(CN) – A German agency tasked with overseeing quality control for a now-defunct manufacturer of silicone breast implants may be liable for doing nothing in the face of evidence the implants weren’t fit for human use, Europe’s highest court ruled Thursday.
The European Court of Justice’s preliminary ruling is the latest turn in the six-year saga, after French health authorities discovered in 2010 that the reason Poly Implant Prothese’s silicone breast implants were failing at alarming rates was because the company used inferior industrial-grade silicone that had no business in the human body.
Poly Implant Prothese removed the implants from the EU market and went broke. Meanwhile, a German woman who’d received the implants in 2008 went after the agency that was supposed to audit PIP’s quality-control system for the purposes of EU certification, claiming a cursory inspection of the company’s reports should have made clear to the agency that the wrong silicone was being used.
She seeks $43,000 in punitive damages plus a declaration that the agency, TUV Rheinland, is on the hook for any future compensatory damages.
The German court hearing the case asked the EU high court to weigh in on whether TUV Rheinland can be held liable, since by law liability arises only out of a breach of rule conferring legal protection or contractual obligation.
In its 6-page ruling, the Luxembourg-based high court acknowledged that EU law doesn’t require agencies like TUV Rheinland to carry out unannounced inspections of medical device manufacturing plants or even examine the devices or business records of the manufacturers. However, the court said once evidence of a medical device’s failure comes to light, notified agencies have a duty to investigate.
The court also noted the duty of agencies like TUV Rheinland is to protect the recipients of medical devices. But whether the agency failed in its duty to the point where it should be held liable in this case is governed by German law and must be decided there, the court said.
In the wake of the scandal, the European Commission proposed new regulations to require extensive testing of all medical devices before they hit the market as well as a post-implantation tracking system to improve safety and communication down the road.
Last year, a French appeals court upheld the criminal fraud conviction of PIP’s founder and former owner, including a four-year prison sentence and a fine of $86,000.
No U.S. woman received PIP’s failed implants. However, the scandal affected at least 125,000 women worldwide.