Product Liability
TGS Baltic / Estonia
The ins and outs of product liability in Estonia. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
A. Civil liability (where a patient claims compensation for damage or injury)
In Estonia, contractual liability and liability for unlawful damage (non-contractual liability, including liability of defective product) are recognised.
The manufacturer shall be liable for causing the death of a person and for causing bodily injury or damage to the health of a person if this is caused by a defective product. The purpose of compensation for damage is to place the aggrieved person in a situation as near as possible to that in which the person would have been if the circumstances which are the basis for the compensation obligation had not occurred. Punitive damages are not recognized.
B. Criminal liability (where the court may impose a punishment (e.g., a fine, pecuniary punishment)
For example, if committed by a legal person, causing death of another person through negligence is punishable by a pecuniary punishment. To legal persons, the court may impose a pecuniary punishment of EUR 4,000-16,000,000.
The different forms of liability can occur in conjunction.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
A. MEDICINES
The producer shall be liable for a defective medicinal product on the basis of the provisions of liability of defective products unless otherwise provided by law. A medicinal product is deemed to be defective if it does not comply with quality requirements or if its packaging, labelling or package leaflet is substandard, inaccurate or misleading and as such, does not meet the requirements provided by MPA or legislation established on the basis thereof.
B. MEDICAL DEVICES
The manufacturer of a medical device is liable for the conforming design, manufacture, packaging and labelling of a medical device, regardless of whether these operations are carried out by themselves or by a third party on their behalf.
The liability of the manufacturer of a medical device also applies to the person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to placing them on the market under his or her own name.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
Potential liability, in certain circumstances, may extend to corporate executives and representatives. Generally, liability does not extend to the employees of the manufacturer, except in cases where damage is caused intentionally by the employee.
4. How can a liability claim be brought?
Liability claims can be brought through court proceedings (in order to force them).
5. What defenses are available?
The manufacturer is not liable for damage arising from a product if the manufacturer proves that:
- the producer has not placed the product on the market;
- circumstances exist on the basis of which it may be presumed that the product did not have the deficiency which caused the damage at the time that the product was placed on the market by the producer;
- the producer did not manufacture the product for sale or for marketing;
- the producer did not produce or market it in the course of the producer’s economic or professional activities;
- the deficiency is caused by the compliance of the product with the mandatory requirements as at the time of placing the product on the market;
- due to the level of scientific and technical knowledge at the time of placing the product on the market, the deficiency could not have been detected.
The limitation period for claims is three years as of the date on which the victim becomes aware or should reasonably become aware of the damage, the deficiency and the identity of the manufacturer.
