UK consumers losing out under product liability regime - is it time for reform?

Product liability solicitors Paola Sproul and Mark Gibson considers the reforms and proposed amendments to frameworks in the UK and the EU, and highlight the need for further change. 

Introduction

The EU and the UK are undergoing significant overhauls of their product liability regimes, primarily driven by the need to address challenges posed by technological advancements, new business models (especially online marketplaces) and increasingly complex intangible products.

In this article we analyse the existing UK framework under the Consumer Protection Act 1987, the reforms introduced by the new EU Product Liability Directive 2024/2853 and the proposed changes in the UK through the Product Regulation and Metrology Bill.

Key takeaways include the difficulties faced by claimants under the current UK law and the more consumer-centric approach of the new EU Directive, compared to the less comprehensive nature of the UK reforms proposed in the Bill.

Difficulties under the existing UK product liability framework

There are significant hurdles faced by claimants in proving a product is defective under section 3 of the Consumer Protection Act 1987 (CPA 1987). The Supreme Court case of Hastings v Finsbury [2022] UKSC 19, concerning a metal-on-metal (MOM) hip implant, serves as a prime example.

Main points:

• Burden of proof:Claimants must prove that a product is defective and that the defect caused their loss. Section 3(1) of the CPA 1987 defines a defect as the safety of a product not meeting the expectations that persons generally are entitled to expect, considering all circumstances at the time of supply.

As highlighted in Hastings, even with evidence suggesting a product did not meet performance expectations, the burden of proving this on the balance of probabilities remains with the claimant. Lord Tyre found the pursuer in Hastings failed to meet this burden.

• Entitled expectation:The test is not what is expected but what persons are entitledto expect regarding a product’s safety. This is assessed at the time the product was supplied, but courts can consider subsequently available information.

The UK Supreme Court in Hastings affirmed that the concept of ‘defect’ is an objective standard of safety evaluated by the court.

• Challenges in proving defect:The Hastingscase illustrates the difficulty in proving inherent risks rendered a product defective, even when there were concerns within the medical community and regulatory alerts. The withdrawal of the product from the market by the defenders did not automatically equate to a finding of defect.

In Hastings, the parties agreed to address the question of what was the ‘entitled expectation’ of safety before assessing if it was met. Ultimately, Lord Tyre found that the pursuer failed to prove his case on the balance of probabilities despite evidence suggesting the product did not meet performance expectations.

• Resource imbalance:Claimants often face significant costs associated with product liability cases, including expert witness fees, while defenders typically have greater resources and access to evidence.
• Limitations of the no-fault system: While the CPA 1987 aimed to create a no-fault system, the high burden of proof and other practical challenges mean this goal has not been fully realised, leading to an uneven playing field between producers and consumers.
• Need for reform:The Hastingscase underscored the urgent need for reforms to modernise the UK product liability regime and make it fit for purpose in the digital age. 

Reforms in the EU: the new Product Liability Directive

The new EU Product Liability Directive (PLD) 2024/2853 repeals the earlier Directive 85/374. The new PLD enhances consumer protection in a number of ways.

Main points:

• Expanded definition of ‘product’:The new PLD broadens the definition of a product to include movable items, electricity, digital files (including software, AI systems and digital manufacturing files) and related digital services necessary for the product’s functionality.

This recognises the growing importance of intangible products and the continued control manufacturers may have after a product is placed on the market, moving away from the ‘factory gate’ principle.

‘Software’ includes updates, whether embedded or standalone, including AI systems. Software is classified as a product regardless of how it is supplied or used, whether stored on a device, accessed through the cloud or provided as a service.

• Expanding the list of responsible parties (‘economic operators’): The new PLD introduces the term ‘economic operator’ to hold various parties in the supply chain accountable, including manufacturers, component manufacturers, modifiers, online platforms (in certain cases) and distributors.

If a manufacturer is outside the EU, liability can fall on importers, authorised representatives or fulfilment service providers. Online platforms can be liable if the producer cannot be identified within a month.

This aims to address the issue of unsafe goods sold online by non-EU based entities. Consumers assume that products purchased from online marketplaces are safe and that they will be afforded the same legal rights as traditional retail purchases.

• Recoverable damages: The scope of damages now includes losses arising from psychological harm and data loss (where not used for professional purposes), aligning with other recent EU consumer protection reforms.
• Evaluation of product defectiveness: The new PLD provides a more comprehensive framework for evaluating defectiveness, considering factors such as presentation, labelling, the product’s ability to learn, cybersecurity requirements, recalls, the specific needs of vulnerable user groups and a product’s failure to fulfil its intended purpose of preventing damage.

Article 7 states: “A product shall be considered defective where it does not provide the safety that a person is entitled to expect or that is required under Union or national law.”

• Disclosure of evidence: The new PLD introduces disclosure obligations for defendants when the claimant presents sufficient supporting evidence, subject to necessity, proportionality and safeguards for confidential information.
• Burden of proof – presumption of defect and causation: The new PLD alleviates the burden of proof for claimants by establishing presumptions of defectiveness in certain situations, such as:
• Failure of the defendant to disclose relevant evidence
• Demonstrating the product does not meet mandatory safety requirements
• Proof that an obvious malfunction caused damage during foreseeable use

A causal link is presumed if the product is defective and the damage is typically consistent with that defect. National courts can also presume defectiveness or causation when the claimant faces significant difficulties due to technical complexity, provided a likelihood is demonstrated.

This is intended to address the imbalance in the evidential burden faced by claimants.

• Extension of prescriptive period:The time limit for bringing a claim is extended to 25 years in cases of latent injuries, providing more protection for claimants where injuries may take a long time to manifest. This is vitally important in medical product cases, as recently seen with the claims made against medical aesthetics company Allergan alleging a link between its implants and BIA-ALCL (breast implant-associated anaplastic large cell lymphoma). 

UK reforms and impact on the UK consumer

Next, we focus on the UK’s proposed reforms through the Product Regulation and Metrology Bill and consider the impact of these and the new EU PLD on UK consumers.

Main points:

• The Product Regulation and Metrology Bill: This Bill aims to modernise the UK’s product regulation regime to address new risks from technological advancements like AI and new business models, particularly online marketplaces. Following its second reading, it has been sent to a Public Bill Committee and is expected to become an Act in mid-2025, with secondary legislation to follow.
• Target of regulations: The Bill establishes a framework for secondary legislation regarding product requirements for marketing and use in the UK, including through online marketplaces. Regulations can apply to those controlling access to online marketplaces, overseeing content, acting as intermediaries or “any other person carrying on activities in relation to a product”.
• Scope of future regulations: These regulations will cover various aspects, including production and components (tangible and intangible, like software), marketing and usage, online marketplace marketing, information sharing (risk disclosures, documentation), product certification, investigation of non-compliance and compliance monitoring.
• Risk to health and safety: The Bill allows for regulations to mitigate product risks, defining risk as when a product, used as intended or foreseeably, “could endanger the health and safety of persons”. This focuses on proactive safety measures.

However, the reference to ‘foreseeability’ could be weaker as it aligns with a common law test, whereas in cases like the MOM hip implants, harm was not always foreseeable at the outset.

• Emphasis on better regulation and surveillance: This stresses the urgent need for effective reporting, detection, monitoring and post-market surveillance, especially for high-risk products like medical implants, echoing recommendations from the Independent Medicines and Medical Devices Safety Review report, First Do No Harm.
• Limited scope of the Bill: Notably, the Bill excludesproducts listed in schedule 1, which includes food, medicines and medical devices (as defined by the Medicines and Medical Devices Act 2021). Remarkably too, the Bill does not mention making insurance mandatory for those on whom product requirements are imposed.
• Piecemeal approach v EU repeal: Unlike the EU’s repeal and replacement of the old Directive, the UK appears to be taking a more piecemeal approach, addressing specific issues through regulations and guidance. Examples include the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 and interim guidance on lithium-ion battery safety in e-bikes.
• Vulnerability of online consumers: UK consumers remain vulnerable when purchasing goods online, and the Bill needs to more clearly define the legal responsibilities and accountability of online marketplaces. In contrast, the new EU PLD allows claimants to sue online marketplaces if the producer’s identity is not disclosed.
• Challenges with overseas sellers: Enforcing regulations against unsafe goods marketed and sold online from sites outside the UK will be problematic and complex, necessitating greater international cooperation.
• Impact on UK consumers: The full impact of the UK regulations (being secondary legislation) remains uncertain. The Bill does not address some of the fundamental hurdles in proving a defect that the new EU PLD seeks to remedy (eg increased disclosure obligations and presumption of defect in certain situations).
• Post-Brexit divergence: Post-Brexit, the UK is not bound by EU law, meaning UK consumers will not directly benefit from the enhanced protections of the new EU PLD. However, UK manufacturers selling in the EU market may need to meet higher safety standards to avoid liability under the new PLD.
• Potential for future alignment: The Bill includes a provision for alignment with EU law, leaving open the possibility of future amendments to the CPA 1987 to provide regulatory stability and adopt a more consumer-centric approach similar to the new PLD. 

Conclusion

The EU’s new PLD represents a comprehensive overhaul aimed at strengthening consumer protection in the digital age, particularly by expanding the definition of product and liable parties, easing the burden of proof and extending limitation periods. In contrast, the UK’s approach through the Product Regulation and Metrology Bill appears more focused on creating a framework for future secondary legislation to address specific issues, with a less direct impact on the core challenges faced by claimants under the existing CPA 1987.

While there is potential for future alignment with EU law, UK consumers will in the meantime remain at a considerable disadvantage in relying on the existing regime and interim measures, which may not adequately safeguard their rights and will not make enforcing their rights through the courts any easier. This will be the basis for our lobby for change in making submissions to the Public Bill Committee that is scrutinising the Bill.

Written by Paola Sproul, a senior solicitor specialising in product liability at Digby Brown LLP, and Mark Gibson, partner in Product Liability department at Digby Brown LLP.