German Federal Court of Justice on burden of proof requirements: No product liability for breakage of a ceramic inlay in a hip prosthesis

In its judgment of August 1, 2023 (case no. VI ZR 82/22), the 6^th Civil Senate of the German Federal Court of Justice ("BGH") dismissed the appeal against the manufacturer in proceedings concerning alleged manufacturing, design and instruction errors in connection with the breakage of the ceramic inlay of a hip prosthesis and, moreover, confirmed (for the time being) the established rules on the burden of presentation and proof in this respect.

Facts of the case

The judgment of the BGH is based on the following facts: In 2007, the plaintiff had been implanted with a hip endoprosthesis manufactured by the defendant. The inlay used for the cup of the prosthesis had been pressed into a metal casing. Due to a fracture of the cup installed in the prosthesis, it was replaced in 2011, approximately four years after implantation. The plaintiff considered the broken cup to be a product defect in the hip prosthesis and demanded material and immaterial damages from the defendant, an Austrian company.

The decision of the BGH

The German courts had international jurisdiction. As the action had been filed before January 10, 2015, jurisdiction (still) arose from Council Regulation (EC) No. 44/2001 of December 22, 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, so-called "Brussels I Regulation" (Sec. 5 No. 3, 60 (1)).

In addition, German law was applicable to the dispute. Due to the uncertainties as to whether, in the context of the ROM II Regulation, the event giving rise to the damage should have been seen as the "time of placing on the market" (before 2007) or whether it should have been the "time of the occurrence of the infringement" (here 2011), the parties made an express choice of law at the oral hearing in the appeal instance - which the BGH (surprisingly) considered to be permissible (whether under Sec. 14 (1) of the ROM II Regulation or under Sec. 14 (2) of the ROM II Regulation).

In terms of content, the BGH then came to the conclusion that the plaintiff was not entitled to the asserted claim for material and non-material damages either pursuant to Sec.1, 3, 8, 9 German Product Liability Act (ProdHaftG) or pursuant to Sec. 823 (1) German Civil Code (BGB). The Court of Appeal, in this case the Higher Regional Court of Brandenburg, had already assumed without error of law that the plaintiff had not proven that the product manufactured by the defendant was defective within the meaning of Sec. 3 (1) ProdHaftG. The 6^th Senate of the BGH explained very clearly why there was neither a manufacturing defect nor a design defect nor an instruction defect: According to Sec. 1 (4) sentence 1 ProdHaftG, the injured party bears the burden of proof for the existence of a product defect and the causal link between the defect and the damage. The fact that the ceramic inlay had a distance of 0.65 mm from the upper metal edge of the metal coating did not constitute a manufacturing defect. In this respect, the expert in question had not been able to establish that the sinking of the ceramic inlay into the metal coating could have had an effect on the fracture resistance. Contrary to the opinion of the appeal, the Higher Regional Court had also not misjudged the occurrence of prima facie evidence here; on the contrary, the typical sequence of events for the occurrence of prima facie evidence was lacking (in the specific case). And the fact that the inlay had broken - as the Court of Appeal rightly pointed out - did not allow the conclusion to be drawn that there was a design defect, as the use of a different material would not have meant any more safety. At the time the product was placed on the market, there was no reliable scientific evidence that the use of a different material would have resulted in fewer fractures. Finally, there was no instruction error, as a risk beyond the generally existing risk of breakage was not known at the time the product was placed on the market and it was therefore not even logically possible at that time to provide any information.

In addition, the BGH emphasized in its reasoning, which is particularly relevant in practice, that the 4^th Senate of the Higher Regional Court of Brandenburg had correctly denied the use of the main features of the decision of the Court of Justice of the European Union ("ECJ") from 2015, according to which a defect within the meaning of Sec. 3 (1) ProdHaftG could already be assumed for certain medical products (such as pacemakers or implanted cardioverter defibrillators) if there was a "suspicion of a product defect". Therefore, the defect had to be specifically proven, which was not possible. In the opinion of the BGH, the very interesting question of whether the case law of the European Court of Justice on pacemakers and implantable cardioverter defibrillators is transferable to risks posed by implantable products such as hip endoprostheses was not relevant. According to the plaintiff's submission, the breakage of the ceramic inlay had led to a malfunction of her prosthesis. The subsequent replacement operation had served to eliminate this malfunction and not to eliminate the risk of future failure of the product. The BGH therefore ruled that the manufacturer was not liable because even if a potential serial defect had been assumed, it would not have been the cause of the plaintiff's physical injury.

Notes for the practice

The decision of the BGH is convincing and deserves special attention, as the rules established in product liability law regarding the burden of presentation and proof are confirmed (for the time being).

However, this could change in the future: Industry experts will be aware that the key points for a new product liability directive are already available. As the case cited by the Federal Court of Justice again shows, it is not always easy for injured parties to prove the defectiveness of the product and the causal link between the defectiveness and the damage incurred. One of the core concerns of the new Product Liability Directive is therefore likely to be the facilitation of evidence and access to evidence for injured parties. While the full burden of proof for the damage remains with the injured party, the defectiveness and also the causal link should always be rebuttably presumed by the court seized of the case if it would be excessively difficult to provide evidence due to technical or scientific complexity. The injured party may then only have to prove that the product was "probably defective" or prove that this probable defectiveness "probably caused" the damage.

Furthermore, the draft Product Liability Directive provides for injured parties to be granted access to (relevant) evidence to a large extent in future. The injured party should be able to request access to evidence in the manufacturer's possession in order to better assert claims. This obligation to disclose evidence is a different approach towards the previous German law (and goes far beyond Sec. 142 of the Code of Civil Procedure (“ZPO”)).

As representatives of producers and/or liability insurers, we can only make an urgent appeal with regard to the proposed significantly increased liability risks and, moreover, hope that courts will deal with these new approaches - should they come into force - in a restrictive manner.