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The silicone implants of the French brand Poly Implant Prothése (hereinafter referred to as: PIP) have been a much-discussed subject in terms of liability. In 2010 it emerged that the company had committed a large-scale fraud in its manufacturing process by using substandard industrial silicone gel. Since then damages actions brought against various actors – such as manufacturers and distributors – have all been extensively reviewed by courts. In 2017 the liability of hospitals has been brought up to Dutch courts.[1] According to plaintiffs, hospitals also should be held accountable for the use of a defective medical device under article 6:77 of the Dutch Civil Code (DCC). In this way, plaintiffs seek compensation for material and non-material harm caused by the use of PIP implants.

In article 6:77 of the DCC the liability for the use of auxiliary equipment can be found. In the performance of an obligation, equipment may appear to be unfit for this purpose. The shortcoming that arises will, in principle, be imputed to the promisor. Exceptions are possible in the view of the content and scope of the legal act from which the obligation arises, the generally accepted principles and lastly when there are other circumstances that make attribution of risk unreasonable. In 2018 the Court of Appeal of Den Haag referred questions to the Dutch Supreme Court regarding the liability on the basis of 6:77 DCC and the (potential) liability of hospitals, due to an attributable shortcoming on their side.[2]

In June 2020 the Dutch Supreme Court delivered a judgment in which it answered the preliminary questions from the Court of Appeal.[3] For there to be liability, according to article 6:74 of the DCC, there must be a shortcoming in the medical treatment agreement of article 7:446 DCC. The Supreme Court first of all clears up what their understanding of a shortcoming in medical context is. For this, the state of art is used as a standard. When the promiser – acting under the medical treatment agreement –complies with the medical insights of that time, this may form an obstacle to speak of a shortcoming. The state of art in the medical context therefore are the medical insights at the time the equipment, like an implant, is inserted. In October 2020, the Court of Appeal of ‘s-Hertogenbosch finds that PIP implants with industrial silicone gel were not the state of art.[4] For that reason a shortcoming can be found.

However, even if industrial silicone gel was used on the plaintiff, the Court of Appeal of ‘s-Hertogenbosch concludes that the shortcoming is not attributable to the hospital in question. In line with the Dutch Supreme Court, the Court of Appeal finds that the hospital should not be held liable due to the circumstances of the case. Firstly, it is emphasized that this is a large-scale fraud in the production and inspection of the implants. The (greater) expertise of hospitals therefore is not of significance. Secondly, the liability of hospitals for the damage that the plaintiff has suffered will consequently lead to a large number of damage claims. The Court of Appeal, just like the Dutch Supreme Court, finds that this is problematic due to limited possibilities of hospitals to insure against such claims. The producer of the PIP implants has gone bankrupt, so that means it is also not possible for hospitals to take recourse against the producer. Plaintiffs therefore cannot successfully seek compensation from hospitals for harm caused by the use of PIP implants.

[1] Court of Limburg 31 May 2017, ECLI:NL:RBLIM:2017:4981; and Court of Amsterdam 24 May 2017, ECLI:NL:RBAMS:2017:3491

[2] Court of Appeal Den Haag 13 February 2018, ECLI:NL:GHDHA:2018:166.

[3] The Dutch Supreme Court 19 June 2020, ECLI:NL:HR:2020:1090

[4] Court of Appeal ’s-Hertogenbosch 27 October 2020, ECLI:NL:GHSHE:2020:3319

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