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TÜV is not liable for defective breast implants

TÜV is not liable for defective breast implants

TÜV Rheinland does not have to pay for the removal of the defective PIP breast implants

In the scandal surrounding the defective silicone cushions of the French manufacturer PIP (Poly Implant Prothèse), the regional court of Nuremberg-Fürth dismissed the lawsuit brought by AOK Bavaria, with which the health insurance company wanted TÜV Rheinland to pay for the removal of the inferior breast implants. The court explained that the TÜV had no illegal behavior in relation to its monitoring and control function, referring to a judgment of the Oberlandesgericht Zweibrücken of January 30.

The AOK stated in a press release regarding the dismissal of the complaint that it was “difficult for AOK Bavaria to understand”, because in its view “TÜV Rheinland acted contrary to duty and its monitoring and control function in connection with the PIP breast implants was insufficiently completed” have. Therefore, the health insurance company will now examine "what legal remedies can be brought against the dismissal of their lawsuit." In view of the impending health damage caused by breast implants made of inferior industrial silicone, the AOK had paid for the removal of the implants in 26 affected persons and then wanted the costs from the TÜV Get Rhineland refunded. In the room there was a claim of around 50,000 euros.

Court sees no misconduct on the part of TÜV Rheinland At the end of January, the Higher Regional Court in Zweibrücken had already stated that TÜV Rheinland was only responsible for checking PIP's quality assurance systems. The control and monitoring of the production operations at PIP was, however, the responsibility of the national supervisory authority. In principle, on the same grounds, the Nuremberg-Fürth District Court now dismissed AOK Bayern's action. In view of the dismissal of the complaint, Dr. Helmut Platzer, CEO of AOK Bayern, that "patient safety in France is obviously rated much higher". In Toulon, the commercial court "already ordered the TÜV in November 2013 to pay several million euros to a total of around 1,700 women." Platzer comes to the conclusion that a decision by the European Court of Justice may be necessary to bring about a final clarification.

Apparent security for patients? According to the decision of the Nuremberg-Fürth Regional Court, the TÜV Rhineland did everything the legislator intended to protect patients, reports the AOK. "Then the existing control regulations would also be exposed as senseless," emphasized the CEO of AOK Bayern. Because in this case, only a false security is suggested, which could pose a risk to the patient. Patient safety and consumer protection are not guaranteed if medical devices tested by the TÜV are faulty. If this judgment persists, "it should be a warning siren for both national and European legislators," concludes the AOK. "Stricter Europe-wide regulations for the medical device market are urgently required here," emphasized Dr. Helmut Platzer. (fp)

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