Defective equipment and negligence

Doctors and hospitals should not be held liable for using defective equipment unless a patient can show they were specifically negligent in doing so, according to a leading legal opinion. The opinion, if adopted by the European Court of Justice, could ultimately prove a potent defence for ophthalmologists sued for inserting lenses or using equipment that they only later learn was defective.

The opinion, by an advocate general at the Court of Justice, arose in a case in which a patient is suing a hospital in France for compensation for burns he sustained from a heated mattress in October of 2000.

The court of Justice is currently reviewing the case after a French court asked the Luxembourg-based court for preliminary ruling on whether the patient could use EU law to make it easier for him to succeed in his compensation claim against the hospital.

Under EU law, a preliminary ruling by the Court of Justice can assist a national court in interpreting any provision under EU law. It is then for the national court to dispose of the case in accordance with the Court's decision. The preliminary ruling is also similarly binding on other national courts confronted with similar issues. Before giving its preliminary ruling, the court's judges routinely ask for an opinion from an Advocate General to assist them in their deliberations. While the opinion is not binding on the Court of Justice, the court more often than not adopts the opinion as its own judgment.

The French case was brought by Thomas Dutreux, who was aged 13 years at the time of the accident at the University Hospital of Besançon. In his lawsuit, Mr Dutreux attributed his burns to a defective temperature control mechanism in the mattress.

Under the EU's Product Liability Directive, a 'producer' of any product is ultimately liable to the consumer for any injury caused by a defect in the product. The definition of 'producer' includes 'the manufacturer of a finished product.'

The law alters the standard burden of proof in legal cases. Under traditional rules of law in most European countries, a consumer had to prove negligence against a producer or manufacturer to collect compensation for any injury caused by the product. Negligence can often be a time-consuming task involving extensive investigation – and cost – because negligence requires that a consumer prove the state of knowledge of the producer or manufacturer. That often translates into proving that officials in the manufacturing company knew or should have known that the product was defective when they first decided to place the product on the market.

The Product Liability Directive, which was adopted in 1985, changed all that. Now, the burden of proving negligence has been lifted from the shoulders of the consumer harmed by a product. Now, a consumer need only prove that the product was defective to collect compensation for any injury caused by that defect. A defective product is defined by the directive as one that 'does not provide the safety which may reasonably be expected'.

Whether the manufacturer was at fault in putting such a product on the market is of no concern. The language of the directive is quite simple: 'The producer is liable for damage caused by a defect in his product.'

If a consumer cannot identify – and thus sue – the manufacturer of a product, the directive provides that the consumer can sue the person or company who 'supplied' the product:

'If the producer of the product cannot be identified, each supplier will be treated as its producer unless he informs the injured person, within a reasonable time, the identity of the producer or person who supplied him with the product.'

The 'supplier' provision became of particular importance in the French case because the French court reviewing the case also had to consider whether the directive had any bearing on French national law. Under French law, a public hospital must, even where it is not at fault, pay compensation for injury suffered by a patient as a result of a defect in equipment or a product used in the treatment. On that basis, the French court asked the Court of Justice whether the hospital should be considered a 'supplier' for the purposes of the directive and thus be culpable for any defect if the manufacturer of a product were not identifiable.

The advocate general, Mr Paolo Mengozzi, answered that a hospital was not a supplier or distributor for the purposes of the directive. According to the advocate general, Mr Dutreux should not be viewed as a consumer but as a patient. Mr Dutreux 'was not a customer came in for a mattress, but a patient who entered a hospital. The safety of defective mattress should be considered in connection with the provision of care itself.'

On that basis, Mr Mengozzi concluded that the Besançon University Hospital cannot be considered a 'supplier' within the meaning of the directive.Therefore, the scope of the directive does not extend to the liability of a service provider for injury caused by a defective product in connection with the provision of a service.

Although the directive does not apply to a hospital, the advocate general was quick to add that the directive did not affect the application of French national law, which, independently of EU law, required the hospital to pay compensation to Mr Dutreux for his burns without deciding whether the hospital was negligent.

The directive 'allows Member States to define the responsibility of those who use assistive devices or defective products in the framework of the provision of services and cause thereby damage to the recipient of the benefit,' the advocate general informed the court.

Judgment in the case is expected in the near future. For more details about the case, view the website of the European Court of Justice at www.curia.eu.