I have been asked to comment on the European Court of Justice decision of October 18 relating to the application of public procurement rules to a drug supply arrangement between a privately owned hospital and a public hospital.
Last week the PIP legal saga took another unexpected turn.
On October 10, 2018 the French Court of Cassation overturned the decision of the Appeal Court, which had cleared from liability TUV Rheinland, the notified body involved in the PIP case, and sent the case back to the Appeal Court.
Breast implants made by the French firm Poly Implant Prothèse (also known as “PIP”) had been marketed for years until, in 2010, it was discovered that silicone used for such breast implants was industrial, rather than biomedical. The investigation found that employees of PIP removed evidence of the industrial silicone gel before inspections by TUV Rheinland, the notified body who was in charge of audits on the manufacturing of the breast implants.
Breast implants are medical devices that may be marketed in the European Union if they are granted a CE marking, which is based on the certification by a notified body that the device satisfies legal requirements. The scandal, although linked to a criminal scheme, showed certain weaknesses of the medical device legislation and ultimately led to the adoption of the EU Medical Device Regulation in 2017.
PIP closed down in 2010 and, although its founder was jailed and fined, the many thousands of affected women could not be compensated by PIP. TUV Rheinland was initially condemned for negligence in 2013 and ordered to pay damages of 5.7 million euros, but was later cleared from liability by a French Appeal Court in 2015.
The Court of Cassation has now sent back the case to the Court of Appeals in order to shed light on two issues. TUV’s press release on the decision can be read here. According to Maître Cécile Derycke, Counsel for the TÜV Rheinland companies: “The TÜV Rheinland companies are serene. […] We are confident that the Court of Appeal to which the case has been referred back will confirm that TÜV Rheinland LGA Products GmbH performed its mission as a notified body diligently and in total compliance with the applicable regulations and TÜV Rheinland France SAS committed no fault.”.
Stay tuned to find out if TUV Rheinland’s is found to be a victim or a perpetrator in the PIP scandal… and if affected patients are entitled to compensation by TUV.