EU Court Backs Geographic Limits on Insurance for Faulty Breast Implants

A silicone gel breast implant is shown in 2006 in Irving, Texas. (AP Photo/Donna McWilliam)

LUXEMBOURG (CN) — In a blow to 300,000 women with faulty French breast implants, the EU’s highest court ruled Thursday that patients who underwent surgery outside of France cannot seek compensation.

The ruling from the European Court of Justice stems from the bankruptcy of Poly Implant Prothèse, or PIP, a French company that had filled its breast implants with an industrial silicone, which intended for mattresses, rather than medical-grade silicone.

PIP’s faulty implants were used in some 300,000 surgeries across 65 countries, but the company had a clause in its insurance contract limiting the geographical extent of coverage.

On Thursday, the Grand Chamber of the Luxembourg-based Court of Justice found that the territorial limits did not violate EU law.

“That contract does not therefore fall within the scope of the exercise of the freedom to provide services,” the court wrote.

The ruling closes the book on a lawsuit by a woman described in court records only as RB, who underwent breast-augmentation surgery with PIP implants in her home country of Germany.

RB’s surgery was performed in 2006, and she had the implants replaced in 2012 based on the advice of national health authorities, after which she sought compensation from her doctor; PIP’s insurer, a company that has since been succeeded by Allianz; and the German regulator TÜV Rheinland.

Back in 1997, PIP had commissioned TÜV Rheinland to carry out regular inspections of its manufacturing systems and other issues.

PIP filed for bankruptcy on the same day in 2010 that French health care watchdog AFSSAPS observed it had been using the unauthorized silicone. In December 2013, the company’s founder and president, Jean-Claude Mas, was jailed for four years and fined 75,000 euros ($82,500) for his role in the scandal.

The Higher Regional Court Frankfurt am Main referred RB’s case to the Court of Justice.

Thursday’s ruling meanwhile finds no basis in EU law for Allianz to face claims in Germany. “Such a situation does not fall, as EU law currently stands, within the scope of application of EU law,” the court wrote. 

Earlier this year, in a nonbinding opinion, a magistrate for the EU court argued that it was up to member states “to regulate insurance policies applicable to medical devices used on their territory.”

Advocate General Michal Bobek said there was no harmonization of the regulation of such devices under the Treaty on the Functioning of the European Union, one of two treaties forming the constitutional basis of the EU. 

The 15-judge panel decides in line with the opinions from its advocates general around 80% of the time. 

In a related case in 2017, the Court of Justice held that German courts could decide if the regulator TÜV Rheinland was responsible for the damage done by the products it determined were safe. The safety body claimed it never found evidence substandard silicone was used. 

The German high court ultimately found that TÜV Rheinland was allowed to rely on data provided by the manufacturer and did not have to go to factories to inspect the products themselves.  RB’s case will now be returned to the German court for a final ruling. 

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