WELLS BY MAIHAFER v. ORTHO PHARMACEUT.

• Decision Date: 29 July 1985
• Docket Number: Civ. A. No. C82-1921A.
• Citation: 615 F. Supp. 262
• Parties: Katie Laurel WELLS (Infant) by her mother and next friend, Mary MAIHAFER, and father, Gary S. Wells, and Mary Maihafer (Individually), Plaintiffs, v. ORTHO PHARMACEUTICAL CORPORATION, Defendant.
• Court: U.S. District Court — Northern District of Georgia

615 F. Supp. 262

Katie Laurel WELLS (Infant) by her mother and next friend, Mary MAIHAFER, and father, Gary S. Wells, and Mary Maihafer (Individually), Plaintiffs, v. ORTHO PHARMACEUTICAL CORPORATION, Defendant.

Civ. A. No. C82-1921A.

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

July 29, 1985.

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

James C. Simmons, Jr., A. Leroy Toliver, Marilyn Dye, Atlanta, Ga., for plaintiffs.

Robert Pennington, John J. Dalton, N. Karen Deming, Atlanta, Ga., for defandant.

ORDER

SHOOB, District Judge.

Plaintiffs — Mary Maihafer and Gary S. Wells, on behalf of their infant daughter Katie Laurel Wells, and Mary Maihafer, individually — brought this products liability action against defendant Ortho Pharmaceutical Corporation to recover damages arising from multiple birth defects suffered by Katie Wells. The central issues that emerged at trial were (1) whether Ortho-Gynol Contraceptive Jelly, a spermicide manufactured and marketed by defendant and allegedly used by plaintiff Mary Maihafer several months before and several weeks after Katie Wells was conceived, proximately caused these birth defects; and (2) whether defendant negligently failed to warn plaintiff Mary Maihafer that an increased risk of birth defects accompanied the use of its product.

At the parties' request, the case was tried before the Court without a jury.¹ After an exhaustive two-week trial with competent and well-prepared counsel for each side, the Court's decision was not an easy one. The medical and scientific evidence presented was in direct conflict. Still, the Court recognized then, and reiterates now, that its task was not to presume the expertise to resolve, once and for all, the dispute within the scientific community about the safety of spermicides. Rather, the Court's function was to render a legal decision, not a medical one. That is, the Court's duty was to weigh carefully the evidence that these parties presented to this Court in the trial of this case and to determine with reference to the facts of the case at hand whether plaintiffs had satisfied their burden of proving that they were entitled to the relief sought.

At trial the key evidence was the testimony of highly qualified expert witnesses and various medical and scientific studies. In considering this evidence, the Court kept in mind plaintiffs' burden of proof: plaintiffs could not recover if the Court found that there was only a "bare possibility" that the spermicide caused these birth defects or that other theories of causation were equally plausible. See Maddox v. Houston County Hospital Authority, 158 Ga.App. 283, 284, 279 S.E.2d 732 (1981). Rather, to authorize recovery plaintiffs' evidence must have shown to a "reasonable degree of medical certainty" that defendant's product was responsible. Parrott v. Chatham County Hospital Authority, 145 Ga.App. 113, 115, 243 S.E.2d 269 (1978); see also Defendant's Trial Brief at 3.

The testimony of plaintiffs' and defendant's experts conflicted on several crucial points. Experts on each side testified that, to a reasonable degree of medical certainty, their side's theory of the case was correct. Attempting to resolve these direct conflicts in the experts' opinions, throughout the trial the Court regularly examined daily transcripts of much of the expert testimony and spent an entire weekend reviewing the studies introduced. Although some of the studies suggested a connection between spermicides and birth defects, overall the studies failed to show conclusively whether or not the spermicide caused any or all of the birth defects suffered by Katie Wells. The Court emphasizes, however, that plaintiffs' ultimate burden was not to produce an unassailable scientific study which proves that spermicides have caused birth defects in rats, rabbits, or members of a large group health plan, but rather to show from all the evidence presented, to a reasonable degree of medical certainty, that the spermicide caused some or all of Katie Wells' birth defects.

The Court's decision, therefore, turned on the oral testimony of a variety of expert witnesses whose opinions often were diametrically opposed on the major issues presented in the case. In assessing the credibility of these witnesses, the Court considered each expert's background, training, experience, and familiarity with the circumstances of this particular case; and the Court evaluated the rationality and internal consistency of each expert's testimony in light of all the evidence presented. The Court paid close attention to each expert's demeanor and tone. Perhaps most important, the Court did its best to ascertain the motives, biases, and interests that might have influenced each expert's opinion.

With few exceptions, the Court found the testimony of plaintiffs' experts generally to be competent, credible, and directed to the specific circumstances of this case. The testimony of defendant's experts, in contrast, often indicated bias or inconsistency. Primarily because the Court found plaintiffs' expert testimony to be far more credible than defendant's, at the conclusion of trial the Court announced that plaintiffs had carried their burden of proving that the spermicide proximately caused some, but not all, of Katie Wells' birth defects and that defendant had been negligent in failing to warn plaintiff Mary Maihafer of this danger. As a result, the Court awarded damages to plaintiffs Katie Wells and Mary Maihafer. The following discussion explains in detail how the Court arrived at this decision from the evidence presented at trial and sets forth the Court's findings of fact and conclusions of law in accordance with Rule 52, Fed.R.Civ.P.

Plaintiffs' Contentions

Plaintiff Mary Maihafer, the mother of plaintiff Katie Wells, is a thirty-two year old college instructor who, plaintiffs contended, has no family history of birth defects and who in 1979 gave birth to a child with no birth defects. According to plaintiffs, Gary S. Wells, the father of Katie Wells, also has no family history of birth defects and is the father of a child born in 1974 without birth defects.

In July 1980, Ms. Maihafer obtained from her gynecologist a prescription for a diaphragm to be used for contraception and a sample tube of Ortho-Gynol Contraceptive Jelly ("the Product"). At that time, plaintiffs contended, a nurse instructed her on the proper use of the diaphragm and spermicidal jelly, and Ms. Maihafer read the "Directions for Using Ortho-Gynol Contraceptive Jelly," which accompanied the Product.²

Plaintiffs alleged that Ms. Maihafer had used the diaphragm and Ortho-Gynol Contraceptive Jelly in accordance with these instructions every time she had sex with Gary Wells from the time the diaphragm was prescribed in late July 1980 until mid-November 1980. Transcript at 80-81. Notwithstanding these precautions, Ms. Maihafer missed her menstrual period that was due to occur around November 1, 1980, and later discovered that she had become pregnant in October 1980.

On July 1, 1981, Ms. Maihafer gave birth to plaintiff Katie Wells, who was born with the following birth defects: (1) a cleft lip; (2) an abnormal formation and shortening of her right hand; (3) the absence of the distal joint of her right ring finger; (4) the complete lack of a left arm; and (5) only partial development of the left clavicle and shoulder. Later Katie Wells was diagnosed as also suffering from hypoplasia of the right optic nerve, which according to plaintiffs has made her almost ninety percent blind in that eye. Transcript at 11.

Plaintiffs filed this action on September 2, 1982, seeking to recover for damages to both Katie Wells and Mary Maihafer.³ The complaint stated causes of action for negligence, strict products liability, intentional tort, and breach of warranty.⁴ Plaintiffs asserted that the spermicide's active ingredient, a non-ionic surfactant that works to break down sperm cell membranes, caused these birth defects through one of the following "mechanisms":

(1) injury to a sperm that ultimately fertilizes an egg;

(2) injury to an unfertilized egg;

(3) injury to a fertilized egg or zygote; or

(4) injury to the developing fetus, either by direct contact with the fetus or by absorption by the mother.

Transcript at 21-22. Moreover, plaintiffs alleged that, at the time Mary Maihafer purchased and used the Product, defendant knew or should have known of certain studies that were available to the scientific community linking the use of spermicides to birth defects in the children of mothers who used spermicides around the time of conception.

According to plaintiffs, defendant's actual or constructive knowledge of this increased risk imposed on defendant a duty to warn health professionals and prospective users of this risk by placing a warning on the Product. Plaintiffs argued that defendant's failure to warn constituted a defect in the Product and thus established defendant's liability under a strict products liability theory. Further, plaintiffs maintained that the failure to warn was also a basis for finding defendant negligent. Transcript at 13. Finally, plaintiffs maintained that they were entitled to punitive damages because defendant's failure to warn was part of a conscious decision to protect its market share. Transcript at 34-35.

Defendant's Contentions

Defendant vehemently denied any association between the use of Ortho-Gynol Contraceptive Jelly and birth defects. Defendant pointed out that the Product's active ingredient, a non-ionic surfactant called pdiisobutylphenoxypolyethoxyethanol or octoxynol-9, is almost identical to non-ionic surfactants used by other manufacturers of spermicides.⁵ Since 1950, defendant has sold the Product in its present form to millions of women.

Defendant maintained that the Product is safe and effective when properly used. Defendant suggested that Ms. Maihafer may not have used the spermicide in strict accordance...