Breast Implants TÜV pays no compensation

No compensation from TÜV for faulty breast implants

31/01/2014

In Germany, TÜV Rheinland has to pay no compensation for bad breast implants of the French manufacturer PIP. The Higher Regional Court decided that. The judges dismissed the pain-and-pay lawsuit of a 64-year-old, since it was not demonstrable that the TÜV had neglected his duty to examine. The complaint was admitted for revision at the Federal Court of Justice (BGH) in Karlsruhe. In France, the TÜV may have to pay damages to 1,600 affected women.

Sentency claim dismissed because of incorrect breast implants
A woman from the front palatine used breast implants from the French company Poly Implant Prothèse (PIP) after a cancer screening operation. As it became known in 2011, the silicone cushions were filled with cheap industrial silicone instead of high quality medical material. Affected women thus have a significantly increased risk of inflammation in the chest and other complications. The TÜV was responsible for testing the production processes at PIP, so that the manufacturer was awarded the European CE seal on this basis. Hundreds of thousands of women around the world have used the defective breast implants. In Germany, more than 5,000 women are affected.

The 64-year-old woman raises serious allegations against the TÜV in this context. The testing organization did not sufficiently monitor PIP. According to media reports from last year, there have actually been inconsistencies. So reported „Handelsblatt“ from internal reports (https://www.heilpraxisnet.de/naturheilpraxis/tuev-wusste-von-fehler-pip-brustimplantaten-9017643.php), which document that the TÜV in February 2001 had registered a special test at PIP and from 2002 no more certifications for quality management of hydrogel products exhibited. Nevertheless, the TÜV did not carry out any checks and also certified the quality management of the silicone implants until 2010.

TÜV was only responsible for checking the quality assurance system, but not for checking the silicone
After the woman had failed in the first instance before the district court Frankenthal with a complaint, she moved to the Higher Regional Court Zweibrücken. The 64-year-old demanded compensation of initially 100,000 euros and later of 40,000 euros from the TÜV. But even at the Higher Regional Court, the judges did not decide in their favor. According to the court, there was no evidence that the TÜV violated its inspection obligations. It was only the task to check the quality system of the manufacturer. The nature of the products themselves would not be covered, the judges said. Consequently, TÜV did not have to check whether PIP was using the correct silicone for the implants. This examination was the responsibility of the French authorities.

As expected, TÜV reacted very positively to the verdict. The decision of the judges shows that the testing organization acted in accordance with all legal requirements, said the defense counsel Ina Brock. It had never been known that PIP had acted fraudulently. In addition, the TÜV also does not have the means to detect this.

But the plaintiff also rated the verdict as a success. After all, the revision was approved by the BGH. This will be used, according to lawyer Christoph Manthei. Eventually, the case may end up in the European Court of Justice. (Ag)