Drug firms 'failed to issue Pill warnings'

The contraceptive pill went on trial yesterday, 40 years after it was launched, in a test case involving 100 women who claim they suffered serious injury from blood clots caused by the hormones it contains.

The women have been stricken by conditions including deep vein thrombosis, pulmonary embolism (blood clots in the lungs) and strokes.

In the High Court, Lord Brennan, QC for the women, told the judge, Mr Justice Mackay, of the damage they had suffered. "Some are moderately injured. Several of them are the victims of disastrous injury which will incapacitate them throughout their lives," he said.

The case, the first group action involving a pharmaceutical product to be brought under the Consumer Protection Act, will draw attention to the risks of a drug taken by three million women in Britain. The tangled network of commercial imperatives and conflicting interests that drives the world of scientific research might also be exposed.

Among those who attended yesterday's hearing were Yvonne Berry, whose daughter, Nancy, died one month after starting on the Pill. Trudi Banning, 28, was in a coma for weeks after suffering a clot in a vein supplying her intestines and had to have a large part of her bowel removed, and Michelle Markey also suffered side-effects of the Pill.

The women are suing the manufacturers of third generation contraceptive pills, which were launched in the 1980s. The Pill has always been known to carry a slightly increased risk of blood clots but third generation pills, which contain a combination of the hormones progestogen and oestrogen, were at first thought to carry a markedly lower risk than earlier versions.

Research published in 1995 suggested that third generation pills in fact had a higher risk of thrombosis (blood clots) – 30 cases per 100,000 users per year compared with 15 cases for second generation pills. The finding so alarmed the Government that it responded by issuing a sudden warning to women about the newly discovered threat. This triggered widespread fear and led thousands of women to dump their remaining supply of the Pill, against official advice, and risk pregnancy until they could obtain a new prescription for a different kind.

The result was a surge in unwanted pregnancies and three months later the abortion rate hit a record high. The Government was criticised for its mishandling of the incident, which some experts condemned as panic. Governments elsewhere in Europe did not react by issuing national safety alerts but left it to doctors to advise patients when they next attended for a family planning consultation.

Lord Brennan QC said yesterday: "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 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."

The manufacturers, Schering Healthcare (producers of Femodene), Wyeth (Minulet and Tri-Minulet), and Organon Laboratories (Marvelon and Mercilon), are expected to argue that the epidemiological evidence suggesting their products are less safe is flawed and that the regulatory authorities overreacted.

The Family Planning Association said yesterday: "The Pill has been available for more than 40 years and is one of the most thoroughly researched drugs of all time. This research shows conclusively that when the Pill is appropriately prescribed by trained health professionals to healthy women with no adverse risk factors, it is extremely safe to use."

The association said that doses of hormones used in the Pill had been greatly reduced. Even the slightly increased risk associated with the Pill was "significantly less than those associated with pregnancy and childbirth".

The case is expected to last five months.