LUXEMBOURG (CN) – Only the victims of defective breast implants made by French manufacturer PIP who had their surgeries in France are eligible for compensation, an adviser to the EU’s highest court said Thursday.
The advisory opinion of European Court of Justice Advocate General Michal Bobek is a blow to some 300,000 women across 65 countries who received implants filled with an industrial silicone intended for mattresses, rather than medical-grade silicone, manufactured by French company Poly Implant Prothèse, or PIP.
“The civil liability insurance of breast implant producer PIP could validly be limited to women who underwent surgery in France,” Bobek said in his opinion for the Court of Justice.
Though opinions from advocate generals are nonbinding, rulings from the Luxembourg-based court usually follow the same legal reasoning.
The Higher Regional Court Frankfurt am Main referred the case to the Court of Justice, after a woman who received a defective PIP implant in 2006 sued PIP’s insurer Allianz in German court. According to a clause in the agreement between Allianz and PIP, the insurance company was only liable for products used in France and the woman had her surgery in Germany, so Allianz claimed it wasn’t responsible.
According to the advocate general, under current EU law, it is up to member states “to regulate insurance policies applicable to medical devices used on their territory.” Bobek found there is 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.
French health care watchdog AFSSAPS withdrew PIP implants from the market in 2010 following complaints from surgeons, and the company went into bankruptcy the same day. 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 Court of Justice is expected to issue its ruling later this year.