PIP implants: the German Federal Supreme Court recognizes the responsibility of the certifier TÜV RHEINLAND

By a judgement dated 27/02/2020, the highest German court (BGH – Bundesgerichthof) annulled a decision which had rejected the responsibility of the certifier TÜV Rheinland, holding that the guarantee of individual health protection for patients with PIP implants is not solely the responsibility of the manufacturer (PIP) “but also to the notified body”, certifier of these implants. We remind that the German quality assurance giant acted as a notified body for PIP from 1997 until the discovery of the scandal in 2010 and it was its so-called control that enabled PIP to affix the CE mark on its certified, albeit adulterated products.

The BGH rules that “the notified body, with regard to its rights and obligations, as defined in Directive 93/42/EEC, has a position that is independent of its client and its testing activities serve not only the manufacturer but also, and above all, the final recipients of medical devices…, it is necessary that the notified body is exposed to the risk of criminal proceedings on the part of third parties in the event of negligent checks. The German Supreme Court thus finds that “the conformity assessment procedure… replaces an official approval procedure in the European conception of the law of medical devices” and that “taking into account the health risks linked to the use of defective medical devices, … an individual claim for damages against the notified body is justified“. It adds that “the rejection of a tort responsibility for the notified body in the event of a culpable failure to fulfil its obligations would call into question the meaning and the objective of the conformity assessment procedure”.

This decision, which comes following the prosecution of TÜV Rheinland by the insurance company AOK Bayern, is another decisive victory for the 300,000 victims of the PIP breast implants. It reinforces the proceedings initiated in 2010 by the Parisian lawyer Olivier Aumaître, who first sought responsibility for TÜV Rheinland for this case. According to PIPA’s lawyer, “this decision validates our action once again and reinforce the chances for the final compensation of all women with PIP implants”. Olivier Aumaître further points out that “after the European Court of Justice, the French and German supreme courts are now ruling against TÜV”. For him, “the strategy of TÜV is a complete failure, and it is high time that TÜV come to the negotiating table to end this long-standing dispute”.

Five court decisions have already ordered TÜV Rheinland in France to compensate PIP patients. The Court of Cassation has already brought justice to the victims represented by Olivier Aumaître by its decision from 10 October, 2018. It has indeed confirmed the grounds for the first decision (November 2013) which had sentenced TÜV Rheinland for their negligence, the failure of their controls and their infringement of European regulations. The highest French court had in particular indicated that the certifier was held to an obligation of vigilance and that in the presence of indications of non-conformity it had to carry out in-depth controls of the raw materials and the finished products and to perform unannounced visits. However, TÜV had failed to meet any of these obligations.

The German and French supreme courts also point out that TÜV Rheinland had to keep its independence from PIP. However, this was undermined by the commercial relationship which linked TÜV, via its French entity, to the implant manufacturer (TÜV Rheinland invoiced training services in particular and helped PIP penetrate the Asian market).

Beyond the procedures which have already given rise to the first compensation for more than 20,000 victims, new proceedings have been initiated. French Social Security is claiming 17 million euros from TÜV Rheinland. The Commercial Court of Toulon will examine the claim of nearly 2,000 victims during a hearing on March 4. A new procedure will also be implemented in the coming weeks, in which more than 3,000 new patients from around the world have already mandated PIPA