The ECJ has to deal again with faulty PIP breast implants

Frankfurt Higher Regional Court asks a question about discriminatory insurance cover

The European Court of Justice (ECJ) has to deal again with the defective breast implants of the French manufacturer PIP. The Oberlandesgericht (Higher Regional Court, Frankfurt am Main) on Tuesday, September 11, 2018, asked the Luxembourg judges whether the manufacturer was allowed to restrict his insurance cover to customers in France and whether this would result in a liability of the insurer to customers in other EU countries. Countries (Az .: 8 U 27/17).

The breast implants of the now insolvent French company Poly Implant Prothèse (PIP) have been sold ten thousand times worldwide. They did not contain the usual special but cheaper industrial silicone. The management has been convicted in France for fraud.

According to an estimate by the Federal Institute for Drugs and Medical Devices (BfArM), around 6,000 women in Germany have PIP implants. After reports of ruptured and leaking silicone pads piled up, the French authorities stopped selling in April 2010.

Since it is not possible to predict whether and when there will be problems with the implants, in early 2012 the BfArM recommended women to have PIP implants removed. In the dispute, the plaintiff had also followed suit.

In order to get the costs replaced despite the PIP insolvency, numerous women had initially filed against the operating physicians. However, this did not succeed in the courts in Germany (so OLG Karlsruhe, judgment of 20 April 2016, Az .: 7 U 241/14, JurAgentur-message from 21 April 2016 with further references).

Further complaints were directed against TÜV Rheinland, which had awarded the European CE seal of approval for the implants. On the submission of the Federal Court of Justice (BGH) in Karlsruhe, the ECJ ruled that the CE certification was not associated with a comprehensive monitoring order, even for medical devices; the external audit relates only to the manufacturing process and not the product itself (Judgment and JurAgentur Report of 16 February 2017, Ref .: C-219/15). As a result, the Federal Court of Justice dismissed a corresponding claim (judgment and JurAgentur report dated 22 June 2017, ref .: VII ZR 36/14).

In the Frankfurt case, the claim is now directed against the liability insurance of the manufacturer PIP. After his contract with PIP, the insurance cover was limited to claims in France.

The Higher Regional Court now wants to know from the ECJ whether this was compatible with the European prohibition of discrimination or whether it would rather lead to discrimination against EU citizens from other countries. However, it is unclear whether the prohibition of discrimination can only be observed by the EU and its member states, or whether it can also apply to private persons, such as insurance here. This has not yet been decided by the ECJ.

In the meantime, unannounced inspections and random checks are possible for CE certification for medical devices; from 2020 they are mandatory. mwo