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PIP breast implants case: The French Supreme Court refers a case back to the Paris Court of Appeal

10/10/2018France

Cologne, October 10th, 2018 – As mentioned in a previous statement, the French Supreme Court (Cour de Cassation) handed down decisions today in the scope of the PIP breast implants case, a month after another of its decisions that has definitively recognised the notified body TÜV Rheinland LGA Products GmbH as a victim of the fraud committed by PIP's managers.

In today's decisions, the French Supreme Court dismissed all the plaintiffs' criticisms of the way the Aix-en-Provence Court of Appeal had interpreted the applicable regulations. The French Supreme Court thus confirmed the analysis of the applicable regulations made by the Aix-en-Provence Court of Appeal, which had excluded the liability of the German notified body TÜV Rheinland LGA Products GmbH and the French company TÜV Rheinland France SAS (hereafter the "TÜV Rheinland companies").

Moreover, the French Supreme Court dismissed the appeals of nearly 850 plaintiffs. This means that the appellate judgment of the Aix-en-Provence Court of Appeal is now final vis-à-vis these plaintiffs, who represent approximately 26% of the plaintiffs. Amongst these plaintiffs, those who had received a provisional payment in 2014 will have to pay it back to the TÜV Rheinland companies.

With respect to the other parties, the French Supreme Court considered that the Aix-en-Provence Court of Appeal had not sufficiently addressed, in its decision, two of their allegations. Consequently, the French Supreme Court referred these plaintiffs and the TÜV Rheinland companies back to the Paris Court of Appeal to clarify these points.

According to Maître Cécile Derycke, Counsel for the TÜV Rheinland companies: "The TÜV Rheinland companies are serene. Firstly, today's decisions confirm a procedural principle fundamental to any legal proceedings, which the TÜV Rheinland companies have been defending since the beginning of these proceedings: claims brought against them must be declared inadmissible if the persons bringing those claims do not prove their right of action. The French Supreme Court also dismissed the criticisms of the way the Aix-en-Provence Court of Appeal interpreted and applied the regulations. The referral of the case back to the Paris Court of Appeal is only due to the fact that the Aix-en-Provence Court of Appeal did not sufficiently address two plaintiffs' arguments. We are confident that the Court of Appeal to which the case has been referred back will confirm that TÜV Rheinland LGA Products GmbH performed its mission as a notified body diligently and in total compliance with the applicable regulations and TÜV Rheinland France SAS committed no fault. The position of the TÜV Rheinland companies in this respect is supported by a long series of positions taken in their favour by many courts and authorities that have examined the merits of the PIP case".

Today's decisions are another step in the dispute resulting from the fraud PIP committed for years to the detriment of the concerned women, but also of the notified body TÜV Rheinland LGA Products GmbH. The French Supreme Court, which did not decide on the issue of the liability of the TÜV Rheinland companies, provides courts, and notably the Court of Appeal to which the case has been referred back, with indications as to the factual points that remain to be examined in the case.

French courts currently dealing with disputes, and notably the Paris Court of Appeal to which today's case has been referred, will examine the cases referred to them in light of today's decisions and on the basis of the numerous exhibits, which demonstrate that the TÜV Rheinland companies are not liable.

For years, the manufacturer of breast implants PIP systematically deceived the French authorities in charge of market surveillance and the notified body TÜV Rheinland LGA Products GmbH. The fraud committed by PIP was not detectable by TÜV Rheinland LGA Products GmbH, and could not be discovered in the scope of the missions entrusted to notified bodies by the applicable regulations and in light of the information available to the auditors commissioned by TÜV Rheinland LGA Products GmbH at PIP's premises.

This is the line of a long series of positions taken in favour of the TÜV Rheinland companies by many courts and authorities that have examined the merits of the PIP case so far. At the European level, the Court of Justice of the European Union ("CJEU") ruled in February 2017 that notified bodies, such as TÜV Rheinland LGA Products GmbH, are under no general obligation to carry out unannounced inspections, to examine the devices or to examine the manufacturer's business records. Further to this decision, the German Supreme Court (Bundesgerichtshof), which had referred the matter to the CJEU, ruled that the notified body TÜV Rheinland LGA Products GmbH was not required to pay unannounced visits to PIP, to test the products and/or to examine PIP's business records as there was no evidence indicating PIP's fraud.

In the scope of criminal proceedings, TÜV Rheinland LGA Products GmbH has been recognised victim of the fraud committed by five managers and executives of PIP by the Marseilles Criminal Court in December 2013, which the Aix-en-Provence Court of Appeal and then the French Supreme Court confirmed in May 2016 and September 2018 respectively. These managers and executives liable for the fraud committed to the detriment of the concerned women and TÜV Rheinland LGA Products GmbH were sentenced to prison sentences – in certain cases, for several years.

Background: PIP deliberately manufactured silicone gel breast implants using – at least temporarily – a non-declared silicone filler gel. PIP deceived the notified body TÜV Rheinland LGA Products GmbH ("TRLP") and always declared that it only used the silicone gel that it declared to TRLP as raw material. PIP provided the auditors from TRLP with extensive documentation (design dossier, batch records, manufacturing instructions) regarding the alleged use of the declared silicone gel. Any clue or element concerning the use of different raw materials was systematically concealed by PIP. Through this large-scale and particularly complex fraud, PIP deceived all the parties involved: first and foremost the women with PIP implants, but also the health authorities and TRLP. As soon as PIP's fraud was discovered in late March 2010, TRLP suspended the certificates it had granted to PIP. TRLP is very sensitive to the concerns of the persons with PIP implants and share these persons' interest in a full investigation of PIP's criminal actions being carried out. Consequently, TRLP filed a criminal complaint against PIP and its managers.

TÜV Rheinland is a global leader in independent inspection services, founded 145 years ago. The group maintains a worldwide presence of more than 20,000 people. The independent experts stand for quality and safety for people, technology and the environment in nearly all aspects of life. TÜV Rheinland inspects technical equipment, products and services, oversees projects, and helps to shape processes and information security for companies. Its experts train people in a wide range of careers and industries. To this end, TÜV Rheinland employs a global network of approved labs, testing and education centers. Since 2006, TÜV Rheinland has been a member of the United Nations Global Compact to promote sustainability and combat corruption. Website: www.tuv.com

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