Case C-503/13, Boston Scientific Medizintechnik GmbH – are pacemakers with a significantly increased risk of failure defective? [judgment 2015, ECLI:EU:C:2015:148]

If a type of pacemaker has a significantly increased risk of premature failure, then does that make it defective for the purposes of the EU’s ‘defective product’ Directive 85/374/EEC? And if so, should a patient’s health insurer be compensated for the costs entailed in removing the patient’s pacemaker and implanting a different one?

Facts
At the turn of the last millennium, two patients in Germany were fitted with a specific type of pacemaker. Five years later, the manufacturer issued an urgent warning about the technical safety of those devices. Consequently, the patients’ pacemakers were surgically removed and replaced with other ones.

A dispute arose between the patients’ insurer and the company which had imported the pacemakers into the EU – a company subsequently absorbed into Boston Scientific Medizintechnik.

One of the key points of the dispute is that the claimant insurer has relied on expert evidence that states that the chance of this model of pacemaker prematurely failing was between 17 and 20 times higher than that which would normally be expected. The defendant has denied liability on the basis that no-one had ascertained whether the particular devices that had been implanted into these two particular patients were in fact defective.

The dispute was escalated to the German Supreme Court, which felt that the success of the claim turned on the wording of the EU’s ‘defective products’ Directive, namely, Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ [1985] L210/29).

For whereas Article 1 states as clear as day, ‘The producer shall be liable for damage caused by a defect in his product’, Article 6 of the Directive then defines when a product is ‘defective’, namely:

1. A product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including:
(a) the presentation of the product;
(b) the use to which it could reasonably be expected that the product would be put;
(c) the time when the product was put into circulation.
…

The phrase giving rise to the problem was ‘the safety which a person is entitled to expect’. Now was this ‘person’ to be a specialist doctor, or the patient? The manufacturers submitted that the safety expectation was that held by a medical specialist. Furthermore, there was never a one hundred percent guarantee of safety when implanting a pacemaker.

The Supreme Court was minded to understand ‘the person’ as being the patient. Risk was not to be assessed in terms of a patient’s health and the introduction of a properly working pacemaker. Rather, the risk related to the pacemaker failing prematurely. A doctor did not need to rely on the pacemaker, it was the patient who reckoned on the pacemaker working. And given the risks to a patient’s health that would result from a pacemaker failing prematurely, a patient was in principle entitled to expect almost no margin of error.

Assuming that a significantly increased risk of premature failure rendered the pacemaker ‘defective’ for the purposes of the Directive, then the question arose as to whether the insurer qualified for compensation.

Here, the relevant provision of the Directive was Article 9:

For the purpose of Article 1, ‘damage’ means:
(a) damage caused by death or by personal injuries;
(b) damage to, or destruction of, any item of property other than the defective product itself, with a lower threshold of 500 ECU, provided that the item of property:
(i) is of a type ordinarily intended for private use or consumption, and
(ii) was used by the injured person mainly for his own private use or consumption.
This Article shall be without prejudice to national provisions relating to non-material damage.

But what Article 9 meant was unclear. Did the phrase, ‘damage caused by … personal injury’, mean that the insurer should be compensated for the costs entailed with surgically removing the pacemaker and introducing a new one?

A five judge chamber of the German Supreme Court decided to ask questions of the CJEU.

Questions Referred
According to the Curia website, the German Supreme Court has asked:

1. Is Article 6(1) of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products […] to be interpreted as meaning that a product in the form of a medical device implanted in the human body (in this case, a pacemaker) is already defective if devices in the same product group have a significantly increased risk of failure, but a defect has not been detected in the device which has been implanted in the specific case in point?

2. If the answer to the first question is in the affirmative:
Do the costs of the operation to remove the product and implant another pacemaker constitute damage caused by personal injury for the purposes of Article 1 and point (a) of the first sentence of Article 9 of Directive 85/374/EEC?