On 5 March 2015, the European Court of Justice issued a preliminary ruling on two issues arising under the EU Product Liability Directive in a case involving defective pacemakers and defibrillators. Despite the wide range of issues arising under this directive, the Court has had only a few occasions to construe its ambiguous terms. This case, however, provided an opportunity to the Court to settle key issues relating to the defect test and the scope of damages compensable under the directive. 

This alert summarizes the facts and the Court’s judgment. It then discusses some of the consequences of the judgment for businesses, both producers and importers.

1. The Facts

A company now owned by Boston Scientific Corporation (“BSC”) manufactures and sells pacemakers and implantable cardioverter defibrillators. It imported and marketed in Germany two models of pacemakers manufactured in the United States and an implantable cardioverter defibrillator manufactured in Europe. 

By letter of 22 July 2005, addressed to treating physicians, BSC indicated that its quality control system had established that a component utilized to hermetically seal the pacemakers which it marketed may experience a gradual degradation which could adversely affect the device’s therapeutic efficacy. That defect could lead to premature battery depletion, resulting in loss of telemetry and/or loss of pacing output without warning. On this basis, BSC recommended that physicians consider replacing such pacemakers for the patients affected. Although the warranty for the pacemakers might have expired, BSC offered to provide replacement devices free of charge for pacemaker-dependent patients and  those deemed by their physicians to be best served by replacement.

Not only did the pacemakers have issues, but also the defibrillators had issues. In a letter to physicians in June 2005, BSC announced that an investigation had shown that a magnetic switch in those defibrillators might remain stuck in the closed position. If the “enable magnet use” mode was activated and the magnetic switch became stuck in the closed position, treatment of ventricular or atrial arrhythmias would be inhibited. As a consequence, any cardiac dysrhythmia that could be fatal would not be recognised by the defibrillators and no potentially life-saving shock would be given to the patient. In light of these issues, BSC recommended that treating physicians deactivate the magnetic switch in the

defibrillators concerned. If that function is deactivated, the patient monitor feature remains unaffected; it does not result in a health risk, but simply a restriction of the functions which the defibrillator can perform.