Key legal info on product liability in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
Types of liability recognized in Croatian jurisdiction are civil liability as contractual liability and non- contractual (liability as a result of fault, liability for another person, liability for damage caused by dangerous thing or activity, liability for defective product and other special cases of liability such as liability of events organiser, liability for a refusal to provide emergency aid, liability for a failure to conclude the contract and liability concerning the performance of activities of public interest – the so called out-of-contract liability, tort) and also a criminal liability.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
Liability for defective product (out-of-contract, tort) is regulated by Civil Obligations Act (Official Gazette Nos. 35/2005, 41/2008, 125/2011, 78/2015, 29/2018).
Authorization of a medicinal product does not affect the financial and criminal liability of the manufacturer and/or of the marketing authorization holder.
A manufacturer who has placed a product on the market is liable for damage caused by defectiveness of that product, regardless of fault. Above-mentioned refers to material damage caused by death or physical injury and damage caused by destroying or damaging the injured party’s thing, different from the defective product, if the nature of the product is such that it is generally intended for personal use and if the injured party mainly used this thing for that purpose.
The injured party has a right to a compensation for damage caused by destroying or damaging the thing, only for the portion of damage which does not exceed the kuna equivalent of EUR 500. Compensation for a non-material damage caused by defective product may only be requested in accordance with the general rules concerning liability for damage.
Special provisions of Civil Obligations Act concerning the compensation for material damage in the case of death, physical injury or health impairment apply, as appropriately, to the scope of compensation for material damage caused by death or physical injury.
Provisions regulating liability for defective product preclude the motion of rules on liability for damage caused by a dangerous thing or dangerous activity, rules on liability for material defects of performance, and rules on contractual and non-contractual liability for damage.
The injured party has to prove the defect of a product, damage and causality between product defect and damage.
The manufacturer of a medical device has to be insured against harmful effects which might occur by the use of the medical device.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
Recourse liability is regulated by Labour Act. A worker who at the workplace or in relation to the work, either intentionally or due to utmost negligence, causes damage to a third party, and compensation for damages has been paid by the employer, has to pay to the employer the amount of compensation paid to the third party.
Potential liability by the general regime of tort law is regulated in a manner that board of directors are not held liable for the omissions done by the company.
4. How can a liability claim be brought?
The injured party has to prove the defect of a product, damage and causality between product defect and damage. Time limits for exercising the rights are 10 years from the date when the injured party has become aware or should have become aware of damage, defect and a person who produced the product.
A right to a redress for damage caused by a defective product expires within ten years from the date of its placing on the market, unless within that period, a procedure before court or some other competent authority has been initiated against the manufacturer for the purpose of establishing or settling the claim for a redress for referred damage.
Liability claims can be brought through court proceedings.
5. What defenses are available?
Manufacturer is not liable for damage arising from a product if the manufacturer proves that:
- he did not place the product on the market;
- it is evident from the circumstances that neither a defect nor its cause existed at the time the product was placed on the market;
- the product is not produced for sale, lease or any other business purpose, not that it is produced or placed on the market within his operations;
- the defect results from non-compliance with the enforcement measures that were in force at the time the product was placed on the market;
- the development stage of science or technical knowledge, at the time the product was placed on the market, did not allow for detection of defects, and
- damage is caused exclusively by the action of the injured party or a person for whom that party is liable, or by the action of a third party which could not have been foreseen by the manufacture or the consequences of which could not have been avoided or eliminated.
Manufacturer of raw material or a part of the product is also exonerated from liability if he proves that a defect is caused as a result of construction of the main product or the instructions issued by the manufacturer of the main product.
The manufacturer has to be partially exonerated from liability if the injured party, or a person for whom that party is liable, has partially contributed to the occurrence damage.
Where a third party has partially contributed to the occurrence of damage, that party is liable solidarily with the manufacturer.