Turpin v. Merrell Dow Pharmaceuticals, Inc.

• Decision Date: 11 March 1992
• Docket Number: No. 90-5690,90-5690
• Citation: 959 F.2d 1349
• Parties: 34 Fed. R. Evid. Serv. 1206, Prod.Liab.Rep. (CCH) P 13,088 Gary TURPIN, Plaintiff-Appellant, Betty Turpin, Individually and as Parent and Natural Guardian of Brandy Turpin, a Minor, Plaintiff, v. MERRELL DOW PHARMACEUTICALS, INC., Defendant-Appellee.
• Court: U.S. Court of Appeals — Sixth Circuit

Page 1349

959 F.2d 1349

34 Fed. R. Evid. Serv. 1206, Prod.Liab.Rep. (CCH) P 13,088

Gary TURPIN, Plaintiff-Appellant, Betty Turpin, Individually and as Parent and Natural Guardian of Brandy Turpin, a Minor, Plaintiff, v. MERRELL DOW PHARMACEUTICALS, INC., Defendant-Appellee.

No. 90-5690.

United States Court of Appeals, Sixth Circuit.

Argued Feb. 14, 1992.

Decided March 11, 1992.

Peter Perlman (briefed), Lexington, Ky., and Barry J. Nace (argued and briefed), Paulson, Nace, Norwind & Sellinger, Washington, D.C., for plaintiff-appellant.

Frank W. Woodside, III (argued and briefed), Stephen M. Rosenberger (briefed), Dinsmore & Shohl, Cincinnati, Ohio, for defendant-appellee.

Before: MERRITT, Chief Judge; KENNEDY and JONES, Circuit Judges.

MERRITT, Chief Judge.

For a judicial system founded on the premise that justice and consistency are related ideas, the inconsistent results reached by courts and juries nationwide on the question of causation in Bendectin birth defect cases are of serious concern. In this Bendectin causation case, Judge Eugene Siler concluded that the evidence adduced on summary judgment was insufficient to allow a rational jury to find that Bendectin, a drug given to pregnant women to counteract the nausea of "morning sickness," caused the minor plaintiff's birth defects. 736 F.Supp. 737.

The general issue for review here is whether the trial judge erred by withdrawing the case from the jury and by granting summary judgment for the defendant pharmaceutical company. The more specific issues are, first, whether a court should judge for itself the validity of the reasoning process by which various competing qualified experts have reached their conclusions or should instead leave that question for the jury; and second, whether the evidence in this case, if so reviewed, is sufficient to withstand the defendant's motion for summary judgment.

We agree with Judge Siler that, although judges should respect scientific opinion and recognize their own limited scientific knowledge, nevertheless courts have a duty to inspect the reasoning of qualified scientific experts to determine whether a case should go to the jury. Based on the record before us, we also agree with Judge Siler that whether Bendectin caused the minor plaintiff's birth defects is not known and is not capable of being proved to the requisite degree of legal probability based on the scientific evidence currently available. Taken in the light most favorable to the plaintiffs, the scientific evidence that provides the foundation for the expert opinion on causation in this case is not sufficient to allow a jury to find that it is more probable than not that Bendectin caused the minor plaintiff's injury. Therefore the case should not go to a jury.

We will first summarize the Bendectin causation issue and the case law that has developed during the past twelve years. We will then analyze the evidence in greater detail and show why it does not meet the legal test of causation.

I. Overview

The nausea of morning sickness affects many pregnant women and, although the causes are not completely understood, in extreme cases may cause permanent injury to the sufferer's unborn child. Merrell Dow manufactured and marketed Bendectin as an anti-nauseant prescription for morning sickness from 1956 until 1983 when it took the drug off the market despite continued approval from the Food and Drug Administration. Estimates indicate that Bendectin was prescribed from 1957 until 1982 to over 30 million women worldwide and to more than 17.5 million women in the United States. These women commonly took Bendectin during the first trimester of pregnancy.

Approximately seven weeks after becoming pregnant, Betty Turpin ingested Bendectin to combat morning sickness. The initial development of the fetus's fingers and toes occurs some four to eight weeks after conception. Seven months after Ms. Turpin first took the drug, her child, Brandy Turpin, the infant plaintiff in this case, was born with "limb reduction defects": severely deformed hands and feet, specifically fused joints and shortened or missing fingers and toes. Ms. Turpin took no other drugs during the course of her pregnancy, nor can her child's deformities be traced to any known genetic disorders.

Causation here is a matter of trying to measure probabilities. It requires a complex series of inferences drawn from scientific experiment and observation and statistical comparisons. For example, the plaintiffs rely primarily on animal experiments from which an inference is drawn that since chemical compounds in Bendectin, if administered at certain levels, cause birth defects in animals, they may cause similar defects in humans. The plaintiffs draw a further inference that Bendectin caused the birth defects in this particular case. These inferences are necessary because physicians who treated Brandy Turpin and other similarly situated children cannot diagnose the cause of these anomalies.

The defendant, too, reasons from the results of scientific studies to a particularized conclusion with respect to these plaintiffs. Merrell Dow relies primarily on statistical studies that purport to show that the incidence of certain birth defects is no higher with women who used Bendectin than with those who did not or, in the alternative, that where statistical associations indicating a possible causal relationship exist, they would not lead a reasonable expert to infer that Bendectin causes birth defects.

The causation proof in Bendectin birth defect cases is offered by expert witnesses who speak in terms of population groups and statistical samples rather than specific individuals. The expert witnesses on each side are often the same, from case to case, and even when different the scientific conclusions and theories are based on the same or similar statistical studies and scientific experiments. The cases are variations on a theme, somewhat like an orchestra which travels to different music halls, substituting musicians from time to time but playing essentially the same repertoire.

A brief survey of the reported Bendectin cases illustrates the inconsistency of courts that have dealt with the scientific problem of causation. We find only one reported case finally upholding a finding of causation. In Oxendine v. Merrell Dow Pharmaceuticals, Inc., 506 A.2d 1100 (D.C.App.1986), aff'd in part on appeal after remand, 563 A.2d 330 (D.C.App.1989), cert. denied, 493 U.S. 1074, 110 S.Ct. 1121, 107 L.Ed.2d 1028 (1990), the appellate court reversed the trial court's grant of a judgment n.o.v. and motion for new trial to the defendant and reinstated the jury's $750,000 verdict for the plaintiffs. On the other hand, in four other reported cases, juries returned verdicts for the defense which were allowed to stand. Wilson v. Merrell Dow Pharmaceuticals, 893 F.2d 1149 (10th Cir.1990) (affirming judgment for the defendant and noting also that the plaintiffs' motion for judgment n.o.v. was correctly denied by the district judge); Will v. Richardson-Merrell, Inc., 647 F.Supp. 544 (S.D.Ga.1986) (denying plaintiffs' motion for judgment n.o.v.); In re Richardson-Merrell, Inc. "Bendectin" Products Liability Litigation, 624 F.Supp. 1212 (S.D.Ohio 1985), aff'd, 857 F.2d 290 (6th Cir.1988) (denying plaintiffs' motion for judgment n.o.v. in an order addressing 818 of 844 consolidated multidistrict cases in the largest of all Bendectin cases); and Cosgrove v. Merrell Dow Pharmaceuticals, Inc., 117 Idaho 470, 788 P.2d 1293 (1990) (affirming jury's finding that Bendectin was not the proximate cause of child's injuries).

Four federal circuits have held that plaintiffs failed as a matter of law to establish causation of birth defects. The Fifth Circuit, without ruling specifically on the admissibility of the plaintiffs' expert testimony, reversed a jury verdict for the plaintiffs and granted judgment n.o.v. to the defendant because adequate proof of causation was lacking. Brock v. Merrell Dow Pharmaceuticals, Inc., 874 F.2d 307, reh'g. denied, 884 F.2d 166 (5th Cir.1989), cert. denied, 494 U.S. 1046, 110 S.Ct. 1511, 108 L.Ed.2d 646 (1990), limited by Christopherson v. Allied-Signal Corp., 902 F.2d 362, 367 (5th Cir.1990), rev'd on reh'g on other grounds, 939 F.2d 1106 (5th Cir.1991) (en banc). Another circuit, the Ninth, affirmed a grant of summary judgment for the defendant after holding that the plaintiffs' reanalyses of Merrell Dow's epidemiological studies were unreliable for lack of peer review. Daubert v. Merrell Dow Pharmaceuticals, Inc., 951 F.2d 1128 (9th Cir.1991). Two other circuits reached the same result by ruling inadmissible the plaintiffs' expert testimony on grounds that it was not the type "reasonably relied upon" by qualified experts in the specific fields of study. Richardson v. Richardson-Merrell, Inc., 857 F.2d 823 (D.C.Cir.1988), cert. denied, 493 U.S. 882, 110 S.Ct. 218, 107 L.Ed.2d 171 (1989) (reversing jury verdict for the plaintiff; in the face of the defendant's epidemiological evidence, an insufficient foundation existed for the plaintiffs' animal and chemical studies); Lynch v. Merrell-Nat'l Labs., 830 F.2d 1190 (1st Cir.1987) (holding that the plaintiff's in vivo and in vitro studies were inadmissible; therefore, insufficient evidence existed to avoid summary judgment for the defendant); see also Ealy v. Richardson-Merrell, Inc., 897 F.2d 1159 (D.C.Cir.), cert. denied, --- U.S. ----, 111 S.Ct. 370, 112 L.Ed.2d 332 (1990) (reversing jury verdict for the plaintiff for $20 million in compensatory damages and punitive damages of $75 million, and granting judgment n.o.v. to the defendant after concluding that the plaintiff's evidence was inadmissible under Richardson ), and Ambrosini v. Richardson-Merrell, Inc., No. 86-278 (D.D.C. June 30, 1989) (relying on Richardson in granting judgment for the defendants).

Four District Court cases nationwide have granted summary judgment to the defendant for various...