The European Commission has recently started trilogue negotiations to revise the Medical Devices and Diagnostics Directives. The new revisions would potentially mean that manufacturers not only have to have their product file and quality system tested, but must have a physical sample tested as well. In many cases, this will create more work than is currently required by the so-called ‘interim measures’ already imposed. The risk environment is increasingly friendly to the consumer, so manufacturers must focus on compliance and development and agree on contractual indemnities.
Although Europe is trying hard to harmonise legislation, courts in several jurisdictions are struggling with the interpretation of the applicable European Directives. This leads to inconsistent approaches and results across jurisdictions. For example, in the Poly Implant Prothèse (PIP) case, patients started proceedings against the notified body across Europe. PIP was a French company that supplied thousands of women with defective breast implants. In Germany, it was found that the notified body did not violate its duty of care, whereas in France it was found that it did. In appeal, the judgment of the French court was reversed. However, the scope of the liability principle according to the Medical Devices Directive still remains vague and unclear. The European Court of Justice (ECJ) will soon provide further guidance as the German Supreme Court has referred a question to the ECJ regarding the scope of the notified body’s responsibilities in the PIP case.
PIP patients in the Netherlands employed a different strategy, issuing a summons to the hospital for implanting defective breast implants. In 2014, the Dutch Court of Appeal in ‘s-Hertogenbosch’s preliminary ruling assumed that the breast implants were defective and awarded the claim by attributing the manufacturer’s negligence to the hospital.
However, in a PIP case where health insurers had summoned various hospitals, the Dutch Court of Amsterdam came to an opposite judgment in 2016. These two judgments show that even in the same jurisdiction, European Directives can be applied differently. Another striking point is that the Amsterdam Court explicitly took into consideration the judgment of the French Court of Appeal, which ruled in 2015.
Another example is the Boston Scientific case. The ECJ found a pacemaker by the medical device maker to have an increased failure rate which was nearly 20 times higher than the normal rate. However, the claimants were unable to prove that the pacemaker in question was defective as the device had been disposed of. The ECJ applied a broad definition of a defect, requiring the claimants to prove that the product was part of a series or group which is subject to a potential defect. They also stretched the definition of damages to include costs relating to the replacement of a defective product, under the condition that such an operation is necessary to overcome the defect.
While from a consumer perspective the Boston Scientific judgment may sound fair, it potentially imposes a higher level of risk on the whole medical devices sector. Manufacturers could now be confronted with risk liability claims for defective products and also for potentially defective products. Care should be taken to ensure this line of argumentation is not easily applied to other kinds of medical products.
Eva Schothorst-Gransier, Partner, CMS Netherlands