The low-down on the situation regarding product liability in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for GBP 99.
1. What types of liability are recognized in your jurisdiction?
There are four main sources of product liability in Ireland:
The Liability for Defective Products Act 1991 transposed the EU Product Liability Directive 85/374/EC and is the primary source of product liability legislation in Ireland. It adds to the traditional theories of product liability available in tort and contract. It provides for strict liability where damage is caused either wholly or partly by the defect in a product.
The tort of negligence can also apply to claims for defective products. The relevant test is to establish whether the defendant (e.g. manufacturer, the supplier or importer) owed a duty of care to the plaintiff, whether they breached this duty and the breach caused the alleged damage.
Sales of goods are regulated by the Sale of Goods Act 1893 and the Sale of Goods and Supply of Services Act 1980. The legislation implies a contractual obligation on the seller to ensure that the products they are selling are of merchantable quality. They will be deemed to have breached this implied term if their products are not fit for the purpose or purposes for which goods of that kind are commonly purchased, if they are not as durable as is reasonable to expect having regard to their description, their price and all other relevant circumstances, and if a product can foreseeably be considered to breach the implied term that it correspond with its description. The EC (Certain Aspects of the Sale of Consumer Goods and Associated Guarantees) Regulations 2003 also apply and require that goods delivered under a contract of sale must be in conformity with that contract.
The EC (General Product Safety) Regulations 2004 (GPSR) implemented EC Directive 2001/95, and under this piece of legislation it is an offence for a producer to place an ‘unsafe’ product on the market. ‘Producer’ is defined as being either:
- A manufacturer of the product;
- A manufacturer’s representative in the EU (if the manufacturer is not established in the EU);
- The importer (in certain circumstances); or
- Other professionals working within the supply chain of the dangerous product (and this can include distributors).
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
All of the above types of liability apply to manufacturers of medicines and medical devices and allow consumers to bring product liability claims against them.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
Yes, liability can extend beyond manufacturers to their employees, corporate executives and their various representatives as well others in the supply chain. For example, some offences committed by a body corporate with the consent or connivance of, or attributable to any neglect on the part of, a director, manager, secretary or other officer of the body corporate, that officer or any person purporting to act in such capacity shall also be guilty of an offence.
4. How can a liability claim be brought?
In the context of a medicinal product or medical device, a product liability claim will most likely be initiated through the filing and serving of a personal injury summons by the party bringing the claim.
Once a summons is issued, they must be personally served on defendants, within a year of their issuance, either by pre-paid post or to their place of residence or business, or to their solicitor if they have authority to accept service. Once a summons has been served, a defendant enters a memorandum of appearance and the time limit for filing a defence will depend on the court in which the particular action is taking place. In Ireland, there are mechanisms available to seek a resolution before a full hearing of the case on its merits.
5. What defences are available?
Section 6 of the Liability for Defective Products Act 1991 sets out the defences available to defendants. A producer will not be liable if they can prove:
- that he or she did not put the product into circulation, or
- that, having regard to the circumstances, it is probable that the defect which caused the damage did not exist at the time when the product was put into circulation by him or that that defect came into being afterwards, or
- that the product was neither manufactured by him for sale or any form of distribution for an economic purpose nor manufactured or distributed by him in the course of his business, or
- that the defect concerned is due to compliance by the product with any requirement imposed by or under any enactment or any requirement of the law of the European Communities, or
- that the state of scientific and technical knowledge at the time when he or she put the product into circulation was not such as to enable the existence of the defect to be discovered, or
- in the case of the manufacturer of a component or the producer of a raw material, that the defect is attributable entirely to the design of the product in which the component has been fitted or the raw material has been incorporated or to the instructions given by the manufacturer of the product.
A claim in tort will fail where the defendant can establish there was no duty of care between him or her and the plaintiff. If a duty of care did exist between the plaintiff and defendant then the plaintiff’s claim will fail if the defendant can show that said duty was not in fact breached. If the injury or loss stemming from a breach of duty was not reasonably foreseeable by the defendant, and was too remote, then the claim will fail. In order to establish causation, plaintiffs are required to demonstrate that ‘on the balance of probabilities’, the injury they sustained was as a result of the defect in the product.
The Civil Liability Act 1961 provides for the defence of ‘contributory negligence’, and this is available for defendants in a personal injury claim. Under Section 34(1), where it can be shown that the injury suffered by the plaintiff was caused partly by their own negligence, then blame and the damages recoverable will be apportioned accordingly.
Under Regulation 5 of the GPSR, if a company can prove that a product is safe and complies with any specific rules of the MS in laying down health and safety requirements that the product must satisfy to be marketed or if it conforms with the voluntary Irish standards transposing the European standards, then it may be able to resist a conviction. The Competition and Consumer Protection Commission (CCPC) is still able to take “appropriate measures” where it considers that a product is dangerous to consumers and may require its recall or withdrawal and impose restrictions on it being placed on the market.
Any defences regarding breach of contract are premised on the nature and specific terms of the contract itself.