Decisions of the French Supreme Court in the PIP breast implant case

The French Supreme Court delivered 4 decisions in the scope of proceedings against the notified body TÜV Rheinland LGA Products GmbH ("TRLP") and the company TÜV Rheinland France ("TRF") by plaintiffs who claim to have received PIP silicone gel breast implants as well as former PIP breast implant distributors.

The French Supreme Court was referred with this matter in the scope of appeals lodged by TRLP and TRF, firstly, and by the plaintiffs and some former distributors, secondly. These appeals follow several appellate judgments delivered in 2021 a few months apart by various courts of appeal. These appellate judgments have resulted in very different decisions.

Since these appellate judgments were delivered, the French Supreme Court already ruled twice on 9 February and 20 April 2023 and dismissed the appeals lodged by people that the Versailles and Aix-en-Provence Courts of Appeal had declared inadmissible. In relation to these people, there has thus been a final ruling that they cannot bring claims against the TÜV Rheinland company.

The 25 May 2023, the French Supreme Court quashed part or all of the abovementioned appellate judgments from the three Courts of Appeal.

These decisions are another step in the dispute resulting from the fraud PIP committed for years to the detriment of the concerned women, but also of the notified body TRLP, as the Criminal Court ruled in a final ruling.

The French Supreme Court has sent the case back to the Lyon Court of Appeal. The future judgments by the Lyon Court of Appeal could once again be subject to appeal before the French Supreme Court.

At European level, the Court of Justice of the European Union ruled in February 2017 that notified bodies, such as TRLP, are under no general obligation to carry out unannounced inspections, to examine devices or to examine the manufacturer’s business records. In the scope of criminal proceedings, TRLP was found to be a victim of the fraud committed by PIP and its managers by the Marseilles Criminal Court in 2013, the Aix-en-Provence Court of Appeal in 2016 and then the French Supreme Court in 2018, which made this decision final.

Background: PIP deliberately manufactured silicone gel breast implants using – at least temporarily – a non-declared silicone filler gel.

By way of a large-scale and particularly sophisticated fraud, PIP deceived all the parties involved: first and foremost women with PIP implants, but also health authorities and the notified body TÜV Rheinland LGA Products GmbH ("TRLP"). PIP always declared that it only used the silicone gel that it declared to TRLP as raw material. PIP provided TRLP auditors with extensive documentation (design dossier, batch dossiers, manufacturing instructions) regarding the alleged use of the declared silicone gel. Any evidence or element concerning the use of different raw materials was systematically concealed by PIP. Pursuant to regulations, the role of TRLP as notified body was to verify the procedures implemented by the manufacturer, not to test the final products.

As soon as the fraud committed by PIP was discovered in late March 2010, TRLP suspended the certificates it had granted to PIP.

TRLP is very mindful of the concerns of women with PIP implants and shares their interest in PIP's criminal actions being cleared up. This is the reason why TRLP filed at the beginning of the case a criminal complaint against PIP and its managers. This has led to PIP and its managers being convicted in a final ruling as guilty of fraud against TRLP.