Product Liability & Safety 2023 Comparisons

EU Directive 85/374/EEC on product liability was implemented in Italy in 1988 by the Product Liability Act (PLA), amended by Legislative Decree No 25 of 2001. The PLA was, to a certain extent, supplemented by Legislative Decree No 115 of 1995, which implemented the European Directive 92/59/EEC (as amended by European Directive 2001/95/EC, implemented by Legislative Decree No 172 of 2004, which introduced general obligations on product safety), imposing an obligation on manufacturers and producers to withdraw unsafe products from the market. All the above acts were subsequently incorporated into the Consumer Code, enacted in 2005 (Legislative Decree No 206 of 2005).

The provisions of the Consumer Code only apply to those products that are not covered by other sector-specific legislation (eg, toys, food, machinery and pharmaceuticals). The Consumer Code also complements the provisions of sector-specific legislation, to the extent that the latter does not cover certain aspects.

The main regulatory authority in charge of overseeing several aspects of product liability is the Ministry for Enterprises and Made in Italy and, in particular, the General Division for Market, Competition, Consumers, Supervision and Technical Legislation.

In addition, depending on the type of product involved, other authorities, specifically empowered to regulate each sector and area (eg, the Ministry of Health for medical or pharmaceutical products; the Ministry of Agricultural, Food and Forestry Policies for food products), have sector-specific regulatory competencies, aimed at (i) ensuring that products placed on the market are safe; and (ii) taking all necessary measures to guarantee consumers’ safety (this may include ordering recall or withdrawal of products from the market).

Lastly, ordinary courts hold jurisdiction over enforcement against producers in case of product liability issues, with the power to order compensation for any damages suffered by consumers.

According to Article 104 of the Italian Consumer Code, where producers and distributors know or ought to know, on the basis of the information in their possession, that a product they have placed on the market or otherwise supplied to the consumer may pose risks that are incompatible with the general safety requirement, they shall immediately inform the competent authorities, specifying the action taken to prevent risks to consumers.

In the event of a severe risk, the information to be provided shall include at least:

• specific elements permitting precise identification of the product or batch of products;
• a full description of the risk posed by the products concerned;
• all available information enabling the product to be traced; and
• a description of the measures taken to prevent risks to consumers.

As a general rule, producers and distributors must notify the competent authorities of the member states if a product they have placed on the market does not meet the definition of “safe product” provided in Article 103 of the Consumer code (identical to that of Article 2(b) of the General Product Safety Directive) and poses a risk to consumers “that is incompatible with the general safety requirement”.

However, according to the Guidelines for the notification of dangerous consumer products to the competent authorities of the member states, notification is only required in certain cases, taking into account a number of factors such as:

• the potential severity and likelihood of harm to health and safety;
• the seriousness of the damage;
• the characteristics of the products (certain products, like mechanical ones, may have a higher accepted risk level than others, such as toys or products intended for vulnerable users); and
• the warnings provided to end users.

For example, according to the above-mentioned guidelines, producers are not required to notify the competent authorities when:

• the defect is limited to identified products or lot of products;
• corrective actions have been taken by the manufacturer; and
• the problems are related to the functional quality of the product, and not to its safety.

It is important to highlight that these obligations persist throughout the product’s lifecycle. Furthermore, if a claim related to an accident that occurred in Italy is reported, the producer must notify the Italian competent authority promptly.

Article 112 of the Italian Consumer Code imposes a fine ranging from EUR1,500 to EUR30,000 for failure to notify the competent authorities when required.

Furthermore, Italian law provides for other more specific penalties if the manufacturer or the distributor places dangerous products on the market, violates a ban from the competent authorities not to market a certain product, or fails to adopt measures aimed at remedying the risks arising from an unsafe product. More specifically:

• unless the conduct constitutes a more severe criminal offence, the manufacturer or distributor that markets dangerous products, or violates a ban issued by a government authority to market a product, may face up to one year in prison and an administrative fine ranging from EUR10,000 to EUR 50,000;

• unless the conduct constitutes a more severe criminal offence, the manufacturer or distributor that does not comply with an order issued by the competent authorities to ensure that a certain product placed on the market is safe or to warn consumers about possible dangers may face an administrative fine ranging from EUR10,000 to EUR25,000;
• a manufacturer or distributor that does not co-operate with the competent authorities in the performance of their monitoring and surveillance activities may face an administrative fine ranging from EUR2,500 to EUR40,000; and
• if a more serious crime is also involved (eg, injury or manslaughter), the relevant criminal provisions will also apply.

A product is defective “when it does not provide the safety a person can reasonably expect, taking into account all circumstances” or, in the case of manufacturing defects, when it does not provide the safety normally provided by other category specimens. In assessing this standard, several factors are considered, including how the product was distributed and marketed, its characteristics, the instructions provided, the intended use of the product and the time the product was put on the market.

Three categories of defects are set forth by the Consumer Code: manufacturing defects (eg, when the defect is the result of a fault in the production); design defects (eg, when the defect derives from the design of the product); and defects based on inadequate information (eg, when the product is well conceived and manufactured, but it is dangerous as it was placed on the market without providing adequate information to consumers).

A claim for product liability can be brought by consumers directly affected by the product defect and who claim to have suffered damage, as well as by consumer associations.

The limitation period is three years from the day the injured party became, or should have become, aware of the damage, the defect and the identity of the liable party. In cases where the damage intensifies over time, the limitation period does not commence until the day the injured party became, or should have become, aware of a damage severe enough to warrant initiating a lawsuit.

In addition, any rights to compensation for damages expire after ten years from the date the product was put on the market.

As a general rule, according to Article 3 of the Italian International Private Law No 218/1995, Italian jurisdiction applies when the defendant is domiciled or resides in Italy. The Italian Consumer Code further specifies that legal actions against a producer must always be initiated in the court of the consumer’s residence.

No pre-action procedures are required before commencing judicial proceedings.

The law stipulates a mandatory duty for companies and professionals to preserve documents, the duration of which may vary based on the document type. However, as a best practice, it is strongly advised to preserve these documents for a duration that aligns with the limitation period for potential damage compensation claims.

Focusing specifically on product liability issues, Article 104 of the Italian Consumer Code provides that  distributors must act diligently to help ensure that safe products are placed on the market. This includes an obligation to participate in product safety oversight by maintaining and providing relevant documentation that traces the product’s origin. This preservation obligation exists for a period of ten years from the date the product was made available to the end consumer.

During the proceedings, either party may ask the judge to order the other party or a third party to submit certain documents before the court. The judge, when issuing such an order, stipulates the method and extent of the disclosure. In addition, when ordering a third party to disclose a piece of evidence, the judge shall balance the interest of justice with the third party’s rights.

In the event of non-compliance with the order without a valid reason, the judge may interpret such conduct as circumstantial evidence.

When the case requires specific technical knowledge, the judge may appoint, also at the request of a party, one or more court technical experts (Consulente Tecnico d’Ufficio or CTU) who serve as assistants to the judge and provide their technical opinion.

CTUs are chosen from a list of experts at the court.

CTUs cannot make legal evaluations; their role is strictly limited to answering technical questions put to them by the judge. Each party may appoint their own expert (Consulente Tecnico di Parte or CTP) to co-operate with the CTUs.

The judge may disagree with the conclusions reached by a CTU, provided that the disagreement is substantiated with adequate reasons in the decision.

Even if the judge does not appoint a CTU, the parties may appoint trusted experts who may prepare technical reports to be submitted to the judge as attachments to the case.

According to Article 120 of the Italian Consumer Code, the injured party must give evidence of the defect of the product, the damage suffered, and the causal connection between the defect and the damage.

The producer must give evidence of the facts that can exclude liability, namely:

• that they did not place the product on the market;
• that the defect that caused the damage probably did not exist when the manufacturer placed the product on the market;
• that the producer did not manufacture the product for sale or any other form of economic distribution, nor did they manufacture or distribute it in the course of their professional activity;
• that the defect is due to the product’s compliance with a mandatory legal norm or binding measure;
• that the state of scientific and technical knowledge, at the time the producer placed the product on the market, did not yet allow the product to be considered defective; and
• in the case of the manufacturer or supplier of a component part or raw material, that the defect is entirely due to the design of the product into which the part or raw material was incorporated or the conformity of it with the instructions given by the manufacturer who used it.

In addition, when a product placed on the market is considered inherently dangerous due to its capacity to cause damages even in the absence of defects (eg, drugs, cars), the manufacturer is liable for damages unless they can prove that all possible measures (consistent with the state of scientific/technical knowledge) aimed at preventing damages were taken.

Product liability cases are typically handled by civil courts, except in situations where criminal conduct is involved.

There is no jury in civil proceedings, nor is there an upper limit set for damages. The amount of damages awarded is directly connected to the specific injury suffered by the consumer.

An appeal against the judgment delivered by the first instance court can be lodged at the competent court of appeal within 30 days of receiving the judgment notification from another party involved in the proceedings. Alternatively, an appeal can be made within six months from the date of its publication by the court if no notification has been served. Under certain conditions specified by the Italian Civil Procedural Code, decisions made by the court of appeal can be further appealed to the court of cassation.

The court of appeal reviews the judgment issued by the first instance court but, as a general rule, cannot allow the submission of new evidence or documents. The court of cassation examines the legitimacy of the decision issued by the court of appeal, but has no authority to consider the case on its merits.

Non-compliance with mandatory technical requirements outlined in sector-specific regulations is considered as a defect. This can lead to product liability if the non-compliance is causally linked with the damage incurred.

As a general rule, the “loser pays” principles applies.

However, when the case is of particular complexity, the court may decide that each party bears its own legal costs.

The Italian legal system provides public legal aid to citizens with insufficient means, provided their claims are not manifestly unfounded. This system grants exemption from certain costs, which are borne by the state.

Access to public legal aid is assessed on a case-by-case basis.

Class actions are available in Italy. In particular, there are two different procedures that can be followed:

• The procedure sets forth by Articles 840bis of the Italian Civil Procedural Code: any subject having suffered the violation of a homogeneous right can take action, whether or not it is a consumer.
• The procedure sets forth by the Italian Consumer Code, as the result of the implementation of EU Directive 1828/2020: consumers and consumers’ associations included in the relevant list provided by Regulation (EU) 2017/2394, national independent public bodies referred to in Article 3(6) of Regulation (EU) 2017/2394 of the European Parliament and of the Council of 12 December 2017, who make the relevant request, as well as the bodies designated by another member state per the list indicated in Article 5(1) of Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020, are entitled to bring representative actions.

Both procedures are based on an opt-in system and are aimed at granting compensation for damages and/or injunctive relief.

The procedure provides for a first phase where the admissibility of the case is assessed and a subsequent phase for the joining of the members, the collection of evidence and the final decision.

Unfortunately, class actions in Italy are not yet a frequently adopted tool. Indeed, since 2021, only a dozen class actions have been brought before the courts, some of which have been declared inadmissible.

One of the most relevant cases initiated in Italy relates to the “Dieselgate” scandal. Following the manufacturer’s recall of the vehicles involved, an Italian consumer association brought two class actions for breach of contract and unfair business practices. Both class actions were declared admissible. According to press reports, more than 95,000 people exercised their right to join the actions, and the total value of the lawsuits was reported to be around EUR400 million, making them probably the largest class actions in Europe.

The majority of product liability cases concern drugs, medical devices, food products and beverages, toys, electrical/electronic appliances as well as other equipment (eg, brush cutters, bike racks). The automotive sector is also involved in public liability matters. With regard to software, the rules on product liability also apply to the supply of goods that incorporate or are inter-connected with digital content and to digital services.

In Italy, there are currently no developments involving new technologies, such as AI, IoT and cybersecurity. However, as a member state, Italy will be required to implement/directly apply any forthcoming EU rules on such matters. 

The rules on product liability have not been affected by the emergency legislation issued during the pandemic period.