All you need to know about product liability in Latvian pharma. Prepared in association with TGS Baltic, a leading law firm in Latvia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for GBP 99.
1. What types of liability are recognized in your jurisdiction?
Liability regarding damage to persons or property following from supply of defective or faulty products can be claimed on the basis of a tort (non-contractual) or contract (contractual).
Tort law-based claims can be brought on the basis of the Law on Liability for Defects in Product or Service (strict liability), or on the basis of the Civil Law providing (fault-based liability). The scope of liability that can be claimed on the basis of Product Liability Law is limited to damages to the life or health of an individual (e.g., disease or injury) and damages to property.
Contractual liability can be claimed on basis of the Civil Law and Consumer Rights Protection Law.
Administrative liability can be imposed by competent institutions in the form of fines, orders to take particular actions, prohibition to engage in particular actions for breach of certain statutory requirements under the Pharmaceutical Law, Product Liability Law, the Products and Services Safety Law, the Consumer Rights Protection Law, and other applicable laws.
Criminal liability may arise only for serious offences, e.g., manufacturing medicinal products/medical devices in the form of a business or in large amounts without holding a licence; or the sale of medicines which were manufactured without an authorisation for the purpose of handling them and these medicines could have caused a threat to human health or life or have resulted in a person’s death or a serious injury. Criminal liability may arise on the basis of the Criminal Law.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
In case of civil liability, a responsible person may be obliged to compensate both direct and indirect damages. In case of contractual liability, there is also a general right to require specific performance from both parties.
Criminal liability may arise only for serious offences, as already indicated under Question 1.
Administrative liability may be imposed for administrative offences, e.g., a violation of regulations and other legal acts governing medical device safety, quality, performance, operation, and marketing; or a violation of medicinal products marketing regulations.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
According to the Product Liability Law, the liability for the fault/defect largely rests with the manufacturer or the importer. If it is not possible to identify the manufacturer or importer of the product, the Product Liability Law permits the claim to be brought against the distributor of the product or against any other person, who has sold or otherwise distributed the product. Other claims can be brought on the basis of tort (see above in Question 1).
4. How can a liability claim be brought?
All those involved in selling and/or distributing medicinal products can be liable in civil actions for harm derived from a defective medicinal product.
5. What defences are available?
It is necessary to prove the defect, damage (loss) and the causation between the defect and damage (loss). In all other claims, whether tort or contract law based, the claimant will have to prove the fault as well.
The manufacturer may release itself from the liability, if it proves that one or several of the following circumstances took place:
- the manufacturer has not released the product for circulation;
- at the time, when the product was released for circulation, it did not have the defect, which caused loss, respectively, such defect occurred later;
- the product was not intended for offering, sale or for other commercial distribution;
- at the time when the product was released for circulation the level of the scientific and technological development had not reached the level to allow to discover the deficiency or defect;
- the defect was caused due to compliance of the manufacturer with the requirements set forth by the state or self-government.
A provider of services may not be liable, if he or she proves that:
- taking into account the relevant circumstances, there is a reason to believe that the defect, which caused the loss appeared after provision of the service;
- the level of scientific and technological development at the time, when the services were provided, was not so high as to enable the deficiency to be discovered;
- the deficient services resulted from the fact that the manufacturer complied with the requirements set by the State or a local government.
The liability of the manufacturer can also be limited or excluded if the manufacturer proves circumstances indicating to malicious intent or negligence of the plaintiff.