Guest guest Posted March 9, 2002 Report Share Posted March 9, 2002 - " Ken " <shining Friday, March 08, 2002 11:19 PM Pill 'caused long-term damage' > Monday, 4 March, 2002, 15:30 GMT > Pill 'caused long-term damage' > http://news.bbc.co.uk/hi/english/health/newsid_1848000/1848697.stm > > 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. 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