Want to know more about product liability in Czech Republic? Read on! Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
Two types of liability are recognized in the Czech Republic:
- contractual liability, arising from the failure to comply with one’s contractual obligations;
- non-contractual(civil)liability, arising as a consequence of causing harm to a third party, usually by way of a breach of a legal obligation.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
Contractual liability applies upon the purchase of a product under a contract of sale, however, it primarily applies to the seller of the product, not the manufacturer. Non-contractual liability applies to manufacturers in case their product is sold on the market to third parties who are consequently harmed by the product. Under Czech law, there is also general product liability in respect of damage caused by dangerous products (this is based on the EU Product Liability Directive (85/374/EC)) as well as specific liability in respect of drugs set out in the Act on Drugs, which applies to the holder of the relevant marketing authorization.
Furthermore, the manufacturer and the marketing authorization holder (and the importer, should the importer market the product) are jointly and severally liable in case of a faulty product. Goods are generally considered faulty if they are less safe than reasonably expected, taking into account their purpose and the time of their introduction to the market.
The marketing authorization does not relieve the manufacturer or the holder of the marketing authorization from liability for damage caused by the drug when used in accordance with the Summary of Product Characteristics and the package leaflet. The marketing authorization holder is liable for damage caused by an effect of the drug not listed in the Summary of Product Characteristics (SPC); if such effect is listed in the SPC, the marketing authorization holder is liable as far as it can be proved that he caused such effect. Generally, it is the healthcare provider and not the marketing authorization holder who is liable for damage caused by the use of a drug without a marketing authorization or the use of a drug with a marketing authorization but in a manner, which is not in accordance with the marketing authorization (off-label use).
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
Theoretically liability could extend to a manufacturer’s statutory bodies (such as board members); the basic principle is that if the members of such statutory bodies do not act with due managerial care, they may be personally liable if the injured party is unable to get recourse from the company (manufacturer). In practice, however, most product liability cases concern manufacturers and not their statutory bodies. No such personal liability may be attributed to a manufacturer’s employees. The situation remains unclear with respect to the manufacturer’s representatives (proxies), where a direct recourse against such representative may be available depending on the circumstances.
4. How can a liability claim be brought?
A liability claim can be brought through civil courts.
5. What defenses are available?
Generally, the plaintiff carries the burden of proof before the court. In practice the manufacturer and/or the marketing authorization holder (or the importer, should the importer market the product) can build the defense on arguments such as:
- negligent / incorrect use of the product;
- the lack of a causal link between the administration of the drug and the occurrence of the alleged damage;
- the reasonable assumption that the product was not faulty at the time it was put on the market or that any fault had occurred later;
- the product was not produced by the defendant;
- in the case of a manufacturer of a component, that the defect is attributable to the design of the product in which the component has been fitted or to the instructions given by the manufacturer of the product.
- the product was not marketed by the defendant;
- the product was not produced or marketed for commercial purposes or within the defendant’s commercial activity;
- the product was faulty as a consequence of compliance with statutory requirements;
- the state of scientific and technical knowledge did not allow for the identification of the fault;
- (contractual) awareness of the risk connected to the use of the product; or
- force majeure.