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PIP breast implants: German Federal Court of Justice remits the proceedings against TÜV Rheinland to the appellate court for a further decision

02/27/2020Karlsruhe

The German Federal Court of Justice [Bundesgerichtshof – BGH] (7th Civil Panel) in Karlsruhe today responded to the appeal on questions of law filed by a health insurance fund in proceedings against TÜV Rheinland LGA Products GmbH ("TRLP") in connection with silicone gel breast implants manufactured by the French company Poly Implant Prothèse ("PIP"). The health insurance fund claims for reimbursement of the surgery costs allegedly borne for several of its insurees, who had their PIP breast implants removed. The German Federal Court of Justice did not issue a final decision in this case but remitted the matter to the Nuremberg Court of Appeals [Oberlandesgericht – OLG] for decision.

"We are confident that the Nuremberg Court of Appeals will come to the conclusion that TÜV Rheinland LGA Products GmbH has, at all times, fulfilled its duties as a notified body responsibly and in compliance with all applicable laws and regulations. This has been confirmed by numerous German courts at all instances, in particular the German Federal Court of Justice in its judgment of 22 June 2017", said Ina Brock of law firm Hogan Lovells LLP, TRLP's lawyer.

The District Court [Landgericht – LG] of Nuremberg-Fürth had dismissed the claim in 2014 and the Plaintiff's appeal against this ruling was then dismissed by the Nuremberg Court of Appeals [Oberlandesgericht – OLG] in 2018, which decided that no claim could be brought against TRLP under German law for legal reasons alone. In today’s hearing, the German Federal Court of Justice did not concur with this decision. and the Court of Appeals must now examine whether the prerequisites for a breach of duty have been met in the individual case.

For many years, the French manufacturer of the PIP breast implants systematically deceived all the parties involved – first and foremost the patients, but also the responsible French market surveillance authorities and TRLP as the notified body. PIP's fraudulent actions were not recognisable to TRLP, nor could they have been detected with the means the law provides for a private notified body.

In its judgment of 22 June 2017 in another proceeding relating to PIP breast implants, the 7th Civil Panel of the German Federal Court of Justice had already denied the liability of the notified body TRLP as no breach of duty had been committed. Previously, by judgment of 16 February 2017, the Court of Justice of the European Union ("CJEU"), which had been seized by the German Federal Court of Justice, decided in these proceedings that the European Medical Devices Directive itself does not provide for any liability on the part of notified bodies such as TRLP. Furthermore, according to the CJEU, notified bodies do not have any general duty under the Medical Devices Directive to “carry out unannounced inspections, to examine devices and/or to examine the manufacturer’s business records”. According to the CJEU, Notified Bodies may have further-reaching duties to act only in the face of evidence that a medical device may not comply with the requirements laid down in the Medical Devices Directive. The CJEU thus confirmed TRLP's position in its decisive points.

Pursuant to the legal view taken by the German Federal Court of Justice, the Nuremberg Court of Appeals must now make further findings of fact in order to assess this element in this individual case, while being bound by the stipulations of the German Federal Court of Justice and the CJEU.

Background: PIP deliberately manufactured silicone breast implants using – at least temporarily – a non-declared silicone filling. PIP deceived TRLP and always claimed that it only used the silicone that it declared to TRLP as a raw material. PIP provided the inspectors from TRLP with complete documents (e.g. the design dossier, batch records, manufacturing instructions) regarding the alleged use of the declared silicone. PIP systematically concealed any indications of the use of different raw materials.

By way of large-scale and complex fraud, PIP deceived all the parties involved – first and foremost the patients, but also the health authorities and TRLP. When PIP's fraud became known at the end of March 2010, TRLP suspended its certificates for PIP.

TRLP has the utmost appreciation for the concerns of patients with PIP implants and shares the women's interest in a full investigation of PIP's criminal actions. Consequently, TRLP has filed a criminal complaint against PIP and the individuals involved.

Contact for media inquiries: Hartmut Müller-Gerbes
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