A Paris appeals court ruled Thursday that the German safety certification firm TUV Rheinland was liable for improperly approving faulty breast implants and ordered it to pay damages to hundreds of victims.
The latest decision in a 10-year legal battle over implants made by French company Poly Implant Prothese potentially opens the door for tens of thousands of women worldwide to receive compensation.
TUV has faced multiple lawsuits since the scandal erupted in 2010, when French regulators discovered that implants made by Poly Implant Prothese (PIP) had been made with industrial-grade silicone gel, cheaper and more dangerous than medical-grade silicone.
The implants were used for some 400,000 women, most of them in Latin America. Ruptures caused severe lymph node inflammation, and thousands of patients had to have them removed.
The certifier has denied any wrongdoing, with a lawyer telling the Paris court in November that PIP “did everything it could to deceive patients as well as the health authorities and TUV.”
Other courts have cleared TUV of any responsibility despite its finding no causes for concern even after 13 inspections of PIP between 1997 and 2010, most recently an appeals court in the Paris suburb of Versailles.
In a statement after the ruling Thursday, TUV contested the court’s decision that “some pieces of evidence could have led (the company) to take additional measures as of September 2006.”
“The evidence in this case clearly shows that TUV Rheinland acted diligently, in compliance with applicable regulations, and it was not its role to track down the fraud pursuant to regulation,” the company said.
A spokeswoman was not immediately available to confirm if TUV would try to appeal the ruling.