ECJ is to work up breast implants scandal

European Court of Justice is to work on breast implants scandal

04/10/2015

After the scandal involving inferior breast implants of the French manufacturer Poly Implant Prothèse (PIP), the question of responsibility and thus the payment of appropriate compensation has not been finally clarified. In this context, TÜV Rheinland is accused by a plaintiff of infringing its inspection and monitoring obligations, as the processing of the unauthorized industrial silicone in the breast implants had not attracted any attention.

After the lawsuit of the woman for damages in the amount of 40,000 euros against the TÜV Rheinland by the competent Landesgericht Frankenthal was rejected and the appeal failed before the Higher Regional Court (OLG) Zweibrücken, the plaintiff went in revision at the Federal Court (BGH), who now with possible violation of the inspection obligations by TÜV. At the BGH, however, the case (Ref .: VII ZR 36/14) was temporarily suspended and a questionnaire was sent to the European Court of Justice (ECJ) in Luxembourg to clarify the interpretation of European law in relation to the obligations of the TÜV. The decision in the method is eagerly awaited, as it is also expected that a signal effect for other outstanding processes.

Plaintiff received two breast implants in 2008
In 2008, according to the BGH in Germany, the plaintiff had two silicone breast implants from the now insolvent French company PIP used. As medical devices, silicone breast implants may only be placed on the market if u.a. A conformity assessment procedure has been carried out according to the Medical Devices Act (MPG) and the Medical Devices Ordinance (MPV) in conjunction with Annex II of Council Directive 93/42 / EEC of 14 June 1993 on medical devices, reports the BGH. An essential part of the evaluation is the „Review (audit) of the quality system, product design review and monitoring.“ The test is carried out by a body appointed by the manufacturer.

TÜV Rheinland sued for 40,000 euros in damages
The French manufacturer had commissioned TÜV Rheinland as Notified Body to test the silicone breast implants. The TÜV did not notice that poor quality industrial silicone was used in the manufacture of breast implants, contrary to the quality standards. Finally, in 2010, French authorities revealed the scandal and, on medical advice, many affected women - like the plaintiff in 2012 - removed the implants. The plaintiff here is of the opinion that TÜV Rheinland has not sufficiently fulfilled its duties as a notified body. For example, production by means of industrial silicone would have required attention when reviewing business records and product testing, so that it would not have been possible to use silicone breast implants. The woman therefore demands „a compensation of € 40,000 and the determination of liability for future material damage“, so the statement of the BGH.

Questions to the European Court of Justice
TÜV Rheinland, on the other hand, takes the position that the inspection of the product was not part of the inspection obligations, but rather that the manufacturer's quality assurance systems were checked. Thus, the BGH must now clarify how the test is actually interpreted. For this purpose, the Federal Court of Justice has referred to the European Court of Justice three essential questions concerning the interpretation of Council Directive 93/42 / EEC of 14 June 1993 concerning medical devices. Until the ECJ answers them and tells them how far the obligation to inspect the „notified body“ If and to what extent a claim for damages can be deduced from breaches of duty, the current proceedings shall be suspended.

Hundreds of thousands of women affected by the breast implants scandal
Hundreds of thousands of women worldwide were affected by the PIP breast implants scandal, and the use of inferior silicone often involved severe health problems as the implants ruptured and silicone leaked out. Similar to the Federal Institute for Drugs and Medical Devices (BfArM), the health authorities in many other countries have therefore struggled to remove the implants. The company PIP had to file for bankruptcy relatively soon after the scandal was discovered, so that the affected women can not hope for any compensation here. The founder of the company was sentenced to four years' imprisonment at the end of 2013 due to the use of inferior silicone and the deliberate deception associated with it by trial sites, medical professionals and patients. (Fp)