On the 2nd July 2015, the Aix-en-Provence Court of Appeal in France overruled the judgment issued by the Toulon Commercial Court in 2013 establishing the principle of Notified Body liability for defective medical devices.
In opposition to the 2013 ruling, the French Court of Appeal stated that the Notified Body TÜV Rheinland and its French subsidiary had “fulfilled their obligations” in certifying the implants made by French manufacturer Poly Implant Prothese (PIP).
This judgment overturns the decision issued by the lower Court and raises questions about the principle of liability of the Notified Bodies responsible for granting the CE marking in the case of defective devices. As a result the victims will have to repay the interim compensation that was given to them, however, the scope of the liability principle still remains vague and unclear.
Background and Context
The so-called PIP scandal exploded between 2010 and 2011, when almost 300,000 patients throughout more than 60 countries alleged that they had suffered serious damage from the implantation of breast prostheses manufactured by PIP and certified by TÜV Rheinland.
In 2013, the Commercial Court of Toulon found TÜV Rheinland responsible and ordered the Notified Body to pay compensatory damages to the patients and distributors amounting to 5.8 million euro. This decision outlined the possibility to consider Notified Bodies liable in the case of negligent violation of the obligations derived from Article 11 of the Directive 93/42/EEC including the auditing of the manufacturer’s quality management system, examination of product design, product tests and assessment of the existing post-market surveillance system.
Now, the decision made by a French court of appeal excludes this kind of liability and clearly states that TÜV and its French subsidiary are not guilty, as they had “fulfilled the obligations incumbent upon them as a certifying body”.
Perspectives and Potential Impact
The recent decision of the French Appeals Court will certainly increase the number of discussions at EU level concerning the liability for defective medical devices and will most likely result in a number of legislative and regulatory interventions aimed at ensuring a high level of safety for patients and the restoration of patient confidence. The latter will definitely have a consistent impact on medical device manufacturers, who should carefully follow the upcoming development and seriously consider the liability risks associated with their medical products.
The clearing of this principle by the French jurisprudence demonstrates the complexity of the issues related to the responsibility and liability for defective devices. These matters will definitely be the focus of upcoming legislative and regulatory interventions at EU level with a huge potential impact on medical device manufacturers.
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