There has been a long-standing debate in the literature and case law about whether a doctor and/or hospital should be liable for the use of an unsuitable ancillary. Consider, for example, an implant that turns out to be defective, but suture used during surgery also falls under the concept of an ‘ancillary item’ for which a physician and/or hospital could possibly be held liable. My colleague Irene Timmermans among others, has contributed to this discussion in the literature.1
On February 21, 2020, Advocate General to the Supreme Court Wissink submitted two conclusions. These conclusions discuss the liability of doctors and/or hospitals for ‘product failure’ of medical aid cases under Article 6:77 of the Civil Code.
Advocate General Wissink has written conclusions for the following two cases that - except for specific facts related to the case - are identical:
- Miragelplombezaak (a cassation proceeding);
- PIP implant case (a preliminary ruling with questions from the ‘s-Hertogenbosch Court of Appeal).
In this blog, I discuss these conclusions and my main take-aways thereof.
Wissink's summary answers
It all revolves around the following article of law (Art. 6:77 BW):
If in the performance of an obligation use is made of an item of property unsuitable for that purpose, the resulting shortcoming shall be imputed to the debtor, unless this would be unreasonable in view of the contents and scope of the legal act from which the obligation arises, generally accepted practice and the other circumstances of the case.
The debate is whether this section of the law can be used to establish physician and/or hospital liability when a medical device was used (which ultimately caused problems) in the context of the treatment agreement.
Wissink indicates that some extension of physician and/or hospital liability may be warranted. However, he does not arrive at a clear answer for all cases. It always comes down to making clear on what basis it is judged that the auxiliary case is unfit, that this constitutes a deficiency, and why it is reasonable to attribute this deficiency to the debtor or not.
Wissink believes that a certain amount of restraint is appropriate in this regard, and the question of whether a particular cause of ‘failure’ of the case falls within the ambit of the practitioner's or hospital's risk should be approached as an open question (and not one that comes from the mold of main rule exception).
Wissink thus indicates that it is a matter of customization and, as far as he is concerned, no main rule-exception rule should be formulated. This is also how he concludes his conclusions:
10.13 [...] “At the current state of affairs, the case law will still have to find its way, assuming that the Supreme Court were to chart a course that strikes a middle ground between an approach that may be generally too strict for patients (type: there is never contractual liability for defects that the practitioner did not and could not know about) and an approach that may be generally too strict for practitioners and hospitals (type: Article 6:77 of the Civil Code establishes liability for defective items as the main rule with only a limited exception possibility).”
I discuss the conclusions in more detail below.
Structure of conclusions
As mentioned, Art. 6:77 BW is the main subject of the conclusions. Prior to that, Wissink discusses three other topics:
- Regulation and CE marking of medical devices;
- Legal relationship between patient, practitioner and hospital;
- Legal regulations on unfit and/or defective items in general.
In doing so, Wissink provides a nice overview of the current status of each topic.
Wissink then proceeds to the core of the conclusions: application of Art. 6:77 of the Civil Code for unqualified medical aid cases and the liability of doctors and/or hospitals for this. In this regard, Wissink asks himself three main questions:
- Does Art. 6:77 even apply? Is a medical item such as an implant “used” in the performance of the treatment agreement and/or is there “delivery” of it?
- How to determine whether an ancillary item is unfit and its use constitutes a deficiency?
- How is the sphere of risk of practitioner and hospital further defined?
Main question 1
This is actually more of a preliminary question: do we get around to applying Art. 6:77 DCC in the present cases? After all, Art. 6:77 BW talks about “making use” of an object. Wissink answers this question in the affirmative. If (for example) an implant is placed in a body in the context of a treatment agreement, then it is indeed “used” in the performance of that treatment agreement.
Main question 2
Among other things, Wissink argues here that unfitness and defectiveness of an item do not automatically coincide. A non-faulty thing can be unfit; a faulty thing need not be unfit.
Main question 3
To answer this question, Wissink looks at two issues:
- Distinction between different types of medical aid cases;
- Viewpoints.
Subject 1
According to Wissink (and others), it may be helpful to distinguish between:
- Auxiliary items characteristic of treatment (e.g., an implant);
- Other ancillary items (e.g., suture and instruments used).
(Very) briefly, Wissink argues that for “other auxiliary matters” there may be certain arguments that point more toward an extension of the physician's and/or hospital's sphere of risk for product failure.
Topic 2
According to Wissink, the question for allocating the risks of the auxiliary case should additionally consider the following circumstances/viewpoints:
- Physician's unawareness of unfitness;
- Expertise of physician and patient;
- Which party benefits from the use of the auxiliary case?;
- Insurability;
- Portability (and recourse and the number of unqualified auxiliary cases);
- Choice of parties;
- Control of parties.
According to Wissink, the strength of these arguments depends on the circumstances of the case and thus may vary depending on whether the case is a typical auxiliary case or an other auxiliary case.
Comment
I enjoyed reading these conclusions and, as far as I am concerned, they provide a nice summary of the current state of affairs on this subject. I can understand why Wissink does not want to formulate hard rules: it remains a precarious subject with divided opinions in the literature and case law. It is also questionable whether it is desirable to formulate such hard rules - that might turn out to be disadvantageous for the patient, which I, as a personal injury lawyer for victims, do not find desirable.
Whether the Supreme Court will also take this ‘cautious’ approach remains to be seen. A ruling by the Supreme Court in the Miragelplombe cassation proceedings will probably follow in a few months. The Supreme Court will also answer the preliminary questions raised by the ’s-Hertogenbosch Court of Appeal, after which the case will go back to the Court of Appeal and be judged by it.
In any case, it is clear that the last word on the subject has not yet been written.
If you have questions about this blog, please contact the author, Laura-Jean van de Ven
1. I.C. Timmermans, “Contractual liability for medical aid cases”, VR 2014/13 and “Should a health care provider vouch for the quality of breast implants?”, AV&S 2015/4, p. 26.