English Hepatitis Legislation 2

English Hepatitis Litigation: High Court declined to make a preliminary reference to the European Court

Around 130 patients are suing the English and Welsh Authorities after they contracted hepatitis C as a result of blood transfusions. A generic trial is planned for October 2000. The only live issue is whether there is liability under the Consumer Protection Act 1987.

The plaintiffs applied for a preliminary reference to the Court of Justice of the European Communities for clarification of the meaning of Articles 6 and 7(e) of Directive 85/374/EEC. Mr Justice Burton rejected this application on 28 October 1999 as being inappropriate and not beneficial to the expeditious, convenient or just disposal of the claims.

The plaintiffs claim that a blood or blood product which was infected with HCV was defective, in that it was not as safe as persons generally were entitled to expect. The defendants claim that the expectation in relation to the safety of products supplied by way of medical treatment is not that they will be free of the risk of injurious effect but (at most) that any such risks are of a kind which are generally known to doctors who may use them.

The defendants also seek to rely on the "development risks" defence in section 4(1)(e) of the CPA, arguing that in the state of scientific and technical knowledge at the time that the products were supplied, the Regions could not be expected to have discovered any contamination with the HCV virus. They could only be expected to have discovered such contamination when (a) the virus had been scientifically identified; (b) a reliable method of testing donated blood for the virus had become readily available; (c) practical systems were in place for the administration of such tests. The defendants say that those conditions were not satisfied until 1 September 1991. The claimants respond that the existence of the defect was known to the defendants at all material times, in that they knew that blood and blood products were infected on occasion with a hepatitis virus, later called HCV. The claimants argue that risk of such infection was not a development risk but a production risk, to which Article 7(e) of the Directive has no application.

In the alternative, the claimants argue either that the state of scientific and technical knowledge was such as to enable the existence of the defect to be discovered, by the practice of surrogate testing of donors for anti-HBC or for serum ALT levels, or by anti-HCV testing from 1 March 1998.

The claimants requested that the following questions be referred to the ECJ:

1. Are transfusion blood products (or in one case transplanted body parts) to be regarded as "defective products"? Further, would different levels of expectation of safety apply to an unconscious patient needing an emergency transfusion, a patient undergoing elective surgery whose needs could have been met by autonomous transfusion, or a patient accustomed to being treated with blood products? Would the answer be different if the contaminating viral material was difficult to detect?

2. Is the "development risk" defence open if it is known that blood, products and body parts were at risk of being infected with the hepatitis virus and on occasion were infected? If so, is the defence available to producers of contaminated products produced before HCV was identified even though the producers were capable of reducing, albeit not eliminating, the risk of infection by rejecting some of the products which might be infectious? Further, is the defence available if the then available technology which could have detected the presence of the virus, albeit at a cost of false positives, was not used? Does it make a difference that such technology was used in other countries to reduce the risk?

The judge decided the issue of whether a reference should be made on the question of whether it would be advantageous for him as proposed trial judge, in accordance with English and Community authority. In Irish Creamery Milk Suppliers' Association the government of Ireland and others [1981] ECR 735, the ECJ said that considerations of procedural economy and efficiency are to be weighed only by the national court. The judge analysed the questions which arise and various possible outcomes and timings and concluded that a reference on these questions would not be appropriate in advance of his making findings of facts and perhaps a provisional judgement.

The judge commented that the "expectation test" of safety "at least arguably imports an objective test". Counsel for the claimants had described the words "all circumstances" in Article 6 of the Directive ("...... the safety which a person is entitled to expect, taking all circumstances into account...") as " somewhat mush words, puff words". The judge thought that the words may mean exactly what they say, or they might be "mush and puff", or they might lead, notwithstanding the wide language, to the inclusion of some circumstances and the exclusion of others.

He also said that the wording in Article 7(e) "would appear to allow less room to the defendants for the consideration of background circumstances" if the claimants establish that "existence of the defect" means "existence of the defect in the population of products", although the word "such" might still perhaps allow or necessitate consideration of some evidence. But in any event, all the evidence which the defendants wish to adduce about detectability and the state of research, which would be excluded in respect of Article 7(e) if the claimants' interpretation of it were right, would in any event be lead under Article 6, unless they were also able to exclude it there.

For information on any product liability issues, please contact Chris Hodges on Tel 0171 367 2738 or e-mail [email protected]