Drug firms face £10m claim over pill

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100 women who had potentially lethal blood clots begin historic court action

Clare Dyer, legal correspondent

Tuesday March 5, 2002

The Guardian

More than 100 women who claim they suffered potentially lethal blood clots after taking contraceptive pills - and the families of seven who died - brought a ground-breaking £10m compensation claim to the high court yesterday.

The women are suing over the third-generation pills, introduced in the 1980s, which their counsel, Lord Brennan QC, said proved to be more than twice as risky in terms of blood clots than the earlier second-generation pills. Some survivors had suffered "disastrous injury which will incapacitate them throughout their lives", he told the court.

The case, which will run until August, is the first large group action to brand a pharmaceutical product defective because there was no warning of an increased risk.

It is being brought under the little-used Consumer Protection Act 1987, which makes manufacturers of defective products liable for injury they cause, even if they were not negligent. The act specifically states that a product can be considered defective if any warning issued with it is defective.

The third-generation pills, which contained new artificial progestogens, were initially assumed to be safer than their predecessors.

It was only in 1995 that studies were published and the regulatory authorities issued cautions.

Disastrous injuries

Lord Brennan told Mr Justice Mackay that the women suing suffered from conditions which included deep vein thrombosis, pulmonary embolism, stroke and cerebral vein thrombosis. Some were moderately injured, but others had suffered disastrous, incapacitating injuries.

The claims are against Schering Healthcare, manufacturer of Femodene; Wyeth, the maker of Minulet and Tri-Minulet; and Organon Laboratories, which manufactures Marvelon and Mercilon.

Lord Brennan said: "The case is that those third-generation products carried an increased risk of venous thromboembolism when compared with the second generation of products.

"Because of that increased risk, there should have been a warning to prescribers and users. There was no such warning and the claimants suffered the various conditions I have described.

"Had they been warned, it is their case that they would not have taken the third-generation pill, but either the second or some other form of contraception.

"A product that carries such a risk, but doesn't carry a warning about it is, we submit, a defective product under that statute."

He said that the increased risk of third-generation products had featured in a major debate among epidemiology experts, as well as among regulatory authorities, such as the World Health Organisation.

"The complexity of the case should not detract from the simplicity of the issues. The complexity, we submit, comes from the defendants' concerted argument that the mainstream epidemiology is wrong, that the regulatory authorities have over-reacted, and that their group of experts is right."

He added that there was a saying that you could torture statistics into admitting anything. Despite the complexity of the scientific debate, the claimants' case was simple: the product they received was defective and that defect caused them injury.

An important issue in the case is the disparity in the results of studies funded by the drug industry, which showed little or no increased risk from the third-generation pills, and independent studies, which found a significant increased risk.

After the results of several studies were published in 1995 and 1996, the drug watchdog, the committee on safety of medicines, advised doctors that the third-generation pills should not be their first choice.

The litigation focuses on seven lead claimants, who are scheduled to give evidence in July: Carol Ann Townsend, 31, of Oxford; Karen Roberts, 39, of Denbigh, north Wales; and Jacqueline Diplock-Webb, 43, of Ferndown, Poole, Dorset, who all suffered deep vein thrombosis; Debra Jones, 31, of Aberdare, south Wales, who had a cerebral venous thrombosis; stroke victim Andrea Massey, 25, of Wrexham, north Wales; and Nicola Moores, 35, of Fulham, south-west London, and Ellen Silcock, 24, of Corby, Northamptonshire, who both suffered pulmonary embolism.

The manufacturers will outline their case today.

They claim that the results of the studies stem from doctors prescribing the third-generation pill for women who were at greater risk of blood clots.

'Effective'

The chief medical officer, Sir Liam Donaldson, who is not involved in the case, said in a statement yesterday: "Oral contraceptive pills are highly effective and have an excellent safety record. Venous thromboembolism is very rare and can affect any woman, whether she is taking the pill or not.

"However, evidence shows the risk is very small and the facts indicate that a pregnant woman is more than twice as likely to develop VTE as a woman taking third-generation pills.

"It is vital to stress that, based on the evidence being presented in this case, there is no reason for any woman to stop taking the pill."

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