Opinion ID: 2121050
Heading Depth: 1
Heading Rank: 2

Heading: history of des

Text: The history of the development of DES and its marketing in this country has been repeatedly chronicled, especially in cases which address the issues of conspiracy and concert of action. (See Ryan v. Eli Lilly & Co. (D.S.C.1981), 514 F.Supp. 1004; Martin, 102 Wash.2d 581, 689 P.2d 368; Sindell, 26 Cal.3d 588, 607 P.2d 924, 163 Cal. Rptr. 132; Lyons v. Premo Pharmaceutical Labs, Inc. (App.Div.1979), 170 N.J.Super. 183, 406 A.2d 185; Note, The DES Causation Conundrum: A Functional Analysis, 32 N.Y.L.Sch.L.Rev. 939 (1987); Comment, Market Share Liability: A New Method of Recovery for D.E.S. Litigants, 30 Cath.U.L.Rev. 551 (1981).) Nevertheless, before getting into the market share issue, we believe that a brief account of the drug's history will be helpful. Diethylstilbestrol is a synthetic substance which duplicates the activity of estrogen, a female sex hormone crucial to sexual development and fertility. Professor E.C. Dodds and his associates first synthesized the drug in England in 1937. The drug was not patented by Professor Dodds, but was left available for general production by pharmaceutical companies. In 1940, a number of pharmaceutical companies in the United States sought the approval of the Food and Drug Administration (FDA) to market DES in up to 5 milligram doses to treat vaginitis, engorgement of the breasts, excessive menstrual bleeding and symptoms of menopause. Standard procedure at the FDA required the filing of a new drug application (NDA), which included clinical data establishing the drug's safety, its chemical composition, methods of manufacture, the proposed uses of the drug and proposed labeling. In an effort to avoid duplication of time and effort in determining the sufficiency of the documentation presented, the FDA requested that the drug companies withdraw their NDAs and submit their data jointly in a master file. Accordingly, a working committee of four companies was formed which collected all the data, prepared the master file and submitted it to the FDA. In September 1941, the FDA approved the production and marketing of DES for the requested uses, none of which were for problems related to pregnancy. The first supplemental NDAs seeking FDA approval for DES as a miscarriage preventative were filed in 1947. These NDAs were filed separately and relied on clinical studies published in medical journals which attested to the safety and effectiveness of DES for this purpose. The FDA subsequently approved these applications. In 1952, the FDA declared that DES was no longer a new drug within the meaning of the Federal Food, Drug, and Cosmetic Act, and was therefore considered safe for general use. This declaration meant that any manufacturer could market the drug without submitting additional data to the FDA concerning its safety and effectiveness. Between 1947 and 1952, approximately 85 companies manufactured DES. By the end of 1952 up to 191 companies were manufacturing and distributing DES. In 1971, two medical studies suggested that there was a statistically significant association between the outbreak in young women of clear cell adenocarcinoma, a form of cancer, with the maternal ingestion of DES during pregnancy. Later that year the FDA banned the marketing of DES for use by pregnant women. It has been estimated that at the time of this ban as many as 300 companies had produced DES for sale. Many of these companies are no longer in existence, having merged with other concerns or gone into liquidation. Although DES is no longer used during pregnancy, it is still prescribed as an estrogen replacement in cases of hormone deficiency, for treatment of unusual menopausal symptoms, and for treatment of certain kinds of cancers of the breast and prostate, and is a major ingredient in the morning after pill, a post-coital contraceptive. Beginning in the 1970s, hundreds of lawsuits were filed against manufacturers of DES by the daughters of women who took the drug while pregnant. These plaintiffs are commonly referred to as the DES daughters. The seriousness of the injuries they suffer cannot be questioned and the hysterectomy required for Sandra Smith was not unusual. (See Bichler v. Eli Lilly & Co. (1982), 55 N.Y.2d 571, 577, 436 N.E.2d 182, 184, 450 N.Y.S.2d 776, 778; Namm v. Charles E. Frosst & Co. (App. Div.1981), 178 N.J.Super. 19, 25-26, 427 A.2d 1121, 1124; Lyons v. Premo Pharmaceutical Labs, Inc. (App.Div.1979), 170 N.J. Super. 183, 189, 406 A.2d 185, 188; see also Enright v. Eli Lilly & Co. (Supp.1988), 141 Misc.2d 194, 195, 533 N.Y.S.2d 224, 226.) The defendants before us, however, point out that statistics regarding DES daughters have not shown a high incidence of cancer and that it is not widely accepted that the injuries suffered are the consequence of the maternal ingestion of DES (see, e.g., Sindell, 26 Cal.3d at 620-21, 607 P.2d at 942, 163 Cal.Rptr. at 150 (Richardson, J., dissenting) (incidence of cancer is estimated at one-tenth of one percent to four-tenths of one percent), though the plaintiff contests these assertions). Whether or not there is a correlation sufficient to establish a cause of action is an issue properly for the finder of fact. We have before us only the legal issue of the viability of the causes of action.