Liability for damages caused by defective medical devices: the ECJ in the Boston Scientific case

(An Italian version of this post is published on Diritto 24 – Il Sole 24 Ore)

By decision of 5 March in joint cases C-503/13 and C-504/13, the European Court of Justice (“ECJ”) provided a preliminary ruling on the liability for damages caused by defective medical devices. The national proceedings from which the decision originates dealt with some pacemakers and implantable cardioverter defibrillators (collectively the “devices”) marketed before 2005 by Guidant, a company that later merged with Boston Scientific.

In 2005 Guidant found that their models of pacemaker named “Pulsar 470” and “976 Meridian” had a defect that determined the early depletion of the battery, and it therefore recommended physicians replace them, providing free replacement pacemakers. In addition, it found that the magnetic switch of its model of automatic implantable defibrillator named “Contak Renewal 4 AVT 6” could get stuck in the closed position, and, to avoid that defect, it advised physicians to turn off this switch. Following the ensuing interventions, three patients who had been implanted with such devices acted for damages, which were identified in two cases in the costs of setting up the replacement pacemakers and, in the third case, in the replacement costs of the defibrillator. It was actually not known whether the original devices were in fact defective, as they were destroyed without any expert opinion being obtained as to their functioning.

In this context the ECJ, answering the questions posed by the referring judges, firstly clarified that “where it is found that such products belonging to the same group or forming part of the same production series have a potential defect, it is possible to classify as defective all the products in that group or series, without there being any need to show that the product in question is defective”. According to the Court, this would derive from Art. 6 of Directive 85/374/EEC on liability for defective products, according to which a product is defective when it does not provide the safety that a person is entitled to expect, taking all the circumstances into account, including the presentation of the product, the use to which it could reasonably be expected that it would be put and the time when the product was put into circulation: “in the light of their function and the particularly vulnerable situation of patients using such devices, the safety requirements for those devices which such patients are entitled to expect are particularly high”; “the potential lack of safety which would give rise to liability on the part of the producer under Directive 85/374 stems from the abnormal potential for damage which those products might cause to the person concerned”.

The ECJ also confirmed that the damages claimed by the three patients are among the damages that the manufacturer of the defective product must compensate for in accordance with Art. 9(a) of the Directive, which states the manufacturer is liable for the damages “caused by death or personal injuries”. In fact, the Court stated that this notion of damages must be given a broad interpretation, and that “compensation for damage thus relates to all that is necessary to eliminate harmful consequences and to restore the level of safety which a person is entitled to expect, in accordance with Article 6(1) of Directive 85/374”. In conclusion, “the damage caused by a surgical operation for the replacement of a defective product, such as a pacemaker or an implantable cardioverter defibrillator, constitutes ‘damage caused by death or personal injuries’ for which the producer is liable, if such an operation is necessary to overcome the defect in the product in question”.

The decision in question seems to determine, although with a not too detailed motivation, an extension of liability for manufacturers of medical devices. We will see if national courts will apply the above principles to life-sustaining devices only or also to other devices, and whether or not they will apply these principles in cases where it will be proved that the individual devices were actually not defective although belonging to the defective series or model.