PARIS (AP) — France’s highest court overturned Wednesday an appeals court ruling that would have required some 1,700 women in multiple countries to pay back compensation they received over rupture-prone breast implants.
The decision by the Court of Cassation means the years long case involving German products-testing company TUV Rheinland must be retried. The company initially was ordered to pay damages of 5.7 million euros (currently $6.5 million) to the women.
TUV Rheinland said in a statement that the company was not at fault and had “performed its mission … diligently and in total compliance with the applicable regulations.” It said it was “serene” about the ruling.
While 1,700 women are directly affected by the decision, the French high court’s ruling could have fallout for thousands more seeking damages from TUV Rheinland in other lawsuits.
The legal drama involves tens of thousands of women from Europe and South America who received the faulty implants, which were made with industrial-grade silicone instead of medical silicone. The scandal helped lead to tougher European medical device regulations.
The manufacturer of the implants, French company Poly Implant Prothese, or PIP, was convicted of fraud. But the bankrupt manufacturer couldn’t pay damages to the women with often painful, leaky implants. They sought compensation from TUV Rheinland instead, arguing it should have never certified the product in the first place.
The ruling issued Wednesday overturned a 2015 decision from an appeals court in Aix-en-Provence that the German company was not liable for the faulty implants and the women had to pay back the damages.
The Court of Cassation concluded otherwise, ruling that “vigilance” is “an obligation.” Evidence of potential problems with a medical device means a company like TUV Rheinland “must take all needed measures,” including conducting surprise visits to manufacturers.
TUV Rheinland lawyer Cecile Derycke said the company has paid 5.7 million euros ($6.5 million) overall to the women involved in the French court case, many of them living in Colombia but also around Europe and elsewhere.
Derycke argued that TUV Rheinland was unfairly held responsible for PIP’s wrongdoing.
A lawyer representing women with the implants, Olivier Aumaitre, warned before the ruling that if no one were held responsible for the defective implants, Europe’s consumer product certification system was meaningless.
“We’re in a new phase of the process,” Aumaitre said after the decision. “Until now, there was a period of doubt.” He said the high court clarified what the appeals court had ignored.