Oxendine v. Merrell Dow Pharmaceuticals, Inc., 83-1055.

• Decision Date: 25 March 1986
• Docket Number: No. 83-1055.,83-1055.
• Citation: 506 A.2d 1100
• Parties: Mary Virginia OXENDINE, Appellant, v. MERRELL DOW PHARMACEUTICALS, INC., Appellee.
• Court: D.C. Court of Appeals

506 A.2d 1100

Mary Virginia OXENDINE, Appellant, v. MERRELL DOW PHARMACEUTICALS, INC., Appellee.

No. 83-1055.

District of Columbia Court of Appeals.

Argued February 5, 1985.

Decided March 25, 1986.

As amended June 2, 1986.

COPYRIGHT MATERIAL OMITTED

Barry J. Nace, with whom Thomas H. Tate, Washington, D.C., was on brief, for appellant.

Sidney G. Leech, with whom Daniel W. Whitney, Baltimore, Md., and Mark L. Austrian, were on brief, for appellee.

Jeffrey Robert White, Washington, D.C., David S. Shrager, Philadelphia, Pa., Robert Cadeaux, and Jacob A. Stein, Washington, D.C., filed a brief for amici curiae, Ass'n of Trial Lawyers of America and Ass'n of Plaintiffs' Trial Attys. of Metropolitan Washington.

Before PRYOR, Chief Judge, TERRY, Associate Judge, and PAIR, Senior Judge.

TERRY, Associate Judge:

In this product liability case, appellant seeks reversal of an order of the trial court setting aside a jury verdict in her favor. She contends that there was sufficient evidence to send the case to the jury, and that the court therefore erred in entering a judgment notwithstanding the verdict. In addition, she argues that the court abused its discretion by ordering a new trial in the alternative because the verdict was not against the great weight of the evidence. We agree with both contentions, reverse the judgment, and remand the case with directions to reinstate the verdict and proceed to trial on appellant's claim for punitive damages, which has not yet been tried.¹

I

On January 25, 1971, appellant was born with a shortened right forearm and only three fingers on her right hand. Those fingers were fused together.

Appellant, through her parents, filed a complaint in the Superior Court on February 1, 1982, alleging that her birth defects were caused by her mother's use during pregnancy of a prescription drug manufactured by appellee. The drug, known as Bendectin, was designed to alleviate the nausea which commonly accompanies pregnancy. The complaint stated five counts against appellee, alleging negligence, breach of express warranty, breach of implied warranty, strict liability, and misbranding under the Federal Food, Drug, and Cosmetic Act. It sought ten million dollars in compensatory damages and ten million dollars in punitive damages.²

After hearing the testimony of eighteen witnesses in the course of a three-week trial, the jury awarded appellant $750,000 in compensatory damages. Appellee then filed a motion for judgment notwithstanding the verdict or, in the alternative, for a new trial. The trial court granted both parts of the motion after a hearing, stating in an order the basis of its decision:

In support of her case to establish proximate cause, plaintiff relies on four principal grounds. The first is the structural activity of Bendectin which included an antihistaminic component, together with the awareness that certain antihistamines have been determined to be teratogenic in certain animals. Plaintiff also relies on the animal or in vivo studies. The third ground involves the in vitro studies performed at the National Institutes of Health. Finally, plaintiff relies on human epidemiological data.

It is clear to the Court from review of the evidence adduced at the trial of this action that no conclusion one way or another can be drawn from any of the above relied upon bases, respecting whether Bendectin is a human teratogen. And it is also clear from the evidence that plaintiff has failed to prove that use of Bendectin by her mother proximately caused her birth defect.

This appeal followed.

II

A judgment notwithstanding the verdict is proper only in "extreme" cases, in which no reasonable person, viewing the evidence in the light most favorable to the prevailing party, could reach a verdict in favor of that party. District of Columbia v. Cooper, 445 A.2d 652, 655 (D.C. 1982) (en banc); accord, e.g., Lewis v. Washington Metropolitan Area Transit Authority, 463 A.2d 666, 669 (D.C. 1983) ("Where the evidence is such that reasonable persons could differ, the issue is properly put before the jury"); Washington Metropolitan Area Transit Authority v. Jones, 443 A.2d 45, 49 (D.C. 1982) (en banc). We have often stressed that cases "in which only one conclusion reasonably could be drawn from the evidence, and in which negligence . . . and proximate cause will not be questions of fact for the jury," are "unusual" cases. Rich v. District of Columbia, 410 A.2d 528, 532 (D.C. 1979) (citations omitted); see District of Columbia v. Cooper, supra, 445 A.2d at 655 n. 3. On appeal, this court must apply the same standard as the trial court. See District of Columbia v. Cassidy, 465 A.2d 395, 397 (D.C. 1983); Faniel v Chesapeake & Potomac Telephone Co., 404 A.2d 147, 150 (D.C. 1979). We must be particularly cautious about setting aside jury verdicts in cases, such as this one, which present difficult medical issues of causation, with expert testimony going both ways.

Judges, both trial and appellate, have no special competence to resolve the complex and refractory causal issues raised by the attempt to link low level exposure to toxic chemicals with human disease. On questions such as these, which stand at the frontier of current medical and epidemiological inquiry, if experts are willing to testify that such a link exists, it is for the jury to decide whether to credit such testimony.

Ferebee v. Chevron Chemical Co., 237 U.S. App.D.C. 164, 169, 736 F.2d 1529, 1534, cert. denied, ___ U.S. ___, 105 S.Ct. 545, 83 L.Ed.2d 432 (1984).

The transcript of the hearing on the motion for judgment n.o.v. helps to clarify what the trial court meant when it said in its order that "no conclusion" could be drawn from the evidence presented at trial. Dr. Alan Done, appellant's sole causation witness, had testified that no conclusion about Bendectin's effect on humans could be drawn from any of the four types of scientific data upon which he had principally relied when each type was considered separately from the others. The court focused on this fact and concluded that if each type of data, viewed in isolation, was not sufficient to prove that Bendectin caused birth defects, then all of them taken together could not prove it either. In so ruling, the trial court erred.

III

Dr. Done relied on four kinds of evidence in reaching his conclusion that Bendectin caused appellant's birth defects: (a) structure-activity information, (b) in vivo studies, (c) in vitro studies, and (d) epidemiological studies. We shall discuss each in turn.³

A. Structure-activity information

The first category of data upon which Dr. Done based his opinion involved what he termed the "structure-activity" of Bendectin. He explained that pharmacologists are "frequently able . . . to look at the structure [of a chemical compound] and predict what kind of activity that compound will have. And one of the jobs of pharmacology is to try to find that out, because that is how we design drugs to do certain jobs." Dr. Done said that the type of "activity" or function that a drug performs usually "has a bearing on the issue of . . . teratogenicity"; some antihistamines, for example, have been found to have teratogenic effects. One of the three components of Bendectin, doxylamine succinate, is an antihistamine.⁴ Dr. Done testified that it is a known teratogen for some animals and that it is suspected of being a human teratogen as well.

Appellee correctly states in its brief that "[c]onsidered alone, the structure-activity of Bendectin did not provide a basis for Dr. Done to conclude that Bendectin was a teratogen." But Dr. Done did not consider it alone, as he made clear before he even began to discuss Bendectin's structure-activity. On direct examination he was asked, "So you can't just take the structure by itself and make a determination [as to Bendectin's teratogenicity]?" He responded, "That's right. Never can you take one and say it will not be." On cross-examination he said the same thing. Dr. Done was asked, with regard to "the chemical activity and chemical structures, those alone wouldn't enable you to reach an opinion on what caused Mary Virginia Oxendine's birth defect, would they?" He answered, "Not alone, no."

At the hearing on the motion for judgment n.o.v., however, the court recalled Dr. Done's testimony on the structure-activity of Bendectin somewhat differently: "he told me that . . . no conclusions can be drawn because Bendectin has an antihistamine in it, and it proved to be teratogenic in animals, yet no conclusions may be drawn, and yet he said, however, that [this information is] helpful." The court's recollection of the testimony was unfortunately flawed. Dr. Done did not say that "no conclusions" could be drawn from the structure-activity information. On the contrary, he testified that the information provided a "clue" about Bendectin's possible teratogenicity, which helped him to reach his final opinion in the case. He specifically said that teratologists generally rely on such data in combination with in vitro, in vivo, and epidemiological studies in reaching conclusions regarding the teratogenicity of a substance; "the whole collection is what is generally used."

B. In vivo studies

Dr. Done next turned to the in vivo (animal) studies relating to Bendectin. He first discussed a study entitled "Reproductive Study of Offspring of Bendectin-Treated Dams," which was conducted by appellee and reported by a Dr. Staples. The study was designed to discover whether Bendectin would cause birth defects in the offspring of female rabbits. Dr. Done quoted the pertinent findings and conclusions of Dr. Staples:

The limb alterations observed following Bendectin administration to female rabbits during gestation are considered to have been of no consequence in view of the mildness of the change and in view of its presence among the kits of controlled females.

The sternal changes noted involving shifting ossification [bone formation]...