Geographic restriction of insurance cover for medical devices sanctioned by Advocate General

Disputes resulting from substandard silicone breast implants manufactured by the French company Poly Implant Prothèse (PIP) continue to arise. The latest concerns the scope of PIP’s liability policy and in particular a clause which restricted cover to damage caused in France. The issue was referred to the European Court of Justice by a German court which was considering damage sustained by a German patient in Germany.

The claimant had implants manufactured by PIP inserted in Germany in 2006. PIP was liquidated in 2011 and by 2012 the German authorities recommended complete removal of PIP implants.

French law imposes compulsory insurance for manufacturers of medical devices and provides claimants with a direct right of action against the insurer. The claimant began proceedings in Germany against: her surgeon, Allianz France (which provided liability to cover to PIP) and TUV Rheinland, the notified body which was commissioned by PIP to carry out conformity assessments.

The Allianz policy had a clause which limited cover to damage sustained in France. The claimant argued that to uphold this restriction in her case would amount to unlawful discrimination on the grounds of nationality, which was specifically prohibited by article 18 of the European Treaty. The point was referred to the Court of Justice (CJEU) and Advocate General Bobek delivered his opinion on 6 February 2020.

In the AG’s view, EU law was engaged on three levels: the cross-border movement of goods, the receipt of insurance services in another Member State and the normative regimes of the two directives, ie on product liability and on medical devices. He noted, however, (the underline has been added) that “none of those directives contain specific provisions regarding insurance  against civil liability for harm caused to end users of medical devices, which is the specific issue raised by the present case. Unlike, for instance, in the motor insurance sector, where an insurance obligation for vehicles covering the entire territory of the European Union was laid down, it was manifestly not the intention of the EU legislature to harmonise the Member States’ legislation regarding insurance against civil liability arising out of the use of medical devices.

The present case was certainly the result of the fact that the EU had chosen not to harmonise the matter of liability insurance for medical devices. Nevertheless, it would fall to Member States to regulate policies for medical devices used in their territory even when such devices are imported from another Member State.

While it was correct that rules on free movement (here, of goods) and article 18 covered the flow of goods across borders, they did not apply to the subsequent use of those goods in the destination Member State. The AG found that to decide otherwise would mean that “the movement of goods in Europe would become (once again) reminiscent of medieval legal particularism, whereby each product would, like a person, carry its own laws with it. Goods would be like snails, carrying their homes with them in the form of the legislation of their country of origin, to be applicable to them from their production to their destruction.”

The press release accompanying the Opinion makes this point less colourfully and it simply says that the fact that goods once came from another Member State is not a sufficient reason to suggest that anything later concerning those goods is covered by EU law.

The restriction in the Allianz policy was permitted under French national law and that was a legitimate legislative choice for the French state to make.

The Advocate General’s Opinion is not necessarily the end of the matter, however. While the court will decide the case with the benefit of the Opinion, it is not obliged to follow it. It will be worth looking out for its judgment later in the year.


Alistair Kinley, Director of Policy & Government Affairs

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