(B) The liability of manufacturers and pharmacists

The liability of manufacturers of medicines and serum and of pharmacists for their supply was governed by private law and until 1998 formed an exception to the willingness of French courts to impose liability for products without proof of fault.¹¹⁸ (p.147) For until that year, the liability of pharmaceutical manufacturers was based only on delictual fault: a patient could not claim against a manufacturer based on the garantie légale of the law of sale extended by way of action directe or a contractual obligation de résultat extended by way of stipulation pour autrui,¹¹⁹ nor on article 1384 alinéa 1 of the Civil Code as gardien of the drugs, even where their container exploded!¹²⁰

What counted as ‘delictual fault’ for this purpose and how strictly was it assessed? Certainly, putting onto the market a ‘defective medicine’ was not treated as in itself a fault,¹²¹ but the courts did hold that manufacturers should take ‘exceptional care in developing their products’,¹²² even if they did not guarantee that they would in no circumstances cause their users harm.¹²³ More concretely, according to one court, where a product is causally related to a claimant’s harm, its manufacturer’s liability ‘is conditional on the existence of fault in the conception, manufacture or presentation of the medicine’,¹²⁴ but it should not be liable for harm which was abnormal or unforseeable at the time of putting it onto the market, even where unrelated to any special reaction.¹²⁵

On the other hand, a manufacturer of a pharmaceutical product was found to have been at fault in failing to withdraw it from the market. For example, in one case the claimant had suffered an intestinal blockage after taking the defendant’s tablets, which had been prescribed by her doctor.¹²⁶ Their manufacturer argued that over 130,000 boxes of the tablet had been sold in France without problems since its introduction, but an expertise reported that in the few months preceding the claimant’s own use of it, several cases of injuries had been reported, possibly due to a modification in its formula. The court therefore held that the manufacturer was at fault in failing to undertake further research as to its product before offering it for sale to the public and in failing to give more detailed and clearer warnings to alert its consumers to the risks of the product. It further held that the manufacturer could not escape its liability by pointing to a failure in either the claimant or her doctor to follow the instructions which had been given, given that these were incomplete and not of a type to strike the attention of a patient.¹²⁷

(p.148) However, in 1998 the Cour de cassation took a different view, ‘implementing’ the Product Liability Directive just before the legislator.¹²⁸ There the claimant had in 1988 taken a medicine wrapped in indigestible sponge, which was aimed at allowing the pharmaceutical to be absorbed gradually but which had to be surgically removed. The manufacturer of the medicine argued that it owed the patient an obligation de sécurité’ to deliver ‘a product having a therapeutic effect conforming to accepted scientific practices, without usually presenting for its user disadvantages or dangers higher than the therapeutic effect which it bears’, so that in the absence of any defect (défectuosité) being found by expertise, the lower court should not have held it liable. However, the Cour de cassation held that ‘the manufacturer must deliver a product exempt of any defect [défaut] of a nature to create a danger for persons or property, that is to say, a product which offers the safety which one is legitimately entitled to expect’. So, the lower court was right to hold the manufacturer of the medicine liable as their findings made clear that the claimant’s harm was caused by the very characteristics of the non-digestible wrapping of the medicine which stuck in his intestine which was a defect in the relevant sense. Interestingly, in upholding liability, the Cour de cassation rejected the manufacturer’s argument which articulated clearly that the product was not defective because on balance its benefits outweighed its costs.

The position of the suppliers of pharmaceuticals to the general public was treated in a similar way to the liability of their manufacturers, though without the final twist towards liability without fault. In France, all medicines and other pharmaceutical products are supplied only by pharmacists or dispensing chemists (pharmaciens officines), who are subject to considerable legislative control, both as to their organisation and their professional duties, though acting within the private sphere conducting a ‘liberal profession’.¹²⁹ Patients pay the pharmacist the full price of the prescription drugs, but may claim the reimbursement of the cost or some of the cost from their insurers. While this supply looks like a contract of sale, the courts have not imposed liability under the garantie légale,¹³⁰ but instead only on the basis of proven (usually contractual) fault to their customers for harm caused to those to whom they supply medicines.¹³¹ However, the standard of care imposed on them is a high one, and pharmacists must check the input of others (such as doctors or manufacturers) into their own practice, though they are not expected to verify a branded product, which is received ready-packaged and which it would be impracticable to check.¹³² Pharmacists must also give proper advice as to the products which they supply, this being particularly important where the customer is not under the care of a medical practitioner.¹³³