An intro to the legal situation for product liability in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
The majority of product liability claims for medical products in the United Kingdom are brought under the Consumer Protection Act 1987 (CPA) and / or in negligence. Claimants may also have remedies under the Sale of Goods Act 1979 or under contract.
Under the CPA there is strict liability for damage wholly or partly caused to a consumer by a defect in a product. Defect is defined as where “the safety of the product is not such as persons generally are entitled to expect.” Recent case law has focused on the meaning of “defect” under the CPA.
Claims in negligence are brought on the basis of a manufacturer or supplier owing a duty of care to a Claimant which has been breached, and which has caused harm which was foreseeable.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
The CPA applies to the “producer” of the product. The definition of “producer” includes the manufacturer of the product. The CPA also extends liability to anyone who puts their mark on the product or who imports it into the EU in order to supply it.
A negligence claim can be brought against the manufacturer of a product provided that they owed a duty of care to a Claimant or Claimants in respect of a product.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
Liability under the CPA only extends to the “producer” and, in some circumstances, the “supplier” of a product. Civil liability under the CPA does not extend to corporate executives or employees. In English law, a corporate body is vicariously liable for the acts or omission of its employees provided those actions took place in the course of employment. There is no requirement to name individuals in a claim.
4. How can a liability claim be brought?
A claim can be brought on behalf of an individual by issuing a Claim Form at court and paying the requisite fee. Proceedings setting out the details of the allegations need to be served on a Defendant within 4 months of a Claim Form being issued at court. There is a pre-action protocol which sets out the steps that should ideally be taken before resorting to issuing a claim.
Group litigation is also possible either via the court using its case management powers to manage claims with multiple claimants or via a formal Group Litigation Order.
A claim must be brought within the limitation period which is 3 years from the date on which the cause of action accrued or (if later) the date on which the consumer first discovered or should have discovered the defect.
There are some exceptions to this but the CPA includes an absolute overriding period of 10 years in favour of the supplier after which a claim cannot be brought.
If a claim is brought in negligence there is a provision whereby the Claimant can apply to the court to exercise its discretion and disapply the 3 year limitation period. This would be decided by the court at a preliminary limitation hearing and all the circumstances of the case would be taken into account.
5. What defenses are available?
Under the CPA a claim will be defeated if a Claimant is unable to prove that a product is defective or that the defect caused the loss.
In addition, there are 6 other defences set out in the CPA. These are:
- that the defect is attributable to compliance with any requirement imposed by or under any enactment or any EU obligation;
- that the Defendant did not supply the product;
- the person proceeded against is a non-business party;
- that the defect did not exist in the product at the relevant time;
- the state of technical knowledge at the relevant time was such that the producer could not have been expected to discover the defect (the “development risks” defence); and
- in respect of suppliers of component parts, if the defect constituted a defect in the subsequent product and was wholly attributable to the design of the subsequent product or to compliance by the producer of the product in question with instructions given by the producer of the subsequent product.
In a negligence claim, a claim will be defeated if a Claimant is unable to establish that there has been a breach of a relevant duty of care owed to them or that the breach of duty caused the Claimant to suffer loss. Defences are therefore available on the basis of the facts but also on the basis of expert evidence.