Carita Richardson, Infant, by S. & E. Richardson, Guardians v. Richardson-Merrell, Inc., a Delaware Corporation

857 F.2d 823, 273 U.S. App. D.C. 32, 26 Fed. R. Serv. 1415, 1988 U.S. App. LEXIS 13180, 1988 WL 98895
CourtCourt of Appeals for the D.C. Circuit
DecidedSeptember 27, 1988
Docket87-7023, 87-7024
StatusPublished
Cited by161 cases

This text of 857 F.2d 823 (Carita Richardson, Infant, by S. & E. Richardson, Guardians v. Richardson-Merrell, Inc., a Delaware Corporation) is published on Counsel Stack Legal Research, covering Court of Appeals for the D.C. Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Carita Richardson, Infant, by S. & E. Richardson, Guardians v. Richardson-Merrell, Inc., a Delaware Corporation, 857 F.2d 823, 273 U.S. App. D.C. 32, 26 Fed. R. Serv. 1415, 1988 U.S. App. LEXIS 13180, 1988 WL 98895 (D.C. Cir. 1988).

Opinion

Opinion for the Court filed by Circuit Judge SPOTTSWOOD W. ROBINSON.

SPOTTSWOOD W. ROBINSON, III, Circuit Judge:

Carita Richardson and her parents brought an action in the District Court alleging that her eongential 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.

I. The BackgRound

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 FDA approval has never been rescinded.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 útero. Sadly, Carita was born with limb-reduction defects. 3

A. The Procedural History

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 elect *825 ed 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 orga-nogenesis of a unborn child and that Ben-dectin 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 Richard-sons.

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.

*826 B. The District Court’s Opinion

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 Bendec-tin; 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.”

Related

Beyene v. Washington Hilton LLC
958 F. Supp. 2d 247 (District of Columbia, 2013)
Williams v. Johnson
870 F. Supp. 2d 158 (District of Columbia, 2012)
Noveck v. PV Holdings Corp.
742 F. Supp. 2d 284 (E.D. New York, 2010)
Medina v. District of Columbia
718 F. Supp. 2d 34 (District of Columbia, 2010)
Medina v. Dc Government
District of Columbia, 2010
Brainard v. American Skandia
Sixth Circuit, 2005
Cagle v. Cooper Companies
318 F. Supp. 2d 879 (C.D. California, 2004)
United States v. Gray
292 F. Supp. 2d 71 (District of Columbia, 2003)
Christian v. Gray
2003 OK 10 (Supreme Court of Oklahoma, 2003)
New York v. Solvent Chemical Co., Inc.
225 F. Supp. 2d 270 (W.D. New York, 2002)
Lloyd v. Ashcroft
208 F. Supp. 2d 8 (District of Columbia, 2002)
Bourne Ex Rel. Bourne v. E.I. DuPont De Nemours & Co., Inc.
189 F. Supp. 2d 482 (S.D. West Virginia, 2002)
Meister, Brenda G. v. Medical Engineering
267 F.3d 1123 (D.C. Circuit, 2001)
Siharath v. Sandoz Pharmaceuticals Corp.
131 F. Supp. 2d 1347 (N.D. Georgia, 2001)
Blum v. Merrell Dow Pharmaceuticals, Inc.
764 A.2d 1 (Supreme Court of Pennsylvania, 2000)
Kuhn v. Sandoz Pharmaceuticals Corp.
14 P.3d 1170 (Supreme Court of Kansas, 2000)
Soto v. Gaytan
Appellate Court of Illinois, 2000
Awad v. Merck & Co., Inc.
99 F. Supp. 2d 301 (S.D. New York, 1999)
Blum Ex Rel. Blum v. Merrell Dow Pharmaceuticals, Inc.
705 A.2d 1314 (Superior Court of Pennsylvania, 1997)

Cite This Page — Counsel Stack

Bluebook (online)
857 F.2d 823, 273 U.S. App. D.C. 32, 26 Fed. R. Serv. 1415, 1988 U.S. App. LEXIS 13180, 1988 WL 98895, Counsel Stack Legal Research, https://law.counselstack.com/opinion/carita-richardson-infant-by-s-e-richardson-guardians-v-cadc-1988.