UK: XYZ and Others -v- Schering, Organon and John Wyeth and Brother Ltd

After 42 days of evidence and argument the English High Court has concluded, on the trial of a preliminary issue, that the Defendants’ "third generation" Combined Oral Contraceptives were not defective products, within the meaning of Section 3 of the Consumer Protection Act and the Product Liability Directive 85/374/EEC.

The trial involved seven lead claims in group litigation against three drug companies in respect of their products. There were in total 99 claims, following one of the biggest "pill" scares which had occurred in the history of oral contraception in the United Kingdom.

The Claimants alleged that they had suffered various cardio-vascular injuries as a result of taking on prescription different brands of the Combined Oral Contraceptive (COC). Their injuries came under the collective description of Venous- Thromboembolism (VTE). The commonest forms of this are Deep Vein Thrombosis (DVT) and Pulmonary Embolism. Some of the Claimants had also suffered Cerebral Venous Thrombosis and some had suffered from strokes.

The COCs produced and marketed by the Defendants were known as third generation COC’s (COC 3s) and contained a synthetic estrogen and a synthetic progestogen combination. The synthetic progestogen element of the product, as developed by Organon, was Desogestrel (DSG). Schering introduced to the market in 1987 (under the name Femodene) a COC, the synthetic progestogen content of which was Gestodene (GSD). This latter product was licensed to the Third Defendant, Wyeth, and was marketed as Tri-Minulet from 1992. The previous (second) generation of COCs had contained a progesteron comprising Levonorgesterel (LNG).

On 18 October 1995 the Committee on Safety of Medicines (CSM) circulated a warning to all prescribers of COCs saying that the CSM had become aware of the results of three unpublished epidemiological studies on the safety of oral contraceptives in relation to VTE. These three new studies indicated that COCs containing DSG and GSD were associated with around a two-fold increase in the risk of VTE, compared with those containing other progestogens. The CSM went on to advise that COCs containing GSD or DSG should not be used by women with risk factors for VTE including obesity, varicose veins or a previous history of thrombosis from any cause. It further advised that COCs containing GSD or DSG should only be used by women who were intolerant of other COCs, and prepared to accept an increased risk of thromboembolism.

The Claimants’ case was that the action by the CSM was fully justified by the studies they relied on, as well as by later studies and that the warnings that the CSM gave in 1995 were those which should have been and still should be attached to COC 3s.

The Defendants’ case was that the CSM advice was precipitate and ill-considered and that it led to a public health disaster. They cited the fact that in 1997 the Office for National Statistics estimated that in the eight months alone following the announcement there were 30,000 conceptions in the UK beyond the number that might have been projected from trends in place before the announcement. 10,000 of these were terminated by abortion. The Defendants also relied on the fact that the equivalent European regulatory body, the CPMP, had adopted a different approach to that of the CSM.

THE ISSUES IN THE LITIGATION

There were five principle issues in the litigation. However, the Judge decided that it was appropriate to try as a preliminary issue whether the Claimants had proved that COC 3s, alternatively DSG/GSD, carry a true excess risk of VTE which is more than twice that carried by COC 2s containing LNG. The Defendants conceded that if the Claimants did prove the alleged level of increased risk of VTE (twofold) in respect of their products, those products could properly be described as being defective within the meaning of Section 3 of the Consumer Protection Act 1987, i.e. their safety was "not such as persons generally [were] entitled to except". Realistically, the Defendants accepted that if the true risk of VTE was more than doubled, even if the overall risk was very low in absolute terms, women and their prescribers were entitled to be told of this before making their decisions and given advice, and they were not.

The trial of this issue occupied some 42 days, including submissions. The trial of the remaining issues in the litigation was estimated to last about as long again and to add a seven-figure sum to the total costs of the litigation. In the circumstances, the Judge considered it right to give judgment in relation to the preliminary issue without hearing the remainder of the evidence.

The Judge heard complex evidence in relation to cohort studies, case-controlled studies and database studies, in addition to listening to "live" evidence from ten epidemiological experts. Those experts were largely irreconcilable in their differences. The usual practice of courts these days is to order that the experts meet pre-trial to resolve or narrow the issues. However, in this case, the Judge (and counsel), considered that the experts were so entrenched in their views that such a meeting was unlikely to resolve anything. The Judge described the debate between the experts at the trial of the preliminary issue as being "almost rancorous in tone" and, with a few exceptions, "devoid of willingness to countenance that there may be two sides to the question". The Claimants categorised the Defendants’ witnesses as eccentric mercenaries isolated from the rest of scientific opinion on this issue.

The Judge rejected both the Claimants’ characterisation of the Defendants’ experts and concluded that there was not, as a matter of probability, any increased relative risk of VTE carried by any of the third generation oral contraceptives (COC 3s) supplied to these Claimants by the Defendants as compared with the second generation products containing Levonorgesterel. It followed that the Judge concluded that the Defendants’ products were not defective within the meaning of Section 3 of the Consumer Protection Act.

The Judge’s conclusion was based on a particular study (the Cox Regression Analysis) which he found to be "the most compelling evidence in the case".

The Judge went on to find that, even if he was wrong about the validity of the Cox Regression Analysis, he would have found on the basis of other studies and expert evidence that the increased risk of VTE in third generation COCs, over the second generation, was less than two-fold and that consequently the Claimants’ action would fail on that basis.

This litigation and decision raises interesting issues. First, it is another important decision in the field of product liability decided by the English Courts in recent years and there is now a developing body of case law in relation to product liability in this country.

Secondly, the decision illustrates the wisdom of identifying at an early stage a preliminary issue which can dispose of product liability litigation on a reasonably cost-effective basis. The savings in this case in terms of legal costs alone amounted to millions, leaving aside issues of the management time which would have been required to assist with investigating the other issues.

The other interesting aspect of the case was the Judge’s willingness to reach a conclusion which was contrary to that which had been adopted by a UK regulatory body, the Committee on Safety of Medicines (CSM) as well as the Licensing Authority of the Medicines Control Agency.

The Judgement marks a comprehensive and cost-effective (although by no means inexpensive) victory for product manufacturers.