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RICHARDSON v. RICHARDSON-MERRELL

December 19, 1986

CARITA RICHARDSON, et al., Plaintiffs,
v.
RICHARDSON-MERRELL, INC., Defendant



The opinion of the court was delivered by: JACKSON

 THOMAS PENFIELD JACKSON, U.S. District Judge

 This products liability case is presently before the Court on defendant's motion for judgment n.o.v. or a new trial following a jury verdict for plaintiffs of $1.16 million after a lengthy trial. It is one of a number of cases filed across the country in which the plaintiffs allege that a child's congenital limb deformities were caused by Bendectin, an anti-nauseant medication manufactured by defendant to be taken orally by the mother during pregnancy to alleviate "morning sickness."

 This trial was a virtual reprise of Oxendine v. Merrell Dow Pharmaceuticals, Inc., 506 A.2d 1100 (D.C. 1986), the only other such case known to the Court to have been tried to conclusion in a plaintiff's verdict which has survived all post-trial proceedings to date. The trial judge in Oxendine set aside the verdict and judgment with only a brief statement of reasons, but the District of Columbia Court of Appeals reversed, in an opinion which, although accurately summarizing the testimony, did not address the significance of certain evidence bearing upon the current state of scientific knowledge. In consequence, it judicially reopened an esoteric twenty-year-old controversy which is by now essentially settled within the scientific community. *fn1"

 This Court, having heard substantially the same evidence as the trial judge in Oxendine, is of the same opinion as to its efficacy. No reasonable jury could find on the basis thereof that this infant plaintiff's birth defects were more likely than not to have been caused by her intrauterine exposure to Bendectin; alternatively, even if such a finding were reasonable, it is nevertheless so clearly contrary to the weight of the evidence that the case must be retried. For the reasons hereinafter set forth, therefore, defendant's motion will be granted, and judgment notwithstanding the verdict will be entered for defendant, with a new trial granted in the alternative.

 I.

 Carita Richardson, the fourth child of Etheleen and Samuel Richardson, was born in the District of Columbia on February 16, 1976. Her siblings were normal at birth. At her birth Carita had a deformed left arm, with an underdeveloped humerus fused to the radius at the elbow, terminating in a hand with only two digits. Her right arm was normal. The right and left femurs were likewise underdeveloped, and, while her lower left leg was normal, she had no lower right leg at all. An appendage resembling a foot (later amputated) was attached directly to her right hip.

 Etheleen Richardson (then aged 38) conceived Carita approximately May 28, 1975. She developed "morning sickness," i.e., the nausea which occasionally occurs in early pregnancy (onset at about 21-28 days post conception) and began taking Bendectin, on her doctor's prescription, on or about June 28, 1975, two tablets at night and one in the morning, for at least the duration of the period of organogenesis, when Carita's limbs were forming in utero (from about the 24th through the 56th days post conception).

 In 1975 Bendectin contained 10 mg. each of dicyclomine hydrochloride, doxylamine succinate, and pyridoxine hydrochloride - an anti-cholergenic, antihistamine, and Vitamin B-6, respectively - the latter two ingredients included for their ostensible anti-nausea and anti-emetic properties. *fn2"

 Bendectin (also known as "Debendox" in the British Commonwealth, and "Lenotan" in West Germany) had been marketed by Merrell-Dow Pharmaceuticals, Inc., or its predecessors, Wm. S. Merrell Co. and Richardson-Merrell, Inc. (hereinafter "Merrell"), as an anti-nauseant since 1956. In the United States it has always been available only by prescription; in some other countries it was sold over-the-counter.

 Expert witnesses for both sides generally agreed that congenital birth defects are present in approximately two to four per cent of all live births; that limb reduction defects, specifically, occur at a rate of approximately three per thousand; that genetic or chromosomal abnormalities account for from 10 to about 15 per cent of all birth defects, and maternal illnesses, e.g. diabetes, or viral or bacterial infections, will explain perhaps three to five per cent more; and that there is a large category - a majority - to which no cause can be ascribed with certainty. They are also agreed that "environmental" factors can and do cause some of the remainder, including substances ingested by the mother. Plaintiffs assert that Carita Richardson's afflictions were caused by the Bendectin her mother took in the summer of 1975. Defendant denies it, but, being without evidence to implicate another of the known causes of birth defects, places Carita in the "unknown" category for which science has yet to find an explanation. *fn3"

 Defendant's case consisted, in part, of discipline-by-discipline retorts to plaintiffs' witnesses, supplemented by the testimony of several clinicians with extensive experience in prescribing Bendectin for pregnant women or in treating malformed children, all of whom were certain no connection existed between the medication and the malformations. At least equally well-qualified defense experts asserted that a structural chemical resemblance does not import similar chemical activity; that in vitro studies on animal tissues have never been scientifically validated as predictors of physiological effects upon living human beings, and, indeed, are generally regarded as useless for the purpose; and that Merrell's animal tests had been, in fact, both properly conducted and properly interpreted, reflecting precisely the conclusions Merrell had drawn from them. Moreover, they declared, animal studies, too, are of limited usefulness in assessing a drug's teratogenic potential in humans; of some 600 known animal teratogens, only a small fraction of them have been shown to have such an effect upon human embryos. All defense witnesses, as might be expected, were of the opinion that Bendectin is not a human teratogen.

 Plaintiffs' principal witness on causation was, as in Oxendine, Dr. Alan K. Done, a pediatrician, and until three years ago, a professor of pediatrics, pharmacology, and toxicology at Wayne State University in Detroit. *fn6" (Tr. 776-1370). Based upon his knowledge of Bendectin's chemical structure, the in vitro studies, the animal teratology studies conducted by Merrell (and others), and the "human data" he had reviewed, i.e., epidemiological studies which he found defective, inconclusive, or both, Dr. Done stated that, in his opinion, to a "reasonable degree of medical certainty," Bendectin was not only "capable" of causing birth ...


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