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No compensation for pain and tear from the TÜV for defective breast implants
In Germany, the TÜV Rheinland does not have to pay compensation for pain due to defective breast implants from the French manufacturer PIP. The decision of the Higher Regional Court in Zweücken. The judges dismissed the 64-year-old's claim for pain and suffering because there was no evidence that the TÜV had neglected its duty to inspect. The lawsuit was approved for revision at the Federal Court of Justice (BGH) in Karlsruhe. In France, the TÜV may have to pay compensation to 1,600 women affected.
Claims for compensation for damages for defective breast implants were rejected A breast cancer implant from the French company Poly Implant Prothèse (PIP) was used after an operation to prevent cancer. As it became known in 2011, the silicone pillows were filled with cheap industrial silicone instead of high-quality medical material. Affected women have a significantly increased risk of inflammation in the breast and other complications. The TÜV was responsible for checking 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 5000 women are affected.
The 64-year-old woman makes serious allegations against the TÜV. The inspection organization had not adequately monitored PIP. According to media reports from the past year, there have actually been inconsistencies. For example, the “Handelsblatt” reported on internal reports (https://www.heilpraxisnet.de/naturheilpraxis/tuev-wusst-von-fehler--pip-brustimplantaten-9017643.php), which document that the TÜV passed a special inspection in February 2001 had registered with PIP and from 2002 no longer issued any certifications for the quality management of hydrogel products. 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 with the Frankenthal district court, she moved to the Zweibrücken Higher Regional Court. The 64-year-old claimed compensation for pain and suffering of initially EUR 100,000 and later EUR 40,000 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 manufacturer's quality assurance system. The nature of the products themselves would not be included, according to the judges. As a result, the TÜV did not have to check whether PIP was using the correct silicone for the implants. This test was the responsibility of the French authorities.
As expected, the TÜV reacted very positively to the judgment. The decision of the judges showed that the testing organization had acted in accordance with all legal requirements, explained the process representative Ina Brock. It was never known that PIP had acted fraudulently. In addition, the TÜV does not have the means to uncover this.
But the plaintiffs also rated the judgment as a success. After all, the revision had been approved by the BGH. This will be used, said lawyer Christoph Manthei. The case may ultimately end up in the European Court of Justice. (ag)