"It is a great victory for patients because it opens the door to compensation for all those affected by PIP," Olivier Aumaitre, the French lawyer who initiated the lawsuits against the certifier, told a press conference in Paris. The decision reverses the decision of a Court of Appeals in Aix-en-Provence, which, in 2015, exempted TÜV from liability in the case of defective breast implants, as decided by several courts of first instance.
TÜV granted the French company Poly Implants Prothèses (PIP) the certification required by a European directive of 1993 to be able to commercialize breast implants. The company became the third largest producer of breast implants worldwide. The French subsidiary of the German certifier carried out, between October 1997 and January 2010, up to 13 controls in the PIP premises, without at any time finding a breach of the regulations. The scandal erupted shortly after the last inspection, on March 29, 2010, when the French health insurance agency banned the sale and use of these pre-filled silicone gel prostheses after discovering that PIP used an industrial silicone gel since 2001 fill the implants.
A notice to European certifiers
According to Aumaitre, the decision of the highest court in France is also "good news for Europe", because the PIP case has questioned the European quality certification. This ruling "will change the practices of certifiers and we imagine that insurers will also be much stricter", said the lawyer, who appeared before the press accompanied by other colleagues representing clients from Europe and Latin America, where almost half of the approximately 400,000 affected by defective implants are concentrated, around 10,000 in Spain.
A victory for the victims
Berta Gómez is one of those affected. This Venezuelan, resident for a year and a half in France, put the PIP implants in 2008 in their country of origin, with 50,000 victims the second country after Colombia in number of affected. A few years later, he told this newspaper, he began to feel "cramps". The two implants had been broken. An allergic reaction caused by the implant fluid, which had reached his lungs, prevented an initial intervention to replace the implants and has left him with serious respiratory problems since then. After hearing the decision, she declared herself satisfied. "Any amount of money given to all the women who had these implants is not equivalent to the suffering and all the diseases that we are suffering from that product, but I am happy that we have won," he said.
The decision of the French supreme court refers only to one of the three processes underway – and a fourth that is expected to be presented at the end of the year – against the TÜV certifier opened by PIPA World, the association that brings together the victims of the defective implants. But the complainants believe that the ruling will positively affect all cases. This is what the lawyers call the "TÜV 1", the first of the trials underway and by which a commercial court in Tolón ordered in 2013 to repair the damages caused to the 1,700 victims represented in the civil trial, starting with the payment of an advance of 3,000 euros. The certifier appealed the decision and the court of appeals of Aix-en-Provence exempted her from responsibility three years ago, a decision that has now been revoked. The case will be tried again, this time by the Paris appeals court.
Two more processes, TÜV 2 and 3, bring together some 20,000 patients. In 2017, TUV was again sentenced to compensate the victims and to pay 60 million euros, at a rate of 3,000 euros to each of the 20,000 claimants from 14 countries. According to the PIPA lawyers, the judges who must review this sentence again were awaiting the decision of the Court of Cassation, which makes them feel very hopeful that no court will reject from now the responsibility of the German certifier and your French subsidiary. "Now it will be very difficult for TÜV to escape from its responsibility," said Aumaitre, according to which the compensations that the certifying body must pay could be multimillion-dollar, since it is estimated that there are some 400,000 affected by defective implants, although only a small percentage has joined the demands so far. The lawyers calculate that the average compensation will be around 15,000 euros.
The lawyers, who have also proposed the creation of a "compensation fund" to accelerate payments to victims who can not afford the removal of the implants or the medical consequences that have left them, do not rule out that this ruling leads to the certifier to seek an out-of-court settlement that accelerates payments to victims.