Doctor and hospital not liable for harm caused by manipulated PIP breast implants

19 June 2020

The Dutch Supreme Court, in a preliminary ruling on questions referred by the Court of Appeal of ’s-Hertogenbosch, has declared that a doctor and a hospital are not liable for harm suffered by patients caused by PIP breast implants that were faulty due to fraud.

The Court of Appeal is hearing proceedings between a patient and a hospital on whether the hospital is liable for the harm that the patient suffered because of being given a PIP breast implant in 2000. The French manufacturer of these implants, which were used in numerous cases of breast enlargement surgery worldwide from mid-2000 until April 2010, committed large-scale fraud in its manufacturing process and quality inspections over a period of several years. It used industrial (rather than medical) silicones for the production and deceived the quality inspection agencies. PIP implants have an increased risk of ruptures and leaks. The implant manufacturer has since gone bankrupt and offers no recourse for compensation.

The Court of Appeal asked the Supreme Court whether the hospital (which by law is subject to the same rules as the doctor carrying out the procedure) is liable for the harm suffered by its patients and what circumstances must be considered when answering that question.

The Supreme Court ruled that, by using a PIP implant that had been involved in fraud, the hospital had not performed the medical treatment contract properly (constituting what is legally referred to as a ‘breach’). The principle that applies in these situations is that any costs caused by a defect in an object used in the contractual performance – such as the implant used here – are for the expense of the party that used the object, which in this case is the hospital. For these PIP implants, however, the Supreme Court ruled that the hospital is not ‘culpable’ for the breach, and the resulting costs are therefore not for the hospital's expense. This means that the hospital is not liable for harm arising from the faults in the PIP implants caused by the fraud. The Supreme Court's ruling is based on a series of specific circumstances, including the fact that the matter involved serious fraud on a large scale, and that liability on the hospital's part would lead to numerous and often major claims for compensation, together with the fact that hospitals in the Netherlands have limited possibilities for insuring against such claims. Moreover, as a consequence of the manufacturer's bankruptcy, the hospital would be unable to recover the compensation that it pays to the patient from the manufacturer.

The Court of Appeal of ’s-Hertogenbosch will now draw on this ruling as it adjudicates the case.

The Dutch Supreme Court today also pronounced judgment (ECLI:NL:HR:2020:1082) in another case concerning the liability of a doctor and hospital for harm suffered as a result of a medical implant.

Preliminary ruling
The Dutch Supreme Court issues preliminary rulings on questions that a district court or a court of appeal refers to determine how a legal rule should be construed. This guidance might be necessary if the Supreme Court has not previously ruled on how that particular rule is construed. Questions referred for a preliminary ruling must arise in a concrete case being heard by a district court or court of appeal and must have bearing on judgments in significant numbers of other cases.

Source: de Rechtspraak