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
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
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
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  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