Mary Smillie has been quoted in an article published by Scrip Regulatory Affairs on the CJEU ruling that if a medical device has a potential defect based on quality control checks, it is possible to classify all products of the same model as defective "without the need for showing that the product is defective in each individual case". You can read the full article below.

The Court of Justice of the European Union has delivered a preliminary ruling on defective medical devices that could introduce new costs for manufacturers.

The CJEU ruled that where a medical device has a potential defect based on quality control checks, it is possible to classify all products of the same model as defective "without the need for showing that the product is defective in each individual case"1,2

In addition, it ruled that the manufacturer would have to reimburse the costs relating to the replacement of any potentially defective products, where such replacement is necessary to restore the level of safety which a person is entitled to expect.

The CJEU ruling has product liability implications for medtech manufacturers because "there is no need to show the actual defect in the product which has been used in the patient," explains Lincoln Tsang, a partner in the law firm Arnold & Porter.

In simple terms, the court ruling means, if there is a high likelihood of there being a defect by reference to the product characteristics shared by products in the same class, then a product belonging to the same class could be classified as defective, Dr Tsang told Scrip Regulatory Affairs.

The CJEU judgment should serve as a reminder to all medical device manufacturers that they are responsible for monitoring the safety of their products throughout the lifecycle of those products, said Mary Smillie, a solicitor at firm Rouse.

In light of the CJEU ruling, device manufacturers should check that they have appropriate systems in place for reporting potentially faulty products and adequate product liability insurance. "If their devices will be implanted into thousands of patients, they will need to check that the insurer will reimburse them for the costs of any remedial action such as product replacement surgery that they may be required to bear," Ms Smillie told SRA.

"The CJEU has ruled that where the 'recall' is of a product (like a pacemaker), which has to be surgically replaced in a patient, the device manufacturer may also be liable for the cost of the surgery. They may be required to pay, even if, after replacement, the individual medical device is shown not to be defective," she added.

The matter was brought before the CJEU on the request of the German Federal Court (Bundesgerichtshof) to clarify the interpretation of the EU Product Liability Directive (85/374/EEC). The case concerns medtech manufacturer Boston Scientific Medizintechnik and health insurance providers AOK Sachsen-Anhalt and Betriebskrankenkasse RWE.

In this case, Boston Scientific had carried out quality control checks on pacemakers and implantable cardioverter defibrillators that it sold in Germany and found that these products might be defective and constitute a danger to patient health. It recommended that physicians replace the pacemakers implanted in patients with other pacemakers provided free of charge, and to deactivate a switch in the defibrillators.

The matter was before the federal German court when companies that had provided health insurance to patients, whose pacemaker or defibrillator had been replaced, claimed reimbursement of the costs relating to such replacement from Boston Scientific.

The CJEU's input was sought because to claim damages under the Product Liability Directive, a consumer has to first prove that the concerned product was defective. In this case, the pacemakers and defibrillator were replaced or deactivated on the presumption they could stop working in the future based on extensive testing of copies of these products.

The CJEU was asked to rule on whether it is necessary to show that each product is actually defective or whether a defect can be "inferred" by reference to the fact that other products in the same class have a significantly increased risk of failure or malfunction, explained Dr Tsang.

The central question resides on an assessment of what constitutes a defective product. Under the Product Liability Directive, a product is termed defective when it does not provide the safety which a person is "entitled to expect". In the case of medical devices, such as pacemakers and implantable cardioverter defibrillators, the court observed patients are entitled to expect particularly high level of safety requirements.

The CJEU ruled that if products in the same group or product series have a potential defect, then it is possible to classify as defective all products in the entire group or series, without there being a need to show that the product in question is defective. " The judgment that such products belonging to the same group or forming part of the same production series [can be classified as defective], without the need to show that the individual product in question is defective widens the scope of protection under the Product Liability Directive," notes Ms Smillie.

The CJEU noted that its interpretation is consistent with the objectives of the Product Liability Directive, which seeks to pursue a fair apportionment of the risks inherent in modern technological production between the injured person and the producer.

With regard to monetary compensation for replacing potentially defective pacemakers, the court held the medtech company liable for such costs. Regarding implantable cardioverter defibrillators, in respect of which Boston Scientific recommended merely the deactivation of a switch, the court left it up to the German court to determine whether that is appropriate for correcting the defect in those products or whether it is necessary to replace the product for that purpose.

Ms Smillie points out that device manufacturers must also implement their own procedures for reporting product defects which potentially impact product safety and quality (including labeling or packaging defects) and any problems with the manufacturing process. Any defect which could result in a product being recalled must be reported immediately to the national competent authority.

This article was first published in Scrip Regulatory Affairs on 11 March 2015.