Pill 'caused long-term damage'

The women say they were not warned of the risks

A test case involving more than 100 women who say they were exposed to potentially lethal side effects of the third generation contraceptive pill has started at the High Court.

Lawyers representing the families are taking action against three pharmaceutical companies, saying the women were not warned of the possible dangers of the Pill.

They claim the third generation Pill caused the women to develop blood clots which led to long-term damage to their health, and in around 10% of cases proved fatal.

We can say our Pills are not associated with any greater risk than any other Pill available today or before today

Dr Rob Kaper, Organon

The companies say they will vigorously defend the claims and reject suggestions that the third generation Pill, introduced in the 80s, is slightly riskier than its predecessors.

They say there is no link between the women's problems and their products.

The case is the first of its type and, if successful, could lead to massive compensation payouts, expected to total about £10m.

The legal challenge, being brought under the Consumer Protection Act, is expected to last many months.

The companies being sued are Schering Healthcare, Organon Laboratories and Wyeth.

Third generation Pills include Femodene, Femodette, Marvelon, Mercilon, Minulet, Triadene and Tri-Minulet.

'Disastrous injury'

Pill history

First generation: high dose of oestrogen and one of two progesterones

Second generation: lower dose of oestrogen, same progesterones

Third generation: same lower dose of oestrogen, different progesterones

Lord Brennan QC told Mr Justice Mackay the group included those who had conditions including deep vein thrombosis, pulmonary embolism, strokes and cerebral vein thrombosis.

He said: "Some are moderately injured. Several of them are the victims of disastrous injury which will incapacitate them throughout their lives."

The litigation, involving some claims brought on behalf of women who have died, will focus on seven individual cases.

Lord Brennan said the Consumer Protection Act provided for all consumers, such as the women in the case, to have a legitimate expectation that they would be warned of the kind of risk he had described.

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

Thromboembolism risk

In women not taking the Pill or who are not pregnant - five per 100,000

In women using 'second generation' Pills - 15 per 100,000

In women using 'third generation' Pills - 25 per 100,000

In women who are pregnant - 60 per 100,000

Source: Department of Health

Organon insists there is no difference in risk of thrombosis between second and third generation Pills, and this will form the backbone of its case.

Organon's medical director in the UK, Dr Rob Kaper, said: "The Pills are safe.

"Based on the latest studies, we can say our Pills are not associated with any greater risk than any other Pill available today or before today.

"The association between Pills and thrombosis has been known since the late 60s and all Pill packets have contained the warning and that's for any type of Pill."

The Department of Health has issued guidelines on the risks associated with venous thromboembolism (VTE) - blood clots in the veins - and third generation oral contraceptives.

'Unfounded' claims

It says VTE is "very rare and may occur in any woman whether she is taking the Pill or not".

However, it suggests the risk of VTE is slightly higher in women taking any combined oral contraceptive Pill, compared with those not on the Pill.

But this risk is "very small and far lower than the risk in pregnancy".

It says there is no reason for women to stop taking the pill.

Schering, which makes Femodene, has issued a statement saying the women's claims are "unfounded".

It said their product was effective, and posed only a tiny risk. In addition, it protected women from endometrial and ovarian cancer.

Dr Peter Longthorne, medical director of Schering Health Care Ltd, said: "In some cases, the claimants have had tragic experiences, and we have a great deal of sympathy for them.

"This is why we feel it particularly important that a conclusion be drawn for the benefit of everybody involved.

"However, the claimants have not established that there is a link between their problems and our products or put forward a good case that Schering are legally responsible to compensate them."

Lord Brennan told the court 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 seven claimants' details were outlined in court:

Carol Ann Townsend, 31, of Oxford, who was taking Femodene suffered a deep vein thrombosis in August 1993

Debra Jones, 31, of Aberdare, south Wales, who was taking Femodene, suffered a cerebral venous thrombosis in December 1994

Andrea Massey, 25, of Wrexham, north Wales, who was taking Femodene, suffered a stroke in July 1995

Karen Roberts, 39, of Denbigh, north Wales, whowas taking Femodene, suffered a deep vein thrombosis in August 1995

Jacqueline Diplock-Webb, 43, of Ferndown, Poole, Dorset, who was taking Marvelon, suffered a deep vein thrombosis in August 1993

Nicola Moores, 35, of Fulham, south-west London, who was taking Mercilon, suffered a pulmonary embolism in November 1993 and August 1995

Ellen Silcock, 24, of Corby, Northamptonshire, who was taking Minulet, suffered a pulmonary embolism in October 1995.