(B) The affaire du sang contaminé: Part II—State liability for failures in the control of safety

The important decision of the Assemblée of the Conseil d’Etat in 1993 in the affaire du sang contaminé is perhaps the most striking example of this changing basis of (p.316) liability.⁸⁸ The claimants were three haemophiliacs who had been transfused with blood in the course of 1983, 1984 and 1985 and who had been diagnosed HIV positive in January, March and June of 1985 and the public body which administered a special legislative fund for the compensation of the transfusion or haemophiliac victims of HIV.⁸⁹ The defendant was the State, as responsible for the Minister of Health.⁹⁰ The basis of the claims was that the Minister of Health had failed in the exercise of his legal powers of control over the safety of the blood distributed and regulated by the National Blood Transfusion Centre and distributed via local Blood Transfusion Centres to hospitals and clinics:⁹¹ these were not claims in respect of the supply or manufacture of the blood.⁹² The State had two types of power: a power to regulate the collection of blood and the conditions of use of blood products in France (including a power to order the withdrawal of any products from distribution) and a power of supervision over the National and local blood transfusion centres, this being an example of what is termed a pouvoir de tutelle.⁹³

According to the Conseil d’Etat, before October 1984 information as to the possible risks and prevention of infection by HIV was uncertain, but by that time the scientific community accepted that the HIV virus could be transmitted by blood transfusion but could be de-activated by heat treatment; it was also known that if blood products were not so treated, at least 10 per cent of those who contracted the HIV virus would develop AIDS, of whom 70 per cent would die.⁹⁴ The Conseil d’Etat noted that these facts had been drawn to the attention of the relevant State authority in writing by an epidemiologist at the Direction générale de la Santé in November 1984. By March 1985 the relevant public authority had been clearly told of the exceptional risk of contamination by blood transfusion,⁹⁵ but it was not until October 1985 that the State ordered the withdrawal of the affected blood and blood products from the distribution service.⁹⁶ According to M. Légal, the Commissaire du gouvernement, this failure to intervene in the State authorities was explained by a concern about the (p.317) unknown effects of heat treatment on blood, a desire not to make a fuss which might lead to the ostracism of HIV-positive persons and a misplaced confidence in French blood products.⁹⁷

In holding the State liable to all the claimants before it, the Conseil d’Etat dealt firmly with both issues of the standard of fault applicable and difficulties of causal connection between any fault in the State and the harm caused to transfusional victims of HIV.⁹⁸

First, should the appropriate standard of fault in relation to the exercise of the State’s powers be faute simple or faute lourde? All the courts through which this litigation progressed were willing to find faute lourde in the State in its failure to act as of March 1985 when it had been informed of the exceptional risk of infection, but before this date (and after November 1984) they found only faute simple owing to the remaining degree of uncertainty as to the risks involved. The question whether faute lourde was required for liability therefore remained significant, for if it were, only those persons who received blood and were diagnosed HIV-positive after March 1985 could recover and one of the claimants in the case itself (and, no doubt, others not actually party to it) had been diagnosed HIV-positive before this date.⁹⁹

For both the courts below, the relevant standard was faute lourde: as Mme Stahlberger, the Commissaire du gouvernement at first instance explained, the exercise of the powers in question was difficult¹⁰⁰ or involved difficult questions of assessment of a situation or a finely-balanced control, citing the affaire Stalinon, in the context of the licensing of pharmaceuticals.¹⁰¹ However, in the view of the Commissaire du gouvernement of the Conseil d’Etat, M. Légal, the administrative courts had not always required faute lourde in respect of the exercise of powers of this type,¹⁰² ‘distinguishing’ the decision in the affaire Stalinon on the basis that the State has no control over the research activities of pharmaceutical companies in the development of a new drug, whereas:

blood derivatives are developed under the administration’s control (like a vaccine which has been made compulsory), their products and their manner of manufacture are, or ought to be, known in advance by the Minister of Health.¹⁰³

(p.318) These arguments (together, one suspects, with their practical effect on compensation for those diagnosed with HIV earlier and otherwise left only partially compensated) convinced the Conseil d’Etat, which held that:

having regard to the extent of the powers which [the relevant provisions] confer on the State services as regards the general organization of the public blood transfusion service, the control over those bodies which are charged with the performance of this service and the promulgation of rules appropriate to ensure the quality of human blood, its plasma and derivatives, and the purposes for which these powers have been granted to them, the liability of the State may arise where any fault is committed in the exercise of these powers.¹⁰⁴

By so deciding, the Conseil d’Etat followed its general tendency away from a requirement of faute lourde to one of faute simple, but it did so in cautious and qualified terms, relying on the States special powers over and the special organisation of the blood transfusion service. Public powers over the manufacture and distribution of blood were (and are) very different from more general public powers over the design or marketing of a commercial product by a private company or private companies and so it is possible that cases such as the affaire Stalinon may therefore remain subject to a requirement of faute lourde,¹⁰⁵ although the Conseil d’Etat’s subsequent decision in Améon required only faute simple in respect of the safety certification of sea-going vessels.¹⁰⁶

The second issue which the Conseil d’Etat had to determine in the affaire du sang contaminé related to the causal connection required between the State’s fault and any individual claimant’s harm. At first instance, the Minister of Social Affairs argued that it was for the claimants to show that their infection with the HIV virus was caused by their receipt of transfusions with contaminated blood and thereby with any alleged administrative fault, although it was for the court to order any expertise to this end: it was not enough to adduce statistical data connecting receipt of blood with diagnosis of the infection as there were other possible sources of infection with the virus.¹⁰⁷ While this argument reflects the established burden of proof as to causation as regards the liability of public authorities, it was rejected by all three of the administrative courts before whom the litigation came. For Mme Stahlberger at first instance, where an expert report pointed with ‘sufficient certainty’ to transfusion as the source of infection at a particular period, then a court should apply a presumption of causation¹⁰⁸ and the Conseil d’Etat took a similar view, simply recording the receipt by a claimant of blood in late 1984 and early 1985 and his diagnosis as HIV-positive. As was observed at the time, this was a very generous view of the requirement of causation.¹⁰⁹

Thirdly, the Conseil d’Etat also rejected the State’s argument that it should not be liable beyond the proper share of its responsibility, by way of application of the defence of Fait d’un tiers. Here, as I shall note in explaining the more general significance of this defence, the Conseil d’Etat was at its most radical.¹¹⁰

(p.319) Overall, this decision of the Conseil d’Etat was an important one, but its importance was as much symbolic and political as legal and far-reaching. Its symbolic importance was as a recognition of the State’s responsibility for the failures in the ministries charged with the regulation and control of the Blood Transfusion Service: to establish this responsibility was as much a reason for the case being brought by the haemophiliac recipients of the blood as the recovery of damages which they would thereby receive supplementary to the sums awarded under the special legislative compensation scheme.¹¹¹ For, at much the same period when the Conseil d’Etat imposed responsibility on the State in respect of faults in the administration and control of the blood transfusion service, the criminal process was, at least in the views of many of the victims of the infected blood, proving singularly inadequate in attributing responsibility to the individuals involved, whether in the management of the blood transfusion service or in the government itself¹¹² It is understandable that in the highly charged atmosphere surrounding this affaire in the early 1990s, the Conseil d’Etat would wish to avoid deciding that, while at fault in supervising the blood transfusion service, the State’s fault was not bad enough to attract responsibility; or, secondly, that even if its fault had been bad enough, it was for those who had received blood transfusions to show that it was the receipt of this blood which caused their HIV, rather than their ‘lifestyle’; or, finally, that the State could escape its own responsibility in part by pointing to other people’s fault.