatment in hospitals, they do 85/374 in respect of preparations which it in fact finance hospitals through the pay- produces and uses in the course of provid- ment of taxes. So, it is not to be concluded ing a specific publicly-financed service to that a public hospital is free from liability the person suffering injury and in respect of on the ground that the injured person has which that person has not paid any con- not paid any consideration. The French, sideration. Austrian and United Kingdom Governments and the Commission hold the same view. The opposite view is held by the respondent in the main proceedings and by the Danish and Irish Governments.

C — The third question

26. I agree with the parties which argue that the fact that a hospital is publicly owned and its patients do not pay for treatment cannot exempt it from liability where it has used a defective product which 28. Thirdly, the national court asks whether was prepared by its own staff. As the Community law imposes requirements

I - 3581

OPINION OF MR COLOMER — CASE C-203/99

as to how Member States should define the 'damage' contained therein and do not have expressions 'damage caused by death or by any latitude to alter its meaning. personal injuries' and 'damage to, or destruction of, any item of property' in Article 9 of Directive 85/374 or whether, alternatively, Member States are free to decide what meaning is to attach to these expressions.

32. Here again, there is disagreement among the parties which have submitted observations on these questions. The appel- 30.1 agree with the argument that the lant in the main proceedings is of the terms should be interpreted according to opinion that, since he was the intended Community law. The aim of Directive recipient of the organ, he had a property 85/374 is to harmonise the laws of the right at the time when it became unusable, Member States concerning the liability of with the result that the damage he suffered producers for defective products and Art- amounts to personal injury within the icle 9 thereof defines, in a quite detailed meaning of Article 9(a) of Directive manner, what is meant by 'damage' for the 85/374. In the event that the Court does purpose of Article 1, leaving aside from not agree with this argument, the appellant coordination only national provisions relat- contends that the damage can be construed ing to non-material damage. Consequently, as being covered by the term 'damage to, or when transposing the provisions of Direct- destruction of, any item of property other ive 85/374 into national law, Member than the defective product itself' within the States are bound by the definition of meaning of Article 9(b) of the directive.

I - 3582

VEEDFALD

Article 9(a) and (b) effectively provides for 35. For the reasons I have given, I propose two heads of damage, namely, damage that the Court, in reply to the last two caused by death or by personal injuries questions, should rule that Article 9 of and damage to, or destruction of, any item Directive 85/374 must be construed as of property other than the defective pro- meaning that damage caused to a human duct itself. Having regard to the fact that a organ at the time when it is removed from human organ does not fulfil the require- the body of a donor for immediate trans- ments laid down by Article 9(b)(i) and (ii) plantation into another person's body is in order for there to be damage to an item covered by the expression 'damage caused of property, namely that the item must be by personal injuries' but not by the expres- of a type ordinarily intended for private use sion 'damage to, or destruction of, any item or consumption and that it must have been of property'.

I - 3583

OPINION OF MR COLOMER — CASE C-203/99

VI — Conclusion

36. In view of the foregoing considerations, I propose that the Court of Justice should reply as follows to the Højesteret:

As Community law stands at present, Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products does not apply to cases of liability for defective services, which include damage caused by a professional operator as a result of his using, in the course of his business, a product which he himself prepared and which is intended for use solely within his organisation.

I - 3585