Turpin v. Merrell Dow Pharmaceuticals Inc.

• Decision Date: 25 April 1990
• Docket Number: Civ. A. No. 84-105.
• Citation: 736 F. Supp. 737
• Parties: Gary TURPIN, et al., Plaintiffs, v. MERRELL DOW PHARMACEUTICALS INC., Defendant.
• Court: U.S. District Court — Eastern District of Kentucky

736 F. Supp. 737

Gary TURPIN, et al., Plaintiffs, v. MERRELL DOW PHARMACEUTICALS INC., Defendant.

Civ. A. No. 84-105.

United States District Court, E.D. Kentucky, London Division.

April 25, 1990.

Barry J. Nace and Thomas H. Tate, Paulson, Nace, Norwind & Sellinger, Washington, D.C., for plaintiffs.

Frank C. Woodside, III, Joseph E. Conley, Jr. and Stephen M. Rosenberger, Dinsmore & Shohl, Cincinnati, Ohio, for defendant.

MEMORANDUM

SILER, Chief Judge.

This action is before the Court on the motion of the defendant Merrell Dow Pharmaceuticals Inc. (Merrell Dow) for summary judgment pursuant to Fed.R.Civ.P. 56. After reviewing the voluminous materials submitted by the parties, including affidavits of experts, trial and deposition transcripts, excerpts of transcripts, summaries of published scientific studies, and numerous decisions of other courts regarding the same or similar issues, the Court is convinced that no genuine issues of material fact exist and the case can therefore be decided as a matter of law. Thus, for the reasons stated below, Merrell Dow's motion for summary judgment will be granted.

It appears from the record that the parties do not dispute the facts out of which this action arose. Brandy Turpin, minor-plaintiff, was born on February 27, 1982, to plaintiff-parents, Gary and Betty Turpin. Brandy was born with various deformities to both hands and feet which have required several surgical procedures to partially correct. Betty Turpin ingested the drug Bendectin during her pregnancy with Brandy. Bendectin was a prescription pharmaceutical product manufactured by Merrell Dow, and prescribed for the treatment of nausea and vomiting during pregnancy. Bendectin was the only anti-nauseant approved by the Food and Drug Administration (FDA) to combat "morning sickness" experienced by mothers during pregnancy. Merrell Dow removed the product from the marketplace in 1983 due to the increased costs of litigation surrounding the drug.

The plaintiffs assert that Betty Turpin's Bendectin ingestion caused her daughter's birth defects. Merrell Dow argues that the plaintiffs can submit no evidence that supports the contention that a causal association between Bendectin and birth defects exists. Thus, the primary issue to be decided by the Court is whether the plaintiffs have submitted sufficient evidence that Bendectin is teratogenic (capable of causing birth defects) to survive a grant of summary judgment.

I.

Rule 56(c) of the Federal Rules of Civil Procedure provides that after an adequate opportunity for discovery, see Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 2552, 91 L.Ed.2d 265 (1986); Anderson v. Liberty Lobby, 477 U.S. 242, 250 n. 5, 106 S.Ct. 2505, 2511 n. 5, 91 L.Ed.2d 202 n. 5 (1986), the moving party shall be granted summary judgment when it appears that "there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." "A party seeking summary judgment always bears the initial responsibility of informing the district court of the basis for its motion, and identifying those portions of `the record' which it believes demonstrates the absence of a genuine issue of material fact." Celotex, supra, 477 U.S. at 323, 106 S.Ct. at 2552. However, there is "no express or implied requirement in Rule 56 that the moving party support its motion with affidavits or other similar materials, negating the opponent's claim." Id. (Emphasis in original.)

Once a properly supported motion for summary judgment is made, "the nonmovant must go beyond the pleadings and by affidavits or by `depositions, answers to interrogatories, and admissions on file' designate `specific facts showing that there is a genuine issue for trial.'" Potters Medical Center v. City Hospital Ass'n, 800 F.2d 568, 572 (6th Cir.1986), quoting Fed.R. Civ.P. Rule 56(c), (e). See also Anderson, supra, 477 U.S. at 248-49, 106 S.Ct. at 2510-11.

The standard for granting summary judgment is identical to the standard for a directed verdict under Fed.R.Civ.P. 50(a), "which is that the trial judge must direct a verdict if, under the governing law, there can be but one reasonable conclusion as to the verdict.... If reasonable minds could differ as to the import of the evidence, however, a verdict should not be directed." Anderson, supra, at 250-51, 106 S.Ct. at 2511-12. "The evidence must be viewed in a light most favorable to the party opposing summary judgment and that party must be given the benefit of all reasonable inferences." Potters, supra, at 572. See also Matsushita Electric Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986); Bouldis v. United States Suzuki Motor Corp., 711 F.2d 1319, 1324 (6th Cir.1983).

II.

Merrell Dow contends that human epidemiology studies demonstrate that there is an absence of any evidence connecting Bendectin with birth defects. To support its position, Merrell Dow submitted the summary of over thirty (30) separate human epidemiology studies, none of which demonstrated any connection between birth defects and Bendectin ingestion. The plaintiffs have submitted contrary testimony. The defendant urges the Court to conclude that this expert testimony, tendered by the plaintiffs, is inadmissible under Fed.R.Evid. 703, as their opinions are not based on facts or data "of a type reasonably relied upon by experts in the particular field." Fed.R.Evid. 703. Merrell Dow argues that as the plaintiffs have offered no confirmed, statistically significant, epidemiological data establishing a causal relationship between Bendectin use and birth defects, summary judgment is appropriate.

The plaintiffs attempt to prove Bendectin's teratogenicity through the presentation of expert opinion testimony of seven scientists representing a variety of fields relating to birth defects including pathology, epidemiology, chemistry, developmental biology, pharmacology, toxicology, embryology, teratology, and dysmorphology. These experts include Drs. Johannes Thiersch, Shanna Swan, Stewart Newman, Frederick Crescitelli, Andrian Gross, Jay Glasser, and John Palmer. While testifying to Bendectin's teratogenicity, these experts draw their opinions from four areas of evidence; studies of analogous chemical structures, in vivo and in vitro animal studies, and from the criticism and reanalysis of various of the epidemiological studies submitted by the defendants.

A review of the record reveals the content of each expert's trial testimony. Dr. Johannes Thiersch, a specialist in pathology and pharmacology, would testify that a chemical's composition and its physiological activity is a decisive factor in teratogenic investigations. Dr. Shanna Swan, an epidemiologist and biostatistician, would testify considering all available data, and using the methodology reasonably relied upon by epidemiologists, that with a reasonable degree of medical certainty Bendectin is associated with limb reduction defects. Dr. Stewart Newman, a specialist in developmental, cell, and molecular biology, would testify based on in vitro studies and the pharmacological aspects of Bendectin, that Bendectin is a human teratogen capable of causing birth defects in the developing limbs of human beings. Dr. Adrian Gross, a veterinarian with experience in pathology and toxicology, would testify based on animal studies that Bendectin is teratogenic. Dr. Jay Glasser, a professor of biometry and computer science, with other teaching experience in epidemiology, statistics and biostatistics, would testify based on data reasonably relied upon by biometrists, epidemiologists, and biostatisticians, that Bendectin was epidemiologically statistically associated with limb defects. Dr. Frederick Crescitelli, a biologist with accessory training in physics and chemistry, would testify based on analysis of Bendectin's antihistaminic component, that Bendectin is a teratogen. Dr. John Palmer, a physician and pharmacology professor, would testify based on pharmacological data, animal studies, in vitro studies, epidemiological data and other human data, that Bendectin, specifically its antihistaminic component, has teratogenic properties. Dr. Palmer also examined the medical records pertaining to Brandy Turpin and would testify that within a reasonable degree of medical certainty Bendectin was taken during a period of time that would affect the cells that produce normal limbs in Brandy Turpin and that Bendectin did in fact cause the limb defects from which she suffers. The plaintiffs also submitted materials regarding the credentials and testimony of Dr. Alan Done, Dr. Wayne Snodgrass, and Dr. W.G. McBride, but did not indicate that their testimony would be offered at trial. See Daubert v. Merrell Dow, 727 F.Supp. 570, 574-75 (S.D.Cal.1989) (outlining more fully the proffered testimony of each expert above, with the exception of Dr. Crescitelli).

III.

Fed.R.Evid. 703 requires that the grounds 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. "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, 857 F.2d 823, 829 (D.C. Cir.1988), cert. denied, ___ U.S. ___, 110 S.Ct. 218, 107 L.Ed.2d 171 (1989); see United States v. Kozminski, 821 F.2d 1186, 1194 (6th Cir.1987), aff'd, 487 U.S. 931, 108 S.Ct. 2751, 101 L.Ed.2d 788 (1989). In Kozminski, the Sixth Circuit developed a four-part test that must be satisfied for expert testimony to be admissible. To be admissible the testimony must: (1) be by a qualified expert; (2) be on a proper subject; (3) be in conformity to a generally accepted explanatory theory; (4) and have a probative value which outweighs any prejudicial effect. Kozminski, supra, at 1194. See also Novak v....