Sources of law

Product liability statutes

Is there a statute that governs product liability litigation?

Strict liability for product liability claims in England and Wales is imposed by the CPA, which implemented the European Product Liability Directive (85/374/EEC). Under the CPA, a producer is liable for damage caused by defective products (namely, those products that are not as safe as ‘persons generally are entitled to expect’). The claimant does not need to show any fault on the part of the producer, only the presence of the defect and a causal link between the defect and the damage.

Traditional theories of liability

What other theories of liability are available to product liability claimants?

Claimants may also bring a claim in tort (negligence) or contract.

In order to establish a negligence claim, claimants must show that the defendant (usually the manufacturer) owed a duty of care to the claimant (there is an established duty between manufacturers and consumers at common law in England and Wales), that the duty was breached and that the breach caused damage to the claimant’s person or property.

A claim in contract can only be brought against the party who supplied the defective product to the claimant (as the only party with whom the claimant has a direct contractual link or ‘privity’). The claimant would usually rely on a term implied by statute into the contract for sale that the goods would be of satisfactory quality and reasonably fit for the purpose for which they were supplied. Consumer contracts are now regulated by the CRA, which came into force on 1 October 2015 (see question 20).

Product liability claims in England and Wales are commonly pleaded concurrently under the CPA, in negligence and in contract. Liability under the CPA or for death or personal injury resulting from negligence cannot be excluded in any contract.

Consumer legislation

Is there a consumer protection statute that provides remedies, imposes duties or otherwise affects product liability litigants?

In England and Wales, claimants can bring a claim for breach of statutory duty where it is clear that a statute is intended to create private rights for individuals.

The CRA came into force on 1 October 2015, strengthening the law relating to the supply of goods and services to consumers and on unfair contract terms, as well as introducing a new limited opt-out collective action for competition law claims (see question 7). The legislation contains provisions including requirements that contracts to supply goods must now include a term that the goods are of satisfactory quality and comply with the description applied to them, and that statements made by manufacturers, importers, distributors and retailers of the product, for example, in labelling and advertising, must be factually correct and will form part of the contract with a consumer. These statutory rights may not be excluded in a contract.

Under a 2014 amendment to the Consumer Protection from Unfair Trading Regulations 2008, where a trader has engaged in certain forms of misleading or aggressive behaviour, a purchaser may be entitled to a refund of up to 100 per cent of the item’s value, or damages. The latter can be in respect of not just financial loss but also physical distress, inconvenience or discomfort.

Further, as mentioned in question 18, the CPA imposes strict liability for product liability claims in England and Wales.

Criminal law

Can criminal sanctions be imposed for the sale or distribution of defective products?

The General Product Safety Regulations 2005 (the GPSR), implementing the European Product Safety Directive (2001/95/EC), impose a duty on producers to place only safe products on the market, and additionally to notify the authorities where an unsafe product has been marketed.Criminal sanctions are imposed on producers who breach their duties under the GPSR, which can include a fine of up to £20,000 and imprisonment of up to 12 months.

These regulations will likely be replaced once the ‘Product Safety and Market Surveillance Package’ that is currently before the European parliament is eventually enacted. This will make provision for revisedproduct safety and market surveillance rules.

Novel theories

Are any novel theories available or emerging for product liability claimants?

In March 2015, the European Court of Justice (ECJ) ruled in the Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt – The health fund case that, even if a medical device is functioning correctly, it can be deemed defective by virtue of it belonging to the same group or production series of products that have a significantly high risk of failure or have already malfunctioned. While this decision is of most direct relevance to implanted devices, it may have wider implications in the context of products whose operation can have far-reaching health consequences. In its judgment, the ECJ also found that the damage caused by a surgical operation for the replacement of a defective implanted medical device, such as a pacemaker or an implantable cardioverter defibrillator, can constitute an injury for which the producer is liable. This is only the case if such an operation is necessary to overcome the defect in the product in question. The ECJ added that it is for the national court to verify whether that condition is satisfied.

Product defect

What breaches of duties or other theories can be used to establish product defect?

In order to establish a product defect under the CPA, the claimant must show that the product is not as safe as persons generally are entitled to expect, taking into account all the circumstances. When deciding whether a product meets such a standard of safety, the court will take into account all the relevant circumstances, including:

  •  the manner in which the product was marketed;
  • any instructions or warnings given with it;
  • what might reasonably be expected to be done with it; and
  • the time the producer supplied the product.

A product will not be judged to be defective merely because a product supplied at a later date by the same manufacturer has a higher standard of safety.

The High Court judgment in Wilkes v DePuy International Limited [2016] EWHC 3096 (QB) provided important clarification on the assessment the level of safety that persons are generally entitled to expect. The court held that the focus must first be on whether the product suffered from a ‘defect’ and not on identifying ‘the harmful characteristic which caused the injury’. The court also confirmed that the level of safety is not to be ‘assessed by reference to actual expectations of an actual or even a notional individual or group of individuals’ but rather by what persons ‘generally are entitled to expect’. The case of Colin Gee v DePuy International Limited [2018] EWHC 1208 (QB) supported the decision in Wilkes and shed further light on what is to be taken as the definition of ‘defect’, stating that no product, and in particular a medicinal product, if effective, can be absolutely safe. In this case, the court found that an inherent tendency of a metal-on-metal hip to shed metal debris through normal use was not a ‘defect’ within the meaning of CPA 1987.

Defect standard and burden of proof

By what standards may a product be deemed defective and who bears the burden of proof? May that burden be shifted to the opposing party? What is the standard of proof?

The claimant bears the burden of proving that the product is defective on a balance of probabilities (namely, it is more probable that the product is defective than not).

The burden of proof may be shifted to the defendant where certain statutory defences are raised (see question 30).

In Baker v KTM Sportmotorcycle UK Ltd & Anor (2017) EWCA Civ 378, the claimant was injured in an accident involving alleged brake failure in a motorbike. The court held that there was no need for the claimant to plead and prove a specific design or manufacturing defect, or for the claimant to show how a defect was caused, provided that there was sufficient evidence for the court to find that there was a defect.

Possible respondents

Who may be found liable for injuries and damages caused by defective products?

Under the CPA, a claimant may bring a claim against the producer of the product, any person who has held him or herself out to be the producer by applying his or her own name to the product (referred to as ‘own branders’) and any person who imported the product into the EU in order to supply it to others in the course of his or her business. Others within the supply chain can also be liable in certain circumstances if upon request they do not give details of the aforementioned producer, own brander or importer.

A claim in negligence may be brought against any defendant from whom the claimant can show he or she was owed a duty of care. This will normally include the manufacturer of the product.

A contract claim may only be brought against a defendant with whom the claimant has a direct contractual relationship. This will normally be the party that supplied the product to the claimant (who may or may not also be the manufacturer).


What is the standard by which causation between defect and injury or damages must be established? Who bears the burden and may it be shifted to the opposing party?

The claimant bears the burden of proof to show, on the balance of probabilities, that the defendant’s defective product caused the damage inrespect of which it is claiming. In Hufford v Samsung Electronics (UK) Ltd [2014], it was held that the claimant does not need to specify or identify the defect with precision. He or she only needs to prove in general terms that a defect exists and that it caused the damage.

The simple ‘but for’ causation test has recently developed into a more complex legal issue in a line of cases dealing with multiple potential causes of damage in relation to mesothelioma claims (eg, Fairchild v Glenhaven (2002), Barker v Corus (2006) and Sienkiewicz v Greif (UK) Ltd (2011)). In these cases, causation was established where the claimant demonstrated that the defendant’s wrongdoing had materially increased the risk of injury. The principle was extended to a lung cancer claim where the cause of damage was multiple exposures to asbestos (Heneghan v Manchester Dry Docks Ltd and Others [2016] EWCA 86). In the Sienkiewicz case, UK Supreme Court justices commented that the courts would be wary about extending the exception to other types of claim and this view was confirmed by the Supreme Court in Ministry of Defence v AB and others [2012] UK SC9. In Heneghan, the Court of Appeal stated that the exception could be applied to situations that are ‘not materially different’ to the Fairchild case, so it would appear unlikely at present that the courts will extend this exception to product liability claims.

In Howmet v Economy Devices (2016), the Court of Appeal considered a claim in negligence in connection with a product issue concerning a fire risk control device that was malfunctioning. The court found that a system put in place by the claimant to deal with a product it knew to be defective in essence interrupted the chain of causation and led to failure of their claim.

Post-sale duties

What post-sale duties may be imposed on potentially responsible parties and how might liability be imposed upon their breach?

Various post-sale obligations are imposed on producers by the GPSR. While parties will remain liable for damage caused by their defective products under the CPA and common law regimes described above, they may incur criminal sanctions (a fine of up to £20,000 and 12 months’ imprisonment) for failure to comply with their obligations under the GPSR, which include providing warnings and information regarding risks posed by a product that are not obvious, taking appropriate measures (including recall if necessary) to ensure the continuing safety of consumers and notifying the authorities where an unsafe product has been placed on the market. Post-sale duties at common law will be harder to enforce in the event that the product continues to be used despite awareness of the alleged defect.

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