On November 14, 2013, the Toulon Commercial Court found TÜV Rheinland liable towards victims of the PIP (Poly Implant Prothèse) scandal. The Court concluded that TÜV Rheinland had been negligent in carrying out its duties as a “notified body,” a key element of the European medical devices regulatory framework. This in turn allowed PIP, a French medical device manufacturer, to commit one of the most significant cases of fraudulent activity in the medical devices sector to date.
For over seventeen years, TÜV Rheinland was the notified body for PIP. It granted the necessary certificates allowing PIP to apply the CE-mark, which guarantees compliance of the breast implants with the EU Medical Devices Directive. According to the Court, despite all the means at its disposal, such as unannounced inspections or sample testing, TÜV Rheinland failed to expose the fraud perpetrated by PIP, which had been deliberately substituting cheap industrial silicone for the high quality silicone required for use in breast implants.
In its ruling, the Court adopts an expansive interpretation of the duties of notified bodies. It states that the notified body had an obligation to undertake unannounced on-site inspections, and that it failed to fulfill its obligations of control, prudence, and vigilance in not doing so. Accordingly, the Court ordered TÜV Rheinland to compensate the damage caused to patients, as well as to the distributors and importers of PIP breast implants. TÜV Rheinland is ordered to pay a provisional amount of € 3,000 per victim, pending further assessment of individual damages. As more than 1,600 women and several distributors and importers had lodged a claim, TÜV Rheinland may, under that decision, be liable for millions of euros. The Court ordered provisional execution of the judgment, meaning that it is immediately applicable.
TÜV Rheinland has already lodged an appeal, challenging the Court’s conclusions regarding the duties of notified bodies. It claims that it fully complied with the regulations in place, as it was only responsible for controlling the design and the quality system, that is to say, the manufacturing process, and not the implants themselves. It further argues that it had been systematically deceived by PIP, which presented false documents, and that it did not have sufficient powers to take further actions to unmask the fraud under the legal framework in place at the time.
It is relevant to note that TÜV Rheinland was sued on similar grounds in Germany, where it has not been found liable. The District Court of Nürenberg-Fürth dismissed the action for damages brought by a patient. The Court found that the notified body was not obliged to make unannounced inspections or to examine specific implants. It reached the conclusion that the fraud could not have been detected with the means which the law had given to notified bodies. In March 2013, the District Court of Frankenthal issued a similar decision in another case and stated that “the role of the notified body in the conformity assessment of the manufacturer is to avoid inadvertent errors by the manufacturer; it is not intended to protect against intentional fraud”.
The Toulon Commercial Court ruling was delivered after the adoption in September 2013 of the Commission Regulation No 920/2013 on the designation and the supervision of notified bodies and the Commission recommendation on the audits and assessments performed by notified bodies in the field of medical devices. These measures envisage higher scrutiny of notified bodies and more in-depth controls, including unannounced audits, in order to restore patient and professional trust in medical devices.