Judges see no claims for damages in the breast implant scandal
The scandal of low-quality breast implants by the French manufacturer Poly Implant Prothèse (PIP) had caused massive waves across Europe last year. The implanted silicone cushions had to be removed for thousands of women due to impending health risks. However, at the start of the first lawsuit for damages in Germany, the judges of the Karlsruhe Regional Court found no complicity from the German authorities or the TÜV.
The judges not only excluded general liability from the authorities, but also gave the women concerned little hope of being compensated by the liability insurance of the now insolvent French manufacturer PIP. According to French law, claims against PIP's insurance are limited to damage that occurs within France, explained the judges of the Karlsruhe Regional Court. This "geographical limitation of cover protection is probably lawful" and therefore a claim of the women concerned cannot be enforced, the judges said at the hearing on Tuesday. The verdict is due to be announced on November 30
Inferior breast implant is a massive health risk
The French manufacturer PIP used inferior industrial silicone in the production of the breast implants, which is not suitable for medical purposes. The result was increased cracks in the silicone cushions and severe inflammation due to the emerging silicone gel. The experts estimate that around 5,000 women in Germany received a corresponding PIP breast implant. In 2010, the French regulatory authority warned for the first time about the inferior implants. By then, however, tens of thousands of patients had used such a silicone pillow. In order to avoid health risks, the authorities in France and in Germany advised patients to have the cheap implants removed again. The Federal Institute for Drugs and Medical Devices (BfArM) issued a corresponding notification last January. Around 1,000 implants were removed from affected patients by the middle of this year. The silicone pillow is said to have already cracked in over a quarter of the patients and apparently the inferior industrial silicone had already leaked out in 20 percent of the women.
Woman is suing for damages and compensation for pain and suffering
In view of the impairments caused by the PIP breast implant, a woman from Waghäusel in Baden-Württemberg has now sued for damages and compensation for pain and suffering. A corresponding breast implant was inserted in 2007. The plaintiff directed her claims in the amount of approximately 20,000 to 30,000 euros against her specialist in plastic and aesthetic surgery, the German chemical trading company, which apparently had supplied the implant manufacturer PIP with the industrial silicone used without checking the intended use, the French liability insurer of PIP, one company belonging to TÜV Rheinland, which certified the implants by PIP in the sense of medical device law and the Federal Republic of Germany through official liability, since the BfArM did not follow the warnings in good time. However, the judges of the Karlsruhe Regional Court gave little hope of success at the plaintiff's hearing.
Court sees chances of success for claims for damages
The presiding judge, Eberhard Lang, was unable to recognize a failure by the German authorities, since the Federal Institute for Drugs and Medical Devices had no obligation to intervene before the warning from the French supervisory authority in 2010. However, in the course of the current trial, the judges criticized the insufficient documentation of the checks by TÜV Rheinland against the court. A company belonging to TÜV Rheinland had certified the implants from PIP in accordance with medical device law. The plaintiff was of the opinion that the test obligations were not or not properly complied with as part of the procedure for CE marking the implants. According to her lawyers, the TÜV should have controlled the French manufacturing company without notice. However, the presiding judge did not follow this view, but said: "We are more likely to have doubts." No concrete omissions by the TÜV were set out.
Compensation for a few inferior breast implants only against doctors?
The final decision of the Karlsruhe Regional Court is not expected until November 30th, but it can already be seen that - if the judges stick to their position - those affected can only address their claims for damages to the treating doctors. However, a claim for damages directly from the doctor presupposes that either a treatment error or insufficient information about the risks associated with the treatment can be demonstrated. With the verdict at the end of November, the claim for damages against the doctors is initially left out and only the remaining claims of the plaintiff are decided, the court explained. (fp)
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