Country

The Netherlands

Court

Court of Appeal of The Hague of 18 September 2012 (LJN BX8413 and JA 2012,212)

Topics

Product liability

Defective product

"Advantage Heart valve"

Articles

Articles 6:185 et seq. of the Dutch Civil Code ("DCC")

EU Product Liability Directive (Directive 85/374/EC, the "Directive")

Facts

On 29 January 2004, the claimant underwent a heart surgery in the Leiden University Medical Centre (LUMC) during which she received a mechanical heart valve prosthesis - the so-called "Advantage heart valve" - manufactured by Medtronic B.V. in Heerlen, the Netherlands ("Medtronic"). The Advantage heart valve was first affixed with the CE mark on 12 August 2003 and had been in use in Europe since then.

In August 2004, during the claimant's half-yearly medical examination, her doctor discovered that the heart valve did not close properly (known as intermittent regurgitation ("IR")). Since the IR could have been caused by a surgical thread or connective tissue coming loose, it was decided - in consultation with the claimant - to carry out revision surgery.

During further surgery, on 3 November 2004, the treating surgeon confirmed that the heart valve did not close properly, but he was unable to find the cause of the fault. It was decided to implant a new Advantage heart valve from exactly the same series as the first. However, the outcome of the claimant's next half-yearly medical examination again showed IR. Since the claimant was not suffering from any complaints, the medical specialist from the Academic Medical Centre in Amsterdam (AMC) to whom the claimant had been referred for medical treatment decided to pursue "expectative policy" (expectation beleid: Expectative policy means a "wait and see" approach to surgery, by watchful waiting and closely monitoring the health situation of a patient and to adjust the medical treatment when it is clear that the health situation get worse, meaning that in that case a further surgery would be carried out), a policy which is still in use in relation to the claimant.

On 27 July 2005, Medtronic informed doctors and users that it had received reports from patients of IR in combination with the Advantage heart valve, without those patients having any other complaints and without undergoing further surgeries. The claimant initiated legal proceedings against both the hospital and the treating surgeon (i.e. the surgeon from the LUMC hospital who implanted the heart valves (i.e. the surgeon from the LUMC hospital who implanted the heart valves), as well as against Medtronic as the manufacturer of the heart valve prosthesis. The claimant's case against Medtronic was that she had twice received a defective product that had caused her to suffer IR as a result of which she suffered from health injury and, in consequence, she held Medtronic liable for all the damages she had suffered as a result. More specifically the claimant alleged that her existing heart condition was "injured" as a result of the IR.

The District Court in first instance denied the claimant's claim. Subsequently, she initiated appeal proceedings before The Hague Court of Appeal.

Legal questions

Can a leaking heart valve be considered a defective product within the meaning of the Dutch law (i.e. Article 6:186 DCC) implementing the Directive?

Decision

The Court of Appeal confirmed the decision of the District Court in first instance that the claimant's Advantage heart valve prostheses could not be considered defective within the meaning of Article 6:186 DCC.

Firstly, the Court of Appeal considered that it had not been established that the Advantage heart valve contained a design defect (ontwerpfout), since the Advantage heart valve obtained a CE mark and was used extensively. Moreover, only a few patients who received the Advantage heart valve suffered from IR and this usually did not result in clinical complaints or in revision surgery.

According to the Court of Appeal, the mere fact that the heart valve does not always close properly did not mean that it does not work properly or that it is unsafe. Like the District Court in first instance the Court of Appeal decided that this was a "good-natured phenomenon". The claimant had not sufficiently stated or substantiated that the Advantage heart valve does not provide the safety which one is entitled to expect from a mechanical heart valve. The claimant could not reasonably expect that the Advantage heart valve would be 100% leak-proof. Moreover, the Court of Appeal ruled that the claimant had not plausibly made out that she had suffered from any damage caused by the IR of the Advantage heart, nor had it become evident that the health situation of the claimant had got worse after the surgeries.

Furthermore, the Court of Appeal ruled that Medtronic had not failed in its duty to disclose information (informatieplicht). In this respect, the Court of Appeal considered that it was not evident that Medtronic was already aware of the cause of IR with the Advantage heart valve prior to 2004. According to the Court of Appeal Medtronic had taken sufficient steps to further investigate the relationship between IR and the Advantage heart valve, and had then informed the users of the Advantage heart valve of the IR issues in July 2005.

The Court of Appeal also dismissed- consistent with the District Court in first instance - the claimant's claim against the hospital and the surgeon.

Comments:

This judgment of the Court of Appeal further demonstrates the circumstances that can be important when deciding whether or not a product is defective within the meaning of Article 6:186 DCC. Article 6:186 requires that all the circumstances must be taken into account, but - as is also brought forward by the annotator to the judgment - the safety which a person is entitled to expect is an important issue in this respect (reference is made to the note of the annotator Mr. J.P.M. Simons). The Court of Appeal concluded in this case that the leaking heart valve was not defective pursuant to Article 6:186 NCC. The main reasons for this were that, although the Advantage heart valve caused IR, it continued to function properly and patients did not suffer from any further complaints. The Appeal Court also considered it important that the IR occurred only in a very small percentage of patients who had an Advantage heart valve. This judgment highlights that in order to be able to successfully claim damages, there must actually be some form of damage; the Appeal Court held in this case that damage had not been proven.