Ireland: Product Liability Comparative Guide

1. Product liability regimes

1.1 What are the legal regimes under which consumers who are injured by a defective product can bring a claim for compensation? What is the most common way in which such product liability claims are brought?

Product liability claims are generally brought under:

• common law contract and tort principles, including negligence; or
• statutory provisions, including the Liability for Defective Products Act 1991, which transposed the EU Product Liability Directive (85/374/EEC) into Irish law.

In most cases, product liability claims are initiated by issuing a personal injury summons in the High Court, the Circuit Court or the District Court (depending on the value of the claim). A personal injury summons must be formally served, within one year of being issued, on the defendant, either:

• personally; or
• by registered post to:
• • the defendant's residence or place of business; or
  • its solicitors, if the solicitors have confirmed that they have authority to accept service of the proceedings.

Once service of a summons has been effected, the defendant must enter a memorandum of appearance to the summons. The defendant must then file a defence to the claim. The timeframe for filing a defence will differ depending on the court in which the particular action has been taken. Pleadings containing assertions or allegations in a personal injuries action must be accompanied by an affidavit of verification sworn by the relevant party.

1.2 Do any special regimes apply in specific sectors?

Although most product liability claims will rely on the regimes set out above, additional regulatory requirements apply to certain sectors (eg, pharmaceutical products and medical devices), which may also be relied upon in product liability claims.

1.3 Are the courts in your jurisdiction generally considered sympathetic to claimants in product liability suits?

Although the Irish courts are not necessarily more sympathetic to claimants in their approach to product liability suits, aspects of the statutory regime governing product liability claims are more sympathetic to claimants. In line with the EU Product Liability Directive, the Liability for Defective Products Act allows a year longer for defective product claims to be brought under that legislation than the limitation period allowed for a personal injury claim (three versus two years). Accordingly, a claimant has three years to bring an action under the Liability for Defective Products Act from:

• the date on which the cause of action accrued; or
• the date (if later) on which it became aware, or should reasonably have become aware, of:
• • the damage;
  • the defect; and
  • the identity of the producer.

This right of action is subject to a 'long-stop' provision under which a claimant's rights are extinguished on the expiry of 10 years from the date on which the producer put into circulation the actual product that caused the damage, unless the claimant has in the meantime instituted proceedings against the producer. This gives a claimant a significant opportunity to become aware of a defective product and still be able to bring a claim without the risk of the claim being statute barred.

In addition, under the Liability for Defective Products Act, where the producer of the product cannot be identified by taking reasonable steps, any person that supplied the product (whether to the person who suffered the damage, to the producer of any product in which the product is incorporated or to any other person) will be liable as the producer. This means that it is very likely that the claimant will be in a position to identify a suitable defendant. This provides the claimant with additional recourse.

Further, in Boston Scientific Medizintechnik GmbH (Joined Cases C‑503/13 and C‑504/13), the Court of Justice of the European Union held that where a product belongs to the same group or production series of products that had a potential defect, such a product may be classified as defective without there being any need to establish that the product has such a defect. This eases the burden on a potential claimant. Furthermore, in relation to the question of whether a risk of failure could constitute a defect, the court held that for high-risk products (eg, in this case, pacemakers) the potential lack of safety would constitute a defect and give rise to liability.

2. Parties

2.1 Can representative bodies bring product liability suits in your jurisdiction on behalf of groups of consumers? If so, which bodies may do so and what is the applicable procedure?

Representative bodies cannot currently bring product liability suits on behalf of groups of consumers.

The adoption of the EU Collective Redress Directive (2020/1828) is expected to lead to the implementation of a national scheme providing for a form of collective action under EU consumer protection law. Each EU member state must designate at least one 'qualified entity' to bring actions on behalf of consumers and a list of qualified entities will be maintained by the European Commission.

These qualified entities (eg, consumer organisations) will be empowered to bring collective actions on behalf of consumers for breaches of a wide range of EU legislation (listed in Annex I of the Collective Redress Directive). Qualified entities will be able to obtain either:

• injunctive relief to secure the cessation or prohibition of practices that infringe EU law; or
• remedies such as compensation, repair, replacement, price reduction, reimbursement or contract termination, as available under law.

The Competition and Consumer Protection Commission is likely to be a qualified entity in Ireland. Member states must apply these measures from 25 June 2023.

The Collective Redress Directive has been transposed into Irish law by the Representative Actions for the Protection of the Collective Interests of Consumers Act 2023.

2.2 Are class actions or other forms of collective action available in your jurisdiction? If so, what restrictions and requirements apply in this regard? Are they commonly used?

Class, group or other collective action mechanisms are currently not available in Ireland. Once commenced, the Representative Actions for the Protection of the Collective Interests of Consumers Act 2023, which transposes the Collective Redress Directive into Irish law, will put in place a mechanism for a national scheme allowing at least one qualified entity to bring actions on behalf of consumers.

Currently, multi-party litigation in Ireland is generally dealt with by means of 'test cases'. Where a number of separate claims arise from the same circumstances, a test case (or a group of test cases) is brought to trial first to determine the legal principles that may be relevant to the remainder of the cases. Although test cases create a precedent that is likely to be followed in subsequent similar cases, they are not automatically binding on subsequent cases, particularly if there are distinguishing features in subsequent cases.

The Rules of the Superior Courts (Order 15, Rule 9) provide a procedure for representative actions. Where there are numerous persons with the same interest in a cause or matter, the procedure allows one or more of them to sue on behalf of all interested persons. However, the procedure is rarely used as there are several limitations to it, including:

• a strict interpretation of the 'same interest' test; and
• authority restricting the ability to award damages through the procedure.

2.3 Which parties may potentially be held liable for defective products in your jurisdiction?

Statute: The Liability for Defective Products Act lays liability firmly at the door of the 'producer' of the defective product. The 'producer' of a product is defined as:

• the manufacturer or producer of a finished product;
• the manufacturer or producer of any raw material or the manufacturer or producer of a component part of a product;
• in the case of products of the soil, of stock-farming or of fisheries and game which have undergone initial processing, the person that carried out such processing;
• any person that, by putting its name, trademark or other distinguishing feature on the product or using its name or any such mark or feature in relation to the product, has held itself out to be the producer of the product; or
• any person that has imported the product into an EU member state from a place outside the European Union in order, in the course of any business, to supply it to another.

Tort: In tort, liability extends to anyone that is found to have breached a duty of care that it owed to a party who suffered damage as the result of a defective product. This could cover a number of parties involved in the supply chain of the product.

Contract: Privity of contract in Irish law means that only those parties that are party to a contract can enforce the rights and obligations under the contract. In effect, this means that a seller will only be liable in contract to a buyer with which it has contracted. Third parties have no right to enforce a contract.

Criminal: The European Communities (General Product Safety) Regulations 2004 (GPSR), which transposed the EU General Product Safety Directive (2001/95/EC) into Irish law, make it an offence for a producer to place an 'unsafe' product on the market.

The GPSR define a 'producer' as:

• the manufacturer of the product;
• the manufacturer's representative in the European Union (if the manufacturer is not established in the European Union);
• the importer (in certain circumstances); and
• other professionals working within the supply chain of the dangerous product.

Under the GPSR, it is also an offence for distributors to supply or attempt to supply a product that they know, or reasonably presume (based on information in their possession), to be a dangerous product.

2.4 Can parties outside the jurisdiction be the target of a product liability suit? What requirements and restrictions apply in this regard?

Yes, if it can be established that the Irish courts have jurisdiction over the defendant. The European Union has sought to standardise and simplify jurisdiction rules between member states. These rules must be considered where the proposed defendant in an action to be brought in Ireland ordinarily resides or carries on its business in another member state. Similarly, these rules must be considered when deciding whether an action which arose in another EU member state can be litigated in the Irish courts. Irish common law rules apply to cases not falling within the applicable EU regulations.

3. Basis for liability

3.1 What are the most common grounds for action in your jurisdiction where a consumer is claiming damages for injuries caused by a defective product?

The Liability for Defective Products Act transposed the EU Product Liability Directive (85/374/EEC) into Irish law and is the primary legislation in Ireland concerning product liability. The Liability for Defective Products Act supplements existing common law remedies under tort and contract and provides for strict liability where damage is caused wholly or partly by a defect in a product.

Product liability claims also generally rely on common law tort and contract principles.

Tort: Product liability claims also generally rely on the tort of negligence. The relevant test is whether:

• the person (eg, manufacturer, supplier or importer) owed a duty of care to the injured party, which was breached; and
• the breach caused damage.

Contract: In Ireland, sales of goods are regulated by the Sale of Goods Act 1893 and the Sale of Goods and Supply of Services Act 1980 ('Sale of Goods Acts'). This legislation implies a contractual obligation on the seller to ensure that its products are of 'merchantable quality'. This implied term will be breached if a product:

• is not fit for the purpose or purposes for which goods of that kind are commonly bought;
• is not as durable as it is reasonable to expect with regard to:
• • the description given to them;
  • the price; and
  • all other relevant circumstances; or
• can foreseeably be considered to breach the implied requirement that a product correspond with its description.

In addition to the Sale of Goods Acts, the European Communities (Certain Aspects of the Sale of Consumer Goods and Associated Guarantees) Regulations 2003 apply to contracts for the sale of goods to consumers. The regulations require that goods delivered under a contract of sale to the consumer conform with that contract.

The Consumer Rights Act 2022 (CRA) introduced widespread changes to consumer protection laws in Ireland, including enhanced rights of redress for consumers. The CRA transposed the EU Digital Content Directive (2019/770), the revised Sale of Goods Directive (2019/771) and provisions of the Omnibus (or Modernisation and Enforcement) Directive (2019/2161) into Irish law. The CRA also repealed and amended several existing pieces of Irish consumer legislation.

3.2 Can criminal penalties be imposed for the manufacture or sale of defective products?

Under the European Communities (General Product Safety) Regulations (GPSR), it is an offence for a producer to place an 'unsafe' product on the market. The GPSR defines a 'producer' as:

• the manufacturer of the product;
• the manufacturer's representative in the European Union (if the manufacturer is not established in the European Union);
• the importer (in certain circumstances); and
• other professionals working within the supply chain of the dangerous product.

It is also an offence under the GPSR for distributors to supply or attempt to supply a product that they know, or reasonably presume (based on information in their possession), to be a dangerous product.

The GPSR also gives the Competition and Consumer Protection Commission (CCPC) powers to ensure that only safe products are placed on the market. Distributors and producers are under an obligation to cooperate with and inform the CCPC about any unsafe products placed on the market and may be guilty if they fail to adhere to these obligations. A person found liable on conviction can be made subject to a fine not exceeding €5,000 (a 'Class A' fine), a term of imprisonment not exceeding three months or both.

At present, an offence of corporate manslaughter does not exist in legislation in Ireland. The Corporate Manslaughter Bill introduced in 2016 followed a Law Reform Commission Report in 2005, which recommended that this new offence be created. However, this bill has now lapsed.

4. Defective products

4.1. How is a 'defective product' defined in your jurisdiction?

Statute: The Liability for Defective Products Act provides that a product will be considered defective if, taking into consideration all the circumstances, it does not provide the level of safety that consumers are entitled to expect. This includes:

• presentation of the product;
• the use to which it could reasonably be expected that the product would be put; and
• the time at which the product was put into circulation.

Tort: To establish tortious liability, the injured party must show that:

• there was a duty of care owed to him or her;
• this duty was breached; and
• the breach caused him or her damage.

Manufacturers can also be held liable if they fail to issue adequate instructions or warnings about the safety of the product – for example, in relation to the risks that a product poses.

Contract: The European Communities (Certain Aspects of the Sale of Consumer Goods and Associated Guarantees) Regulations assist consumers by establishing a presumption that any lack of conformity that becomes apparent within six months of the date of delivery of the goods is deemed to have existed at the time of delivery of the goods. The burden of proof rests on the seller to prove the contrary. This presumption does not apply if it would not be a reasonable inference that the lack of conformity existed at the time of delivery by reason of the nature of the goods concerned or the nature of the lack of conformity concerned.

The Sale of Goods Acts imply a contractual obligation on the seller that the goods supplied are of 'merchantable quality' – that is, that they are:

• fit for the purpose or purposes for which goods of that kind are commonly bought; and
• as durable as it is reasonable to expect with regard to:
• • any description applied to them;
  • the price (if relevant); and
  • all other relevant factors.

If products are deemed not to meet this standard, the seller is in breach of the implied term.

Criminal: Criminal liability is governed by the European Communities (General Product Safety) Regulations (GPSR). This legislation outlines a number of offences under which producers or distributors can be prosecuted. These include:

• placing dangerous products on the market; and
• supplying or attempting to supply a product that they know or should reasonably presume to be dangerous.

Whether a product is dangerous is assessed by reference to whether it fails to meet the criteria for a 'safe product'. The GPSR defines a 'safe product' as a product which, under normal or reasonably foreseeable conditions of use (including duration and, where applicable, putting into service, installation and maintenance requirements) does not present any risk or 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.

4.2. What are the standards for proving that a product is defective? Who bears the burden of proof? Is it possible to shift the burden of proof?

Generally, the onus under contract and tort law is on the injured party to establish damage and the defect, and the causal link between both. This is also outlined in Section 4 of the Liability for Defective Products Act. The standard of proof in statutory, tort and contract claims is 'on the balance of probabilities' – that is, 51% or 'more likely than not'; whereas in criminal proceedings, the standard of proof is 'beyond reasonable doubt'.

The Liability for Defective Products Act operates on the basis of strict liability. Therefore, it is not necessary to establish negligence on the part of the defendant. The majority of product liability claims are based on a combination of tortious, contractual and statutory bases.

The European Communities (Certain Aspects of the Sale of Consumer Goods and Associated Guarantees) Regulations provide for a presumption that any lack of conformity that becomes apparent within six months of the date of delivery of the goods is deemed to have existed at the time of delivery of the goods. The burden of proof rests on the seller to prove the contrary. This presumption does not apply if it would not be a reasonable inference that the lack of conformity existed at the time of delivery by reason of the nature of the goods concerned or the nature of the lack of conformity concerned.

4.3. What are the standards for proving the causal link between the product defect and the damage suffered established? Who bears the burden of proof? Is it possible to shift the burden of proof?

Under Irish common law and the Liability for Defective Products Act, the burden is on the plaintiff to prove a causal link between the injury or damage sustained and the alleged defective product. If the plaintiff cannot prove this 'on the balance of probabilities', he or she will be unable to establish causation.

4.4. What else must be proven to succeed in a product liability action? What specific concerns and considerations should be borne in mind in this regard?

It is necessary for a plaintiff to prove that there is a 'product' that is 'defective' that has caused a compensable injury. A concern may be categorising what exactly falls into the definition of a 'product'. Technological advances have led to the creation of a new generation of products that challenge some of the traditional concepts of the definition of a 'product'. This has made it increasingly difficult for a consumer to prove that a defect in a product caused the damage suffered in the case of some technically complex products. In the Proposal for a Revised EU Product Liability Directive, this is one of the specific product liability concerns addressed, with the definition of a 'product' now proposing to include software and digital manufacturing files. The defences and limitations in relation to product liability claims in Ireland are discussed in question 5.

5. Defences and limitations

5.1. What is the limitation period for bringing a product liability suit in your jurisdiction? What requirements and restrictions apply in this regard?

Statute: The Liability for Defective Products Act allows a period of three years from the date on which the cause of action arose (two years for claims under the Liability for Defective Products Act for personal injuries). The date runs from the date on which the claimant became aware, or should have become aware, of the damage. The Liability for Defective Products Act also provides for a long-stop limitation period, which extinguishes a claimant's right to bring a claim on the expiry of 10 years from the date on which the product was put into circulation.

Criminal: Proceedings for summary offences under the European Communities (General Product Safety) Regulations (GPSR) must be brought within six months of the commission of the offence.

Tort: Personal injuries actions must be brought within two years of the date on which the cause of action accrued or the date of knowledge of the person injured. The date of knowledge is the date on which the person injured first had knowledge:

• that he or she had been injured;
• that the injury was significant;
• that the injury was attributable in whole or in part to negligence, nuisance or breach of duty;
• of the identity of the defendant; and
• if it is alleged that the act or omission was that of a person other than the defendant, of the identity of that person and the additional facts supporting the bringing of an action against the defendant.

Contract: The limitation period for contractual claims is six years from the date of the alleged breach of contract. This is the date on which the breach occurred and not the date on which the injury or damage was suffered.

Statutory time limits can act as full defences to a claim and can have the effect of barring a claimant's ability to seek redress.

5.2. What defences to product liability suits are available in your jurisdiction?

The defences available under the Liability for Defective Products Act include the following:

• The producer did not put the product into circulation;
• 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 the producer or that that defect came into being afterwards;
• The product was not manufactured by the producer for sale or any form of distribution for an economic purpose, or was not manufactured or distributed by the producer in the course of its business;
• The defect concerned is due to compliance by the product with any requirement imposed by or under any enactment or any requirement of EU law;
• The state of scientific and technical knowledge at the time when the producer 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, 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.

The burden of proving these defences rests with the defendant. For example, to prove that the state of scientific and technical knowledge at the time when the producer put the product into circulation was not such as to enable the existence of the defect to be discovered, the defendant would have to show, on the balance of probabilities, that the discoverability of the alleged defect was hindered by the limitations of science and technology at the time.

Statute: All statutory defences available to producers are set out under Section 6 of the Liability for Defective Products Act (see above).

Tort: A claim in tort will fail if the defendant can establish that no duty of care existed between it and the plaintiff. Should such a duty exist, the plaintiff's claim will fail if the defendant can establish that the duty was not breached. A claim in tort will also fail in circumstances where the injury or loss flowing from a breach of an established duty of care was not reasonably foreseeable and too remote. The plaintiff fails to establish causation if he or she fails to demonstrate that, on the balance of probabilities, the alleged injury sustained was caused by a defect in the product.

In Ireland, the defence of contributory negligence is available in personal injury claims under the Civil Liability Act 1961. Section 34(1) of the act states that where it can be shown in an action that the damage suffered by the plaintiff was caused partly by the negligence or want of care of the plaintiff, the damages recoverable will be apportioned accordingly.

Contract: Defences as regards breach of contract will ultimately depend on the specific terms of the contract itself, such as limitation of liability clauses.

5.3. Can a party exclude or limit its liability for defective products in your jurisdiction? If so, how? What specific concerns and considerations should be borne in mind in this regard?

Under Section 10 of the Liability for Defective Products Act, the liability of a producer to an injured individual cannot be limited or excluded by any term of contract, notice or provision.

However, an action for recovery of damages under the Liability for Defective Products Act must be brought within three years of:

• the date on which the cause of action occurred; or
• the date on which the claimant became aware or should have reasonably become aware of the damage, defect and identity of the producer.

The 10-year longstop provision set out in the Liability for Defective Products Act also means that after the expiry of 10 years from the date on which the producer put the product which caused the damage into circulation, the claimant will no longer have a right of action.

6. Forum

6.1. In what forum(s) are product liability suits heard in your jurisdiction?

Ireland is a common law jurisdiction and its court system was originally based on the English legal system, which is divided into two branches: criminal and civil. Broadly, Irish civil courts hear disputes between individuals, organisations or the state.

In Ireland, the person that takes an action is known as the plaintiff. The person against which an action is taken is known as the defendant. The court in which the action is heard depends on the level of compensation sought by the plaintiff:

• The District Court has jurisdiction to hear claims up to €15,000;
• The Circuit Court has jurisdiction to hear claims between €15,000 and €75,000, other than personal injury claims, which are capped at €60,000; and
• The High Court has jurisdiction to hear claims above €75,000 (other than personal injury claims above €60,000).

Ireland has a Court of Appeal that sits between the High Court and Supreme Court. It hears all appeals from High Court decisions, and, except in exceptional circumstances, its decision is final.

The Supreme Court hears only cases of public significance or where an important point of law or constitutional issue is at hand.

Finally, Ireland is a member of the European Union, and any cases involving EU law may be referred to the Court of Justice of the European Union (CJEU). The CJEU consists of the General Court, which was formerly known as the Court of First Instance, and the Court of Justice.

6.2. Who hears product liability suits in your jurisdiction (eg, judges or juries)?

Ireland has an adversarial court system and the role of judges in civil proceedings is to adjudicate on the merits of the cases in front of them. Judges listen to evidence presented by both sides and to submissions made by the parties' respective barristers (or solicitors) to decide which party should win and which party should lose the case. Judges can ask questions of any of the witnesses presented and of the lawyers involved in the case.

Juries are not needed for the vast majority of civil cases. When they are used, they are relied on to determine the facts which are in dispute. They must reach a decision considering only the evidence presented to the court during the course of the trial.

6.3. Is there any opportunity for forum shopping in your jurisdiction? If so, what are the implications?

No, as the forum is based solely on the level of compensation sought by the claimant.

Should the claimant instigate his or her claim in a court of a higher level of compensation than his or her claim, if successful, he or she will be entitled to recover against the defendant only such costs as would have been allowed had the action been brought in the appropriate lower court.

If the claimant initiates his or her claim in a lower level of compensation court, the claim will be capped by the jurisdiction of claim value held by that court.

7. Filing a product liability suit

7.1. What are the formal, procedural and substantive requirements for filing a product liability suit? How does this process typically unfold and what is the timeframe?

In most cases, product liability claims will be initiated by filing and serving a personal injury summons in the High Court, the Circuit Court or the District Court.

A summons must be formally served, within one year of being issued, on the defendant either:

• personally; or
• by prepaid post to:
• • the defendant's residence or place of business; or
  • its solicitors, if they have confirmed that they have authority to accept service.

Once service of a summons has been effected, the defendant must enter a memorandum of appearance to the summons. The defendant will then need to file a defence to the claim. The timeframe for filing a defence will differ depending on the court in which the particular action is taking place.

Pleadings containing assertions or allegations in a personal injury action must also be accompanied by an affidavit of verification sworn by the relevant party.

The length of time it takes for an action to get to the trial stage depends on:

• the efficacy of the parties in dealing with pleadings and court procedure; and
• the complexity of the matters at hand.

In reality, most matters are not heard for a period of between 18 months and two years from service of proceedings. However, any interlocutory applications (eg, discovery applications) will also have a delaying effect and it is not unusual for matters not to be heard for three years or more.

7.2. Do any pre-filing requirements apply before commencement of the suit?

Prior to instituting a claim for personal injuries in court, an application must first be made to the Personal Injuries Assessment Board (PIAB).

The PIAB, an independent body established by the PIAB Act 2003, deals with all personal injury claims (excluding medical negligence cases) for compensation in the first instance. If the defendant does not wish for the PIAB to assess the claim, or if either side rejects the PIAB's proposed reward, the matter can then be referred to court.

There are currently no pre-action protocols in Ireland. However, through the Legal Services Regulation Act 2015, there are plans to introduce them in the context of clinical negligence claims.

The Mediation Act 2017 places the obligation to consider mediation prior to filing proceedings on a statutory footing, and litigants must confirm to the courts that they have considered mediation and provide evidence of this when filing their summons.

7.3. How is jurisdiction over the product liability suit determined?

The court in which the action is heard depends on the level of compensation sought by the plaintiff:

• The District Court has jurisdiction to hear claims up to €15,000;
• The Circuit Court has jurisdiction to hear claims between €15,000 and €75,000, other than personal injury claims, which are capped at €60,000; and
• The High Court has jurisdiction to hear claims above €75,000 (other than personal injury claims above €60,000).

7.4. How is the applicable law determined?

The Liability for Defective Products Act 1991 is the primary piece of legislation in Ireland as regards product liability, and is robustly supplemented by the principles of common law and requisite European product regulations. The product liability legislation in Ireland has developed gradually over the years and is heavily influenced by EU product regulatory changes. The EU product regulatory regime is generally considered to be highly developed. For example, the European Commission recently published a proposal for a draft General Product Safety Regulation to revise and update the existing General Product Safety Directive, as well as a proposal for a draft artificial intelligence (AI) regulation. The increasing prevalence of AI in various sectors of the Irish economy (including as part of all sorts of products) has also been recognised with the publication by the Irish government of AI – Here for Good: A National Artificial Intelligence Strategy for Ireland.

7.5. Under what circumstances (if any) must security for costs be provided?

The court has discretion as to whether to make an order regarding security for costs. In the case of personal plaintiffs, a prerequisite of the court granting an order for security is that:

• the plaintiff is ordinarily resident outside the jurisdiction, excluding Northern Ireland; and
• the defendant establishes a defence on the merits.

Usually, the master of the High Court is requested to measure the appropriate sum. This is intended to give the defendant some comfort to the extent that should an award of costs be made against the plaintiff, the defendant will have a fund against which to claim the costs. The master does not, as a general rule, measure the full costs of action. It is more usual to confine the measurement to one-third thereof, with greater sums occasionally being measured.

8. Disclosure and privilege

8.1. What rules apply to disclosure/discovery in your jurisdiction? Do any exceptions apply?

Pre-trial preservation: There is a general obligation to preserve documents for disclosure once litigation is contemplated. In addition, Section 12 of the Personal Injuries Assessment Board (PIAB) Act 2003 allows for the plaintiff to make an application to oblige the defendant to preserve evidence that the plaintiff may need to prove his or her case. There may also be regulatory and professional sanctions applicable where evidence is destroyed or suppressed, particularly in the healthcare and life science sectors.

Although rare, the court can also make an Anton Piller order – a form of injunction requiring the defendant to permit the plaintiff or the plaintiff's agents to enter the defendant's premises, to inspect documents or other articles and remove any that belong to the plaintiff – although generally this will not be required.

Pre-trial discovery: Generally, discovery formally arises after the close of pleadings – that is, when the defendant serves its defence. On the whole, discovery is voluntary; however, in circumstances where either side fails to comply with a request for voluntary discovery, either the defendant or the plaintiff can make an application to the courts for an order for discovery. The parties can agree on discovery at an early stage and if they do not agree, discovery can be court ordered.

Where discovery has been ordered by the court, the parties are obliged to swear affidavits of discovery in respect of privileged and non-privileged documentation.

8.2. What rules on privilege apply in your jurisdiction? Do any exceptions apply?

Privilege is the entitlement of a party involved in litigation to refuse production of the contents of a document whose existence must be disclosed. The right to refuse inspection of a privileged document lasts throughout a case and can be relied upon not only at the discovery stage, but also in response to service of a notice of inspection, a notice to produce or a subpoena. The question of whether a document is privileged arises once the document has been assessed as relevant and necessary for discovery purposes. Legal professional privilege is the main class of privilege invoked in discovery. The privilege covers two subclasses of privilege: legal advice privilege and litigation privilege. Legal advice privilege protects from production confidential communications passing between lawyer and client which were created for the sole or dominant purpose of giving or seeking legal advice, provided that the communications took place in the course of the professional relationship between them. Litigation privilege is broader and protects from production of confidential communications made in contemplation of litigation or after litigation has commenced between lawyer and client/third party for the sole or dominant purpose of such litigation.

In certain limited circumstances, the courts will override a claim to legal professional privilege if it can be established that the communications were not legitimate. This can arise where it is found that the documents:

• were created in furtherance of fraud or a crime, or in connection with a conspiracy; or
• are injurious to the interests of justice.

Similarly, the court will not uphold a claim to legal professional privilege where a party is guilty of wrongdoing or moral turpitude (even if not guilty of fraud), where such wrongdoing amounts to an abuse of process.

8.3. What are the specific implications of the rules on discovery/disclosure and privilege in product liability suits?

While the same discovery principles and rules apply in product liability personal injury cases as in all other cases, there are some additional obligations relating to the exchange of expert reports. The Rules of the Superior Courts (No 6) (Disclosure of Reports and Statements) 1998 (SI 391/1998) require the disclosure of expert reports and statements in personal injury cases. The purpose of these rules is to ensure the efficient conduct of personal injury actions by requiring the sharing of information which might facilitate a settlement or withdrawal of the claim. These rules sit side by side but do not replace either the availability or the desirability of obtaining full discovery in many cases. They provide that certain documents over which privilege could previously have been claimed must be made available to the other side. Disclosure of reports is not tantamount to the admission of those reports in evidence and, just like all documents in discovery, these must be formally provided at trial of the action.

9. Evidence

9.1. What types of evidence are permissible in your jurisdiction? How is this typically presented during the proceedings?

In the courtroom, evidence is presented via sworn oral testimony (viva voce), which stems from the rule against hearsay. Experts and witnesses put forth by each party may be asked questions by the judge appointed to hear the case as well as being subject to cross-examination.

There may be some exceptions to the live testimony or 'best evidence' rule – for example, where:

• the parties can agree on the contents of medico-legal reports; or
• evidence can be provided via affidavit.

Due to the COVID-19 pandemic and the entry into force of certain provisions of the Civil and Criminal Law (Miscellaneous Provisions) Act 2020, remote hearings with witnesses giving evidence remotely via video link have become more common. Accordingly, the Irish Courts Service has rolled out a virtual court platform, using video conferencing tool Pexip Infinity. This allows for remote and hybrid hearings to occur in tandem with physical hearings, which provides greater flexibility for cases involving witnesses.

9.2. Is expert evidence accepted in your jurisdiction? If so, how are the experts typically appointed and what input or influence (if any) do the parties have in this regard?

Parties can appoint experts to advance their case and to prepare reports.

Order 36, Rule 41(1) of the Rules of the Superior Courts makes provision for a judge hearing a case in the High Court to appoint an assessor in order to "assist the court in understanding or clarifying a matter, or evidence in relation to a matter, in respect of which that person has skill and experience". Rule 41(3) allows the court to appoint this assessor, nominated either by the parties or by the court. The assessor's report is intended to assist the judge in reaching a final decision.

Order 39, Rule 58(2)(iv) makes provision for a judge sitting in the High Court, of his or her own motion and after hearing the parties, or at the request of the parties, to appoint a joint single expert.

The use of assessors and single joint experts is extremely rare in Ireland.

9.3. What are the specific implications of the rules on evidence in product liability suits?

Section 45 of the Courts and Courts Officer Act 1995 (as amended) gave the Superior Courts Rules Committee, or the Circuit Court Rules Committee as the case may be, the power – with the concurrence of the minister for justice – to make rules in personal injury actions allowing for the admission in evidence of information, documents, reports or statements disclosed pursuant to that section, notwithstanding the rule of law against the admission of hearsay evidence, among other things. The Rules of the Superior Courts (No 6) (Disclosure of Reports and Statements) 1998 were made pursuant to these provisions and apply to High Court proceedings. These rules require the disclosure and exchange of certain reports, statements and information in certain personal injury actions. However, the fact that the parties are statutorily obliged to exchange reports and statements does not mean that either party must accept them without formal proof. Mutual disclosure does not equate to automatic admission. That is, the rules do not interfere in any way with the burden of proof and each party must still prove its respective case.

10. Court proceedings

10.1. Are court proceedings in your jurisdiction public or private? If the former, are any options available to the parties to keep the proceedings or related information confidential?

In Ireland, court proceedings are largely in public, corresponding to the principle that justice must be dispensed in open court. However, there are some exceptions where proceedings can be held in camera; although these are largely limited to family law proceedings or proceedings related to minors.

Proceedings, unless they qualify to be held in camera, are unlikely to be able to remain confidential; however, information may potentially remain confidential if certain documentation can be considered privileged.

A recent proposal for an EU Artificial Intelligence Liability Directive proposes that those seeking compensation would have an opportunity to obtain information on high-risk systems under the EU Artificial Intelligence Act. These requests, however, would need to be "supported by facts and evidence sufficient to establish the plausibility of the contemplated claim for damages". This measure would be open to 'potential claimants', who could request a court to order the disclosure of relevant evidence in advance of submitting a claim for damages. The recitals to the proposal make clear that:

• such orders for disclosure should be proportionate, such that only the relevant parts of records needed to prove non-compliance should be disclosable; and
• the legitimate interests of all parties, as they relate to trade secrets or confidential information, should remain protected.

10.2. How do product liability suits typically unfold in your jurisdiction?

Civil cases for product liability are generally heard by a judge sitting alone. As a general rule, evidence is given orally at trial. Proceedings are held in public unless an application is made to have the matter heard in private in accordance with Section 27 of the Civil Law (Miscellaneous Provisions Act) 2008 (as amended). The person making the application must show that:

• he or she has a medical condition and his or her identification as a person with that condition would likely cause undue stress; and
• the order would not be prejudicial to the interests of justice.

10.3. What is the typical timeframe for product liability suits in your jurisdiction?

The length of time it takes for an action to get to trial stage depends on:

• the efficacy of the parties in dealing with pleadings and court procedure; and
• the complexity of the matters at hand.

In reality, most matters are not heard for a period of between 18 months and two years from service of proceedings. However, any interlocutory applications (eg, discovery applications) will also have a delaying effect and it is not unusual for matters not to be heard for three years or more.

10.4. Are alternative dispute resolution procedures (eg, mediation, arbitration) often used in product liability cases in your jurisdiction? Are these encouraged/mandated by the courts?

Contracts will often include an alternative dispute resolution (ADR) clause that sets out which avenues of ADR parties must engage in before issuing court proceedings.

The Mediation Act 2017 places the obligation to consider mediation prior to filing proceedings on a statutory footing; and litigants must confirm to the courts that they have considered mediation and provide evidence of this when filing their summons.

11. Remedies

11.1. What remedies are available in product liability suits in your jurisdiction?

The remedies applicable to a breach of contract will depend on whether there has been a breach of an express term and/or an implied term of the contract. The main remedies for breach of contract are to sue for:

• damages;
• injunctive relief; or
• an order for specific performance.

The Sale of Goods and Supply of Services Act implies certain terms into contracts for the sale of goods. The remedies available for breach of such an implied term will depend on whether that term is a condition or warranty.

Breach of a condition may give the consumer the right to terminate the contract, reject the goods and sue for damages. Section 62 of the Sale of Goods and Supply of Services Act states that breach of a warranty will allow the consumer the right to sue for damages but not the right to reject the goods and repudiate the contract.

The main remedy for a claim in negligence is an award of damages. The purpose of these damages is to place the claimant in the same position that he or she would have been in had the wrong not occurred.

11.2. What categories of damages are recoverable?

In Ireland, damages are usually paid by way of lump-sum payment, rather than any other form of payment, such as an annuity. As a general rule, damages are calculated in the amount considered necessary to restore the injured party to the position that he or she would have been in had the relevant wrong not occurred.

Section 1(1) of the Liability for Defective Products Act 1991 defines 'damage' as death or personal injury, loss or damage or destruction of any item (used for private use or consumption) other than the defective product. There are two main categories of damages, as follows.

General damages: General damages are those seen to flow from the defendant's wrongful act and can include loss of expectation of life or pain and suffering.

Section 22 of the Civil Liability and Courts Act 2004 (as amended) obliges the courts, when assessing damages in a personal injury action:

• to have regard to the Personal Injuries Guidelines, which came into force on 24 April 2021 pursuant to Section 2 of the Judicial Council Act 2019; and
• to state reasons where they depart from the guidelines.

The Personal Injuries Guidelines set out general guidelines as to the amount of compensation that a person may be awarded in an action for personal injury and replace the previous guidelines, known as the Book of Quantum. However, due to transitional provisions, the Book of Quantum will remain appliable to any claims in which PIAB made an assessment before 24 April 2021 which were not accepted or to proceedings commenced before 24 April 2021.

Special damages: These are damages awarded for financial loss and quantifiable expense suffered and incurred by the plaintiff as a result of the defendant's wrongful act. For example, special damages can be awarded for loss of earnings (past and future) and medical expenses.

11.3. Are punitive damages awarded in your jurisdiction?

The primary purpose of any award is to compensate the injured plaintiff. Punitive or exemplary damages are not commonly awarded in Ireland but may be awarded in exceptional circumstances, such as if a defendant's conduct was particularly affronting and egregious or if there has been a deliberate violation of an individual's rights.

11.4. What factors will the courts consider in deciding on the quantum of damages when liability is established?

In assessing damages in a personal injury action, the court must have regard to the Personal Injuries Guidelines, commenced by Section 99 of the Judicial Council Act 2019. These guidelines replaced the Book of Quantum and contain general guidelines as to the amounts that may be awarded in respect of specific types of injuries. This does not preclude the court from having regard to other matters other than the Personal Injuries Guidelines when assessing damages in a personal injury action.

12. Appeals

12.1. Can the court's decision in the product liability suit be appealed? If so, on what grounds and what is the process for doing so?

First-instance rulings in all civil cases in Ireland can be appealed to a higher court.

Appeals from the High Court are generally made to the Court of Appeal, which sits between the High Court and Supreme Court. Except in exceptional circumstances, the decision of the Court of Appeal is final unless referred to the Supreme Court, which hears only cases of public significance or where an important point of law or constitutional issue is at hand.

Appeals to the Court of Appeal are made to a panel of three judges who have access to all of the material that was before the High Court. However, witnesses will not be re-examined and it is not generally possible to adduce new evidence.

13. Costs and fees

13.1. What costs and fees are incurred when litigating in your jurisdiction? Can the winning party recover its costs?

There is a general principle in Irish legal proceedings that 'costs follow the event' – that is, the losing party must pay the costs of the successful party. Costs include:

• lawyers' fees;
• court fees; and
• any expenses relating to the prosecution or defence of the action.

However, the court has full discretion with respect to the award of costs and can depart from the general principles set out above in circumstances where, for example:

• it finds improper conduct on the part of the successful party; or
• the action was a test case and the implications of the finding have the potential to affect a large group of people.

There are two main categories of costs:

• Party and party costs: These include all costs, charges and expenses reasonably incurred by one party for the purposes of the proceedings that the other side is obliged to pay. The party and party costs may not cover the whole of the costs incurred in an action. All such costs, charges and expenses that appear to the legal costs adjudicator to be necessary and proper in pursuit of the attainment of justice or for enforcing or defending the rights of a person are essentially allowable costs.
• Solicitor and own client costs: These encompass the costs that a client is obliged to pay its solicitor that are not recoverable party and party costs. Generally, a party will not recover 100% of its costs.

13.2. How are the costs and fees allocated among the parties?

Please see question 13.1.

13.3. What happens if the claim is withdrawn before the proceedings have finished?

The party that has withdrawn the claim will likely bear the cost of the claim to date unless an alternative agreement has been reached between the parties to the claim.

13.4. Do the courts manage costs during the proceedings?

No – and most commonly, the courts do not manage costs at all; the management of costs at the finality of the claim is dealt with by the taxing master, who is vested with full discretion with regard to the assessment and measurement of court costs.

13.5. How do the courts assess the costs and fees at the end of the proceedings?

The courts will normally decide the issue on the basis that the costs shall follow the event. Further discretion is vested in the courts whereby the court, where it thinks fit to do so, may order or direct that the costs be taxed on the solicitor and client basis. The order the court makes in regard to costs binds the taxing master as to the basis upon which the costs are to be taxed. Unless an order explicitly awards costs to the successful party on the solicitor and client or some other basis, such costs must be taxed on the party and party scale. An order which directs that a successful party should have 'full costs' of an action can still only be interpreted as awarding party and party costs.

14. Funding for product liability suits

14.1. Is legal aid available for product liability cases in your jurisdiction? If so, what requirements and restrictions apply in this regard?

Legal aid is available in Ireland but it is rarely provided in product liability claims. To succeed in obtaining legal aid, the plaintiff must pass a means and merit test and may be required to make a contribution to the costs. The majority of personal injury claims are funded by the plaintiff in their entirety.

14.2. Are contingency fees and similar arrangements permitted in your jurisdiction in product liability cases? If so, what requirements and restrictions apply in this regard?

In Ireland, contingency fees are viewed as champerty, which is against the law (see question 14.3). There is, however, a widespread and accepted culture of solicitors taking on cases on a 'no win, no fee' basis – that is, if the plaintiff's action is unsuccessful, the solicitors will not charge a professional fee for their services.

14.3. Is third-party funding permitted in your jurisdiction in product liability cases? If so, what requirements and restrictions apply in this regard?

No. The Supreme Court confirmed in Persona Digital Telephony Limited v The Minister for Public Enterprise, Ireland [2017] IESC 27 that third-party funding of litigation in Ireland would be considered champerty and maintenance, which are prohibited by Irish law.

Champerty is where a third party receives a share of what the plaintiff recovers if the action succeeds. Maintenance is the provision of financial assistance by a party with no legitimate interest in the claim to the party bringing an action.

This case also confirmed that for third-party litigation funding to be established in Ireland, it would have to be brought about by legislative change rather than through the courts.

15. Product safety regimes

15.1. What rules and regulations govern product safety in your jurisdiction?

As Ireland is an EU member state, the Irish product safety rules and regulations derive primarily from EU product safety law, which is comprised of a suite of EU legislation that includes the following:

• the EU General Product Safety Directive (2001/95/EC), implemented in Ireland by the General Product Safety Regulations 2004;
• the EU Market Surveillance Regulation (2019/1020), given further effect in Ireland by the European Union (Market Surveillance and Compliance of Certain Products) Regulations 2022 (SI 261/2022)); and
• various harmonised sector-specific frameworks such as:
• • the EU Radio Equipment Directive (2014/53/EU), implemented in Ireland by the European Union (Radio Equipment) Regulations 2017 (SI 248/2017);
  • the EU Electromagnetic Compatibility Directive (2014/30/EU), implemented in Ireland by the European Communities (Electromagnetic Compatibility) Regulations 2017 (SI 69/2017);
  • the EU Restrictions of Hazardous Substances Directive (2011/65/EU), implemented in Ireland by the European Union (Restriction of Certain Hazardous Substances in Electrical and Electronic Equipment) Regulations 2012 (SI 513/2012) (as amended);
  • the Toys Directive (2009/48/EC), implemented in Ireland by the European Communities (Safety of Toys) Regulations 2011 (SI 14/2011) (as amended)
  • the EU Cosmetics Regulation (1223/2009), given further effect in Ireland by the European Union (Cosmetic Products) Regulations 2013 (SI 440/2013) (as amended);
  • the EU Medical Devices: Regulation (2017/745), given further effect in Ireland by the Medical Devices Regulations 2021 (SI 261/2021) (as amended); and
  • the EU Tobacco Products Directive (2014/40/EU), implemented in Ireland by the European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016 (SI 271/2016) (as amended).

15.2. Do any special regimes apply in specific sectors?

Yes.

Harmonised frameworks: Please see question 15.1 in relation to various EU sector-specific harmonised frameworks and their Irish implementing legislation. A comprehensive list of EU harmonisation legislation, the corresponding Irish legislation and the relevant Irish market surveillance authorities/competent authorities as of October 2022 has been published by the Department of Enterprise, Trade and Employment (DETE) and is available here.

Food and feed: Irish product safety rules applicable to food and animal feed products are also primarily derived from various EU frameworks stemming from the EU General Food Regulation (178/2002).

Some national rules in relation to certain categories of food products supplement these EU frameworks. For example, the Public Health (Alcohol) Act 2018 sets out various minimum pricing, labelling and advertising requirements relating to alcoholic beverages.

Medicines: Irish product safety rules applicable to medicinal products are also primarily derived from EU legislation and various EU frameworks stemming from the EU Medicinal Products Directive (2001/83/EC).

Chemicals: Hazardous chemicals are regulated in Ireland by:

• the Chemicals Act 2008 and the Chemicals (Amendment) Act 2010; and
• various pieces of secondary Irish legislation which give effect to:
• • the EU Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (1907/2006); and
  • the EU Classification, Labelling and Packaging of Substances and Mixtures Regulation (1272/2008).

Commercial products: Ireland also has separate legislation (not sourced in EU law) covering the safety of products intended for commercial use under the Safety, Health and Welfare at Work Act 2005 (as amended).

15.3. Which bodies are responsible for enforcing these rules and regulations? What is their general approach in doing so?

There is no central body in Ireland responsible for market surveillance generally and no single piece of overarching market surveillance legislation. Responsibility for enforcing Irish product safety rules is dispersed across a high number of government departments and state agencies relative to other EU member states, including:

• the Marine Survey Office, which is part of the Irish Maritime Administration, Department of Transport;
• the Health Products Regulatory Authority (HPRA);
• the National Standards Authority of Ireland Legal Metrology Service;
• the Dublin City Council National Building Control and Market Surveillance Office;
• the Pesticides Controls Division, Department of Agriculture, Food and the Marine;
• the Feedingstuffs, Fertilisers, Grain and Poultry Division, Department of Agriculture, Food and the Marine;
• the Sustainable Energy Authority of Ireland;
• the Firearms and Explosives Licensing and Inspection Division, Department of Justice;
• the Competition and Consumer Protection Commission (CCPC);
• the Commission for Communications Regulation;
• the Environmental Protection Agency;
• the Health and Safety Authority;
• the Health Service Executive; and
• the Food Safety Authority of Ireland (FSAI).

The activities of these bodies are coordinated via a national Market Surveillance Forum (MSF) which meets on a quarterly basis.

A comprehensive list of EU harmonisation legislation, the corresponding Irish legislation and the relevant Irish market surveillance authorities/competent authorities as of October 2022 has been published by the Department of Enterprise, Trade and Employment (DETE) and is available here.

The CCPC is the contact point for Safety Gate RAPEX in Ireland and the DETE is the single liaison office under Article 10 of the Market Surveillance Regulation.

Generally speaking, a compliance approach is favoured by Irish regulators, unless there is a clear risk to public health warranting immediate formal corrective action and/or a significant breach of product safety legislation warranting prosecution. In line with this preferred approach, Irish regulators tend to publish easily accessible guidance and information for stakeholders. For example, the websites and guidance documents maintained by the HPRA and the FSAI are comprehensive and well maintained.

15.4. What are the penalties for failing to comply with applicable product safety rules?

Under Irish law, breaches of product safety rules can give rise to criminal prosecution which can lead, on conviction, to administrative fines and custodial sentences. Most regulatory offences can be tried either summarily (case heard by a judge without a jury) or on indictment (case heard by a judge and jury). A summary conviction can result in a fine of up to €5,000 (a 'Class A' fine), three months' imprisonment or both. Offences tried on indictment generally attract higher fines and terms of imprisonment – for example, fines of up to €100,000, a maximum 12-month imprisonment term, or both. Increased sentences can often be imposed upon conviction for repeat offences.

Irish regulatory authorities can also choose to exercise broad investigative and enforcement powers to ensure compliance with product safety rules. Although not strictly speaking penalties that are imposed to punish breaches, these types of enforced corrective actions can include:

• the seizure and destruction of non-compliant goods;
• the issue of suspension notices (temporarily suspending the supply or marketing of the products that are believed to be in breach of product safety requirements); and
• the issue of compliance notices requiring various remedial steps such as updates to labelling and packaging, as well as providing further information and warnings to consumers where necessary.

The Irish regulatory authorities may also order the withdrawal or recall of products in certain circumstances (see question 16.1).

16. Product safety issues and product recalls

16.1. Under what circumstances must a product be recalled in your jurisdiction?

The decision on whether to recall a product is case specific and can be made using a risk assessment methodology provided for in Commission Implementing Decision (EU) 2019/417. Although Irish product safety regulators have the power to order product recalls, the decision to recall a product is first and foremost a matter for the manufacturer, which must be prepared to take appropriate action to avoid risks posed by its product, up to and including recall of the product where necessary. Regulatory agencies can step in and order product recalls where they are satisfied that certain criteria provided for under the relevant product safety legislation are met. These criteria ordinarily refer to a threshold of risk to consumers and/or members of the public arising from a breach of product safety rules.

16.2. Are there obligations to report product safety issues or product recalls to the regulatory authorities? Who bears those responsibilities? What are the details of the requirements? What penalties apply for failure to comply?

Notification obligations: Yes, although the applicable Irish legislation will vary depending on the type of product and the risk identified. Examples include the following:

• In respect of the General Product Safety Regulations, the obligation to notify is triggered where the relevant economic operator knows or, on the basis of information in its possession and as a professional, ought to know that a product which it has placed on the market poses a risk to the consumer that is incompatible with the safety requirements of the General Product Safety Regulations or of the EU General Product Safety Directive.
• In respect of the Radio Equipment Directive Regulations, the Low Voltage Directive Regulations and the Irish Electromagnetic Compatability Regulations, the obligation is triggered where the relevant economic operator considers or has reason to believe that:
• • the relevant product is not in conformity with the requirements of the given regulations; and
  • the product presents a risk.
• In respect of the Irish Restrictions of Hazardous Substances Regulations, the obligation is triggered where the relevant economic operator considers or has reason to believe that the electrical and electronic equipment that it has placed on the market is not in conformity with any provision of those regulations.
• Under Irish food safety law, a food business operator must immediately inform the relevant competent authority if it considers or has reason to believe that a food that it has placed on the market may be injurious to human health.

Responsible persons: Generally speaking, these notification requirements will apply to all economic operators across the supply chain of the relevant product.

Requirements: Specific requirements vary according to the relevant market surveillance authority; however, the necessary information generally relates to details about:

• the impacted product(s);
• the nature of the defect;
• details of the risk assessment carried out; and
• the action being taken as a result.

Penalties: Subject to the applicable legislation, failure to make the necessary notifications will ordinarily constitute a prosecutable offence, which can result on conviction in fines and custodial sentences (see question 15.4).

16.3. What other rules and requirements apply to product recalls? Do these vary between voluntary and mandatory recalls?

There are various other rules and practices related to the carrying out of a product recall that stakeholders should be aware of. The general principles governing how to carry out an effective recall do not necessarily differ depending on whether the recall is mandatory or voluntary. The common goal is to arrive at a proportionate risk-based and evidence-based solution. However, regulators do have powers to order that stipulated corrective actions be taken where they take a view that a business has not gone far enough to address a product safety risk, and it can be an offence to fail to comply with these types of notices and orders.

Content of recall notices: Competition and Consumer Protection Commission (CCPC) guidance states that a 'good and clear' recall notice should:

• Attract attention, stand out clearly from advertisements and be sufficiently large;
• have the word 'RECALL' in the heading. If a different measure is involved, this can be described in the heading (eg, 'IMPORTANT SAFETY NOTICE');
• include a picture and identifying information of the product (eg, the trade name or brand, model, batch or serial number, rating plate or similar);
• state clearly what kind of a risk the product may pose (eg, excessively long cords in the head and neck area of small children's hoodies may pose a risk of choking);
• include clear instructions for consumers on how to act (eg, stop using the product immediately/move the product out of the reach of children and return it to the place of purchase); and
• include a phone number or online contact information

The CCPC also provides a recall notice template for use by business.

Mode of communication: Typical advertising channels used to notify affected consumers about product recalls are advertisements in the local media and the press, in-store notices, web postings, emails and social media. However, the form of advertising used will depend on:

• the seriousness of the risk involved;
• the type of product that is affected; and
• the group of consumers likely to be affected.

A proposed communication plan will ordinarily be submitted to the relevant competent authority as part of the recall notification process. If the competent authority does not consider the approach to communication of information to consumers/the public to be adequate, additional or alternative forms of communication and/or corrective action can be requested.

In some sectors, there will be involvement by the regulator in the chain of communication. For vehicle recalls, the Road Safety Authority of Ireland can address and send letters directly to registered vehicle owners. The Food Safety Authority of Ireland and the Health Products Regulatory Authority can also publish their own alerts in relation to unsafe food and healthcare products respectively.

Updates on progress: Competent authorities are likely to request update reports as to the status of any corrective action that is taken and may require additional measures to be adopted, including repeat recall notices, if they consider the response by consumers/the public to a corrective action is unsatisfactory.

Remedies: There is no positive obligation on a manufacturer conducting a recall under Irish product safety law to offer to repair or replace the product or pay compensation as part of its corrective action programme. However, the seller of the product may be required to offer these remedies under consumer protection rules. In practice, unless the items in question are of low value or perishable, manufacturers generally tend to offer these remedies as part of a recall.

Rights of recovery for any loss or damage relating to the product simply ceasing to be useable will largely be against the seller from which the consumer directly purchased the products (unless he or she has suffered injury or property damage, when a claim in that regard against the manufacturer or importer into the European Union may be made). Whether the seller can obtain recourse for the costs of repair or replacement and suchlike from the manufacturer or others in the supply chain is an issue that will be determined by reference to the terms of the relevant supply contracts.

16.4. What other types of corrective action are typically taken in your jurisdiction where a product is found to be defective?

The type of corrective action carried out will ultimately be determined by the risk assessment conducted. However, other types of corrective action short of recall can include:

• sending information and warnings about the correct use of products to consumers;
• modifying products at the customer's premises or elsewhere (eg, updating labelling with stickers or providing updated information to accompany the product);
• changing the design of products; or
• withdrawing products from the distribution chain.

Competent authorities can also issue various types of notices and orders requiring economic operators to take required actions to bring products into compliance with the applicable product safety legislation within set timeframes. These types of notices and orders can often include directions not to move and/or sell affected products unless and until required actions have been carried out.

16.5. What best practices should be borne in mind in relation to product safety in your jurisdiction?

We recommend the following:

• Maintain strong relationships with supply chain partners to ensure that potential safety issues are notified and appropriate action is taken as quickly as possible. Where appropriate, relevant agreements can be updated or revised to reflect the requirements and expectations of both parties, which may go beyond minimum legislative requirements.
• Develop and maintain strong traceability systems in order to:
• • quickly isolate the source of a safety issue to specific lots or batches of affected product;
  • develop a focused and proportionate corrective action plan using a risk assessment based on accurate information;
  • quickly update the relevant competent authority with an appraisal of the extent of the safety risk caused by a product and an evidence-based proposal for addressing same; and
  • provide the relevant competent authority with regular updates on the number and location of impacted products on the market and in the supply chain.
• Foster constructive and collaborative relationships with authorised officers with responsibility for inspecting premises and products on behalf of competent authorities. Irish product safety regulators tend to favour a compliance approach whereby authorised officers note areas of non-compliance and request that voluntary steps be taken before considering issuing formal notices and directions and seeking to prosecute offences in some cases.
• Have in place a structured system for soliciting feedback from business partners and screening incoming customer complaints for potential safety issues that can be escalated and investigated on a proactive basis.
• Develop and agree a clear corrective action response plan within your organisation. This should involve measures such as establishing a crisis response team with:
• • designated deputies;
  • clear reporting lines; and
  • structured timelines for required action linked to the severity of the potential or actual risk identified.

17. Criminal liability

17.1. Can parties be found to be liable under criminal law for defective products in your jurisdiction?

There is no direct basis for criminal liability under Irish product liability rules. For example, an offence of corporate manslaughter is not provided for in Irish legislation at present. The Corporate Manslaughter Bill introduced in 2016 followed a Law Reform Commission Report in 2005, which recommended that this new offence be created; however, this bill has now lapsed.

However, related breaches of product safety legislation amount to criminal offences that can be prosecuted by the relevant market surveillance authority. Answers to the questions below are therefore provided with reference to Irish product safety legislation as opposed to product liability rules.

(a) Which parties can be held responsible?

This will be determined by the specific legislation applicable to the relevant product. However, generally speaking, Irish product safety legislation tends to provide for a wide range of offences that can be committed by various economic operators beyond the manufacturer or producer of the product in question. For example:

• the General Product Safety Regulations provide for various offences that can be committed by distributors and producers; and
• the Medical Devices Regulations provide for offences that can be committed by manufacturers, importers, distributors and authorised representatives.

(b) Can individual officers or employees be held responsible?

Generally speaking, the Irish product safety legislation provides that where an offence committed by a body corporate is proved to have been committed with the "consent, connivance or approval of, or to have been attributable to any neglect" on the part of, a director, manager, secretary or any other officer of the body corporate, or someone purporting to act in any such capacity, that person, as well as the body corporate, can be found guilty of that offence and sentenced accordingly.

(c) What is the basis for liability?

Prosecutions will ordinarily be based on:

• a proven breach of product safety requirements as provided for in the relevant legislation; or
• failure to comply with an order or direction made under the relevant legislation in order to address a risk of harm to the public and/or to remedy an identified breach of product safety rules.

(d) What penalties can be imposed?

The range of penalties for non-compliance with product safety laws varies and can include administrative fines and custodial sentences. Most offences can be tried either summarily (judge only) or on indictment (judge and jury). Conviction for a summary offence can typically result in a fine of up to €5,000 (a 'Class A' fine), three months' imprisonment or both. Convictions on indictment generally attract higher fines and terms of imprisonment which are set out in the relevant legislation.

17.2. Are there any examples of the criminal law being used in your country in cases involving defective products?

As set out in question 17.1, an offence of corporate manslaughter does not exist in Irish law.

Products that are alleged or deemed to be defective and/or non-compliant with product safety legislation can often result in:

• civil product liability claims brought by consumers that have suffered damage as a result of the defect in a product; and
• parallel prosecutions by competent authorities for related breaches of product safety legislation.

Irish law provides that breaches of product safety legislation can constitute criminal offences that are prosecutable by the relevant market surveillance authority. However, official information on specific cases, conviction rates and sentencing decisions is limited. This is because these prosecutions tend to take place at the District Court and Circuit Court levels, where reported judgments are rare and public access to court records is not available. The Health Products Regulatory Authority Annual Report 2021 states that it initiated five prosecutions during that time:

• three relating to the unauthorised supply of anabolic steroids;
• one relating to the unauthorised supply of sildenafil citrate; and
• one relating to the supply of medicinal products from a market stall.

The Food Safety Authority of Ireland's (FSAI) annual report states that 10 prosecutions against food businesses were initiated during that time. Five of these prosecutions were publicised: three by the Health Service Executive and two by the FSAI. It is not clear how many (if any) of these prosecutions had civil claims for damage caused by alleged defects in the non-compliant products associated to them.

18. Trends and predictions

18.1. Have any significant product liability and/or product safety cases been reported in your jurisdiction in the past five years? What were the details and why are they significant?

Product liability: Although reported in 2017, one of the more significant recent Irish cases on product liability is Dineen v Depuy International Limited [2017] IEHC 723. In this case, Justice Cross analysed whether a medical device manufactured by the defendant was defective per Section 5 of the Liability for Defective Products Act 1991, as well as the potential application of the 'state of the art defence' provided for under Section 6 of the Liability for Defective Products Act. The case is significant as it provides clarity on the interpretation of these concepts under Irish law with reference to case law in other jurisdictions – for example:

• A v National Blood Authority [2001] 3 AER 289;
• Wilkes v DePuy International Limited [2016] EWHC 3096 (QB); and
• European Commission v United Kingdom [1997] AER (EC) 48).

There have since been various other reported Irish cases involving claims relating to defective products; however, these decisions have tended to involve consideration of procedural issues. Examples include the following:

• Delay/dismissal for want of prosecution:
• • Ahearne v O'Sullivan [2020] IEHC 46;
  • Kenny v Motor Network Ltd t/a Jennings Truck Centre & J Harris Assemblers [2020] IECA 114; and
  • Gallagher v PW Shaw & Company Ltd [2018] IEHC 556.
• Discovery: Michael O'Doherty (Fermoy) Limited v James McMahon Limited [2021] IEHC 228.
• Use of interrogatories: Blackwell v Minister for Health and Children [2020] IEHC 427.
• Litigation privilege: Kelland Homes Limited v Ballytherm Ltd [2019] IEHC 305.
• Management of similar sets of proceedings/modular trials:
• • Ryan v O'Donnell; Brennan v Hughes [2023] IEHC 329;
  • Biomass Heating Solutions Ltd v Geurts International BV [2023] IEHC 66; and
  • Avoncore Limited v Leeson Motors Limited [2021] IEHC 163.
• Conflict of laws/jurisdiction:
• • Joe Moroney Coach Hire Ltd v Moseley In The South Ltd [2022] IEHC 586; and
  • Health Service Executive v Roftek Limited [2022] IEHC 710.
• Alternative dispute resolution schemes: DePuy ADR Process v DePuy International Limited [2019] IEHC 922.
• The scope of the Personal Injuries Assessment Board Act 2003: Creedon v Depuy International Ltd [2018] IEHC 790.

Product safety: Prosecutions by competent authorities for breaches of product safety law tend to take place at the District Court and Circuit Court levels, where reported judgments are rare and access to court records is not available to the public. There is the potential for the decisions made in these courts of local and limited jurisdiction to be appealed to, or judicially reviewed by, the High Court, where judgments are regularly reported on. However, there have been no such recent high-profile Irish decisions related to product safety.

18.2. How would you describe the current product liability and product safety landscapes and prevailing trends in your jurisdiction?

Other jurisdictions have witnessed a rise in product liability claims in relation to fitness trackers and wearables including virtual reality headsets. While we have not yet seen this trend before the Irish courts, this may not remain the case for much longer, given that the Internet of Things has now become a part of Irish consumers' everyday experience.

The COVID-19 pandemic has also had a profound impact on consumer behaviour, with:

• a marked acceleration in the move to online shopping by Irish consumers;
• the increased adoption of various digital services, including digital health solutions;
• heightened awareness of issues such as data privacy and health and wellbeing; and
• drastic changes in consumer spending patterns more generally.

Many of these changes and patterns have now become embedded, with a corresponding shift in focus to the regulation and enforcement of product safety rules in the context of online sales.

Focus on the regulation of innovative products regulated under the Tobacco Products Directive (ie, e-cigarettes and refill containers) is growing, with an increased level of enforcement activity on the part of the Health Service Executive. The Food Safety Authority of Ireland has also been active in inspecting and enforcing compliance with food safety law requirements among businesses selling cannabidiol products.

18.3. What new developments are anticipated in the next 12 months, including any proposed legislative reforms to the product liability and/or product safety regimes?

There are a number of important legislative developments that have the potential to significantly impact product liability and product safety law in Ireland:

• the planned transposition of the EU Collective Redress Directive into Irish law;
• the coming into effect of the EU General Product Safety Regulation in December 2024 and the expected publication of new and/or amended national legislation giving further effect to same;
• the adoption of a revised EU Product Liability Directive;
• the adoption of an EU Artificial Intelligence (AI) Liability Directive; and
• the adoption of an EU AI Regulation.

The transposition of the Collective Redress Directive is expected to lead to the implementation of a national scheme providing for a form of collective action under EU consumer protection law in Ireland. The Competition and Consumer Protection Commission is likely to be a qualified entity in Ireland.

19. Tips and traps

19.1. What are your top tips for avoiding product liability and product safety issues in your jurisdiction, and what potential sticking points would you highlight?

Product liability: Our top tips are as follows:

• Carefully consider whether alleged defects giving rise to product liability claims identify any safety issues that require investigation and engagement with product safety regulators.
• Identify any similarities or overlaps with claims or cases in respect of impacted products in other jurisdictions and aim to ensure that the approach to actual or contemplated litigation remains as consistent as possible across your markets.

Potential sticking points include the following:

• Ireland does not have a 'class action' litigation process. Effectively managing high volumes of individual claimants (which can be common in cases involving alleged defects in a widely used product) with different representatives can therefore become challenging and can require added resources.
• Monetary awards for general damages (ie, 'pain and suffering') given to successful claimants in Ireland are high relative to those in other EU jurisdictions. This should be borne in mind when considering strategies for managing litigation in this jurisdiction.

Product safety: Our top tips are as follows:

• Regularly reassess product design, packaging, labelling and other accompanying product information in light of legislative developments and market feedback (eg, customer complaints).
• For non-harmonised products, scope the requirements of the General Product Safety Regulation and ensure that compliance can be achieved on or before December 2024.
• Closely monitor updated guidance and newsletters issued by Irish regulators with responsibility for ensuring compliance with legislation applicable to your products.

See also question 16.5 in relation to crisis management and best practices to be borne in mind in relation to product safety.

Potential sticking points include the following:

• Responsibility for enforcing Irish product safety rules is dispersed across a high number of government departments and state agencies relative to other EU member states. Extra time and resources are often required to determine which Irish regulator is the appropriate contact point in respect of a given product safety issue.
• Irish product safety legislation is enforced 'on the ground' by authorised officers appointed by competent authorities. These officers tend to operate with a high degree of autonomy and have broad discretion to interpret and apply requirements under Irish and EU product safety legislation as they deem appropriate. This can result in what is sometimes perceived by stakeholders as inconsistent application of product safety rules between officers or across different parts of the country.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.