European Union Justice Court has recently (decision published in Contratti, No. 4/2015, 568) ruled on two preliminary ruling from the German Supreme Court.

This decision is characterized by a wide interpretation of two constitutive elements of the producer liability for defective product – i.e. the one which “does not offer the safety that can be legally expected having regard to all circumstances” (Art. 6 Dir. 85/374/CEE, the “Directive”, in Italy transposed into the Legislative Decree 206/2005) – according to the need of prevention of the damage to the person.

A pacemakers producer company had spread in the marked some products that then turned out – according to the intern quality control – being part of a high risky production series, because of the insertion of flawed components. The producer has voluntarily provided to patients new stimulators, which were replaced with the old ones, and these last destroyed without technical assessment.

The insurance companies of two patients, subrogated after having covered the medical expenses related to the pacemakers substitution, sued the producer company for the repayment of the substitution costs, due on the basis of the producer liability for defective product (the Directive, faithfully transposed both in Germany and in Italy). The upraised issues were the following:

  1. if, the defectiveness can be deduced from the simple belonging to a lot, even without the proof of defect of the involved product (in this case, destroyed without technical assessment );
  2. if the substitution cost can also be compensable as damage to the person (the kind of damage relevant according to this regime).

The decision responds positively to both of these issues:

  1. the safety standards are particularly high in consideration of the “particular vulnerability” of patients, therefore the lack of safety is relevant even if only ascertained potential where the products are “belonging to the same lot of series, such as pacemakers and implantable automatic stimulators”;
  2. the definition of “compensable damage”, pursuant to the Directive, or the only “damage caused as a consequence of death or personal injuries” (art. 9 of the Directive) must be interpreted extensively by virtue of the nature of the involved protected situations (safety and health of consumers); therefore it includes every cost “necessary to remove the defect of the involved product” and restore the due level of safety.

With regard to the first issue, the Court, while giving a wide interpretation of “defective product”, seems consistent with art. 6, let. b) of the Directive, which links the defect to the “usage to which can be reasonably intended to be used”: if the use of pacemakers is vital, it has to guarantee a safety standard consequently high. This interpretation moreover, in the preliminary phase of the proceedings, had a fundamental role: otherwise the claimants’ legal actions would have been paralyzed, as lacking the proof of the defectiveness of the single product (destroyed after the change). As to the second issue, instead, the decision does not seem to be perfectly consistent, by including “the costs for the peacemakers substitution, included the cost for surgeries”, classifiable as patrimonial damages, within the compensable damages pursuant to the Directive, i.e. the damages caused “by death or by personal injuries” (Art. 9 of the Directive), usually classified as non-patrimonial damages. The interpretation of the Court seems to be influenced by concrete need of protection, where it seems to include the costs for the product substation within the damages to the person, in order to prevent the risk of death or personal injuries (i.e. the graver non-patrimonial damage, to which these last would be exposed in case of non-replacement of the pacemakers).