Re H.I.v Haemophiliac Litigation
| Jurisdiction | England & Wales |
| Judge | LORD JUSTICE RALPH GIBSON,LORD JUSTICE BINGHAM,SIR JOHN MEGAW |
| Judgment Date | 20 September 1990 |
| Judgment citation (vLex) | [1990] EWCA Civ J0920-1 |
| Court | Court of Appeal (Civil Division) |
| Docket Number | 90/0783 |
| Date | 20 September 1990 |
[1990] EWCA Civ J0920-1
IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
MR. JUSTICE ROUGIER
Royal Courts of Justice
Lord Justice Ralph Gibson
Lord Justice Bingham
and
Sir John Megaw
90/0783
MR. RUPERT JACKSON Q.C. and MR. HUGH EVANS (instructed by Messrs Deas Mallen Souter, Newcastle-upon-Tyne) appeared on behalf of the Appellants (Plaintiffs).
MR. ANDREW COLLINS Q.C., MR. JUSTIN FENWICK, and MISS FIONA SINCLAIR (instructed by the Treasury Solicitor) appeared on behalf of the Respondents (Defendants).
This is an appeal by the plaintiffs and a cross-appeal by the Department of Health, one of the defendants, against the order of Mr Justice Rougier of 31st July 1990 whereby he directed production to the court of a number of documents but refused to direct production of other documents. The documents are listed in a certificate given by the Permanent Under Secretary of State at the Department of Health in which immunity from disclosure of the documents is claimed on the grounds of public interest. The appeal and cross-appeal are brought with the leave of the judge. The plaintiffs ask that this court should order production of some additional documents. The Department of Health submits that there should be no order for production of any of the documents.
In the action the plaintiffs, who are haemophiliacs, or the wives and children of haemophiliacs, claim damages for personal injuries which are alleged to have been caused by the breach of statutory duty and negligence of the defendants. In consequence of the alleged breaches of duty it is said (among other grounds of claim) that many of the haemophiliac plaintiffs were treated with Factor VIII concentrate imported from the U.S.A. which was infected with Human Immuno-deficiency Virus ("HIV") and, therefrom, those plaintiffs, and in some cases their wives and children, have become infected with HIV and either have developed or will develop Acquired Immune Deficiency Syndrome ("AIDS").
The litigation
There are now 962 plaintiffs in this litigation. The majority are haemophiliacs who have suffered infection by HIV. Of them 76 have died and the claims are pursued by their representatives; 50 have contracted AIDS; and 326 are suffering from AIDS-related complex ("ARC"). Of the 962 plaintiffs, 730 are haemophiliacs and 177 are intimates of haemophiliacs, namely wives or children; and the remaining 55 plaintiffs are as to the majority haemophiliacs and as to the remainder their intimates. As to the 177 intimates, 23 have been infected by HIV, one has AIDS, and 11 have contracted ARC. There is some uncertainty as to precise numbers and categories of the plaintiffs at this time because the plaintiffs are represented by 70 separate solicitors and the detailed information with reference to the plaintiffs has not yet been fully collated. The trial of the action, which is fixed for March 1991 and is expected to require some 26 weeks for the hearing, will be of the claims of certain plaintiffs in various categories whereby it is intended that the main issues on liability and causation will be determined and, if relevant, decisions will be made as to their claims on the issue of damages.
There are a large number of defendants but the present appeal is between the plaintiffs and the Department of Health only, because the Department alone holds the documents in question. The Central Defendants, as they are described in the action, are the Department of Health and the Welsh Department; the Licensing Authority established under the Medicines Act 1968; and the Committee on the Safety of Medicines established under an order made under section 4 of the Medicines Act 1968. The remaining defendants, of which there are 220, are all the Regional Health Authorities; all the District Health Authorities; and certain special authorities, including the Central Blood Laboratories Authority.
The re-amended main statement of claim of the plaintiffs, which does not deal with the facts relating to individual plaintiffs, extends to 117 pages. The appendices, which contain particulars of the facts and matters (mainly references to articles in learned journals) upon which the plaintiffs rely for proof of relevant knowledge or means of knowledge on the part of the defendants, contain another 61 pages. On the issue of "self sufficiency", as it has been called, the plaintiffs' basic contention is that the failure of the Central Defendants to achieve self sufficiency in blood products for England and Wales was a breach of duty owed to the plaintiffs individually which caused many of the haemophiliac patients to be treated with Factor VIII concentrate imported from the U.S.A. which was infected with HIV. The following summary of the plaintiffs' allegations on that issue is intended to be no more than a sufficient description for the purposes of this appeal:
(i) The use of blood products, including Factor VIII for treatment of haemophiliacs, gave rise to an increased risk of those treated contracting hepatitis from the presence of viruses in the products;
(ii) There was a greater risk of contracting hepatitis from blood that was (a) manufactured commercially; (b) made from large donor pools; (c) made from donations of paid donors;
(iii) There was a similarly increased risk in respect of "other viral infections" apart from hepatitis, including HIV;
(iv) It was economically more efficient to produce Factor VIII concentrate in the United Kingdom than to import commercial concentrates;
(v) The matters set out in (i) to (iv) above were known to, or should have been known to, the Central Defendants;
(vi) Estimates of the number of units of Factor VIII required to achieve self sufficiency for the National Health Service in the United Kingdom (and thereby to avoid the risks from using imported commercially manufactured products) varies from 38–53m in 1974 to 100m in 1981;
(vii) In about 1975 the Department of Health accepted the desirability of achieving self sufficiency in good time;
(viii) Actual consumption of units of Factor VIII increased from about 16m units in 1973 to 88m in 1987, while the N.H.S. share (i.e. produced by the N.H.S.) grew from 2.5m in 1973 to 40m. in 1984 before temporarily reducing (because of the introduction of heat treatment) to 25m in 1987;
(ix) The amounts of money invested in order to increase production of blood products including Factor VIII were in 1975 £.5m in the National Blood Transfusion Service; in 1980 £1.25m. and in 1981 £21.1m. in the Blood Products Laboratory of the N.H.S. at Elstree;
(x) The Blood Products Laboratory was declared unfit for good manufacturing practice in 1980;
(xi) Between 1970 and the mid-1980s, the sizes of donor pools within the National Health Service production increased from approximately 200 to approximately 15,000;
(xii) From about 1976 the Protein Fractionation Centre in Scotland was capable, with some further investment, of producing all or a substantial proportion of the additional Factor VIII and IX requirements of England and Wales as the central defendants knew or should have known;
(xiii) The National Blood Transfusion Service was managed by Regional Health Authorities with little or no central administration or co-ordination;
(xiv) The Department of Health:
(a) should have achieved self sufficiency in the United Kingdom in blood products at an earlier date;
(b) failed to devote enough capital expenditure to the B.P.L.;
(c) failed to create an effective and integrated N.B.T.S. removed from R.H.A. funding;
(d) failed to assess future needs for blood products and to set appropriate targets;
(e) failed to expand the spare production capacity in Scotland;
(f) failed to instruct or to advise Health Authorities to approach commercial blood manufacturers to fractionate plasma from volunteer donors in England and Wales;
(xv) The Department of Health, by the acts and omissions alleged, were guilty of breaches of statutory duty and of negligence which caused the injuries to the plaintiffs by infection from contaminated blood products;
(xvi) Insofar as any act or omission occurred in the purported exercise of a discretion under statutory powers the Department of Health has not acted within the proper limits of the discretion conferred by statute, and/or has acted unreasonably and so as to frustrate the objects of the statute conferring the discretion.
Further issues are raised on the plaintiffs' allegations to the effect that, by separate breaches of duty, a number of plaintiffs were treated with Factor VIII or Factor IX concentrates which caused them to be infected with HIV. In summary those allegations are:
(i) Warnings and screening: despite warning signs, which were known to or should have been known to the defendants, that the AIDS epidemic might reach this country and create grave danger for the plaintiffs, the defendants failed to do what they should have done to exclude blood donors in this country who were at high risk of AIDS and they failed to use such tests as were available to screen donors so as to prevent the taking of infected blood.
(ii) Heat treatment: it was known by the late 1970s that heat treatment of blood products gave protection against hepatitis B. Heat treatment was available by 1983, heat treated Factor VIII concentrate was commercially available in this country from Autumn 1984 and available from the National Health Service from April 1985 but should have been available at an earlier date.
(iii) Other steps: imported commercial...
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