Introduction

According to Art. 1 of the EU Product Liability Directive (Council Directive 85/374/EEC) (the PLD) and the relevant national implementation legislation (Sec. 1 of the German Product Liability Act (Produkthaftungsgesetz)), the manufacturer of a medical implant can be held liable for damages such as the costs of replacement surgery, provided that the patient can prove that the implant is defective. 

The European Court of Justice (ECJ) has now clarified two points in its Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt — Die Gesundheitskasse judgment (joined cases C-503/13 and C-504/13). Firstly, manufacturers of pacemakers and implanted cardioverter defibrillators can be held liable for such costs, without the claimant having to prove that the product in question has a defect, provided that products belonging to the same group or forming part of the same production series have a potential defect. In this case, the manufacturer had expressly warned surgeons that an issue with a component of the pacemaker in question could lead to premature battery depletion. Secondly, replacement surgery costs relating to such implants do constitute a damage that must be reimbursed by manufacturers. 

This decision increases the extent of liability for manufacturers of life-sustaining medical implants only. According to a close analysis of the ECJ’s reasoning, it has no general impact on the concept of product liability under the PLD, in particular in relation to the obligation to show evidence of a defect. In the context of medical implant litigation, it will be key for a manufacturer to show that its products cannot be considered “life-sustaining” and thus ensure that the existing position – whereby the claimant has to prove that his or her specific product was defective – continues to apply. 

Indeed, it may be that in due course this decision is found to have an even narrower application – to cases where it would not be possible to determine whether the relevant device was defective without removing it from the claimant, and where removing it from the patient would harm the claimant’s life or health. If so, the decision would also have no application to cases where a medical device had been successfully explanted and was available for expert analysis.

German courts held manufactures of pacemakers and implanted cardioverter defibrillators liable

In two recent cases, German appeals courts had, in the context of pacemakers and implanted cardioverter defibrillators, held that manufacturers may be held liable for replacement costs regardless of whether or not a defect can later be shown, if:  

  • the model type to which the implant belongs is shown to have a failure rate that is appreciably higher than that of other, comparable models;
  • it is not possible to establish whether the particular implant is defective without explanting it; and
  • the life or health of the patient would be threatened if the suspected defect were to materialise.

Following further appeals, the German Supreme Court (Bundesgerichtshof, BGH) referred both cases to the ECJ for preliminary rulings on the interpretation of the underlying PLD. In its referral, the BGH suggested that patients’ justified safety expectations in relation to pacemakers and implantable cardioverter defibrillators meant that, in this case, a 17- to 20-fold increase in the risk of failure was sufficient to constitute a product defect, even if that risk of failure still fell below 1%. This is due to the critical safety functions performed by such implants.

Judgment of the ECJ

As set out above, the ECJ ruled that specific medical products like pacemakers and implantable cardioverter defibrillators may be defective, even if a defect is not established, provided “that products belonging to the same group or forming part of the same production series […] have a potential defect”. This decision was in the context of the manufacturer specifically having warned surgeons that the range of devices in question had battery problems which, for medical reasons, were impossible to assess for each individual patient (as removal for testing could result in death). Furthermore, the ECJ held that the costs incurred as a result of surgical intervention to replace such defective products constitute damage for which the manufacturer is liable, so long as the operation is necessary to rectify the defect in question.

Product defect depends on legitimate safety expectations

A product is defective when it does not provide the safety that a person is entitled to expect. In its reasoning, the ECJ emphasised that these legitimate safety expectations depend in particular on the product’s intended purpose and objective characteristics and properties, as well as the specific requirements of the group of users for which the product is intended. 

High legitimate safety expectations regarding products associated with abnormal potential for damage

In the context of pacemakers and implantable cardioverter defibrillators, the ECJ stressed the products’ exceptional function and the particularly vulnerable situation of patients using such devices. Given these two factors, the safety requirements such patients are entitled to expect of these devices are particularly and unusually high. 

The potential lack of safety that would give rise to a manufacturer’s liability stems from the abnormal potential for damage which these products might cause to the person concerned. In this regard, the ECJ cross-referred to the opinion of Advocate General (AG) Bot, who stated that the defect was a risk of damage of such a degree of seriousness that it affects the public’s legitimate safety expectations. AG Bot also carefully described the exceptional character of pacemakers and implanted cardioverter defibrillators as follows:

  • They are active implantable medical devices that are classified as the most critical medical devices (so-called Class III devices)
  • They are implanted in patients who are made vulnerable by disease and at risk of death.
  • If defective, they are abnormally dangerous, exposing patients to a risk of heart failure or death.

Replacement surgery costs

Given that such implants normally have to be replaced after a certain period of time, the defendant before the German courts rejected liability for the costs associated with the surgical replacement on the basis that they would have been incurred anyway. However, the ECJ ruled that, due to the objective of protecting consumer health and safety pursued by the PLD, compensation for damage “relates to all that is necessary to eliminate harmful consequences and to restore the level of safety which a person is entitled to expect”. In particular, this includes the costs relating to the replacement of the defective product. However, this is only the case where such an operation is necessary to overcome the defect in the product in question. 

Consequences for the interpretation of the PLD 

In its decision, the ECJ outlined the concept of defect in the context of life-sustaining products. However, the decision must be read in light of its underlying facts. The BGH, AG Bot and the ECJ all emphasised the life-sustaining function of pacemakers and defibrillators, the vulnerable nature of patients implanted with such devices and the manufacturer’s admission that the range of products in question could be defective. The abnormal potential for harm associated with such products justifies the high legitimate safety expectations under the PLD.

It is important to determine the exact scope of the decision. There is a risk that this ruling could be misinterpreted, i.e. applied to cases that do not relate to the exceptional circumstances of these cases, in particular to products that – if defective – do not expose patients to a comparable life-threatening risk. It is noteworthy that the ECJ avoided answering the BGH’s rather broad question in respect of implanted medical devices in general, choosing instead to expressly limit its interpretation of the PLD to pacemakers and implantable cardioverter defibrillators. It would be mistaken to apply this ruling to any implant that lacks these twin factors of life-sustainability and particular patient vulnerability. In all such cases, a claimant will still have to prove that the product has a defect. 

Given the above, this decision is important, but it should not alter the general landscape of liability for product defects under the PLD. It is only in circumstances concerning “life-saving” implants that the basic principle requiring claimants to prove a defect will be set aside, leading to extended manufacturer liability. As such, in medical implant litigation, the impact of this decision will turn on whether or not the product in question is considered to be “life-saving” by the relevant court.

It remains to be seen whether or not national courts will appreciate the limits of the ECJ’s decision regarding allocation of liability. Prudent courts should carefully analyse whether a case is comparable to ensure that manufacturers’ liability is not overly extended. The final decision of the BGH is expected to be released in the second half of the year.

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