Cour de cassation:

Given that Kaléorid, a capsule marketed by the Laboratoires Léo, consists of an indigestible outer coating whose spongy quality permits the gradual diffusion of potassium chloride into the digestive tract, the coating normally being extruded by natural process of evacuation; that from June 1988 M. Scovazzo took one Kaléorid capsule per day as prescribed until October of that year when he was urgently admitted to hospital with grievous pains in the right iliac cavity; that surgery disclosed a serious inflammation round an abscess near the start of the large intestine where a Kaléorid capsule had lodged; that the inflammation was so severe that the surgeon could do no more than drain it, and that a further operation was required in August 1989 for acute appendicitis; that M. Scovazzo attributed his condition to the presence of the Kaléorid capsule which had not been evacuated, and sued the laboratory, which the Court of Appeal of Versailles on 25 January 1996 held liable to him in damages;

Given that the laboratory criticises the court of appeal for holding it liable whereas if a pharmaceutical company’s supplies a product whose therapeutic effect is scientifically verified and whose therapeutic value normally exceeds the inconvenience or risk to the patient, its safety obligation as producer “is limited” and does not extend in law to all the damage which can arise from the use of the medicament; given that it also criticises the court for adopting the expert’s report without finding that the medicament and so violating article 1147 Code civil;

But given that the manufacturer is bound to supply products which are free from any defect apt to prove dangerous to person or property, that is, a product which offers the safety which one has the right to expect, that the harm suffered by M. Scovazzo is attributable to the very characteristics of the indigestible covering of the capsule which, lodged in the victim’s intestine, caused the inflammation and its sequelae, and that the court of appeal in treating this as a defect in the product gave a legal basis for its decision;

For these reasons;

DISMISSES the appeal.

This note on subsequent developments reflects the legal situation as of October 2004.

Civ 1, 3 March 1998 : Pharmaceutical laboratories are, just like other manufacturers, liable for dangerous defects in their products. The obligation of safety expressed here concerning the supply of medicines has later been extended to a hospital which had supplied a patient with medicines which caused him burns (Civ 1, 7 November 2000 , Bull no 279). More generally, this judgment comes within a more extensive line of case law, elaborated by the Cour de cassation and then repeated by the Law of the 19 May 1988, under which the manufacturer of a product - whatever it may be - is bound to deliver the product free from any defects likely to cause danger to person or property, ie a product which offers the safety which can legitimately be expected. However, it is important to point out that in this case the litigation only concerned the outer covering of the medicine and not its active ingredient, leaving open the question of possible secondary effects and of the manufacturer's liability in the light of these effects.

Translation by Raymond Youngs

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