
- •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
COMPAR ING PRODUCT SAFET Y AND LIABILIT Y L AW IN JAPAN 339
PL Law itself, for example by extending coverage to primary (unprocessed) agricultural produce, as occurred in 1999 with the EC Directive in the wake of Europe’s much more extensive BSE epidemic. As in Europe, however, most focus will instead be directed on broader reforms in access to civil justice. Those reforms will provide additional scope for judges and commentators to restate or reformulate a growing corpus of PL law. Already, however, there has been and will be significant re-regulation, bolstering the substantive requirements and enforcement mechanisms in product safety regulation. So far, this has occurred on a productor industry-specific basis in Japan. However, a new regulatory framework on product safety generally can be expected, probably again along EU lines, namely its recently revised Product Safety Directive. Such regulatory schemes offer considerable potential for synergy with – not just substitution for – private law liability regimes, to address appropriately the increasingly complex problems thrown up by the likes of BSE.
Americanisation, Europeanisation or globalisation?
Despite significant advances in understanding about BSE, the disease and its links to variant Creuzfeldt-Jakob Disease (fatal to humans) continue to generate scientific uncertainty and public controversy. In Japan, a twelfth mad cow was confirmed on 9 September 2004, the first in the Kyushu region. The news came just after the government’s new Food Safety Commission moved to relax requirements that all cows be tested in Japan, limiting tests to those aged twenty months or older.8 This should still help resolve an impasse with the US, created by Japan’s ban on imports of US beef following the discovery there of its first mad cow in December 2003, because Japan had insisted that the US test all its cows. However, negotiations will be needed on the age below which untested US beef can be sent to Japan, as testing in the US (and the EU) is limited to cows aged 30 months or older. The US also does not track birth dates precisely, and wants to persuade Japan to accept some statistical sampling.9 Thus, BSE
8Of the mad cows detected so far in Japan, one was 21 months old and another was 23 months old. All others were more than 30 months old, the norm in other countries. Meanwhile, it was reported on 1 June 2004 that Kirin Brewery Co. and a US biotechnology firm have succeeded in genetically engineering a cow to make it immune to BSE, but that the cow’s cells will only be used to develop medicines for humans; it will not be used as a food source. See the news archives searchable at http://mdn.mainichi.co.jp (copies on file with the author).
9‘An End to Japan’s Ban on American Beef May Be in Sight’, The Economist, 11 September 2004, 75.
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LUKE NOT TAGE |
remains a major issue in global trade and diplomacy, as well as domestic law and politics. Yet the governance regime established by the World Trade Organisation retains serious enforcement and legitimacy problems. On the other hand, the experience first in the United Kingdom, then in Japan, and perhaps now in North America, suggests how powerful domestic interests may dominate or divert the norm-settling and enforcement potential of national regulators. Although the EU governance regime had its own difficulties in dealing with BSE, those prompted many reforms, now linked to a raft of broader governance changes for the EU. At least for some sectors, therefore, there seems to be considerable scope for Japan to develop a ‘regional’ governance regime. One pragmatic way to advance this agenda may be to add an explicit harmonisation agenda, with EU-like institutions, to its growing set of bilateral free-trade agreements.10
Even without injecting such a novel EU-like element into Japanese law and policy-making, it is clear that Japan has been heavily influenced by the European model in generating and implementing its strict liability PL regime. The model gained even more kudos from its adoption beyond Europe, as in Australia and other parts of the Asia-Pacific region. That process demonstrates that globalisation still does not equate to Americanisation, at least where – as in PL law and (especially) practice – the US maintains many idiosyncrasies.11 Certainly, it is misleading to provide PL as an example of the ‘Americanisation of Japanese law’, even though Japan over the 1990s has indeed been subjected to political fragmentation, economic deregulation and growth in legal services markets.12 Japanese private law’s ongoing ‘Europeanisation’ also underpins the likelihood of Japan ‘re-regulating’ product safety more on EU models. However, the extent and timing is likely to vary depending on the sectors involved, and the models that happen to be available. Coupling legal reform in Japan to rapidly evolving EU law therefore places growing demands on Japan’s policymakers, including the academic community more generally.
10L. Nottage, with M. Trezise, ‘Mad Cows and Japanese Consumers’ 14(9) (2003) Australian Product Liability Reporter: 125; L. Nottage, ‘Redirecting Japan’s Multi-level Governance’, paper presented at the symposium on ‘Changes of Governance in Europe, Japan, and the US: Corporations, State, Markets, and Intermediaries’, Japan-German Center Berlin, 9–11 September 2004 (forthcoming in proceedings co-edited by Harald Baum and Klaus Hopt).
11M. Reimann, ‘Liability for Defective Products at the Beginning of the Twenty-First Century: Emergence of a World-Wide Standard?’ 51 (2003) American Journal of Comparative Law: 751.
12D. Kelemen and E. C. Sibbitt, ‘The Americanization of Japanese Law’ 23 (2002) University of Pennsylvania Journal of International Economic Law: 269.
Appendix: Council Directive of 25 July 1985 on the approximation of the law, regulations and administrative provisions of the Member States concering liability for defective products (85/374/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,
Having regard to the proposal from the Commission,1 Having regard to the opinion of the European Parliament,2
Having regard to the opinion of the Economic and Social Committee,3
Whereas approximation of the laws of the Member States concerning the liability of the producer for damage caused by the defectiveness of his products is necessary because the existing divergences may distort competition and affect the movement of goods within the common market and entail a differing degree of protection of the consumer against damage caused by a defective product to his health or property;
Whereas liability without fault on the part of the producer is the sole means of adequately solving the problem, peculiar to our age of increasing technicality, of a fair apportionment of the risks inherent in modern technological production;
Whereas liability without fault should apply only to movables which have been industrially produced; whereas, as a result, it is appropriate to exclude liability for agricultural products and game, except where they have undergone a processing of an industrial nature which could cause a defect in these products; whereas the liability provided for in this Directive should also apply to movables which are used in the construction of immovables or are installed in immovables;
Whereas protection of the consumer requires that all producers involved in the production process should be made liable, in so far as their finished product, component part or any raw material supplied by
1 |
OJ No. C 241, |
14. |
10. 1976, p. 9 and OJ No. C 271, 26. 10. 1979, p. 3. |
|
2 |
OJ No. C 127, |
21. |
5. 1979, p. 61. |
3 OJ No. C 114, 7. 5. 1979, p. 15. |
341
342 |
APPENDIX |
them was defective; whereas, for the same reason, liability should extend to importers of products into the Community and to persons who present themselves as producers by affixing their name, trade mark or other distinguishing feature or who supply a product the producer of which cannot be identified;
Whereas, in situations where several persons are liable for the same damage, the protection of the consumer requires that the injured person should be able to claim full compensation for the damage from any one of them;
Whereas, to protect the physical well-being and property of the consumer, the defectiveness of the product should be determined by reference not to its fitness for use but to the lack of the safety which the public at large is entitled to expect; whereas the safety is assessed by excluding any misuse of the product not reasonable under the circumstances;
Whereas a fair apportionment of risk between the injured person and the producer implies that the producer should be able to free himself from liability if he furnishes proof as to the existence of certain exonerating circumstances;
Whereas the protection of the consumer requires that the liability of the producer remains unaffected by acts or omissions of other persons having contributed to cause the damage; whereas, however, the contributory negligence of the injured person may be taken into account to reduce or disallow such liability;
Whereas the protection of the consumer requires compensation for death and personal injury as well as compensation for damage to property; whereas the latter should nevertheless be limited to goods for private use or consumption and be subject to a deduction of a lower threshold of a fixed amount in order to avoid litigation in an excessive number of cases; whereas this Directive should not prejudice compensation for pain and suffering and other non-material damages payable, where appropriate, under the law applicable to the case;
Whereas a uniform period of limitation for the bringing of action for compensation is in the interests both of the injured person and of the producer;
Whereas products age in the course of time, higher safety standards are developed and the state of science and technology progresses; whereas, therefore, it would not be reasonable to make the producer liable for an unlimited period for the defectiveness of his product; whereas, therefore, liability should expire after a reasonable length of time, without prejudice to claims pending at law;
APPENDIX |
343 |
Whereas, to achieve effective protection of consumers, no contractual derogation should be permitted as regards the liability of the producer in relation to the injured person;
Whereas under the legal systems of the Member States an injured party may have a claim for damages based on grounds of contractual liability or on grounds of non-contractual liability other than that provided for in this Directive; in so far as these provisions also serve to attain the objective of effective protection of consumers, they should remain unaffected by this Directive; whereas, in so far as effective protection of consumers in the sector of pharmaceutical products is already also attained in a Member State under a special liability system, claims based on this system should similarly remain possible;
Whereas, to the extent that liability for nuclear injury or damage is already covered in all Member States by adequate special rules, it has been possible to exclude damage of this type from the scope of this Directive;
Whereas, since the exclusion of primary agricultural products and game from the scope of this Directive may be felt, in certain Member States, in view of what is expected for the protection of consumers, to restrict unduly such protection, it should be possible for a Member State to extend liability to such products;
Whereas, for similar reasons, the possibility offered to a producer to free himself from liability 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 a defect to be discovered may be felt in certain Member States to restrict unduly the protection of the consumer; whereas it should therefore be possible for a Member State to maintain in its legislation or to provide by new legislation that this exonerating circumstance is not admitted; whereas, in the case of new legislation, making use of this derogation should, however, be subject to a Community stand-still procedure, in order to raise, if possible, the level of protection in a uniform manner throughout the Community;
Whereas, taking into account the legal traditions in most of the Member States, it is inappropriate to set any financial ceiling on the producer’s liability without fault; whereas, in so far as there are, however, differing traditions, it seems possible to admit that a Member State may derogate from the principle of unlimited liability by providing a limit for the total liability of the producer for damage resulting from a death or personal injury and caused by identical items with the same defect, provided that this limit is established at a level sufficiently high to guarantee adequate