Breast implant scandal No compensation?
Judges see no claims for damages in the breast implant scandal
13.11.2012
The scandal involving low-quality breast implants made by French manufacturer Poly Implant Prothèse (PIP) had hit massive waves throughout Europe last year. Thousands of women had to remove the implanted silicone pads due to the threat of health risks. At the beginning of the first case in Germany led compensation process, however, the judges of the district court Karlsruhe could not find any fault of German authorities or the TÜV.
The judges not only excluded the general liability of the authorities, but also made the affected women little hope for damages through the liability insurance of the now insolvent French manufacturer PIP. Claims against the insurance of PIP are limited under French law to damages that occur within France, the judges of the district court of Karlsruhe explained the legal situation. These „geographic limitation of coverage is probably legitimate“ and a claim of affected women therefore unenforceable, the judges said at the hearing on Tuesday. The verdict is to be announced on 30 November
Inferior breast implant a massive health risk
The French manufacturer PIP had used inferior industrial silicone in the production of breast implants, which is not suitable for medical purposes. The result was increased cracks in the silicone pads and severe inflammation caused by the silicone gel exiting. According to the experts, around 5,000 women in Germany received a corresponding PIP breast implant. In 2010, the French regulator warned for the first time before the inferior implants. Until then, however, tens of thousands of patients have used such a silicone pad. In order to avoid health risks, the authorities in France as well as in Germany advised the patients to have the cheap implants removed. The Federal Institute for Drugs and Medical Devices (BfArM) issued a notice last January. By the middle of this year, about 1,000 implants were removed in affected patients. In more than a quarter of the patients, the silicone pad is said to have cracked and in 20 percent of the women, the inferior industrial silicone had evidently already leaked out.
Woman is suing for damages and compensation
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. She was used in 2007, a corresponding breast implant. The applicant directed its claims in the amount of approximately 20,000 to 30,000 euros against its specialist for plastic and aesthetic surgery, the German chemical trading company, which apparently supplied the implant manufacturer PIP the industrial silicone used, without examining the intended use, the French liability insurer of PIP, a company belonging to TÜV Rheinland, which has certified the implants of PIP in the sense of medical device law and the Federal Republic of Germany by way of official liability, since the BfArM did not follow up the warnings in time. However, the judges of the district court of Karlsruhe made little hope of success at the hearing of the plaintiff.
Court sees kau chances of success for claims for damages
A failure of the German authorities could not recognize the presiding judge Eberhard Lang, as for the Federal Institute for Drugs and Medical Devices prior to the warning in 2010 by the French regulator had no obligation to intervene. However, the judges complained in the course of the current hearing, the lack of documentation of the controls of the TÜV Rheinland to the court. A company belonging to TÜV Rheinland had certified the implants of PIP in the sense of the Medical Device Law. The applicant was of the opinion that in the context of the procedure for CE marking of the implants, the inspection obligations were not or not properly fulfilled. According to their lawyers, the TÜV should have checked the manufacturer in France without prior notice. However, the presiding judge did not follow this view but stated: „We are more in doubt.“ Concrete failings of the TÜV are not stated.
Damages few inferior breast implant only against doctors possible?
Although the final decision of the District Court of Karlsruhe is expected only on 30 November, it can already be seen that - should the judges stay in their position - those affected can only address their claims for damages to the attending physicians. However, a claim for damages directly to the doctor presupposes that either a mistake in treatment or inadequate information about the risks in the course of treatment can be proven. It is possible that in the verdict at the end of November, the claim for damages against the doctors initially also left out and decided only on the remaining claims of the plaintiff, explained the court. (Fp)
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Picture credits: Florentine