Module 17 2024

04/12/2024

What are the legal bases for product liability claims?

Legal basis

What is the claim for? Look first at the supply chain

1 Contract

Damages claim for breach of contract terms re Quality (Safety) and Fitness for Purpose

2 Negligence

Damages claim for breach of duty of care causing reasonably foreseeable damage

3 Strict liability for “EOs” (new Product Liability Dir. 2024/2853 ((new) EU PLD )/ “producers” (Consumer Protection Act 1987) 4 MDR/IVDR potential AR liability – Art.11(5)

Damages claim for losses caused by defective products

Damages claim for losses caused by defective products IF ex-EEA Manufacturer has also breached Art.10 MDR obligations

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In the EU/UK pipelines…

EU Collective Redress Directive 2020/1828/EU (entered into force 24 Dec 2020)

• Domestic and cross-border injunction and redress representative actions • E.g. Product Liability Directive, infringements of Chapter II MDR/IVDR which harm collective interests of consumers & future EU Directive on AI Liability •Expect increased risk of ‘class action’ litigation in MSs with currently low levels of collective redress litigation • National transposition by 25 Dec 2022; date of application: 25 June 2023 • By 26 June 2028, the EC will evaluate the Directive/present a report of its main findings. UK: breach of statutory duty (civil) claim in the Medicines and Medical Devices Act 2021 for “ any person who may be affected by a breach” of UK Medical Devices Regulations (MMDA 2021, Ch. 3, s.38)

UK: AI Regulation White Paper (March 2023) and MHRA Policy Paper on Impact of AI on the regulation of medical products (April 2024)

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