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Legal Opinion Given on Liability for Defective Medical Devices

An Advocate General of the Court of Justice of the European Union has recently given her opinion in an interesting case concerning liability to patients for faulty medical devices.

Defective Implants

The case concerned a German woman, Ms Elisabeth Schmitt, who had silicone breast implants fitted in December 2008 that had been made by a French company. It was subsequently discovered that the company had been using low-grade industrial silicone to manufacture these implants, and so, following medical advice, Ms Schmitt had her implants removed in 2012.

She took legal action in Germany, claiming €40,000 in compensation for non-material damage and also seeking a declaration opening the way to further compensation for any material damage that she may suffer in the future because of the defective implants.

Claim for Damages

As the French manufacturer had become insolvent Ms Schmitt brought the action against the German company responsible for auditing the manufacturer’s quality system in its capacity as ‘notified body’ for the products in question under the Medical Devices Directive.

The German courts referred the case to the Court of Justice for a decision on the nature of the duties incumbent on notified bodies, as well as the scope of their liability towards patients if they fail to perform these duties adequately.

Product Liability

Advocate General Sharpston has now given her opinion on the matter, in which she noted that, although the Directive imposes primary liability for the product’s compliance on the manufacturer, it does not prevent this liability from being extended to other parties. She pointed out that the Court has already recognised that national legislation may impose liability on importers for specific obligations arising from EU product safety rules.

If a Member State can impose such liability on importers, who occupy a relatively minor role in ensuring product safety, it must also be entitled to do so for notified bodies that have a crucial role in this area, she said.

She therefore concluded that bodies monitoring the quality system of manufacturers of medical devices may be liable to patients for failure to fulfil their duties arising from EU product safety rules. If such a body is put on notice that a medical device may be defective, it is under a duty to take all necessary measures to determine whether its certification of that device may stand.

However, considering the risk of serious economic repercussions of her proposed solution, she has also suggested that the Court limit the temporal effect of its ruling.

This is an interesting opinion that, if followed, could have widely felt repercussions. However, it is important to note that the Advocate General’s opinion is not binding on the Court of Justice. It is their role to propose a completely independent legal solution to the Court on the cases they are responsible for. The Judges of the Court are now beginning their own deliberations in this case, and will give their judgment at a later date.

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If you would like to discuss the possibility of bringing a personal injury claim for harm caused by faulty medical devices, then contact our expert personal injury lawyers today.

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