PIP breast implant case
A fraud by a French manufacturer that filled its breast implants with industrial-grade silicone gel, uncovered in 2010, whose court cases settled the liability of the certification body and the territorial reach of the manufacturer's insurance.
The PIP case is the fraud committed by Poly Implant Prothèse, a manufacturer in La Seyne-sur-Mer that filled its breast implants with unapproved industrial-grade silicone gel. The French health authority suspended the implants in March 2010 and the company was liquidated that year. Some 30,000 women in France had them, and several hundred thousand worldwide. The founder, Jean-Claude Mas, was sentenced in Marseille in December 2013 to four years in prison. With the manufacturer insolvent, victims turned to two other pockets. The first was the German notified body that certified the quality system, TÜV Rheinland. The EU Court of Justice held on February 16, 2017 (Schmitt, C-219/15) that a notified body may skip unannounced inspections, except when there are signs of nonconformity. The Cour de cassation on October 10, 2018, overturned the Aix-en-Provence ruling that had cleared it. The Paris Court of Appeal then found it liable, and the Cour de cassation upheld that finding in 2023. The second pocket was the manufacturer's liability insurer, whose policy covered only harm occurring in France. For the underwriter, the case shifted risk toward the certifier. EU Medical Device Regulation 2017/745 now requires notified bodies to carry liability insurance and to perform unannounced audits. Not to be confused with an unintentional series defect: here the fraud was deliberate.
On June 11, 2020, the EU Court of Justice ruled on a patient implanted in Germany who sued PIP's French insurer directly (C-581/18). The policy limited cover to harm occurring in France. The Court held that, absent EU harmonization of liability insurance for medical devices, the nondiscrimination principle does not apply to that clause. Patients implanted outside France were left with no insurance to claim against.
PIP implants, PIP breast implant scandal, PIP notified body liability
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