German firm found liable in breast implants case

AP News
Posted: Nov 14, 2013 4:36 PM

PARIS (AP) — A French commercial court on Thursday ordered a German product-testing company to pay damages to more than 1,600 women and six distributors after ruling that it failed to properly check silicone breast implants that turned out to be prone to leakage.

The court in southeastern Toulon ordered TUeV Rheinland to pay yet-to-be-determined damages to plaintiffs seeking at least 50 million euros ($67.2 million). Experts will now decide the appropriate damage award — a process expected to take months.

TUeV has denied responsibility and plans to appeal.

The trial was part of a string of cases centered on the now-bankrupt French implant vendor Poly Implant Prothese (PIP), whose founder and several former employees are facing a criminal trial in nearby Marseille over claims the company used cheap silicone to fill tens of thousands of implants that were prone to ruptures and leaking. A verdict is expected in that case on Dec. 10.

Because PIP is bankrupt, the 5,000 women who have joined a complaint against the French company aren't likely to retrieve much compensation. But TUeV Rheinland, a leader in the industry which was charged with checking the quality of the implants, has deep pockets.

Plaintiff lawyers argued that the French unit of TUeV Rheinland that conducted the inspections was competent for inspecting home appliances like vacuum cleaners and washing machines — not silicone breast implants.

Laurent Gaudon, a patients' lawyer, called the ruling "a great victory. The court has been audacious by deciding important compensation for PIP victims."

Olivier Aumaitre, a lawyer for the distributors, said the ruling could open the way for tens of thousands of women worldwide to potentially claim financial damages in France against TUeV Rheinland.

Defense lawyer Cecile Derycke suggested TUeV Rheinland was being targeted as a scapegoat because it's solvent.

"This ruling is totally shocking. It goes against the case file, the argument of the state prosecutor in the hearing — who asked for TUeV Rheinland to be cleared of any responsibility — and when I read the ruling, I see no reference to documents or specific information," she said by phone. "People are on the hunt for someone who can pay these patients."

PIP once claimed its factory in France exported to more than 60 countries and was one of the world's leading implant makers. The implants were not available in the United States, but at least 125,000 women worldwide received them until sales ended in early 2010 — possibly many more. According to government estimates, more than 42,000 women in Britain received the implants, as well as over 30,000 in France, 25,000 in Brazil, 16,000 in Venezuela and 15,000 in Colombia.

After PIP went out of business, regulators across Europe began demanding tighter oversight of medical devices.