- •Contents
- •Figures
- •Foreword
- •Contributors
- •Preface
- •1 Introduction
- •Product liability and overlapping interests
- •The European Directive and harmonisation
- •Product liability: why compare?
- •Contents of the book
- •Introduction
- •The medicine
- •The English legal principles
- •Preparation of the case
- •German law
- •Consulting the retired draftsman of the directive
- •Research in other EC Member States and in the United States concerning relevant writings and judicial experience
- •Carrying out research at the Max Planck Institute
- •Collecting all language versions of the legislation and preparing translations of other material
- •The request for a reference in 1999
- •The non-issues
- •Product
- •Producer
- •Consumer Protection Act versus Directive
- •The core issues
- •Comparative law features of the oral argument
- •The judgment
- •Envoi
- •Postscript by Nicholas Underhill QC
- •3 Spanish product liability today – adapting to the ‘new’ rules
- •Introduction: the application of the Spanish Product Liability Act by the courts
- •Consumer Protection Act or Product Liability Act: which rules apply?
- •Strict liability versus fault liability. Which grounds for liability?
- •The legal concept of ‘product’: products or services?
- •The legal concept of ‘defect’. Manufacturing defects or useless products?
- •The legal concept of ‘manufacturer’: back door for the supplier?
- •Defences, in particular, the full development-risks defence for public bodies
- •Recoverable damage: how to compensate non-pecuniary loss and the problem of the ‘lower threshold’
- •Compensation for death and personal injury
- •The 500 ECU threshold
- •Conclusion
- •4 Interaction between the European Directive on Product Liability and the former liability regime in Italy
- •Introduction
- •Italian background to the European Directive
- •The implementation of the European Directive
- •The role of warnings and advertising
- •The expectation test and the distribution of liability between the parties
- •Manufacturer liability
- •Court’s pro-claimant attitude: joint and several liability
- •Recovery for emotional distress
- •The use of presumptions
- •Drawing a consumer model
- •The (dis)advantages of the European Directive in competition with other liability regimes
- •Limitations to the consumer’s right of claim
- •Product liability function betrayed
- •Access to justice in mass tort cases
- •Conclusion
- •Introduction
- •Damages liability under French law
- •Law of contract
- •Obligation to guarantee against defects
- •Tort law
- •Article 1384 (1) of the French Civil Code
- •Implementation of the Directive
- •Commission v France
- •Parallel regimes and extent of harmonisation
- •Conclusion
- •6 German product liability law: between European Directives, American Restatements and common sense
- •Introduction
- •Product liability based on pre-market defects
- •Contract
- •Tort
- •1. Breach of a duty of care
- •2. Breach of statutory duty
- •Product Liability Act
- •1. Defect
- •3. Defences
- •4. Causation
- •Liability based on breach of post-marketing duties
- •Duty of care
- •Product safety laws
- •Liability for drugs
- •Background
- •Scope of the Drug Act
- •Defective drug
- •Causation
- •Compulsory insurance
- •State compensation schemes
- •Practice and procedure
- •Pre-trial discovery
- •Experts
- •Trial on preliminary issues
- •Fee arrangements and legal costs
- •Class or representative actions
- •7 Dutch case law on the EU Product Liability Directive
- •Introduction
- •Defect and development risk defence
- •Presentation of the product and expected use
- •Proof of the defect
- •Proof of causal relationship between defect and damage
- •Information about the identity of producer or importer
- •Putting a product into circulation
- •The position of the supplier
- •The DES-case: proof of causation
- •Conclusion
- •8 Defect in English law – lessons for the harmonisation of European product liability
- •Comparative law in the courtroom
- •Strict liability is different from negligence
- •General standard
- •Relevant factors
- •Non-standard products
- •Warnings
- •Implications
- •Application of defectiveness standard across Europe
- •Development risks
- •Development of European private law
- •9 Product liability: basic problems in a comparative law perspective
- •Negligence or strict liability?
- •Was this decision correct?
- •Is the limitation of the amount of damages an essential feature of strict liability?
- •Development risk liability
- •10 The development risks defence
- •Introduction
- •History
- •Implementation
- •The meaning of the defence
- •Decided cases
- •Early cases
- •The infringement proceedings
- •1. The legal meaning of the provisions
- •2. The arguments of the parties
- •3. The Opinion of Advocate General Tesauro
- •4. The judgment of the Court of Justice
- •5. Discussion
- •Cases after the Infringement Proceedings
- •Unresolved issues
- •State of knowledge
- •Accessibility
- •Knowledge
- •Wide or narrow interpretation
- •Conduct of the producer
- •Manufacturing defects
- •Discoverability in the individual product
- •Reform
- •Conclusion
- •11 Approaches to product liability in the EU and Member States
- •The essential components of product liability
- •Substantive law
- •Procedure
- •Damages
- •Jurisdictional issues
- •Does the Community have jurisdictional competence to propose a new Directive on product liability?
- •Conclusion
- •12 Product liability – a history of harmonisation
- •Introduction
- •How much harmonisation is necessary?
- •Modernisation
- •Defect and development risk
- •Conclusion
- •13 Harmonisation or divergence? A comparison of French and English product liability rules
- •Liability according to the legislative rules
- •The liability of the manufacturer
- •The liability of the supplier
- •French court decisions under the new regime
- •The contractual and extra-contractual actions
- •The English law
- •The French law
- •The future of liability rules in France following the incorporation of the Directive
- •Conclusion
- •14 Product liability law in Central Europe and the true impact of the Product Liability Directive
- •Introduction
- •Methodology and structure of the study
- •The political momentum for the implementation of the Directive – Central Europe striving to join the European Union
- •Implementation of the Directive
- •The internal momentum for change – Central Europeans striving for strict liability and beyond
- •The context of product liability laws in Europe – consumer policies, consumer position and consumer law – differences between the East and the West
- •Central Europe and consumers – particular sources of divergences
- •Central European legal systems and their effect upon the product liability regimes
- •Central European product liability regime – before the implementation of the Directive and the new regulation
- •Introductory remarks
- •Contractual liability
- •Tortious liability
- •Legal bases of tortious liability regimes
- •Products within the scope of application of product liability laws
- •The requisites of tortious product liability:
- •Introduction into circulation of a defective product
- •1. Introduction into circulation
- •2. Defective product
- •3. Fault – the attribute of the defendant’s conduct
- •4. Defences in a ‘fault’ liability system of Central European tort law and in the ‘strict’ liability system of the Directive
- •Damages
- •Causal link between the defendant’s act and the damage
- •1. Time limits for bringing action
- •Conclusion
- •Introduction
- •Orientation of United States products regimes
- •Orientation of the European Union Directive and its clones
- •Pre-manufacture generic infection cases
- •Response of the Restatement Third
- •Response of the Directive and its clones: the Hepatitis C judgment
- •Other responses to pre-manufacture generic infection cases
- •Conclusion
- •Mitsubishi, mad cows and Minamata
- •Comparing product liability and safety in Japan
- •Americanisation, Europeanisation or globalisation?
- •THE COUNCIL OF THE EUROPEAN COMMUNITIES
- •HAS ADOPTED THIS DIRECTIVE
- •Article 1
- •Article 2
- •Article 3
- •Article 4
- •Article 5
- •Article 6
- •Article 7
- •Article 8
- •Article 9
- •Article 10
- •Article 11
- •Article 12
- •Article 13
- •Article 14
- •Article 15
- •Article 16
- •Article 17
- •Article 18
- •Article 19
- •Article 20
- •Article 21
- •Article 22
- •Index
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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,
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Medical containing 283 paragraphs). |
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32 |
Para. 15.i. |
33 Para. 15.ii. |
34 Para. 44. |
35 |
Para. 14. |
36 Para. 55. |
37 Para. 53.i.a. |
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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.
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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. |
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47 |
Para. 73. |
48 |
Para. 65.ii. |
49 Para. 73. |
50 Para. 65.ii. |
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51 |
Para. 80. |
52 |
Para. 80. |
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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
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paragraph 15 of the judgment). |
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56 |
Para. 64. |
57 |
Para. 74.iii. |
58 Para. 76. |
59 Para. 52. |
60 Para. 76. |
61 |
Para. 77. |
62 |
Or NANB. |
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