The main pieces of legislation which make up the legal framework for product safety (in criminal regulatory law, as opposed to civil product liability) in England and Wales are:

• the General Product Safety Regulations 2005;
• the Health and Safety at Work etc. Act 1974; and
• the Consumer Protection Act 1987 and “safety regulations” made under it.

The General Product Safety Regulations 2005 (GPSR)

This is the primary legislation governing the regulation and enforcement of product safety in England and Wales. The GPSR were originally enacted to implement EU law in the form of Directive 2001/95/EC of the European Parliament and of the Council on general product safety. The EU Withdrawal Act 2018 preserved the Regulations and enabled them to be amended so that they can continue to function effectively now the UK has left the EU.

As their title suggests, these regulations are designed to cover products that are not otherwise the subject of specific legislation concerning their safety. There are numerous separate sets of “safety regulations” (made under Section 11 of the Consumer Protection Act 1987 – see 1.4 Obligations to Notify Regulatory Authorities) dealing with the safety of certain types of products, including such diverse categories as furniture and fittings, medical devices, electrical plugs and sockets, pedal bicycles, and children’s toys. These are not therefore captured by the GPSR, which deal with everything else.

Products within the scope of the GPSR

The GPSR are aimed at products supplied in the course of a commercial activity (whether for payment or not) that are either intended for consumers or that are likely to end up being used by consumers. They cover not just new products but also (subject to some qualification in regulation 4) those that are used or reconditioned.

The general safety requirement

The GPSR set out the “general safety requirement” (as defined in regulation 2) that only safe products should be placed on the market. This is the fundamental principle which underpins the duties imposed and powers provided by the GPSR.

By regulation 2, a product is a “safe product” if, under normal or reasonably foreseeable conditions of use:

• it does not present any risk; or
• it presents only the minimum risks compatible with the product's use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons – regulations 2 and 6(3) set out the matters that are to be taken into account in making that assessment.

Regulation 2 defines a “dangerous product” as a product other than a safe product.

Presumption of conformity

Regulation 6 provides that a product that complies with certain legal requirements or standards shall be deemed to be safe in the respects covered by those requirements or standards, unless there is evidence to the contrary.

Obligations of producers and distributors

The GPSR impose obligations on the producers and distributors of a product. “Producers” are widely defined to include any manufacturer, anyone presenting themselves as a manufacturer, anyone reconditioning a product, anyone representing a manufacturer of a product that is based outside of the UK, and any other professional in the supply chain whose activities may affect the safety properties of a product. “Distributors” are other professionals in the supply chain whose activities do not affect the safety properties of a product.

Different obligations are imposed on producers and distributors but in summary the following applies.

• Producers should not supply or agree to supply or place a product on the market that is anything other than a safe product, and they should provide consumers with all relevant information to enable them to assess and guard against the risks inherent with normal or reasonably foreseeable use.
• Distributors should not supply or agree to supply a product that they know or ought to have known to be a dangerous product, and are to participate in the monitoring of the safety of the product by passing on necessary information as to any inherent risk and co-operating with the producer and regulatory authorities in taking action to avoid any such risk.

In addition, by regulation 10, a producer or a distributor who knows that a product they have placed on the market or supplied poses risks to the consumer that are incompatible with the general safety requirement must notify an enforcement authority (see further below).

Offences

Regulation 20 provides for offences, including failure to comply with the duties imposed on producers and distributors, and failure to comply with the requirements of a safety notice (see 1.2 Regulatory Authorities for Product Safety).

Regulation 31 provides for the liability of:

• a party whose act or default has caused another party to commit an offence; and
• a director, manager, secretary or other similar officer (or anybody purporting to act in such a capacity) where an offence by a body corporate is attributable to their consent, connivance or neglect.

Defences

Offences under the GPSR are subject to the defence of “due diligence” (ie, acting with reasonable care) in regulation 29.

Information gathering and market surveillance

Regulations 32 to 39 set out the arrangements for the Secretary of State to be informed of notifications received by other enforcement authorities in relation to product safety issues and of any enforcement action taken, for co-operation and information-sharing between enforcement authorities, and for market surveillance.

By regulation 41, summary proceedings (ie, proceedings before a magistrates’ court) must be brought within three years from the date of the offence or within one year from the discovery of the offence by the prosecutor, whichever is earlier. There is no time limit for bringing a prosecution for an either way offence (ie, an offence that can be heard in a magistrates’ court or the Crown Court).

The Health and Safety at Work etc. Act 1974

The Health and Safety at Work etc. Act 1974 contains the core duties and framework for the regulation of health and safety in England and Wales.

Section 6

The key provisions regarding product safety are to be found in Section 6, and are aimed not at consumer products but at “articles for use at work” (or any article of fairground equipment).

Section 6 requires any person who, in the course of a trade, business or other undertaking, designs, manufactures, imports or supplies any article for use at work to:

• ensure it is safe (so far as reasonably practicable) whilst being set, used, cleaned or maintained by a person at work;
• carry out or arrange for the carrying out of such testing and examination as may be necessary in relation to its safety;
• take such steps as are necessary to ensure those using the article at work are provided with adequate information about any conditions necessary to ensure that it will be used safely for its purpose; and
• take such steps as are necessary to secure, so far as is reasonably practicable, that those using the article at work are provided with updates of any such safety information as may become necessary following safety incidents, near misses or developing knowledge, including scientific knowledge.

Where a duty or requirement in the 1974 Act is qualified by reasonable practicability, the dutyholder bears the burden of proving, on the balance of probabilities, that it was not reasonably practicable to do more than was in fact done to satisfy the duty or requirement (Section 40).

The General Product Safety Regulations 2005

Enforcement authorities

In the context of the GPSR, “enforcement authority” means the Secretary of State, any other Minister of the Crown in charge of a government department, any such department and any local authority or council mentioned in regulation 10 (see regulation 2). The Office for Product Safety and Standards (OPSS) is the UK’s national product regulator, within the Department of Business and Trade.

In practice, however, it is local authorities that are principally responsible for the enforcement of the GPSR within their geographical area and for serving safety notices (see below).

Regulation 10 further provides that, in enforcing the GPSR, an enforcement authority must act in a manner proportionate to the seriousness of the risk and shall take due account of the precautionary principle. It must encourage and promote voluntary action by producers and distributors but may take any action urgently and without first encouraging and promoting voluntary action if a product poses a serious risk.

Safety notices

Enforcement authorities are empowered to serve a variety of “safety notices”, including suspension notices (regulation 11), requirements to mark (regulation 12), requirements to warn (regulation 13), withdrawal notices (regulation 14) and recall notices (regulation 15).

Regulation 28 provides a power for the Secretary of State to obtain information and samples of products in order to decide whether to serve, vary or revoke a safety notice.

The Health and Safety at Work etc. Act 1974

Enforcing authority

The enforcing authority for Section 6 of the 1974 Act is the Health and Safety Executive (HSE) (see regulation 4(a) of the Health and Safety (Enforcing Authority) Regulations 1998), which is the national regulator for health and safety in Great Britain.

In considering and carrying out enforcement action, the HSE will follow the requirements of its Enforcement Policy Statement and the Enforcement Management Model. The HSE also publishes guidance for inspectors, in the form of the Enforcement Guide, as well as Approved Codes of Practice and guidance for dutyholders.

Powers of inspectors

HSE inspectors are given powers including powers of entry and seizure and to require the provision of documents and information (Section 20), and are able to serve improvement notices (Section 21) and prohibition notices (Section 22).

The Consumer Protection Act 1987

Enforcement is principally performed by local authority trading standards departments (in accordance with similar scope and powers as under the GPSR – see above) or, at a national level, the Competition and Markets Authority (CMA). Under the Digital Markets, Competition and Consumers Act 2024, the CMA is now able to decide whether consumer protection laws have been infringed, to order redress to affected consumers, and to impose financial sanctions (without a court process) on businesses that fail to comply. However, the CMA’s role is more focused on egregious breaches of consumer law relating to business practices and fairness to the consumer, rather than product safety.

There are requirements for persons to take corrective action in certain circumstances.

Requirements to Notify

These include the obligation imposed on producers and distributors of products to notify enforcement authorities of product safety risks under regulation 9 of the GPSR (see 1.4 Obligations to Notify Regulatory Authorities).

Enforcement and Safety Notices

There are also requirements to take corrective action in response to the service of enforcement and safety notices, which can be served under the legislation referred to in 1.2 Regulatory Authorities for Product Safety.

The following powers prevent the continued placing on the market or supply of the product:

• prohibition notices, served under Section 13 of the CPA, prevent the recipient from supplying the product, or offering to do so, without the consent of the Secretary of State;
• suspension notices, served under regulation 11 of the GPSR or Section 14 of the CPA, prevent the recipient from placing the product on the market or supplying it, or offering to do so, without the consent of the enforcement authority; and
• improvement notices, served under Section 21 of the 1974 Act, require the recipient to take the action specified in the notice or some equally effective action to resolve an alleged breach of health and safety law. Such a notice could, in effect, prevent the continued placing on the market or supply of a product where this would breach Section 6 of the 1974 Act.

The following powers require the recipient to take steps to warn consumers of risks associated with a product:

• notices to warn, served under Section 13 of the CPA, require the recipient to publish a warning about any product they have supplied that is considered to be unsafe;
• requirements to mark, served under regulation 12 of the GPSR, require the recipient to mark the product with a warning and/or to include a warning in the marketing of the product;
• requirements to warn, served under regulation 13 of the GPSR, require the recipient to give warning, so far as is practicable, to any person who has already been supplied with the product, to publish a warning likely to come to the attention of such persons, and/or to ensure that the product carries a warning; and
• improvement notices, served under Section 21 of the 1974 Act, could require the provision of information about risks (for instance, in compliance with the ongoing duty in Section 6(1)).

There are also powers requiring more significant corrective action, in the form of withdrawal and recall notices.

Withdrawal Notices

Withdrawal notices, served under regulation 14 of the GPSR, prevent the recipient from placing the product on the market or supplying it, or offering to do so, without the consent of the enforcement authority. A withdrawal notice may also require the recipient to take action to alert consumers to the risks that the product presents, and to keep the authority informed of the whereabouts of any such product in which the recipient has an interest.

Given the significant impact of a withdrawal notice, where a product is already on the market, a withdrawal notice may only be served where the action being taken by the producer or distributor concerned is unsatisfactory or insufficient to address the risk, unless the product poses a serious risk that the enforcement authority believes requires urgent action.

Recall Notices

Recall notices, served under regulation 15 of the GPSR, require the recipient to use reasonable endeavours to organise the return of the product from consumers either to them or to another person specified in the notice. The notice can require the recall to be effected in accordance with an applicable code of practice, or can specify the steps to be taken, which may include requirements relating to contacting consumers, publishing information about the risk, and making arrangements for the collection, return or disposal of the product.

Given the significant consequences of a recall notice, an enforcement authority may only serve a recall notice where:

• other action would not be sufficient;
• the action taken by the producer or distributor concerned is unsatisfactory or insufficient to address the risk; and
• the enforcement authority has given not less than ten days’ notice of its intention to serve the notice.

The recipient may require the enforcement authority to seek advice on the safety of the product and the proportionality of a recall notice, and the authority must take account of that advice. The second and third requirements do not apply where the product poses a serious risk that, in the view of the enforcement authority, requires urgent action.

A recall notice may also require the recipient to keep the authority informed of the whereabouts of any product to which the notice relates, so far as they are able to do so.

Where the enforcement authority is not able to identify any person on whom to serve a recall notice, or the person upon whom it has been served has failed to comply with it, the enforcement authority itself may take such action as could have been required by a recall notice. In the latter case, the enforcement authority may recover the cost of such action from the person on whom the notice was served.

Provisions of the legislation referred to in 1.1 Product Safety Legal Framework include obligations to notify enforcement authorities of product safety risks. Those provisions operate in parallel with requirements to report certain categories of safety incidents that may raise product safety concerns.

The General Product Safety Regulations 2005

Regulation 9 provides that a producer or a distributor who knows that a product they have placed on the market or supplied poses risks to the consumer that are incompatible with the general safety requirement must notify an enforcement authority as quickly as is reasonably possible in writing of that information and of the action taken to prevent risk to the consumer.

This obligation does not apply where the safety issue relates to isolated circumstances or products.

In the event of a “serious risk” (defined in regulation 2 to include risks whose effects are not immediate but require rapid intervention), the notification shall also include:

• information enabling a precise identification of the product or batch of products in question;
• a full description of the risks that the product presents;
• all available information relevant for tracing the product; and
• a description of the action undertaken to prevent risks to the consumer.

The Health and Safety at Work etc. Act 1974

The 1974 Act does not include any provision requiring notification of product safety risks to the HSE or any other enforcement authority. However, the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013 (RIDDOR) would require notification if a product were involved in a “dangerous occurrence” arising out of or in connection with work that could potentially cause harm to others.

Where such a report and any subsequent investigation raises a product safety issue, the authority notified will liaise with other enforcing authorities and agencies as necessary in respect of that issue. For instance, where a product safety issue is raised with a local authority, the local authority should liaise with the HSE to ensure that any concerns going beyond the local authority’s geographical area can be addressed.

The Consumer Protection Act 1987

The CPA does not include any provision requiring notification of product safety risks to an enforcement authority, but safety regulations made under Section 11 may require the provision of information in certain circumstances, including the notification of product safety risks. Where such safety regulations do not include provisions regarding notification, the provisions of the GPSR apply (see above).

Reporting of Product Safety-Related Incidents

In addition to the obligation under RIDDOR to report work-related fatal and other serious accidents, diseases and ill health, and other dangerous occurrences, there are other obligations to report certain categories of safety incidents to regulatory authorities, that may relate to the use of a product. These include obligations to report certain incidents to the Rail, Marine and Air Accident Investigation Branches, the Maritime and Coastguard Agency, the Driver and Vehicle Standards Agency and the Medicines and Healthcare products Regulatory Agency (MHRA), among others.

The General Product Safety Regulations 2005

Breaches of the most serious obligations (including breaches of safety notices) are either way offences, punishable:

• on indictment in the Crown Court by up to 12 months’ imprisonment, an unlimited fine, or both; and
• on summary conviction in the magistrates’ court by up to three months’ imprisonment, an unlimited fine, or both.

Other less serious offences are punishable on summary conviction only, again by up to three months’ imprisonment, an unlimited fine, or both.

There is no sentencing guideline for offences relating to product safety specifically. However, it would be open to a sentencing court to have regard to the Sentencing Council Definitive Guideline for Health and Safety Offences, Corporate Manslaughter, and Food Safety and Hygiene Offences (the Guideline).

The Health and Safety at Work etc. Act 1974

Breaches of Section 6 and failures to comply with the requirements of an improvement or prohibition notice are either way offences, punishable:

• on indictment by up to two years’ imprisonment, an unlimited fine, or both; and
• on summary conviction by up to 12 months’ imprisonment (although the powers of the magistrates’ court are currently limited to six months per offence, and 12 months for two or more either way offences), an unlimited fine, or both. The Guideline would apply to sentencing for these offences.

The Consumer Protection Act 1987

A breach of safety regulations or of a prohibition notice or notice to warn is punishable on summary conviction only, by up to six months’ imprisonment, an unlimited fine, or both.

A breach of a suspension notice is punishable on summary conviction only, by up to three months’ imprisonment, an unlimited fine, or both.

Again, it would be open to a sentencing court to have regard to the Guideline.

Prosecutions

It is not uncommon for prosecutions to be brought under the legislation set out in 1.1 Product Safety Legal Framework by the HSE, local authorities and other regulatory agencies, although there are relatively few reported cases. In the context of the GPSR, see for example R v Kayani [2014] EWCA Crim 2635 and R v Bettridge [2010] EWCA Crim 41; in the context of Section 6 of the 1974 Act, see for example R (Junttan Oy) v Bristol Magistrates Court [2003] UKHL 55 and R v Patchett Engineering Ltd [2001] 1 Cr. App. R. (S.) 40.

There are three main causes of action for bringing product liability claims in England and Wales:

• “strict liability” claims under the Consumer Protection Act 1987 (CPA);
• claims in negligence; and
• claims in contract.

“Strict Liability” Claims Under the CPA

The CPA holds producers liable for damage caused by defective products, particularly those that cause personal injury, death or damage to private property. The CPA creates a legal framework for consumers to claim compensation from the product’s producer when they suffer harm due to a defect, in the absence of the claimant having to prove any fault.

Against whom?

A claim under the CPA can be brought against:

• the “producer” of the product, which normally means the person who manufactured it;
• any person who holds themselves out to be the producer of the product by virtue of putting their name or trade mark on the product; or
• any person who has imported the product into the UK in order to supply it to another during the course of their business.

In limited circumstances, a claim under the CPA can also be brought against the supplier of a product, where a claimant requests the supplier to identify one or more of the persons identified above, and the supplier fails to comply with that request or identify the person.

Where two or more persons identified above are liable for the same damage, their liability is joint and several.

Key elements

In order to bring a claim under the CPA, the following key elements must be established:

• defect;
• damage; and
• causation.

Defect

Under Section 3, there is a defect in a product “if the safety of the product is not such as persons generally are entitled to expect”. Safety in relation to a product includes:

• safety with respect to products comprised in that product;
• safety in the context of risks of damage to property, as well as death or personal injury;
• the manner in which, and purposes for which, the product has been marketed;
• the use of any mark in relation to the product;
• the use of any instructions for or warnings with respect to the use of the product;
• what might reasonably be expected to be done with or in relation to the product; and
• the time when the product was supplied by its producer to another.

In the leading case of Gee & Others v DePuy International Limited [2018] EWHC 1208 (QB), Andrews J provided the following guidance on the definition of “defect” under the CPA.

• Where the development of the alleged defect is one of the normal risks inherent in the use of the product, a defect is characterised in such a product by the abnormal potential for harm – ie, the feature that increases the underlying risk beyond the level of safety the public is entitled to expect.
• In deciding what circumstances a court can take into account, a court must maintain a flexible approach, and the relevant circumstances and the weight given to those circumstances will vary from case to case.
• A product’s benefits, cost and avoidability were features that could, in appropriate cases, be taken into account, as was the existence of a learned intermediary (such as a surgeon) and warnings provided to that intermediary, as well as compliance with regulatory standards.

Damage

Under Section 5, damage means death or personal injury, or any loss of or damage to property (including land). Under the CPA, a defendant is not liable for the loss of or damage to the product itself, nor for any damage which is not for private use, occupation or consumption. The total amount of damages to be awarded must exceed GBP275.

Causation

A claimant must prove that the damage claimed was caused wholly or partly by the defect in the product. Where any damage is caused partly by the defect in the product and partly by the fault of the person suffering the damage, the normal rules in relation to contributory negligence apply.

The “but for” test is the primary method for proving causation under the CPA. This means that a claimant must demonstrate that “but for” the defective product, the resulting damage or injury would not have occurred.

In Gee, in light of its findings on defect, the court declined to rule on what a claimant must establish in order to prove causation where the defect is one that increases a background risk inherent in the product. DePuy argued that a doubling of the risk was required, but that point remains to be resolved on another occasion.

Claims in Negligence

In addition to strict liability claims under the CPA, the manufacturer of a product, together with other relevant parties in the supply chain (a supplier, distributor, etc), can be liable in common law negligence in respect of a product. In order to bring a claim in negligence, a claimant must prove the following key elements:

• the manufacturer or seller owed the claimant a duty of care in respect of the production or sale of the product;
• the manufacturer or seller breached the duty of care – ie, failed to meet the required standard of care;
• the breach of duty caused the claimant’s loss or damage; and
• the claimant suffered loss and damage that was foreseeable.

The manufacturer's or supplier’s negligence may be:

• a failure to take care during the manufacturing process, resulting in a particular product being defective;
• a failure to take care during the design of the product, including a failure to carry out sufficiently careful research and/or testing;
• a failure to provide an effective warning of a danger; or
• a failure to recall a product, or to issue appropriate warnings (for example, to cease use) if a danger becomes apparent after the product has been put into circulation.

As with any tortious liability, the claimant must establish fault on the part of the defendant. This may be difficult and expensive for the claimant to prove (and can often involve expert evidence), and therefore claims in negligence are generally considered to be more difficult to bring than claims under the CPA.

Claims in Contract

Product liability in contract law refers to the liability of a seller or manufacturer for damages caused by a defective product, based on the terms of the contract of sale or supply of the goods. This liability can arise from breach of an express or implied term of the contract.

The law implies certain terms into contracts for the sale or supply of goods, as follows.

• The Consumer Rights Act 2015 (CRA 2015) sets out implied terms for consumer contracts, including that goods must be of satisfactory quality, goods must be reasonably fit for purpose, and goods must correspond with their description. The CRA 2015 provides consumers with certain rights to reject defective goods for a full refund (within 30 days of purchase), or to request a repair or a replacement.
• The Sale of Goods Act 1979 (SGA 1979) also deals with implied terms and remedies for defective goods, particularly in contracts where goods are sold in the course of a business. The SGA 1979 likewise implies terms in respect of goods being of satisfactory quality, reasonably fit for purpose, and matching any description.
• The Supply of Goods and Services Act 1982 applies to the transfer of goods.

Unlike negligence claims, a breach of contract claim does not require the claimant to prove that the seller was at fault, merely that there was a breach of contract. However, sellers will often seek to limit or exclude their contractual liability by way of standard terms and conditions. A manufacturer or seller cannot exclude liability for personal injury or death.

Claims Under the CPA

Claims under the CPA may be brought by “consumers”. A consumer is a natural person who purchases or uses the product in question for private use. Persons who purchase or use products for the purpose of resale or for commercial use are not covered. The consumer must have suffered damage of a kind covered by Part 1 of the CPA.

Claims in Negligence

Claims in negligence can be brought by all those who can reasonably be expected to make use of a product – ie, anybody who may reasonably be affected by a defect in the product. This means that a claim in negligence is not limited by the doctrine of privity of contract, and a claim may be brought by a consumer-purchaser of the product, a person who uses the product, or a third-party bystander who is injured by the product.

Claims in Contract

Generally, a claim for breach of contract is limited to parties who were part of the original contract of sale or supply (the doctrine of privity of contract), but in certain circumstances a third party may seek an enforcement under the Contract (Rights of Third Parties) Act 1999; claimants might include those who have validly taken an assignment of the contractual cause of action.

Time limits for bringing product liability claims in negligence and contract are governed by the Limitation Act 1980.

A claim for personal injury must be brought within three years from the later of the date the injury or loss is suffered or the date of knowledge of the damage, the defect and the identity of the producer. The “date of knowledge” relates to what the claimant knew, or reasonably ought to have known. The three-year period can be extended at the court’s discretion.

For non-personal injury claims, the claim must be brought within six years from the date on which the damage or loss occurred (negligence), or six years from the date of the breach (contract), or three years from the date of knowledge for claims concerning latent damage – ie, a hidden defect.

A claim under the CPA must also be brought within ten years from the date on which the product was put into circulation, known as the ten-year long-stop period. Absent the issuing of court proceedings, a right of action under the CPA is extinguished after this period and cannot be extended.

In Wilson v Beko Plc [2019] EWHC 3362 (QB), Knowles J ruled that consumers are not entitled to rely upon Section 41 of the CPA to circumvent the ten-year limitation long-stop.

Generally, UK courts will assume jurisdiction to try a case where the injury, loss or damage occurs, or where both parties are domiciled in that country. This is straightforward where both the claimant and the defendant are domiciled in England. Complications might arise where the intended defendant is domiciled out of the jurisdiction.

In order for a claimant to establish that English courts have jurisdiction in respect of product liability claims, the court will consider whether in all the circumstances England is clearly or distinctly the appropriate forum. This will include the ground of jurisdiction within which the claimant’s claim falls (eg, where England is the place where the contract was made, or the tort was committed), the defendant’s residence or place of business, and the applicable substantive law (eg, the law of the contract).

For tortious claims (negligence claims and under the CPA), a claim is made in tort where:

• damage was sustained, or will be sustained, within the jurisdiction;
• damage that has been or will be sustained results from an act committed, or likely to be committed, within the jurisdiction; or
• the claim is governed by the law of England and Wales.

These requirements are often easily satisfied in product liability claims where the claimant is English, has bought or used the product in England, and the damage (ie, any personal injury or property damage) was suffered in England.

In relation to “applicable law”, the relevant approach depends on the timing of the claim. Where the event giving rise to damage occurred on or after 11 January 2009, Regulation (EC) No.864/2007 on the law applicable to non-contractual relations (the Rome II Regulation) applies, so the general rule is that the applicable law is the law of the country in which the damage occurs – ie, England.

In relation to contractual claims, the substantive applicable law is the law of England and Wales if England is the place where the contract was made. Furthermore, the contractual terms agreed by both parties ordinarily determine the applicable law, jurisdiction and location of proceedings in respect of contractual breaches.

Whilst there is not a single, specific pre-action protocol solely for product liability claims, there are mandatory steps in the form of other applicable pre-action protocols in respect of product liability claims that must be complied with prior to the commencement of formal claims.

Under the Civil Procedure Rules Practice Direction for Pre-Action Conduct and Protocols, the following Pre-Action Protocols may typically be applicable to product liability claims (depending on the value and complexity of the claim):

• Pre-Action Protocol for Personal Injury Claims;
• Pre-Action Protocol for Low Value Personal injury (Employers’ Liability and Public Liability) Claims; and
• Pre-Action Protocol for Disease and Illness Claims.

The common aim in all of the above protocols is to set out the conduct the court would normally expect prospective parties to follow prior to the commencement of proceedings, including:

• establishing a reasonable process and timetable for the exchange of early and full information relevant to a dispute (including disclosure and any expert evidence);
• encouraging contact and better and earlier pre-action investigation by all parties;
• setting standards for the content and quality of letters of claim and response; and
• setting standards for the conduct of pre-action negotiations and ADR.

Where either party fails to comply with the above protocols, the court may impose sanctions. When deciding whether to do so, the court will look at:

• whether the parties have complied in substance with the relevant principles and requirements;
• the effect any non-compliance has had on another party; and
• whether the non-compliances are minor or only technical shortcomings.

Sanctions that the court may impose include requiring an explanation for any breach or variation of protocols (by way of a formal witness statement), awarding costs, and staying proceedings entirely until there has been compliance with the relevant pre-action protocol.

Whilst there are no specific rules for the preservation of evidence in product liability claims, broad documentation preservation obligations are imposed on all parties to proceedings in England and Wales, including product liability claims.

The Civil Procedure Rules (CPR) Practice Direction 31 paragraph 7 relates specifically to the “preservation of documents”. As soon as litigation is contemplated, the parties’ legal representatives must notify their clients of the need to preserve disclosable documents. Those documents include electronic documents that would otherwise be deleted in accordance with a document retention policy, or in the ordinary course of business.

The extent of the reasonable search required by CPR Rule 31.7 for the purposes of standard disclosure will depend on the circumstances of the case, including in particular the factors referred to in rule 31.7(2), such as:

• the number of documents involved;
• the nature and complexity of the proceedings;
• the ease and expense of retrieval of any particular document;
• the availability of documents or contents of documents from other sources; and
• the significance of any document that is likely to be located during the search.

Depending on the circumstances, matters for the parties to consider when preserving documents include:

• hard copy documents;
• the nature and extent of the electronic storage systems;
• date ranges;
• documents in a particular place or places;
• documents falling into particular categories; and
• custodians.

The preservation of all relevant evidence must be considered, including any relevant products, devices, design files, testing information, etc. The nature and extent of what is to be preserved will depend on the detail and ambit of the case set out in the Letter of Claim. Once a preservation requirement is in place, the provision relates to all past, present and future documents.

Failure to comply with these preservation requirements – including by interfering with evidence that is likely to be subject to standard disclosure (by deleting, overwriting, updating or destroying documents and evidence) – has far-reaching consequences. The courts can and do impose the following “sanctions”:

• penalties for interference with evidence, including a party not being able to rely on certain documentary evidence and/or witness evidence;
• satellite litigation regarding affected documents, including orders for specific disclosure;
• costs sanctions;
• striking out the whole or part of a party’s particulars of claim or defence; and
• in the absence of any proper explanation as to why certain documents were not properly preserved, the drawing of adverse inferences as to the likely contents of those documents.

There are extensive rules relating to disclosure of documents and other evidence in product liability claims. Those rules are set out in the Civil Procedure Rules (CPR) Part 31.

Contrary to its ordinary meaning, “disclosure” of a document does not mean sending the document to the other party, but rather stating that a document exists or has existed. Under CPR Rule 31.3, a party to whom a document has been disclosed has a right to inspect that document, except where:

• the document is no longer in the control of the party who disclosed it (eg, because it has been lost or destroyed);
• the party disclosing the document has a right or duty to withhold inspection of it (eg, because it is privileged), or;
• where it would be disproportionate to the issues in the case to permit inspection.

Under CPR Rule 31.6, “standard disclosure” describes what documents are to be disclosed, as follows:

• the documents on which a party relies;
• the documents that adversely affect their own case, or another party’s case;
• the documents that support another party’s case; and
• the documents that they are required to disclose by any relevant practice direction.

Any duty of disclosure continues until the proceedings are concluded, meaning that if documents come to a party’s notice at any time, they must immediately notify the other party.

Given the prevalence of electronic documents and sources in modern litigation, specific rules apply to electronic documents, including in relation to product liability claims. CPR Rule 31 and Practice Directions 31A and 31B relate to disclosure of electronic documents – ie, any document held in electronic form.

These Practice Directions automatically apply only to proceedings that are or are likely to be allocated to the multi-track (higher value claims and/or more complex claims), and only apply to proceedings started on or after 1 October 2010. The purpose of these Practice Directions is to encourage and assist the parties to reach agreement in relation to the disclosure of electronic documents in a proportionate and effective manner. By way of example, a party requesting specific disclosure of certain electronic documents that are not reasonably accessible must demonstrate their relevance in order to justify retrieving them.

The rules relating to expert evidence in product liability cases are set out in the following:

• CPR Part 35, which sets out the rules relating to experts and assessors;
• Practice Direction 35, which supplements the above;
• Guidance for the Instruction of Experts in Civil Claims (2014); and
• Annex C to the Practice Direction (Pre-Action Conduct).

The overarching principle in relation to expert evidence is that it should be restricted to that which is reasonably required to resolve the proceedings (CPR Rule 35.1). The court’s power to restrict expert evidence also means that no party may call an expert or put an expert’s report in evidence without the court’s permission (CPR Rule 35.4). The court can also limit the use of oral expert evidence, and order evidence from a single joint expert.

An “expert” is a person who has the requisite expertise to give or prepare expert evidence for the purposes of proceedings, and it is the expert’s over-riding duty to help the court on matters within their expertise (this duty over-rides any duty to the party who instructs them).

Ordinarily, expert evidence is given in a written report. A party may put written questions to an expert about this report, and experts from opposing parties may be ordered to have discussions in order to identify the issues, reach agreement where possible, and produce a joint statement setting out those areas on which they agree and disagree, with a summary of their reasons for disagreeing.

The contents of an expert’s report must comply with the requirements set out in Practice Direction 35 – in particular, there must be a statement of compliance, and the expert must set out the substance of their instructions and the documents they have relied upon in forming their views. Expert evidence should be independent, provide objective unbiased opinions, and consider all material facts.

Complex product liability claims often involve wide-ranging expert evidence, regarding both the cause of any alleged damage and a plethora of medical evidence in personal injury and disease and illness cases. The cost of expert evidence is often a central feature in any product liability claim, and courts are increasingly limiting the use of experts or limiting the costs recoverable in relation to any particular expert’s evidence, in order to control costs.

In respect of each cause of action in product liability claims, the claimant bears the burden of proof. The standard of proof required, in respect of each discrete action, is to prove the case against the defendant on the balance of probabilities (civil standard).

However, there are certain elements of product liability claims where the above may be different. For example, what a claimant must establish in order to prove causation where the defect increases a background risk inherent in the product (a doubling of the risk?) remains undecided. There may also be certain discrete issues where the defendant bears the burden of proving that something is relevant – eg, whether a particular factor should or should not be taken into account when determining a “defect”.

There is no prescribed court for bringing product liability claims. In civil proceedings, the choice of court is generally dictated by the value of the claim and the level of complexity or importance. Product liability actions involving defective consumer goods that have resulted in personal injury or property damage are frequently brought in the County Court, or in High Court district registries. Claims of substantial value, or group actions, are likely to be brought in the High Court in London.

There are no specific rules on appeals in relation to product liability claims in civil actions. It is likely, however, that a court’s finding on whether a product is defective will be fact-specific, and so obtaining permission to appeal will be challenging.

The defences that are available in product liability claims depend on the cause of action.

Common Law Actions

For claims in negligence and breach of contract, there are no specific defences that apply solely to product liability actions, and the “normal” common law defences apply.

For a claim brought purely in tort, it is particularly important to be aware of the general exclusionary rule in relation to pure economic loss. Absent a special relationship, it is normally necessary for a claimant to show that the defective product has caused the claimant personal injury, or damage to some other product: a claim in tort does not normally exist just because an item is defective in quality.

Contractual claims can be defeated by appropriately worded exclusion clauses, although there are several statutory restrictions on exclusion clauses, particularly where the claimant is a consumer. For example, a party cannot use a contract term to exclude their liability for negligence that causes death or personal injury.

The rules on causation often provide a defence in product liability actions. A claimant who continues to use a product after discovering a defect may not be able to recover damages for a subsequent accident.

Consumer Protection Act

For claims under the Consumer Protection Act 1987, a number of specific defences are set out in Section 4 of the Act.

• A defendant is not liable if they can show that “the defect is attributable to compliance with any requirement imposed by or under any enactment or with any assimilated obligation” (Section 4(1)(a)). This defence rarely succeeds. Most statutory requirements impose minimum safety obligations on a manufacturer, but do not dictate precisely how a product is to be designed and produced.
• A defendant is not liable if they can show that they “did not at any time supply the product to another” (Section 4(1)(b)). A defendant who is the owner of a defective product will not be liable under the Consumer Protection Act to someone injured by it if that defendant did not put the product into circulation by supplying it to some other person.
• A defendant is not liable if they can show that the product was supplied for non-profit activities. A person is not liable if “the only supply of the product to another by the person proceeded against was otherwise than in the course of a business of that person’s”, and they only produced/branded or imported the product “otherwise than with a view to profit” (Section 4(1)(c)).
• A defendant is not liable if they can show that “the defect did not exist in the product at the relevant time” (Section 4(1)(d)). The producer of a car, for example, will not be liable for a defect in the car that did not exist when the car was produced and sold.
• A defendant is not liable if they can show that “the state of scientific and technical knowledge at the relevant time was not such that a producer of products of the same description as the product in question might be expected to have discovered the defect if it had existed in his products while they were under his control” (Section 4(1)(e)). This is the “state of the art” defence. Given the obvious concern of the courts that this would water down the “strict” protection given to consumers by the Act, this provision is construed narrowly.
• A defendant is not liable if they supplied a product that becomes a component of another product (a subsequent product) and the subsequent product is defective in its design (Section 4(1)(f)).

As noted in 2.12 Defences to Product Liability Claims, a defendant is not liable under the Consumer Protection Act 1987 if they can show that “the defect is attributable to compliance with any requirement imposed by or under any enactment or with any assimilated obligation” (Section 4(1)(a)). In practice, this defence does not commonly arise, because strict compliance with an enactment is unlikely to lead directly to the existence of a defect in a product.

A more controversial question is whether a defendant can rely on the fact that a product has obtained regulatory approval as a defence to a claim that the product is defective. Under the 1987 Act, a product is defective “if the safety of the product is not such as persons generally are entitled to expect” (Section 3(1)). Where a regulator allows a product (eg, a pharmaceutical product with a list of known side effects) to be placed on the market, such regulatory approval is relevant in assessing whether legitimate safety expectations: see the discussion in Gee v Depuy [2018] EWHC 1208 (QB) at paragraphs 170–178.

There are no specific rules on costs in relation to product liability claims; the normal rules on costs apply. Where a claimant has suffered a personal injury, the rules on Qualified One-Way Costs Shifting provide the claimant with protection against the risk of paying a defendant’s costs.

Where a product liability action is subject to a Group Litigation Order (GLO), costs are divided between “individual costs” (costs incurred in relation to an individual claim on the group register) and “common costs” (mainly costs incurred in relation to the GLO issues and costs incurred by the lead legal representative in administering the group litigation).

Under CPR Rule 46.6, the default position is that any order for common costs against group litigants imposes several liability on each group litigant for an equal proportion of those common costs.

Product liability actions do not themselves attract any specific funding rules. However, many product liability actions are run as large group actions, in which solicitors act under Conditional Fee Agreements, or where large commercial funders stand behind the action. Many product liability actions that arise out of damage to property (eg, fires and floods) caused by a defective product will be subrogated actions brought by, and funded by, insurance companies.

Large class actions are commonly encountered in product liability actions. Several of the most substantial product liability claims in England and Wales in the last few decades have been large group actions, arising out of defective medical products, such as pharmaceuticals or prosthetics. The diesel emissions litigation is currently one of the largest ever group actions in England and Wales, with over 1.5 million claimants, subject to different Group Litigation Orders against various manufacturers of diesel vehicles.

It remains comparatively rare for product liability cases to reach trial, and there have been no major decisions in the field of product liability in the last 12 months.

The most significant litigation in the field at present is the Diesel NOx Emissions litigation, in which it is alleged that diesel vehicles produced by a range of manufacturers contained “Prohibited Defeat Devices” (PDDs) within the meaning of the Emissions Regulation 715/2007. Several pieces of group litigation are being case managed together, with over 1.5 million claimants, and the question of whether PDDs are present in a selection of sample vehicles drawn from a pool of five manufacturers will be determined at a trial of preliminary issues in Autumn 2025. That trial is also expected to decide various points of law, including a question relating to whether any breach of statutory duty proven by the claimants is actionable. Other issues, including some aspects of quantification, are due to be tried in 2026. For those working in the product liability sphere, it is a key piece of litigation to watch over the coming 12 months.

In terms of decided cases, most recent cases have tended to turn on their own facts in relation to claims in contract or tort. The most significant cases in recent years are the run of cases concerning the Consumer Protection Act 1987 in the context of medical devices, which have provided much-needed and clear guidance on the question of what amounts to a defect, and how a claimant may prove their case.

Hastings v Finsbury and Stryker [2022] UKSC 19 was the first Supreme Court decision to consider the CPA in detail. In that case, the appellant sought to argue that defect could be established by adducing “prima facie evidence” that might suggest the presence of a defect, which the defendant must then rebut. This would have resulted in at least a partial reversal of the burden of proof. However, the Court affirmed the position that the burden of proof rests on the consumer to establish a defect and a causal link to the injury. Whilst “prima facie evidence” could form part of the patchwork of facts that a judge was entitled to take into account when determining whether a product was defective, such evidence did not have the effect of provoking a reversal of the burden of proof. Instead, a court must consider whether a claimant has established the presence of a defect in all the circumstances.

This cemented the approach taken by the High Court in Wilkes v DePuy International Ltd [2016] EWHC 3096 (QB) and Gee v DePuy International Ltd (The DePuy Pinnacle Metal on Metal Hip Litigation) [2018] EWHC 1208 (QB), both of which involved claims under the CPA 1987 relating to the presence of alleged defects in hip prostheses. The key principles arising from Gee are that the Court, agreeing with the earlier decision in Wilkes, held that a court could take a wide range of circumstances into account when determining whether a product was defective. In particular:

• a court must maintain a flexible approach to the assessment of the appropriate level of safety, and the relevant circumstances and weight given to these will vary from case to case;
• a product’s benefits, cost and avoidability were features that could, in appropriate cases, be taken into consideration when assessing whether a product is defective;
• the rigid distinction between standard and non-standard products used by Burton J in A v NBA was to be rejected, although it might be a useful starting point in the analysis of whether a product is defective;
• the existence of a learned intermediary (such as a surgeon) and warnings provided to that intermediary are relevant circumstances in assessing defect under the CPA, the weight given to which will differ from case to case; and
• in an appropriate case, evidence of compliance with regulatory standards will have considerable weight, because they have been set at a level that the appropriate regulatory authority has determined is appropriate for safety purposes.       

The last 12 months have seen important legislative and policy developments, both domestically and within the EU. Whilst the UK is no longer part of the EU, it is increasingly important to understand areas of divergence. It is imperative for those advising UK producers and insurers to be aware of European law developments, given the potential implications for manufacturers and distributors selling into the EU, and insurers’ risks in relation to such products. The EU regime may well, also, influence parliament’s approach to future UK legislation, for reasons addressed in 3.2 Future Policy in Product Liability and Product Safety.

The central development in the EU comes in the form of the (new) Product Liability Directive (EU) 2024/2853 (“new PLD”), which replaces and repeals the original Product Liability Directive (85/374/EEC) (PLD). The original PLD was, of course, the basis for the Consumer Protection Act 1987, lending an even greater significance to the developments within the EU. The key features of the new PLD include the following.

• The range of potential defendants is considerably widened in comparison with the original PLD. For example, a manufacturer’s authorised representative in the EU, a distributor, a person who modifies a product, and the operator of an online marketplace are each, in some circumstances, susceptible to a claim by an injured consumer.
• The range of claimants is substantially the same as the original PLD, but the new PLD makes express provision for subrogation.
• The definition of a “product” is expanded. For the first time, it expressly includes software and services or updates/upgrades, including those provided by a third party where the manufacturer approves of that supply.
• The definition of defect is materially the same as the original PLD but the new PLD provides a clearer and longer list of the range of circumstances that may be taken into account.
• The PLD retains a test of strict liability when considering whether a product is defective. However, and importantly (particularly in the context of the domestic law decision in Hastings), the new PLD makes a substantial and claimant-friendly change to the burden of proof. The new PLD makes provision for:
1. a rebuttable presumption of causation “where it has been established that the product is defective and that the damage caused is of a kind typically consistent with the defect in question”; and
2. a rebuttable presumption of defect and/or causation where the “claimant faces excessive difficulties, in particular due to technical or scientific complexity, in proving the defectiveness of the product or the causal link between its defectiveness and the damage, or both” and “the claimant demonstrates that it is likely that the product is defective or that there is a causal link between the defectiveness of the product and the damage, or both.”
• The limitation long-stop is extended from ten to 25 years in cases of latent damage, although it remains to be seen how the European courts will approach the issue of latent damage.

These are major and important changes. What impact they will have on the approach taken by parliament in domestic law remains to be seen, but it is clear that these changes will have major consequences for UK manufacturers selling into the EU, and for others (such as distributors) who may be potential defendants under the new PLD.

In domestic law, an important change has occurred in relation to the post-market surveillance requirements in respect of medical devices. The Medical Devices (Post-market Surveillance requirements) (Amendment) Great Britain) Regulations 2024 will come into force on 16 June 2025 and will result in a greater burden on manufacturers of medical devices in relation to post-market surveillance activities. These regulations require manufacturers to maintain a post-market surveillance system for each device, to identify incidents (falling into various categories), to identify preventative and corrective actions, to monitor trends, and to ensure that the matters gleaned through post-market surveillance are reflected in the technical documentation. This forms part of the MHRA’s revised roadmap towards the future regulatory framework for medical devices, published on 11 December 2024.

The EU has also taken the first steps in producing a comprehensive regime for the regulation of artificial intelligence in the form of the EU’s Artificial Intelligence Act, which came into force on 1 August 2024 and aims to regulate AI risks across a wide range of sectors. Its aim is to regulate the producers of AI systems rather than creating enforceable rights on individuals, and it classifies AI applications by reference to their risk of causing harm:

• AI applications with an unacceptable risk are banned;
• high-risk and general-purpose AI applications must comply with a range of requirements;
• limited-risk AI applications must comply with transparency requirements; and
• minimal AI risks are not regulated.

This will create challenges for developers producing AI products for use in both EU and non-EU (eg, UK) jurisdictions.

There are a number of important developments on the horizon in relation to policy and legislative changes in the product liability arena. In terms of concrete developments, the Product Regulation and Metrology Bill is currently progressing through parliament. This is a critical piece of domestic legislation, and one which all those who specialise in this area must watch with care. The precise requirements of the bill are evolving as it passes through parliament (it is at the committee stage at the time of writing) but, at present, the following appear to be key features.

• It applies to the whole of the UK.
• It creates a framework for secondary legislation by way of statutory instrument in relation to:
1. reducing or mitigating risks presented by products (defined widely as “a tangible item that results from a method of production”);
2. ensuring that products operate efficiently or effectively; and
3. ensuring that products designed for weighing or measuring operate accurately.
• It provides scope for market surveillance authorities to share information about products.
• It beefs up the enforcement regime by:
1. creating new powers of entry, search and seizure;
2. imposing new product recall requirements and product enforcement notices;
3. allowing the Secretary of State to appoint inspectors and create new offences;
4. conferring on the courts the power to order the forfeiture of products that do not comply with product regulations; and
5. allowing for cost recovery for a regulatory body in carrying out functions conferred on it by regulations made under the proposed Act.
• It allows civil penalties as an alternative to prosecution.

One aspect of particular importance is the purpose of the bill. The Department for Business and Trade conducted an impact assessment in which it identified that the bill was required because the UK lacked the power to end recognition of existing EU regulations, or to recognise new, post-Brexit EU regulations. The bill will allow the government to do so rapidly, by way of secondary legislation. This is a potentially major, and overlooked, consequence of the proposed legislation, as it may allow for the rapid adoption and recognition of EU regulations post-Brexit, but also creates scope for regulatory divergence.