2007 DES Case: Kelley v. Eli Lilly & Co.

Abstract

… “While living in Massachusetts, pregnant with the plaintiff, the plaintiff’s mother was allegedly prescribed Diethylstilbestrol (“DES”) by Dr. Safon in 1970 and 1971. The plaintiff’s mother was allegedly prescribed DES even through she was not experiencing any unusual symptoms during her pregnancy. The plaintiff was subsequently born at the Boston Hospital for Women, in Boston, Massachusetts, on August 24, 1971. The physician who allegedly prescribed DES to the plaintiff’s mother, Dr. Safon, is now deceased. According to both parties, there are no medical records demonstrating that Dr. Safon prescribed to the plaintiff’s mother the defendant’s DES, as opposed to a generic prescription or a specific prescription for another drug company’s brand of DES. In fact, both parties agree that there are no medical records or prescription records demonstrating that Dr. Safon prescribed the plaintiff’s mother DES at all.

KELLEY v. ELI LILLY & CO., Leagle, 2007616517FSupp2d99_1607, United States District Court, District of Columbia, April 27, 2007.

The drug DES itself was never proprietary to any company. During the time period that the plaintiff’s mother allegedly ingested DES, there were only 6-8 national companies that produced DES and a number of companies who acted as local rebottlers, selling DES regionally. Federal Regulations at the time of the plaintiff’s mother’s pregnancy required all manufacturers of prescription medications, such as DES, to provide instructions and warnings for physicians on prescription medications that could only be obtained through the order of a licensed medical practitioner. The defendant, in producing its product literature never expressly rejected its use in pregnant women, having made reference to the use of DES in pregnant women no less than five times without warning or the risks or advising against its use during pregnancy.

Furthermore, the plaintiff has a letter, which if all inferences are given to the plaintiff, states that DES labeling was industry wide, with the defendant taking the lead with the Food and Drug Administration. With the testimony of Dr. Richard Falk, the plaintiff contends that the defendant should have known and warned of the dangers of DES by 1953. Through the testimony of Dr. Julius Piver, the plaintiff contends that had warnings regarding the dangers of taking DES during pregnancy, it would have been a departure from the standard of care for an obstetrician to prescribe DES to a pregnant woman.

The defendant contends and the plaintiff admits that the plaintiff has provided no evidence that Dr. Safon ever read or consulted the defendant’s product warnings and literature in determining whether or not to prescribe a medication to the plaintiff s mother. However, the plaintiff has a statement from the Pharmacist, Steven Baker, who worked at the Drug Fair Pharmacy where the plaintiff’s mother allegedly filled her DES prescriptions during the relevant time period. The plaintiff states Mr. Baker would testify that if a woman came into the pharmacy during the relevant time period with a prescription for “DES,” “Stilbestrol,” or “Diethylstilbestrol,” the defendant’s brand would have been dispensed.

The defendant now comes before the Court asking for its motion for summary judgment to be granted on all counts. The defendant argues that they are entitled to summary judgment as a matter of law because the plaintiff cannot come forward with any evidence that her mother’s treating and prescribing physicians read or relied on any warnings or statements made by the defendant in deciding to prescribe the defendant’s product to the plaintiff’s mother.” …

… read the full paper KELLEY v. ELI LILLY & CO. on Leagle.

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