The discovery in March 2010 of a massive fraud involving silicone gel breast implants manufactured by Poly Implants Prothèses (PIP) had shaken the thousands of victims affected and the entire healthcare sector. Indeed, an inspection carried out by the AFSSAPS revealed that, for around ten years, the company had been using a ‘homemade’ silicone gel instead of the approved silicone gel specified in the (certified) manufacturing procedure for the implants. It emerged from this situation that the implants produced under these conditions had bypassed all the safety guarantees associated with the manufacture and monitoring of a Class III implantable medical device (which constitutes the highest risk).
Nearly one in three women affected by this fraud had undergone breast reconstruction following a cancer diagnosis. This extremely difficult situation, due to the double burden it imposes on the women affected, led the National League Against Cancer, following the discovery of the health scandal, to release emergency funds to provide psychological, social and material support to the women concerned, as well as legal support for the victims through a dedicated unit, which the firm managed. The harm suffered by women with these implants, linked to the substandard quality of the prostheses, had manifested itself in some cases as premature ruptures, serous fluid leakage and the development of siliconomes. In addition to these physical injuries, the women who had the implants – or those who had had a PIP implant in the past – began to experience anxiety, leading the vast majority of them to undergo preventive explantation.
In order to stand alongside the victims and champion the interests of healthcare users, the National League Against Cancer and the association Vivre comme avant decided to bring a civil action in the fraud trial held in April and May 2013 before the Marseille Criminal Court, and in November 2015 before the Court of Appeal of Aix-en-Provence. The law firm was also representing a number of women who were civil claimants. Almost six years after the fraud was uncovered, the Court of Appeal of Aix-en-Provence upheld the convictions handed down at first instance against the company’s former executives and directors for aggravated deception, fraud (to the detriment of the certifying body) and complicity in these offences, as well as the compensation awarded to the victims.
For the first time, compensation for anxiety-related distress was awarded outside of asbestos-related litigation. The sentences handed down by the Criminal Court were upheld by the Court of Appeal, with the company’s chief executive receiving the maximum sentence available for the offence of deception (four years’ imprisonment without parole), as well as a fine of 75,000 euros and a permanent ban on practising in the healthcare sector and managing a company. The Court of Cassation upheld the convictions in September 2018.
In this case, the association, through its lawyer Capucine Lanta de Bérard, placed particular emphasis on the need for the offence to be recognised as aggravated fraud, “posing a danger to human health”, rather than mere fraud, as the defendants had argued. This classification was essential to ensure that the trial, through this conviction, would serve to strengthen health safety in the future and that manufacturers of medical devices would be aware of the seriousness of such fraud and the need to comply with the ‘essential safety requirements’ laid down in this area.
The Court of Appeal recognised this need – which had been strongly emphasised by the League – by ruling that, ‘by disregarding all these requirements and choosing to fill the medical devices intended for implantation in the human body with a gel which was not only different from that specified in the design dossier drawn up with a view to obtaining CE certification, but which, moreover, was manufactured using products not approved for medical use and which had not been tested in accordance with the required standards under conditions that would establish their safety, the defendants, as the court found, exposed the users of these devices to a risk to their health”.
This case is emblematic in many respects – not only because of its scale, the seriousness of the alleged offences and the suffering of the victims, but also because of its legal and procedural peculiarities. As the first criminal case in France to involve more than 7,500 civil claimants, it required extraordinary organisational measures and highlighted the limitations of the current criminal procedure when it comes to conducting a mass trial.
It also represents an innovation on the part of the Public Prosecutor’s Office, which had decided to separate the proceedings relating to fraud from those opened during the preliminary investigation for bodily harm and manslaughter, primarily in the interests of speed (the preliminary investigation is still ongoing nearly ten years after the fraud was uncovered). The Public Prosecutor’s Office had also chosen to open the preliminary investigation file to cross-examination, even though no legislation provided for this at the time. This separation of the case led to part of the evidence from the ongoing investigation file being admitted during the trial proceedings to enable the defence to exercise its rights. The legal victory for the civil parties will, however, remain largely symbolic.
Indeed, it is impossible for them to receive effective compensation, as the five defendants – private individuals – are unable to pay the compensation to which they were ordered to pay, given that PIP was in compulsory liquidation at the time of the trial. SARVI made up for this shortfall, but only in part. Similarly, the company’s insurer paid partial compensation. This case highlights the difficulty of reconciling criminal liability with effective redress for victims in a case where the defendants alone cannot bear the burden. Certain parallel proceedings were brought against the State and the certifier of the implants. In reality, only the creation of an ad hoc compensation fund – by bringing together all the parties involved in the case around the same table – would have made it possible to find a more acceptable solution for the victims.