The low-down on the situation regarding product liability in Spain. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
The regime for product liability established in Spain is of a strict nature. It imposes strict liability upon the “producer” of a defective product. The producer will be liable for personal injury or death or damage to property caused by the defective product, provided that these might affect goods which are objectively intended for private use or consumption and have been utilized mainly as such by the injured party. It is on the claimant to prove that (i) the product was defective, (ii) the damage occurred and (iii) there was a causal link between the defective product and the damage suffered.
This strict liability system does not preclude other liability systems providing the injured party with a greater protection neither affects any other right to compensate damages, including moral damages, that the injured party may have as a consequence of contractual liability, based on the lack of conformity of the goods or any other cause of non-performance or defective performance of the contract, or of any non-contractual liability that may apply.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
Under the Spanish product liability regime only the “producer” bears responsibility for the fault of the product.
It is considered as “producer”, depending on the case, any or all of the followings: (i) the manufacturer or the importer in the European Union of a finished product, raw material or component of the product; and (ii) the apparent producer of the product (i.e. any person presenting itself as the producer of the product by providing its name, trademark or other identifying features along with the product, whether on the container, wrapping or other any protective or presentational component).
In the event that the “producer” cannot be identified, the supplier of the product (i.e. the distributor or the “retail” supplier) shall be considered as such, unless it informs the injured party about the identity of the manufacturer or of the person who supplied the product to it, within a term of three months before it is requested to give such information. This same rule applies in the case of imported products in the European Union, if the product does not indicate the name of the importer, even if it indicates the name of the manufacturer.
The supplier of a defective product shall also be liable towards the injured party as if it were the producer if it supplied the product knowing that the defect existed.
Therefore, according to Spanish law not only the final manufacturer, or the importer in EU, of a medicinal product or a medical device will be subject the Spanish product liability regime. Such regime will also apply to the manufacturer, or importer in the EU, of raw material or component of said product as well as to the apparent producer of said medicinal product or medical device and to the supplier under certain circumstances.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
As above said, under the Spanish regime on liability for defective products, the responsibility for damages caused by a defective product is only borne by the “producer” [i.e. (i) the manufacturer or the importer who introduces the product into the European Union; (ii) the apparent producer and; (iii) the supplier only under certain circumstance]. Therefore, as the corporate executives, employees, and representatives are not the producer, they will not be responsible under this regime.
4. How can a liability claim be brought?
A liability claim shall be brought by filing a claim before the Courts. When the injured party is a group of consumers, then the claim can be brought by associations of consumers (collective action) or by the Public Prosecutor’s Office.
5. What defenses are available?
The producer shall not be liable if it can prove that:
- it did not put the product into circulation;
- given the circumstances of the case, it may be presumed that the defect did not exist when the product was put into circulation;
- the product had not been manufactured for sale or for any other form of distribution with an economic purpose, nor that it was manufactured, imported, supplied or distributed within the context of a professional or entrepreneurial activity;
- the defect is due to the fact that the product was manufactured in accordance with existing mandatory rules; and
- the state of scientific and technical knowledge existing at the time the product was put into circulation did not allow for the discovery of the existence of the defect.
The producer of a part that is integrated into a finished product shall not be liable if it proves that the defect is attributable to the design of the product into which the part was integrated, or to the instructions provided by the manufacturer of the finished product.
Additionally, the doctrine points out that the apparent producer shall not be liable if it can prove that it was not the one who placed the sign, brand, logo or stamp that identifies it as apparent producer in the defective product or its packaging.
In the case of medicinal products, foods or foodstuffs intended for human consumption, the persons liable shall not be able to invoke the state of scientific and technical knowledge defence set out before in this answer.