from one of the leading academic writers in the field, Professor Jane Stapleton in Product Liability,14 but in the event it was conceded by the time of trial that blood and blood products were ‘products’.

Producer

The defendant admitted that it was responsible for the liabilities of its predecessors in the National Blood Transfusion Service and the Bio Products Laboratory15 and in effect accepted that they were the producers within the meaning of the CPA. During the course of the trial it was submitted by the defendant that in approaching the question of the consumer’s legitimate expectation as to the safety of blood, the court should put in the defendant’s favour the fact that, unlike a purely commercial producer, the defendant had no alternative but to continue supplying blood to hospitals and patients, as a service to society. Burton J rejected this argument in paragraph 42 of his judgment: noting that the defendants did not put forward a defence under Art. 7(d) ‘that the defect is due to compliance of the product with mandatory regulations issued by the public authorities’, he concluded that there was no necessary reason why a public authority or a non-profit-making organisation should be in any different position from a commercial undertaking if the product is unsafe. He also noted that that was the opinion expressed by the Advocate General (Colomer) in the ‘Danish Kidney Case’.16 This was before the ECJ gave its judgment in the case17 on various questions referred to it by the Højesteret (Danish Supreme Court).

Consumer Protection Act versus Directive

There are significant differences between the wording not merely of Article 7(e) and section 4(1)(e) CPA but also between Article 6 and

14 Published by Butterworths, London, 1994. Professor Stapleton is Research Professor, Research School of Social Sciences, Australian National University, Ernest E. Smith Professor, University of Texas School of Law, Commonwealth Fellow, British Institute of International and Comparative Law and Academic Associate, Fountain Court.

15The Regional Health Authorities and the Central Blood Laboratories Authority.

16Henning Veedfald v Århus Amstkommune Case C-203/99, para. 27.

17Holding that Art 7(c) (‘. . . . 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’ ) did not furnish a defence where the defective product is used in the course of a medical service financed entirely from public funds and for which the patient is not required to pay any consideration. The Court also addresses some interesting questions directed to whether the damage suffered in the case (loss of a harvested kidney through contamination prior to transplant into the plaintiff) was within Article 9 of the Directive.

section 3 in the definition of defect. The differences between Article 7(e) and section 4(1)(e) were considered by the European Court of Justice in the enforcement proceedings brought by the Commission against the UK18 to challenge the adequacy of the UK’s implementation of the Directive. As the pleadings developed, a pattern emerged of the claimants sticking resolutely to the wording of the Directive, while the defendant stuck to the wording of the CPA. By the time of the trial, however, it was accepted on both sides that the dominant provision was the Directive and that insofar as the CPA’s wording differed from the wording of the Directive, the CPA should not be construed differently from the Directive. As Burton J said: ‘. . . and consequently the practical course was to go straight to the fount, the Directive itself’.19 The clash of the statutes, feared by the Commission in its challenge to the UK’s implementation of the Directive and an issue on our pleadings,20 did not in fact take place, although a great deal of time was spent analysing Commission v UK, in at least three language versions.

The core issues

The two fundamental issues were:

a.Is the infection of blood with hepatitis C virus a defect within the meaning of Article 6?

b.If so, was the state of scientific and technical knowledge such that the existence of the defect could not be discovered as provided by Article 7(e)?

Article 6 (1) provides: ‘A product is defective when it does not provide the safety which a person is entitled to expect, taking all the circumstances into account, including:

i.the presentation of the product;

ii.the use to which it could reasonably be expected that the product would be put;

iii.the time when the product was put into circulation’

20Despite the terms of section 1(1) CPA: ‘This Part [of the Act] shall have effect for the purpose of making such provision as is necessary in order to comply with the product liability Directive and shall be construed accordingly.’

The main points of common ground were:21

a.That liability under the CPA is ‘defect-based’ not ‘fault-based’ (Recitals 2 and 6 of the Directive).

b.That the question to be resolved is the degree or level of safety or safeness which persons generally are entitled to expect.

c.The expectation is that of the public at large.

d.The expectation is not the actual expectation of persons generally, but what they are entitled to expect. ‘Legitimate expectation’ became the common formulation of the expectation, which was consistent with other language versions of the Directive, e.g. ‘. . . la s´ecurit´ a` laquelle on peut l´egitimement s’attendre . . .’

e.The court decides what the public is entitled to expect.

Against that common background, a. The claimants’ primary case on defect was that:

i.The legitimate expectation of people generally throughout the relevant period22 was that transfused blood would not infect patients with hepatitis C.

ii.The conduct of the producer is irrelevant and questions of avoidability of the defect, practicability of its avoidance and economic feasibility thereof are all irrelevant.

b.The defendant’s case on defect was that:

i.The risk of infection with hepatitis C was known to the treating doctors, for whom it was a risk worth running for the sake of the patient in need of a transfusion.

ii.Avoidability or unavoidability is a circumstance for the purpose of Article 6.

iii.The legitimate expectation of people generally was not that blood would be 100 per cent clean but that all legitimately expectable (reasonably available) precautions had been taken.

iv.It would therefore be necessary to investigate whether the producers had taken all legitimately expectable steps to avoid the risk of the product being defective.

21See para. 31, where Burton J lists in detail a number of points of common ground.

22From 1 March 1988.

c.The claimants’ fallback case on defect, in consequence, was:

i.That the defendant’s case is contrary to the intention of the Directive as revealed by the travaux pr´eparatoires, the Recitals and the observations of the Advocate General and the European Court of Justice in Commission v UK, requiring as it did an investigation of fault in all but name.

ii.That nevertheless, the investigation required by the defendant’s case in fact reveals that throughout the relevant period the producers had failed to take all legitimately expectable steps to avoid the risk of the product being defective: (1) From 1 March 1988 in failing to perform routine surrogate testing of blood donors; (2) From 1 January 1990 in failing to perform anti-hepatitis C Elisa testing of blood donations.

Article 7(e) provides: ‘The 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.’

a.The defendant’s case on Article 7(e) was that in the then state of scientific and technical knowledge, the defect in the particular product could not be discovered, given the shortcomings of both surrogate testing and anti-hepatitis C Elisa 1st generation tests. In other words, the defect has to be discoverable in the blood in the bag in question.

b.The claimants’ case on Article 7(e) was that the defence is not available once the risk of the product being defective was known (which had been the case since the 1970s), whether or not the defect can be discovered in a particular product. In other words, the existence of the defect in the population of products in general has to be undiscoverable for the defence to arise.

Comparative law features of the oral argument

Once the trial began, the European law case was opened by referring to the adoption of the BGB in 1896, and the evolving interpretation of Article 823, which is the basis for establishing liability due to fault under German law. German law in the 1950s and 1960s found against plaintiffs who had unquestionably been injured but were unable to demonstrate fault against a diligent manufacturer who could show the existence of all possible precautions. Thereafter the law changed, reflecting what English lawyers would call a decision to shift the burden of proof, concluding with

the celebrated case of the child injured by the exploding mineral water bottle. This case concerned a young claimant injured by an exploding mineral water bottle resulting from a very fine hairline crack, not discovered despite what was found to be a technical and supervisory procedure in the defendant’s factory in accordance with the very latest technology. Both the Court of Appeal of Hamm and the BGH had experienced little difficulty in concluding that the bottle was a defective product under Article 6 of the Directive, categorising the bottle as an Ausreisser, as a rogue product or sub-standard product. The battlefield in the German courts was Article 7(e) and the young claimant was the victor in the BGH. German law was thus presented as an example of legal evolution in accordance with the principles ultimately espoused by the Product Liability Directive. There was then a very thorough examination of the travaux pr´eparatoires over a period of about fifteen years, from which, so argued the claimants, one could observe that many of the arguments advanced by the defendants had been voiced, examined and not accepted by the drafters of the Directive. The claimants of course had to concede that it was the words of the Directive which should prevail, and that the travaux pr´eparatoires could not supply principles which were not present in the adopted text. It was interesting to observe that the travaux pr´eparatoires contained submissions from chambers of commerce, memoranda from governments, and reports by successive chairmen of the Council Working Group charged with the responsibility of reaching a consensus among the Member States. The books and articles published by those involved in the drafting process, especially Professor Taschner, were particularly relied on.

The claimants also referred to English and Scottish cases such as Smedleys v Breed [1974] AC 839 (the factory produced 3,500,000 cans of peas a year successfully but was convicted when four caterpillars, of the same colour, shape and density as the peas, escaped detection in its food preparation processes and were discovered in a can of peas), and Donoghue v Stevenson [1932] AC 56223 (concerning the alleged snail in the bottle of ginger beer) was invoked as authority for the proposition that what manufacturers claimed was ridiculously severe nonetheless could make

23It should be recorded that, despite its absence from the lists of authorities in both the Lloyd’s Rep Med and the All ER reports of A v NBA, the great case of Donoghue v Stevenson was referred to in argument on at least ten occasions! Reading the dissenting speeches in Donoghue v Stevenson was a salutary reminder that famous cases were not foregone conclusions; Mrs Donoghue was fortunate in having a dogged solicitor who believed he could change the law.