BGH: No liability-based breach of duty by TÜV Rheinland
TÜV Rheinland is not liable for the defective breast implants from the French manufacturer PIP. He did not violate any of his duties as part of his close inspection, the Federal Court of Justice (BGH) in Karlsruhe (Az .: VII ZR 36/14) ruled on Thursday, June 22, 2017. After that, the certification only concerned the manufacturing process, so the TÜV was not responsible for the quality of the end product.
In doing so, the BGH dismissed the claim for damages from a person concerned and implemented a judgment of the European Court of Justice (ECJ) in Luxembourg in February 2017.
The breast implants of the now insolvent French company Poly Implant Prothèse (PIP) were sold ten thousand times worldwide. They did not contain the usual special, but cheaper industrial silicone. The management has already been convicted of fraud in France.
According to an estimate by the Federal Institute for Drugs and Medical Devices (BfArM), around 6,000 women in Germany had PIP implants inserted. The French authorities stopped sales in April 2010 after reports of burst and leaking silicone pads.
Since it cannot be predicted whether and when there will be problems with the implants, the BfArM recommended in early 2012 that women affected had PIP implants removed again. The plaintiff followed this in the event of a dispute.
In order to get the costs reimbursed despite the PIP insolvency, numerous women had initially sued the operating doctors. However, this was unsuccessful before the courts in Germany (see OLG Karlsruhe, judgment of April 20, 2016, ref .: 7 U 241/14; JurAgentur report of April 21, 2016 with further references).
TÜV Rheinland was therefore the last hope for thousands of women. The background is that the awarding of the European CE seal for medical devices is linked to certification by an outside company. PIP had commissioned TÜV Rheinland to do this, which awarded the seal.
In the specific case, the plaintiff claimed damages and compensation for pain and suffering in the amount of 40,000 euros. Like the Frankenthal Regional Court in the first instance, the Higher Regional Court (OLG) Zweibrücken dismissed the lawsuit (judgment and JurAgentur notification of January 30, 2014, file number: 4 U 66/13).
The BGH subsequently appealed to the European Court of Justice (ECJ) in Luxembourg. The decision was made on February 16, 2017 that CE certification is not yet associated with a comprehensive monitoring mandate for medical devices; the external inspection relates only to the manufacturing process and not the product itself (file number: C-219/15; JurAgentur report from the day of the judgment).
According to the ECJ judgment, liability of the TÜV Rheinland would only have been considered if the TÜV had also violated its very tight inspection obligations.
This, according to the BGH, was not the case. The TÜV had no evidence of fraud. Unannounced visits were not required, as was a check of the business documents or random checks of the product itself.
Unannounced controls and spot checks are now possible. According to the new EU Medical Device Regulation that came into force on May 25, 2017, such more extensive tests will be mandatory from 2020.
mwo / fle