Smith v. Ortho Pharmaceutical Corp.

• Decision Date: 30 January 1991
• Docket Number: Civ. A. No. 1:84-CV-1440-HTW.
• Citation: 770 F. Supp. 1561
• Parties: Donald G. SMITH, Sr., and Brenda Smith, individually and as natural parents, guardians and as next friend of Crystal Smith, a minor, Plaintiffs, v. ORTHO PHARMACEUTICAL CORPORATION, Defendant.
• Court: U.S. District Court — Northern District of Georgia

770 F. Supp. 1561

Donald G. SMITH, Sr., and Brenda Smith, individually and as natural parents, guardians and as next friend of Crystal Smith, a minor, Plaintiffs, v. ORTHO PHARMACEUTICAL CORPORATION, Defendant.

Civ. A. No. 1:84-CV-1440-HTW.

United States District Court, N.D. Georgia, Atlanta Division.

January 30, 1991.

F. Glenn Moffett, Jr., Leonard Prentice Eager, III, Moffett & Henderson, Atlanta, Ga., for plaintiffs.

John J. Dalton, Nancy Karen Deming, Robert L. Pennington, Troutman Sanders Lockerman & Ashmore, Atlanta, Ga., Barry L. Shapiro, Sills, Cummis, Zuckerman, Radin, Tischman, Epstein & Gross, Newark, N.J., for defendant.

ORDER OF COURT

HORACE T. WARD, District Judge.

This matter is pending on defendant's motion for summary judgment and defendant's motion to preclude the testimony of plaintiffs' proposed causation experts or, in the alternative, for a hearing in limine to determine their qualifications and the admissibility of their opinions. Also pending is plaintiffs' motion to strike certain affidavits.

I. INTRODUCTION

Plaintiffs in this products liability action seek damages for Crystal Smith, who was born with a genetic or chromosomal abnormality. Crystal has a number of malformations, all of which derive from this genetic abnormality. Plaintiffs' complaint alleges that Conceptrol, a vaginal spermicide manufactured by Ortho Pharmaceutical Corporation ("Ortho") caused Crystal's malformations. The complaint also alleges that Ortho failed to warn that Conceptrol causes birth defects.

II. PROCEDURAL BACKGROUND

Plaintiffs have previously moved for partial summary judgment based on the doctrine of offensive collateral estoppel. Relying on Wells v. Ortho Pharmaceutical Corp., 615 F.Supp. 262 (N.D.Ga.1985), aff'd & modified in part, remanded, 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S. 950, 107 S.Ct. 437, 93 L.Ed.2d 386 (1986) ("Wells"), the plaintiffs sought to avoid litigating the issue of whether defendant's spermicide causes birth defects.¹

This court denied plaintiffs' motion because of the factual differences between this case and Wells and the availability of new scientific data. The issue of causation with respect to spermicide and birth defects has been extensively researched since the Wells decision. The defendant, in turn, seeks to use this new research data to demonstrate that as a matter of law plaintiffs cannot prove that Crystal's malformations were caused by Mrs. Smith's use of spermicide.

Defendant moves to preclude the testimony of plaintiffs' proposed causation experts or, in the alternative, for a hearing in limine to determine their qualifications and the admissibility of their opinions. Defendant argues that the opinions of plaintiffs' experts are not admissible under F.R.Evid. 703, as neither of plaintiffs' experts bases his opinion on the type of data reasonably relied upon by experts in the medical field in forming opinions.

The parties filed their briefs and supporting material and a hearing was held on July 11, 1988. After reviewing the arguments and supporting material the court took the motions under advisement and permitted the parties to file supplemental law as it became available.² This matter has remained under advisement for an extended period of time in order for the court to study the materials in depth and to permit more of a consensus on the disputed issues to develop in the legal and scientific communities.

III. BACKGROUND

Brenda Smith was 38 years old at the time she conceived Crystal. She first purchased Conceptrol in July, 1979, and states that she read the label of the product at that time. The label of the product did not contain a warning that use of the product might lead to an increased risk of birth defects. Mrs. Smith states that she used Conceptrol as her method of birth control for a ten-month period of time prior to the conception of Crystal Smith and for a period of time thereafter until such time as she was sure she was pregnant. Crystal Smith was born in January 1981 with serious birth defects resulting from a chromosomal abnormality known as Trisomy-18.

A. The Nature of Conceptrol Spermicide.

Conceptrol is a vaginal spermicide sold as an over-the-counter product. It contains one active ingredient, nonoxynol-9, which is a nonionic surfactant. A surfactant is a "surface active agent." The term includes substances commonly referred to as "wetting agents, surface tension depressants, detergents, dispersing agents and emulsifiers."³ Nonionic surfactants comprise a class of detergents that have been shown to be effective spermicidal agents.⁴ The spermicidal activity appears to be a result of the interaction of the surfactant with the sperm cell membrane resulting in increased cell permeability, loss of mobility and eventual destruction.⁵ One of the most commonly utilized nonionic detergent spermicidal agents is nonoxynol-9. While a number of spermicidal agents are designed to be used with a diaphragm, Conceptrol is designed to be used alone.

B. The Regulatory History of Nonionic Surfactant Spermicides.

In the early 1970's the Federal Food and Drug Administration ("FDA") established several expert advisory panels to review the "safety and efficacy" of all over-the-counter drugs.⁶ The panel designated to review spermicides first met on August 2, 1973. Because of its concern over the use of spermicide and its affect on the health of women and their offspring:

The panel ... concluded that as part of its mandate, it would give special attention to the issues involved in labeling and patient instructions, effectiveness rates, delivery systems, vaginal absorption, fetal and infant damage, mutagenicity, and carcinogenicity.⁷

The panel last met on December 9, 1978 and, thereafter, submitted to the FDA its proposed final report concerning vaginal contraceptive drug products.⁸ The panel noted that more studies would be desirable with respect to several issues but concluded that vaginal contraceptives containing nonionic surfactants are safe and effective for over-the-counter use.⁹

The FDA's interest in vaginal spermicides was renewed in November 1983 when the Agency requested that one of its standing expert committees, the Fertility and Maternal Health Drugs Advisory Committee ("FMHDAC"), evaluate the safety of vaginal spermicides.¹⁰ After considering the evidence, which included the studies then available, the FMHDAC found that:

The preponderance of the weight of the currently available evidence indicates no association between the maternal spermicide exposure and an increased rate of abortions or congenital malformations.¹¹

On June 24, 1986, the FDA issued a "Talk Paper" stating that:

Recent lawsuits have attempted to show a link between spermicides and an increased risk of birth defects. As a result, there have been questions regarding FDA's position on the question.

The article discussed some studies showing a risk of increased birth defects from spermicide use, and then concluded:

The FDA concurred with the Fertility and Maternal Health Drugs Advisory Committee and forwarded its recommendation (that a warning was not warranted) to FDA's Over-The-Counter Drugs division, which is completing a review of vaginal contraceptive products.¹²

The FDA subsequently reaffirmed its adoption of the FMHDAC report, noting that:

The FDA has concluded that the weight of the present evidence does not support an association between the use of spermicides and birth defects or miscarriage.

* * * * * *

Based on all available data, FDA has concurred with its Advisory Committee on Fertility and Maternal Health Drugs in concluding that there is no need for a labeling revision of spermicidal products. The Agency will continue to monitor the situation and advise the medical community should there be further developments.¹³

IV. DISCUSSION

A. The Legal Standard for Summary Judgment.

The standard for the grant or denial of summary judgment is set forth in the Supreme Court's trilogy of 1986 decisions that clarified the proper analytical framework. See Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986); Celotex Corp. v. Catrett, 477 U.S. 317, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). In those cases, the Supreme Court explained that the standard for determining whether summary judgment is appropriate 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 251-52, 106 S.Ct. at 2511-12. "The requirement is that there be no genuine issue of material fact." Id., at 248, 106 S.Ct. at 2510.

The party opposing a summary judgment motion has the burden of producing proof to support its legal claim, particularly when the opposing party has had an opportunity to conduct discovery. Celotex Corp., 477 U.S. at 322-23, 106 S.Ct. at 2552-53. All facts and inferences "must be viewed in the light most favorable to the party opposing the motion." Matsushita, 475 U.S. at 587, 106 S.Ct. at 1356 (quoting United States v. Diebold, Inc., 369 U.S. 654, 655, 82 S.Ct. 993, 994, 8 L.Ed.2d 176 (1962)).

Rule 56 of the Federal Rules of Civil Procedure controls summary judgment practice in federal district courts and is proper only where the federal standard is satisfied. Reinke v. O'Connell, 790 F.2d 850, 851 (11th Cir.1986). See also, Schultz v. Newsweek, Inc., 668 F.2d 911, 917 (6th Cir.1982).

Under Georgia product liability law, a plaintiff must prove as part of its prima facie case that the defendant's product was the proximate cause of the injuries alleged. Blackston v. Shook & Fletcher Insulation Co., 764 F.2d 1480, 1482 (11th Cir.1985); Talley v. City Tank Corp., 158 Ga.App. 130, 279 S.E.2d 264, 269 (1981). Plaintiffs bear the burden of proving causation to a reasonable degree of medical certainty....