- •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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and one is alleged to be undiscoverable even though the other has been discovered.76
Since the English Hepatitis C decision, the Austrian Supreme Court has held that a coffee machine which caught fire for no clear reason was defective, even though the claimant could not explain the mechanism which led to the outbreak of the fire.77 The defendant ran the development risks defence on the basis that, since 60,000 similar machines had been supplied without any similar incidents, the defect must have been undiscoverable. The Court rejected this argument since the defendant had not proved that it was unknowable at the relevant time that coffee machines could catch fire by reason of ‘unavoidable and perhaps undiscoverable defects’. This is a firm application of the defence in keeping with the goals of consumer protection and liability without fault.
Unresolved issues
State of knowledge
The Court of Justice did not resolve the classic difficulty of defining the ‘state of scientific and technical knowledge’. As discussed above, the notion that the most advanced idea, however abstruse, counter-intuitive or unsupported by evidence, may set the standard is puzzling.78 It is unclear how such an approach fits with the concept of a ‘state’ of knowledge, a phrase which seems to imply some consensus or settled basis.
Accessibility
As a fetter on the effect of such an approach (and, as we have seen, introducing a two-stage test of uncertain textual provenance) the Court of
76Suppose a drug can cause damage to joints and to the liver. If the capacity to cause liver damage is discoverable in 2000 but that to cause damage to joints in 2003, it is uncertain when the defence is lost in relation to the latter. Claimants will attempt to define the defect as the capacity to cause injury per se. Defendants will wish to define the injury with more specificity. This question goes to the definition of defect but clearly affects the availability of the defence. There is no authority on the question.
7710 Ob 98/02p (22 October 2002) discussed in 11 (2003) European Product Liability Review: 37–8.
78Contrast the approach of the US Supreme Court in Daubert v Merrell Dow Pharmaceuticals Inc 509 US 579 (1993) which sought to refine the concept of the state of scientific knowledge, in particular by insisting that the materials relied upon by expert witnesses in their evaluation of scientific controversies should have undergone peer review.
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Justice qualified its view that Article 7(e) is directed ‘unreservedly, at the state of scientific and technical knowledge, including the most advanced level of such knowledge’ by the requirement that such knowledge must have been accessible.79 Burton J was content to follow the qualification although he added no elucidation of the meaning of ‘accessible’ to the gloss imposed on the literal wording of the Directive by the Court of Justice. It is implicit in his judgment that the following would not be considered accessible: (i) an unpublished document and (ii) unpublished research not available to the general public retained within the laboratory or research department of another enterprise. It is not clear whether these are intended to be exhaustive. By inference publication is generally a prerequisite for accessibility.
Does it follow that anything recorded on a searchable database is presumed to be within the producer’s knowledge? Or only that in the same language as that spoken by the producer? Or only that contained in the databases which a producer of products of the type in question is in the habit of searching? It is easy to see that the constraint itself raises satellite questions of degree and interpretation.
Knowledge
A further uncertainty concerns the definition of ‘knowledge’ itself. Traditionally scientific advances are put forward as hypotheses rather than assertions. What is the standard of proof (or level of comfort) required before an idea can fairly be described as knowledge capable of being part of ‘the state of . . . knowledge’? Is the idea itself a sufficient element of knowledge or must the controversy be resolved in its favour? This is clearly important: the controversial suggestion that the measles mumps rubella (MMR) vaccine may have a causal role in the development of autistic symptoms was first made in the Lancet of 28 February 1998 in these terms ‘We have identified a chronic enterocolitis in children that may be related to neuropsychiatric dysfunction.’80 This suggestion was and is still hotly disputed. It is uncertain whether such a statement is sufficiently robust to qualify as (the most advanced) knowledge.
A related dilemma is the question whether an idea must be complete before it is capable of comprising knowledge. If not, the elements which, if connected together, would have constituted the knowledge will
79 EC v UK at para. 26. |
80 A. J. Wakefield, The Lancet 151 (1998) 637–41. |
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themselves, very likely at a far earlier date, defeat the availability of the defence. The Court of Justice did not engage with these problems save to the extent that it decided that the knowledge concerned must be the most advanced. Again, the reason for this was likely to have been the basis for the case – Infringement Proceedings – so that the Court was not inclined to make a judgment on what would and would not have been in issue on a fact-based reference for the interpretation of any of these concepts.
When does a researcher’s idea become knowledge? To what extent can the claimant argue that the conjunction of different strands of thought adds up to discoverability? How does this dilemma interact with the provisions of Article 6.2?81 As Stapleton argued (before the Court of Justice had given prominence to the concept of accessibility): once the criterion for discoverability involves leaps of curiosity or creativity, a succession of value questions are introduced, the inevitable consequence of which is that liability should exist only in respect of defects discoverable by reasonable means, for there is no logical halfway house between absolute undiscoverability (rendering the defence nugatory) and undiscoverability by reasonable means (aping the negligence standard).82
Wide or narrow interpretation
Whilst there is as yet no formal determination of the question whether the wide or narrow interpretation of the defence is correct, the introduction of the criterion of reasonableness into the accessibility of knowledge by the Advocate General has gone a long way to suggest that the defence should be given the wider interpretation.83 Indeed the dictum of the Court of Justice that the accessibility criterion was implicit in the wording of Article 7(e) strengthens this view.84
Conduct of the producer
A further concern relates to the conduct of the producer. The general approach of the court is likely to exclude consideration of the conduct of the producer at the instance of either party. It is to be disregarded for the purposes of ascertainment of defect.85 But it may be taken into account for
81An old car is not defective because a later model incorporates air cushions. But how far do the familiar notions of the softness of a balloon, rapid deceleration on impact and the capacity of hard surfaces to cause wounding combine to make the absence of preventive measures a discoverable defect?
82See Stapleton, Product Liability, pp. 239–42.
83 Para. 24. |
84 Para. 28. |
85 Hepatitis C case para. 72. |
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the purpose of Article 7(e).86 In the circumstances the remark of Burton J: ‘Negligence, fault and the conduct of the producer or designer can be left to the (limited) ambit of Article 7(e)’ raised but did not solve the problem.87 That is not surprising since the context in which the remark was made was whether the defect had to be discoverable in the individual product. It may be that he intended to convey no more than that the defence is the escape route for the producer ‘who has done all he could reasonably be expected to do (and more)’.88
Exclusion of the producer’s conduct from the question of discoverability would, however, allow the producer to fail to take steps to ascertain the true incidence of the unwanted effects of its products with impunity.89 In the Hepatitis C case the defendants unsuccessfully submitted that they must be given the opportunity to do all they could to avoid injury.90 Defendants would presumably argue that they are liable to perform the requirements of the regulator and any criticism that they had not gone far enough should be made in negligence. What is not resolved is whether a court should decide whether a defect would have been discoverable, for example by the producer taking certain steps.
In the English oral contraceptive litigation, the Committee on Safety of Medicines issued a safety warning relating to the third-generation product in October 1995 after three research reports suggested a significant increase in the incidence of venous thrombo-embolism (VTE) in women using them compared to the incidence in those using second-generation products. Since many of those affected had been exposed to the alleged defect before suspension of the licences, the claimants sought to argue that the defendants could and should have set up post-marketing surveillance studies forthwith upon placing the products on the market. If they had done so, the argument ran, the existence of the defect would have been discoverable far earlier. The defendants relied on the argument that the defence asked only whether (that is, when) the defect had been discoverable and they had been under no obligation relevant to the questions posed by the Directive to take steps to collect, analyse and publish the data. They accepted their obligations under the regulatory regime but no more.
86Ibid., para. 73.
87Ibid.; the remark at paragraph 49 (ii) ‘Article [7(e)] is not concerned with the conduct or knowledge of individual producers’ should presumably be read subject to para. 73.
88Para. 64.
89For the contrary view, see C. Hodges in M. Mildred (ed.), Product Liability: Law and Insurance (London: LLP Ltd, 2001), paragraph 2.92.
90Para. 75.