German court decides on liability for suspected faultiness of hip endoprotheses - ECJ on pacemakers/ICD revisited

The decision by the European Court of Justice (ECJ) (joined cases C-503/13 and C-504/13 dated 05 March 2015) on the risk of faults being product defects within the meaning of the Product Liability Directive 85/374/EEC has triggered a lively debate on the applicability to other (medical) devices. The ECJ (and subsequently the German Federal Court of Justice in its judgments dated 09 June 2015) had decided on the matter of revision surgeries concerning pacemakers and implantable cardioverter defibrillators (ICD). The Kammergericht (Berlin), equivalent to a Higher Regional Court, now followed the ECJ decision on “suspected faultiness” in a judgment dated 28 August 2015 (4 U 189/11) published recently: For a hip endoprosthesis that is still implanted into the patient and functional.

Facts

In 2004, a multimodular primary implant (Varicon shaft system) manufactured by the defendant was inserted into the plaintiff. Later it was discovered that the breakage rate for this implant system was at 4 to 5%. In comparison, an average breakage rate of no more than 0.017% can be taken as a basis for conventional non-multimodular implants and of 0.1% for other multimodular implants.

The plaintiff’s implant has not broken yet. In addition, the plaintiff had not undergone a revision surgery to replace this implant until the date of the decision. Instead, the plaintiff has sought the decision that the defendant manufacturer be liable for all future material and immaterial damages of the implanted medical device. Furthermore, the plaintiff has already demanded compensation for pain and suffering. The plaintiff has reasoned that the breakage rate alone substantiates a faultiness of the inserted implant.

Court decision by ECJ on suspected faultiness applicable to hip endoprostheses

The Kammergericht has confirmed the faultiness of the implanted hip endoprosthesis invoking the decision by the ECJ in the joined cases C-503/13 and C-504/13. To recap: The ECJ decided on the term of defect under the Product Liability Act that Article 6 (1) of Council Directive 85/374/EEC dated 25 July 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability of defective products be interpreted to the effect that a product pertaining to a group or production series of products such as pacemakers and implantable cardioverter defibrillators for which a potential defect has been declared can be classified as defective without the need for the defect to have been declared for such product.

Such definition of the term defect - according to the Kammergericht - shall also be applicable to hip endoprostheses. The wording used by the ECJ referring to product groups “such as pacemakers and implantable cardioverter defibrillators” shall not exclude an application to hip endoprostheses. The potential lack of safety of products such as pacemakers and implantable cardioverter defibrillators entails from the abnormal potentiality of personal damage that can be caused by them. The interpretation by the Kammergericht has emanated from the fact that the ECJ referred to the effects on health as being applicable without the need for a danger to life and limb of the patient. The Kammergericht has further stated that a fault in a hip endoprosthesis may not have the same drastic effects as a failure in a pacemaker or an ICD, yet “the effects on the affected patient’s health can still be considerable.” A fault in a hip endoprosthesis can be expected to cause personal damage that generally is attributable to such fault in the hip endoprosthesis. According to the Kammergericht this tendency to cause damage results in the assumption of a product defect on the basis of the term “lack of safety” specified by the ECJ. Against this background, the single prosthesis as a part of a series shall be considered defective within the meaning of Section 3 subsection 1 German Product Liability Act, as it does not provide the safety that can be legitimately expected considering all circumstances. A breakage rate of 4 to 5% compared to breakage rates of 0.1 to 0.017% does not fulfil the safety expectations placed in hip prostheses. In this regard, the Kammergericht has also invoked the defendant’s behaviour of reacting to the lack of safety by taking the Varicon system off the market after the problems associated with it having become known.

Interest to seek a declaratory judgment despite revision surgery not having been performed

The plaintiff can seek declaration of the defendant’s obligation to render compensation, as the damage has not yet fully developed in her case. The plaintiff could suffer future material and immaterial damages should a revision surgery become necessary as a result of a failure in the Varicon system. The Kammergericht has equated a “failure” with a future “breakage of the hip prosthesis due to design fault”.

The court has only declined the claim for compensation of immaterial damages (compensation for pain and suffering): The plaintiff had not been able to prove psychological distress caused by the implant of the system suspected of a defect.

Practical significance

The decision by the Kammergericht has been, as far as can be seen, the first decision published in Germany to consider decisions by the ECJ as well as the Federal Court of Justice on “suspected faultiness” of pacemakers and ICD to be applicable to other (medical) devices.

The reasons given by the Kammergericht for applying to a hip endoprosthesis the “abnormal potentiality” in case of a failure in a pacemaker stressed by the ECJ are too feeble to be really convincing. The Kammergericht has equated the ECJ formula showing an “abnormal potentiality” with an “increased risk” that personal damage may occur. Applying this empty formula renders a risk-based definition completely arbitrary in specifying which products a suspected defect in a series shall be inherent to and which not. A mere risk increase cannot be considered to be a product defect in general even after the decision by the ECJ.

Furthermore, the assumption made by the Kammergericht that the plaintiff has an interest to seek a declaratory judgment, although, in fact, she has not undergone a revision surgery due to the suspected defect and does not seem to intend to is remarkable. The court has only referred to future material and immaterial damages that will occur as a result of a breakage of the prosthesis. In contrast, the ECJ has confirmed with its decision the proximate cause for the costs of a revision surgery with regard to the suspected defect. In other words: The ECJ has considered the suspected defect (that cannot be dispelled in situ) to be the cause for the revision surgery, which is why the costs incurring in connection to it were to be replaced.

In this regard, the Kammergericht has considered future damages to be indemnifiable only if a hip endoprosthesis should break “due to design fault.” The added value the declaration of a legal liability for the “effects of a suspected defect” is meant to have does not reveal itself: A design fault is a (specific) product defect that is inevitably inherent to all products of a series. In this case it is not unclear whether the product has a design fault, but whether and when the fault will arise. As soon as the fault arises, the damage will not be the result of a suspected defect, though. Therefore, there is no need for the category of a suspected defect or a “suspected faultiness” as such.

Above all, the declaratory judgment passed by the Kammergericht must not be taken as an inducement to overrule the defendant manufacturer’s objection that the breakage in a specific case may not be the result of a design fault, but of eg a faulty installation, undue stress or - especially after a significant period of time has passed after the implant being inserted - plainly normal wear and tear. To be more specific: The plaintiff has to comprehensively prove that the breakage, provided that it even comes about, has arisen due to the design fault and which damages have resulted therefrom.