1992 DES Case: Hibbs v. Abbott Laboratories

Abstract

Joan Hibbs was born on November 7, 1950. Prior to her birth, Joan’s mother, Bernadine Raymond, was prescribed diethylstilbestrol (DES), a synthetic estrogen, by Dr. Robert N. Rutherford to prevent miscarriage during her pregnancy with Joan.

Joan Hibbs has been diagnosed as having anatomical changes of the genital tract and reproductive system, including a “T” shaped uterus, and a cervical ridge. She is unable to successfully carry a child to term. In July 1987, Hibbs underwent surgery for an ectopic pregnancy which resulted in the partial removal of her right fallopian tube. Currently, she must follow a rigorous schedule of frequent vaginal and colposcopic examinations.

HIBBS v. ABBOTT LABORATORIES, Leagle, 199151362WnApp451_1461, January 15, 1992.

On April 20, 1988, the Hibbses sued Eli Lilly & Company, the G.W. Carnrick Company, and other manufacturers of DES claiming that Joan Hibbs’ injuries were caused by her in utero exposure to the drug.1 In their complaint, the Hibbses alleged, inter alia, that the manufacturers were liable for marketing an unsafe product and for failing to provide adequate warnings.

In April 1989, Lilly brought a third party action against Kirkman Laboratories, Inc. Lilly alleged that Kirkman manufactured and distributed DES in Washington prior to Joan Hibbs’ birth and thus should be included in determining the defendant manufacturers’ market share liability, citing Martin v. Abbott Laboratories. On July 27, 1989, the Hibbses amended their complaint to include Kirkman as a defendant.

On April 4, 1990, Lilly moved for summary judgment and dismissal, contending that the Hibbses could not demonstrate that Lilly’s alleged failure to issue adequate warnings was the proximate cause of Joan Hibbs’ injuries.

In support of the motion, Lilly submitted excerpts from the deposition of Dr. Rutherford, Bernadine Raymond’s obstetrician. Dr. Rutherford testified that he first learned about the use of DES in treating pregnancy complications in 1939 while a resident at the Free Hospital for Women in Brookline, Massachusetts. It was there that he worked closely with Drs. Olive and George Smith, two respected pioneers in the study of using DES to prevent miscarriages. Dr. Rutherford agreed with the Smiths’ conclusion that DES was a safe and efficacious drug for use as a miscarriage preventative. He also testified that his decision to prescribe DES was based on his own observation of its beneficial effects on patients and his ongoing review of scholarly literature, not on drug company promotional literature.

In response to the motion for summary judgment, the Hibbses submitted the affidavits of two experts: Henry T. Lynch, M.D., and Robert J. Stillman, M.D.

Dr. Lynch testified that he was familiar with the state of scientific knowledge regarding DES in 1950. He related that drug companies selling DES for use during pregnancy did no research into whether the drug was safe for use during pregnancy .This failure to independently test DES occurred despite the existence of animal studies in the 1940’s showing that DES caused abnormalities in the reproductive organs of rodent offspring exposed in utero. Dr. Lynch added that valid studies in the 1950’s conclusively demonstrated that DES did not reduce the risk of spontaneous abortion. In summary, Dr. Lynch opined that DES should not have been marketed for use during pregnancy in 1950 because there was valid evidence available to DES manufacturers disproving the safety and efficacy of the drug.

Dr. Stillman testified that scientifically valid studies in the 1950’s showed that women who used DES during pregnancy had no greater rate of pregnancy-salvaged births than control groups. The studies demonstrated that DES did not reduce the risk of spontaneous abortion. In Dr. Stillman’s opinion, had drug companies conducted such studies before they began selling DES for use during pregnancy, they would have arrived at the same results which could have been conveyed to the medical community.

On April 10, 1990, Kirkman and Carnrick joined in Lilly’s motion for summary judgment. Kirkman submitted excerpts from the depositions of its founders, Lyle Wellman and William Graham, taken in another case. According to Wellman and Graham, Kirkman’s involvement with DES consisted of purchasing the drug from other pharmaceutical companies, tabletizing it, and then reselling the drug generically.

Prior to oral argument on the motion for summary judgment, Lilly settled with the Hibbses and was dismissed from the case. On May 10, 1990, the trial court granted summary judgment in favor of Kirkman and Carnrick. Given Dr. Rutherford’s testimony about his reasons for prescribing DES, the trial court determined that the Hibbses could not, as a matter of law, establish proximate cause. Carnrick has since been dismissed, leaving Kirkman as the only remaining respondent on appeal.”

… continue reading the full paper HIBBS v. ABBOTT LABORATORIES, on Leagle.

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