Product Liability for Medical Implants – BGH Strengthens Manufacturer Security
No Liability for Breakage of Ceramic Inlay in Hip Prosthesis
The Federal Court of Justice (BGH) ruled in its judgment of August 1, 2023 (Az. VI ZR 82/22) that a manufacturer is not automatically liable when a ceramic inlay in a hip prosthesis breaks. Such a break, on its own, does not establish product liability under the Product Liability Act (ProdHaftG), provided that the design and production conformed to the state of science and technology at the time of marketing.
What Happened?
A patient received a hip prosthesis with a ceramic inlay in 2007. This inlay broke four years later and had to be replaced. The affected individual filed a lawsuit for damages – without success. Neither the regional court, the higher regional court, nor the BGH recognized any liability on the part of the manufacturer.
Important Statements by the BGH:
- A product defect in the sense of § 3 ProdHaftG exists only if the product does not provide the safety that can reasonably be expected.
- A higher risk – such as the known breakage susceptibility of larger ceramic inlays – is not automatically a defect if the benefits outweigh the risks.
- It is crucial to determine whether there was an avoidable risk from an objective perspective and whether there were alternative, safer product solutions available.
- Warning notices are only necessary if there are concrete, serious indications of a risk. Such indications were not present in 2007 – breaks of this nature were documented only starting from 2009.
Importance for Manufacturers of Medical Devices:
The ruling provides legal certainty for companies in the medical technology sector, particularly in the area of implants. The BGH clarifies that absolute product safety is not required. What matters is that technical risks are manageable and that the benefits of the product outweigh those of comparable alternatives.
Practical Tip:
Manufacturers should comprehensively document their technical documentation, risk assessments, and test reports, and regularly review them for new scientific findings. A standardized risk management system according to MDR or ISO standards helps minimize liability risks.
Source:
BGH Judgment of August 1, 2023 – VI ZR 82/22