Is a manufacturer liable without any time limit for defective products?

In this article we examine whether a producer or manufacturer is liable for a defective product without any time limit or whether, on the contrary, there are legal limits to liability over time for the producer/manufacturer of that defective product.

A “defective product” is one that does not offer the safety that could legitimately be expected, taking all circumstances into account, especially its presentation, the reasonably foreseeable use of the product and the time it was put into circulation.



The answer to this question can be found in Royal Legislative Decree 1 of 16 November 2007, which approved the Consolidated Text of the General Law for the Defence of Consumers and End-Users and other complementary laws. And the answer is in the affirmative, since the rights afforded to a party injured by a defective product are extinguished after 10 years from the date on which the specific product causing the damage was put into circulation.

Therefore, manufacturers should not be liable for any damages if they are claimed after 10 years from the date the particular product was placed in circulation. This is what is known in legal terms as the lapsing of the action.

This limitation, which was already included in the now repealed Law 22/1994 on defective products, has its origin in Spain’s compliance with European Council Directive 85/374/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products.

Article 11 of the Directive states that:

“Member States shall provide in their legislation that the rights conferred upon the injured person pursuant to this Directive shall be extinguished upon the expiry of a period of ten years from the date on which the producer put into circulation the actual product which caused the damage, unless the injured person has in the meantime instituted proceedings against the producer.”

In the recitals to the Directive, it is stated that it is not reasonable to hold the producer liable for the defective condition of his product for an unlimited period of time, which is why it is necessary to lay down a limitation period starting from the date on which the specific product is put into circulation, after which the rights of the injured party are extinguished. The recital states in particular:

“Whereas products age in the course of time, higher safety standards are developed and the state of science and technology progresses; whereas, therefore, it would not be reasonable to make the producer liable for an unlimited period for the defectiveness of his product; whereas, therefore, liability should expire after a reasonable length of time, without prejudice to actions pending at law”.

This limitation of liability is particularly relevant to the health sector and also applies to implantable medical devices such as prostheses. In fact, it is common to hear in the healthcare sector that most medical prostheses have an average life of 10 years, after which it is advisable to replace or substitute them. This is the situation today, but given that science is constantly making great advances, we cannot rule out that this limitation may change in the future if science and research can guarantee the greater durability of the products in question.



The interpretation of what is to be understood by “putting the product into circulation” has been particularly controversial, especially in cases where different intermediaries are involved before the product is placed on the market. However, this issue was clarified by the European Court of Justice (First Chamber) in the case of Declan O’Byrne v. Sanofi Pasteur MSD Ltd, Judgement 9 February 2006 (ECJ/2006/34), which explained that a product is put into circulation when it leaves the manufacturing process and enters the marketing process and remains available to the public for use or consumption. When should this be understood to occur in the case of an implantable medical device: When the doctor/hospital/professional buys the prosthesis from the manufacturer or when the patient receives the implant? From my point of view, they could both be considered valid, though the date of the implant would seem to offer greater guarantees or, at least, be more easily identifiable.



As with any rule, there are exceptions: if, within 10 years of the product entering circulation, a legal claim has already been made, then the action is not time-barred.

It is important to note that the legal action referred to in the regulations must have been initiated in relation to the specific defective product, and it is not possible for the affected party to cite other legal claims made by other affected parties in relation to products from the same series or batch. This situation may commonly arise in relation to implantable medical devices. I will give an example to clarify this: let us imagine that several people are affected by a particular batch of implantable medical devices (breast prostheses, dental prostheses, etc.). The fact that one affected “X” has filed a legal claim against the manufacturer before the 10 years have elapsed does not reserve the passing of those 10 years for the rest of those affected “Y”, at least in the light of Spanish case law and regulations.

In short, manufacturers are liable for their defective products, but not for an unlimited period of time. The rights of the injured party expire 10 years after the product is put into circulation. A separate matter is the limitation of the period during which an action may be brought by the injured person, who has 3 years to claim from the time the damage is suffered. However, if it turns out that the damage appears after 10 years, then they will no longer be in time to claim against the manufacturer.