Elkins v. Richardson-Merrell, Inc.

• Decision Date: 20 October 1993
• Docket Number: RICHARDSON-MERREL,No. 92-6172,INC,92-6172
• Citation: 8 F.3d 1068
• Parties: , Prod.Liab.Rep. (CCH) P 13,729 James A. ELKINS, Sr.; Mary Jo Elkins; James A. Elkins, II, Plaintiffs, James Elkins, Jr., Plaintiff-Appellant, v., Defendant-Appellee.
• Court: U.S. Court of Appeals — Sixth Circuit

Page 1068

8 F.3d 1068

27 Fed.R.Serv.3d 268, Prod.Liab.Rep. (CCH) P 13,729

James A. ELKINS, Sr.; Mary Jo Elkins; James A. Elkins, II Plaintiffs James Elkins, Jr., Plaintiff-Appellant, v. RICHARDSON-MERRELL, INC., Defendant-Appellee.

No. 92-6172.

United States Court of Appeals Sixth Circuit.

Argued Aug. 3, 1993.

Decided Oct. 20, 1993.

Kenneth J. Chesebro, Cambridge, MA (argued and briefed), Barry J. Nace, Paulson, Nace, Norwind & Sellinger, Washington, DC, George E. Copple, Jr., Nashville, TN, for James Elkins, Jr., plaintiff-appellant.

Frank W. Woodside, III (argued and briefed), Stephen M. Rosenberger, Dinsmore & Shohl, Cincinnati, OH, R. Franklin Norton, Norton & Luhn, Knoxville, TN, Frederick M. Erney, Cincinnati, OH, for defendant-appellee.

Before: GUY and NELSON, Circuit Judges; and WELLFORD, Senior Circuit Judge.

WELLFORD, Senior Circuit Judge.

Once again this court considers a product liability action alleging that Bendectin, a drug manufactured by Richardson-Merrell, Inc., (RMI), caused a severe birth defect. The district court granted summary judgment in RMI's favor based on the similarity between this case and two recent Bendectin cases in this circuit, both of which ended in summary judgment for the defendant. Lee v. Richardson-Merrell, Inc., 772 F.Supp. 1027 (W.D.Tenn.1991), aff'd, mem., 961 F.2d 1577 (6th Cir.), cert. denied, --- U.S. ----, 113 S.Ct. 197, 121 L.Ed.2d 139 (1992); Turpin v. Merrell Dow Pharmaceuticals, Inc., 736 F.Supp. 737 (E.D.Ky.1990), aff'd, 959 F.2d 1349 (6th Cir.), cert. denied, --- U.S. ----, 113 S.Ct. 84, 121 L.Ed.2d 47 (1992). The plaintiff now appeals the entry of summary judgment against him.

I.

Bendectin has been approved by the FDA for the purpose of combatting morning sickness since 1956. Faced with costly litigation involving the use of Bendectin, however, Merrell-Dow voluntarily withdrew the drug from the market in 1983. Notwithstanding Bendectin's withdrawal from the marketplace, the FDA has maintained its support of Bendectin as a safe and effective drug for the purpose of relieving nausea and vomiting associated with pregnancy. Moreover, comparison studies have failed to detect any significant reduction in the incidence of birth defects since Bendectin became unavailable in 1983.

The proof in this case is identical to the proof offered in the two other recent Bendectin cases in this circuit--Turpin and Lee. ¹ In all three cases, as in myriad Bendectin cases in other circuits, the plaintiffs rely on in vitro (in the test tube) studies, in vivo (animal) studies, and reanalyses of human epidemiological studies. The defendants, on the other hand, rely on more than 30 human epidemiological studies, all of which concluded that there was no identifiable link between Bendectin and birth defects. ² Relying almost exclusively on Turpin, the magistrate recommended that summary judgment be issued in Merrell's favor. The district court found "no material differences" between Elkins and Lee, and, relying also on Turpin, accepted the magistrate's recommendation.

The plaintiff argues on appeal that under the United States Supreme Court's recent decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., 506 U.S. ----, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), the scientific opinions offered by the defendant's expert witness were inadmissible; that the defendant therefore failed to show the absence of a genuine issue of material fact; that under Tennessee law, which must be applied here pursuant to Erie Railroad v. Tompkins, 304 U.S. 64, 58 S.Ct. 817, 82 L.Ed. 1188 (1938), it was error for the district court to take a "hard look" at the basis for the scientific theories and inferences embodied in the plaintiffs' affidavits, and that the district court violated the Seventh Amendment by failing to preserve the plaintiffs' right to trial by jury.

II.

In Turpin v. Merrell-Dow, Inc., 959 F.2d 1349 (6th Cir.), cert. denied, 506 U.S. ----, 113 S.Ct. 84, 121 L.Ed.2d 47 (1992), we dealt at length with the difficult issues attending the nature of proof presented by plaintiffs in Bendectin actions like this one. In an opinion authored by Chief Judge Merritt, this court affirmed the district court's grant of summary judgment, based on the weakness of the causal link between Bendectin and birth defects. We held that:

Based on the record before us, ... 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.

Turpin, 959 F.2d at 1350. ³

In Turpin, we found additional authority supporting the view of the court: Wilson v. Merrell Dow Pharmaceuticals, 893 F.2d 1149, 1154 (10th Cir.1990) (finding "particularly significant" the "absence of epidemiological evidence showing a causal relationship between Bendectin and birth defects"); Brock v. Merrell Dow Pharmaceuticals, 874 F.2d 307, 315 (5th Cir.1989), cert. denied, 494 U.S. 1046, 110 S.Ct. 1511, 108 L.Ed.2d 646 (1990) (verdict for plaintiff set aside by j.n.o.v.--"we are convinced that the Brocks did not present sufficient evidence regarding causation to allow a trier of fact to make a reasonable inference that Bendectin caused Rachel Brock's limb reduction defect"). We also considered Daubert v. Merrell Dow Pharmaceuticals, 951 F.2d 1128 (9th Cir.1981), and DeLuca v. Merrell Dow Pharmaceuticals, 911 F.2d 941 (3d Cir.1990), in Turpin.

We construe Turpin to treat the plaintiff's expert opinion indicating a basis of support for the plaintiffs' theories in animal studies to be admissible but "simply inadequate ... [to] permit a jury to conclude that Bendectin more probably than not causes limb defects." Id. at 1360. This court found the evidence to be admissible, we believe, but that it presented too wide an "analytical gap" for reasonable inferences on causation "to be drawn on the ultimate issue of human birth defects." Turpin, 959 F.2d at 1360. As we have already indicated, the evidence offered by Elkins does not differ in any material respect from evidence presented in both Turpin and Lee. We agree with the district court that this case is factually indistinguishable from Turpin and Lee. Thus, unless the plaintiffs have demonstrated some reason, aside from any factual argument, why those cases should not apply here, Turpin and Lee control this case, and mandate summary judgment in Merrell's favor.

A.

The plaintiff argues that, considering the Supreme Court's recent decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., 506 U.S. ----, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), the defendants failed to meet their burden, under Rule 56(c), of showing, "that there is no genuine issue as to any material fact and that [Merrell] is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c). Under Daubert, the plaintiffs contend, the only affidavit used to support the defendant's motion for summary judgment has not been shown admissible. Thus, the plaintiffs argue that summary judgment must be reversed, or in the alternative, that remand is necessary, so the district court may determine, consistent with Daubert, whether the defendant's affidavit is admissible.

The plaintiff has misinterpreted the defendant's burden regarding summary judgment. Because Merrell does not bear the ultimate burden of persuasion on the causation issue, Merrell need only point out the lack of a genuine issue regarding causation. See, Calderone v. United States, 799 F.2d 254, 259 (6th Cir.1986) ("[w]hen the moving party does not have the burden of proof on the issue, he need show only that the opponent cannot sustain his burden at trial.") Moreover, Merrell had no obligation to support its motion for summary judgment with any affidavits. Rule 56 provides that a defending party may "move with or without supporting affidavits for summary judgment in the party's favor." Fed.R.Civ.P. 56(b) (emphasis added). As the Supreme Court has explained,

regardless of whether the moving party accompanies its summary judgment motion with affidavits, the motion may, and should, be granted so long as whatever is before the district court demonstrates that the standard for the entry of summary judgment, as set forth in Rule 56(c) is satisfied.

Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 2553, 91 L.Ed.2d 265 (1986).

Merrell pointed out the absence of a genuine factual issue on the material element of causation. The district court agreed that the plaintiffs had failed to establish a genuine factual dispute regarding causation. In doing so, the court relied on Turpin, where this court determined that, even

"[t]aken 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."

Turpin, 959 F.2d at 1350. The reason for summary judgment was not the strength of the defendant's proof, but the insufficiency of the plaintiffs' proof. Thus, the admissibility of Merrell's affidavit under Daubert is irrelevant; the district court properly determined that the plaintiffs failed to demonstrate the existence of a genuine factual dispute regarding causation. The plaintiffs bear the burden of establishing causation. As a result, Daubert does not invalidate the district court's summary judgment analysis in this case.

B.

Even though the plaintiff concedes that he relies on "evidence similar to that found in Turpin and Lee," he argues that Tennessee law, not federal law, is controlling under Erie Railroad v. Tompkins, 304 U.S. 64, 58 S.Ct....