The legal framework for product liability in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
Product liability could be attributed to the manufacturer, importer and/or the sales channel (to consumer) and it could be administrative (e.g. regulatory), civil or criminal depending on the defect and the harm caused by the product.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
The Customer Protection Act No. 17,250 provides for a mandatory warranty for damages caused by defective products which shall be borne by the manufacturer and the importer. This liability expires after four years from the date in which the consumer knew or should have known of the damage or defect, with a maximum term of 10 years from the date in which the product was introduced into the market.
The manufacturer or importer could also be held criminally liable for placing in the market a product that represents a hazard to health (article 220 of the Uruguayan Criminal Code).
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
The Technical Department of the manufacturer is responsible for compliance with technical regulations in the manufacturing of products of each establishment and therefore, of the quality, security, efficacy and safety of products. Such responsibility may not be delegated, regardless of the manufacturer’s joint and several liability and of the quality assurance.
Corporate executives, employees and representatives could be held liable when the claimed act was caused by willful misconduct, fraud, gross negligence, negligence, etc.
4. How can a liability claim be brought?
A liability claim can be brought by different ways:
- administrative (e.g. by filing a claim before the Consumer’s Protection Department or Ministry of Health);
- civil claim before Civil Courts;
- criminal claim before Criminal Courts.
5. What defenses are available?
Defenses are not limited and will depend on the case and the object of the claim.