Given that after an operation on a pharyngeal tumour in 1980, Pascale Y…, born on 3 October 1970, ceased to grow, and was treated from January to June 1985 by growth hormones by permission of the National Commission which controls their distribution; that in August 1999 when Pascale Y… was having trouble with her equilibrium her family obtained an expert report from the interlocutory judge of the tribunal de grande instance of Montpellier; that on 25 May 2001 she was diagnosed as having CJD and died  less than three weeks later; that her heirs now seek compensation for the contamination from defendants including the Institut Pasteur and the Endocrinological Association of France, the mother also claiming for her material loss;

The first ground of complaint is that the court below refused to hold the claim against the Institut Pasteur time-barred whereas, it is said, a domestic judge seised of a claim which falls within the domain of a Directive is bound to interpret the national law in the light of its terms and purpose, and that since the rules of prescription of the national law, which necessarily operate ex post facto,   are incompatible with those of the Directive no. 85/374 of 25 July 1985, whose article 11 provides that the rights of the victim against the producer are extinguished ten years after the product is first put into circulation, the court of appeal’s refusal, on the ground that the product in question was marketed before the Directive was notified to the Member States, to declare the claim time-barred violated articles 1147 and 1382 of the Code civil, interpreted in the light of the Directive, and also misapplied article 2262 of the Code civil;

But given that the court below, having found that the products were first circulated in February 1985, was right to infer that it was not inconsistent with article 17 of the Directive no. 85/374 of 25 July 1985 to hold that on an issue of prescription the national law need not be interpreted in the light of the Directive; so that the complaint is groundless;

On the second ground of complaint:

Given that the decision is criticised for holding the Institut Pasteur liable in damages for the contamination, in that

1. since Pascale Y… was the beneficiary of an implied clause in the contract between the Institut Pasteur and the Endocrinological Association of France, the court below violated articles 1147 and 1382 Code civil, interpreted in the light of the Directive of 25 July 1985, in holding the Institut liable for the contamination by the infectious product which triggered the Creutzfeldt Jakob disease;

2. the court below reversed the burden of proof in violation of article 1315 Code civil, interpreted in the light of the Directive no. 85/374 of 25 July 1985, by holding on the mere ground that the Institut Pasteur was unable to show either that patients had been contaminated by the growth hormone Kabi or that Pascale Y… was especially  vulnerable to contamination that there was a causal link between the treatment with the growth hormone from the Endocrinological Association and the disease contracted by Pascale Y…

3. the court below deprived its decision of the requisite statutory basis under article 1147 and 1382 Code civil, interpreted in the light of the Directive no. 85/374 of 25 July 1985, since the reason it gave for its decision,   namely that all the patients who developed Creutzfeldt Jakob disease after treatment with a growth hormone had been treated with the Endocrinological Association hormone, was an abstract and general one;

But given that in deciding on the application of articles 1147 and 1382 Code civil the court of appeal had no need to refer to the provisions of the Directive which were irrelevant to the issue; that it was right to hold, first, that where damage is due to a product the producer is liable to both immediate or secondary victims and to both contractors and third parties, that it then found that the central pharmacy of the public assistance of the Paris hospitals had never been charged or entitled to do a pharmaceutical analysis of the growth hormone produced by the firm Kabivitrum, which, according to the expert report,  controlled every stage in its production,  and it was undeniable that all the patients who developed a disease such as that of Pascale Y… had been treated with the growth hormone endorsed by the Endocrinological Association of France and that furthermore when the court, having  held that the Institut Pasteur had not adduced any new evidence that the patients had been contaminated by the Kabivitrium hormone or that Pascale Y… was particularly vulnerable to contamination, was not founding on an abstract and general reason or reversing the burden of proof, but on serious, precise and concordant findings from which it could be inferred that the CJD contracted by Pascale Y… was due to the growth hormone supplied by the Endocrinological Association of France;

Thus the first two grounds of this complaint are irrelevant and the third wrong in point of fact;

On the third ground of complaint, that the court was wrong to decide as it did, given, according to the complainants, that

1. the court’s refusal to grant the Institut Pasteur the defence of development risk – that a producer is not liable if he can prove that at the moment he circulated his product the state of scientific and technical knowledge was not such as to permit the discovery of the defect – despite its finding that it was only in April 1985 that the risk was first recognised that the infection causative of CJD could be transmitted by the growth hormone,  constituted a failure to draw the proper legal consequences from its own findings, which were to the effect that any defect in the basic hormone used for the growth hormones which  the central pharmacy of the Paris hospitals supplied for Pascale Y… on 22 February and 14 March 1985 were necessarily undiscoverable at the time when the Institut Pasteur relinquished its product; accordingly the court violated articles 1147 and 1382 Code civil, interpreted in the light of Directive no. 85/374 of 25 July 1985;

2. it was in violation of articles 1147 and 1382 Code civil, interpreted in the light of Directive no. 85/374 of 25 July 1985, for the court to hold that since the Institut Pasteur had not required the central pharmacy of the hospitals of Paris to recall the growth hormone in view of its potential for contamination, it could not use the defence of development risks, although that no requirement of recall is attached to the defence by article 7 of Directive no. 85/374 of 25 July 1985;

But given that the provisions of the Directive are inapplicable, the complaint is irrelevant;

On the fourth ground of complaint:

1. since the only reason given by the court for holding that the Institut Pasteur was in breach of its obligation of care and diligence and so liable for the illness and death of Pascale Y…was that there were some shortcomings in its radio-immunological unit’s control of the growth hormone, mentioned in a report drawn up by IGAS in 1992, without explaining how adoption of the measures suggested could have avoided the contamination in the batches delivered to Pascale Y… its failure to identify a direct and certain link between the shortcomings of the Institut Pasteur and the illness of Pascale Y… deprived its judgment of a statutory basis under article 1147 Code civil;

2. in holding the Institut Pasteur at fault in its control of the production of the growth hormone solely on the basis of the conclusions of the report by the IGAS team in 1992 without inquiring whether, given the state of scientific and technical knowledge at the time of extraction of the basic hormone used to produce the batches of growth hormone supplied to Pascale Y…, the Institut Pasteur could be taken to have known that the precautions whose absence was stigmatised  by the subsequent IGAS report were necessary to avoid the risk of contamination, the court below failed to provide the statutory basis for the application of article 1147 Code civil;

3. in giving as the sole ground for holding that the Institut Pasteur was answerable for the harm resulting from the inadequacy of the precautions taken in the preparation of the glandular material by the Endocrinological Association of France  the fact that the  Director of the former sat on the administrative council of the latter, which by no means indicates that the Institut Pasteur had any control over the Association, the court of appeal again failed to provide a statutory basis for its decision under article 1147 Code civil;

But given that the court of appeal, which was not obliged to follow the arguments of the parties in every particular, did make the inquiries requested by indicating that already in 1980 the report of M. Montagnier had emphasised the absolute necessity of taking every precaution in the extraction, purification and preparation of growth hormones and that despite this report the precautions recommended had not been implemented, so that it was possible to infer that there was a certain and direct causal link between the negligence imputed to the Institut Pasteur and the harmful contamination of Pascale Y…; and finally that contrary to the assertions of the complainant, the judgment stated that on 14 May 1985 it was by agreement between the Institut and the Association that the decision was taken to continue treatment with the extracted hormone;

Thus the complaint is erroneous, partially in fact and partially in law;

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