Richardson by Richardson v. Richardson-Merrell, Inc., RICHARDSON-MERREL
| Decision Date | 27 September 1988 |
| Docket Number | Nos. 87-7023,RICHARDSON-MERREL,INC,87-7024,s. 87-7023 |
| Parties | , 26 Fed. R. Evid. Serv. 1415, Prod.Liab.Rep.(CCH)P 11,930 Carita RICHARDSON, Infant, by S. & E. RICHARDSON, Guardians, et al., Appellants, v., a Delaware Corporation, et al. |
| Court | U.S. Court of Appeals — District of Columbia Circuit |
Barry J. Nace, with whom Thomas H. Tate, Lynn S. Spradley, Irving R.M. Panzer and Timothy D. Junkin, Washington, D.C., were on the brief, for appellants.
Mark L. Austrian, with whom John B. Williams and Frederick D. Baker, Washington, D.C., were on the brief, for appellee.
Geoffrey R.W. Smith and Bruce J. Brennan, Washington, D.C., were on the brief for Pharmaceutical Mfrs. Ass'n, amicus curiae, urging affirmance.
Before ROBINSON, SILBERMAN and D.H. GINSBURG, Circuit Judges.
Opinion for the Court filed by Circuit Judge Spottswood W. ROBINSON.
Carita Richardson and her parents brought an action in the District Court alleging that her congential limb defects resulted from ingestion of Bendectin by her mother, Etheleen, during her pregnancy. At the time, Bendectin, an anti-nausient drug, was manufactured by Richardson-Merrell, Inc., which since has been succeeded by Merrell-Dow Pharmaceuticals, Inc. Following a lengthy trial, the jury returned a verdict awarding damages in the sums of $1 million to Carita and $160,000 to the parents. On Merrell's motion, the District Court granted judgment n.o.v. in its favor, and the propriety of doing so is the single question on this appeal. After careful consideration of the record, we agree that the evidence was so one-sided as to warrant fully the court's action. Accordingly, we affirm.
The Bendectin taken by Mrs. Richardson was a combination of pyridoxine hydrochloride (vitamin B-6), doxylamine succinate (an antihistamine), and dicyclomine hydrochloride (an antispasmodic). 1 In 1956, the drug was approved by the Federal Drug Administration (FDA) as safe for the treatment of nausea and vomiting during pregnancy. Between 1957, when Bendectin was initially marketed, and 1983, when Merrell discontinued marketing of the drug--apparently as the result of litigation--Bendectin was used by more than thirty million pregnant women. FDA approval has never been rescinded.
Early in her pregnancy, 2 Mrs. Richardson developed morning sickness, the nausea that pregnant women sometimes suffer. On her doctor's prescription, she began taking two Bendectin tablets at night and one in the morning. That she continued to do for at least the duration of the period of organogenesis--from about the 24th through the 56th day post-conception--the time during which Carita's limbs were forming in utero. Sadly, Carita was born with limb-reduction defects. 3
Carita and her parents filed suit in the District Court for the District of Columbia. Along with over 1,500 other Bendectin lawsuits, the case was transferred for pretrial proceedings, pursuant to an order of the Judicial Panel on Multidistrict Litigation, to the Southern District of Ohio, 4 where a jury trial was held on the common issue of causation for all plaintiffs who had not opted out. 5 Because the Richardsons elected not to participate in the common-issues trial, their case was retransferred to the District Court here.
At trial, to avoid a compromise verdict, the District Court submitted the case to the jury in two stages, first on the issue of causation and then on issues of failure to warn and damages. The jury found that Bendectin was a human teratogen, a substance capable of causing birth defects, when taken in recommended doses by a pregnant woman during the period of organogenesis of a unborn child and that Bendectin was the proximate cause of Carita's birth defects. The jury also found a lack of proper warning of the dangers associated with the drug, and accordingly, returned its $1.16 million verdict for the Richardsons.
Merrell moved for judgment n.o.v. or, in the alternative, for a new trial. The court granted the motion for judgment n.o.v., holding that on the basis of the evidence presented no reasonable jury could find that Carita's birth defects were more likely than not caused by Bendectin. 6 Alternatively, the court granted Merrell's motion for a new trial 7 on the ground that the verdict was "clearly contrary to the weight of the evidence." 8
The Richardsons argue that the District Court erred in both respects because there was sufficient credible evidence to support the verdict in their favor. 9 Merrell contends that judgment n.o.v. was proper because the opinions of the Richardsons' experts were inadequate to demonstrate causation by a preponderance of the evidence. After an exhaustive review of the trial transcript and the exhibits introduced by the parties, we conclude that judgment n.o.v. was appropriate.
In granting judgment n.o.v., the District Court stated:
No reasonable jury could find on the basis [of the evidence presented] 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. 10
The court summarized the evidence, focusing on the testimony of Dr. Alan K. Done, the Richardson's principal witness on causation. On the basis of (1) Bendectin's chemical structure, (2) in vitro (test tube) studies, (3) in vivo (animal) teratology studies conducted by Merrill and others, and (4) the "human data" he had reviewed--epidemiological studies which he found "defective, inconclusive, or both" 11--Dr. Done expressed the opinion that "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." 12
Despite this opinion, the court held that there was no "battle of experts" in this case, a circumstance which, if true, would have required that the verdict remain standing. 13 The court apparently concluded that there was not an adequate foundation for Dr. Done's theory on Bendectin, a theory undermined by an overwhelming array of contrary opinion published in the scientific literature and presented by the defense.
The District Court also examined closely the testimony of Dr. Raymond Seltser, an expert witness for the defense, who testified about the significance of the scientific literature on Bendectin. Dr. Seltser's review of the literature uncovered fourteen cohort studies and seven case control studies, "in none of which is there to be found a statistically significant increase in the relative risk of any congential limb malformations associated with Bendectin exposure." 14 By the court's estimate, "the importance of [Dr. Seltser's] testimony lies in his presentation of the totality of the published scientific literature [on Bendectin], which collectively represents the sum of all that can be said to be scientifically 'known' of the matter at present." 15 The court added:
Excepting their own empirical observations, the "literature" is to scientists both the ultimate authority as to and the most respected repository of scientific knowledge. And the literature on Bendectin, individually and in the aggregate, fails to demonstrate Bendectin's teratogenicity to a scientifically acceptable degree of accuracy. 16
The District Court observed that Dr. Done had neither performed his own studies nor published his criticisms of the studies performed by others, but nonetheless testified in contradiction to "not only Dr. Seltser but to the findings of all those researchers who have studied and published in the twenty-odd years since the investigation of Bendectin began." 17
The District Court also noted that Dr. Seltser's judgment regarding the current state of knowledge about Bendectin within the scientific community was corroborated by FDA's Fertility and Maternal Health Drugs Advisory Committee, which was convened in 1980 to evaluate the evidence on alleged Bendectin-related malformations. 18 After studying the literature and considering testimony presented during a two-day hearing, the Committee concluded that there was no increased incidence of birth defects among Bendectin-exposed infants; that there was no need for further animal or epidemiological studies; and that Bendectin should not be withdrawn from the market. 19 FDA adopted the findings of the Committee and has not since changed its position. 20
The District Court concluded that in light of Bendectin research and the published literature, Dr. Done's opinion was beyond the range of acceptability. The court's summary of its analysis is succinct:
Though Dr. Done might disagree, there is now nearly universal scientific consensus that Bendectin has not been shown to be a teratogen, and, the issue being a scientific one, reasonable jurors could not reject that consensus without indulging in precisely the same speculation and conjecture which the multiple investigations undertook, but failed, to confirm. That Dr. Done remains an unbeliever and was willing to testify to his disbelief "with reasonable medical certainty" does not mandate that this case be left as the jury decided it. Without a genuine basis "in or out of the record," even his expert "theoretical speculations" are insufficient to sustain the plaintiff's burden of proving, by a preponderance of the evidence, that Bendectin not only causes congenital defects generally, but that, in particular, it caused those limb reduction defects with which Carita Richardson was most unfortunately born. 21
As a result, the court granted Merrell's motion for judgment n.o.v.
The standard for awarding judgment n.o.v. is the same...
To continue reading
Request your trial
-
Ball v. Joy Mfg. Co., Civ. A. No. 1:87-0268
......v. . JOY TECHNOLOGIES, INC. (formerly Joy Manufacturing Company), a Pennsylvania ...Contrast Richardson v. Richardson-Merrell, Inc., 857 F.2d 823 (D.C.Cir.1988); ......
-
O'CONNER v. Commonwealth Edison Co., 88-1272.
...of its foundation." Peterson v. Sealed Air Corp., 1991 WL 66370, 1991 Lexis 5333 (N.D.Ill.1991) (quoting Richardson v. Richardson-Merrell, Inc., 857 F.2d 823, 829 (D.C.Cir.1988)). Otherwise any case in which an expert was willing ... to testify "to a reasonable degree of scientific certaint......
-
Werlein v. US
...14 Again, such an injunction would be subject to the concerns expressed by the Court supra in note 12. 15 In Richardson v. Richardson-Merrell, Inc., 857 F.2d 823, 831 (D.C.Cir.1988), an almost identical Bendectin case, the court also ruled that the lack of epidemiological evidence connectin......
-
Town Sound & Custom Tops v. Chrysler Motor Corp.
...(expert opinion which does not establish an issue of fact does not defeat a motion for summary judgment); Richardson v. Richardson-Merrell, Inc., 857 F.2d 823, 829-832 (D.C.Cir.1988) (expert's declaration, full of assertions but empty of facts and reasons, is insufficient to get a case past......
-
Attacking the Opposing Expert
...danger of unfair prejudice, confusion of the issues or misleading the jury. (Fed. R. Evid. 403.) Richardson v. Richardson-Merrell, Inc. , 857 F.2d 823, 830 (D.C. Cir. 1988) was a case involving the testimony of experts relating to the cause of birth defects. The court noted that whether the......
-
Attacking the Opposing Expert
...danger of unfair prejudice, confusion of the issues or misleading the jury. (Fed. R. Evid. 403.) Richardson v. Richardson-Merrell, Inc. , 857 F.2d 823, 830 (D.C. Cir. 1988) was a case involving the testimony of experts relating to the cause of birth defects. The court noted that whether the......
-
Attacking the Opposing Expert
...R. Evid. 403.) ATTACKING THE OPPOSING EXPERT §443 QUALIFYING AND ATTACKING EXPERT WITNESSES 4-108 Richardson v. Richardson-Merrell, Inc. , 857 F.2d 823, 830 (D.C. Cir. 1988) was a case involving the testimony of experts relating to the cause of birth defects. The court noted that whether th......
-
Table of Cases
...v. Ins. Co. of N. America , 940 F.2d 542 (9th Cir. 1991), § 8:530 D-6 n table of cases Richardson v. RichardsonMerrell, Inc. , 273 U.S. App. D.C. 32, 41; 857 F.2d 823 (1988), § 9:520.3 Ridenour v. Nationwide Mut. Ins. Co. , 273 Or. 514, 541 P.2d 1377 (1975), § 8:551 Ridner v. Towne , 2003 M......