Our Law Firm has experience in handling issues related to product liability - that is, liability that may arise as a result of the marketing of a device dangerous to a consumer in the European Union. Such liability may arise in certain situations, for example when, due to the use of a medical device the patient is injured, or the device has a concealed manufacturing defect (e.g. it includes a harmful ingredient) and thus its use leads to health problems.

Companies in the medical devices industry often encounter claims related to product liability - there are more and more cases of this kind. Patient's claim can be raised for various reasons, such as (the following examples are based on our practice):

  • mistakes in the use manual of the medical device,
  • incorrect information on acceptable clinical situations in which the device may be used,
  • premature rundown of an implanted active medical device battery, etc.

In the given area, the key in legal counselling is to develop appropriate communication methods with the consumer and product claim management procedures, especially since in many cases consumers' claims are of repeatable nature.

It is also extremely important to determine which entity in the distribution chain bears product liability (in accordance with EU law it is the manufacturer or importer of the device to the EU). Claims of this kind should be distinguished from “ordinary” warranty/guarantee claims, which can be raised by the buyer (including a consumer) against the seller. Such claims have different content, limitation periods and legal effects.