In May 1941, the small committee submitted the “master file” of clinical data to the FDA. The FDA approved the marketing of DES for uses unrelated to problems of pregnancy in late 1941. Thereafter, the small committee was disbanded, never again to reconvene. The ADMA continued to file NDAs up through 1943 on behalf of other companies seeking to market DES for the uses previously sanctioned.
Experimental use of DES as a miscarriage preventative began in the early 1940’s. Several drug companies supplied DES to independent researchers for such experimentation. The drug companies also sent representatives to medical conferences on this topic.
The first supplemental NDAs for the use of DES as a miscarriage preventative were filed in 1947. Only a few companies conducted their own experiments to establish the safety and efficacy of DES for this purpose. Among these, none tested DES on pregnant laboratory animals. The applicants relied instead upon published studies done by independent researchers to support their applications, in particular, the work of Dr. Karl John Karnaky of Houston and Drs. O. Watkins Smith and George Van S. Smith of Boston. The supplemental NDAs did not refer to the “master file” of clinical data that had been submitted with the 1941 NDAs. The FDA’s policy in reviewing supplemental NDAs, however, was to take into consideration all of the material that it had in support of the original NDAs.
The FDA began approving the supplemental NDAs in July 1947. Soon thereafter, DES was marketed as a miscarriage preventative. Some companies marketed the drug under a trade name; others marketed it generically. Several companies supplied DES to competitors. Because the DES compounds produced by the drug companies were chemically identical, pharmacists often filled prescriptions for DES with whatever company’s drug was in stock, a practice that the firms were aware of. None of the companies warned physicians about the possibility of carcinogenic or other risks to the offspring of women who took DES. Several, however, had warned against the use of DES in women having a history of cancer.
The number of firms marketing DES has fluctuated considerably over the years. In 1941, ten firms filed NDAs for DES. By 1947, 71 companies were producing or distributing the drug. In 1957, this had increased to 151 firms. And by 1967, the number of firms marketing DES had dropped back to 91. Additionally, companies have entered and left the DES market at different times.
In 1952, the FDA decided that DES was no longer a “new drug” within the meaning of § 505 of the Food, Drug, and Cosmetic Act. This meant that companies wishing to market DES for the first time would not have to file NDAs.
In 1971, Dr. Arthur Herbst and several other physicians published a study linking the outbreak in young women of clear cell adenocarcinoma, a form of cancer, with the ingestion of DES by their mothers during pregnancy. In November of that same year, the FDA required the drug companies to include a statement on all labels that “DES is contraindicated for use in the prevention of miscarriages.” Today, the FDA continues to permit the use of DES in treatments unrelated to problems of pregnancy. …
PAYTON v. ABBOTT LABS, Leagle, 19811543512FSupp1031_11381, April 23, 1981.
… In order to survive defendants’ motion for partial summary judgment, plaintiffs must establish the existence of a genuine and material issue of fact under any of these theories. …
Concert of Action
Plaintiffs argue that the drug companies that marketed DES tortiously agreed not to test the drug properly to determine its safety and efficacy as a miscarriage preventative and not to warn of the carcinogenic danger which DES posed to the fetus. For purposes of this motion, it will be assumed that the individual drug companies acted tortiously.5 The only issue, then, is whether plaintiffs have met the burden of presenting evidence creating a genuine issue of fact as to whether such an agreement between the defendants existed. …
Aiding and Abetting
Plaintiffs argue that the drug companies gave substantial assistance and encouragement to each other in marketing DES for use as a miscarriage preventative and, therefore, that they are collectively liable for any injuries resulting from such use. In plaintiffs view, the following undisputed facts raise a genuine issue as to whether the defendants substantially assisted and encouraged one another:
- the DES marketed by all drug companies was chemically identical;
- physicians frequently prescribed DES generically;
- and pharmacists often filled such prescriptions with whatever drug company’s DES they happened to have in stock. …
Plaintiffs argue that the marketing of DES had all the characteristics of a joint venture. They reason that the generic aspects of the DES market created a community of pecuniary interest among the companies, to which all contributed and from which all received benefit. This, in addition to the firms’ cooperative efforts in 1941, raises an issue of fact as to the existence of a joint venture, in their view. ” …
… read the full paper PAYTON v. ABBOTT LABS on Leagle.