Women sue over Pill

A case involving around 100 women who claim that they were exposed to potentially lethal side effects by using the third generation contraceptive pill began at the High Court in London today.

It is the first major group action involving the application of the Consumer Protection Act to a pharmaceutical product where it is alleged that the product carried an increased risk of danger to the user of which there was no warning.

Lord Brennan QC told Mr Justice Mackay that the group included sufferers from conditions including deep vein thrombosis, pulmonary embolism, strokes and cerebral vein thrombosis.

"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.

The claims against Schering Healthcare are in respect of Femodene which appeared in 1987.

Wyeth is involved through its production of Minulet in 1988 and Tri-Minulet in 1992, while Organon Laboratories faces claims over its products of Marvelon, in 1981, and Mercilon, in 1989.

Lord Brennan said that contraceptive pills had been in use since the early 1960s and throughout their history, they had been associated with a risk of thrombosis.

"Women who took the contraceptive pill, and those who still do, no doubt want and expect safety from the product they use - in particular the third generation of the contraceptives with which we are concerned, which were introduced in the 1980s."

He added: "The case is that those third generation products carried an increased risk of venous thrombosis embolism when compared with the previous 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 their case that they would not have taken the third generation pill but either the second or some other form of contraception."

Lord Brennan said that 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."

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.

He said that the court would have to decide, over the five months the case is expected to last, whether there was an increased risk as between the third and second generation pills and whether there was a defect under the Act.

"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.

He told the judge: "And I am very concerned to advise you in this very long case that refined scientific argument is no substitute for common sense.

"The ultimate question is to determine the issues I've described on the balance of probability."

The seven lead claimants are not scheduled to give their evidence until the end of July.

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