XYZ & Others v Schering Health Care Ltd
| Jurisdiction | England & Wales |
| Judge | MR JUSTICE COOKE |
| Judgment Date | 31 March 2004 |
| Neutral Citation | [2002] EWHC 1420 (QB),[2004] EWHC 823 (QB) |
| Docket Number | No: 68R/2004,Case No: 0002638 |
| Court | Queen's Bench Division |
| Date | 31 March 2004 |
[2002] EWHC 1420 (QB)
IN THE HIGH COURT OF JUSTICE
QUEENS BENCH DIVISION
The Honourable Mr Justice Mackay
Case No: 0002638
Lord Brennan QC, Mr. Oppenheim, Mr. Edis and Mr. Hermer (instructed by Houghton & Co. and Leigh, Day & Co. Solicitors) for the Claimants
Mr. Spencer QC, Dr. Powers QC, Mr. Waite QC and Miss Power (instructed by Arnold & Porter Solicitors) for the 1 st and 3 rd Defendants
Mr. Underhill QC, Mr. Brook Smith QC and Miss Hamilton (instructed by Beachcroft Wansbroughs Solicitors) for the 2 nd Defendants
Hearing dates : 5 th March 2002 – 31 st May 2002
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
THE HONOURABLE MR. JUSTICE MACKAY
Mr Justice Mackay
SECTION A: INTRODUCTION
General.
This is the trial of seven lead claims in group litigation against three drug companies in respect of their products. There were at the last count 99 claims currently in being. 40 are brought against Schering Health Care Ltd (Schering), 46 against Organon Laboratories Ltd (Organon) and 13 against John Wyeth and Brother Ltd (Wyeth). All the Claimants took on prescription different brands of the Combined Oral Contraceptive (COC) and say they have suffered various cardio-vascular injuries as a result. Their injuries come under the collective description of Venous-thromboembolism (VTE). The commonest forms of this are Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). Some claimants have suffered Cerebral Venous Thrombosis (CVT) and some have suffered from strokes.
All claimants say that the products they took were defective under the provisions of the Consumer Protection Act 1987 and/or the Product Liability Directive 85/374/EEC 25 th July 1985. I set out below the seven lead claimants and the conditions from which they suffer. The distinction between the different products which each claimant took will have to be considered in detail below.
These claims follow one of the biggest pill scares which has occurred in the history of oral contraception in this country; "pill scare" is a phrase used as a convenient shorthand by commentators on this issue which I will adopt, but its use is in no way to be taken as minimising the seriousness of the questions this event raised. On the 18 th October 1995 the UK Committee on the Safety of Medicine (CSM) wrote a "Dear Doctor" letter to all relevant prescribers stating that three unpublished studies into the safety of COCs in relation to VTE had indicated "around a two-fold increase in the risk" of such conditions as against the preceding generation of COCs. The Claimants say that a proper consideration of those studies in their published form and of other studies linked to them supports their claim. The Defendants say that there is no increased risk associated with their products, that the warning from the CSM was misjudged and that it should never have been given. The CSM's letter engendered a heated debate among those practising in this field.
The lead Claimants in this group litigation with very brief details of their claims are as follows:
(i) Carol Townsend. She was born on the 28 th December 1970 and was first prescribed Schering's COC Femodene by her General Practitioner in November 1991. She was then just under 20. On the 20 th August 1993 she suffered a DVT. She has continued to suffer leg pain and loss of mobility and has needed help in the home from her sister.
(ii) Debra Jones was born on 23 rd August 1970 and was first prescribed Femodene in August 1991 when she was 21. She suffered a CVT on the 4 th December 1994 when she was just over 24. She has suffered from very severe headaches, despite repeated lumbar punctures, with nausea and giddiness. Her working ability and social activities are both restricted.
(iii) Andrea Massey was born on the 24 th September 1976 and was first prescribed Femodene in June 1995 when she was 18 3/4. On the 23 rd July 1995 she suffered a stroke as a result of a paradoxical embolism a very short time after starting on the product. I do not as yet have full details of her current symptoms.
(iv) Karen Roberts was born on the 9 th June 1962 and was first prescribed Femodene in January 1995 when she was 32. On the 8 th August 1995 she suffered a DVT seven months after that first prescription. She has a swollen left leg, her walking is limited and she has an increased risk of recurrence of VTE.
(v) Jacqueline Diplock-Webb was born on the 2 nd January 1958 and was prescribed Organon's product Marvelon in March 1993 having also been prescribed it in 1983 and 1985. On 29 th August 1993 when she was just over 25 1/2 she suffered a DVT. She has a constant ache in her leg made worse by walking and climbing stairs.
(vi) Nicola Moores was born on 14 th February 1967 and was prescribed Organon's product Mercilon in September 1990 when she was 23. In November 1993 and again in August 1995 she suffered episodes of PE she then being 26 and 28. She has had episodes of chest pain and dyspnoea. She has suffered a severe loss of confidence and is worried by the thought of a recurrence of PE.
(vii) Ellen Silcock was born on the 16 th December 1977 and was prescribed Wyeth's product Minulet in July 1993 when she was aged 15. On the 4 th October 1995 when just under 18 she suffered a PE. She had similar symptoms. She is anxious and has sleep disturbance. She lost her job and cannot play sports.
All these women, as will be seen, have suffered very significant health problems as a result of their conditions. They have been selected as broadly representative of the range of injuries said to have been caused by the defective nature of the products at the heart of this case. Several of the non-lead cases are more serious in degree and include some fatal cases.
The Combined Oral Contraceptive.
Oral contraceptives began to be prescribed for women in the United Kingdom in the early 1960s. "The Pill" as it came commonly, almost affectionately, to be called rapidly achieved a significant share of the contraceptive market. Few if any pharmaceutical products have made such an impact on the lives of the persons for whom they were prescribed and the society in which they lived. It is no part of this judgment's task to analyse let alone evaluate the impact of the Pill on modern life. This much, however, has to be observed from the outset. As a pharmaceutical product it is almost unique in being prescribed for and taken by women who are, by and large, healthy and who choose to take it for the purpose of regulating their own fertility. There exist alternatives to oral contraception. Almost from the outset it was recognised as carrying risks accompanying the benefits it brought to those who took it. There has been a more or less continuous debate for 40 years in medical circles as to the nature and degree of those risks.
Combined Oral Contraceptives, as their name suggests, contain in combination two distinct constituents both of which are synthetic hormones. Over the years the nature and dose of these constituent parts have both changed. The first constituent is a synthetic oestrogen and in almost all COCs that now takes the form of ethinyloestradiol (EE). The second part of the combination is a synthetic progestogen. This litigation is concerned with two. Desogestrel (DSG) was developed by Organon and introduced into the UK market in 1982 in a COC under the brand name Marvelon which contained 150?g of DSG in combination with 30?g of EE. In 1989 Organon introduced Mercilon which contained an identical dose of DSG but a smaller dose (20?g) of EE. The second synthetic progestogen involved in these claims is gestodene (GSD). Schering introduced this into the market in 1987 in the UK under the name Femodene (known in Germany as Femovan) which contained 75?g of GSD and 30?g of EE. An identical product was licensed to Wyeth who marketed it under the name Minulet in 1988 and, in a Triphasic version called Tri-Minulet in 1992. All bar Tri-Minulet, were monophasic COCs, that is to say the dose remained constant throughout the pill-taking weeks of the cycle; in the triphasic version the dose varied. In this case no significance attaches to this distinction, or to the fact that the GSD and DSG based COCs contained different doses of their respective progestogens.
It is important to bear in mind from the outset that DSG and GSD are chemically distinct products, albeit designed to achieve the same biological result. Despite this they have been frequently referred to in the literature collectively as "third generation" progestogens and the COCs of which they were constituent parts have been referred to as "third generation COCs". I shall deal below with the extent to which it is legitimate to lump together or aggregate these products. I shall use the abbreviation "COC3" to stand for "third generation COCs" by which I mean "combined oral contraceptives with an EE content equal to or less than 30?g and with as a synthetic progestogen either DSG or GSD".
For the purposes of this case it is necessary to understand only this much about the action of a COC. During pregnancy a woman's body produces high levels of oestrogen and progesterone. This has the effect of suppressing ovulation. A COC is taken daily for 21 days of the menstrual cycle followed by a seven day break. When a woman takes a COC the plasma levels of oestrogen and progestogen in her body are increased by the synthetic hormones in the COC which mimics the natural process that occurs during pregnancy. Thus her body is in effect deceived in such a way as to prevent...
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