In 2007, the plaintiff had been implanted with a total hip endoprosthesis (“artificial hip joint”) manufactured by the defendant. About four years after the implantation, the hip prosthesis had to be replaced. The reason for this was a malfunction of the prosthesis, triggered by the breakage of a cup built into the prosthesis.
The plaintiff considered the defective cup to be a product defect of the hip prosthesis and claimed damages from the medical device manufacturer. The German Federal Court of Justice (BGH), however, ruled that the plaintiff was not entitled to the asserted claim for damages – neither according to the rules of no-fault liability pursuant to §§ 1, 3, 8, 9 of the German Product Liability Act (ProdHaftG) nor according to tort liability under § 823 subs. 1 of the German Civil Code (BGB).
Product defect – yes or no?
In order to establish a possible defectiveness of the hip prosthesis, the BGH first drew on the common concepts of defect. The relevant safety expectations under the German Product Liability Act are generally assessed according to the same objective standards as the manufacturer’s obligations to ensure safety in the context of tortious liability. Therefore, it is generally possible to refer to manufacturing, design and instruction defects, which categorise the specific obligations to ensure safety in the context of tortious product liability. The BGH held that there was no manufacturing, design or instruction defect in the specific case in question. In the opinion of the BGH, the manufacturer had complied with its obligations to ensure product safety. However, the plaintiff could not benefit from the reversal of the burden of proof in favour of the injured party in the present case.
Potential serial defect?
Following the principles of the so-called “suspected defect judgment” of the European Court of Justice (ECJ, NJW 2015, p. 1163), the court also addressed the question of whether the hip prosthesis suffers from a potential serial defect.
In the case of medical devices of higher risk classes, a product defect pursuant to § 3 subs. 1 ProdHaftG is already deemed to exist if a malfunction has occurred in a significant number of products of the same product group or production series. The requirements for the safety of certain medical devices need to be particularly strict, since a potential product defect involves an extraordinarily high potential for harm to affected persons. Accordingly, a defect in other products of the same product group or production series is deemed to establish a firm suspicion of a defect in the specific product, the defectiveness of which then need not be specifically proven, but is presumed.
However, the BGH did not assume a potential serial defect in the specific case in question either. In this context, the BGH considered the fracture rate of ceramic inlays with a size of 36 mm and drew a comparison with ceramic inlays of all sizes. Although marginal differences were found, they were not considered as relevant. The BGH explained that only those parts that were comparable to the relevant product in terms of size, material and construction should be taken into account, because otherwise it could not be assumed that the product group was the same. Moreover, the breakage rate itself was so low that it was not sufficient to assume a serial defect. Regardless of these considerations, the BGH found that the manufacturer’s liability also had to be denied because even if a potential serial defect had been assumed, it would not have been the cause for the plaintiff’s physical injury. The BGH did not address the question of whether the ECJ’s case law can be applied at all to hip prostheses as medical products similar to, for instance, defibrillators. The courts currently hold different positions on this question. Medical device manufacturers can expect further developments on this issue.
The ruling is a welcome development for medical device manufacturers. It demonstrates that the courts do not make undifferentiated rulings to the detriment of manufacturers, which was feared in the light of the “suspected defect judgment”. It also proves that a well-functioning quality management system can successfully implement compliance with manufacturer obligations to ensure safety and thus minimise liability risks.back