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General climate and recent developments

State of legal development

In general terms, how developed are the product regulation and liability laws in your jurisdiction?

Product regulation and liability laws in Italy stem from and are consistent with the related EU legislation. Specifically, the EU General Product Liability Directive (85/374/EEC) was implemented in Italy by means of Presidential Decree 224/1988, as amended by Legislative Decree 25/2001, which was subsequently incorporated into the Consumer Code (Legislative Decree 206/2005). Similarly, in relation to product safety, the EU General Product Safety Directive (95/2001/EC) has been implemented in Italy through its incorporation into the Consumer Code. In addition, product safety and regulatory issues are further specified by legislative decrees in several national transpositions of EU directives, including:

  • the EU Radio Equipment Directive;
  • the EU Waste Electric and Electronic Equipment Directive;
  • the EU Toy Safety Directive; and
  • the EU Electromagnetic Compliance Directive.

Subject to the foregoing, the Italian courts often try cases that would in principle fall under the scope of the Consumer Code by referring to national rules for general tort liability or the national strict liability regime for dangerous activities.

Recent developments

Have there been any notable recent developments in relation to product liability law and product safety law in your jurisdiction, including any regulatory changes and case law?

No – there have been no notable recent developments in Italian legislation and regulations on product liability and product safety. As the criteria for assessing and proving defect and causation are not set out by statutes or regulations, they are constantly developed by case law.

Legal framework

Legislation

What primary and secondary legislation governs product safety and liability in your jurisdiction?

In Italy, both product liability and product safety are governed by the Consumer Code (Legislative Decree 206/2005). The Consumer Code includes the national laws implementing, among other directives on consumer-related issues, the EU Product Liability Directive (85/374/EEC) and the EU General Product Safety Directive (95/2001/EC). In addition, legislative decrees form the basis of national transpositions of several EU directives, including:

  • the EU Radio Equipment Directive;
  • the EU Waste Electric and Electronic Equipment Directive;
  • the EU Toy Safety Directive; and
  • the EU Electromagnetic Compliance Directive.

Both the Consumer Code and these legislative decrees are primary legislation. Further secondary legislation, in the form of ministerial decrees issued by the competent ministry dealing with the issue in question, also exist for certain details and technical aspects of product safety (eg, packaging and labelling of dangerous substances). Ministerial decrees aim to clarify uncertain or general expressions contained in primary legislation.

Regulatory and enforcement authorities

Which government authorities regulate and enforce product safety and liability laws in your jurisdiction, and what is the extent of their powers?

The Ministry of Economic Development is the general authority responsible for the market surveillance of product safety issues. It works in close cooperation with the local chambers of commerce, which carry out random inspections, and with the assistance of Italian police authorities (typically, the Italian tax police or the Carabinieri’ Nuclei Antisofisticazioni e Sanità dell’Arma food safety and health section), where needed. The competent authorities have a wide range of powers depending on the nature of the product and the degree of danger or safety risk posed. The powers of the competent authorities include:

  • inspecting production plants, warehouses and retailers;
  • requesting information;
  • taking and testing samples and imposing controls on the sale or distribution of products pending the outcome of the testing process;
  • seizing and destroying goods; and
  • ordering the remedy of any non-conformity, withdrawing or recalling products where the measures implemented by producers and distributors are considered ineffective or inadequate to address the safety risk.

If a producer wishes to appeal an order made by the competent authority, the local chambers of commerce can hear complaints and appeals via their administrative review processes. Further, a chamber of commerce decision can be challenged by means of judicial review through the courts.

Liability

Product defects

How is a ‘product defect’ defined in your jurisdiction?

The definition of ‘product defect’ is contained in Article 117 of the Consumer Code, pursuant to which a product is defective when it does not offer the safety level that a person is reasonably entitled to expect taking into account all circumstances, including:

  • the way in which the product was distributed;
  • the product’s packaging and evident features, and the instructions and warnings provided;
  • the product’s reasonably expected use and life cycle; and
  • the date on which the product was put into circulation.

Causation and burden of proof

How is causation of loss or damage established in relation to product liability claims and where does the burden of proof lie? Can this burden be shifted in any way?

With regard to causation, no statutory definition of ‘causal link’ is provided. Therefore, Italian case law – including that which relates to product liability claims – has developed and consistently applies the ‘more probable than not’ standard, whereby causation is established if it is more probable than not that the damage has been caused by the alleged event (ie, the product’s alleged defectiveness), rather than by any alternative events. In applying this test, the Italian courts usually take into account:

  • the scientific likelihood;
  • the statistical frequency; and
  • the possibility to exclude known alternative causes.

The mere temporal link between the damage and the allegedly harmful event (ie, use of the allegedly defective product) is not sufficient per se to establish causation.

Since the product liability regime set out by the Consumer Code coexists with the national general tort liability regime, as well as with the national strict liability regime governing the exercise of dangerous activities, the burden of proof varies depending on which liability regime forms the basis of the claim. Regarding product liability claims under the Consumer Code, the injured party has the burden of proving:

  • that the product was defective;
  • the loss or damage incurred; and
  • causation between the alleged defect and the damage or loss.

No evidence of manufacturer fault is required. If the case is assessed and decided on the basis of the national general tort liability regime, evidence of manufacturer fault is required.

The burden of proof shifts entirely in cases where the claim is assessed and decided on the basis of the national strict liability regime applicable to the exercise of dangerous activities. In such cases, the manufacturer of the allegedly defective product has the burden of proving that it adopted all of the safety measures necessary to avoid the damage.

Legal bases for claims

On what legal bases can a product liability claim be brought?

Product liability claims can be brought pursuant to the Consumer Code and the national general tort liability regime under Article 2043 of the Civil Code. Since the Consumer Code allows consumers to seek – alternatively or cumulatively – other forms of protection provided by law, product liability claimants often sue under the Consumer Code and Article 2043 of the Civil Code, and in certain circumstances under the national strict liability regime for dangerous activities. In addition, claimants often bring product liability claims that rely on a number of liability regimes.

Criminal liability

Can a defendant be held criminally liable for defective products?

Yes. In particular, placing dangerous products on the market is considered a misdemeanour, but can also amount to a felony where it causes serious consequences (eg, death or personal injury). A misdemeanour may be punishable by six months’ to one year’s imprisonment and a pecuniary penalty ranging from €10,000 to €50,000.

Liable parties

Which parties can be held liable for defective products?

The manufacturer is the prime liability target in cases of defective products. The importer, supplier or distributor of the allegedly defective product may also be held liable when:

  • the manufacturer is unidentified; or
  • the supplier does not provide the injured party with the identity of the manufacturer within three months from:
    • receiving a request from the injured party; or
    • service of the writ of summons.

Limitation of liability

Can liability be excluded or mitigated in any way?

To exclude its liability, a product manufacturer must prove that:

  • it did not put the product into circulation;
  • the defect did not exist when the product was put into circulation;
  • the product was neither manufactured for sale nor manufactured or distributed in connection to the manufacturer’s professional activity;
  • the defect is a consequence of complying with a binding law or provision;
  • the state of the art and the scientific knowledge on the date that the product was put into circulation prevented the defect from being identified; or
  • the defect was entirely due to:
    • the design of the product in which the raw material or component was incorporated; or
    •  compliance with the instructions provided by the manufacturer for incorporation of the raw material or component into the final product. (This defence applies in cases where the manufacturer or the supplier provided only the raw material or a product component.)

Further, liability can be excluded or reduced if the injured party adopted negligent conduct (eg, wrongful use of the product) which contributed to the cause of the damage.

Litigation

Procedure

What is the procedure for filing a product liability claim before the courts in your jurisdiction?

Product liability claims are not regulated by special procedures, but rather follow those set out in the Code of Civil Procedure for all civil law proceedings. To file a product liability claim before the court, the claimant must summon the defendant before the competent court by serving a writ of summons, which includes all the claims alleged against the defendant. After service, the writ of summons must be filed and enrolled with the general register of the relevant court. In addition, claimants that aim to reach an out-of-court settlement may file with the competent court a motion for preliminary technical appraisal proceedings. In these proceedings, the court appoints an expert (eg, a doctor or an engineer, depending on the nature of the technical issued to be assessed) who – after evaluation of all the circumstance of the case – drafts a report containing his or her technical assessment of the case and requests the parties to enter into settlement discussions. This process may end either with the parties reaching a settlement agreement or with the filing of the court-appointed expert’s report, on the basis of which the claimant may commence ordinary proceedings.

Interlocutory motions

Can the court issue interlocutory orders or judgments in product liability cases? If so, what rules and procedures apply?

In product liability cases, as well as other ordinary civil proceedings, the court can issue interlocutory orders and judgments according to the Code of Civil Procedure. Such orders typically address preliminary procedural objections or preliminary objections on the merits (eg, lack of jurisdiction, lack of standing to be sued or expiry of the applicable statute-of-limitation period), which may be successfully raised by the defendant in order to obtain an early dismissal of the claim.

Interlocutory judgments are rarely issued, as the Italian courts often decide the above preliminary objections after the evidence gathering stage, in their final decision.

Pre-trial disclosure

What pre-trial disclosure/discovery mechanisms are available in product liability cases, if any?

There are no pre-trial disclosure/discovery mechanisms in Italy.

Evidence standards

What evidence is accepted to support claims in product liability cases? What formalities apply to evidence submission?

In product liability cases, as well as other ordinary civil proceedings, both oral (eg, witnesses) and documentary evidence is accepted. The filing of documents and the request for admission of witnesses must be made within specific procedural deadlines. A list of the proposed questions to the witness must be filed in writing within the term granted to the parties for the filing of their respective briefs on evidence. Subject to compliance with the applicable filing deadlines, documents are in principle always admissible, 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 it unnecessary or considers the testimony inadmissible for other reasons. If the court permits witness evidence, the witness is examined by the judge directly – the parties’ advocates make no cross-examination in Italian civil proceedings.

Expert evidence

Under what circumstances will the court appoint an expert to assist it in examining the merits of the case? What rules and procedures apply?

If the parties request or the court considers that the case requires specific technical knowledge, the court may appoint an expert to assess the technical issues underlying the case. The court-appointed expert is chosen from a list of experts available in each court. Where this occurs, the parties can appoint their own experts. The parties’ experts participate in all the technical operations which may be directed by the court-appointed expert or the court. The court sets the timetable for provision of the expert reports and for the parties’ experts to submit any observations on the report of the court-appointed expert. The court-appointed expert’s final report must consider the party-appointed experts’ observations and specify any reasons for disregarding them.

The conclusions drawn by the court-appointed expert in his or her final report are not binding on the court; however, in practice judges often rely greatly on expert reports.

Can the parties rely on expert witness testimony to support their claims? If so, what rules and procedures apply?

To support their claims or defences, the parties may file their own expert’s written opinion or technical reports. These need no authorisation by the judge and are treated as exhibits, which are admitted once they have been filed. However, the documents do not constitute evidence of the circumstances and representations contained therein are considered mere allegations of the party submitting them. Therefore, the reports bear no evidentiary value. In cases where the court-appointed expert is summoned by the judge to provide clarifications on his or her final report, the parties’ experts may also attend the hearing scheduled and express their own comments on the technical issues at hand.

Class actions

Are class actions or any other collective proceedings available for product liability claims in your jurisdiction? If so, what is the procedure for their formation and what benefits do they afford claimants? Are class actions formed on an opt-in or an opt-out basis?

Pursuant to Article 140bis of the Consumer Code, consumers may bring (directly or through a representative body) class actions to protect their collective or individual interests, provided that these interests are homogeneous. Class actions may be brought in order to seek, among other things, redress for the violation of rights arising from product liability. Class actions must be brought before the main regional court where the defendant has its registered office and are heard by a three-judge panel of the civil court. Class action proceedings largely follow the ordinary rules of civil procedure; however, they are characterised by some peculiarities. In particular, after the first hearing, the court rules on the admissibility of the class action, which may be dismissed at this preliminary stage if:

  • the action appears blatantly groundless;
  • there is a conflict of interests;
  • the rights which the lead claimant seeks to uphold are not homogeneous to the entire class; or
  • it appears that the lead claimant cannot adequately protect the interests of the class.

Further, the writ of summons must be served on the public prosecutor, who may express his or her opinion on the admissibility of the action. Italy has adopted an ‘opt-in’ model for class actions. Accordingly, if the class action is deemed to be admissible, the court orders the defendant to publish a notice at its own expense, in order to allow other potential members of the class to opt-in within a certain deadline (which cannot exceed 120 days from the publication of the class action notice).

Class actions afford no specific benefits to claimants – the main advantage of a collective action is to increase the pressure on the defendant and publicity around the issue, which can garner greater leverage in settlement discussions.

Class actions are rare in Italy due to the strict admissibility requirements, which often represent an obstacle for claimants.

Appeals

What rules and procedures govern appeals of court decisions?

First-instance court decisions may be appealed before the second-instance courts (ie, the courts of appeal). Appeal proceedings are aimed at judicial review of the first-instance trial, including a review of the facts of the case. The review is strictly limited to the facts and allegations filed in the first-instance proceedings. Therefore, new claims, objections or evidentiary requests are precluded. Court of appeal decisions can be challenged before the Supreme Court on limited grounds only. These grounds are set out by the law and include:

  • breach of the rules of law on jurisdiction or proper venue;
  • violation or false application of the law;
  • nullity of the challenged decision or proceedings; or
  • failure by the second-instance court to examine a fact of the case that is decisive and has been discussed between the parties in the course of the proceedings.

Accordingly, appeals before the Supreme Court cannot be grounded on the facts or flaws in reasoning in the factual findings.

Statute of limitations

What is the statute of limitations for filing product liability claims?

The applicable limitation period for product liability claims under the Consumer Code is three years from the date on which the injured party became (or should have reasonably become) aware of:

  • the damage;
  • the product defect; and
  • the identity of the producer.

Further, a 10-year forfeiture period from the date on which the allegedly defective product was put on the market applies to product liability claims under the Consumer Code. If a claim is brought under the national general tort liability regime, the applicable limitation period is five years.

Timeframe

What is the typical duration of proceedings in product liability cases?

The duration of product liability cases varies depending on the size and related workload of the court before which the action is brought, as well as the complexity of the evidence stage of the proceedings (eg, use of court-appointed experts or permissibility of witness evidence). On average, proceedings range between 24 and 48 months.

Costs, fees and funding

Can the successful party to the litigation recover court and attorneys’ fees and any other related expenses from the losing party? If so, what rules and procedures apply?

As a general rule, the Italian civil legal system implements a ‘loser pays’ rule for costs liability. However, the court may order that each party bear its own costs in cases where the claim was unusually complex. Further, where the court applies the ‘loser pays’ rule, the successful party will rarely recover all costs incurred in the proceedings. Fees are calculated pursuant to the parameters set out by a decree on legal costs issued by the Ministry of Justice. 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.

What rules and restrictions (if any) govern contingency fee arrangements?

Italian law prohibits any agreement whereby the solicitor receives a share of the judgment award as payment for his or her work. However, the party and its solicitor may structure a fee agreement to allow for a part of the agreed fees to be paid contingent on the outcome of the suit.

Is third-party litigation funding permitted in your jurisdiction? If so, do any rules or restrictions apply?

Third-party litigation funding is admissible in Italy, although it is underdeveloped and unregulated.

Is legal aid (ie, public funding) available to claimants in product liability cases? If so, what rules, restrictions and procedures apply?

In Italy, indigent parties may file an application with the local bar associations to obtain legal aid. Aid is granted provided that the applicant’s annual income falls within the thresholds set by Presidential Decree 115/2002 (as amended) and the claim is not manifestly groundless.

Settlement

What rules and procedures govern the settlement of product liability cases?

No specific rules govern the settlement of product liability cases. A settlement agreement may be reached by the parties before or during the proceedings, either organically or by means of alternative dispute resolution (ADR) proceedings. Claimants that aim to reach an out-of-court settlement may file with the competent court a motion for preliminary technical appraisal proceedings. In these proceedings, the court appoints an expert who – after evaluating all the circumstance of the case – drafts a report containing his or her technical assessment of the case and encourages the parties to reach a settlement agreement. This process may end either with the parties reaching a settlement agreement or with the filing of the court-appointed expert’s report, on the basis of which the claimant may commence ordinary proceedings. Alternatively, claimants can apply for assisted negotiation or mediation proceedings (two types of ADR), which the defendant can join. Although participation in ADR is not compulsory, failing or refusing to participate in proceedings can be considered by the court and form the basis for finding the reluctant party liable for an award of aggravated damage due to poor or unreasonable conduct in the proceedings.

How common are settlements in product liability cases?

Settlement is rare in product liability cases. However, as settlements are usually covered by confidentiality clauses, limited information is available to assess the true percentage of product liability claims that are resolved via settlement.

Alternative dispute resolution

Are any alternative dispute resolution (ADR) methods required or advised before or in lieu of proceeding with litigation?

In some cases, claimants must initiate ADR proceedings before taking action before the courts. This happens in cases regarding, among other things, damages arising from medical and healthcare liability. In such cases, claimants must first pursue either preliminary technical appraisal proceedings or mediation proceedings, both of which aim to reach an amicable settlement of the dispute. In all other cases, even if not required to do so, claimants can opt for ADR proceedings or invite the defendant to attend assisted negotiation proceedings.

How commonly is ADR used in relation to product liability cases in your jurisdiction?

As the pursuit of pre-trial ADR proceedings is not usually required in relation to product liability cases, ADR is rare for such disputes.

Defences

Available defences

What defences are available to defendants in product liability cases?

Other than forfeiture, limitation and lack of standing, which are all preliminary objections, the main defence strategy available to product liability defendants relies on the claimant’s failure to meet the burden of proof (ie, to establish the defect, damage or causation). The Consumer Code also sets out the following statutory defences:

  • The producer did not put the product into circulation.
  • The defect did not exist when the product was put into circulation.
  • The product was neither manufactured for sale nor manufactured or distributed in connection to the manufacturer’s professional activity.
  • The defect is a consequence of mandatory law or a binding provision.
  • The state of the art and scientific knowledge on the date that the product was put into circulation prevented the product from being considered defective.
  • The defect was entirely due to:
    • the design of the product in which the raw material or component was incorporated; or
    • compliance with the instructions provided by the manufacturer for incorporation of the raw material or component into the final product. (This defence applies in cases where the manufacturer or the supplier provided only the raw material or a product component.)

Product liability defendants may also advance positive evidence to reduce or exclude liability (eg, proving that the claimant used the product inappropriately).

Preliminary actions

What preliminary procedural mechanisms are available to defendants, if any?

Other than preliminary procedural objections (eg, objections based on jurisdiction or the defendant’s lack of standing to be sued), no preliminary procedural mechanisms are available to defendants.

Remedies

Damages

What types of damages may be awarded in product liability cases? What rules and standards govern their calculation? Are damages capped?

Regarding product liability claims, all damages suffered by the injured party – including pecuniary and non-pecuniary damages – may be awarded. Pecuniary damages include all the expenses incurred by the injured party as a result of the product defect, as well as any related loss of profit (eg, loss of current and future income), and may be awarded where the claimant has provided evidence of their existence and related amount. The amount claimed may also be subject to equitable evaluation when the existence of the damage is assessed. Non-pecuniary damages include personal injury damages and general moral damage (eg, pain and suffering). Pursuant to case law, non-pecuniary damages can be awarded only in the cases provided for by law or in cases in which – although compensation of such kind of damage is not expressly provided for by any legal provision – the tort prejudiced a personal right that is protected by the Constitution. The amount of such damages is generally assessed by the judge on the basis of a technical expert’s report and is usually 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.

Are punitive damages allowed?

Punitive damages are not awarded in Italy.

Other remedies

Are any other remedies available?

No.

Product recalls

General requirements

Are there any statutory criteria under which a product must be recalled or other corrective action be taken?

There are no fixed statutory criteria under which a product must be recalled or other corrective actions must be taken. The manufacturer or the competent product safety authorities must evaluate the circumstances on a case-by-case basis. Products may be recalled by the manufacturer on a voluntary basis or following a request from the competent product safety authority. In particular, as the manufacturer must adopt proportionate measures to avoid safety risks, a product will be recalled when other measures are insufficient to prevent the risks that could arise from its use. The competent product safety authority may also recall a product when the measures adopted by the manufacturer or distributor are insufficient or unsatisfactory. This provision must:

  • be reasoned;
  • contain the terms by which it can be appealed; and
  • be served on the manufacturer or distributor of the concerned product within seven days from its adoption.

Notification

What rules and procedures govern notification of the product recall to government authorities and the public?

Pursuant to general product safety provisions, which also apply to product recalls, if a manufacturer or distributor becomes aware that a product in circulation is unsafe, it must immediately inform the competent product safety authorities, specifying the measures that it adopted or proposes to adopt to avoid the risks. If a serious safety risk is posed, the information provided to the authorities must include:

  • specific elements allowing precise identification of the product or the batch of products;
  • a complete description of the risk;
  • all the available information to retrace the product; and
  • a description of the measures adopted to prevent the risks for consumers.

The manufacturer must also keep consumers informed about the measures adopted to prevent any risks, including any product recalls. Further, the rapid alert system under the EU General Product Safety Directive (2001/95/EC) allows for the rapid exchange of information between EU member states and the commission on the measures and action taken in relation to products posing a serious risk to the health and safety of consumers. In Italy, the relevant point of contact for rapid alert notifications is the Ministry of Economic Development.

Repairs, replacements and refunds

What rules and procedures govern repairs, replacements and refunds for defective products?

Repairs, replacements and refunds for defective products are governed by Article 130 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. Consumers can request a partial refund, alternatively to the contract resolution, if:

  • the repair and replacement are impossible or too expensive;
  • the seller did not repair or replace the product within a reasonable timeframe; or
  • the repair or replacement carried out by the seller has caused serious inconvenience to the consumer.

To determine the sum of the partial refund, the use of the product must be taken into account. After a complaint is filed by the consumer, the seller can offer one of the above 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.

Non-compliance

What penalties apply for non-compliance with the legal provisions governing product recalls?

The penalties for non-compliance with the legal provisions on product recalls range from a fine of between €1,500 and €30,000 to the penalties applicable for a felony offence, where the non-compliance and conduct caused serious consequences (eg, personal injury or death).