Wells by Maihafer v. Ortho Pharmaceutical Corp.
615 F. Supp. 262 (N.D. Ga. 1985), modified, 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S. 950 (1986)


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. 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 conclusion of law in accordance with Rule 52, Fed. R. Civ. P.


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.

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. 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.

Plaintiffs filed this action on September 2, 1982, seeking to recover for damages to both Katie Wells and Mary Maihafer. The complaint stated causes of action for negligence, strict products liability, intentional tort, and breach of warranty. 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.

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. 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.


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 p-diisobutylphenoxypolyethoxyethanol or octoxynol-9, is almost identical to non-ionic surfactants used by other manufacturers of spermicides. 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 with the instructions. Defendant also pointed out that the Product carried a warning that no form of birth control is one hundred percent effective.

According to defendant, no additional warning was or is necessary. Defendant argued that at the time of Katie Wells' conception in the fall of 1980, no published reports or studies had concluded that spermicides cause birth defects; further, according to defendant, it had received no other complaints nor had access to any other evidence suggesting a link between its Product and birth defects.

Defendant argued that, on the contrary, "[t]he overwhelming weight of the credible scientific evidence has established that use of such products does not cause birth defects." Defendant criticized studies relied on by plaintiffs' experts as "flawed" and "not scientifically reliable." According to defendant, numerous respected scientists have conducted extensive testing and critical review of non-ionic surfactants and have concluded that the Product is safe and effective. Defendant pointed out that at least one select panel appointed by the government has concluded that the Product should carry no warning that it might cause birth defects.

Finally, defendants argued that even if plaintiffs succeeded in proving a causal link between the Product and Katie Wells' birth defects, defendant had no duty to place a warning on the Product in 1980 because of the absence of any reliable information at that time connecting spermicides and birth defects. Thus, according to defendant, the Product was not defective, defendant had not been negligent, and the failure to provide any such warning was not the result of a conscious marketing decision that might support a claim for punitive damages.



Plaintiff Mary Maihafer testified on direct examination consistently with plaintiffs' theory of the case outlined above. Ms. Maihafer testified positively that she had used the diaphragm and spermicidal jelly according to the instructions every time she and Gary Wells had sex from late July until mid-November 1980. She further stated that she had continued to use the Product for one to two weeks after she missed her menstrual period of November 1, 1980. Ms. Maihafer also mentioned that several months into this pregnancy she had used the prescription drug Decadron for bronchitis and some prescribed antibiotics for an ear infection. In addition, she testified that after Katie Wells' birth, she interrupted her college teaching career for two years to take care of the child. On cross-examination, Ms. Maihafer admitted that she had known, at the time she obtained the diaphragm and spermicide, that diaphragms are not one hundred percent effective in preventing conception.


Gary Wells testified that, to his knowledge, Mary Maihafer used the diaphragm and spermicide every time they had sex from the time she obtained it until mid-November 1980. Counsel for both sides questioned him about his use of drugs. He testified that he had used LSD once in 1971, amphetamines three or four times in 1979, and methaqualone in two or three doses in 1979. Further, he stated that he had smoked marijuana on infrequent occasions from 1969-72 and that he may have smoked marijuana once or twice in 1980 during the time he dated Mary Maihafer.


Plaintiffs' primary expert witness was Dr. Bruce Buehler, who is an associate professor of pediatrics and pathology at the University of Nebraska Medical Center, the director of the Center for Human Genetics, and the director and dean of the Meyer Children's Rehabilitation Institute. Dr. Buehler is board-certified in pediatrics, chemical genetics, and biochemical and metabolic genetics. His research area is biochemical teratology, the study of the effects of drugs and environmental agents on developing fetuses. The list of Dr. Buehler's credentials is long and impressive.

Dr. Buehler testified that the Meyer Children's Rehabilitation Institute each year handles approximately 25,000 visits by handicapped persons from birth through age sixty. The Institute, which employs an estimated ninety professionals who work with handicapping disorders, has a national reputation that attracts patients from all over the country.

Dr. Buehler had examined Katie Wells in person, as opposed to merely viewing her medical records. Before testifying about his findings in the examination and his conclusions that followed, Dr. Buehler explained what a geneticist looks for in an examination to determine the cause of birth defects, and he demonstrated with Katie Wells in court certain aspects of the examination.

The doctor testified that in examining patients with birth defects, a geneticist attempts to determine at what stage of fetal development the defects or abnormalities occurred. He stated that because genetic problems "tend to do their dirty work" from the moment of conception, they result in abnormalities in the body that are symmetrical. On the other hand, Dr. Buehler explained, birth defects tend to be asymmetrical when they are caused by the environment, drugs, and a few genetic problems. Thus, in examining Katie Wells, Dr. Buehler testified that he and a colleague spent much time studying the symmetry of her body and the placement and size of her body parts.

Dr. Buehler explained his findings as he re-enacted portions of the examination in court with Katie Wells. What the doctor found most significant, and what the Court partially observed, was the condition of Katie's left shoulder: the shoulder was totally smooth, the shoulder blade and scapula were half their normal size, and the size of the muscles was normal. Dr. Buehler testified that although most limb deficiencies show some attempt at making an arm or finger--such as a hand or piece of tissue attached to the shoulder--the complete smoothness of this shoulder was rare and suggested total disruption of the limb bud. He also found surprising the normal musculature of a shoulder with no arm.

Although Dr. Buehler testified definitively that vascular disruption had caused the birth defects of Katie Wells' shoulder and hand, he would not attribute her other defects to the same cause. He testified that although he could not rule out the possibility of vascular disruption, he did not have "enough data to make a cleft lip a vascular accident as I do with limb deformities." With respect to the hypoplasia of the optic nerve, Dr. Buehler stated as follows:

It is much easier to explain eye formation and optic nerve formation on a vascular basis than it would be for me for a cleft p]. That is not what I ruled out or ruled in. I have not included that in my opinion because I have focused on the arms, which are the most comfortable to me.

That Dr. Buehler was careful in limiting his opinion to matters within his area of expertise greatly enhanced his credibility in the view of the Court....

The Court found Dr. Buehler to be the most credible of all the witnesses presented in this case. His credentials and experience in biochemical teratology were impressive. Unlike defendant's experts, he had personally examined Katie Wells. His uncontradicted testimony was that he formed no opinion until after this examination. His opinion at trial was the same as the opinion that he previously had offered at his deposition, which defense counsel conducted within an hour of his examination of Katie Wells. That Dr. Buehler limited his testimony to the area of his expertise--limb defects--and would not say that all Katie Wells' defects were caused by the spermicide, made his opinion even more believable. His detailed explanation of how he had ruled out other possible causes demonstrated that his opinion was the product of a careful, methodical reasoning process, not mere speculation. His demeanor as a witness was excellent: he answered all questions fairly and openly in a balanced manner, translating technical terms and findings into common, understandable language, and he gave no hint of bias or prejudice. In short, this witness could hardly have been more credible....

As discussed above, 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.


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