PIP breast implants: Last claim for damages against TÜV Rheinland in Germany definitively dismissed

German courts unanimously conclude across all instances that TÜV Rheinland LGA Products GmbH (“TRLP”) acted responsibly and in compliance with all applicable laws and standards / Belgian, Italian and Spanish courts also rejected claims

The last claim for damages pending in Germany against TÜV Rheinland regarding Poly Implant Prothèse (“PIP”) breast implants has been definitively dismissed. The judgement of the Darmstadt Regional Court from September 2023 is now final. The final decision is aligned with more than 240 decisions dismissing claims in Germany by 20 regional courts and 17 higher regional courts, as well as the decision of the Federal Court of Justice of 22 June 2017 and the Court of Justice of the European Union of 16 February 2017.

Fraudulent activities not detectable by the Notified Body

The German courts have thus come to the unanimous conclusion across all instances that TRLP fulfilled its duties as the Notified Body of the French breast implant manufacturer PIP, responsibly and in accordance with all applicable laws and standards at all times and there is therefore no basis for claims for damages against TRLP. In the scope of its mission and within the means available to a private entity such as a Notified Body, TRLP could not detect PIP’s fraudulent actions. TRLP is not responsible for the massive fraud put in place by PIP within all levels and departments of its company.

TÜV Rheinland has always and continues to fully sympathise with the women affected by PIP’s fraud. TÜV Rheinland has always fully cooperated with the authorities to investigate PIP's criminal activities. From these investigations and the facts and information that have been assessed in many cases, TÜV Rheinland believes that there is no legal basis for claims for damages against the company. TÜV Rheinland bears no responsibility for the damage caused by PIP's fraud.

Courts in Belgium, Italy, Spain also rejected claims

Similar to all proceedings in German courts, courts in Belgium, Italy and Spain have also dismissed lawsuits in connection with PIP implants. Exceptionally, courts in France have ruled differently. It can therefore be expected that legal proceedings will continue in France with regards to the PIP case.

Background:

TÜV Rheinland never tested the implants manufactured by PIP, but certified PIP's quality management system – as was required for this type of medical device in the European Union. Like many others, TÜV Rheinland is one of those deceived by PIP. The French manufacturer of the PIP breast implants had systematically deceived patients in the first place, but also the French market surveillance authorities and TRLP as its Notified Body for years. Some PIP managers were sentenced to prison for fraud December 2013 in the scope of criminal proceedings, with the main defendant Jean-Claude Mas, CEO and founder of PIP, receiving a four-year prison sentence – notably for fraud against TÜV Rheinland. Jean-Claude Mas passed away in 2019.

PIP deliberately manufactured silicone breast implants using – at least in some instances – an undeclared silicone gel. PIP deceived TRLP and always claimed to use only the declared silicone gel. PIP provided TRLP’s auditors with complete documentation (e.g., the design dossier, batch documentation, production instructions) on the alleged use of the declared silicone gel. Furthermore, PIP systematically concealed all indications of the use of undeclared raw materials. After PIP’s fraud came to light at the end of March 2010, TRLP suspended and then withdrew PIP's certificates.