Die Zweckmäßigkeit der arzneimittelrechtlichen Gefährdungshaftung

2021 ◽  
Author(s):  
Johannes Rein

In this doctoral thesis, the medicinal product law strict liability from § 84 AMG is evaluated with regard to its expediency. First, the institute of strict liability is comprehensively explained. The focus of the work is the problem of proving causality. It becomes clear in the work that even the presumption of causality from § 84 para. 2 AMG does not solve the problems of proof. The author argues for a lowering of the standard of proof and cites European law arguments for this. In the author's opinion, the presumption of causality from § 84 Para. 2 AMG contradicts the European Product Liability Directive, which, in the author's opinion, must guide medicinal product liability.

Author(s):  
Fairgrieve Duncan ◽  
Richard Goldberg

Product Liability is a recognised authority in the field and covers the product liability laws through which manufacturers, retailers, and others may be held liable to compensate persons who are injured, or who incur financial loss, when the products which they manufacture or sell are defective or not fit for their purpose. Product defects may originate in the production process, be one of design, or be grounded in a failure to issue an adequate warning or directions for safe use and practitioners advising business clients or claimants will find this book provides all the necessary information for practitioners to manage a product liability claim. This new edition has been fully updated to take account of 10 years of development in case law and regulation, and the increasing impact of cross-border and transnational sale of goods. The Court of Justice of the European Union handed down major rulings concerning the Product Liability Directive which affect the application of the Directive and national arrangements and Fairgrieve and Goldberg examines this in detail. For any legal practitioner operating in areas which require knowledge of European product liability law, an understanding of the impact of recent developments is essential and this work is an essential resource for practitioners working on product liability, sale of goods, personal injury and negligence. The work provides comprehensive coverage of the law of negligence as it applies to product liability, of the strict liability provisions of the Consumer Protection Act 1987, and of the EU's Product Liability Directive on which the Act is based. Although the majority of cases involve pharmaceuticals and medical devices, in recent English cases the allegedly defective products have been as diverse as a child's buggy, an All Terrain Vehicle, and even a coffee cup. Many cases are brought as group actions, and the book examines the rights of those who are injured by defective products. As well as considering the perspective of the law as it has developed in the UK, this edition contains detailed discussion of case law from other jurisdictions including the USA, Australia, New Zealand, Canada, France and Germany. The coverage in the work is complemented by a full analysis of issues which arise in transnational litigation involving problems of jurisdiction and the choice of laws.


2011 ◽  
Vol 41 (1) ◽  
pp. 1
Author(s):  
Ari Wahyudi Hertanto

AbstrakInti dari product liability adalah pelaku bertanggungjawab atas kerusakan, kecacatan,penjelasan, ketidaknyamanan dan penderitaan yang dialami oleh konsumen karenapemakaian atau mengkonsumsi barang atau jasa yang dihasilkannya. Product Liabilityumumnya disebut juga dengan istilah tanggung jawab produk, tanggung gugat produk, atautanggung jawab produsen. Di dalam praktek pun, adagium yang menyatakan bahwa konsumen selaku pembeli harus hati-hati (caveat emptor) masihlah sangat relevan. Banyak kendala-kendala yang dihadapi dalam mewujudkan prinsip tersebut agar dapat diterapkansecara adil dan tepat.


2021 ◽  
Vol 12 (1) ◽  
pp. 40-64
Author(s):  
Thomas Verheyen

Abstract This theoretical article identifies the asymmetry between the producer and the consumer as the key to understanding product liability law. In an attempt to resolve the endless scholarly and jurisprudential debates on the proper criterion for defectiveness in European law, it first tracks the ways in which the commonly opposed consumer expectations and risk-utility test each fail to address the typical asymmetries between producers and consumers in a satisfying manner. Building upon the concept of ‘behavioural asymmetry’, it then develops a new criterion for defectiveness under European law: the behavioural risk-utility test. Under a behavioural risk-utility test, the producer is liable if the product is not reasonably safe for average users suffering from cognitive biases and other behavioural shortcomings. This test aptly combines the systemic point of view of risk-utility balancing with an evidence-based conception of asymmetry, and therefore provides a meaningful criterion for adjudicating product liability disputes.


Author(s):  
Carol Brennan

This chapter discusses the law on product liability. Common law product liability is based upon the law of negligence. Beginning with the narrow ratio in Donoghue v Stevenson (1932), it further developed the concept of intermediate examination in Grant v Australian Knitting Mills (1936). The relevant statute is the Consumer Protection Act 1987, passed in response to a European Union Directive. This introduces strict liability, when a defective product causes damage. The CPA establishes a hierarchy of possible defendants beginning with the producer. Defences under the CPA include the ‘development risks’ defence to protect scientific and technical innovation. If damage relates to quality or value, the only remedy will be in contract.


1985 ◽  
Vol 4 (1) ◽  
pp. 69-79 ◽  
Author(s):  
Terry Morehead Dworkin ◽  
Mary Jane Sheffet

In the last decade recent court decisions have greatly increased the manufacturer's liability. Expansion of strict liability, increases in awards of punitive damages, and development of new theories such as market share liability to deal with the so-called “delayed manifestation” cases are examples of this judicial expansion. This paper discusses these decisions, the recent legislative proposals made to counter them, and delineates some steps manufacturers should take for protection.


1999 ◽  
Vol 48 (2) ◽  
pp. 419-430 ◽  
Author(s):  
Simon Taylor

The 1985 European Communities Directive on Product Liability1aims to harmonise member State product liability rules and to improve the level of protection of victims by basing the liability of producers for physical injury and damage to personal goods on the proof that the victim's damage was caused by a defect in the product supplied. On 19 May 1998, ten years after the deadline for transposition, France finally enacted legislation incorporating the Directive into national law.2The Directive was incorporated into English law by Part I of the Consumer Protection Act 1987.


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