In the Netherlands, there are three potential grounds for product liability. One of these is article 6:185 of the Dutch Civil Code, which is a codification of European product liability rules and holds a specific tort liability norm for the introduction of products in the economical market.
Another premise is article 6:162 of the Dutch Civil Code, which holds the general tort liability norm. The final basis is article 6:77 of the Dutch Civil Code, which doesn't hold a tort liability norm but instead a risk liability norm for the use by the contractor of a defective tool for the execution of the agreement.
Recently, the Court of Appeal ruled on a case (ref: ECLI:NL:GHARL:2018:10336) concerning a medical aid implant which, in retrospect, is considered defective for the intended use.
This ruling is an example of the liability risks under Dutch law based on article 6:77 of the Dutch Civil Code predominantly for medical aid implants which, after some time, prove to be defective for the intended use, although nobody was aware of the defect at the time of introduction and time of use of that medical aid implant.
On 2 July 1992, retinal detachment of the right eye was recorded by the claimant. On 6 July 1992, the claimant's right eye was operated on by Prof. D., opthalmologist at Radboud University Medical Centre (Radboud UMC) to repair a retinal detachment.
In the procedure undertaken, an elastic plastic strap is placed around the eye and the defect is fixed by means of freezing, after which a medical implant called a Miragelplombe is attached at the level of the retinal tear.
Since 1993, the claimant experienced complaints and restrictions (double vision and turbidity) that make him unfit for work. From 2003 onwards, the complaints increased, and during 2005-2007, various treatments were prescribed for this.
In a letter dated 3 September 2007, the claimant held Radboud UMC liable for the damage he suffered as a result of the retinal operation and the subsequent treatments. In the following proceedings, the central question is whether Miragelplombe is a defective tool, as defined in art. 6:77 Dutch Civil Code.
The District Court considers that Miragelplombe used as a tool within the meaning of art. 6:77 BW, and that the characteristics of Miragelplombe mean that it (in retrospect) is to be considered unsuitable for the intended purpose.
As a result, the District Court ruled that Radboud UMC failed to comply with the obligations outlined in the medical treatment agreement made with the claimant.
Subsequently, the District Court investigated whether this shortcoming could be attributed to Radboud UMC and ruled that this was not the case, because Radboud UMCl wasn't aware of the defect at the time. The claimant then appealed this judgment.
Miragelplombe has proved unsuitable due to its composition/characteristics, as a result of which the later complications have arisen. The fact that Miragelplombe was at that time "state of the art" – and that the doctors did not know about future complications – does not change this.
According to the Court of Appeal, it is certain that the aforementioned complications have occurred in this case. The Court of Appeal decision partly aligns with that of the District Court: in principle, according to the main rule in art. 6:77 of the Dutch Civil Code, the use of a defective medical aid item results in a shortcoming in the execution of the medical treatment agreement.
The exception, as mentioned in art. 6:77 of the Dutch Civil Code, that the shortcoming is not imputed when this is unreasonable, does not apply, the Court of Appeal concluded (other than the District Court has ruled).
In the opinion of the Court of Appeal, "ignorance" about a (future) defect in the medical aid item is not sufficient to make an exception to the main rule of (risk) liability in art. 6:77 of the Dutch Civil Code.
Attributing the shortcoming to Radboud UMC is not unreasonable, as the Court of Appeal has taken into account the content and scope of the medical treatment agreement, the general commercial principles and the other circumstances of this case. Radboud UMC is therefore liable for the damage suffered by the claimant as a result of the defect.