In brief

With judgment No. 2149 dated 19 January 2022, the Court of Cassation acknowledged the liability of a manufacturer of medical devices for damages suffered by a patient due to their medical devices breaking during surgery.

Key takeaways

  • In this regard, the judges of the Supreme Court stated that the “manufacturer is liable, as holder of a position of guarantee, for harmful events causally linked to structural defects of the device placed on the market, unless the user has carried out on the same device transformations of such nature and entity as to be considered a supervening cause sufficient to cause the event.”
  • According to the court, the source of this guarantee obligation is to be found in Legislative Decree No. 46/1997, requiring the manufacturer to produce medical devices “in such a way as their use does not compromise (…) the safety of patients (…), it being understood that any risks must be of an acceptable level (…)”.
  • The Court of Cassation also pointed out that, pursuant to Legislative Decree No. 46/1997, the solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles and eliminate or reduce risks as far as possible; where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and inform users of the residual risks due to any shortcomings of the protection measures adopted.