Summary

This thesis focuses on the liability of the healthcare provider for the use of medical devices. Due to different approaches to the interpretation of the applicable rule, it is currently unclear whether the liability of the healthcare provider in the Netherlands is strict or fault-based. To answer whether the healthcare provider should be liable for the use of medical devices and whether this rule should be strict or fault-based, research is done into Dutch, German, French and English law. Also, the question has been approached from a law and economics perspective. To assess which remedies are available to the patient who has suffered damages caused by a medical device, the research has not solely focused on the liability of the healthcare provider, but also on the potential liability of the producer of a medical product and the potential liability of a notified body.

The liability of the producer of a medical product has been discussed in Chapter 2 of this dissertation. The rules on product liability in the Netherlands, Germany, France and England have been implemented Directive 85/374/EEC on product liability. For a patient who has suffered damage due to a defective medical product, the regime of the Directive contains several challenges. First of all, the Directive does not allow for a farther-reaching liability regime of actors whose position is regulated by the Directive. Therefore, a rule of strict liability of (e.g.) a supplier of products is not allowed. A patient is supposed to bring its claim against the producer. This might be undesirable for a patient due to difficulties in finding the source of the injury, and if it is established that the source is the medical product, proving the defectiveness of this product. Furthermore, it might jeopardise the protection of the patient if the producer appears to be insolvent. Secondly, the Directive does not provide for rules on several requirements for liability that play an important role in the medical context, such the requirement of causation and the right to immaterial damages. Lastly, the relatively short limitation period of the Directive might be problematic for a patient who has suffered damage caused by a medical product, since defects of medical products could manifest after a long period of time.

The liability of the notified body has been discussed in Chapter 3. When a producer wants to put a product with a certain risk profile on the European market, it will enter into a contract with a notified body for the certification of the product. In collaboration with the producer, the notified body will assess if the product is in conformity with the requirements of Directive 93/42/EEC on Medical Devices. If this is the case, then the product will receive a CE-mark with which it can be sold on the European market. If, in a later stage, the product appears to be unsafe, the question arises if the patient can claim compensation from the notified body who – by providing the product with a CE-mark – has declared the product safe. With regard to this question, the CJEU has ruled that a general duty of care rest on the notified body in relation to patients, which requires the notified body to carefully conduct research and take measures in case of an indication that the product is (no longer) in conformity with the requirements of the Directive. If the notified body has breached this duty of care, it can be held liable on the grounds of rules of national private law of the member states. Successfully establishing liability of a notified body before a national court will most likely not be an easy task due to a lack of specific requirements for the notified body in the Medical Devices Directive, unclarity as to the scope of the duty of care formulated by the CJEU and possible problems with establishing causation.

Chapter 4 has focused on the liability of the healthcare provider for the use of a defective medical device in the Netherland. In the Netherlands, the patient and the healthcare provider are in a contractual relationship. This means that the question on the liability of the healthcare provider boils down to whether the provider acted in breach of the contract. A successful claim for breach of contract requires non-performance of an obligation arising out of the contract and attribution of the non-performance to the debtor. The non-performance is attributable to the debtor if it is the result of a fault, if the attribution follows from a specific legal provision, if the non-performance is in the sphere of the debtor’s risk by a juridical act or if the attribution derives from common opinion. Article 6:77 of the Dutch Civil Code (hereafter: BW) is an example of attribution deriving from a specific legal provision. This article contains a general rule of strict liability for the use of devices, but also provides for an exception. Under the general rule, if the debtor makes use of a device which is unfit for the performance of the contract, the resulting non- performance can be attributed to him. On the basis of the exception, the non- performance cannot be attributed to the debtor if this would be unreasonable in light of the content and scope of the obligation (1), common opinion (2) or the circumstances of the case (3).

(1) A relevant circumstance with regard to the content and scope of the obligation is the freedom of choice of the debtor for the device he wishes to use for the performance of his obligation. If this freedom is limited by the creditor, attribution to the debtor could be unreasonable. It is argued by legal scholars that it is also relevant to look at the distinction between obligations of means and obligations of result in assessing the content and scope of the obligation. This argument, however, is regarded as invalid since the qualification of an obligation as an obligation of result or an obligation of means is – if it is relevant at all – only relevant for establishing non-performance; not for establishing attribution.

(2) Relevant circumstances with regard to common opinion are: the law, case law, literature, a difference between the reward the debtor has received and the possible damage of the creditor, insurance and possibilities of redress. In this context, the question has been raised if the possible liability of the producer towards the patient should safeguard the healthcare provider from liability. An affirmative answer to this question could follow from the circumstance that the possible liability of the producer safeguards the supplier of a product from liability, as well as the keeper of a product. However, a dismissive answer could follow from the circumstance that the potential liability of the producer does not safeguard a contractor from liability for the use of a medical device in the performance of a contract for work. The obligation of the healthcare provider, who provides a service, shows more similarities with the obligation deriving from a contract for work than with the obligation to supply a good. This could offer an indication against an exclusion of liability of the healthcare provider for the use of a medical device due to the possible liability of the producer.

(2) In relation to this, the relevance of the development risk defense has been discussed. This defense stems from the Product Liability Directive and should, according to some, be available to the producer as well. The fact that liability of the healthcare provider for a development risk could, through redress, lead to the liability of the producer for a development risk (who has been safeguarded from this by the Directive) could plead for the adoption of such a defense for the healthcare provider. If liability of the healthcare provider for a development risk would not lead to redress on the producer, i.e. because the producer has excluded his liability in a contract with the healthcare provider, then the liability of the healthcare provider would be greater than the liability of the producer. The question is whether there is a justification for such a greater liability. A dismissive answer to that question could follow from the circumstance that the supplier and keeper of a product have a right to invoke this defense as well. An affirmative answer to that question could follow from the circumstance that a contractor does not have such a right. An affirmative answer could also be found in the reasoning that a development risk is a communal risk, and therefore the risk should be borne by the community – not the individual victim. This can, in part, be established by allocating the risk to the healthcare provider who is capable of spreading the risk through the price of the service he provides. Lastly, an affirmative answer could be found in the circumstance that there would be a lack of gap in consumer protection if neither the producer nor the healthcare provider would be liable for development risks.

(2) With regard to case law and literature it was established that the exception of article 6:77 BW is rarely granted outside the medical context, while it is often granted in the medical context. This distinction at the detriment of patient who have suffered personal injury due to a medical device, is heavily criticized by legal scholars.

(2) With regard to the difference between reward and possible damage, an established principle in case law is that attribution to the debtor could be unreasonable in case of a considerable difference between the reward the debtor has received and the possible damage of the creditor.

(2) In assessing the (un)reasonableness of attribution, the use of insurance in a certain group or profession to which the debtor or creditor belongs is relevant as well. If there is a use of insurance, this could plead against unreasonableness of attribution.

(3) Circumstances of the case that might be relevant in assessing the reasonableness of attribution are: the nature of the unsuitability of the product for the performance of the obligation (is the product generally or only incidentally unfit for the performance?) and the presence of a CE-mark. The relevance of both circumstance has been denied. Article 6:77 BW does not only apply to generally unfit or defective products, but also with products that have failed only once and caused damage to the creditor. The presence of a CE-mark is not relevant because the mark is an administrative tool, not meant to exclude or influence liability of users of those products, say something about the general characteristics of the product. Also, the fact that the healthcare provider has used a product with a CE-mark could only speak to his (lack of) culpability, which is irrelevant for a strict liability rule such as article 6:77 BW.

In Chapter 5 the liability of the healthcare provider for the use of a medical device under German law was discussed. The relationship between the patient and the healthcare provider is contractual in nature in Germany. The rules regarding the contractual relationship between the healthcare provider and the patient are laid down in the Patientenrechtegesetz. § 630a BGB contains the duty of care of the healthcare provider. If the patient wishes to claim damages from the healthcare provider on a contractual basis, he has to base his claim on § 280 section 1 BGB jo. § 276 section 2 BGB. § 280 BGB provides for the general rule of contractual liability and § 276 BGB contains the requirements for attribution. According to § 276 BGB, the debtor is liable in case of intent or negligence. Section 2 of the article states that the debtor has acted negligently if he has breached his duty of care. With regard to the liability of the healthcare provider, the interpretation of this section is determined by the duty of care formulated in § 630a BGB. A claim for damages can also be based on the rule of non-contractual liability of § 823 section 1 BGB. This requires a breach of the duty of care of the healthcare provider, which is identical to the duty of care required for contractual liability.

The general rules of liability apply to the liability for damage caused by a medical device. The BGH ruled that a high level of care is required from the healthcare provider in dealing with medical devices. This entails that the healthcare provider has to visually inspect the devices before using them, has to overlook the purchasing and maintenance of the devices and has to pay attention to the relevant instructions following from the instruction manual and (medical) literature. If the patient alleges the healthcare provider has breached an Organisationspflicht by, for example, neglecting the maintenance or cleaning of the medical device, the patient could benefit from a reversal of the burden of proof. When the risk of using a medical device is voll beherrschbar, the healthcare provider has an erfolgsbezogene Leistungspflicht to prevent the risk. If he has not done so, he is assumed to have breached his duty of care according to § 630h Abs. 1 BGB.

In Chapter 6 the liability of the healthcare provider for the use of a medical device under French law was discussed. When a patient receives treatment in a French private facility, the patient enters into a contractual relationship with the healthcare provider. When a patient receives treatment in a French public facility, there is no contractual relationship. In both instances, the same law applies: the Code de la santé publique (CSP). The general rule on liability of the (private and public) healthcare provider is laid down in article 1142-1 CSP. The article contains a fault-based rule for liability of the healthcare provider. The only exceptions to this rule are damage caused by hospital acquired infections and damage caused by a defective medical product.

With regard to damage resulting from a defective medical product, from 1999 until 2012, the Cour de Cassation qualified the obligation of the healthcare provider as an obligation de sécurité de résultat for which the healthcare provider was strictly liable. Since 2012, this obligation is qualified as an obligation de moyens for which the healthcare provider is liable in case of fault. In 2013, the Cour de Cassation ruled that this not only applies to the use of a product but also to the supply of a product. This change from a strict to a fault-based approach could be related to the introduction of a public compensation scheme that the patient can call upon if the healthcare provider (and/or the producer) is not liable and the damage results from a hospital acquired infection, an iatrogenic disease or a medical accident causing very serious harm. Since the Marzouk ruling in 2003, the Conseil d’état applies a rule of strict liability to the healthcare provider as the user of a defective medical product. In 2011, the CJEU ruled that the rule deriving from Marzouk was not in violation with the Product Liability Directive. In 2013, the Conseil d’état ruled that the regime of strict liability also applies to cases where a product was implanted in the body of the patient (not qualifying this situation as the supply but, rather, as the use of a product).

In Chapter 7 the liability of the healthcare provider for the use of a medical device under English law was discussed. The qualification of the relationship between the healthcare provider and the patient determines the basis of a claim for damages of an English patient. If a patient has received treatment in a private facility, there will be a contractual relationship between the patient and the healthcare provider. Such a relationship will not exist if the patient has received treatment in a public facility which is financed by the NHS. If the relationship between the patient and the healthcare provider is contractual, a claim for damages can be based on the breach of a contractual obligation. If the relationship is not contractual, a claim for damages must be based on a tort, such as the tort of negligence. In both instances, the duty of the healthcare provider towards the patient is the duty of care defined in Bolam v Friern HMC. If the healthcare provider has not acted ‘in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art’ he will have breached his duty of care and (if the other requirements of this tort have been met) will be liable for negligence.

If the patient’s injury is caused by the use of a defective medical device, he can only successfully claim compensation from the healthcare provider when the latter has breached the aforementioned duty of care. The fault-based nature of the liability for the use of medical devices, in combination with the desire of the NHS litigation authority to minimize the number of claims, results in a lack of case law on this topic.

If the (private) healthcare provider has supplied a medical device to a patient, such as an implant or prosthetic, the Consumer Rights Act 2015 could be applicable. This means that there is an implied warranty that the device is of sufficient quality and/or fit for purpose. The healthcare provider will then be (strictly) liable if he has breached this warranty by supplying a device of insufficient quality or a device that is not fit for purpose.

Chapter 8 dealt with the most noticeable findings from the comparative analyses on the liability of the healthcare provider in Dutch, German, French and English law. It showed that a rule of strict liability is not incompatible with the (position/ role of the) healthcare provider. A rule of strict liability of the healthcare provider exists in both France and in England. The comparative analysis showed as well that in each country, a distinction is made between the qualification of the general obligation of the healthcare provider and the obligation concerning the use or supply of medical products. Lastly, the comparative analysis has shown the downsides of a fault-based rule on the existence of (successful) claims for compensation. Where a fault-based rule applies, very little case law exists due to culpable behaviour generally being absent in cases concerning damage resulting from the use of medical product.

In Chapter 9 the research question was approached from a law and economics perspective. An application of the factors found relevant in the law and economics approach of liability leads to the conclusion that a strict liability rule of the healthcare provider for the use of medical devices is preferable over a fault-based rule. Relevant factors in this context are: the information of the healthcare provider compared to the information of the patient and the information of a judge, the fact that ‘care’ has multiple facets, the costs of the system of liability, the role of the patient and the circumstance that he accident is generally unilateral, the activity level, problems related to moral hazard and adverse selection. A disadvantage of a rule of strict liability is the risk of defensive behaviour of the healthcare provider. On the other hand, since a fault-based rule would imply an open-ended norm, defensive behaviour could follow from a rule of strict liability as well.

Chapter 10 focussed on answering the research question. An analysis of the circumstances that are relevant under the application of article 6:77 BW has shown that a strict liability rule should apply to the healthcare provider who has caused damage by using a medical device in the performance of an obligation. Relevant circumstances are: the fact that the healthcare provider profits from the use of medical devices, the fact that the healthcare provider is a professional party and can, therefore, spread the damage through the price of the service he offers, and the circumstance that the liability of the healthcare provider brings about a central liability of the hospital. Also relevant is the use of insurance under healthcare providers and the coverage of a (third party) liability insurance compared to the coverage of a first party insurance of a patient. In addition, the expertise of the healthcare provider in comparison to the (lack of) expertise of the patient, and the freedom of choice of the healthcare provider with regard to the medical device that is used and the lack of influence of the patient on this choice, offers an indication in favour of strict liability of the healthcare provider. The desirability of a rule of strict liability is supported by the law and economics approach and such a rule has been shown to exist in other countries as well. The presence of a CE-mark will, as was mentioned earlier, not lead to a different conclusion. Liability of the healthcare provider under article 6:77 BW could be unreasonable if his freedom of choice for the medical device was limited (and he has, in addition, not breached a duty to inform the patient on the choice the patient imposed on him). In addition, attribution could possibly be unreasonable if the damage is a result of the realisation of a development risk.