Legal & Regulatory > Italy > Product Liability

 The low-down on the situation regarding product liability in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99.

1. What types of liability are recognized in your jurisdiction?

The Italian system recognizes the following types of liability:

• criminal liability for violation of the Italian Criminal Code;
• liability for breach of contract according to Article 1218 of the Italian Civil Code;
• liability for torts according to Article 2043 of the Italian Civil Code.

Tort liability entitles the injured party to compensation for damages suffered. Furthermore, Italian legislative decree 206/2005 (Italian Consumer Code) provides for a specific type of tort liability that entitles consumers to compensation vis-à-vis manufacturers for damages suffered because of defective products (so-called product liability).

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

Manufacturers of medicines and devices may face all three kinds of liability (e.g. criminal liability, liability for breach of contract and tort liability) depending on the specific violation committed. Generally speaking, product liability is the most relevant when it comes to risks that manufacturers incur by selling the medicines and devices they produce.

Article 114 of the Italian Consumer Code holds manufacturers liable for damages caused by their defective products. The concept of manufacturer is broad and includes all persons involved in the production of a product, including the following:

• the manufacturer of the finished product;
• the manufacturer of a component included in the finished product;
• the manufacturer of the raw material.

Further, Article 117 of the Italian Consumer Code sets out the definition of defective product. Products are defective when they fail to offer the safety that one can legitimately expect taking into account all specific circumstances, including the following:

• the way the product is marketed, its manifest characteristics, presentation, instruction for use and warnings provided;
• the reasonably intended use for the product and the behaviors that could be reasonably expected in connection with the product;
• the time of first marketing of the product.

Should the product be defective, the injured party will have to prove the defect, the damage suffered and the fact that the damage claimed was caused by the specific defect in the product. Conversely, it is not required to establish the damaging party’s negligence or willful misconduct: the manufacturer may be held liable regardless of its guilt.

However, the manufacturer can prove that he was not responsible for the specific defect. To exclude its liability, the manufacturer must prove either that the defect, damage or the link between the defect and damage does not exist or any of circumstances listed under Article 118 of the Italian Consumer Code. These circumstances include the following:

• that the manufacturer did not place the product on the market;
• that the defect did not exist at the time the product was placed on market;
• that the scientific state of the art at the time the product was placed on market could not establish that the product was defective;
• in case of manufacturers of components or raw materials, that the defect was entirely caused by the design of the product in which the component or raw material was included.

The right to compensations may not be waived or limited in any way, including by agreement between the manufacturer and the consumer. To this end, Article 124 of the Italian Consumer Code clarifies that any agreement to exclude or limit the right to compensation of the consumer is null and void.

Finally, should the defective product cause the death and or a physical injury to the end user, criminal liability will apply.

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

Product liability in connection with the manufacturing and marketing of products, including medicines and devices, typically occurs vis-à-vis manufacturers as legal entities.

In contrast, criminal liability arising out of damages caused by defective products may only be addressed to natural persons. In such an event, the chief executive officer of the damaging company will be prosecuted, instead of the company itself, for criminal offences caused by the defective product.

4. How can a liability claim be brought?

Product liability claims may be brought in courts. The injured party may start a lawsuit within three years from the day he/she should have been aware of the damage, defect and the responsible party’s name and address. In any case, no right to compensation may be available to consumers after ten years from the day the defective product was first placed on market.

Apart from individual claims by injured parties, product liability claims may also be pursued through class actions. Article 140bis of the Italian Consumer Code provides that one or more consumers – acting as promoters – may, either individually or through consumers’ association they appointed or committees they take part in, bring a class action to establish liability of the manufacturer and seek compensation for damages suffered. Other consumers experiencing the same or a similar situation may join the class action once it started. Class actions are not compatible with individual actions based on the same claim: should a consumer decide to join the class action, he/she may no longer seek compensation through an individual action.

Class actions may be brought in courts. Should the claim be considered admissible, the Court must issue an order stating:

• The deadline for disclosing the action to the public so that any interested party can join it;
• The deadline for interested parties to join the class action.

Further, class actions do not require involvement of lawyers, but consumer may act in their own capacity.

The class action was first introduced in 2010. However, to date, only few class actions have been initiated, among which only a small number was decided on the merits with a positive outcome for claimants.

5. What defenses are available?

In general, manufacturers may prove that they cannot be held liable by showing that the defect in the product and/or the alleged damage and/or the link between the defect and the damage does not exist.

Further, manufacturers can substantiate that they are not responsible by proving the circumstances set forth in Article 118 of the Italian Consumer Code. These circumstances include, inter alia, the following:

• that the manufacturer did not place the product on market;
• that the defect in the product did not exists at the time the product was placed on market;
• that the scientific state of the art at the time the product was placed on market could not establish that the product was defective;
• in case of manufacturers of components or raw materials, that the defect was entirely caused by the design of the product in which the components or raw materials were included.

Finally, Italian law does not allow any contractual defense for manufacturers. To this end, Article 124 of the Italian Consumer provides that liability for defective products may not be excluded or limited in the agreement with consumer. Should the agreement provide for such an exclusion or limitation, the relevant clause will be deemed null and void.