France: Surgeon’s liability for use of a defective medical device

02 March 2010

Diane Bandon-Tourret

In September of 1988, a surgeon fitted a patient with artificial ligaments. In 1992, the patient had to undergo the ablation of the ligament surgery material because of inflammation caused by the defective material implanted. The patient then sought to establish the liability of the surgeon and the manufacturer of the defective ligaments.

In a judgment of 22 January 2008, the Appeal Court of Lyon declared that the liability claim filed against the surgeon was inadmissible. The Court reasoned that only the liability of the supplier of the product, in this instance the manufacturer, could be sought where the manufacturer was identifiable, and the case was based on facts arising after the deadline for the transposition of Directive N° 85/374/CE dated 25 July 1985.

The Court also held that the action brought against the manufacturer was time barred. The Court reasoned that the action brought, on the sole applicable grounds of Article 1383 of the Civil Code, was time barred after ten years from the time of removal of the surgical material in 1992 whereas the patient’s action did not begin until 2005.

The patient appealed this decision using two series of arguments:

Where the liability of the practitioner is concerned, the patient pointed out that the contract between patient and doctor binds the latter to an obligation of safe result regarding the equipment used for performing diagnostic procedures or administering medical treatment. He alleged that the Court violated Article 1147 of the Civil Code in neglecting to examine whether the doctor should have been regarded as the user of the product.

As regards the time barring of action concerning the manufacturer, the patient alleged the Court did not interpret the texts in the light of Directive N° 85/374/CEE dated 25 July 1985, which should have been transposed by the date of the insertion of the defective ligaments.

In a ruling of 22 October 2009, the first Civil Chamber of the Supreme Court rejected the appeal. The Court pointed out that the judges hearing the case on the merits, reasoned that the surgeon had supplied the defective equipment, thus excluding any consideration of him as the user of the product. The Court also considered that the argument based on the of absence of time barring of the action concerning the manufacturer was inadmissible since there was no indication of how the interpretation of the domestic legislation in the light of the Directive would have caused the patient’s legal action to be admissible.

As a result, the patient can base his case for liability of the surgeon on the deficiency of the implanted material and not the error of the practitioner. This is in accordance with Article L. 1142-1 of the Public Health Code, which, as an exception to the principle of liability due to error on the part of the health professional, provides for the situation in which liability is incurred because of a health product, a category that encompasses medical devices.