ECJ rules against woman given faulty breast implants
February 16, 2017
The European Court of Justice (ECJ) ruled on Thursday that German regulator TUV Rheinland is not responsible for health risks incurred by defective breast implants that it had certified as safe.
According to the decision, testing, inspection and certification organizations like TUV are not required to go to factories to inspect the quality of medical products themselves and are allowed to rely on data provided by the manufacturer.
The case was brought by a woman in Germany, who had been asking for 40,000 euros ($42,555) in damages. On medical advice, the plaintiff removed her implants made by the now-defunct French prosthetics firms Poly Implant Prothese (PIP).
In 2010 it was revealed that the company was using industrial grade silicon instead of medical grade - resulting in a major increase in risk of ruptures or leaking and most likely causing several cases of breast cancer and even death due to system toxicity. The French government immediately ordered a recall of the implants.
Hundreds of thousands affected
Some 300,000 women from 65 different countries are thought to have been affected by the scandal. In January, a court in Toulon, France ordered TUV Rheinland to pay 3,000 euros ($3,180) in damages to each of the 20,000 French plaintiffs who had brought a similar suit against the regulator. When the German victim brought this most recent case to her country's high court in Karlsruhe, however, the judges kicked the matter up to the ECJ in order to establish a EU-wide precedent on the matter.
TUV Rheinland had consistently argued in both cases that it was duped by PIP, which they said presented their inspectors with false documentation.
Dozens of other cases involving TUV have found the safety body not liable for faulty medical devices, as the costs could destroy the firm that is relied on to test safety and rule-compliance for products around the world.
es/rt (dpa, AFP)