Richardson v. Richardson-Merrell, Inc.
649 F. Supp. 799 (D.D.C. 1986)
 

Jackson, J.

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.

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.

Bendectin . . . 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.

Unable to prove directly how Bendectin actually (or could have) affected Carita while in her mother's womb, plaintiffs here proceeded (as did the plaintiff in Oxendine) with circumstantial evidence. Through the testimony of experts in several disciplines—pharmacology, embryology, veterinary medicine, and the like—they established the similarity of the chemical structure of doxylamine to that of other antihistamines known to be teratogenic in animals. Witnesses described the effects of Bendectin components in solution in in vitro experiments upon frog nerve fibers and the mesenchyme cells of mouse limb buds, postulating that other effects might occur in the human intra-uterine environment, when Bendectin is infused via the mother, which could inhibit the development of fetal organs. And they criticized the animal experiments conducted by Merrell in 1963 and 1966, suggesting that Merrell's raw data had been misassessed, and the number of tests and dosage levels had been insufficient to dispel doubts about Bendectin's safety. Moreover, when such observations as Merrell had made were properly interpreted, they said, the studies did indicate Bendectin's teratogenic potential in animals which raised suspicions of a similar effect in humans.5

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 pediability of 45, admission would be proper for any jury perception below 90--which arguably includes most cases--and the greatest possible net loss would be limited to 10, in the case where the jury gave full weight to the evidence (an assessment of 100). However, once these subtleties are combined with the argument of probative force, the justification for Judge Weinstein's approach should be more properly viewed as derived from the entire framework presented in this Note.

5. 27. The Federal Rules have two sets of exceptions--those for which availability of the declarant is immaterial and those for unavailable declarants. Fed. R. Evid. 803, 804. There is no across-the-board rule admitting the hearsay of available declarants. Thus, the Federal Rules go to great lengths to differentiate among the hearsay of available declarants in determining admissibility. See Advisory Comm. Note, Fed. R. Evid. 803.

The existence of rule 803(24) of the Federal Rules of Evidence is difficult to explain. If the declarant is unavailable, identical exception 804(b)(5) may be used; if the declarant is available, the criteria of the exception seem impossible to meet since "the statement [must be] more probative on the point for which it is offered than any other evidence which the proponent can procure through reasonable efforts.'' Fed. R. Evid. 803(24).

6. 30. Exclusion serves to minimize the potential for manipulation when the decision not to call the available declarant may provide some strategic benefit. Also, it avoids disruption that might result from allowing the opponent to cross-examine the declarant immediately after direct examination of the witness testifying to the hearsay statement, possible surprise to the opponent if no notice is required, and placing burdens on the opponent to procure the declarant....

7. 39. In other words, focus is upon absolute reliability instead of upon the reliability gap.

For analysis of the absolute reliability in isolation to provide the same result as a complete examination of the residual hearsay gap, the jury must always give full weight to hearsay evidence. In that event, any unreliability contributes to the reliability gap. But, if the jury gives the hearsay anything less than full weight, including the possibility of giving too little weight, the unreliability of the evidence overstates the warrant for exclusion. It is impossible for the jury always to give hearsay full weight when conflicting hearsay is presented by opposing parties. Similarly, it seems unlikely that it would give hearsay full weight when conflicting nonhearsay evidence on the issue is present since this implicitly assumes that the jury gives full weight to the dubious hearsay evidence while giving no weight to the other evidence, which may be of greater reliability. This makes the full weight assumption implausible regardless of how able one thinks jurors are....

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15. 66. A priori, one can predict only that error and value decline as the quantity of other evidence increases; these declining functions need not be linear, as portrayed in Figures 1 to 4. Thus, combinations of cases three and four in general are possible, wherein the proper ruling alternates between admitting and excluding the hearsay evidence as the amount and quality of other available evidence increases.

16. 67. Chadbourn, Bentham and the Hearsay Rule--A Benthamic View of Rule 63(4)(c) of the Uniform Rules of Evidence, 75 Harv. L. Rev. 932, 947 (1962); cf. Advisory Comm. Note, Fed. R. Evid. 104(b) ("If preliminary questions of conditional relevancy were determined solely by the judge, as provided in subdivision (a), the functioning of the jury as trier of fact would be greatly restricted and in some cases virtually destroyed.'').

One condition argued to be necessary to rationalize the exclusion of evidence because it is hearsay was that the reliability gap would not exceed value had the evidence been in-court testimony. But acceptance of the legitimacy of the reliability gap/value balancing test formulation in fact suggests that any evidence that could not be effectively tested before the jury should be excluded.

17. 100. The use of such evidence in reaching the decision would be contrary to the trial judge's belief that the evidence was inadmissible. This practice is inconsistent with conscientious judicial behavior and, in any event, will not be imputed by the appellate court; an error in fact may result though no error in law is admitted. Furthermore, if inadmissible evidence is to be entered into the record, trial judges will give less thought to questions of admissibility in the first instance, making ultimate reliance upon improper evidence more likely.

18. 101. The result is effectively to exclude admissible evidence since the judge as trier of fact ignores it, but, as a consequence of the act of admitting the evidence into record, the judge's erroneous belief is insulated from review. In fact, an appellate ruling might be unnecessary since the evidence would have been admitted and there would not be any ruling by the lower court that the evidence was ignored. For example, the lower court may admit the evidence and simply make no mention of it in a finding of fact, directed verdict, or judgment notwithstanding the verdict. See Note, Improper Evidence in Nonjury Trials: Basis for Reversal?, 79 Harv. L. Rev. 407, 409-11 (1965).

 

pharmacology, and toxicology at Wayne State University in Detroit.6 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 defects in humans, but that it had, in fact, caused those limb defects with which Carita Richardson had been born.7

5. Plaintiffs were not permitted to introduce into evidence, nor were their experts allowed to rely upon, so-called "drug experience reports" or "adverse reaction reports," i.e., anecdotal case reports of birth defects observed in the offspring of mothers whose histories included Bendectin usage. The Court made a disputed preliminary finding that such reports are neither exceptions to the hearsay rule nor data reasonably relied upon by experts in the field of making determinations of causality.

6. Since May, 1983, Dr. Done has been a proprietor (or an investor in) and for a time the chief executive officer of, an enterprise known as the Association of Consulting Toxicologists which provides "medicolegal and forensic investigation" services.

7. Had the epidemiological studies reported a statistically significant association between Bendectin and limb reduction defects, Dr. Done would have found the causal connection to have been established to a "scientific" certain

 


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