Lee v. Richardson-Merrell, Inc., 84-2228 GB.

• Decision Date: 30 January 1991
• Docket Number: No. 84-2228 GB.,84-2228 GB.
• Citation: 772 F. Supp. 1027
• Parties: Ronnie LEE, et al., Plaintiffs, v. RICHARDSON-MERRELL, INC., Defendant.
• Court: U.S. District Court — Western District of Tennessee

772 F. Supp. 1027

Ronnie LEE, et al., Plaintiffs, v. RICHARDSON-MERRELL, INC., Defendant.

No. 84-2228 GB.

United States District Court, W.D. Tennessee, W.D.

January 30, 1991.

ORDER GRANTING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT

GIBBONS, District Judge.

Before the court is the motion for summary judgment of defendant Merrell Dow Pharmaceutical Inc. (formerly Richardson-Merrell, Inc.). Plaintiffs Ronnie and Evonne Mackey Lee sue on behalf of their minor child, Michael Lee, to recover damages for birth defects that allegedly resulted from Mrs. Lee's ingestion of the antinausea prescription drug Bendectin, manufactured by defendant,¹ while she was pregnant with Michael. The issue raised by the summary judgment motion is whether plaintiffs evidence is sufficient to create a genuine issue of material fact on the causation issue.

Plaintiffs allege that around September 21, 1973, Mrs. Lee, who was about seven weeks pregnant, took Bendectin. Michael Lee was born on March 27, 1974, with limb defects — shortness of his fingers, "webbing" and generalized smallness of his hands. Plaintiffs allege that Mrs. Lee ingested no other drugs during this period of time and that no other substance caused or contributed to Michael Lee's limb defects. In addition, plaintiffs allege that Michael's defects are not genetically related. Finally, plaintiffs allege that Mrs. Lee's ingestion of Bendectin, at the point in pregnancy that the extremities are beginning to develop, was the proximate cause of Michael's limb defects.

Both plaintiffs and defendant have submitted expert opinion evidence to the court in the form of affidavits, depositions, and prior trial testimony. Several of plaintiffs' experts offer an opinion that the ingestion of Bendectin by Mrs. Lee caused Michael Lee's birth defects. The issue therefore is not whether plaintiffs can present any expert proof on the issue of causation. Rather, the issue is whether plaintiffs' expert proof on causation creates a genuine issue of material fact, in view of the bases for the opinions of plaintiffs' experts.

Defendant asserts that human epidemiology studies comprise the only competent evidence on the question of Bendectin's teratogenicity, or ability to cause birth defects. More than thirty such studies have found no causal connection between Bendectin and birth defects. Defendant argues that plaintiffs' proffered expert testimony is inadmissible under Federal Rules of Evidence 702 and 703, because the opinions of plaintiffs' experts are not "in conformity to a generally accepted explanatory theory," United States v. Kozminski, 821 F.2d 1186, 1201 (6th Cir.1987), and are not based on facts or data "of a type reasonably relied upon by experts in the particular field." Fed.R.Evid. 703. Plaintiffs' experts base their opinions on in vivo testing in animals, in vitro testing on isolated cells and tissue, and human data (which includes criticism and reanalysis of various epidemiological studies submitted by defendant and additional studies).

Federal Rule of Civil Procedure 56 provides that a motion for summary judgment shall be granted if, based on the record as a whole, there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. In a motion for summary judgment, the moving party bears the burden of clearly establishing the non-existence of any genuine issue of material fact, and the evidence as well as the inferences drawn therefrom must be read in the light most favorable to the nonmoving party. Kochins v. Linden-Alimack, Inc., 799 F.2d 1128, 1133 (6th Cir. 1986).

According to Rule 56(e) of the Federal Rules of Civil Procedure, when confronted with a properly supported motion for summary judgment, the non-moving party must "set forth specific facts showing that there is a genuine issue for trial." A genuine issue of material fact exists "if the evidence presented by the non-moving party is such that a reasonable jury could return a verdict for the non-moving party." Anderson v. Liberty Lobby Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 2510, 91 L.Ed.2d 202 (1986).

In a motion for summary judgment, the non-moving party must "go beyond the pleadings and by his own affidavits, or by the `depositions, answers to interrogatories, and admissions on file,' designate `specific facts showing that there is a genuine issue for trial.'" Celotex Corp. v. Catrett, 477 U.S. 317, 324, 106 S.Ct. 2548, 2553, 91 L.Ed.2d 265 (1986) (quoting Fed.R.Civ.P. 56(e)). "The mere existence of a scintilla of evidence in support of the plaintiff's position will be insufficient; there must be evidence on which the jury could reasonably find for the plaintiff." Anderson, 477 U.S. at 252, 106 S.Ct. at 2512. The party opposing summary judgment "must do more than simply show there is some metaphysical doubt as to the material facts," Matsushita Electrical Industrial Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586, 106 S.Ct. 1348, 1356, 89 L.Ed.2d 538 (1986), but instead must present "concrete evidence supporting its claims and establishing the existence of a genuine issue of fact." Cloverdale Equipment v. Simon Aerials Inc., 869 F.2d 934, 937 (6th Cir. 1986). In essence, the inquiry is "whether the evidence presents a sufficient disagreement to require submission to a jury or whether it is so one-sided that one party must prevail as a matter of law." Anderson, 477 U.S. at 252, 106 S.Ct. at 2512.

Federal Rule of Evidence 702 provides that "if scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training or education, may testify thereto in the form of an opinion or otherwise." The United States Court of Appeals for the Sixth Circuit in United States v. Green, 548 F.2d 1261 (6th Cir.1977), enunciated the standard for admissibility of expert testimony under Rule 702: (1) a qualified expert must be offered; (2) the expert must testify on a proper subject; (3) he must testify in conformity to a generally accepted explanatory theory; and (4) the probative value of the testimony must outweigh any prejudicial effect. Id. at 1268.

This standard was reaffirmed by the Sixth Circuit in the case of United States v. Kozminski, 821 F.2d 1186 (6th Cir.1987). See also Novak v. United States, 865 F.2d 718, 721 (6th Cir.1989) (applying test in a civil action). The Kozminski court elaborated that the third element of the test, "conformity to a generally accepted explanatory theory," must be firmly anchored in sound, reliable, and sufficiently accurate scientific principles. Id. at 1201. The court stated that scientific explanatory theory must have: (a) received at least some exposure within the scientific peerage to which it belongs; (b) been subjected to peer evaluation to determine its scientific validity and reliability; and (c) achieved general acceptance within the scientific community to which it belongs. Id. at 1201.

Rule 703 requires that the data relied upon in the formulation of an expert opinion be of "a type reasonably relied upon by experts in the particular field in forming opinions or inferences upon the subject." Fed.R.Evid. 703. Thus, if expert opinion is not based upon data of "a type reasonably relied upon by experts in the particular field," the expert fails to be helpful, but, rather, is confusing or misleading. See Daubert v. Merrell Dow Pharmaceuticals, Inc., 727 F.Supp. 570, 572 (S.D.Cal.1989). "Whether an expert's opinion has an adequate basis, and whether without it an evidentiary burden has been met, are matters of law for the court to decide." Richardson v. Richardson-Merrell, 649 F.Supp. 799 (D.D.C.1986), aff'd, 857 F.2d 823, 829 (D.C.Cir.1988), cert. denied, 493 U.S. 882, 110 S.Ct. 218, 107 L.Ed.2d 171 (1989).

The first category of data on which plaintiff's experts rely is in vivo (animal) studies. In this category are opinions reflected in the affidavits of Drs. Adrian Gross, Frederick Crescitelli and John Palmer. Plaintiffs' Response, p. 53. Dr. Gross, a veterinarian, states that, based upon animal studies, the doxylamine succinate component of Bendectin is in fact a teratogen.² Affidavit of Adrian Gross filed in Daubert, Plaintiffs' Attachment 41. Dr. Crescitelli, a biologist, also states that doxylamine succinate is a teratogen. Affidavit of Frederick Crescitelli filed in Daubert, Plaintiffs' Attachment 39. Dr. Palmer, a physician and pharmacology professor, avers that, based upon animal studies, in vitro studies, and pharmacological data, Bendectin is a teratogen. Affidavit of John Palmer filed in Elkins, Plaintiffs' Attachment 43. Plaintiffs also assert, without accompanying evidence, that several other experts would testify similarly at trial.

Second, plaintiffs rely on in vitro studies to support their position. In vitro studies are studies conducted in test tubes or petri dishes. Plaintiffs' experts relying on this type of study are Drs. Stuart Newman, Shanna Swan, Crescitelli and Palmer. Plaintiffs' Response, p. 57. Dr. Newman, a developmental biologist, asserts in his affidavit and in prior trial testimony that, based upon in vitro studies, Bendectin is a teratogen. Affidavit of Stuart Newman filed in Elkins, Plaintiffs' Attachment 42; trial testimony of Newman in Ealy, Plaintiffs' Attachment 18.

Dr. Swan, an epidemiologist and biostatistician practicing in the field of reproductive epidemiology, states that to a reasonable degree of certainty, considering all available data provided in animal, in vitro, and epidemiological studies, Bendectin is associated with limb reduction defects. Affidavit of Shanna Swan filed in Daubert, Plaintiffs' Attachment 40. Dr. Swan bases her opinion on "the methodology that is generally and reasonably relied upon by epidemiologist to analyze, study and interpret data that has been collected, published and unpublished in trying to draw...