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German can't claim compensation over faulty breast implants

June 11, 2020

French manufacturer PIP's insurers are only liable for claims within France, the EU's top court has ruled. The decision could have ramifications for thousands of women seeking damages.

A woman gets her PIP breast implants replaced during an operation
Image: picture-alliance/dpa/P. Blanchard

The European Court of Justice (ECJ) ruled on Thursday against a German woman seeking €40,000 ($42,555) in damages over defective breast implants.

The verdict comes 10 years after a scandal involving faulty silicone breast implants by a French manufacturer came to light.

The plaintiff had her implants — made by the now-defunct French prosthetics firms Poly Implant Prothese (PIP) — removed on medical advice.

PIP's insurance company declined her request for financial liability, claiming that its contract only applied to France. She later sued the French insurance company for damages before German courts.

The Frankfurt Higher Regional Court asked the ECJ to clarify whether the insurer's decision is compatible with European Union law. In February, the responsible expert in the ECJ had already affirmed its view that PIP's liability insurance coverage could in fact be restricted to affected people in France.

The ECJ confirmed that stance to be adherent to EU law in Thursday's ruling

 

Breast implant trial in France

03:39

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The scandal

In 2010, it was revealed that PIP had used cheap industrial grade silicone for breast implants for years instead of medical grade silicone — resulting in a major increase in risk of ruptures or leaking and possibly causing cases of breast cancer and even death due to system toxicity. The French government immediately ordered a recall of the implants. 

In February 2017, the ECJ had ruled that German courts could decide whether regulator TÜV Rheinland — the safety board which approved the products — was  responsible for health risks incurred by defective breast implants that it had certified as safe.

TÜV claimed it had never found any evidence that industrial silicone was being used.

Germany's top court, the Federal Court of Justice, subsequently ruled that testing, inspection and certification organizations like TÜV 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.

Some 400,000 women worldwide are said to have been given the defective implants after cancer or for breast enlargement.

PIP founder Jean-Claude Mas was sentenced to four years in jail in 2016. However, he never began the sentence due to an appeals process. He died in April 2019 at the age of 79. 

mvb/rt (AFP, dpa)

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