PIP silicone breast implants

Background

In 2010 it became known that the French company, Poly Implant Prothèse (“PIP”), had been manufacturing breast implants using poor-quality industrial silicone which had not been approved for medical use. The implants can easily tear, resulting in inflammation and up to 500,000 women worldwide are affected. PIP had commissioned the inspection agency, TÜV Rheinland, as a notified body, to perform the necessary inspections as part of a conformity evaluation procedure under the law governing medical devices.

In Germany, one of the women affected brought an action against TÜV Rheinland seeking € 40,000 damages for pain and suffering and a declaration that all future loss or injury be liable to damages. Both the court of first instance and Zweibrücken Higher Regional Court (Oberlandesgericht) (judgement of 30 January 2014; file no.: 4 U 66/13) dismissed the action (cf. […]). As the grounds for their decision, the courts stated that TÜV Rheinland was not in breach of the duties it was required to fulfil with its conformity evaluation; rather, TÜV Rheinland merely had a duty to inspect PIP’s quality assurance system, not the actual materials used.

Three questions to the ECJ

After an appeal was brought before the German Federal Court of Justice (BGH), the BGH decided on 9 April 2015 to submit three questions to the European Court of Justice by way of the preliminary ruling procedure (case no.: VII ZR 36/14). The questions relate to the interpretation of the Medical Devices Directive (93/42/EEC) adopted on 14 June 1993.

• The first question asks the ECJ to clarify whether it is the sense and purpose of the Directive to ensure that the notified body commissioned with inspection protects all potential patients and can be held directly liable for a culpable breach of duty.
• Secondly, the BGH sees a need to clarify whether the Directive imposes upon the notified body a general or at least situation-dependent duty to inspect Class III medical devices.
• Thirdly, the BGH asks whether in the case of Class III medical devices, the notified body has a general or at least situation-dependent duty under the Directive to view the manufacturer’s business documents and/or carry out unannounced inspections.

What is most remarkable is the fact that the BGH raises the question as to the protective purpose of the Medical Devices Directive in connection with the activities of a commissioned notified body. An agreement with protective effect for third parties might thus ultimately result in the relevant commissioned notified body bearing liability for injured patients. Moreover, if the ECJ confirms a duty to inspect and examine within the meaning of the second and third questions submitted, this could result in the bearing of greater liability by the notified body.