The legal framework for product liability in Poland. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75.
1. What types of liability are recognized in your jurisdiction?
Under Polish law, the following types of liability are recognized:
- criminal liability;
- civil liability for breach of contract or torts.
The injured party may seek compensation for damage before a civil law court. Furthermore, the Polish Civil Code provides for a specific type of tort liability that entitles the injured party to compensation from the manufacturer for damage incurred as a result of a defective product (so-called product liability). Theoretically, compensation may also be sought during criminal proceedings.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
Manufacturers of medicines and devices may be subject to civil liability of a contractual or tortious nature as well as criminal liability, depending on the type of violation.
Generally, product liability under the Polish Civil Code (Art. 4491 and subsequent articles) is the most relevant type of liability for manufacturers. This type of liability applies to:
- a person who produces an unsafe product within the scope of its economic activity,
- the manufacturer of the material, raw material or component part of an unsafe product,
- the importer of an unsafe product into the EU,
- a person that presents itself as the manufacturer of the unsafe product by putting its name, trademark or some other distinguishing feature on it.
The manufacturer is liable under this regime for damage caused by a product which does not ensure the level of safety which one may expect taking into account the ordinary use of the product.
Criminal liability applies to natural persons, not corporate entities. Only in the case of certain offences listed in the Act of 28 October 2002 on the Criminal Liability of Collective Entities for Punishable Offences may the corporate entity be held liable. This list includes the manufacturing of a medicinal product and placing it on the market without the proper authorization.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
Liability for defective/unsafe products on civil grounds applies to manufacturers that are legal entities. Civil liability does not extend to corporate executives, representatives or employees. In certain situations, the manufacturer may seek compensation from the natural person (e.g. employee) for the defect that caused the manufacturer’s liability towards a third person.
In contrast, criminal liability caused by defective products, as a rule, only applies to natural persons. Only in certain exceptional situations may a corporate entity be held criminally liable. In such an event, the relevant board member or employee of the manufacturer will be prosecuted, instead of the company itself, for criminal offences caused by the defective/unsafe product.
4. How can a liability claim be brought?
A liability claim can be brought by way of a regular lawsuit in civil proceedings before a court. In the case of criminal liability, the criminal law authorities may initiate proceedings ex officio or upon request.
5. What defenses are available?
The basic defence strategy is to disprove the following:
- the defect in the product and/or
- the alleged damage and/or
- the causal link between the defect and the damage.
When it comes to the product liability of a civil nature, manufacturers can substantiate that they are not responsible by proving the circumstances set forth in Article 4491 and subsequent articles of the Civil Code. These circumstances include the following:
- the manufacturer did not place the product on market;
- the defect in the product did not exist at the time the product was placed on market;
- the state of scientific and technical knowledge at the time the product was placed on the market could not have established that the product was defective;
- in the case of manufacturers of components or raw materials, that the defect was entirely caused by (i) the design of the product in which the components or raw materials were included or (ii) the manufacturer’s instructions.