The European Court of Justice has held that a manufacturer of pacemakers and implantable cardioverter defibrillators must reimburse a private health insurer for necessary surgical costs of replacing defective products.  

Two cases were referred to the ECJ for ruling. The first involved a pacemaker which was replaced following quality controls which indicated that the part used to hermetically seal the pacemakers could experience degradation with premature battery depletion. The manufacturer sent a letter to doctors recommending replacing the devices of affected patients. While the replacement pacemaker was free of charge, the patient claimed the cost of the associated surgery from private health insurance.

The second case involved an implantable cardioverter defibrillator. Quality control tests found that the defibrillator might be affected by a defect in a component which could limit the device’s efficacy – a magnetic switch could become stuck in the closed position thereby inhibiting treatment of ventricular and atrial arrhythmias. The manufacturer recommended that doctors deactivate the magnetic switch in affected patients and in this case the patient had the device replaced prematurely.

The Court had to consider whether a medical device is defective if devices in the same group have a significantly increased risk of failure but a defect has not been detected in the specific device. The Court also had to consider whether the costs of the operation to remove the defective product constituted damage caused by personal injury.

The Court concluded that where products belonging to the same group have a potential defect, such a product may be classified as defective without there being any need to establish that the product has such a defect. In addition, it found that compensation for damage must cover, amongst others, the costs relating to the replacement of the defective product.