Wells v. Ortho

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Wells v. Ortho Pharmaceutical Corp.
615 F. Supp. 262 (N.D. Ga. 1985)


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. 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. Rather, to authorize recovery plaintiff's evidence must have shown to a "reasonable degree of medical certainty" that defendant's product was responsible.

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.

Plaintiffs carried their burden of proof regarding causation. The Court found that plaintiffs had presented competent and credible medical and scientific evidence that showed to a reasonable degree of medical certainty that the Product proximately caused the birth defects of Katie Wells' left arm and shoulder and right hand.


The Court ... directs that judgment be entered in favor of plaintiffs in the following amounts:

(1) Katie Wells

(a) loss of future earnings $415,000

(b) future medical expenses $1,200,000

(c) past and future pain and suffering $3,000,000

(2) Mary Maihafer

(a) medical expenses of Katie Wells $30

(b) loss of earnings $36,000

(c) mental distress $500,000

The Court further directs that plaintiffs shall recover their costs of this action from defendant.