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A & OTHERS V NATIONAL BLOOD AUTHORITY

29

The judgment

The resolution of these issues as to the true and proper construction of the Directive, having entailed wide-ranging comparative arguments, led to a judgment which refers to authorities from eight30 jurisdictions and numerous learned books and papers.31

The learned judge directed himself that he should approach the travaux pr´eparatoires with caution.32 Bearing in mind that he should be alive to there being an ‘autonomous’ or Community meaning or construction for harmonising pan-European legislation, the judge welcomed the guidance to be obtained from considering the official different language versions of the Directive and was tentatively prepared to look at how the Directive had been implemented and judicially applied in other Community countries;33 a little later in his judgment he shows more enthusiasm for judicial decisions elsewhere in Europe for reasons both of comity and harmony, in approaching this piece of common legislation.34 The judge attached great importance to the Directive’s recitals as aids to its construction, listing the significant ones at an early stage.35

The judgment makes many citations from the academic literature in respect of both Article 6 and Article 7(e). In part this is because of the dearth of previous judicial decisions, particularly on Article 6, but it also demonstrates a willingness by the judge to adopt a broad and purposive approach to the task of construction that faced him. The judge, in formulating his conclusions on Article 6, underpins them at the outset by reference to European academic literature.36

The court decisions that carried most weight with the judge and clearly gave him most assistance were Commission v UK and the decision of the BGH in the mineral water bottle case, both cases directed at Article 7(e) but both offering some assistance on Article 6. It is interesting to observe that the opinion of Advocate General Tesauro (in Commission v UK) needed to be consulted in its original Italian to see that at one point he had used the subjunctive, which had not been carried over into the official English translation.37 The judge took on the task of analysing the BGH ’s very dense judgment in the mineral water bottle case and came

30England, ECJ, New Jersey, Illinois, Germany, Holland, France and Australia.

31The reader should know that the judgment, even by English standards, is long: as handed down it is 170 pages long containing 284 paragraphs (105 pages in Lloyd’s Law Reports,

 

Medical containing 283 paragraphs).

32

Para. 15.i.

33 Para. 15.ii.

34 Para. 44.

35

Para. 14.

36 Para. 55.

37 Para. 53.i.a.

30

MICHAEL BRO OKE AND IAN FOR RESTER

to the conclusion: ‘What the BGH was primarily saying is that if the risks are known, unavoidability of the defect in the particular product is no answer.’38 Burton J’s conclusions on Article 6 may be summarised thus:

a.The words all the circumstances are not exclusive; neither are they unlimited. They are not to be subjected to a restricted construction eiusdem generis to the specific examples given in Article 6. Having regard to other language versions,39 in particular the French where ‘notamment’ ( ‘notably’) is used rather than ‘including’, the specific examples given in Article 6 are intended to be the most significant circumstances. All the circumstances are to be construed as all relevant circumstances.

b.Avoidability (i.e. the defendant’s case on Article 6) is not one of the circumstances to be taken into account within Article 6.40 It is not a relevant circumstance, being outwith the purpose of the Directive,41 which was to relieve consumers not merely of the need to prove fault or negligence but also of the need to show that the producer had taken all legitimately expectable steps. Furthermore, had avoidability been relevant, it would have been a significant circumstance departing from the purpose of the Directive and as such would have been mentioned specifically in Article 6.

c.The first step is to identify the harmful characteristic which caused the injury. The next step is to conclude whether the product is standard or non-standard. If the respect in which it differs from the series includes the harmful characteristic, then for the purpose of Article 6 it is nonstandard. The judge preferred this approach to that taken in the United

States42 of categorising product defects as design, manufacturing

38Para. 53.ii.

39In Para. 34.ii. the judge observes: [a possibility is] that they [“all circumstances”] are to be construed as the most significant examples of the circumstances. There was some support for this proposition, both by way of some exemplars in European legislation – from which it could be suggested that European draftsmen had considered that the matters actually set out as examples were the ones most worthy of mention – and also by reference to the French language version of Article 6, which used the word, before the list of the circumstances, “notamment”, and the German, which used “insbesondere”, both of which I take to mean “in particular” or “especially” – although other language versions use phraseology more similar to the English “including” .’

40Para. 63.

41Having regard, in particular, to the recitals of the Directive, recitals 2 and 6 being most apposite.

42See the American Law Institute’s Third Restatement of the Law of Torts 1998, Cap. 1, Section 2 Categories of Product Defect.

A & OTHERS V NATIONAL BLOOD AUTHORITY

31

or labelling43 defects, which approach has commonly been adopted by academic writers. The judge saw44 no reason to take this approach (he was not invited to do so by either party) and observed both that the Directive made no attempt to categorise defects and that the attempt to fit any particular situation into one of these ‘boxes’ in fact gave no assistance in carrying out the task of deciding under Article 6 whether the product is defective. Materials in the travaux pr´eparatoires deflected the judge from taking the ‘risk/utility’ approach to defect favoured by the US Second Restatement on Torts (1965).45 He was encouraged in his course of preferring ‘standard/non-standard’ as part of the test of defectiveness by the fact that both Italy and Spain by express legislation had provided that non-standard products would automatically be defective within Article 6 of the Directive, an example of implementing legislation in other Community countries feeding our debate.46

d.In the case of non-standard products it will be relevant to compare them with other products on the market and to consider whether the public at large accepted the non-standard nature of the product, but that is not the end of the matter as the court has to decide the question what is the legitimate expectation as to safety of the product, which may be higher or lower than the public expectation.

e.If the unsafe product is standard for the purpose of Article 6, then the judge acknowledged that the process may be more difficult,47 though questions of avoidability would remain irrelevant and social acceptability would only arise through knowledge of the unsafeness.48

f.The judge proceeded to hold:

i.that blood infected with hepatitis C was non-standard49

ii.that the public had not taken it to be socially acceptable for nonstandard units of blood to infect patients with hepatitis C,50 the knowledge of the medical profession being irrelevant to that consideration51

iii.that the public at large were entitled to expect that the blood transfused to them would be free from infection52

iv.that the blood which infected each of the claimants was defective for the purpose of Article 6.

g.Burton J went on to address the defendant’s case on defect and having heard a large body of factual and expert evidence, having made a number of findings of fact, having taken into account:

43

Instructions and warnings.

44 Paras. 39 to 41.

45 Para. 35.i.

46 Para. 36.

47

Para. 73.

48

Para. 65.ii.

49 Para. 73.

50 Para. 65.ii.

 

51

Para. 80.

52

Para. 80.

 

 

 

 

32

MICHAEL BRO OKE AND IAN FOR RESTER

i.all the circumstances on the defendant’s construction of Article 6,

ii.the fact that the precautions of the introduction of surrogate testing and earlier introduction of routine screening were not taken

he came to the conclusion53 that ‘such blood so infected on and after 1 March 1988 did not provide the safety which persons generally are entitled to expect’. Burton J’s conclusions54 on Article 7(e) may be summarised thus:

a.Article 7(e) derogates from the purpose of the Directive and should be construed strictly for that reason.55 The judge had already used the very restrictedness of the Article 7(e) defence as an aid to construction when considering Article 6.56

b.The existence of the defect means the existence of the generic defect, not the defect in the particular product.57

c.Article 7(e) protects the producer in respect of the unknown generic defect; its purpose is to protect the producer against liability for the ‘inconnu’, not to provide a defence in the case of damage caused by a known but undetectable generic defect.58 In his analysis of Article 7(e) the judge acknowledges the guidance of Commission v UK and suggests that his conclusions are in line with the decision of the BGH and the majority of academic writers. When encapsulating the travaux pr´eparatoires for the purpose of Article 7(e),59 the judge records that originally the intention of the Commission was that the Directive should impose liability even for the ‘inconnu’, meaning the inclusion of liability for true development risks; the outcome of the legislative process was the opposite and became Article 7(e). This was a further reason for concluding as the judge did in respect of Article 7(e): ‘Hence it protects the producer in respect of the unknown (inconnu).’60

d.Accordingly non-standard products may qualify under Article 7(e); ‘However once the problem is known by virtue of accessible information, then the non-standard product can no longer qualify for protection under Article 7(e).’61

e.Throughout the relevant period the generic defect of blood some-

times being infected with hepatitis C62 was well known and

53 Para. 173.

54 Paras. 74 to 77.

55Para. 75. Note that in the Danish Kidney case the ECJ said much the same in relation to Article 7(a), treating it as a given but going through a similar thought process (see

 

paragraph 15 of the judgment).

 

 

 

56

Para. 64.

57

Para. 74.iii.

58 Para. 76.

59 Para. 52.

60 Para. 76.

61

Para. 77.

62

Or NANB.