Product Liability & Safety 2026 Comparisons

Last Updated June 18, 2026

Contributed By Fletchers Solicitors

Law and Practice

Authors



Fletchers Solicitors is a nationally recognised, claimant-only firm specialising in product liability, complex serious injury, clinical negligence, and high-value personal injury claims. With a Medical Product Liability team of six, the firm operates across key UK locations, including Manchester, Liverpool, Birmingham, Leeds, Cambridge, Newcastle, Northampton, Southport and Bolton. The firm’s multidisciplinary model combines legal expertise with in-house medical specialists, including nurse analysts and midwives, alongside a dedicated Early Rehabilitation Service to deliver holistic, client-focused support. The Medical Product Liability team is highly experienced in complex defective drug and device litigation, particularly large-scale group actions against multinational manufacturers, including transvaginal mesh, Essure contraceptive devices and metal-on-metal hip implants, combining legal excellence with scientific insight to secure justice for clients affected by life-changing injuries. The team is also actively engaged in advocacy and legal reform, helping shape the future of product liability law.

Main Product Safety Laws and Regulations

The principal legislation forming the product safety regime in England and Wales includes:

  • the General Product Safety Regulations 2005;
  • the Consumer Protection Act 1987; and
  • the Health and Safety at Work etc Act 1974.

General Product Safety Regulations 2005 (GPSR)

The GPSR provide the core framework governing the safety of consumer products that are not subject to sector-specific safety regimes. They originally implemented the EU General Product Safety Directive (2001/95/EC) and were retained (with amendments) as domestic law following Brexit.

Key features include:

  • General Safety Requirement: Only products that are “safe” may be placed on the market (Regulations 5 and 8). A product is safe if, under normal or reasonably foreseeable conditions of use, it presents no risk or only minimal, acceptable risks.
  • Scope: The framework applies to products supplied in the course of business (whether or not for payment) that are intended or likely to be used by consumers, including certain secondhand or reconditioned products.
  • Assessment of Safety: Safety is assessed by reference to the level of protection the public is entitled to expect, taking into account product characteristics, presentation, warnings and foreseeable use.
  • Presumption of Conformity: Compliance with relevant legislation and recognised standards may support a presumption that a product is safe, subject to contrary evidence (Regulation 6).
  • Producer and Distributor Duties: Producers must not place unsafe products on the market and must provide appropriate consumer information and monitoring; distributors must act with due care and cooperate in safety monitoring and corrective action.
  • Notification Obligations: Producers (and, in certain circumstances, distributors) must notify enforcement authorities where a product poses risks incompatible with the general safety requirement (Regulation 10).
  • Enforcement and Offences: The GPSR confer market surveillance and enforcement powers, create criminal offences for non-compliance with safety requirements and safety notices, and provide a due diligence defence.

Consumer Protection Act 1987 (CPA)

The CPA underpins the UK’s product safety regime by providing the statutory framework for making and enforcing product-specific safety requirements, in addition to establishing a separate strict liability regime for defective products.

Key regulatory elements include:

  • Power to Make Safety Regulations: Part II empowers the Secretary of State (notably under Section 11) to make detailed product-specific safety regulations covering design, construction, testing, approvals, labelling and warnings.
  • Product Information Requirements: Safety regulations may require appropriate instructions and warnings and restrict misleading or inadequate safety information.
  • Enforcement Notices: Authorities may issue prohibition notices, suspension notices and notices to warn in order to prevent the supply of unsafe products.
  • Seizure and Forfeiture: Unsafe goods may be seized and detained and, following the statutory process, forfeited.
  • Investigation and Information Gathering: Authorised officers have powers of entry, inspection, search and information gathering, with offences for obstruction.
  • Offences and Defences: Breach of safety regulations or enforcement notices is a criminal offence, subject to a statutory due diligence defence.
  • Relationship With GPSR: Where product-specific safety regulations are made under the CPA, they generally take precedence over the GPSR, which operate as a residual “catch-all” regime for other consumer products.

Health and Safety at Work etc Act 1974 (HSWA)

The HSWA provides the principal framework for occupational health and safety in England and Wales, including obligations relating to products and equipment supplied for use at work.

Key provisions include:

  • Section 6 Duties: Designers, manufacturers, importers and suppliers of articles for use at work must ensure, so far as is reasonably practicable, that products are safe and without risks to health when properly used, tested and maintained, and must provide adequate information and instructions.
  • Ongoing Information Duties: Duty holders must keep users informed of relevant new risks or safety information as knowledge develops.
  • Burden of Proof: Where duties are qualified by the concept of “reasonable practicability”, Section 40 places the burden on the dutyholder to demonstrate that no further reasonably practicable measures could have been taken.

Regulatory Authorities for Product Safety

Product safety regulation in England and Wales operates through a combination of central government oversight, sector-specific regulators and local enforcement authorities. Responsibility is shared across a number of bodies, reflecting the breadth of products covered and the interaction between consumer, workplace and sector-specific safety regimes.

Office for Product Safety and Standards (OPSS)

The Office for Product Safety and Standards (OPSS) is the principal national authority for product safety and standards. It sits within the Department for Business and Trade and provides scientific, technical and regulatory expertise at a national level. The OPSS plays a co-ordinating role across the product safety system, supporting and, in certain cases, directing local enforcement activity.

Its functions include market surveillance, product risk assessment, oversight of product recalls, and direct enforcement action in high-risk, nationally significant or technically complex cases. The OPSS also acts as the UK’s central contact point for international product safety cooperation and information-sharing.

Under the General Product Safety Regulations 2005, the OPSS has wide enforcement powers, including the ability to issue statutory safety notices. These include suspension notices (temporarily preventing supply pending investigation), marking and warning requirements, withdrawal notices requiring removal of products from the supply chain, and recall notices requiring products already supplied to consumers to be returned. The OPSS also has information-gathering powers, including the ability to require documents or product samples where necessary to assess compliance. In practice, it plays a strategic role in managing large-scale recalls and coordinating cross-border safety issues.

Local authority Trading Standards services

Local authority Trading Standards services are the primary frontline enforcers of product safety legislation. They are responsible for the day-to-day enforcement of the General Product Safety Regulations 2005 and the product safety provisions of the Consumer Protection Act 1987 within their local areas.

Trading Standards officers carry out inspections, test products, investigate complaints and pursue enforcement action against non-compliant businesses. Their powers include issuing improvement, prohibition and recall notices, seizing and detaining unsafe goods, and bringing criminal prosecutions. While their remit is local, Trading Standards services often work closely with the OPSS on matters that have regional or national implications.

Border enforcement

At the border, HM Revenue and Customs and UK Border Force play an important role in preventing unsafe or non-compliant products from entering the UK market. Working alongside Trading Standards and the OPSS, they have powers to detain and examine imported goods where there is suspicion of non-compliance with product safety requirements.

Border intervention is particularly significant in relation to high-volume consumer imports and products sold through online marketplaces.

Sector-specific regulators

In addition to the general product safety regime, a number of sector-specific regulators have responsibility for particular product categories.

The Food Standards Agency (FSA) is responsible for food safety and hygiene across England, Wales and Northern Ireland. It oversees food recalls, conducts risk assessments, sets enforcement policy and works with local authorities that carry out inspections and enforcement at a local level.

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components. It has powers to authorise products, monitor safety through post-market surveillance, and require corrective action, including withdrawals and recalls. Given the technical complexity and potential risks involved, MHRA oversight is highly developed and enforcement activity is closely linked to regulatory compliance.

The Driver and Vehicle Standards Agency (DVSA) is responsible for vehicle safety standards. It oversees safety recalls and investigates vehicle-related defects, with powers to require manufacturers to remedy safety issues and to co-ordinate large-scale recall exercises.

The Health and Safety Executive (HSE) enforces product safety obligations in relation to workplace equipment and certain industrial products under the Health and Safety at Work etc Act 1974. Its remit includes products used at work, machinery and industrial equipment, with powers to issue improvement and prohibition notices and to bring criminal prosecutions where risks to health and safety arise.

Scope of regulatory powers

Across these bodies, regulatory powers typically include market surveillance, inspection and testing of products, requirements to provide warnings or corrective action, seizure and destruction of unsafe goods, and civil and criminal enforcement.

The system is designed to allow regulators to intervene proportionately, with criminal prosecution generally reserved for serious or persistent breaches, and an increasing emphasis placed on recalls, corrective action and compliance-led outcomes.

UK law imposes clear obligations on producers and distributors to take corrective action where a product presents a risk to health or safety. These obligations arise both proactively, once a risk is identified, and reactively, in response to regulatory intervention.

Duty to Notify and Take Action

Under the GPSR, producers and distributors are required to notify the relevant enforcement authority where they know, or ought reasonably to know, that a product they have placed on the market poses a risk to consumers (Regulation 9).

This notification duty is coupled with an expectation that appropriate corrective action is taken, which may include issuing warnings, withdrawing the product from the supply chain or organising a recall, depending on the severity and nature of the risk.

Corrective action is expected even where no incident has yet occurred, and the adequacy of voluntary measures is taken into account when regulators consider whether formal enforcement action is required.

Corrective Action Required by Enforcement Authorities

Regulators have wide statutory powers to require corrective action through formal notices issued under the GPSR, the CPA and the HSWA. These powers are graduated and enable proportionate intervention based on the level of risk.

Measures Restricting Supply

Enforcement authorities may take steps to restrict or suspend the supply of products, including:

  • prohibition notices (Section 13, CPA), which prevent the supply of a product except on terms approved by the authority;
  • suspension notices (Regulation 11, GPSR; Section 14, CPA), which temporarily prohibit placing a product on the market pending investigation; and
  • improvement notices (Section 21, HSWA), requiring specified steps to remedy breaches, which may in practice prevent continued supply.

Measures Requiring Warnings and Information

Authorities may also require action to inform users and mitigate risks, including:

  • notices to warn (Section 13, CPA), which require the publication of warnings about unsafe products;
  • marking or warning requirements (Regulation 12, GPSR), which may require warnings to be placed on products, packaging or marketing materials; and
  • improvement notices under the HSWA, which may also require the provision of risk information to users.

These measures may involve mandatory public communications, including advertising or targeted consumer warnings, where necessary to protect public safety.

Withdrawal and Recall

More intrusive measures are available where lesser action is insufficient:

  • Withdrawal notices (Regulation 14, GPSR) require removal of products from the supply chain and may include obligations to alert consumers and trace affected products. These are typically used where voluntary withdrawal is inadequate or the risk justifies formal intervention.
  • Recall notices (Regulation 15, GPSR) require businesses to organise the return of products already supplied to consumers. Recall notices are generally reserved for cases where:
    1. other corrective measures would be inadequate;
    2. voluntary action has not been taken or is insufficient; and
    3. advance notice has been given, unless urgent action is required due to a serious risk.

Recall notices may stipulate how the recall is conducted, including requirements relating to consumer contact, publication of warnings, and arrangements for collection, return or disposal of products.

Where a business fails to comply with a recall notice, or where no responsible economic operator can be identified, the enforcement authority may carry out the recall itself and recover the associated costs.

In England and Wales, product safety notification obligations are primarily risk-based, meaning that businesses are required to notify regulators when they become aware that a product may be unsafe, rather than only after an incident has occurred. However, incident-based reporting obligations also apply in certain regulated sectors.

Risk-Based Notification Under the GPSR

Under Regulation 9 of the GPSR, notification is required where a producer or distributor knows, or ought reasonably to know, that a product they have placed on the market poses a risk to consumer safety and does not meet the general safety requirement.

Key features of this obligation include the following:

  • The duty is triggered by awareness of risk and applies even if no accident, injury or damage has yet occurred.
  • Notification is not generally required for isolated or one-off issues with no wider safety implications.
  • Where sector-specific legislation does not impose its own notification requirements, the GPSR regime will ordinarily apply.

Neither the CPA nor the HSWA imposes a general, standalone duty to notify product safety risks. However, regulations made under Section 11 of the CPA may, in specific circumstances, require information to be provided to enforcement authorities, including details of potential safety concerns.

Who must notify?

The GPSR notification duty applies to:

  • producers, including manufacturers, own branders and importers; and
  • distributors within the supply chain.

Each party is required to act independently when it becomes aware of a relevant risk, regardless of whether another economic operator has already made a notification.

Timing of notification

Notification must be made as soon as reasonably practicable after the relevant risk is identified. There is no prescribed statutory deadline, but regulators expect prompt reporting, particularly where a product presents a serious risk. Delay in notification may be taken into account in enforcement decisions.

Content of notifications and serious risks

Where a product presents a “serious risk” (as defined in Regulation 2 of the GPSR), notifications must include more detailed and structured information. This typically includes:

  • identification of the product or affected batch;
  • a description of the nature of the risk;
  • information enabling the product to be traced through the supply chain; and
  • details of any corrective or preventive action already taken or proposed.

Notifications are usually made to the relevant local Trading Standards authority and/or the Office for Product Safety and Standards, depending on the nature and geographic scope of the issue.

Incident-Based Reporting in Specific Sectors

In addition to the GPSR risk-based regime, incident-based reporting requirements apply in certain contexts. For example:

  • Under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013 (RIDDOR), a report must be made where a product is involved in a defined work-related dangerous occurrence or causes serious injury in the workplace.
  • Sector-specific regulators, such as the Medicines and Healthcare products Regulatory Agency and the Driver and Vehicle Standards Agency, impose their own reporting obligations triggered by specified incidents involving regulated products.

Where incident reports identify wider product safety concerns, regulators will co-ordinate enforcement activity across agencies, including between Trading Standards, the Health and Safety Executive and national regulators.

Breaches of product safety obligations in England and Wales can give rise to criminal liability, including substantial fines and, in serious cases, imprisonment. Enforcement action is typically taken by local authority Trading Standards services, the OPSS or the Health and Safety Executive (HSE), depending on the nature of the product and the regulatory regime engaged.

Penalties Under the General Product Safety Regulations 2005 (GPSR)

Under the GPSR, failure to comply with core obligations – including notification duties and safety requirements – is a criminal offence. More serious breaches, such as failure to comply with statutory safety notices (including suspension, withdrawal or recall notices), may be prosecuted in either the magistrates’ court or the Crown Court.

Penalties include:

  • up to 12 months’ imprisonment and/or an unlimited fine on conviction on indictment; and
  • up to three months’ imprisonment and/or an unlimited fine on summary conviction for less serious offences.

A statutory due diligence defence may be available where the defendant can demonstrate that all reasonable steps were taken to avoid the commission of the offence.

Penalties Under the Health and Safety at Work etc Act 1974 (HSWA)

Breach of duties under the HSWA – including the Section 6 duties relating to products and articles supplied for use at work – or failure to comply with improvement or prohibition notices is a criminal offence.

Penalties include:

  • up to two years’ imprisonment and/or an unlimited fine on indictment; and
  • up to 12 months’ imprisonment and/or an unlimited fine on summary conviction.

Sentencing in HSWA cases often reflects the seriousness of the risk created, the harm caused and the scale of the defendant’s operations.

Penalties Under the Consumer Protection Act 1987 (CPA)

Under Part II of the CPA, breach of product-specific safety regulations or enforcement notices (including prohibition or suspension notices) constitutes a criminal offence.

Penalties typically include:

  • up to six months’ imprisonment and/or an unlimited fine (summary only for most offences); and
  • up to three months’ imprisonment and/or an unlimited fine for breach of suspension notices.

As with the GPSR, a statutory due diligence defence may be available.

Sentencing Approach

There is no bespoke sentencing guideline specifically for product safety offences. In practice, courts frequently apply the Sentencing Council Guidelines for Health and Safety Offences, Corporate Manslaughter and Food Safety and Hygiene Offences, particularly where corporate defendants are concerned. These guidelines emphasise risk of harm, actual harm, culpability and turnover when determining fines.

Enforcement and Prosecution Trends

Trading Standards authorities and the HSE regularly bring prosecutions for serious or persistent breaches, although reported cases remain relatively limited. Illustrative authorities include:

  • R v Winter (Martin) (2024) EWCA Crim 711 (prosecution for breach of health and safety regulations; gross negligence manslaughter was also considered);
  • R v Kayani [2014] EWCA Crim 2635 (GPSR enforcement);
  • R v Bettridge [2010] EWCA Crim 41 (product safety offences);
  • R (Junttan Oy) v Bristol Magistrates’ Court [2003] UKHL 55 (scope of health and safety duties); and
  • R v Patchett Engineering Ltd [2001] 1 Cr App R (S) 40 (sentencing for safety breaches).

In practice, however, regulators increasingly prioritise recalls, corrective action and compliance-led outcomes, with criminal prosecution generally reserved for cases involving serious risk, repeated non-compliance or a failure to act on known safety concerns.

Product liability claims in England and Wales are generally advanced through three routes: statutory strict liability claims under the CPA and claims in negligence and contract.

The CPA provides a regime of strict liability, under which a producer may be held liable for damage caused by a defective product without proof of fault. Liability extends beyond manufacturers to include own-branders and importers, and in some circumstances suppliers who fail to identify the relevant producer. Claimants must establish defect, damage and causation.

A product will be defective if it does not meet the level of safety persons are generally entitled to expect, taking into account all relevant circumstances. The courts have emphasised a flexible and fact-sensitive approach to this assessment, including consideration of warnings, regulatory compliance and the product’s risk-benefit profile.

Damage under the CPA is limited to personal injury, death, and certain categories of property damage, subject to statutory thresholds. The claimant must also demonstrate a causal link between the defect and the damage.

Negligence claims require proof of a duty of care, breach of that duty, causation and foreseeability, and may arise from deficiencies in design, manufacture, warnings or post-market conduct. Contractual claims, by contrast, focus on breach of express or implied terms, particularly those relating to quality and fitness for purpose under consumer and commercial sale of goods legislation.

Standing to bring a product liability claim depends on the cause of action relied upon.

Claims under the CPA are typically brought by individuals who have suffered damage caused by a defective product.

In negligence, standing is broader. Claims may be brought by any person who could reasonably be foreseen as being affected by the product, including end users and, in appropriate circumstances, third parties such as bystanders. There is no requirement for a direct contractual relationship between claimant and defendant.

Contractual product claims remain subject to the doctrine of privity, meaning that only parties to the relevant contract will ordinarily have standing to sue. However, statutory exceptions and mechanisms such as assignment may, in limited circumstances, permit third parties to pursue contractual claims.

The applicable limitation period for a product liability claim depends on the legal basis on which the claim is brought.

Claims in negligence and contract are governed by the Limitation Act 1980. Personal injury claims must generally be commenced within three years from the date on which the claimant knew, or ought reasonably to have known, that they had suffered injury or damage attributable to the relevant act or omission. Other negligence and contractual claims are typically subject to a six-year limitation period, running from the date of damage (in negligence) or breach (in contract), subject to specific provisions relating to latent damage.

Statutory claims under the CPA are subject to a dual limitation regime. Proceedings must be issued within three years of the date of damage or the claimant’s date of knowledge. In addition, such claims are subject to a strict ten-year longstop period, running from the date on which the product was first put into circulation. This longstop cannot be extended and operates as an absolute bar to a claim under the Act.

As a general rule, the courts of England and Wales will have jurisdiction over a product liability claim where the defendant is domiciled in England and Wales, or where the damage and resulting loss were suffered within the jurisdiction. Where both parties are domiciled in England and Wales, jurisdiction will rarely be contentious.

Where a defendant is based outside the jurisdiction, the claimant will generally require the court’s permission to serve proceedings out of the jurisdiction. In deciding whether to grant permission, the court will consider whether the claim falls within one of the recognised jurisdictional gateways and whether England and Wales is the proper forum for the dispute.

In product liability claims framed in tort (including negligence and claims under the Consumer Protection Act 1987), commonly relied-upon gateways include cases where:

  • the damage was sustained (or is likely to be sustained) in England and Wales;
  • the damage results from an act or omission committed within the jurisdiction; or
  • the claim is governed by English law.

In practice, these requirements are often satisfied where the claimant is based in England and Wales, the product was supplied or used here and the alleged injury or property damage occurred domestically.

Questions of applicable law remain relevant to the jurisdictional analysis. For non-contractual obligations, the Rome II regime generally applies, with the default position being that the applicable law is that of the place where the damage occurs.

Where product liability claims are brought in contract, jurisdiction and governing law will usually be determined by the contractual arrangements between the parties, including any choice of court or governing law clauses, subject to mandatory consumer protection rules.

There is no dedicated pre-action protocol specific to product liability claims. However, parties comply with the general pre-action framework set out in the Civil Procedure Rules, together with any applicable sector-specific protocols.

Depending on the nature of the claim, this will commonly include the Pre-Action Protocol for Personal Injury Claims, the protocol for low-value employers’ liability or public liability claims, or the protocol for disease and illness claims. The applicable protocol will depend on the type of harm alleged and the value and complexity of the claim.

The purpose of these protocols is to promote the early exchange of relevant information, enable the parties to investigate the issues in dispute, and encourage settlement without the need for issuing court proceedings. They set out expectations as to the timing and content of pre-action correspondence, including letters of claim and letters of response, and require the parties to consider alternative dispute resolution where appropriate.

Failure to comply may result in sanctions. In determining whether to impose such measures, the court will consider the extent of compliance, the impact of any non-compliance on the other party, and whether any breach is material. Sanctions may include cost consequences or a stay of proceedings pending compliance.

There are no product liability-specific preservation rules in England and Wales. Instead, general duties to preserve evidence arise under the Civil Procedure Rules once litigation is contemplated.

Practice Direction 31 requires parties and their advisers to take reasonable steps to preserve documents that may be disclosable in the proceedings. This obligation applies to both paper and electronic material and includes information that might otherwise be deleted in the ordinary course of business under routine retention or auto-deletion policies.

What constitutes reasonable preservation will depend on the circumstances of the case. Relevant factors include the volume and nature of the documents involved, the complexity of the issues, the proportionality of preservation efforts, and the likely significance of specific categories of material. In practice, this may involve identifying relevant custodians, preserving defined classes of documents, and suspending automatic deletion processes.

Preservation obligations are not limited to documentary evidence. In product liability claims, they may also extend to physical evidence such as the product itself, components, prototypes, design records and testing materials where these are relevant to the issues in dispute.

Non-compliance can have serious consequences. The court has a broad discretion to impose sanctions, which may include adverse inferences, costs penalties, restrictions on the use of evidence, or, in serious cases, the striking out of part or all of a party’s claim or defence.

There are detailed rules governing the disclosure of documents in product liability proceedings, which are set out in Part 31 of the Civil Procedure Rules.

In this context, “disclosure” refers to the obligation to identify documents that exist or have existed, rather than to provide copies in the first instance. A party to whom documents have been disclosed is generally entitled to inspect them, subject to limited exceptions, including where the document is no longer within the disclosing party’s control, is privileged, or where inspection would be disproportionate.

The scope of standard disclosure is defined by CPR Rule 31.6. Parties are required to disclose the documents on which they rely, those which adversely affect their own case or another party’s case, and those which support another party’s case, as well as any documents required to be disclosed by a relevant practice direction. The obligation is ongoing and continues until the end of the claim.

Specific considerations arise in relation to electronic documents, which are now central to most disputes. Practice Directions 31A and 31B provide additional guidance, particularly in cases allocated to the multi-track. These provisions are intended to promote a proportionate and efficient approach to the identification, review and disclosure of electronic material. Where a party seeks disclosure of electronic documents that are not readily accessible, it may be necessary to demonstrate their relevance in order to justify the time and expense involved in retrieval of those documents.

The use of expert evidence in product liability proceedings is governed by Part 35 of the Civil Procedure Rules, together with its associated Practice Direction and supplementary guidance.

The court retains control over the use of expert evidence, and such evidence is limited to what is reasonably required to resolve the issues in dispute. A party may not rely on expert evidence without the court’s permission, and the court may restrict the number of experts to be used in the case.

An expert’s primary duty is to the court, not to the party who instructed them. Expert evidence is typically provided in the form of a written report, which must comply with the requirements set out in the Practice Direction, including confirmation of the expert’s independence and details of the material the expert has relied upon in forming their opinion.

The rules also provide for procedural mechanisms to narrow the issues between the experts. These may include written questions to experts and joint meetings between opposing experts, with a view to producing a joint statement identifying areas of agreement and disagreement, together with reasons.

Given the technical nature of many product liability claims, expert evidence often plays a key role, particularly in relation to defect, causation and quantum. The court will, however, seek to ensure that such evidence remains proportionate.

The burden of proof in product liability claims in England and Wales rests with the claimant.

In claims brought under the CPA, the claimant must establish, on the balance of probabilities, that:

  • the product was defective;
  • the claimant suffered damage; and
  • the defect caused the damage complained of.

The legal burden of proof does not shift to the defendant. However, the evidential position may develop during the course of proceedings. In practice, claimants frequently rely on circumstantial evidence and expert evidence to support allegations of defect and causation. Where such evidence is sufficiently cogent, a defendant may be required to advance an alternative explanation, although the ultimate burden of proof remains with the claimant throughout.

Causation is often a key issue in dispute. The claimant must demonstrate that the damage would not have occurred but for the alleged defect, applying established principles of causation under English law. Given the technical and scientific issues commonly involved, expert evidence typically plays a decisive role in addressing both defect and causation.

While the statutory framework is relatively straightforward in principle, its application is highly fact-specific and depends on the quality, consistency and interaction of the available evidence.

Product liability claims are issued within the ordinary civil court structure in England and Wales. The choice of court is driven by the value of the claim, its legal and factual complexity, and the extent of any technical or expert evidence required.

Lower-value disputes are generally issued in the County Court, whereas higher-value or more complex claims (for example, claims where proceedings involve multiple parties, co-ordinated litigation, involve a defendant who is out of jurisdiction or involve significant evidential complexity) are more commonly issued in the High Court, often within the King’s Bench Division or a relevant district registry.

The court retains a broad discretion to allocate or transfer proceedings between courts where appropriate, having regard to proportionality and the efficient administration of justice. This flexibility allows product liability claims to be managed in a forum suited to their complexity and significance.

There is no specific appeal framework for product liability disputes; appeals proceed under the general Civil Procedure Rules in the usual way. In practice, the prospects of obtaining permission to appeal in such cases are often limited. This reflects the fact that many product liability determinations – particularly those concerning whether a product is defective – are heavily dependent on the trial judge’s assessment of detailed factual and expert evidence. Appellate courts are typically reluctant to interfere with such judgments, unless there is a clear error of law or the conclusion is plainly wrong.

Where an appeal does proceed, it will ordinarily focus on alleged errors of law, misapplication of the statutory test, or procedural irregularities, rather than a re-examination of the evidence and prospects of the case. Accordingly, while appeals are available, they are comparatively uncommon and can be difficult to advance successfully in this field.

Defendants in English product liability litigation can rely on the usual defences applicable to the cause of action pleaded, together with a set of statutory defences for strict liability claims under the CPA.

CPA Defences

Section 4 of the CPA contains the principal statutory defences. In summary, a defendant is not liable if it proves that:

  • the alleged defect is the result of the product meeting a requirement imposed by legislation or an assimilated obligation;
  • it did not put the product into circulation (ie, it did not supply the product to another);
  • the product was supplied otherwise than in the course of business and it was not produced/imported/own-branded with a view to profit;
  • the defect was not present at the “relevant time” (generally, when the product was supplied/put into circulation);
  • the state of scientific and technical knowledge at the relevant time was not such that a producer of similar products could reasonably have been expected to discover the defect (the “development risks” or “state of the art” defence, which is applied restrictively); or
  • it supplied a component and the defect is attributable to the design of the finished product into which the component was incorporated, or to compliance of that finished product with instructions given by the component producer.

Negligence and Other Common Law Claims

Where claims are brought in negligence, defendants can rely on orthodox principles of duty, breach and causation. In particular, a claimant will generally be unable to recover in tort for “pure” economic loss (ie, loss arising solely because the product is of poor quality) in the absence of special circumstances: personal injury or damage to other property is usually required.

Continued use of a product after knowledge of a defect, misuse, or failure to follow instructions/warnings may break the chain of causation, support a defence of contributory negligence and/or (in appropriate cases) voluntary assumption of risk.

Contract Claims

For contract-based claims, parties may seek to rely on limitation or exclusion clauses and other contractual risk allocation provisions. Their effectiveness will depend on construction and statutory controls, including the Unfair Contract Terms Act 1977 (for business-to-business contracts) and the Consumer Rights Act 2015 (for consumer contracts). In particular, liability for death or personal injury caused by negligence cannot be excluded.

Regulatory compliance can be important in product liability cases, but it is not determinative. The CPA provides a defence where the alleged defect arises because the product was required to comply with a mandatory legal rule; in reality, that defence is rarely used because most regulatory regimes set minimum safety standards rather than prescribing the precise design solution.

More often, compliance and regulatory clearance are relied on as part of the wider evidential picture when the court assesses whether a product is “defective”. The statutory question is whether the product provided the level of safety that people are generally entitled to expect, and evidence that the product met applicable regulatory requirements may inform (but not dictate) those expectations.

The court will weigh regulatory material alongside all other relevant circumstances, including the product’s characteristics, the nature and seriousness of the risks, and the content and adequacy of warnings and instructions. In highly regulated sectors (notably pharmaceuticals and medical devices), regulatory approval may carry substantial evidential weight – particularly where known risks have been appropriately disclosed and managed – but it does not operate as a complete defence to liability.

Costs in product liability litigation follow the general civil costs rules. As a starting point, the court will usually deal with costs at the end of the proceedings and will typically order the unsuccessful party to pay the successful party’s costs.

In personal injury claims, Qualified One-Way Costs Shifting (QOCS) generally protects claimants from having to pay the defendant’s costs, subject to statutory and rule-based exceptions (including where the claim is fundamentally dishonest, and where the claimant fails to obtain a result more advantageous than a defendant’s Part 36 offer). Claimants may also obtain after-the-event (ATE) insurance with an appropriate indemnity limit to cover any residual adverse costs risk.

Where claims are pursued on a coordinated basis under a Group Litigation Order (GLO), costs are commonly categorised as:

  • individual costs (incurred in relation to a particular claimant’s claim); and
  • common costs (incurred for the benefit of the group as a whole).

Under CPR 46.6, responsibility for common costs is normally shared equally between claimants on the group register unless the court directs a different approach. Given the scale and complexity of group litigation, common costs can be significant.

Ultimately, costs awards are discretionary. A successful party will commonly recover its costs on the standard basis (to be assessed if not agreed), but the court may order costs on an indemnity basis in appropriate cases – for example, where a party’s conduct is criticised or it has unreasonably refused to participate in alternative dispute resolution (ADR).

In practice, full recovery is unusual: even where a party “wins”, the amount recovered is often reduced through negotiation between the parties and/or on detailed assessment.

A range of private and third-party funding options are available for product liability litigation in England and Wales, and these mechanisms are commonly used in practice (particularly in higher-value claims and group litigation).

Conditional Fee Agreements (CFAs) (“No Win, No Fee”)

CFAs are widely used, including for product-related personal injury claims and claimant-led group actions. Under a CFA, the solicitor’s base costs are payable only if the claim succeeds, and the solicitor may also charge a “success fee” (an uplift on base costs) to reflect the risk of non-payment. Since the LASPO reforms, success fees are generally payable by the client (rather than being recoverable from the opponent), subject to specific statutory caps in personal injury claims at first instance.

Damages-Based Agreements (DBAs) (Contingency Fees)

Contingency fee arrangements are permissible through DBAs, under which a representative’s fee is calculated by reference to a percentage of the damages recovered. DBAs are less common than CFAs in product liability litigation but may be used in suitable cases. Statutory limits apply to the percentage that can be taken from damages (including (for example) a 25% cap in personal injury claims and a 50% cap in most other claims at first instance).

After-the-Event (ATE) Insurance and Legal Expenses Insurance

ATE insurance is frequently used alongside CFAs and (where relevant) third-party funding to cover disbursements and to protect against adverse costs exposure (subject to the QOCS regime in personal injury claims). Before-the-event legal expenses insurance may also be available to some claimants (for example, under household or motor policies), although it is not universal.

Third-Party Litigation Funding

Third-party litigation funding is permitted and is most often seen in complex, high-value product litigation (particularly group claims), where the costs of expert evidence, disclosure and case management can be substantial. Funders typically provide non-recourse funding for some or all of the claimant side’s costs in return for an agreed return if the case is successful, and they will commonly require ATE insurance to be in place to address adverse costs risk. The market operates on a largely self-regulatory basis (including through the Association of Litigation Funders’ Code of Conduct), although the regulatory landscape remains an area of active policy focus.

Legal Aid

Public funding for civil claims is limited and is not generally available for product liability litigation, subject to means/merits and any exceptional case funding in rare circumstances.

Collective and co-ordinated proceedings are well established in product liability litigation in England and Wales. The courts have developed flexible procedural mechanisms to manage large numbers of related claims efficiently.

The primary mechanism is the Group Litigation Order (GLO), which may be made where multiple claims give rise to common or related issues of fact or law. A GLO establishes a group register and provides for the co-ordinated management of proceedings, including common directions on disclosure, expert evidence and the determination of shared issues. In practice, one or more “lead” or “test” cases are selected to proceed first, with other claims stayed pending the outcome, enabling issues of defect, causation or regulatory compliance to be resolved efficiently.

GLOs have been used extensively in product-related group actions, particularly in relation to allegedly defective pharmaceuticals, medical devices and other mass-produced consumer products. More recently, large-scale litigation such as the diesel emissions claims has demonstrated the courts’ capacity to manage exceptionally large claimant cohorts through structured case management, even where claims raise complex technical and evidential issues.

In addition to GLOs, representative actions under CPR 19.8 are available in limited circumstances where multiple claimants share the “same interest” in the claim. However, historically these have been used sparingly in product liability cases given the need for individualised assessments of causation and loss.

Even where formal collective procedures are not invoked, the courts frequently hand down bespoke case management orders to co-ordinate related product liability claims, including consolidation, transfer to a single court or judge, and aligned timetables for disclosure and expert evidence. Taken together, these mechanisms allow complex, multi-party product liability disputes to be litigated in a structured and proportionate manner and are regularly used in practice where the scale or complexity of claims justifies a co-ordinated approach.

It remains relatively uncommon for product liability claims in England and Wales to progress to final trial, particularly under the CPA. As a result, there have been few recent decisions fundamentally reshaping the law. Nonetheless, a small number of major proceedings and authorities continue to shape how key statutory concepts – particularly defect, causation and burden of proof – are understood in practice.

One of the most significant ongoing matters is the diesel NOx emissions litigation, which concerns allegations that diesel vehicles manufactured by a number of producers incorporated “prohibited defeat devices” within the meaning of Regulation (EC) 715/2007.

The litigation comprises multiple co-ordinated group actions, involving in excess of one million claimants, which are being case-managed together. A six-month trial of preliminary issues has recently taken place to determine whether sample vehicles from a group of manufacturers were fitted with prohibited devices and, importantly, whether any breach of statutory duty gives rise to a private right of action and recoverable loss. Judgment is expected in Summer 2026, which is likely to have a significant impact on the interaction between regulatory compliance, statutory duties and liability in large-scale product claims.

In terms of decided cases, the most important recent guidance on the interpretation of the CPA continues to derive from litigation concerning medical devices. The leading authority is Hastings v Finsbury Orthopaedics Ltd and Stryker UK Ltd [2022] UKSC 19, which remains the most recent detailed consideration by the Supreme Court of the CPA regime. The Court rejected arguments that defect could be established by showing a prima facie case which then shifted the burden onto the producer. Instead, it reaffirmed that the claimant bears the burden of proving, on the balance of probabilities, that the product was defective and that the defect caused the damage complained of. While circumstantial or inferential evidence may form part of the overall evidential picture, it does not alter the statutory burden of proof.

The Supreme Court’s reasoning in Hastings confirmed and reinforced principles developed at first instance in earlier High Court decisions concerning hip prostheses, most notably Wilkes v DePuy International Ltd [2016] EWHC 3096 (QB) and Gee v DePuy International Ltd [2018] EWHC 1208 (QB). Those cases remain highly influential in identifying how courts should assess whether a product falls below the level of safety that persons are generally entitled to expect. Together, they emphasise that the assessment of defect is highly fact-sensitive and requires a holistic evaluation of all relevant circumstances, rather than the application of rigid categories.

In Gee, the High Court clarified a number of key aspects of the defect analysis under the CPA. These include the need for a flexible approach to safety expectations, the potential relevance of the product’s benefits and known risks, and the rejection of a strict distinction between standard and non-standard products. The court also confirmed that warnings and instructions, including those provided to learned intermediaries such as clinicians, may be relevant to the defect assessment.

While there has been limited new appellate authority in the past year, the existing body of case law on medical devices continues to provide the clearest judicial guidance on the meaning of “defect”, the evidential burden on claimants, and the relevance of regulatory compliance – principles that are likely to remain central as future claims arise in relation to increasingly complex and technology-driven products.

UK product liability and product safety law has continued to develop incrementally over the past year rather than through wholesale reform. In practice, however, regulatory expectations and enforcement priorities are increasingly shaped by technological change, digitisation of products and supply chains, and comparative developments in other jurisdictions, most notably the EU.

Divergence From EU Developments

A key external influence is the EU’s revised Product Liability Directive (EU) 2024/2853. Although the Directive does not apply in the UK, it is highly relevant in practice because UK-based manufacturers, importers and distributors placing products on the EU market will fall within its scope, and its approach is likely to inform future UK policy debate.

Notable features of the EU regime include:

  • an expanded concept of “product”, encompassing standalone software, software embedded in goods, and post-market updates or upgrades;
  • a broader range of potentially liable defendants, including online marketplaces and fulfilment operators;
  • claimant-friendly evidential mechanisms, including rebuttable presumptions of defect and causation in technically complex cases; and
  • extended longstop limitation periods in latent damage cases.

While these changes have no direct effect in the UK, they are increasingly influencing risk assessments, compliance strategies and litigation planning for businesses operating across multiple jurisdictions.

Expansion of Liability Concepts to Digital Products, Software and AI

Traditional product liability concepts in England and Wales are being tested and incrementally adapted to address digital and software-enabled products. Although the CPA does not expressly define software as a product, the prevailing view remains that software may fall within scope in appropriate circumstances, particularly where it forms part of a tangible product or affects its safety performance.

Artificial intelligence represents a further area of regulatory and litigation interest. The UK has adopted a comparatively flexible, principles-based regulatory approach focused on innovation, in contrast with the EU’s prescriptive AI Act. In practice, legal risk is currently mediated through:

  • sector-specific regulators (for example, the MHRA in relation to AI-enabled medical devices); and
  • existing product safety obligations relating to risk assessment, monitoring and corrective action.

Questions around defect, foreseeability and control in adaptive or learning systems remain legally unresolved and are expected to feature more prominently in future litigation.

Increased Regulatory Focus on Post-Market Obligations

Another clear trend is the growing emphasis on post-market surveillance and life cycle safety obligations. Regulators increasingly expect manufacturers and other economic operators to:

  • actively monitor product performance and emerging safety signals;
  • respond swiftly to risk trends through warnings, withdrawals or recalls; and
  • maintain alignment between post-market data, technical documentation and risk assessments.

This reflects a shift away from viewing compliance as a one-off pre-market exercise, and towards ongoing responsibility throughout a product’s lifespan.

Procedural and Evidential Developments

Several procedural themes continue to attract attention in product liability litigation:

  • Expert-Driven Disputes: Courts are increasingly required to manage complex, expert-heavy cases, particularly in pharmaceuticals, medical devices and technology-focused claims.
  • Collective Proceedings: Group litigation, representative claims and co-ordinated case management orders are being used more frequently in large-scale product disputes, especially in consumer-facing sectors.
  • Regulatory Co-Ordination: There is growing interaction between regulators, including Trading Standards, the Office for Product Safety and Standards, the MHRA and the HSE, particularly where issues cut across consumer and workplace safety.

Case Law and Enforcement Activity

There have been relatively few recent claim decisions redefining core principles of product liability. Instead, change has been driven primarily through enforcement action, recalls and negotiated compliance outcomes. Regulatory activity remains particularly visible in relation to unsafe consumer products and heavily regulated sectors such as medical devices, electrical goods and connected products.

Overall, the direction of travel in England and Wales is towards closer scrutiny of complex and technology-enabled products, increased reliance on expert and technical evidence, and a stronger focus on post-market responsibility, even in the absence of significant legislative reform.

Future Policy Developments in Product Liability and Product Safety

Future policy development in the UK is increasingly focused on whether the existing statutory framework for product liability and product safety remains adequate in light of technological change, evolving supply chains and the growing role of digital functionality in consumer and industrial products. While no comprehensive reform has yet been enacted, both product liability and product safety are the subject of active policy consideration.

Law Commission Review of Product Liability

A central policy initiative is the Law Commission’s ongoing review of the product liability regime under Part I of the CPA. The review proceeds from the recognition that the strict liability regime was designed for a very different commercial and technological landscape and may not adequately address modern risks.

In particular, the Commission is examining whether the current framework remains appropriate given:

  • the increasing prevalence of standalone software and software-driven functionality within physical products;
  • complex, multi-party supply chains and the role of online marketplaces and intermediaries;
  • AI-enabled and autonomous systems, where behaviour may evolve post-deployment; and
  • evidential challenges relating to defect, causation and attribution of responsibility.

Although the project remains at an early stage, a core objective is to assess whether targeted reform is required to ensure legal certainty for businesses, while preserving effective consumer protection where harm arises from emerging technologies.

Modernisation of the UK Product Safety Framework

Product safety regulation is also undergoing review and reform. The UK government has recognised that the GPSR were not designed with modern digital products, connected devices or online distribution models in mind, and that reform is needed to ensure effective market surveillance and enforcement.

As part of a broader programme under the Product Regulation and Metrology Act 2025, policy development is focused on creating a more flexible and risk-based product safety regime capable of responding to:

  • connected and “smart” products incorporating software and remote functionality;
  • rapid product iteration cycles and post-market updates;
  • the role of online marketplaces and fulfilment services in product distribution; and
  • the need for clearer allocation of responsibilities across complex supply chains.

Future secondary legislation and guidance is expected to emphasise accountability of economic operators and improved traceability, particularly for consumer products sold through digital platforms.

Cybersecurity, Software Integrity and Connected Products

A notable area of convergence between product safety and digital regulation is cybersecurity. Cybersecurity risks are increasingly treated as inherent safety risks, particularly for connected consumer and industrial products. The Product Security and Telecommunications Infrastructure Act 2022 and its accompanying regulations already impose baseline security obligations for certain consumer devices, including requirements relating to vulnerability disclosure and software update support.

Looking ahead, policymakers are expected to build on this framework by integrating cybersecurity and software integrity more explicitly into general product safety obligations, reinforcing expectations around secure design, patching and life cycle risk management.

AI, Automation and Emerging Technologies

Artificial intelligence and automated systems remain a key area of future policy attention. While the UK has opted for a sector-led, principles-based approach rather than bespoke AI liability legislation, regulatory guidance and enforcement activity are increasingly addressing AI-related risks through existing safety and liability regimes.

This raises ongoing policy questions around:

  • how defect should be assessed for adaptive or learning systems;
  • the relevance of foreseeability where system behaviour changes over time; and
  • allocation of liability between developers, manufacturers, deployers and downstream users.

These issues are likely to inform both future regulatory guidance and any eventual reforms to the CPA or related legislation.

Direction of Travel

Taken together, future policy development in England and Wales points towards an increasingly integrated approach to product liability and product safety, in which software, cybersecurity and AI considerations are treated as core aspects of product risk rather than peripheral issues. While large-scale legislative reform has yet to materialise, incremental change through consultation, secondary legislation and regulatory guidance is expected to continue, with a longer-term emphasis on ensuring that liability and safety frameworks remain workable for both consumers and businesses in a digitally mediated economy.

Fletchers Solicitors

Fletchers Solicitors
St James Tower
7 Charlotte Street
Manchester
M1 4DZ
UK

+44 161 388 1733

+44 871 971 1622

enquiry@fs.co.uk www.fletcherssolicitors.co.uk
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Law and Practice in UK

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Fletchers Solicitors is a nationally recognised, claimant-only firm specialising in product liability, complex serious injury, clinical negligence, and high-value personal injury claims. With a Medical Product Liability team of six, the firm operates across key UK locations, including Manchester, Liverpool, Birmingham, Leeds, Cambridge, Newcastle, Northampton, Southport and Bolton. The firm’s multidisciplinary model combines legal expertise with in-house medical specialists, including nurse analysts and midwives, alongside a dedicated Early Rehabilitation Service to deliver holistic, client-focused support. The Medical Product Liability team is highly experienced in complex defective drug and device litigation, particularly large-scale group actions against multinational manufacturers, including transvaginal mesh, Essure contraceptive devices and metal-on-metal hip implants, combining legal excellence with scientific insight to secure justice for clients affected by life-changing injuries. The team is also actively engaged in advocacy and legal reform, helping shape the future of product liability law.