France’s highest court has overturned a ruling that required about 1,700 women around the world to pay back compensation they received over rupture-prone breast implants.
The decision by the Court of Cassation means that the years-long case must be retried.
It is one of multiple legal cases stemming from the scandal, which began with a fraud conviction for the manufacturer of the implants, French company Poly Implant Prothese (PIP).
They took their compensation demand to TUV Rheinland, a German products-testing company which was ordered to pay 5.7 million euros (£5 million) in damages. That ruling was overturned in 2015 by an appeals court before the case moved on to France’s highest court.
The women had argued the implants should not have been certified for use.
TUV Rheinland said 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 ruling issued on 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 overall to the women involved in the French court case, many of them living in Colombia but also around Europe and elsewhere.
Mr 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,” Mr 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.