- •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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Failure to take the ‘appropriate action’ will normally lead to liability. Whether and what action is appropriate is not to be judged with hindsight but in consideration of the circumstances at the time when such action was due. However, this is an objective standard focussing on the danger of the product, not on the capabilities of the individual manufacturer. However, it is currently unclear whether failure to recall a product under the requirements of the GPSG is a cause for liability. Clearly, if the relevant authority has ordered a recall, failure to comply with that order will render the producer liable. If there has been no recall order, however, liability will presumably not arise in circumstances where, considering the costs and benefits of such action, it was reasonable not to recall the product, i.e. there is no liability where there would be no liability in negligence.
Liability for drugs
Background
Liability for drugs under the German law of product liability to some extent differs from the Product Liability Directive. The Drug Act 1976 is the only special product liability regime in Europe that existed prior to and is thus exempted from the Directive (Article 13). It includes liability for development risks and renders insurance compulsory. It also incorporates new rules on causation and special rules governing disclosure of information, both of which were introduced in 2002.110 The Drug Act of 1976 was enacted against the background of the thalidomide crisis of the late 1950s, which had struck Germany particularly badly. This incident highlighted the necessity of reviewing the quality, efficacy and safety of medicinal products prior to their marketing, authorisation and sale.
Scope of the Drug Act
The Drug Act only applies to drugs and other medicinal products which hold (or are bound to hold) a marketing authorisation. It does not, for example, apply to veterinary medicines, homeopathic preparations and medicinal products used in clinical trials. The potentially liable ‘pharmaceutical enterprise’ is the entity named on the packaging that has placed
110 See also I. Brock, ‘German Parliament Passes the Second Act to Change the Rules Relating to Damages’ in Lovells, European Product Liability Review, June 2002 at 16 f.; http://www.lovells.com (Publications – Newsletters).
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the product on the German market. Injuries suffered from these medicinal products may be covered by the Product Liability Act and liability based on tort.
Defective drug
According to §84 (2) no. 1 of the Drug Act, the ‘pharmaceutical enterprise’ is liable if ‘a drug, used correctly, has harmful effects which, taking into account the state of medical knowledge, exceed a tolerable level’. That is the case if the overall risks of the product outweigh the overall benefits (macro balance) or if the risks could have been reduced by the adoption of a reasonable safer design (micro balance).111
Alternatively, the distributor is liable ‘if the injury is caused by an instruction which does not adequately represent the state of medical knowledge’ (§84 (2) No. 2). The labelling requirements for the summary of product characteristics and the package insert leaflet are laid down in Articles 11 and 59 of Directive 83 (2001) EC. Product information must, in a clear and appropriate way, point to any product risks and side effects known at the time of circulation, and point out any serious possibility of such risks and side effects. The product information must also include instructions relating to the correct use of the drug and it must in certain circumstances also highlight the possible consequences of foreseeable misuse.112 There is no formal ‘learned intermediary defence’, whereby the warning of doctors is sufficient. However, it is difficult for the patient to prove that he would not have taken the drug in the presence of warnings if the prescribing doctor had been made aware of the risks.
Causation
The claimant, in principle, needs to prove a causal link between the defective drug and the damage. Yet there are exceptions to this rule.
In 2002 the German legislator, in an unprecedented fashion, changed the rules on causation.113 According to the new rules, actual causation between the application of the drug and the damage is presumed if the drug in question is, in the actual circumstances, capable of causing such
111 |
¨ |
|
For an economic analysis of the German Drug Act, see Blantzenberg, ‘Okonomische |
Analyse des deutschen Arzneimittelhaftungsrechtes’, PharmR 2000, 39.
112BGHZ 106, 273, 284 (Asthma Spray).
113For an overview, see Bollweg, ‘Die Arzneimittelhaftung der AmG’, MedR 2004, 486; Pfluger,¨ ‘Kamsalitatsvermutung’,¨ PharmR 2003, 363. Wagner, ‘Reform der Arzneimittelhaftung’, VersR 2001, 1334.
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damage (§84 II 1 Drug Act).114 This rule does not, however, apply ‘if, in the actual circumstances, a different instance is capable of causing the damage’ (§84 II 3 Drug Act). However, another drug which also may have caused the injury is not regarded as a ‘different instance’. This is different if this drug is not considered defective (e.g. because its harmful effects are acceptable in the light of the benefit–risk assessment).
Whether the new causation rules are in compliance with EC law remains to be seen. There are sound reasons why the new rules may contravene Article 13 of the Product Liability Directive. Article 13 allows special product liability systems to remain applicable if they existed at the time when the Directive was adopted by the Council, i.e. on 25 July 1985. The German Drug Act dates back to 1976, yet the amendments relating to causation were enacted in 2002. The question thus is whether Article 13 allows changes to existing systems. The European Court of Justice recently made clear that the Product Liability Directive seeks to achieve maximum harmonisation within its scope.115 That suggests a narrow reading of Article 13, one that does not allow the German legislator to go it alone in the EU and change the only (national) co-existing product liability regime in a way that would, after eighteen years of practical symmetry with the Directive, make a real difference.
Compulsory insurance
A party placing a medicinal product on the German market must be insured against all liability under §84 of the Drug Act, either through a German insurance company or by obtaining a confirmation of cover from a credit institution in Germany or within the EU. The German insurance industry has created a ‘pharma pool’ through which all major insurance companies pool the statutory strict liability risk, thus facilitating affordable insurance premiums.
Liability for genetically modified products
The Genetic Engineering Act came into force on 1 July 1990 and aims at protecting human beings and the environment against dangers which may
114See OLG Koblenz NJOZ 2004, 2983.
115Case C-52/00, Commission v France [2002] ECR I-2553; Case C-154/00, Commission v Greece [2002] ECR I-3879; Case C-183/00, Gonz´alez S´anchez v Medicina Asturiana [2002] ECR I-3901.
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arise from genetic engineering. It also establishes a legal framework for relevant research and development and the exploitation and promotion of this technology. Activities conducted in genetic laboratories are classified into four containment levels according to the degree of risk they involve. §§32 ff. of the Genetic Engineering Act provide for the operator’s absolute liability if damage is caused to third parties as a result of properties of a genetically modified organism. Liability is limited to a maximum amount of €85 million. The Act also includes liability for development risks (i.e. there is no development risks defence).116 Liability based on the Genetic Engineering Act covers material as well as immaterial damages (the latter as of August 2002). In so far as the Genetic Engineering Act derogates from the Product Liability Directive,117 one could query its compliance with Article 13 of the Directive (see above).
State compensation schemes
State compensation schemes play some role in German product liability law. Thalidomide victims have a right to benefits provided by a public foundation established in 1971.118 Another public foundation has been set up to help patients who were infected with HIV through contaminated blood products before 1 January 1988.119 In both cases, the endowments are shared by the state and the relevant pharmaceutical companies. There is also financial aid available for a specific group of people who have been infected with the hepatitis-C virus through particular batches of vaccine.120
Most notably, however, there is a special compensation scheme for accidents at the work place and occupational diseases.121 A large part of asbestos litigation, for example, is for this reason redirected to the social security system.
116§37 II GentechnikG.
117That is, particularly with regard to products without marketing approval (compare §37
IIGentechnikG).
118Gesetz uber¨ die Errichtung einer Stiftung ‘Hilfswerk fur¨ behinderte Kinder’, BGBl. I 1971, 2018 ff.
119Gesetz uber¨ die humanitare¨ Hilfe fur¨ durch Blutprodukte HIV-infizierte Personen, BGBl.
I1995, 972 ff.
120See I. Brock, ‘State Compensation for HCV Infections in the Federal Republic of Germany’ December (2002) European Product Liability Review : at 16–17.
121The competent institutions are the Bundesberufsgenossenschaften.