Introduction

arguments of immunity and ‘non-justiciability’ and at the very least challenging the plaintiffs to establish ‘Wednesbury negligence’3 were only too daunting.

For the victims of infection with the hepatitis C virus through blood transfusions a case based on Community law appeared more promising, precisely because it was intended to remove the need to prove negligence or knowledge on the part of the blood authorities. However, as of the late 1990s, although the EU Product Liability Directive4 had been in force for some fifteen years (and had been under discussion for years before that) it had been little commented upon by courts in the UK or indeed elsewhere in the Common Market. The Newcastle solicitors who represented the majority of the potential claimants had already instructed barristers specialising in common law clinical negligence and product liability to review their clients’ chances. One was also a member of the Paris Bar, with a network of professional colleagues and professional acquaintances in France and elsewhere. Counsel advised the potential claimants they had a sustainable case under the Consumer Protection Act 1987 (‘CPA’) upon the basis that blood infected with hepatitis C virus was defective upon a proper construction of the CPA.

The point being novel and not straightforward the Legal Aid Board authorised the solicitors to seek a second opinion from further counsel, based in Brussels, a member of a London chambers, working with colleagues of different nationalities.

The latter’s opinion on the application of the Directive was first sought in 1997. In March 1997, he gave the opinion that it was reasonable to presume that patients and others would expect to receive uncontaminated blood in a transfusion, and would correspondingly regard as ‘defective’ blood which might infect them with a serious illness. As we will describe further below, the Directive presented a number of questions: would the public at large be entitled to regard as ‘defective’ a blood transfusion which might transmit hepatitis C, and would the various defences contemplated by the Directive avail the defendant blood authority? On this basis, questions of whether the potential defendants had followed good practice with respect to epidemiological probabilities appeared relevant not so much for

3For non-English lawyers, liability of the public authority by reason of its manifestly gross or unreasonable misconduct.

4Council Directive 85/374/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products.

whether the blood was defective under the Directive but rather whether a defence might be available based upon the patient’s acceptance of the risk or the defendant’s unawareness of the risk. The opinion noted that there were surprisingly few judicial decisions applying the Directive, although there was a large quantity of material commenting on the proposal to have a Directive, the dangers and uncertainties of the Directive and its implications for domestic product liability law. Particular attention in counsel’s opinion was given to the writings of the European Commission official charged with drafting the Directive who, from the early 1970s, had been responsible for shepherding the proposal through the process of intergovernmental and intra-institutional negotiation to a conclusion in the form of the promulgation of Directive 85/374/EEC.

The two leading counsel thus separately reached the conclusion that an action based upon the Directive would indeed have a reasonable prospect of success. A number of supplementary opinions were dispatched, on the strength of which the solicitors were able to persuade the legal aid authorities in England that the case was maintainable. (The Scottish legal aid authorities apparently rejected a parallel claim for help in Scotland, on the grounds that the case was not winnable.)

The medicine

It is necessary to give a brief outline of what the scientific case was about. Hepatitis is an inflammation of the liver, which can be caused by various viral infections. Once the hepatitis A virus and the hepatitis B virus had been identified in the early 1970s, it was then appreciated that post-blood- transfusion viral hepatitis continued to occur due to infection with other (as yet unidentified) viruses and NonA NonB Hepatitis (NANBH) was the description applied to this viral hepatitis. It was particularly noted because people were regularly seen to develop symptoms of hepatitis after receiving blood transfusions. At first, there was no direct screening test to identify donors as carrying the virus, but there were practical procedures for excluding blood from donors at increased risk of carrying the virus. These were called ‘surrogate’ tests and the most useful one was to carry out a blood test to check the levels of an enzyme produced in the liver (ALT). High levels of ALT in the blood were suggestive that the person might have some abnormality of liver function, and one possible cause for this was that the donor was a carrier of the NANBH virus. This surrogate testing of blood donors had been routine in Germany since the 1960s;

it was made routine in the USA in 1986 and in France by 1988. Routine ALT screening of blood donors was considered in the UK but was never introduced.

In May 1988 came a breakthrough when the Chiron Corporation of America announced the identification of the hepatitis C virus and the development of a prototype screening test. The first version of the test (the Ortho Elisa) became commercially available in late 1989 (when a licence for the export of the test from the USA was first obtained) and it was soon used in programmes for the routine screening of blood donors in Japan and in France. In May 1990 the US Food and Drugs Administration (FDA) gave approval for use of this test within the USA and so it went into routine use for screening there, as well as in a number of other countries.

There were concerns about the accuracy of this ‘first generation’ test, both as to its sensitivity (not detecting all it should, i.e. false negatives) and its specificity (detecting those it should not, i.e. false positives). A further concern was the lack of a confirmatory or supplementary test to verify positive results and identify some of the false positives. Nevertheless the relevant Department of Health committee (UK Advisory Committee on Virological Safety of Blood: ACVSB) advised, in principle, as early as November 1989 that the Ortho Elisa should be used for routine screening subject to three conditions.5 In May 1990 a confirmatory test (RIBA 1) became available. In July and November 1990 the ACVSB recommended that screening of blood donors should be started, subject to the holding of various trials. Second generation Elisa tests became available by April 1991. Routine screening of blood for hepatitis C was introduced throughout England and Wales on 1 September 1991.

NANBH had been a proxy in the HIV Haemophiliac Litigation (HHL) for the AIDS virus emerging in the 1980s, the argument being that the precautions, which could and should by then have been taken against the contamination of blood products with NANBH, would also have avoided their contamination with the yet to be identified HIV.6

Near the end of the HHL, Mr Justice Ognall allowed the plaintiffs’ lawyers to act in the forthcoming Hepatitis Litigation, using the knowledge acquired when acting in the HHL, particularly resulting from the disclosure provided by the various defendants. In the Hepatitis Litigation NANBH, no longer the proxy, was the target itself.

5Satisfactory pilot tests, FDA approval and availability of a confirmatory test.

6The keystone of the argument was the Scottish decision by the House of Lords in Hughes v Lord Advocate [1963] AC 837.