British women win right to sue U.S. firm

Press, 23 October 1984, Page 13

British women win right to sue U.S. firm

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A group of seriously handicapped British women have won the right to sue a drug manufacturer in the United States for damage allegedly suffered after taking a contraceptive pill. If they win their multi-million dollar suit, drug firms in Britain may be forced to provide more information for patients., Twenty-one women are alleging that they were not told about the pill’s side-effects, even though it was distributed in the United States with a 32-page warning. They say no such advice was issued with the pill in Britain. Norinyl-I was given to thousands of British women in the 19705, but is now less commonly prescribed because of its relatively high oestrogen content. The women’s success in winning the right to sue is the result of a five-year struggle by their lawyers to get the case heard in the United States where settlements are higher and the law more favourable to the plaintiff. Syntex Laboratories Incorporated, of Palo Alto, California, which makes Norinyl-I, maintains that responsibility in Britain lies entirely with its British subsidiary, based in Maidenhead, Berkshire. But the women’s American law firm, which previously won massive settlements in the United States for British victims of the DC-10 air crash in Paris in 1974, claims that there was a corporate decision in California not to warn British women of the pill’s side effects. The women, several of whom are in wheelchairs, suffered a range of complaints from heart attacks to strokes and blood clots in the legs. The case highlights the lack of information provided to British patients, when they are given prescribed drugs, long been

ANNABEL FERRIMAN,

London “Observer”

regarded as a scandal by pharmacologists and health pressure groups. ’ Under British law, the pharmaceutical industry is only obliged to provide detailed data sheets to doctors, and not to the patients themselves. Most prescription medicines come labelled only with the name of the drug and how frequently it has to be taken. Manufacturers of contraceptive pills, however, are increasingly providing information inserts in the packages because of the long-term nature of pill usage and because the consumers are mostly fit and healthy women for whom alternative methods are available. Norinyl-I, for example is now distributed in Britain with a leaflet warning that it should not be taken by anyone who has ever suffered blood clots on the leg, lung, brain or heart, and that women who smoke or suffer from high blood pressure or obesity should discuss the risks with their doctor. Many specialists in Britain want to see the law tightened so that all medicines have to be accompanied by a leaflet, explaining what the drug is supposed to do And what unwanted effects it might have. Ms Michele Claich, speaking for Syntex, says that the company had objected to the cases being brought in the United States because the drug had been manufactured, marketed and prescribed in Britain, in strict conformity with British law. The company, therefore thought the case should be heard in Britain. “With regard to the allegutions themselves, they have never been heard or ruled on in any court and remain unproved,” she adds. The case is likely to be heard in full in the California Superior Court in San Jose at the beginning of 1986.