District Court of Freiburg builds upon the ECJ's case law on suspected defects.

In a recent judgment of 2 August 2019 (Case No.: 1 O 460/11), the District Court of Freiburg ordered a prosthetic hip manufacturer to pay compensation for pain and suffering as well as damages for a defective hip prosthesis system. The judgment deals once again with the question of instruction defects in connection with defective surgery guides, building upon the ECJ's rulings with regard to suspected defects.


The plaintiff suffered from a destructive coxarthrosis in both hips. As a result, she was given a prosthetic right hip in 1996 and the prothesis at issue in this case was implanted on the left side in 2006. The defendants in this case were the manufacturer of the prosthesis system and the company which imported the system into the European Internal Market.

The prosthesis system consists of a "large diameter head" (LDH) prosthesis which was first introduced into the market in 2003. The surgery guide which was made available to the plaintiff, and which was in effect at the time of the implantation, contained statements about how the prosthesis system can be properly inserted into the joint by cutting the bone. In the ensuing period, however, the plaintiff experienced massive pain in the area of her left hip joint, so that revision surgery was indicated, resulting in the finding of massive inflammation in the area of the bursa on the left side, as well as metallic residue and a chromium content of 53.3 µg/l in the patient's blood, with a cobalt content of 54.7 µg/l.


The court granted the complaint and ordered the defendant to pay compensation for pain and suffering in the amount of € 17,500.00, as well as compensation for material damages.

In the District Court's view, it had been established that the prosthetic hip which the plaintiff used was defective since the acetabulum could not be properly inserted because of erroneous instructions in the surgery guide which was in effect at the time (instruction defect). The court also found that the prosthetic system at issue was defective because it was part of a product series with an increased likelihood of failure.

In this judgment, the District Court of Freiburg built upon the case law of the ECJ with respect to suspected defects. In a case involving implantable pacemakers and defibrillators, the ECJ ruled that users of certain product groups may have such high expectations with regard to safety that an increased likelihood of defects within the series is enough for an individual product to be considered defective even if there is no evidence of an actual defect.

The District Court of Freiburg issued similar judgments on the same date in Cases Nos. 1 O 223/12 and 1 O 266/12. The judgments are still subject to appeal.

[October 2019]