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US breast implant agreement
US breast
implant agreement
UK view on :
Coming Corporation, Bristol-Myers : Squibb Company, and Baxter Inter- : national Incorporated have reached a ten: Dow
tative agreement to create a US$3-7 : billion compensation fund to settle a class-action suit by women who claim to have been injured by their silicone breast : implants. The proposed agreement : between lawyers for the companies and a : : committee of attorneys representing : women who are joined in a class-action : lawsuit must still obtain the final approval of the court and the companies’ boards of : directors. If other silicone implant manufacturers join the deal, the fund may eventually top US$4 billion. Under the proposed settlement, any woman who had an implant-related claim against the companies could seek compensation without going to trial. To qualify, a woman would have to be diagnosed with one of eight conditions that have been alleged to be linked to the
!
implants, including scleroderma, systemic lupus erythematosus (SLE), mixed connective tissue disease, Sjogren’s syndrome, and a number of neurological syndromes. She would not, however, be to prove that her condition was caused by the implant. : The amount of compensation would depend on the nature and severity of the woman’s disease and her age; a younger woman, because she has a longer life expectancy, would be paid more than an older women with a similar disease. The amount of compensation will also depend on the number and size of claims the fund must ultimately cover. According to some reports, a young woman with severe SLE or scleroderma might be paid as much as US$2 million, but that sum may be a lot less if large numbers of women file successful claims. To date, an estimated 25 000 women in the USA have claimed that they have been injured by their implants; estimates of the number of women in the USA who have received implants range from less than 1 million to as many as 2 million. : A spokesman for Dow Coming said that the company still believes that there is no good scientific evidence claims that the implants cause disease but that company executives decided that the proposed settlement would prove less onerous than years of court litigation. : Sal Liccardo, a San Jose, California, lawyer who represents 200 breast implant plaintiffs with autoimmune disease, was critical of the agreement. Liccardo said that the settlement terms might be a good deal for women whose breast implant manufacturer is bankrupt or who cannot identify the manufacturer of her implant, but he expected the fund will prove to be far too small to provide fair compensation
required
paid
supporting
compensation scheme
Health authorities in Europe, especially the UK, are concerned about the breast implant compensation fund and its potential effect on medical device supplies, health-care costs, and patient health. The UK Medical Device Directorate, in a position paper sent to other European Union nations, argues that the case for either banning implants or compensating patients is not proven. The paper cites British studies which had not found a link between implants and either cancer or connective tissue disease; a 1990 review by the Department of Health Committee on Carcinogenicity that did not support suggestions of an increased link with breast cancer; and a later committee report that there was no evidence to support suggestions that the polyurethane foam used to coat some implants releases 2,4-toluene diamine (TDA), a known carcinogen in rodents. The committee concluded that no reliable estimate of the possible additional risk of cancer in women with these implants could be made, but polyurethane-foam-coated breast implants are banned in the UK. Following the US Food and Drug Administration’s January, 1992, statement that it was to review manufacturers’ data on silicone get breast implants, the UK launched its own inquiry. A Department of Health independent expert advisory group concluded that there was no evidence of an increased risk of connective tissue disease in patients with implants, and that, except for the polyurethane-foam-coated products, breast implants would continue to be freely available in the UK. A major UK concern about the global settlement is that it could cause anxiety among implanted patients, who will assume that, if compensation is being offered, a causal association must have been proven. The paper says this is likely to mean fewer patients either wishing to have implants or being advised by doctors to have them. "This has implications for a large number of post-mastectomy patients particularly in whom such implants have provided acceptance of a mutilating operation and its consequent psychological sequetae", the paper argues. The British are also concerned that the settlement could add considerably to rising government health-care costs and that it sets a dangerous precedent for the future. Silicone is used for other implants and to lubricate syringes. The UK is also annoyed that European health authorities were not invited to contribute to the US judicial public hearing that preceded the announcement that the fund was expected to go ahead.
Sara Lewis all the women who will eventually file claims. Liccardo predicted that women who enter into the settlement will be paid far less than is now being promised. "If a . woman has a severe disease, a solvent defendant, and a good lawyer-meaning : one who is competent to handle one of these cases-I think it would be a mistake to go into this settlement." : But Dow Coming executive vice-presito
dent Gary E Anderson warned that if too many women choose to go to trial, the companies will withdraw from the agreement and fight it out in court. "What we cannot manage is both paying the immense cost of this settlement and defending ourselves in protracted litigation", Anderson said. Michael
McCarthy
CONFERENCE
Views Several
on
vasoactive substances
and that some forms of hypertension might be due to hypovasodilation. recent The ability of shear stress on the endothelium to induce release of NO among cussed at the IXth international conseems to be a simple, primitive way of the International for of regulating blood flow to an organ, gress Society the Study of Hypertension in Preghe said. When forearm blood flow in nancy in Sydney two weeks ago, and hypertensive subjects was observed at the 15th scientific meeting of the during local administration of noraInternational Society of Hypertension drenaline (a vasoconstrictor) or NGthe following week in Melbourne. : monomethyl-L-arginine (L-NMMA, Giving state-of-the-art talks on a nitric oxide inhibitor and thus an of nitric oxide at both the meetings, Salinhibitor the vasodilation), vador Moncada (Beckenham, UK) response curve for L-NMMA was shifted to the right. Since the degree argued that under physiological restconditions the cardiovascular of vasoconstriction due to L-NMMA ing system is in a state of active vasodilation depends on the amount of nitric stances
endogenous vasoactive subhave been recognised in years. They naturally were the numerous topics dis-
845
implant agreement
UK view on :
Coming Corporation, Bristol-Myers : Squibb Company, and Baxter Inter- : national Incorporated have reached a ten: Dow
tative agreement to create a US$3-7 : billion compensation fund to settle a class-action suit by women who claim to have been injured by their silicone breast : implants. The proposed agreement : between lawyers for the companies and a : : committee of attorneys representing : women who are joined in a class-action : lawsuit must still obtain the final approval of the court and the companies’ boards of : directors. If other silicone implant manufacturers join the deal, the fund may eventually top US$4 billion. Under the proposed settlement, any woman who had an implant-related claim against the companies could seek compensation without going to trial. To qualify, a woman would have to be diagnosed with one of eight conditions that have been alleged to be linked to the
!
implants, including scleroderma, systemic lupus erythematosus (SLE), mixed connective tissue disease, Sjogren’s syndrome, and a number of neurological syndromes. She would not, however, be to prove that her condition was caused by the implant. : The amount of compensation would depend on the nature and severity of the woman’s disease and her age; a younger woman, because she has a longer life expectancy, would be paid more than an older women with a similar disease. The amount of compensation will also depend on the number and size of claims the fund must ultimately cover. According to some reports, a young woman with severe SLE or scleroderma might be paid as much as US$2 million, but that sum may be a lot less if large numbers of women file successful claims. To date, an estimated 25 000 women in the USA have claimed that they have been injured by their implants; estimates of the number of women in the USA who have received implants range from less than 1 million to as many as 2 million. : A spokesman for Dow Coming said that the company still believes that there is no good scientific evidence claims that the implants cause disease but that company executives decided that the proposed settlement would prove less onerous than years of court litigation. : Sal Liccardo, a San Jose, California, lawyer who represents 200 breast implant plaintiffs with autoimmune disease, was critical of the agreement. Liccardo said that the settlement terms might be a good deal for women whose breast implant manufacturer is bankrupt or who cannot identify the manufacturer of her implant, but he expected the fund will prove to be far too small to provide fair compensation
required
paid
supporting
compensation scheme
Health authorities in Europe, especially the UK, are concerned about the breast implant compensation fund and its potential effect on medical device supplies, health-care costs, and patient health. The UK Medical Device Directorate, in a position paper sent to other European Union nations, argues that the case for either banning implants or compensating patients is not proven. The paper cites British studies which had not found a link between implants and either cancer or connective tissue disease; a 1990 review by the Department of Health Committee on Carcinogenicity that did not support suggestions of an increased link with breast cancer; and a later committee report that there was no evidence to support suggestions that the polyurethane foam used to coat some implants releases 2,4-toluene diamine (TDA), a known carcinogen in rodents. The committee concluded that no reliable estimate of the possible additional risk of cancer in women with these implants could be made, but polyurethane-foam-coated breast implants are banned in the UK. Following the US Food and Drug Administration’s January, 1992, statement that it was to review manufacturers’ data on silicone get breast implants, the UK launched its own inquiry. A Department of Health independent expert advisory group concluded that there was no evidence of an increased risk of connective tissue disease in patients with implants, and that, except for the polyurethane-foam-coated products, breast implants would continue to be freely available in the UK. A major UK concern about the global settlement is that it could cause anxiety among implanted patients, who will assume that, if compensation is being offered, a causal association must have been proven. The paper says this is likely to mean fewer patients either wishing to have implants or being advised by doctors to have them. "This has implications for a large number of post-mastectomy patients particularly in whom such implants have provided acceptance of a mutilating operation and its consequent psychological sequetae", the paper argues. The British are also concerned that the settlement could add considerably to rising government health-care costs and that it sets a dangerous precedent for the future. Silicone is used for other implants and to lubricate syringes. The UK is also annoyed that European health authorities were not invited to contribute to the US judicial public hearing that preceded the announcement that the fund was expected to go ahead.
Sara Lewis all the women who will eventually file claims. Liccardo predicted that women who enter into the settlement will be paid far less than is now being promised. "If a . woman has a severe disease, a solvent defendant, and a good lawyer-meaning : one who is competent to handle one of these cases-I think it would be a mistake to go into this settlement." : But Dow Coming executive vice-presito
dent Gary E Anderson warned that if too many women choose to go to trial, the companies will withdraw from the agreement and fight it out in court. "What we cannot manage is both paying the immense cost of this settlement and defending ourselves in protracted litigation", Anderson said. Michael
McCarthy
CONFERENCE
Views Several
on
vasoactive substances
and that some forms of hypertension might be due to hypovasodilation. recent The ability of shear stress on the endothelium to induce release of NO among cussed at the IXth international conseems to be a simple, primitive way of the International for of regulating blood flow to an organ, gress Society the Study of Hypertension in Preghe said. When forearm blood flow in nancy in Sydney two weeks ago, and hypertensive subjects was observed at the 15th scientific meeting of the during local administration of noraInternational Society of Hypertension drenaline (a vasoconstrictor) or NGthe following week in Melbourne. : monomethyl-L-arginine (L-NMMA, Giving state-of-the-art talks on a nitric oxide inhibitor and thus an of nitric oxide at both the meetings, Salinhibitor the vasodilation), vador Moncada (Beckenham, UK) response curve for L-NMMA was shifted to the right. Since the degree argued that under physiological restconditions the cardiovascular of vasoconstriction due to L-NMMA ing system is in a state of active vasodilation depends on the amount of nitric stances
endogenous vasoactive subhave been recognised in years. They naturally were the numerous topics dis-
845