
- •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
INDEX
A v National Blood Authority
and access to justice 14, 15, 33–4 assessment 181–4, 212, 325–30 authority 191, 326
cause of action 13–15 claimants’ case 25, 26
comparative law 17–22, 26–8, 35, 36–9, 215
core issues 24–6 defect 193, 319
defendant’s case 25, 26, 187 development risk defence 212 and drafting of Directive 19–20,
35–6
English legal principles 17 generally 13–34
and German law 18–19, 150, 214, 222
interpretation of words 17 judgment 29–33, 39–40, 326 Max Planck Institute, research at
21, 37
medical facts 15–16 non-issues 22–4
oral argument 26–8, 39–40 preliminary reference, refusal 22,
172, 213
preparation of case 17–22 research in other jurisdictions
20–1
response to pre-manufacture generic infections 325–30
strict liability 140–52 translation work 22, 36
and travaux pr´eparatoires 19, 22, 26, 27, 29, 31, 32, 36
academic writing 21, 214, 300
access to justice
class actions. See class actions and Directive 77–8, 79
English blood contamination case 14, 15, 33–4
European approaches 196–7 Japan 337–8
recurring issue 7
Scottish blood contamination 15 administrative law, France 85 advertising
and concept of defect 71, 102 German law 102
Italian law 71 warnings. See warnings
agricultural products 208, 276 alternative dispute resolution 338 asbestos 81, 122
aspirin 328 Australia
and A v National Blood Authority
28, 150, 213
development risk defence 189, 213
Euro-clone 303, 336, 337
food-poisoning case 330–1 Austria 184, 193, 196, 198
Bayer 101 Belgium 63, 215 Bell, John 84
blood. See contaminated blood ‘blood shield’ statutes 312 Bourgoignie, T. 255
breast implants 215 Brierley, J. 244
350
INDEX |
351 |
|
BSE 302, 306 |
legal profession 259 |
|
EU response 208 |
legal systems 264–6 |
|
French claims 318 |
limitation periods 293 |
|
Japan 339–40 |
market conditions 247 |
|
UK statistics 307–10 |
monitoring 281 |
|
burden of proof |
political context 248–51 |
|
Central Europe 287 |
products, scope 275–7 |
|
civil law systems 195 |
putting into circulation 278 |
|
defects 114–15, 130–1, 148–9, |
regulatory compliance 283, |
|
158–9, 193, 213, 215, 287 |
287 |
|
development risk defence 178 |
relevance 244–5 |
|
Dutch law 130–1 |
res ipsa loquitur 283–4 |
|
England 133 |
strict liability 252–4 |
|
France 148–9, 193, 235 |
tortious liability 270–2 |
|
Germany 102, 114–15, 158–9, |
Chronic Wasting Disease (CWD) 310, |
|
203 |
331 |
|
Italy 78 |
Chrystal, K. A. 255 |
|
|
civil law systems |
|
Calais-Auloy, J. 97 |
academic writing 21 |
|
Canada, HIV case 330 |
burden of proof 195 |
|
causation |
indirect means of control 326 |
|
Central Europe 293 |
and stare decisis 20 |
|
Dutch Law 131–3, 135–7 |
CJD 302, 307–10 |
|
French law 228 |
class actions |
|
German law 116, 120–1, |
Bayer in US 101 |
|
133 |
and Directive 67, 81–2 |
|
reversal rule 132–3 |
European approaches 197–8 |
|
Spanish law 194 |
German law 124 |
|
Central Europe 9 |
Italian law 81–2 |
|
causation 293 |
trends 295 |
|
claimants 275 |
United States 81, 101 |
|
competition 259 |
Coleman, Jules 301 |
|
component parts 276–7, |
Commission v France 94–6, 204–5, 222, |
|
288–9 |
223, 237, 239 |
|
consumer laws 254–64 |
Commission v UK |
|
contractual liability 266–70 |
arguments 174 |
|
damages 289–92 |
discussion 178–9, 324, 326 |
|
defective products 278–82 |
generally 173–9, 213 |
|
defences 286–9 |
importance 211–12, 223–4 |
|
defendants 272–5 |
judgment 177–8 |
|
design defects 280 |
later cases 179–84, 224–8 |
|
effect of implementation 266–75 |
legal meaning of provisions 173–4 |
|
Europe agreements 245, 248–50 |
opinion of Advocate General |
|
force majeure 286 |
176–7 |
|
impact of EU product liability |
common law systems |
|
regime 245–6 |
common features 298–9 |
|
implementation of Directive 246, |
divergences 299 |
|
251–2 |
product regimes 297–300 |
|
352 |
INDEX |
comparative law
A v National Blood Authority
17–22, 26–8, 35, 36–9, 215
basic product liability issues 155–66
compensation ceilings 161–3 cross-fertilisation 6–7 development risk defence 163–6 and English courts 138–40
and harmonisation 139 limitations 333
negligence or strict liability 140–2 uses 4–5, 212
compensation. See damages competition, Central Europe 259 component parts, Central Europe
276–7, 288–9 conditional fees, England 196 Conk, George 317–18 consumer contracts
France 86–9, 159 unfair terms 196 United Kingdom 229
consumer protection Central Europe 254–64
v commercial interests 195 Directorate General 202
and European Directive 2–3, 303, 325
France 241 harmonisation 195 Italian law 74–5
contaminated blood acceptance of risk 15 blood as product 22–3 ‘blood shield’ statutes 312 cause of action 13–15 claims 209–10
defect 14–15, 18, 24
Dutch case 128, 179, 193, 213, 330
England. See A v National Blood Authority
France 169, 225, 231, 235
Germany 108, 122, 163–4 medical facts 15–16 Spanish cases 45–6, 55, 92–3
transfusion services as producers 23
UK crisis 311
US legal response 312–18 contingency fees 124, 196 contractual liability
Central Europe 266–70 Czech Republic 267–8, 274 England 229
France 86–9, 159, 230–2 Germany 101–2 Hungary 268–9
Poland 267, 269 contributory negligence 71, 90 costs
Austria 196 contingency fees 124 England 196 Germany 124, 196 legal aid 196
Council of Europe, Strasbourg Convention on Product Liability 1977 167, 320
court procedures changes 295
European approaches 197–8 Germany 123–5; costs 124; expert
opinions 123; preliminary issues 123–4; pre-trial discovery 123; simplification 197
harmonisation 197 Creutzfeldt-Jakob disease (CJD) 302,
307–10 Croatia 244 Czech Republic
components 277, 288 consumer protection 263 contractual liability 267–8,
274 damages 290–2
defective products 279 definition of products 276 EU membership 250 excluded products 276
identification of producers 273 implementation of Directive 251 joint and several liability 275 legal system 265–6
INDEX |
353 |
manufacturer liability 274, 285 manufacturing defects 280 presumption of fault 282 tortious liability 270, 271
Czechoslovakia Civil Code 265
components 277 consumer protection 261
contractual liability 267–8, 274 damages 290–2
Daihatsu 335 damages
ceilings; German law 116–17, 161, 162, 163; and insurance 162; Spanish law 59–62, 162, 163; and strict liability regime 161–3
Central Europe 289–92 Directive 79
European approaches 198 France 85–6
Germany 63, 116–17, 122, 162, 163
Hungary 290, 292 Italy 75–6 Poland 292
punitive damages 198
Spain, personal injuries 59–62 state compensation schemes 122,
194
threshold; Belgium 63; French implementation 94–5; German law 63; Greece 204; Italian law 62, 69; review of option 208, 210; Spanish law 62–5
David, R. 244 defects 7
A v National Blood Authority 24, 30–2, 142–8, 193, 319
burden of proof 158–9, 215, 287 Central Europe 278–82 classification 103, 107–8, 157–8,
161, 305, 317–18, 327 consumer expectations. See
expectations
contaminated blood 14–15, 18, 24
Czech Republic 279
definition 189
design. See design defects and development risk defence
211–15
Dutch law; causation 131–3; contaminated blood 128, 179, 193, 213, 330; expected use 130; proof 130–1
English law; design defects 229–30; non-standard products 143, 148, 182, 212, 327; relevant factors 143; standard products 142–8; warnings 145–6
European definition 3, 208, 303–4, 321, 322
evidence 215
French law 280; contractual guarantees 86–8; proof 148–9, 193, 215; victim friendly definition 235, 241
German law; contractual liability 101–2; design defects 104–5, 109–12, 157; drugs 120; excessively dangerous products 112–13, 157; manufacturing defects 108–9, 115, 157, 193; Product Liability Act 107; proof 114–15; three types of defects 103, 107–8, 157–8; tortious liability 103
Hungary 279, 282–6 instruction defects 281 Italian law; definition 70–1;
foreseeability 70–1; warnings and advertising 71
legitimate expectations 25, 70 manufacturing. See
manufacturing defects Poland 279–80
Spain 48, 50–4 defences 17
Central Europe 286–9 development risk. See
development risk defence force majeure 55–6, 90, 286 French law 90, 95–6 German law 115
Italian law 72–3
354 |
INDEX |
defences (cont.)
regulatory compliance 23, 283, 287
Spanish law 54–8; drugs 57; force majeure 55–6; liability of public bodies 55–8; ‘other circumstances’ 51–2; private and public law 55–8
time of circulation 115 UK law 23
Denmark 173, 193, 194, 210 DES case 135–7
design defects
Central Europe 280 English law 229–30
German law 104–5, 109–12, 157 nature of liability 160
United States 302, 317–18 development risk defence
Austrian case 184 burden of proof 178 Central Europe 287–8
Commission v UK 173–9, 211–12, 213, 223–4, 324, 326
comparative assessment 163–6 critique 80
Danish case 173
and defect concept 211–15; manufacturing defects 212
Dutch contamination case 129–30, 179–80
economic impact 209 English law 149–51; early case
170–3; later cases 180–1, 224–8; oral contraceptive case 187–8
Finland 165, 168 Fondazione Roselli report 8
French law 165, 168, 181, 188, 224–8
German law 114, 115, 116–17, 163–4, 165, 171–2
history 167–8 Hungary 287 implementation 168–9
issues 8, 184–9; accessibility of knowledge 150, 179–85, 224; conduct of producers 186–8; definition of defect 189;
definition of knowledge 185–6; discoverability of individual products 188–9; manufacturing defects 188; state of knowledge 184; wide v narrow interpretation 186
Italy 69
known risks 150, 182, 213, 227–8 lack of success in courts 191 limitation period 225 Luxembourg 165, 168 ‘Manchuria question’ 182, 212 manufacturing defects 172, 188 meaning 163–5, 169–70
old products 163 option 208
pathogenic infections 319 reform 189–91, 211–15 removal of defence 151, 191 review 208
scarce use 211 scope 163, 212 Spain 54–8, 165, 168
state of knowledge. See state of knowledge
and strict liability 208, 223–5, 319 and UK government 322, 324–5 UK implementation. See
Commission v UK
UK Unilateral Statement 323–5, 326
uncertainty 168 United Kingdom 169
discovery, German procedures 123 drugs
Dutch case 135–7
German liabilities 119–21, 194; categories of drugs 119–20; causation 120–1; defective drugs 120; Drug Act 1976 119; insurance 121; product information 120; strict liability 164
Italian cases 78–9
and product liability regime 78–9 Scandinavian states 194
Spanish law 55, 57 Dupre,´ C. 246
INDEX |
355 |
E-coli 306, 311 electricity 50
emotional distress, Italy 75–6 England
adversarial procedure 40
burden of proof, reversal rule 133 class actions 197–8
comparative law, use 138–40 conditional fees 196 contaminated blood. See A v
National Blood Authority court procedures 34, 197 defects 142–8; evidence 215;
non-standard products 143, 148, 182, 212, 327; relevant factors 143; warnings 145–6 development risk defence 149–51; early case 170–3; later cases
180–1, 224–8; oral contraceptive case 187–8
foreign law evidence 38 harmonisation with Europe 148–9 HIV Haemophiliac Litigation 13,
16
judgments 34, 40, 149
liability rules; compared to France 223; manufacturers 223–6, 274; negligence principles 13–14, 229–30; parallel regimes 229–30; sale of goods 229; strict liability 140–2, 151
oral pleadings 34 pleadings 34
privity of contract 229 punitive damages 198 substitution of defendants 193
European private law 7, 151–2 European Union law. See also Product
Liability Directive competences, new product
liability directive 199–200 influence on Japan 340 internal market 200, 202–4, 206 role of comparative law 5 supremacy 23–4, 139
expectations assessment 159–60 blood products 25
blood transfusion 31, 144 and definition of defect 70 Dutch law 129
English law 141, 142–3, 144, 146–7
German law 108, 109–11, 112, 113 Italian law 72–3
price 111 relevance 180
expert assessors 41, 123
Finland, development risk 165, 168 food poisoning 310–11, 313, 330–1 food products, Spain 54–5, 57 foot-and-mouth disease 306
force majeure 55–6, 90, 286 foreign law evidence 38, 116 foreseeability
and concept of defect 70–1 Italian law 70–1
risks 156, 159 forum shopping 242 France
administrative law 85 blood testing 16
BSE claims 318
burden of proof, reversal 235 causation 228
Commission v France 94–6, 204–5, 222, 223, 237, 239
consumer protection 241 contaminated blood 225, 235 contributory negligence 90
Cour de Cassation reasonings 20 damages liability 85–6
defects; contractual guarantees 86–8; latent defects 86–8, 230–1, 234; proof 148–9, 193, 215; victim friendly definition 235, 241
defences 90, 95–6
delictual liability 89–91, 232–6; things within one’s keeping 90–1, 232–4; third parties 234–5
development risk defence 165, 168, 181, 188, 224–8
356 |
INDEX |
France (cont.)
fault, concept 89–90 and harmonisation 96–8
implementation of Directive 91–6; damages 94–5; defences 95–6; delay 85, 224–8; development risk defence 224–8; disadvantages 222; suppliers’ liability 95
intermediaries, liability 193 judgments 34
liability rules; compared to UK 223–8; contractual 86–9, 159, 230–2; delictual 89–91, 232–6; future 236–41; manufacturers 223–6; suppliers 95, 226
limitation periods 88, 98, 236–7 obligation de s´ecurit´ 88–9, 90,
97–8, 230, 231–2, 234–5, 236, 238–40
parallel regimes 96–8, 204–5, 230–6
pleadings 34 presumptions 87 privity of contract 232
pro-consumer tradition 84, 241 public and private law 85–6 sales contracts 86–9, 159
strict liability 88, 90, 203, 210 vicarious liability 90–1
Fuji Heavy Industry 335
Gajdusek, Carleton 309 gas 50
genetically modified products, German law 121–2
Germany
and A v National Blood Authority
18–19, 26–7, 29, 150, 214, 222 blood testing 15
burden of proof 102, 114–15, 158–9, 203
causation 116, 120–1, 133 class actions 124 contractual liability 101–2 costs 196
court procedures 123–5, 197 damages 116–17; 500 ecu
threshold 63; ceilings 116–17,
161, 162, 163; personal injuries
116–17; state compensation schemes 122
defects; classification of defects 103, 107–8, 157–8; contract 101–2; design defects 104–5, 109–12, 157; drugs 120; excessively dangerous products 112–13, 157; manufacturing defects 103–4, 108–9, 115, 193; proof 114–15; tort 103
defences 115
development risk defence 114, 115, 163–4, 165, 168, 193
drugs. See drugs
genetically modified products 121–2
and global developments 100–1 implementation of Directive
107
joint and several liability 116 law reforms 210
legal aid 196 occupational diseases 122 parallel regimes 121
post-marketing liabilities 117–19; duty of care 117–18; market surveillance 118; notifications 118; product safety regulation 118–19; recall of products 117–18; warnings 118
Product Liability Act 107–17; compensation 116–17; defects 107–14; defences 115; warnings 114
representations 102 representative actions 125 strict liability 162
third parties 101
tortious liability 102–7; design duties 104–5; duty of care 102–3, 156–7; manufacturing duties 103–4; prima facie cases of negligence 106; statutory duties 106; suppliers 107; warnings 105
and US law 100 workplace accidents 122
Gnela, B. 292
INDEX |
357 |
Gonz´alez S´anchez v Medicina Asturiana
45, 46, 92–3, 204, 205–6, 222,
237, 239
Greece 197, 204
Harmathy, A. 246, 269, 290, 292 harmonisation
consumer protection 195 court procedures 197 debate 6, 8–9 divergences 8, 241–2 English law 9, 139, 148–9 French law 9, 96–8 internal market 202–4 issues 8
maximal harmonisation 188–9, 203–6; and English law 139; and France 93–4, 98, 204–5; and Germany 121; necessity 206–7; and Spain 44, 46, 205–6
necessity 202–7, 221
Product Liability Directive 2–4, 84, 94, 202–17
and use of comparative law 139 hepatitis
Australia 330–1 contaminated blood; claims
209–10; and defect 108; England. See A v National Blood Authority ; German compensation 122; Italy 69, 81; Spain 45–6; Trilergan 81; United Kingdom 311; United States 317–18
and United States 302 and vaccines 228
Herman, Shael 21 HIV contamination
Canadian case 330 and defect 108
Dutch case 128, 179, 193, 330
English litigation 13, 16 France 169, 231 German case 164
German compensation 122 Spain 55
United Kingdom 311 United States 302
Hodges, C. 248 horse meat 227
Howells, Geraint 99, 172, 248 Hungary
Civil Code 265 component parts 277, 288 consumer protection 263 contractual liability 268–9 damages 290, 292
defective products 279, 282–6 definition of products 276 development risk defence 287 duty of care 286
EU membership 250 excluded products 276
free market development 260–1 identification of distributors
272–3
implementation of Directive 251 instruction defects 281 manufacturer liability 274 manufacturing defects 280 monitoring products 281 presumption of fault 282 producers of components 277 proof of defects 287
strict liability 252, 253, 284–5 tortious liability 270, 271,
273–4
importers 133–4, 274
infections. See contaminated blood; HIV contamination; pre-manufacture generic infections
insurance
Germany 121, 124 unlimited damages 162
intermediaries, liability 193 internal market 200, 202–4, 206 Ireland, class actions 197 Ishihara, Shintaro 335
Israel 303–4 Italy
burden of proof 78 complexity of procedures 197 consumer bias 74–5 consumer model 77
critique of Directive 77–83
358 |
INDEX |
Italy (cont.)
damages 62, 69, 75–6 defects; definition 70–1;
foreseeability 70–1; warnings and advertising 71
defences; consumers’ conduct 72–3; development risk defence 69
implementation of Directive 69–70
joint and several liability 74–5 manufacturer liability 73–4 mass actions 81–2
parallel legislation 69–70 pharmaceutical products cases
78–9
pre-Directive law 67–9 presumptions 76–7 strict liability 68–9 tortious liability 68–9
Japan
access to justice 337–8 alternative dispute resolution 338 blood testing 16
BSE 307, 339–40 density of litigation 338 Euro-clone 303, 340 governance 339–40
law reform 338–9
product liability law 336–9 joint and several liability 74–5, 116,
136, 275 judgments
England 34, 40
English v continental practice 149 France 34
jurisdiction, cross-border issues 198
Kawasoe, Katsuhiko 334
labelling 102, 145–6
latent defects, France 86–8, 230–1, 234 law reform
development risk defence 189–91 EU competence 199–200
Japan 338–9
review of Directive 208–11, 295–6
legal aid 196 legionnaires’ disease 306Le˛towska, E. 246, 262 Lightman, Justice 33 limitation periods
Central Europe 293 development risk defence 225 Directive 208, 209
Dutch law 128
French law 88, 98, 236–7 reform 210
Lipobay 101 Lipsey, R. G. 255 litigation
forum shopping 242 Japan 338
paucity of European cases 77–8, 201, 216, 295
litis consortium 82 Lovells 242 Luxembourg 165, 168
Maczonkai, M. 253, 287 Malinvaud, P. 84
‘Manchuria question’ 182, 212 manufacturers. See producer /
manufacturer liability manufacturing defects
Central Europe 280
Czech Republic 280 development risk defence 172,
193, 212
and development risk defence 188, 212
England 172
Germany 103–4, 108–9, 115, 157, 193
meaning 157
nature of liability 158–9 pre-manufacture generic infections 313, 328
Spain 50–4
United States 301, 313–14, 315–17 market share liability 116, 137
market surveillance 118 Max Planck Institute 21, 37 Mayhew, Alan 244 medicines. See drugs
INDEX |
359 |
Mitsubishi 101, 334–6 MMR vaccine 185 modernisation 207–11, 216
monitoring products 117–18, 225–6, 281
Morris, D. 257
negligence. See tortious liability Netherlands
causation 131–3, 135–7
court procedures, simplification 197
defects; causation 131–3; contaminated blood 128, 179, 193, 213, 330; expected use 130; proof 130–1
DES case 135–7
development risk defence 129–30, 179–80
identification of producers / importers 133–4
implementation of Directive 126–7
limitation periods 128 parallel regimes 127–8 pre-Directive cases 127 putting into circulation 134 suppliers, liability 134–5
Newdick, C. 172 notifications 118, 193
occupational diseases 122 oral contraceptives 187–8
parallel regimes 7
article 13 222–3; removal 242 betrayal of product liability
function 80 continued use 242 England 229–30
France v England 228–36 French law 96–8, 204–5,
230–6 future 237–41
German law, drugs 121 Italy 69–70
Spain 44–7, 92–3, 205–6 United Kingdom 205
pathogens. See pre-manufacture generic infections
Pearson Commission 168 personal injuries and death
German damages 116–17 maximum compensation 116–17 Spanish damages 59–62
pharmaceutical products. See drugs pleadings 34
Poland
Civil Code 265 component parts 277, 288 consumer protection 262,
263
contractual liability 267, 269 damages 292
defects 279–80
definition of products 276 duty of care 286
EU membership 250 fault 282
force majeure 286 identification of producers 273 implementation of Directive
251–2
importer liability 274 instruction defects 281 limitation periods 293 manufacturer liability 274 monitoring products 281 products, definition 276 proof of defects 287 protective equipment 281 strict liability 252–3 tortious liability 271 unsafe products 279–80
Portugal, damages 162, 163 pre-manufacture generic infections
characteristics 305–6 classification 315
EU legal response 318 miscellaneous cases 330–2
UK Hepatitis C judgment 325–0 UK incidents 307–11
US legal response 312–18
price, and consumer expectations 111 privity of contract 229, 232, 269 procedure. See court procedures
360 |
INDEX |
producer / manufacturer liability blood transfusion services 23 ceiling 83
conduct, and development risk defence 186–8
Czech Republic 223–6, 274, 285 Czechoslovakia 274
France and UK 223–6 Hungary 274
identification of producers 133–4, 226, 272–3
Italy 73–4
Poland 274
producers or suppliers 52–4 Spain 52–4
product liability
basic comparative law issues 155–66
claims 201
common law systems 297–300 complexity 1–2
consumer protection v commercial interests 195
essential components 1, 192–8 European approaches harmonisation history 202–17 lack of litigation 201, 216, 295 substantive laws of Europe 192–6 uses of comparative law 4–5
Product Liability Database 5, 140 Product Liability Directive
and access to justice 77–8, 79 allocation of risks 155, 222, 243,
325–6
betrayal of product liability function 80
and compensation 79 and contaminated blood
transfusion 14–15, 28 context 208
drafting 19–20, 35–36, 161, 164–5, 167–8
effect 248
Euro-fudge 303–4, 319–20 harmonisation. See
harmonisation implementation; Central Europe.
See Central Europe ; France. See
France ; Germany 107; Italy
69–70; Netherlands 126–7;
Spain 44–5; UK. See United Kingdom
internal market or consumer protection 2–3, 303, 325
interpretation issues 7 Italian critique 77–83 length 297
litigation levels 77–8, 213, 235, 295
and mass actions 67, 81–2 modernisation 207–11, 216 new Directive, EU competence
199–200 orientation 303–4
and pathogenic infections 318 reviews 208–11, 295–6
role of comparative law 5 scope 247
supremacy over national laws 23–4
text 341–9
travaux pr´eparatoires 19, 22, 26, 27, 29, 31, 32, 36
uncertainty 282
vague and opaque text 303–4, 320
product safety legislation 118–19, 165, 195, 203
products
agricultural products 208, 276 blood 22–3
Central Europe 275–7 distinction from services 49–50,
331
expected use 130, 194 Spanish concept 49–50
public bodies, Spanish liability 55–8 public law, v private law 55–8, 85–6 punitive damages 198
pure economic loss 116, 127 putting into circulation 3, 57–8, 134,
278
recall of products 117–18, 226 representative actions 125
res ipsa loquitur 18, 131, 283–4
INDEX |
361 |
risks
allocation 155–6, 222, 243, 325–6
development. See development risk defence
failure risks 147 foreseeability 156, 159 information 120, 145 known risks 150, 182, 213,
227–8
risk management 165–6 risk / utility tests 159–60 risks of life 18
Rogers, Horton 48, 129 Roman law 87
Roper, B. 255 Russia 192
Scandinavia, drug damages 194 Scotland 15, 196
services, distinction from products 49–50, 331
‘skeletons’ 34, 38 Slovenia 244 Snowdon, B. 255 social security 78, 194 Soviet Union 293 Spain
case law on Product Liability Act 42–4
causation 194
class actions 197, 198 colza oil case 44, 168 constitutional equality 57 consumer arbitration 64 consumer claims 64–5
damages; ceilings 162, 163; death and personal injuries 59–2; threshold 62–5; volume of claims 64–5
defects 48, 50–4
defences 54–8; development risk defence 54–8, 165, 168; force majeure 55–6; ‘other circumstances’ 51–2
Gonz´alez S´anchez v Medicina Asturiana 45, 46, 92–3, 204, 205–6, 222, 237, 239
implementation of Directive 44–5, 65–6
liability of public bodies 55–8 manufacturer liability 52–4 manufacturing defects 50–4 parallel legislation 44–7, 92–3,
205–6
private and public law 55–8 products 49–0
road traffic liability 60–1 services v products 49–50
strict liability v fault liability 48–9 suppliers or manufacturers 52–4
Stapleton, Jane 23, 37, 41, 141, 172, 186, 248, 282
stare decisis 20
state compensation schemes 122, 194 state of knowledge
A v National Blood Authority 26, 32–3
accessibility 150, 178–9, 184–5, 224, 240
Central Europe 280 contaminated blood transfusion
17 defence 73–4
definition of knowledge 185–6 ECJ interpretation 176–9 expectations 110
French interpretation 181, 240 German law 115
meaning 164 Spanish law 57–8 UK wording 169 unresolved issue 184
Strasbourg Convention on Product Liability 1977 167, 320
strict liability
and ceilings on damages 161–3 Central Europe 252–4 comparative view 156–1 contradictions of Directive 320–5 and development risk defence
208, 223–5, 319 English law 140–2, 151 European laws 192 extension 210
French law 88, 90, 203, 232–6
362 |
INDEX |
strict liability (cont.) German law, drugs 164
Hungary 252, 253, 284–5 Italian law 68–9
or negligence 140–2, 156–61 v other liabilities 206 Poland 252–3
Spain 48–9 suppliers
Dutch liability 134–5 English law 230 French law 95, 226
German tortious liability 107 or manufacturers 52–4 Spanish law 52–4
Svestka, J. 260, 261, 268 Sweden 197
Taiwan 303–4
Taschner, Hans Claudius 19, 27, 35–6, 169, 202, 209, 323, 324, 325
Taylor, S. 87
thalidomide 2, 18, 78, 81, 119, 165, 207, 210, 303–4, 320, 322
third parties 101, 234–5 Tichy, L. 265–6, 285 tortious liability
Central Europe 270–2 comparative view 156–61 English law 13–14, 140–2, 229–30 French law 89–91, 232–6 German law 102–7, 156–7
Italy 68–9
or strict liability 140–2, 156–1 Trade Links 285
trichinae bacteria 227 Trilergan 81
Trubek, D. 255 TSE 310
United Kingdom. See also England; Scotland
blood testing 15, 16
Commission v UK 173–9, 211–12, 213, 223–4, 324, 326
contaminated blood 311
development risk defence 165, 322, 324–5; Unilateral Statement 323–5, 326
food poisoning 310–11 implementation of Directive 17,
23–4, 138; development risk defence 173–9, 211–12, 223–4 liability rules, compared to France
223–8
parallel regimes 205 pre-manufacture generic
infections 307–11 product liability cases 27–8
reports on product liability 167 sale of goods 229
United States 9
and A v National Blood Authority
28, 39
ban on Japanese beef 339 blood testing 16
class actions 81, 101
defect classification 157–8, 317–18 design defects 302, 317–18 diversity of product liability
regimes 203
federal preemption 318 food poisoning 313 legal developments 100
legal response to contamination cases 312–18
liability rules 322, 332 manufacturing defects 301,
313–14, 315–17 market share liability 116
pharmaceutical liability 79 product liability claims 201 product liability regimes 300–2 risk–utility tests 159
Second Restatement of Torts 207, 300–1
standard of care 314–15
Third Restatement of Torts 141, 144, 156, 160, 207–8, 297–300, 301–2
warranty claims 138, 300, 314
vaccines 185, 228, 312 Van Gerven, Walter 135
INDEX |
363 |
vicarious liability 90–1 Viney, G. 98 Vondracek, T. J. 291–2 VTE 187
warnings
and development risk defence 187
English law 145–6, 187 German law 105, 114,
118 Italian law 71
post-circulation 225–6 wool-sorter’s disease 305 workplace accidents, Germany 122