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Will there be more claims against defective medical products?

The ruling states that an injured party need not demonstrate that a potential defect exists in their individual device where it can be shown that defect exists in a product of the same group or product series. If the device should need to be replaced in order to overcome the defect, the ruling also states that this cost be included.

In our original commentary, we predicted an upswing in the number of claims from patients of similar devices, as in the past the onus was on the claimant to provide the proof that a product was defective, which could be costly and time-consuming.

It is important to note that the Product Liability Directive and the Consumer Protection Act (CPA) make the producer strictly liable. A producer is not just the manufacturer of the finished product but any component or person putting their name to it. The definition of producer also includes any importer bringing products in to the European Economic Area (EEA).

As a result, this ruling means that organisations dealing with these types of devices need to check to see if they could indeed be liable. One example which proved to be a widespread issue in recent years was the so-called PIP-Breast-implant scandal, which as of last month reached the Court of Justice of the European Union (CJEU).

PIP stands for the company name Poly Implant Prothèse which, for years, was illegally selling breast implants containing industrial silicone instead of the medical silicone for which they had received the CE mark.

Claimants with illegal, or ‘defective’, breast implants are now in a position of reduced obstacles to prove that their ‘products’ are defective – an issue which may have previously frustrated potential claimants from bringing an action under the CPA.

Overall, it is probable that this ruling will bring increased claims against defective medical products, but only time will tell. Medical devices manufacturers now need to be more cautious with respect to their product liability risks and medical devices vigilance obligations in the EU. This is further recommended in the light of the recent CJEU decision in which the court substantially increased the product liability risks for medical devices manufacturers in the EU (Judgment of the CJEU of 5 March 2015 in joined cases: C-503/13 and C-504/13).