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?

The main legal basis for product liability are as follows:

• Tort law: This is the traditional basis of product liability. Under general tort law, anyone - including both the manufacturer and any other entity in the distribution chain - that intentionally or negligently causes an unjustified injury to any another person (including non-buyers) is liable for damages, as provided by Articles 2043 and following of the Civil Code. Article 2043 provides that "any act by which a person causes damage to another makes the person through whose intention or fault the damage occurred liable to repair such damage". General tort liability can never be excluded or limited by way of disclaimers or general terms and conditions of sale.
• Contract law: The sale of a defective product may also give rise to contractual liability for breach of contract. Under contract law (Articles 1490 and following of the Civil Code), the seller is responsible for the damages caused by the defective product, unless it proves that it was in good faith and not aware of the defect. Contractual liability covers both:
• • the damage/defect/lesser worth of the product that was the object of the sale; and
  • the damages caused by the defective product, in terms of costs and loss of profit.
• Contractual damages may be limited by agreement of the parties; however, limitations cannot validly exclude liability in case of wilful misconduct or gross negligence.
• Consumer Code or strict liability: The Consumer Code (Legislative Decree 206/2005, implementing the EU Product Liability Directive (85/374/EEC) and the EU General Product Safety Directive (2001/95/EC)) imposes a strict liability regime on the manufacturer of a defective product for damage caused by the product. This means that liability can be established without the victim having to prove fault on the part of the manufacturer, provided that the victim proves the existence of a defect, damage and the causal link between them. Some scholars, because of the necessity to establish a causal link, prefer to refer to this liability as 'presumed' rather than 'strict'. Damages include:

• damages for death or personal injury; and
• damage to or destruction of personal property (other than the defective product itself) of a value greater than €387.

• There are no limits to the amount of damages that can potentially be claimed by the injured party.
• Any covenant intended to exclude or limit in advance the liability for defective products towards the damaged party will be null and void.
• Criminal law: In addition, should a defective product cause the death of, or physical injury to, a consumer, criminal liability may apply. If the injuries suffered are not serious, the crime can only be prosecuted upon criminal complaint by the injured person.

1.2 Do any special regimes apply in specific sectors?

Yes. Specific legislation applies in a number of sectors, such as toys, machinery, pharmaceuticals and food. In such cases, the provisions of the Consumer Code either do not apply or apply exclusively to those aspects not covered by special legislation, such as the powers of the relevant public authorities in charge of safety issues.

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

Over the years, the Italian courts have issued a number of judgments on product liability matters, but it is hard to assess whether a claimant-supporting trend has been established.

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?

Yes. See question 2.2.

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?

Yes. Italy implemented class action legislation in 2008. Collective actions can be initiated either by:

• single consumers as class representatives; or
• consumer associations/representative bodies.

There are currently two types of collective actions:

• the general class action (regulated by Articles 840-bis and following of the Civil Procedure Code); and
• the representative action to protect consumers (regulated by Articles 140-ter and following of the Consumer Code).

General class action: The general class action regime was recently reformed by Law 31/2019, which came into force on 19 May 2021. The current general legal framework concerning class action is set out in Articles 840-bis to 840-sexiesdecies of the Civil Procedure Code.

The reform has widened the scope of application of the class action regime, providing that anyone holding a 'homogeneous individual right' - and thus not only consumers - can bring a class action to seek compensation. Pursuant to the new provisions, the claim may be brought by:

• each class member; or
• non-profit organisations or associations enrolled on a public list maintained by the Ministry of Justice.

The new action can be brought against all companies, providers of public services and entities managing services of public utility. The competent court is exclusively the specialised business division of the court at the place where the sued company is registered (Tribunale delle Imprese).

The new regime retains the 'opt-in' system (ie, during the 'admission phase' of the class action, the court sets a deadline for any potential member of the class to opt in). It has also introduced a new two-phase proceeding. In particular, the proceeding starts with the filing of an ad hoc application, which is followed by a court decree scheduling the hearing for the appearance of the parties. After the first hearing, the proceeding continues as follows:

• Admission phase: The court will ascertain the admissibility of the action within 30 days of the first hearing. The action will be considered inadmissible where:
• • it manifestly lacks grounds;
  • it lacks homogeneity;
  • there is a conflict of interest between the claimant and the defendant; or
  • the claimant is not considered to adequately represent the holders of the homogenous individual rights.
• If the court declares the action admissible, it will schedule a hearing for discussion and grant a time limit to join the class action.
• Merits phase: In accordance with the rules on summary proceedings set forth in Articles 702-bis and following of the Civil Procedure Code, the court will uphold or reject the claim. However, Legislative Decree 149/2022 (the so-called 'Cartabia Reform') repealed Articles 702-bis and following of the Civil Procedure Code, without establishing a new regulatory reference for class actions. It is therefore unclear which regime is currently applicable. The class action reform grants the claimant enhanced powers at the evidential stage, such as the power to:
• • appoint a technical expert;
  • avail of statistical data or rebuttable presumptions; or
  • order the disclosure of relevant pieces of evidence.
• In the decision, the court will, among other things:
• • set out the main features of the homogenous individual rights in order to identify the requirements necessary to join the class action; and
  • specify a period of time (from 60 to 150 days) for all individuals to join the class.
• The decision will then be published within 15 days and can be appealed before the competent court of appeal within 30 days after its communication.
• Formation of the class and adjudication of the quantum phase: This phase is led by the common representative of the class and the delegated judge appointed by the court in the abovementioned decision. In this phase, the defendant and the common representative of the class will have the opportunity to file written pleadings concerning the individual applications submitted in the period specified by the court. The delegated judge will then issue a motivated decree:
• • upholding or rejecting each application; and
  • identifying the amount due to each member of the class.

Currently, there are few precedents for this type of action in Italy. However, the changes introduced by the reform may lead to an increase in its use, since they have widened the scope of application of class actions and made it easier for claimants to meet the burden of proof.

Representative action: The representative action was introduced on 10 March 2023 by Legislative Decree 28/2023 implementing Directive 2020/1828/EU on representative actions for the protection of the collective interests of consumers and repealing Directive 2009/22/EC. The new rules aim to:

• consolidate consumer confidence in the internal market; and
• ensure the effective and uniform protection of consumers' rights, while avoiding potential distortions of competition.

The legislative decree introduced a new concept of class action – the representative action – aimed at obtaining injunctive or compensatory relief for the violation of consumer rights, which partially differs from the class action previously introduced by Law 31/2019. While the general class action regime aims to safeguard the 'homogeneous individual rights' of members of a same group, the representative action is an action to protect the collective interests of consumers – defined as interests arising from violations of the regulations and directives expressly listed in the decree (eg, liability for defective products, unfair contractual clauses, general product safety). Furthermore, the representative action may only be pursued by specific entities which are identified by the Ministry of Enterprises and Made in Italy, and not by individual consumers.

Another important difference with respect to the previous class action regime is the extension of passive legitimacy, as the legislative decree allows for representative actions to be brought against any natural or legal person, whether public or private, pursuing commercial, entrepreneurial or professional activity.

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

Tort liability: Under tort liability, a claim for product liability (regardless of the type of damages claimed) can be brought against anyone – including both the manufacturer and any other entity in the distribution chain – that intentionally or negligently causes unjustified prejudice to another subject.

Contractual liability: Contractual liability claims can be brought against the seller and/or the contractual entity that has supplied the product under a contract (a sale, supply or service supply agreement) to the damaged person.

Strict liability: Product liability claims (regardless of the type of damages claimed) pursuant to Articles 115 and 116 of the Consumer Code can be brought against:

• the producer, meaning the manufacturer of:
• • a finished product;
  • a component thereof; or
  • raw materials; and
• in subsidiary order, the supplier of the defective product, if the claimant is unable to identify the producer and the supplier fails to provide the identification details of the producer upon the written request of the claimant (where various persons are being held liable pursuant to the Consumer Code, the latter are jointly and severally liable, pursuant to Article 121 of the Consumer Code).

The definition of a 'producer' in the Consumer Code is not aligned with the definition set out in Section 3 of the Product Liability Directive (85/374/EEC), but has been interpreted by case law and commentators as including entities that – by affixing their own brand to a product manufactured by others – identify themselves as the entity responsible for the safety of the final product.

Criminal liability: If damage occurs, the person responsible for the damage may be prosecuted for manslaughter and negligent bodily injury. If several individuals have negligently contributed to cause the damages the public prosecutor can investigate for aiding and abetting pursuant to Article 113 of the Criminal Code.

In specific cases (see question 15.4), the marketing of a dangerous product is considered an offence under Article 112 of the Consumer Code, even if no damage occurs. In relation to this offence, the public prosecutor will investigate the individual (usually, the legal representative of the entity) who has negligently or maliciously put the product into circulation. However, if other individuals negligently or maliciously contributed to the perpetration of the offence, the public prosecutor can investigate them for aiding and abetting.

In addition, the producer/distributor of an unsafe product can be punished with the crime of fraud in trade under Article 515 of the Criminal Code if it maliciously (ie, with intent) provided the customer with a product that differs from that stated or agreed upon in origin, source, quality or quantity.

Traditionally, criminal liability has intended to be exclusively personal. More recently, however, the concept of corporate criminal liability was introduced to the Italian legal system by Legislative Decree 231/2001. The specific circumstances under which corporate criminal liability may arise under this decree are as follows:

• The criminal offence must be committed by employees who:
• • hold positions of representation, management or direction within the company ('top management'); or
  • are subject to the direction or supervision of the top management;
• The offenders must have acted in the interest or to the advantage of the company; and
• The criminal offence must be included in the list of predicate offences. Negligent offences relating to unsafe/dangerous products are not included in the list of predicate offences. Indeed, corporate criminal liability may arise in relation to manslaughter and negligent body injury pursuant to Article 25-septies of Legislative Decree 231/2001 only in the case of an accident at work arising from a lack of security measures implemented by the employer in the interest or to the advantage of the entity. On the contrary, corporate criminal liability may arise in relation to the crime of fraud in trading pursuant to Article 515 of the Criminal Code and Article 25-bis1, if the other abovementioned requirements are met.

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

The Recast Brussels Regulation (1215/2012) provides for rules on jurisdiction which apply where the defendant is domiciled in the European Union. The basic principle underlying the European regime is that a defendant should be sued in its country of domicile – which, in relation to a corporation, is based on the company's statutory seat, central administration or principal place of business (Article 63(1) of the Recast Brussels Regulation).

Specific rules may apply to product liability claims which alter the broad principles as set out above, as follows:

• A person may, when faced with a claim in tort or for strict liability (as liability under Directive 85/374/EEC is considered by the Court of Justice of the European Union (CJEU) as tort from a jurisdiction perspective), be sued in the courts of the place where the harmful event occurred or may occur (Article 7(2) of the Recast Brussels Regulation). This means either:
• • the place of the event giving rise to the damage; or
  • the place where the damage occurred.
• With respect to a product liability claim brought on the basis of Directive 85/374/EEC, the CJEU (C - 45/13, Kainz v Pantherwerke AG) held that the place of the event giving rise to the damage is the place where the defective item was manufactured. This means that if a product was produced, for example, in Germany by a German company, is sold in Austria by a distributor and produces damage in Italy, the damaged party will be able to claim for damages either in Italy or in Germany, but not in Austria.
• Where the claim is for contractual liability, jurisdiction lies with the courts of the place of performance of the obligation in question. However, with regard to sales contracts, jurisdiction lies with the courts of the place where the goods were delivered or should have been delivered.
• In case of contractual liability and if the claimant is a consumer, Section 18 of the Recast Brussels Regulation may apply, which establishes that jurisdiction lies in with the courts of the place where the consumer is domiciled.

If Italian law applies, the same conflict of laws rules will apply where the defendant is not domiciled in the European Union, as:

• Article 3(2) of Law 218/1995 refers to the 1968 Brussels Convention; and
• the prevailing case law holds that this provision should now be interpreted as referring to the Recast Brussels regulation (see Supreme Court Judgments 18299/2021, 3302/2021 and 3303/2021).

Moreover, pursuant to Article 3(2) of Law 218/1995, the Italian courts may be always addressed if the defendant is domiciled in Italy or has an authorised representative in Italy.

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?

Tort liability: Under general tort liability, the injured person claiming damages bears the burden of proving:

• the defect in the product;
• the causal relationship between the defective product and the damage suffered;
• the manufacturer's/distributor's fraud or negligence; and
• the value of the damage.

The above requirements must all be met for a claim for damages to be granted. Of these, the manufacturer's/distributor's fraud or negligence is often the most difficult element to prove.

The damages that the injured party may claim on the basis of tort law include both:

• economic damages (actual damages and loss of profits); and
• personal damages (including biological and existential damages).

Contractual liability: According to the most recent case law of the Supreme Court, in case of contractual liability, the purchaser should give evidence of:

• the contractual requirements for the product;
• the defect or lack of compliance;
• the damage, in terms of costs and loss of profits; and
• the causal link between the defective/non-compliant product and the damages.

In order to validly claim damages under contract law, the purchaser of a defective product must notify the seller of the defect within eight days of discovery. However, pursuant to Legislative Decree 170/2021, this time limit may not apply if the purchaser is a consumer.

Strict liability: Under strict liability, the injured person has the burden of proving:

• the damage;
• the defect; and
• the proximate cause (ie, that the defective product caused the injuries or damages).

However, the injured person need not prove fraudulent or negligent behaviour on the part of the manufacturer.

Criminal liability: Under criminal law (Article 187 of the Code of Criminal Procedure), evidence must be provided of the facts relating to the accusations, criminal liability and determination of the penalties. In addition, if a civil party joins the criminal proceedings, facts concerning the civil liability resulting from an offence will also be at issue.

In particular, to conviction the indicted party and order compensation for damages, there must be proof that:

• the indicted party carried out the relevant conduct;
• that conduct caused the damage suffered; and
• the indicted party acted with malice or, in specific cases, with negligence.

The burden of proof in relation to the charges and criminal liability falls on the public prosecutor. However, if a civil party joins the criminal proceedings, it can gather all evidence that may prove that the indicted party committed the offence and that damage occurred.

Having examined all evidence during trial, the civil party will present the court with its written conclusions, which will also indicate the amount of damages, if compensation has been requested.

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

Yes; see question 2.3.

From a criminal law perspective, should an unsafe product cause harm to someone, the manufacturer might face criminal charges, depending on:

• the facts of the case; and
• the seriousness of the damage caused by the product (eg, personal injury, manslaughter).

In this case, criminal proceedings may begin and the damaged person may also bring a civil action in the criminal proceedings to seek compensation.

If the injuries suffered are not serious, the crime can only be prosecuted through a criminal complaint filed by the injured person.

See also question 17.1.

4 Defective products

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

A product is defective if it does not provide the safety which a person is entitled to expect, taking all circumstances in account, including:

• the way in which the product has been put into circulation, its presentation, its apparent characteristics and the instructions and warnings supplied with the product;
• the use to which the product could be reasonably expected to be put and the behaviours which, in relation to the same, can be reasonably expected; and
• the time at which the product was put into circulation.

A product is considered defective only if the defect existed when the product was first put on the market, regardless of whether it was only discovered to be defective later on.

On the basis of the origin of the defect, three types of product defects can identified:

• design defects (erroneous technical specifications);
• production defects (use of defective raw materials or components; defects in the production process or non-compliance with the project specifications; inadequate control of the quality of the final product); and
• instruction and supervision defects (inadequacy of instructions for use; inadequate maintenance; insufficient warnings of possible risks).

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?

The injured party bears the burden of proving:

• the defect in the product;
• the damage suffered; and
• a causal link between the defect and the damage.

Pursuant to case law, the existence of a defect in a product may be derived from the existence of the damage and of a causal link between use of the product and the damage itself. This means that the mere fact that use of the product caused the damage will suffice to infer the existence of the defect in the product. Therefore, no specific evidence of the defect will be required.

This trend seems to have been overturned by certain Supreme Court decisions, in accordance with which the general rules on the burden of proof set out in the Civil Code must be applied – that is, the damaged party must prove that the damage suffered was caused by the 'defect' in the product (which must thus be identified), and not merely by the product itself. However, if proof of the defect is not easily obtained, presumptions may be resorted to in order to demonstrate its existence.

According to the Court of Justice of the European Union in a case concerning medical devices, the detection of a potential defect in products belonging to the same group or series may legitimately lead one to assume that a single item from this group or series is defective, without the need to conduct a specific assessment of the single item (Judgment of 5 March 2015, Cases C-503/13 and C-504/13).

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?

See question 4.2.

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?

See question 4.2.

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?

Tort liability: Product liability claims based on tort liability cannot be brought after a period of five years, beginning from the date on which the damaging fact or illicit conduct occurred (which should correspond to the introduction of the defective product on the market).

Contractual liability: In a business-to-consumer scenario, a consumer can validly bring a claim for a defective product against the seller within 26 months of dispatch of the defective product.

The seller's right of recourse against the manufacturer and/or any other party in the distribution chain expires one year after the date on which the seller fulfilled the consumer's request arising from the defective product.

The purchaser of a defective product must inform the seller of the defect within eight days of discovering the same, unless otherwise agreed between the parties (and unless the seller was aware of the defect). The action to claim damages is barred one year after dispatch of the product (pursuant to Article 1495 of the Civil Code).

Shorter terms may be provided for specific types of contracts, as indicated in the Civil Code.

Strict liability: Product liability claims based on strict liability cannot be brought after a period of three years, beginning from the date on which the damaged party became, or should have become, aware of:

• the damage;
• the defect; and/or
• the identity of the person responsible.

Should the damage worsen, the limitation period starts to run from the date on which the injured party became aware, or should have become aware, of damage sufficient to justify a court action.

Unless an action has been initiated or the manufacturer has admitted the defect, product liability claims may no longer be brought once 10 years have elapsed since the date on which the manufacturer put the defective product on the market.

Criminal liability: Article 157 of the Criminal Code states that, in general, the limitation period starts to run when the offence is committed and is equivalent to:

• the maximum of the penalty provided by the law for the relevant offence (if not interrupted); and
• in any event, at least six years for crimes and four years for misdemeanours.

Nevertheless, Article 160 of the Criminal Code states that specific court provisions (eg, the application of precautionary measures; the request of the public prosecutor for committal to trial) will interrupt the limitation period. If interrupted, the limitation period will start to run again, but cannot increase by more than one-quarter of the 'standard' length.

Therefore, the limitation period for:

• the misdemeanour of marketing dangerous products (Article 112 of the Consumer Code) is four years (five years in case of interruption); and
• the crimes of manslaughter (Article 589 of the Criminal Code) and negligent bodily injury (Article 590 of the Criminal Code) is six years (seven years and six months in case of interruption).

The statute of limitations ceases permanently with the pronouncement of a first-instance judgment.

With regard to corporate criminal liability (which may arise only under specific circumstances – see question 2.3), under Article 22 of Legislative Decree 231/2001, the statute of limitations for offences committed by an entity is five years, unless any measures interrupt the limitation period (eg, restraining measures or indictment). However, if the public prosecutor concludes the investigation, the five-year limitation period will resume as of the date on which the public prosecutor proceeds with the indictment.

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

Tort liability: Liability in tort depends on the possibility to link the product defect and the consequent damage to the wilful misconduct or the fault of the defendant, to be proved by the claimant.

Therefore, several defences may be available to the defendant, including:

• the absence of a link between the defect and the action of the defendant;
• lack of proof of the damage and/or its worth;
• the absence of wilful misconduct or fault; and
• the absence of a link between the defect and the claimed damage.

Contractual liability: The common defences available to the seller of a defective product against a claim for contract termination and compensation for damages are as follows:

• The purchaser was aware of the defect at the time of purchase;
• The defect was easily detectable by the purchaser;
• The seller ignored in good faith the presence of a defect in the product; or
• The purchaser failed to timely notify the detection of the defect.

Strict liability: To avoid strict liability claims, the manufacturer/defendant must prove the existence of one of the following exemptions:

• It did not put the product into circulation (a product is considered to have been put into circulation when it is delivered to the courier, purchaser, user or a representative of the same, even if only on an approval basis or for testing);
• The defect did not exist when the manufacturer put the product on the market;
• The manufacturer did not manufacture the product for sale or for any other form of distribution for economic purposes, or manufacture or distribute the same in the course of carrying out its business;
• The defect is due to the product's compliance with mandatory rules or binding measures;
• The state of scientific and technical knowledge at the time when the manufacturer put the product into circulation was not such as would enable the product to be identified as defective (this does not exclude the possibility of the manufacturer subsequently learning of the existence of a defect due to advancements in knowledge); and
• In the case of the manufacturer of a component or of raw materials, the defect was entirely attributable to:
• • the design of the product in which the component or raw materials were incorporated; or
  • the instructions given by the manufacturer which used the component or raw materials.

Criminal liability: In order to exclude criminal liability, the indicted party may prove that:

• its conduct did not cause the damage; and/or
• it did not act with negligence.

In case of corporate criminal liability (pursuant to Legislative Decree 231/2001 – see question 2.3), a company may avoid the application of administrative sanctions (pecuniary sanctions and restraining measures) notwithstanding the commission of criminal offences by individuals acting on its behalf if it can provide the court with evidence that commission of the offence was not due to the lack of any 'corporate blameworthiness'. This may be proved by demonstrating that the offender acted by fraudulently violating fully functional, well-structured corporate policies specifically aimed at preventing the commission of offences of the kind that occurred (the so-called '231 Model' set out in Legislative Decree 231/2001).

Restraining measures may not be applied if the following conditions are satisfied prior to commencement of the trial:

• The company has fully paid for all damages caused by the offence and has eliminated any detrimental/dangerous consequences of the offence (or at least has made serious efforts to eliminate them);
• The company has remedied the organisational deficiencies which facilitated the commission of the offence by adopting and implementing ad hoc compliance programmes aimed at preventing the commission of offences of the kind at hand; and
• The company has placed the profits gained from the offence at the disposal of the competent authorities in order to be confiscated.

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?

Tort and strict liability for damages arising from death or personal injury and/or from damages to proprietary items caused by a defective product cannot be disclaimed or capped, by contract or otherwise.

This limitation, however, does not apply to parties in the same distribution chain (eg, manufacturer, distributor, reseller), which are free to contractually determine the entity that will ultimately bear liability arising from the defective product.

In principle, contractual liability for damages caused to a purchaser by defective goods can be excluded/capped by contract, as long as the exclusion/limitation does not apply if the seller has willingly omitted to disclose the defect. If the contract is concluded through general terms and conditions, specific written approval of the clause providing for such limitation of liability is required.

6 Forum

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

Civil courts usually hear product liability cases, except for death or personal injury cases, where civil actions may be brought and decided in the context of a criminal claim.

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

There are no jury trials in Italy. A tribunal decides all product liability cases at first instance; while a panel of judges decides appeals and cases brought before the Supreme Court.

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

No.

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?

Court proceedings are started by serving a writ of summons on the defendant at least:

• 120 days before the scheduled hearing if the place of notification is in Italy; and
• 150 days before the scheduled hearing if the place of notification is abroad.

If notification of the writ of summons is made abroad, the writ must be accompanied by a certified translation into one of the national languages of the country in which service takes place.

Once the writ has been served, it must be lodged with the competent court, along with copies of all relevant documents. The claimant must pay a court duty to obtain an identification number for the proceeding.

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

There is no general duty to take mandatory steps before filing a product liability claim. However, for specific matters, it is mandatory to try a mediation proceeding prior to filing the case.

For instance, pursuant to Article 5 of Legislative Decree 28/2010, mediation is mandatory where a dispute between two or more parties concerns compensation for damages arising from medical and healthcare liability. In this case, an attempt at resolving the dispute through mediation is a mandatory precondition for proceeding with the action.

Further, if the claim does not exceed a certain amount (€50,000), it is mandatory to first attempt an 'assisted negotiation with lawyers' (Law Decree 132/2014), except where the claim concerns contractual obligations between consumers and professionals.

7.3 How is jurisdiction over the product liability suit determined?

See question 2.4.

7.4 How is the applicable law determined?

Tort law: With regard to claims for defective products based on tort law, the applicable law is determined according to the criteria established by EU Regulation 864/2007, which provides for the applicability of the law of the country in which the person who sustained the damage had his or her habitual residence when the damage occurred, if the product was marketed in that country. Otherwise, the applicable law will be that of the country in which the product was acquired or subordinately that of the country where the damage occurred, if the product was marketed in those countries.

However, if the party against which liability is being asserted could not have reasonably foreseen the marketing of the product or a product of the same type in the relevant countries, the applicable law will be that of the country in which it is habitually resident.

Finally, if the case is manifestly more closely connected to another legal system – for example, because the tort claim indirectly derives from a contract governed by the law of another country – the latter will apply.

Contractual obligations: EU Regulation 593/2008 applies where the claim is based on contractual obligations. The parties may choose the applicable law. If they do not, different rules may apply depending on the type of contract. For example, a sales contract will be governed by the law of the country in which the seller has its habitual residence. If, however, the contract is manifestly more closely connected with the law of another country, the latter will apply.

However, if the buyer is a consumer and the seller was acting in the exercise of its trade or profession, the applicable law may be that of the country where the consumer has his or her habitual residence, pursuant to Article 6 of EU Regulation 593/2008.

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

No security for costs is to be provided under Italian law.

8 Disclosure and privilege

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

Formal US-style rules of discovery do not exist in the Italian procedural regime.

In product liability cases, the applicable rules are those established by the Code of Civil Procedure (eg, cross-examination of the other party; examination of witnesses; order to produce evidence).

Indeed, pursuant to the Code of Civil Procedure, each party must submit to court all documents to support its case. If such documents are not available to the party, it may request the court to issue an order of disclosure against the other party or any third parties holding such documents. The court will assess the relevance of the documents for evidentiary purposes and the possibility of proving the same circumstances through other means. A third party that receives an order of disclosure may object to it before the expiry of the timeframe set by the court.

The key evidence that must be submitted to the court is proof of:

• purchase (ie, the invoice); and
• the alleged defect in the product.

Physical damages are usually proved by photographs, medical records and expert opinions. It may happen that, if the non-conformities alleged by the buyer are challenged by the seller, a court expert will be appointed to carry out a technical appraisal of the product.

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

The common law attorney-client privilege is in some ways similar to the lawyer's duty of professional confidentiality set out in:

• Articles 200 and 256 of the Code of Civil Procedure;
• Article 249 of the Code of Civil Procedure, which extends the applicability of Article 200 of the Code of Criminal Procedure to the hearing of witnesses in civil proceedings; and
• Articles 13, 28 and 58 of the Code of Legal Ethics.

A lawyer may not be obliged:

• to report facts and circumstances learned in the course of his or her mandate; or
• to hand over to the authorities documents, data or computer programs held in the course of his or her mandate (except where obliged to report them to the judicial authority).

The duty of professional confidentiality is waived if the disclosure:

• is necessary in order to defend a client;
• is necessary to prevent the commission of a particularly serious offence;
• is necessary in order to allege factual circumstances in a dispute between the lawyer and his or her client, or the client's client; or
• takes place within the framework of a disciplinary procedure.

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

See questions 8.1 and 8.2.

9 Evidence

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

In product liability cases, as well as in other ordinary civil proceedings, both oral (eg, witness testimony) and documentary evidence is accepted.

The filing of documents and a request for the admission of witnesses must be made within specific procedural deadlines. A list of the proposed questions that will be put to the witness must be filed in writing within the term granted to the parties for filing their respective briefs on evidence.

Subject to compliance with the applicable filing deadlines, documents are always admissible, in principle; while oral evidence and other means of proof are subject to a court decision on relevance and admissibility. The court may refuse to hear witnesses if it deems this unnecessary or considers the testimony inadmissible for other reasons. If the court permits witness evidence, the witness will be examined by the judge directly – the parties' attorneys do not conduct cross-examination in Italian civil proceedings.

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?

Yes. In court proceedings, the judge can order the appointment of a technical consultant (consulente tecnico d'ufficio (CTU)) if this is deemed necessary in order to obtain in-depth knowledge of a certain technical matter.

In the appointment order, the judge will arrange a hearing at which the CTU will appear. The CTU will then draw up minutes of the operations performed and file a final report within the timeframe set by the judge.

Where the judge has appointed a CTU, the parties may appoint a trusted consultant to the role of party-appointed technical consultant (consulente tecnico di parte (CTP)). The CTP will assist the party who appointed him or her, undertaking all operations performed by the CTU.

At the end of the CTU's operations, the CTP will examine the written report produced by the CTU and, if necessary, formulate specific observations in writing. The CTU will assess such observations prior to drafting a final report for the judge.

The judge may disregard the technical arguments contained in the report made by the CTU by resorting to arguments drawn from his or her own personal technical knowledge. However, the judge must give reasons as to why he or she has departed from the assessments of the expert. In most cases, however, judges tend to follow the instructions of the CTU.

Each party may also file an extrajudicial expert's report, although this has no value as evidence with respect to the facts which the expert claims to have ascertained. This report may only be considered as circumstantial evidence, like any document emanating from a third party; as a result, its assessment is left to the discretion of the court and indeed it may be ignored altogether (Supreme Court Decision 2980/2023).

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

In general terms, in the Italian civil law system, considerable weight is given to written evidence. The basic principle is that oral testimony is allowed in cases where documents are either unavailable or unreliable.

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?

As regards civil proceedings, and in general terms, proceedings are not public.

Nonetheless, hearings held for discussion of the case are open to the public, under penalty of the invalidity of the relevant final judgment. Indeed, Article 128 of the Code of Civil Procedure states that the hearing for oral discussion will be public unless security, public order and public customs reasons require otherwise.

Also, third parties that are not a party to the proceedings cannot access the court files; only the parties to the proceedings, through their lawyers, can view and request a full copy of the dossier and the records of the proceedings.

In addition, according to Article 120 of the Code of Civil Procedure, the court, at the request of one of the parties, may order publication of the judgment through specific means of communication, as a restorative measure. The judgment may be published in full or in excerpts.

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

Product liability suits, like civil proceedings in general, unfold in three phases:

• Introductory phase: This involves an assessment of the formal and procedural regularity of the proceedings, with regard to:
• • the parties (relevant legal standing and powers);
  • the jurisdiction of the court seized; and
  • all other procedural issues that may prevent the case from reaching the subsequent phase.
• During this phase, the parties – even before they even appear before the judge – may also produce documents and submit requests for evidence. The court will examine such requests and grant those it deems appropriate.
• Evidentiary phase: During this phase:
• • the evidence admitted by the court is gathered;
  • witnesses are examined; and
  • any experts appointed by the judge render their opinions.
• Decision phase: This involves the evaluation of the evidence and the arguments submitted by the parties. This leads to a final decision. There is no distinction between the pre-trial and trial phases, as is typical in the common law system.

The same judge is in charge of all three phases of the proceedings, which are not formally divided. The judge:

• sets the dates for the hearings;
• checks that there are no procedural flaws;
• rules on requests submitted by the parties;
• appoints experts; and
• conducts and oversees the evidence-gathering activities up to the final decision.

Only the judge can question witnesses; however, he or she will pose questions that have previously been submitted by the parties and that he or she has already approved.

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

Generally speaking, first-instance proceedings (ie, before a tribunal) last from two to three years, mainly depending on:

• the number of parties;
• the nature of the dispute; and
• the type of evidence that the judge decides to admit.

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?

Yes. Alternative methods of dispute resolution such as mediation or arbitration are available.

For example, an attempt at mediation is mandatory for specific matters, such as medical malpractice, prior to filing the case before the competent court; while arbitration is available, for example, when the parties have expressly provided for this in an ad hoc clause inserted in the relevant contract.

11 Remedies

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

A person/entity (including a public entity) that has suffered damage because of a defect in the product can bring claims for compensation for damages (based on either criminal or civil liability).

11.2 What categories of damages are recoverable?

In product liability claims, all damages suffered by the injured party – including pecuniary and non-pecuniary damages – may be awarded:

• Pecuniary damages include all expenses incurred by the injured party as a result of the product defect, as well as any consequential loss of profits (eg, loss of current and future income), and may be awarded where the claimant has provided evidence of their existence and value. The amount claimed may also be subject to equitable evaluation where the exact quantification of the damage is not possible or is excessively burdensome.
• Non-pecuniary damages, include personal injury damages and moral damages (eg, pain and suffering). Pursuant to case law, non-pecuniary damages can be awarded only in:
• • cases provided for by law; and
  • cases in which the tort has prejudiced a personal right that is protected by the Constitution.

Tort liability: Damages that can be claimed under tort law are regulated by Article 2056 of the Civil Code (which refers to Articles 1223, 1226 and 1227 of the Civil Code), as follows:

• Costs and loss of profits can be restored; however, loss of profits may be subject to the judge's equitable evaluation (Articles 1223 and 2056 of the Civil Code).
• Damages that cannot be fully proved may be equitably evaluated by the judge (Article 1226 of the Civil Code).
• Where damage has been partly caused by the claimant's conduct, the claim may be reduced depending on the relevance of the claimant's behaviour and its consequences: damages which could be avoided if the claimant behaved diligently cannot be awarded (Article 1227).

Contractual liability: In a business-to-consumer scenario, under Article 130 of the Consumer Code, the consumer of a defective product is entitled to request the seller to replace or repair the defective product free of charge. The consumer is entitled to claim a price reduction, or to terminate the purchase agreement and obtain reimbursement of the price, if:

• replacement or repair is not a viable solution (eg, repair is not possible, a replacement is not available or repair/replacement would be excessively burdensome for the seller);
• the seller does not repair/replace the defective product within a reasonable time; or
• the repair/replacement causes considerable inconvenience to the consumer.

Consumers cannot terminate the agreement due to minor defects.

If the defect is due to an act or omission by another entity in the distribution chain (eg, the manufacturer and/or a distributor), and unless otherwise provided in the sale/purchase agreement between the seller and these parties, the seller has an action of recourse against the other parties in the distribution chain. The action of recourse must be brought within one year of the date on which the seller has satisfied the consumer's claim.

In a business-to-business scenario, according to Article 1492 of the Civil Code, the purchaser of a defective product is entitled to terminate the contract and seek:

• reimbursement of the purchase price and expenses (unless custom excludes termination for a specific defect) or a reduction in the purchase price; and
• damages arising from the defective product (actual damages and loss of profits), unless the seller proves that in good faith it was unaware of the existence of the defect.

According to Article 1494 of the Civil Code, the seller will always be liable for damages to the purchaser, unless the seller proves that it was not aware of the defect of the product in good faith.

Restorable damages include the same type of damages (under the same conditions) as provided under tort law (see above).

Strict liability: Damages claimable under strict liability include:

• damages for death or personal injury; and
• damage to or destruction of personal property (other than the defective product itself, for which a claim can only be based on contract law and/or tort law) of a value greater than €387, provided that the item of property:
• • is of a type that is ordinarily intended for private use or consumption; and
  • was used by the injured person mainly for his or her own private use or consumption.

Damages for death or personal injuries will be considered as inclusive of both economic and moral damages (including damages relating to the suffering of the partner of the person who died as a consequence of the defect in a product). Economic damages consist of both actual damages – for example, for medical expenses – and loss of profits, such as loss of a business opportunity.

Criminal liability: In the case of crime-related damages, if the damaged/injured person joins the proceedings as a civil party, the criminal court will be responsible for deciding on compensation for damages and may quantify the damages considering the relevant civil law provisions.

However, Article 539 of the Code of Criminal Procedure states that:

11.3 Are punitive damages awarded in your jurisdiction?

No. In general terms, Italian law does not allow for the award of punitive damages in the field of product liability or, more generally, in the field of civil liability.

However, recently the Supreme Court (16601/2017) clarified that punitive damages are not per se incompatible with the Italian legal order or with the nature and function of tort liability under Italian law. It is therefore possible, under certain conditions, to recognise and enforce foreign judgments ordering the payment of punitive damages in Italy.

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

The amount of damages is generally assessed by the judge on the basis of documentary evidence, including a technical expert's report. Where the case deals with non-pecuniary/biological damages, the damage is quantified by referring to tables issued by the Milan and Rome courts (and adopted nationwide), which consider factors such as:

• the severity of the damage;
• the age of the victim; and
• other relevant circumstances.

12 Appeals

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

Yes. If the claim is totally or partially unsuccessful, the claimant can appeal the first-instance judgment pursuant to Articles 341 and following of the Code of Civil Procedure, within:

• a strict deadline of 30 days from the date on which the first-instance decision is served by the successful party on the other party; or
• a longer time limit of six months from the date of publication of the first-instance decision.

Decisions of courts of appeal can in turn be challenged before the Supreme Court for limited reasons of law, but they are not subject to further review on the merits.

Second-instance courts can rule again on the merits of the case. The appeal notice must contain:

• a reference to the parts of the first-instance decision that the appellant intends to contest;
• the requests of the appellant; and
• a refutation of the arguments of the first-instance court.

Moreover, pursuant to Article 345 of the Code of Civil Procedure, the appeal must deal with the same issues and review the same pleadings brought at first instance. No new claims and challenges are allowed. Likewise, no new evidence is admitted and no new documents may be produced in the appeal proceedings unless they could not be produced at first instance for reasons not attributable to the party that wants to produce them.

If new claims or objections are raised, they will be declared inadmissible ex officio. However, since an application that has been declared inadmissible is not dismissed on the merits, the party may relitigate it in an autonomous action.

13 Costs and fees

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

The plaintiff must advance court fees (introduced to the Italian legal system in March 2002) to cover the costs and any additional fees relating to the legal proceedings. The amount will depend on:

• the value of the case;
• the type of legal proceedings (civil, administrative or tax); and
• the stage of the proceedings (first instance or appeal).

The plaintiff must also advance the costs of any procedural activity it has requested (eg, a technical opinion), unless the judge states otherwise.

The winning party can recover its costs. As a general rule, the losing party must pay both the expenses and the fees incurred by the winning party.

However, this does not mean that the winner will certainly and automatically recover all relevant amounts. As a matter of fact, the court does not liquidate the effective costs incurred by the winning party, but determines them based on certain criteria established by law (see question 13.5).

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

The general rule is that the losing party bears all expenses and legal costs of the successful party (see question 13.5).

However, in specific cases, and where the case at stake is particularly tricky, the judge can decide that each party must pay its own costs. The court may (wholly or partly) offset the expenses between the parties where:

• it finds that the costs to be reimbursed to the winning party are excessive or superfluous;
• all parties lose in certain respects under the final decision;
• there are serious and exceptional reasons to do so; or
• the case regards a new matter that has never been decided before by case law or the final decision departs from case law, establishing a principle that revises or overrules what had previously been established by the case law.

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

Under Article 306 of the Civil Procedure Code, if the claim is withdrawn, the proceedings may be declared extinguished by the court and the costs will be borne by the party that withdraws its pleadings (unless otherwise agreed – for example, as a consequence of a settlement).

13.4 Do the courts manage costs during the proceedings?

No.

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

Costs are awarded in the court's final decision. Fees are calculated pursuant to the parameters and criteria set out in a decree on legal costs issued by the Ministry of Justice.

In accordance with these criteria, fees are calculated having regard to:

• the value of the claims; and
• the activities carried out by the attorneys at each phase of the proceedings (ie, study of the case; the introductory, evidence-gathering and ruling phases; and the enforcement procedure).

These parameters consider the work carried out by the average single-lawyer law firm (and do not reflect larger firms' billing systems). General costs and expenses are determined at 15% of the awarded attorneys' fees.

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?

The most common form of funding in civil proceedings in Italy is public funding. This is a form of legal aid granted to 'indigent parties' – that is, citizens who do not have the means to pay for a lawyer. To obtain legal aid, such citizens must:

• file an application with the local bar association; and
• provide proof, with all possible documents:
• • of the lack of means to sustain the costs of a trial; and
  • (as the case may be) that the claim is not clearly groundless.

If they are admitted to legal aid, legal expenses are borne by the state.

Citizens may apply for legal aid to defend themselves or to take action.

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?

Contingency fees are quite rare. Historically, they have not been admitted; but with the introduction of Law Decree 233/2006, the prohibition on contingency fees was repealed (however, there is little evidence of their actual implementation in practice).

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

Contingency fees are quite rare. Historically, they have not been admitted; but with the introduction of Law Decree 233/2006, the prohibition on contingency fees was repealed

15 Product safety regimes

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

Consumer product safety is regulated by Articles 102 to 113 of the Consumer Code, which implements the EU General Product Safety Directive (2001/95/EC). The Consumer Code imposes a general duty on manufacturers and distributors to guarantee consumer safety after a sale, including:

• a duty to warn of the risks inherent in products; and
• an obligation to undertake all necessary actions to prevent injuries, including the recall of unsafe products.

15.2 Do any special regimes apply in specific sectors?

Besides the general provisions of the Consumer Code, there are also rules on product safety for specific product sectors, including:

• Legislative Decree 23/2019 and Decree of the President of the Republic 121/2019, adapting national legislation to the provisions of EU Regulation 2016/426 on appliances that burn gaseous fuels;
• Legislative Decree 17/2019, adapting national legislation to the provisions of EU Regulation 2016/426 on personal protective equipment;
• Legislative Decree 106/2017, adapting national legislation to EU Regulation 2011/305 laying down harmonised conditions for the marketing of construction products;
• Legislative Decree 86/2016, implementing Directive 2014/35/EU on electrical equipment designed for use within certain voltage limits;
• Legislative Decree 80/2016, implementing Directive 2014/30/EU on electromagnetic compatibility;
• Legislative Decree 26/2016, implementing Directive 2014/68/EU on pressure equipment;
• Legislative Decree 54/2011, implementing Directive 2009/48/EC on the safety of toys – which applies to products designed to be used by children under 14 years of age; and
• Legislative Decree 17/2010, implementing Directive 2006/42/EC on machinery.

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

Pursuant to Article 106 of the Consumer Code, the supervisory authorities in charge of product safety controls, recall and withdrawal measures are the Ministries of Economic Development, Health, Labour and Social Policies, Interior, Economy and Finance, Infrastructure and Transport; as well as any other entity responsible for carrying out safety checks in specific product sectors.

In addition, Law 580/1993 entrusts the Chambers of Commerce with numerous tasks and functions, including those of supervision and control of the safety and conformity of market products in the following areas:

• general product safety;
• new cars: fuel economy and carbon emissions;
• electrical products;
• toys;
• personal protective equipment, including sunglasses and protective masks;
• labelling of textile products;
• labelling of footwear;
• construction products; and
• appliances that burn gaseous fuels.

The competent authorities mentioned above have a duty to check that all products placed on the market are safe.

To this end, the competent entities are entrusted with the power:

• to organise suitable checks on the safety properties of a product, even after it has been placed on the market as safe; and/or
• to carry out inspections at production or packaging plant, warehouses and sales depots.

If a product proves to be dangerous to the health and safety of consumers, the competent authorities can:

• implement all measures necessary to limit or prevent the placing on the market of the product; or
• if the product is already on the market, request its withdrawal or recall.

In any case, financial penalties can be imposed (see question 15.4).

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

The Consumer Code sets out the sanctioning regime for breach of product safety obligations.

In particular, Article 112 of the Consumer Code provides as follows:

• A manufacturer or distributor that places dangerous products on the market will be punished with imprisonment for up to one year and a fine of up to €50,000.
• A manufacturer or distributor that fails to comply with measures issued by the competent authority will be punished with a fine of up to €25,000.
• A manufacturer or distributor that does not ensure due cooperation with the competent authority for the purpose of carrying out product safety checks will be subject to an administrative sanction of up to €40,000.
• A manufacturer or distributor that violates the duty to provide to consumers will be subject to an administrative sanction of up to €30,000.

If the breach constitutes a more serious criminal offence, the manufacturer or distributor will be liable for that offence.

16 Product safety issues and product recalls

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

If it is assessed that an unsafe product has been marketed in Italy, then depending on the seriousness of the case, the manufacturer and/or distributor voluntarily or the Ministry of Economic Development may order either:

• the immediate withdrawal of the product from distribution and the adequate notification of consumers; or
• the recall of the product from consumers.

Such measures may be adopted with regard to both the manufacturer and the distributor. Indeed, both of these subjects have a duty to promptly inform the Ministry of Economic Development if they are or should be aware, based on the information at their disposal and in their capacity as professional operators, that a product which they have placed on the market or made available to consumers does not comply with due safety standards.

In order to determine the corrective action needed, it is necessary to assess the risk that the product poses to consumers. The risk assessment usually involves the following steps:

• identification of the hazard, with details of:
• • the nature and cause of the hazard;
  • the total number of products affected; and
  • who could be affected by the hazard;
• an estimate of the level of risk, which depends on both:
• • the severity of the possible injury to those using the product; and
  • the probability of injury; and
• an assessment of the acceptability of the risk for consumers.

If the overall assessment of these elements reveals a serious level of risk, the appropriate measure to take is usually a product recall.

However, the decision on what action is needed may also depend on:

• the possibility of adopting a specific measure in the relevant case; and
• the success rate of this action in previous similar cases.

In any event, it is up to the government authority to evaluate:

• whether the measures taken by manufacturers/distributors are adequate; or
• whether to require different or additional corrective actions appropriate to the case at issue.

Under Article 112 of the Consumer Code, criminal charges can also be brought against a manufacturer or distributor that:

• has placed dangerous products on the market;
• has violated a ban issued by government authorities not to market a certain product;
• has not made efforts to ensure that a certain product was safe or that consumers were warned about the possible connected dangers; or
• has not cooperated with the Ministry of Economic Development and other authorities or public bodies involved in the conduct of their surveillance.

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?

Manufacturers and distributors must inform the competent authority immediately if they become aware of a product hazard, specifying the measures that they have undertaken to prevent any risks to consumers.

The Consumer Code does not specify what 'immediately' means. However, 'immediately' almost certainly has the same meaning as under the EU General Product Safety Directive – that is:

• without delay; and
• in any case:
• • within 10 days of the date on which the company has reportable information; or
  • within three days in the case of serious risk.

The Consumer Code also does not specify when a product defect presents a hazard that must be reported to the market surveillance authorities. Pursuant to the Consumer Code, the manufacturer and/or distributor must inform the competent authorities about products that pose risks for consumers and thus do not comply with general safety requirements. The company makes the decision as to whether a product defect reaches a hazard level that must be reported to the competent surveillance authority.

In the event of a serious risk, the information to be provided includes, at minimum:

• specific elements allowing for the precise identification of the product or batch of products concerned;
• a full description of the risk presented by the products concerned;
• all available information allowing for the traceability of the product; and
• a description of the measures taken to prevent risks to consumers.

If a report is required, the manufacturer and/or distributor must file this with the Department for Enterprise and Internationalisation of the Ministry of Economic Development. The report may alternatively be filed with other ministries, such as:

• the Ministry for Infrastructure and Transport for automobiles; or
• the Ministry of Health for pharmaceuticals or food products.

The report can be submitted:

• through the EU Product Safety Business Alert Gateway (usually when the notification involves other EU member states), which is accessible on the European Commission's website; or
• in any other way, such as by registered letter or courier.

It can also be filed by fax or email to speed up the procedure.

Further, the rapid alert system under the EU General Product Safety Directive allows for the rapid exchange of information between EU member states and the European Commission on the measures and action taken in relation to products that pose a serious risk to the health and safety of consumers.

Pursuant to Article 112 of the Consumer Code, failure to undertake a recall or other corrective actions aimed at keeping dangerous products off the market is punishable by up to one year's imprisonment, provided that no more serious offences are perpetrated (typically, injury or manslaughter), since in this event the relevant criminal provisions will also apply.

Monetary penalties may also be applied.

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

See question 16.1.

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

Other corrective actions may involve repairs, replacements and refunds.

Repairs, replacements and refunds are regulated by Articles 135bis and following of the Consumer Code, under which consumers can request that the seller repair or replace the defective product, without any further costs, unless one remedy is impossible or too expensive compared to the other. The repair or replacement of the defective product must be carried out within a reasonable timeframe.

As an alternative to termination of the contract, consumers can request a partial refund if:

• the seller has failed to repair or replace the goods;
• a lack of conformity becomes apparent despite the seller's attempt to restore the goods to conformity;
• the lack of conformity is so serious as to justify an immediate reduction in price or termination of the contract; or
• the seller has stated or it is clear from the circumstances that the seller will not restore the goods to conformity within a reasonable time or without significant inconvenience to the consumer.

To determine the amount of the partial refund, the use of the product must be taken into account.

Once a complaint has been filed by the consumer, the seller can offer one of the abovementioned remedies (ie, repair or replacement); however, if the consumer requests a specific remedy in the complaint, the seller must implement it, unless:

• the consumer accepts an alternative proposed by the seller; and
• the remedy chosen:
• • is not impossible; or
  • compared with the alternative remedy, would not impose disproportionate costs on the seller.

More specific rules on contracts for the supply of digital content and digital services are set out in Article 135-octiesdecies of the Consumer Code.

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

It is essential to comply with the applicable legislative framework and to collaborate, in the most proficient way, with all regulatory authorities involved in the product safety legal field.

Most product withdrawals and recalls in Italy in recent years have concerned food products and beverages, toys and electrical appliances (especially low-voltage devices).

17 Criminal liability

17.1 Can parties be found to be liable under criminal law for defective products in your jurisdiction? (a) Which parties can be held responsible? (b) Can individual officers or employees be held responsible? (c) What is the basis for liability? (d) What penalties can be imposed?

In addition to civil law, criminal liability for defective products may be assessed on the basis of the following provisions:

• Article 112 of the Consumer Code (for marketing defective products), which is punished with arrest for up to one year and a fine of between €10,000 and €50,000;
• Article 589 of the Criminal Code (for manslaughter), which is punished with imprisonment for between six months and five years;
• Article 590 of the Criminal Code (for negligent bodily injury), which is punished with imprisonment for up to three months and a fine of €309. If the injury is serious, the penalty is imprisonment for up to two years and a fine of between €309 and €1,239; and
• Article 515 of the Criminal Code (for fraud in trading), which is punished with imprisonment for up to two years and a fine of up to €2,065.

In general, criminal liability may arise only for individuals (usually, the legal representative of the entity involved).

In particular, even if no damage occurs, the legal representatives and directors of an entity that markets defective products may be found liable for the marketing of defective products.

Where damages occur, the manager in charge of placing the products on the market may be held liable for negligent bodily injury or even manslaughter, according to Articles 590 and 589 of the Criminal Code.

Instead, corporate criminal liability may arise only under specific circumstances provided for by Legislative Decree 231/2001. These circumstances are as follows:

• The criminal offence must be listed in the predicate offences set out in Legislative Decree 231/2001;
• The criminal offence must have been committed by top management or individuals under its direction/supervision;
• The offender(s) must have acted in the interests or to the advantage of the company; and
• The circumvention of the model implemented according to Legislative Decree 231/2001 (if any).

Neither marketing dangerous products nor manslaughter and negligent bodily injury (except in case of an accident at work) are listed in the predicate offences, so an entity cannot be found liable for such conduct. By contrast, corporate criminal liability may arise in relation to the crime of fraud in trade pursuant to Article 515 of the Code of Criminal Procedure and Article 25-bis(1) of Legislative Decree 231/2001. In this case, the entity may be punished with a fine of up to €774,500 and restraining measures.

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

Supreme Court Judgment 5541/2019: In this case, the Supreme Court found the manager of a machinery company guilty of culpable manslaughter and culpable injuries due to an accident that involved the breakage of a machine, resulting in the death of one worker and serious injury to another.

The structural failure of the machinery was attributed to a manufacturing defect, which was traced back to modifications made by the manufacturer.

The modification, which had not been included in the original design of the machine, had not been approved by the entity that issued the EU conformity certificate. According to Annex VI, Point 5 of the Machinery Directive (98/37/EC) – which requires that the conformity of machinery with the safety requirements of the directive be specifically checked before it is placed on the market – a manufacturer must inform the certifying body of any changes, however minor, that it has made or intends to make to a machine.

The violation of the obligations imposed by the Machinery Directive was made even clearer by the fact that the machinery had been placed on the market accompanied by a certificate of conformity that referred to a different model.

In light of the above, the manager of the manufacturing company was found guilty of culpable manslaughter and culpable injuries. However, since the offences were time barred, no sanction was applied other than the recognition of responsibility.

Supreme Court Judgment 40897/2011: This case concerned some defective medical devices which had been imported into Italy, causing serious injuries for some users and the death of one.

While the Supreme Court found the distributors of the devices not guilty - as they did not have the necessary experience or knowledge to timely verify the correct functioning of the devices; and as the original manufacturer had not issued a recall notice for the defective products - the court found the managers of the manufacturer guilty of culpable manslaughter and culpable injuries.

The defendants had failed to adequately supervise the production of the devices and the safety system adopted for their quality assurance. Despite these behavioural shortcomings, the manufacturers had placed the devices on the market without considering that by doing so, they could not guarantee the highest technically achievable safety standards, thus violating the prohibition on marking such devices imposed by the EU Medical Devices Directive (42/1993).

The defendants carried out tasks which, due to their broad scope and the small size of the company, gave them a broad view of the company's technical and production problems. The potential financial and marketing repercussions linked to the manufacture of the devices and to the activities prior to their marketing led to a conclusion that the whole management was involved in the decisions related to the manufacturing and commercialisation of the devices.

The Supreme Court also held that the delegation of quality assurance and control tasks to an employee could not exclude the defendants from liability.

For these reasons, the defendants were found guilty of culpable manslaughter and culpable injuries. However, since the offences were time barred, no sanction was applied other than the recognition of responsibility.

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?

In recent years, the Italian courts have issued decisions in product liability cases relating to different kinds of products, including cars, bicycles, drugs and paints. All of these actions were brought by individual consumers.

Most of the decisions focused on:

• the causal link between the defect in the product and the damage suffered by the consumer;
• the allocation of the burden of proof between the parties; and
• the kind of evidence that the plaintiff should provide to demonstrate the existence of a causal link.

Significant product liability/safety judgments include the following.

Court of Florence Judgment 3068/2022: In this case, the Court of Florence reiterated that product liability has a presumptive nature and cannot be considered an 'objective liability', since it is independent from the manufacturer's fault and rather depends on the demonstration of the existence of a defect in the product. Therefore, the burden of proof should be shared between the injured party and the manufacturer in such a way that:

• the injured party must prove the causal link between the defect and the damage suffered; and
• the manufacturer should prove that the defect:
• • did not exist at the time the product was placed on the market; or
  • was not recognisable based on the state of the technical and scientific knowledge at the time.

Supreme Court Judgment 12225/2021: In this case, the Supreme Court ruled that in order to exclude a producer's liability, the product's instructions for use must enable the consumer to fully assess all risks and benefits relating to the use of the product, so that it can be argued that he or she voluntarily and consciously accepted the potential risks.

Supreme Court Judgment 2149/2021: In this case, the Supreme Court ruled that a manufacturer will be considered liable, in its capacity as a guarantor, for damages that are causally attributable to structural defects in a medical device placed on the market whose malfunction contributed to causing serious injuries to a patient, unless the user carried out alterations to the device of such a nature and extent as could be considered a supervening cause that may have given rise to the event.

Supreme Court Judgment 34886/2019: This Supreme Court ruling relates to liability in a case involving defective medical products and is one of the few judgments on the matter.

The case is particularly relevant in light of the fact that the court applied a regulation which was intended to apply to producers (Article 112 of the Consumer Code) to a distributor. The defective product had been imported into and distributed in Italy by a company which was not the manufacturer. The court, however, stated that since the company was part of the value chain and was able to affect the safety characteristics of the product, it should be subject to the same (criminal) liability regime as the manufacturer.

However, the company was found not guilty because it was impossible for it to assess the defect of the medical device, since it had been granted all necessary European certificates and the data depicted in the 'black box' had been lost, making it unfeasible to determine whether the product was defective.

Supreme Court Judgment 29828/2018: This judgment concerned the use of presumptions to demonstrate the existence of the claimed defect of the product.

In accordance with this ruling, the existence of a defect in the product must be proved. The plaintiff must provide evidence that the product lacked the general safety conditions that may be expected with regard to the common use for which the product was manufactured and marketed.

If proof of the defect is not easily obtained, presumptions may be considered sufficient by the court. In this regard, the Supreme Court found that where a 'secondary fact' is demonstrated, the court may indirectly infer from that fact the existence of the 'main fact', such as the existence of a defect in the product. However, this is possible only if the secondary facts on which the presumption is built are clearly and specifically demonstrated.

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

Despite the legislative instruments that are available to injured parties, product liability disputes are still relatively uncommon in Italy.

Specifically, the product liability rules set forth by the Consumer Code are rarely invoked in judicial litigation; it is more common to resort to general tort liability rules.

Consumer actions are generally brought as individual claims (or in some cases, as cumulative claims in a single action), because the class action mechanism is not well developed in Italy and is not considered a particularly strong and efficient tool. This is also the view of consumer associations.

As consumer associations are paying heightened attention to this issue, new trends may emerge in the future. In addition, the scenario may change once the class action reforms take effect in the coming months (see question 2.2).

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?

In general terms, we expect that product liability claims will increasingly involve systems, machines, vehicles and similar whose functioning is based on artificial intelligence.

The proposed legislative reforms include the following measures.

Proposal for an EU Machinery Regulation: On 15 December 2022, the European Commission issued a press release stating that the European Parliament and the Council of the European Union had reached a political agreement on a new EU Machinery Regulation.

This regulation would replace the EU Machinery Directive (2006/42/EC) in order to address the emerging risks posed by new technologies to machinery and ensure that the regulatory regime adequately reflects technological advancements (eg, AI). The new rules would:

• require importers of a broad scope of machinery products, intended for either consumer or industrial use, to ensure that the manufacturers have complied with the essential health and safety requirements set out in the regulation; and
• allow user manual instructions to be converted into digital formats.

The regulation also establishes obligations for distributors, which involve:

• verifying that the product has been correctly identified and accompanied by the necessary documentation; and
• conducting due diligence in relation to the transport and storage of the product, to ensure that compliance with the health and safety requirements has not been compromised.

Proposal for a directive on liability for defective product: On 28 September 2022, the European Commission published a proposal for a directive on liability for defective products, which, if approved, will replace the existing EU Product Liability Directive (85/374/EEC).

The proposal aims to update the current product liability regime in order to reflect the realities of today's market. To this end, the scope of the new rules will be extended:

• to innovative products, such as AI systems; and
• to product components and 'related services'. The concept of 'related services' may include the supply of data, meaning that the circle of liable parties will be extended to include service providers and data suppliers, as well as software developers and producers.

The proposal will also significantly ease the burden of proof on consumers by introducing:

• an obligation for manufacturers to disclose the necessary technical information to the injured party in court; and
• rebuttable presumptions regarding the defectiveness of the product and the causal relationship between the defect and the damage.

Finally:

• the concept of damage will be extended to include:
• • damages caused by the alteration or destruction of data;
  • medically recognised damages to mental health; and
  • damages to items used both privately and professionally; and
• the limits on the maximum liability amount for personal and property damages will be removed.

Proposal for a General Product Safety Regulation: On 30 June 2021, the European Commission published a proposal for a Regulation to reform the EU General Product Safety Directive.

This proposal focuses on the safety of new technologies and on threats to consumer protection posed by the growth of online commerce, aimed at:

• ensuring more efficient and uniform market supervision; and
• improving the recall procedures for defective and dangerous products.

The proposal would:

• strengthen the obligations of manufacturers, importers and distributors, increasing their responsibility to ensure the safety of products; and
• improve the traceability of products along the supply chain by ensuring that every party in the various supply chain levels complies with the safety requirements set out by the proposal before the relevant product is placed on the market.

In order to ensure the effectiveness of EU market supervision, the proposal would also establish a consumer safety network to improve cooperation and the exchange of information between market authorities.

The proposal also sets out specific requirements for product recall notices, requiring that any recall notice clearly describe the hazards associated with the product within a specific timeframe. Finally, the proposal introduces the 'right to remedy' – that is, the right of the consumer to an effective, cost-free and timely remedy from the economic operator responsible for the recall.

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?

Based on our experience and our day-to-day work with clients, it is clear that businesses are investing ever-increasing amounts of attention and resources in the topic of product liability and safety, in order to ensure ongoing compliance with the applicable legislative requirements and obligations. Indeed, a number of companies have started to develop internal monitoring, tracking, control and audit policies, in order to mitigate and/or reduce any risks that may arise with regard to product liability and product safety issues.

Where a product may be harmful and may therefore cause damage, it is particularly important for a company that wishes to avoid liability to:

• clearly inform consumers about the risks; and
• describe in detail which uses are appropriate in order to avoid the damage.

Should an issue relating to product liability and safety arise, we would recommend that the assistance of professional consultants and lawyers be sought promptly, to identify the best solution to the issue considering all factors from both operational and legal perspectives.

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.