France, Court of Cassation, 10 October 2018 15-26.093

Identification of the case

• Articles R. 665-1 to R. 665-47 of the Public Health Code and Article R. 5211-40 of the same Code

• Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Summary of the case

The French company PIP, which manufactures and markets breast implants, asked a German company (a notified authority responsible for the certification of implantable medical devices within the meaning of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices) to assess the conformity of its implants with the requirements of the Directive.

The German company delivered a decision to approve PIP's quality system. Following an inspection, the French Health Products Safety Agency found that these implants had been partly manufactured from a different silicone gel than the one that appeared in the file for compliance with the provisions of the directive. Because of the risk of early rupture of the implants manufactured by PIP and the inflammatory nature of the gel used, the French Ministry of Health recommended that all the women concerned have their implants explanted as a preventive measure.

The German company was assigned for liability and compensation for failures in the conduct of the certification procedure and in the implementation of the surveillance and recertification operations provided for by Directive 93/42, in particular during the quality surveillance carried out at PIP's premises in France.

The Court of Appeal ruled that the notified body and its subcontractor had not committed any fault in the performance of their surveillance task. The Court considered that the review of PIP's material accounting didn’t have to be check during the certification body's mission. The Court of Appeal relies on the provisions of the Directive which do not stipulate that auditors have the right to carry out checks on the accounts of an audited company and that an exhaustive and detailed check of the manufacturer's material accounting does not seem to fall within the tasks and objectives of this inspection.

• Civil judicial enforcement

Civil liability of products - Liability of a notified body for damage caused by medical devices.

Relying on the decision of the CJEU (Elisabeth Schmitt C-219/15) concerning the liability of notified bodies for damage caused by medical devices, the Court of Cassation imposed an obligation of vigilance to notified authorities responsible for the certification of implantable medical devices. The Court précises that during their monitoring mission, if indices suggest that the devices are not consistent with the requirements of the Directive 93/42/EEC, these authorities must take all the necessary measures and, in this case, check the documents identifying the raw materials or proceed with unscheduled visits to the manufacturer.

By failing to examine the manufacturer's data relating to PIP's purchases of silicone gel, which would have enabled it to establish that the data were clearly unrelated to the number of prostheses produced, the notified body had not adopted the appropriate measures for the situation. In the absence of such audits, the notified authority was found to be liable.

Elements of judicial dialogue

• Direct dialogue between CJEU/ECtHR and National court (out of preliminary reference procedure)

• CJEU, C-219/15, Schmitt