An insight into product liability in Luxembourg. Prepared in association with Wildgen, a leading global law firm, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
There are four types of product liability recognized in Luxembourg:
- Liability for defective products, governed by the law of 21 April 1989 on the civil liability for defective products as amended;
- Contractual liability foreseen by articles 1603 seq of the Civil Code;
- Tort liability, foreseen by articles 1382 seq of the Civil Code;
- Liability regarding sale agreements concluded by consumers as foreseen by the Consumer Code.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
- Liability for defective products
According to the definition of product provided by article 1 of the law of 21 April 1989 on the civil liability for defective products as amended, medicinal products and devices can be regarded as products and in case of defective medicinal products and devices, the manufacturers will be held responsible under the above-mentioned law.
- Contractual and tort liability
In addition, the manufacturers of medicinal products and devices are also responsible for providing, among others, specific information on medicinal products to users and doctors, in particular as to the possible harmful side effects.
They may be held liable to the extent the breach of their duty is directly linked to a damage suffered by the victim (either contractually or in tort according to the principle of non-accumulation of contractual and tort responsibilities).
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
Taken into consideration the principle of legal personality granted to each legal entity, as general principle, the legal entity should be the only one held liable regarding the manufacturing of medicinal products.
4. How can a liability claim be brought?
A liability claim can be brought by any interested party in judicial courts.
5. What defenses are available?
The defendant may invoke any defenses that are foreseen under common civil law, such as the fact that the defendant did not commit any breach of its duties or that there were circumstances constituting a force majeure.
For instance, according to article 4 of the law of 21 April 1989 on the civil liability for defective products as amended, the producer of a product can invoke the following defenses:
- he did not put the product into circulation;
- the defect which caused the damage did not exist at the moment when the product was put into circulation by him or that the defect was born subsequently;
- the product has not been manufactured for sale or for any other form of distribution for the economic purpose of the producer, nor manufactured or distributed in the course of his professional activity;
- the defect is due to the conformity of the product with mandatory rules emanating from public authorities;
- regarding the manufacturer of a component of the product, that the defect is attributed to the conception of the product in which the component has been incorporated or the instructions given by the manufacturer of the product.