Share:
No compensation for PIP breast implants
TÜV Rheinland is not liable for the defective breast implants of the French manufacturer PIP. As part of his close audit duties, he had violated any obligations, judged on Thursday, June 22, 2017, the Federal Court of Justice (BGH) in Karlsruhe (Az .: VII ZR 36/14). Afterwards the certification concerned only the manufacturing process, for the quality of the final product the TÜV was therefore not responsible.
Image: Gina Sanders - fotolia Thus, the BGH dismissed the claim for damages of an affected person and implemented a judgment of the European Court of Justice (ECJ) in Luxembourg of February 2017.
The breast implants of the now insolvent French company Poly Implant Prothèse (PIP) have been sold ten thousand times worldwide. They did not contain the usual special, but cheaper industrial silicone. The management has been convicted in France for fraud.
According to an estimate by the Federal Institute for Drugs and Medical Devices (BfArM), around 6,000 women in Germany have PIP implants. After reports of ruptured and leaking silicone pads piled up, the French authorities stopped selling in April 2010.
Since it is not possible to predict whether and when there will be problems with the implants, in early 2012 the BfArM recommended women to have PIP implants removed. In the dispute, the plaintiff had also followed suit.
In order to get the costs replaced despite the PIP insolvency, numerous women had initially filed against the operating physicians. However, this did not succeed in the courts in Germany (so OLG Karlsruhe, judgment of 20 April 2016, Az .: 7 U 241/14, JurAgentur-message from 21 April 2016 with further references).
The last hope for thousands of women was therefore TÜV Rheinland. The background is that the awarding of the European CE mark for medical devices is linked to certification by an outside company. PIP commissioned TÜV Rheinland, which awarded the seal.
In the specific case, the plaintiff demanded damages and damages in the amount of 40,000 euros. As in the first instance the district court Frankenthal also the higher regional court (OLG) Zweibrücken had dismissed the complaint (judgment and JurAgentur message from 30 January 2014, Az .: 4 U 66/13).
The BGH then brought the dispute before the European Court of Justice (ECJ) in Luxembourg before. He ruled on February 16, 2017, that the CE certification for medical devices is not yet linked to a comprehensive monitoring order; the external inspection relates only to the manufacturing process and not the product itself (Ref .: C-219/15, JurAgentur notification from the day of the judgment).
According to the ECJ ruling, a liability of TÜV Rheinland would therefore have come into consideration only if TÜV had also violated its very strict inspection obligations.
This, so now the BGH, was not the case. The TÜV had no evidence of the fraud. Unannounced visits were as little prescribed as a check on business records or spot checks of the product itself.
Unannounced controls and random checks are now possible. Following the new EU Medical Devices Directive, which came into force on 25 May 2017, such more comprehensive tests will be mandatory from 2020 onwards.
mwo / fle