Metal-on-metal hip prostheses, pacemakers, birth control implants and breast implants are just a few examples of medical devices that became the subjects of global lawsuits over the past few years. People suffering injuries from a medical device have different routes available to them in their attempts to recover damages. They could try to hold the manufacturer and importer liable based on product liability; the distributor, regulator and government based on tort; and the healthcare providers based on failure in their performance of the medical treatment contract. In relation to the latter, the Amsterdam district court recently decided that 27 healthcare providers were not liable for the damages caused by PIP implants.1

The PIP affair concerns defective breast implants made by the French company Poly Implant Prothèse (PIP). For its implants, PIP secretly used industrial-grade silicon which was unfit for use in medical applications. On top of that, the implants' rupture rate was three times higher than implants from other manufacturers. Approximately 400,000 women worldwide received PIP implants. In the Netherlands, 1,000 - 1,400 women received defective PIP breast implants between 1998 and 2010. Women were recommended to have the PIP implants preventively removed in 2010. In January 2012, Dutch healthcare insurers collectively decided to cover the costs of reversal surgery for Dutch women.

PIP, as the manufacturer of the prostheses, was the most obvious figure to blame, but PIP liquidated in 2010 following the scandal. Executives of PIP were convicted for fraud and the company founder, Jean-Claude Mas, was given a four-year jail sentence. The insurers were also unable to sue the Dutch distributor Rofil as it had liquidated as well.

In December 2014, the healthcare insurers initiated proceedings before the Amsterdam district court against 27 clinics and hospitals. The insurers alleged that these healthcare providers breached their medical treatment contract because they used an unfit product in the performance of their obligation. Under Dutch law, the failure of a used unfit product is attributed to the obligor unless this would be unreasonable in view of the terms and implication of the legal act from which the obligation arises, the generally accepted principles and other circumstances of the case.2

The first question the court had to answer was whether the implant was used in the performance of an obligation or whether the supply of the implant was the core obligation, in which case the failure of the implant would not automatically be attributed to the healthcare provider. The court considered that the purpose of the medical treatment contract was not only to sell and deliver a breast prosthesis, but also to perform a breast reconstruction or breast enlargement. Although the supply of the breast prosthesis was an important part of the obligation, it was not the core obligation. Therefore, according to the court, the implant was used in the performance of an obligation.3

After establishing that the implant was used in the performance of an obligation, and the parties had agreed on the fact that the PIP implant was defective, the court had to determine whether or not, under all the facts and circumstances of the case, attribution to the healthcare providers was reasonable. The burden of proof lied on the healthcare providers. To come to a decision, the court took the following circumstances into consideration:

  • Nature of the obligation. The medical treatment contract was an obligation of means. This type of obligation offers less room for attribution than obligations of result.
  • CE certificate.4 Healthcare providers cannot be expected to examine a product with a CE certificate themselves if there is no indication that the product is defective. Healthcare providers are not experts and are therefore allowed to rely on the knowledge of the regulator, which, despite its expertise, failed to detect the defect itself.
  • Risk distribution. It is a fair distribution of risks that the damages caused are attributed to the healthcare insurers. Healthcare insurers are charged with the coverage of health risks and are therefore able to anticipate potential health risks and include such risks in their premium. The liability insurers of the healthcare providers, on the other hand, are charged with the coverage of faults of the healthcare providers and faults are not at issue here.
  • Liquidation of manufacturer and distributor. The court considers that the healthcare insurers' inability to recover the damages from the manufacturer and distributor cannot be considered part of the healthcare providers’ risk.
  • Limitation of healthcare innovation. The court took into consideration that finding the healthcare providers liable would create the risk that they would act with restraint in the future, which would accordingly limit innovation in the healthcare industry.

Based on the abovementioned circumstances, the court decided that the defective product was not attributable to the healthcare providers and thus the healthcare providers were not liable for the damages.

It is worth noting that the court of appeal in 's-Hertogenbosch recently decided that a healthcare provider was in fact liable for the damages of a woman who received PIP implants.5 This can be explained by the fact that the court always involves all facts and circumstances of the specific case in making its decision. An important distinction between both cases is that, in this case, the patient herself was the claimant rather than a healthcare insurer. It is possible that the court thinks that, while it is reasonable to attribute liability to healthcare insurers above healthcare providers, it is more appropriate to attribute liability to healthcare providers above patients. This fact could have led to the different outcomes in the two described cases, despite them having almost identical facts.