Full opinion text
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. 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. 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. 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. 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 oetoxynol-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. Transcript at 36-37. 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.” Consolidated Pretrial Order at 9. Defendant criticized studies relied on by plaintiffs’ experts as “flawed” and “not scientifically reliable.” Defendant’s Proposed Findings of Fact and Conclusions of Law at 2. 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. Consolidated Pretrial Order at 9. 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. Id. 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. Transcript at 46-47. The Evidence at Trial A. Mary Maihafer 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. Transcript at 76, 80-81. Ms. Maihafer also mentioned that several months into this pregnancy she had used the prescription drug Deeadron for bronchitis and some prescribed antibiotics for an ear infection. Transcript at 63-64. In addition, she testified that after Katie Wells’ birth, she interrupted her college teaching career for two years to take care of the child. Transcript at 963. 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. Transcript at 122. B. Gary Wells 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. Transcript at 151. 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. Transcript at 147-51,155-57. C. Dr. Bruce Buehler 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. Transcript at 203. 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. Transcript at 204-06. 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. Transcript at 220-22. 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. Transcript at 227-28. 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. Transcript at 230. Dr. Buehler considered and rejected the possibility that the shoulder defects were caused by “amniotic banding” that cut off the arm; if a band had been present, he stated, the clavicle and scapula behind the band would have been normal. Moreover, the hospital delivery records included no description of amniotic banding. He also rejected as inconsistent with his experience the possibility that the limb had been trapped in the womb and absorbed or destroyed by the body. He concluded that the limb defect must have been caused by a vascular disruption—an interruption in the blood supply to the developing limb. According to Dr. Buehler, the interruption prevented the development of a left arm and provided insufficient blood supply for the clavicle and scapula to reach their normal size. Transcript at 230-32, 242. Similarly, the doctor concluded that the defects of the right hand probably were caused by a vascular disruption. Although Dr. Buehler observed that the wraps of “fiber material” around Katie Wells' fingers gave the appearance of amniotic banding, he rejected this explanation because the missing portion was in the middle—not at the end—of Katie Wells’ finger. He stated that the missing part must have once been there but disappeared, an occurrence explainable only by loss of blood supply and reabsorption. Dr. Buehler further testified that the formation of the fingers was inconsistent with amniotic banding, with which “you would expect essentially amputation.” Transcript at 232. 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.” Transcript at 233. 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 [lip]. 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. Transcript at 234. 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. Dr. Buehler identified the most likely cause of the vascular disruption in this case as the Product. He testified that diabetes, one possible source of the irritation of the vascular supply, had been ruled out in this family. Instead, Dr. Buehler stated that scientific studies supplied to him by plaintiffs and other studies he had reviewed on his own suggested that exposure to spermicides could produce a higher risk of limb defects. The doctor went on to testify that he was “more comfortable with his opinion and [did] not require the literature as strongly” because Mary Maihafer had used the spermicide not only at conception, but also through the time of development of the limb buds during the first few weeks after conception. Transcript at 243-44, 276. Dr. Buehler elaborated on this conclusion, recalling that certain studies have suggested that spermicides can be absorbed and find their way to the fetal site, where they can irritate or otherwise affect fetal development. Dr. Buehler further testified that he rejected the possibility that LSD and other drugs taken by Gary Wells on occasion or Decadron and Amoxicillin taken by Mary Maihafer during this pregnancy could have caused these birth defects. Dr. Buehler also discussed several pertinent studies and articles that he had reviewed prior to trial. The first was the 1976 Oechsli study, which was prepared for the National Institutes of Health (NIH). According to Dr. Buehler, NIH generally selects excellent researchers, and epidemiologists and teratologists generally rely heavily on such data when available. Dr. Buehler described the Oechsli study as indicating a “question and possible relationship” between spermicides and birth defects. Dr. Buehler further noted that the unpublished Oechsli study was cited to in the March 1980 Harlap article, which was published in a well-respected journal. In Dr. Buehler’s opinion, it appeared that the Oechsli study would have been available to the general medical community. Transcript at 247-54. Next, Dr. Buehler addressed the 1977 Smith article. Although Dr. Buehler observed that the Smith article drew no strong conclusions, he pointed out that it contained data suggesting an association between spermicides and limb deficiencies. Based on these studies, Dr. Buehler concluded that in the 1970’s the existence of a potential problem with spermicides was known. Transcript at 254-56. Dr. Buehler also discussed the 1981 Jick article, which he stated was published in the well-respected Journal of the American Medical Association. According to Dr. Buehler, this article raised a “serious question” about an association between spermicides and limb defects. He testified that after the publication of this article, he began recommending that pregnant women undergo ultrasound testing for fetal limb deficiencies twelve to eighteen weeks after conception. Transcript at 259-62. The next study that Dr. Buehler addressed was the 1982 Buttar study of the potential embryotoxic and teratogenic effects of the non-ionic surfactant nonoxynol-9. Dr. Buehler testified that this study provided a strong basis for his opinion that the spermicide was the most likely cause of Katie Wells’ arm and hand defects because it showed that the spermicide caused an increased number of fetuses to be reabsorbed in rats and in mice. In Dr. Buehler’s view, the “embryolethality” shown by this study was a “very strong suggestion” that the spermicide can reach the fetus and destroy it, a result that suggests the spermicide is teratogenic, notwithstanding the author’s stated conclusion. Transcript at 268-70. Finally, Dr. Buehler addressed the 1982 Jick article. He testified that this article showed a higher miscarriage rate in mothers who, according to Jick’s definition, used spermicides. In Dr. Buehler's opinion, this increased miscarriage rate wa,s another suggestion that spermicides are teratogenic. Transcript at 270-73. Turning from causation to consequences, Dr. Buehler addressed the future medical expenses that would accompany Katie Wells’ birth defects. Based on his experiences with rehabilitation medicine, the doctor testified that prosthetic devices and adaptive equipment “to maximize [Katie Wells’] potential” would cost at least one to one-and-a-half million dollars. Transcript at 282-83. Defense counsel conducted a thorough and probing cross-examination of Dr. Buehler. When asked whether the 1981 Jick study proved that spermicides caused the limb reduction defects that Jick found, Dr. Buehler answered in the negative, but explained that “there isn’t any teratogen study that has proven ‘yes’ or ‘no.’ It is an improbability risk. This raises a probability question.” Transcript at 351. Even after taking into account all the concerns raised by defense counsel, Dr. Buehler concluded, with a reasonable degree of medical certainty, that the spermicide had caused the defects in Katie Wells’ shoulder and hand. Transcript at 327. 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. D. Dr. Earl Sutherland Another expert who testified for plaintiffs was Dr. Earl Wilbur Sutherland, III. Dr. Sutherland, who has a Ph.D. in pharmacology and an M.D., is an assistant professor of medicine in the departments of internal medicine and clinical pharmacology at the University of Colorado School of Medicine in Denver. Since 1980 he has been Medical Director of the Rocky Mountain Drug Consultation Center, which offers information about therapeutic drugs to consumers and health professionals. He is board-certified in internal medicine, and he actively practices in that field. Dr. Sutherland also worked with NIH for several years beginning in 1969. Transcript at 523-39. Dr. Sutherland’s testimony concerned both key issues in this case: the causation of Katie Wells’ birth defects and the adequacy of defendant’s warning. Addressing causation, he testified that non-ionic surfactants work by disrupting the lining of sperm cells, thus either killing or immobilizing them. Transcript at 540-42. According to Dr. Sutherland, non-ionic surfactants are toxic to many other cells as well. He testified that, based on his research of published and unpublished materials, in his opinion spermicides have a “definite role” in causing birth defects. Transcript at 543. Although Dr. Sutherland could not identify with certainty the “mechanism” by which spermicides can cause birth defects, he pointed out that mechanisms have not been discovered for some drugs—such as thalidomide—that are known to cause congenital malformations. Dr. Sutherland did suggest several possible mechanisms: (1) that the spermicide may have injured a sperm which nonetheless fertilized the egg, resulting in abnormal development of the fetus; (2) that the spermicide may have injured the unfertilized egg; or (3) that the spermicide may have injured the fertilized egg. Transcript at 544, 565-66. Further, Dr. Sutherland stated that non-ionic surfactants can cause vascular disruption by irritating or injuring small blood vessels. Transcript at 545-46. Based on his personal examination of Katie Wells, his review of the relevant medical records in this case, his reading of the literature, and his knowledge and experience as a physician and pharmacologist, Dr. Sutherland concluded that the non-ionic surfactant in the Ortho-Gynol Contraceptive Jelly caused Katie Wells’ birth defects. Transcript at 565-66. He explained that non-ionic surfactants are “readily absorbed” by the mother’s body and, because they are toxic to a variety of cells, they create a potential for injury not only to spermatozoa, but also to the ovum, the fertilized egg, and the fetus. Dr. Sutherland also noted the existence of clinical reports suggesting an association between non-ionic surfactants and birth defects. Transcript at 565-568. Therefore, according to Dr. Sutherland, the spermicide had several opportunities to cause these birth defects in Katie Wells, and the lack of certainty about precisely which mechanism or mechanisms were involved was consistent with the uncertainty surrounding how certain known teratogens work. Transcript at 567. Addressing the issue of failure to warn, Dr. Sutherland stated that his background had made him familiar with the pharmaceutical industry’s customary practices regarding warnings and also with the procedures followed in studies and reports made for NIH. He testified that the 1976 Oechsli study, which raised questions about a possible relationship between spermicides and birth defects, was performed under an NIH contract and that, although the study was never formally published, it would have been available to the public and the pharmaceutical industry long before Mary Maihafer purchased and used the spermicide in 1980. Transcript at 553-58. According to Dr. Sutherland, the Oechsli study employed standard, widely-accepted techniques. He also stated that the pharmaceutical industry routinely relies on NIH studies. Transcript at 559-60. Because the Oechsli study and the 1977 Smith study indicated a “serious potential” that spermicides increase the risk of fetal injury, and because both studies were available to defendant before Mary Maihafer began using the Product, Dr. Sutherland concluded that the warning on the label of the Product was inadequate. In his opinion, the Product should have carried a warning that a user should discontinue use if she suspects she is pregnant and that the Product might increase the risk of fetal malformations. Transcript at 562. This opinion, he stated, was based on the studies linking spermicides with birth defects, the known toxicity of the spermicide, and the evidence that non-ionic surfactants are absorbed by mothers using spermicides. Dr. Sutherland emphatically concluded that defendant’s failure to provide such a warning fell beneath the customary standard of care in the pharmaceutical industry. Transcript at 563. Finding Dr. Sutherland more than qualified to address the issues of causation and failure to warn, the Court judged him to be a credible witness. Without being dogmatic, he was positive and emphatic in his conclusions that the spermicide caused Katie Wells’ birth defects and that the warning on the Product was inadequate. His manner suggested objectivity and openness. For example, he readily admitted that he could not pinpoint the mechanism by which the spermicide caused these birth defects. Furthermore, his conclusions withstood a rigorous cross-examination, and he showed no sign of bias or prejudice that might lead the Court to discount his opinion. E. Dr. Joseph Bussey Plaintiffs also called as a witness Dr. Joseph Gibson Bussey, a general surgeon who had been a consultant to a division of Johnson and Johnson, the parent company of defendant Ortho Pharmaceutical Corporation. Dr. Bussey testified that, in his opinion, the spermicide had caused Katie Wells’ birth defects and that the warning on the label of the Product was inadequate. Transcript at 459, 463. Dr. Bussey’s background also included experience in evaluating disabilities: he was a founding member of the National Association of Disability Evaluating Physicians. Transcript at 430. Based on his examination of Katie Wells and his review of her medical records, Dr. Bussey testified that, in his opinion, Katie Wells is totally and permanently disabled. Transcript at 470. With the exception of his testimony concerning the degree of Katie Wells’ disability, the Court did not place much reliance on Dr. Bussey’s testimony. Although Dr. Bussey appears to have an excellent background in surgery, his practice only occasionally involves obstetrics and gynecology, a fact underscored by defense counsel on cross-examination. Further, none of his research or writing has dealt with epidemiological studies or the causes of birth defects. Another fact detracted from Dr. Bussey’s credibility: he testified that he first became interested in a connection between spermicides and birth defects when his wife had a spontaneous abortion after using a spermicide manufactured by defendant. Transcript at 432-37. Because of the inherent potential for bias or prejudice, the Court has given little weight to Dr. Bussey’s testimony concerning causation and failure to warn. F. Dr. John Holbrook Another expert witness who testified for plaintiffs was Dr. John Marshall Holbrook, the Director of Research and Associate Professor at Mercer University School of Pharmacy. Dr. Holbrook’s credentials include a B.S. in Pharmacy and a Ph.D. in Pharmacology. His background in teaching and publishing has included, among other things, the toxic effects of certain drugs on the body. Transcript at 163-72. Dr. Holbrook described from his perspective as a pharmacologist how spermicides containing non-ionic surfactants work. He explained that non-ionic surfactants are detergents that disrupt and inactivate sperm by breaking down their cell walls. By this very mechanism, Dr. Holbrook stated, non-ionic surfactants cause irritation. Transcript at 176-78. In Dr. Holbrook’s opinion, a “definite relationship” exists between the use of spermicides and fetal malformations. Transcript at 710-11. Dr. Holbrook based this conclusion on various articles and studies dating as far back as 1975 that suggested the existence of such a link. The earliest of these, which appeared in January 1975, indicated to Dr. Holbrook that there had been little evaluation of the damage which spermicides might produce and that spermicides might cause birth defects. Transcript at 181-83. The 1976 Oechsli study, in Dr. Holbrook’s view, was a “strong suggestion” that the use of spermicides could lead to serious birth defects. Transcript at 191. Similarly, Dr. Holbrook testified that the 1977 Smith article contained indications that spermicides might be teratogenic. Transcript at 704-05. According to Dr. Holbrook, other articles and studies published after Mary Maihafer began using the spermicide also contributed to his conclusion of a “definite relationship” between spermicides and birth defects. Still, in his opinion, the scientific literature available before July 1980 should have prompted Ortho Pharmaceutical Corporation to warn physicians, pharmacists, and consumers of a possible increased risk of fetal malformations “at the very, very first hint of a problem with the compound.” Transcript at 718-19. Ortho’s failure to issue any such warning was contrary to the ordinary custom in the pharmaceutical industry of monitoring the available medical literature and warning of potential problems with products, according to Dr. Holbrook. Transcript at 715-19. Dr. Holbrook further addressed whether Mary Maihafer’s consumption of alcohol during pregnancy or Gary Wells’ past drug use might change his opinion. He testified that neither of these facts would alter his conclusion concerning the relationship between spermicides and birth defects. The Court found Dr. Holbrook to be a credible witness. His background in pharmacology gave credence to his testimony concerning the potential pharmacological effects of spermicides and the customary procedures concerning warnings in the pharmaceutical industry. His demeanor on both direct and cross-examination indicated that he was giving his honest appraisal of the issues of causation and failure to warn. G. Dr. Dick Gourley A most persuasive witness for plaintiffs on the issue of failure to warn was Dr. Dick Gourley. Dr. Gourley’s background and credentials are extensive: formerly a full professor and chairman of the Department of Pharmacy at the University of Nebraska, Dr. Gourley presently is a full professor and Dean of Mercer University School of Pharmacy. He has published at least thirty-seven articles and six to eight chapters in books relating to pharmacy, including a chapter in the “Handbook of Nonprescription Drugs” (the “O.T.C. Handbook”), a compendium of chapters on nonprescription products published by the American Pharmaceutical Association. Additionally, Dr. Gourley is a senior reviewer of the O.T.C. Handbook and serves on the editorial boards of two pharmaceutical journals. He has received numerous grants and contracts from private foundations, government agencies, and pharmaceutical companies. Most significantly, Dr. Gourley has served as an advisor or consultant to many major pharmaceutical firms, and in this capacity his wide range of responsibilities has included advising these drug companies what information should be included in package inserts and drug information packets. Transcript at 845-864. Dr. Gourley stated forcefully that the warning on the label of Ortho-Gynol Contraceptive Jelly is insufficient. He testified that “as soon as the first study is done and any information that is provided ... gives the hint that there is a possibility of a drug causing birth defects,” the label should be changed to include a warning. Transcript at 870. According to Dr. Gourley, defendant should have warned that its Product carries an increased risk of birth defects soon after that possibility was suggested by the Oechsli study in 1976, and no later than the publication of the Smith study in 1977. Transcript at 870, 876-77. He explained that, according to his experience, firms in the pharmaceutical industry closely watch the workings of the scientific community—including NIH—for any information concerning their products because this information affects their business. In Dr. Gourley’s view, the Smith study, which was published in 1977, certainly was available to defendant that same year. Further, he testified that the unpublished 1976 Oechsli study also would have been available to defendant: The Oechsli study is a study of N.I.H., and studies such as this become public. Now, [it]’s not necessary that it has to be published in a journal for industry to get ahold of something like this. They may not have had it on April the 8th, 1976, but, if they didn’t have it within a few months of that, then somebody was asleep at the wheel. Transcript at 871-73. In Dr. Gourley’s opinion, an adequate warning on the Product’s label might be as simple as the following: “Do not use in case of pregnancy, and if you become pregnant while using the product, please contact or consult your physician.” Transcript at 868. Dr. Gourley emphasized the importance of a patient’s “right to know”: [o]ur attitude towards patients has changed dramatically in the past ten years so [that] patients have a right to know information. They are demanding information; so it should have been there for the patient, without any question. Transcript at 874. Dr. Gourley further stated that defendant also should have warned pharmacists, physicians, and family planning groups of this possibility through mailgrams or through its “detail men,” as is common in the industry when studies suggest that a product might have adverse effects. Transcript at 874-76. All in all, the Court found Dr. Gourley to be one of the most credible witnesses presented by either side. Although he had never worked with Ortho Pharmaceutical Corporation, his background and experience in the pharmaceutical community made him well-qualified to testify on customs and practices in the industry in general. He was positive in his opinion without being dogmatic. His conduct and bearing suggested a balanced, reasoned approach to answering the questions asked of him by both sides. In short, the Court found him to be a highly credible witness. H. Dr. Dan J. Mitchell Dr. Dan J. Mitchell was another witness presented by plaintiffs to address the issue of failure to warn. Dr. Mitchell, whose credentials in pharmacy include a B.S., Ph.D., and post-doctoral training, is Clinical Pharmacy Coordinator and Director of Drug Information at Northside Hospital in Atlanta. He has held a variety of positions that have involved the retrieval and dissemination of information about drugs. In his present capacity as Director of Drug Information, he has developed a formal drug information service to respond daily to questions from physicians and other medical staff. Transcript at 797-806. Dr. Mitchell testified that in providing this service, he relies extensively on information provided by the manufacturer of a drug because other sources of information often are not readily available and because “the manufacturer typically will have access to virtually anything that has been reported.” Transcript at 807. He also stated that he is familiar with drug manufacturers’ customary procedures in providing information about their products. According to Dr. Mitchell, pharmaceutical firms generally furnish such information when a product is first marketed and when changes are made in labelling. Dr. Mitchell further stated that he relies on the pharmaceutical companies to provide current and accurate information about potential side effects of their products. Transcript at 808-09. Dr. Mitchell testified that neither Ortho Pharmaceutical Corporation nor its parent, Johnson and Johnson, ever warned him of the potential teratogenic effects of the Product. After reviewing the Oechsli and Smith studies, he concluded that “[Ortho] definitely should have provided some form of warning ..., particularly to the user of the product and probably also to health professionals,” such as physicians, pharmacists, and family planning workers, of the possible relationship between spermicides and birth defects. Transcript at 809-11. In his opinion, defendant should have provided this warning in 1976 after the Oechsli study became available. Transcript at 811. The absence of such a warning led Dr. Mitchell to conclude that the package insert accompanying the Product in 1980 was insufficient. Transcript at 813-14. On cross-examination, defense counsel questioned Dr. Mitchell at length about the significance of other studies that, unlike Oechsli and Smith, found no connection between spermicides and birth defects or that failed to replicate the findings of those two studies. Dr. Mitchell replied that these studies did not affect his opinion concerning defendant’s duty to warn. Transcript at 839. In his view, even one report suggesting that a product may cause a defect cannot be readily discounted. He stated that the existence of studies disagreeing with Oechsli and Smith does not establish conclusively that those two studies have no significance. Transcript at 822. Dr. Mitchell further testified on cross-examination that the findings of the FDA’s Fertility and Maternal Health Drugs Advisory Committee (FMHDAC), which in 1983 concluded that the Product needs no additional warning, also had no effect on his opinions concerning defendant’s duty to warn. He stated: Those people are readily swayed, I think, by other interests, including pharmaceutical manufacturers, other people to whom they must report and who[m] they represent. I’m not sure what the weight of one of these advisory committees should ultimately be. Transcript at 840. The Court found Dr. Mitchell’s testimony very creditworthy on the duty to warn issue, but assigned no weight to the portions of his testimony that spilled over into the issue of causation. Dr. Mitchell’s expertise in drug information qualified him to comment on whether defendant’s failure to warn satisfied the standards of the industry. His demeanor, particularly under the pressure of a vigorous cross-examination, showed no evasiveness, but rather a willingness to respond in a straightforward manner and to explain his answers. In short, Dr. Mitchell fared well in the Court’s assessment of his credibility. I. Dr. John Brown Plaintiffs presented Dr. John Brown, an economist and actuary who is an assistant professor at Georgia State University, to establish the amount of Katie Wells’ lost future earnings caused by her birth defects. The parties stipulated to Dr. Brown’s qualifications as an expert. Dr. Brown testified that in calculating these lost earnings he used the most conservative “work life expectancy” that he knew—27.91 years—which assumed that Katie Wells would have worked from age 18 to age 45 or 46. He pointed out that if it were assumed that Katie Wells would have worked until age 65, he would have added approximately twenty more years of earnings to his estimate. Dr. Brown produced several different calculations of the net present value of Katie Wells’ lost future earnings by using different assumptions. Under the assumption that Katie Wells would have completed only high school, at a five percent discount rate and four percent inflation rate the net present value of her lost future earnings would be $320,104; at an eleven percent discount rate and a nine percent inflation rate, that figure would be $243,402. Under the assumption that Katie Wells would have completed college, at a five percent discount rate and a four percent inflation rate, the net present value of her lost future earnings would be $415,113; at an eleven percent discount rate and a nine percent inflation rate, that figure would be $308,709. These figures, according to Dr. Brown, are based on the conclusion that Katie Wells is totally disabled. If her disability were deemed less than one hundred percent, Dr. Brown noted that these figures would be adjusted proportionately to reflect her degree of disability. Transcript at 910-27. J. Dr. George S. Braun Defendant began its case with the testimony of Dr. George S. Braun, currently Vice-President of Technical Affairs for Johnson and Johnson, Ortho’s parent corporation. After obtaining a Ph.D. in biochemistry, in 1963 Dr. Braun joined McNeil Labs, a subsidiary of Johnson and Johnson, where he . eventually became executive director of research. In 1972 he moved to defendant Ortho Pharmaceutical Corporation to become a vice-president of research. He remained at Ortho until March 1980. Transcript at 999-1002. Dr. Braun testified that, since approximately 1950, defendant has marketed Or-tho-Gynol Contraceptive Jelly in its present form. When the Product was introduced, Dr. Braun stated, it was tested for effectiveness in preventing conception. He distinguished this spermicide from others that, in the 1960’s and early 1970’s, had contained the active ingredient phenylmercuric acetate, which an FDA panel later declared unsafe. Transcript at 1005-08. Most of Dr. Braun’s testimony concerned his participation during the mid-1970’s on an advisory committee to the FDA, the “O.T.C. Advisory Committee,” which reviewed the safety, efficacy, and labelling of a group of over-the-counter, nonprescription products that included vaginal contraceptives. According to Dr. Braun, the Committee consisted of four or five physicians in the field of obstetrics and gynecology, one or two pharmacists, one basic scientist, one consumer representative, and Dr. Braun as industry liaison. Dr. Braun considered each member of the panel an expert in his or her field. Dr. Braun recounted that, beginning in 1973, this panel met four or five times each year for five years and gathered all the information available concerning the safety and efficacy of various ingredients in the products that it reviewed. According to Dr. Braun, to collect information the Committee searched the available literature, advertised for information from various sources (including NIH), held two symposia, and received information supplied by Ortho. Transcript at 1008-16. In 1978 the Committee sent its final report to the FDA, and in 1980 the report was published in the Federal Register as a proposed monograph. In Dr. Braun’s words, the report classified the non-ionic surfactants tested as safe, effective, and properly labelled. Transcript at 1018-19. Dr. Braun testified that, after reviewing the studies by Oechsli and Smith, he still concluded that in 1977 the Product did not require additional warnings relating to pregnancy. According to Dr. Braun, the “overwhelming preponderance of evidence” indicates that spermicides are not teratogenic. He suggested that the Oechsli and Smith studies were “substantially flawed”; as an example, he explained that some patients in Oechsli’s study may have used spermicides containing the unsafe ingredient phenylmercuric acetate, which is not found in the Product. In light of the “negative teratology studies and all the other data from our experience,” Dr. Braun testified, “there was just no basis for a warning.” Transcript at 1022-23. Dr. Braun further explained that changes in labelling must be done carefully because adding a warning to the label might cause concern among women using that product. Consequently, according to Dr. Braun, these women might not use that particular contraceptive, even though other contraceptives might not be suitable for them. In his opinion, “the risks involved in pregnancy far exceed any potential risks that may be involved in this method of contraception.” Transcript at 1023-24. On cross-examination, Dr. Braun admitted that the Harlap article, which was published in March 1980 and which referred to the unpublished 1976 Oechsli study, was available to defendant in March 1980, in time for defendant to have added a warning to the label before Mary Maihafer allegedly purchased the Product in August or September 1980. Transcript at 1041-43. The Court did not find Dr. Braun to be a particularly credible witness in view of his interest in the outcome of the case and his lack of training as compared to many of the other witnesses. K. Mr. Armond Welch Defendant next presented as a witness Mr. Armond Morris Welch, a registered pharmacist who worked for the FDA from 1946 until 1980. From 1971 until 1980, Mr. Welch had been a panel administrator assigned to the O.T.C. Advisory Committee on vaginal products, the same panel on which Dr. Braun had served. According to Mr. Welch, this panel was one of many formed by the FDA to review various products. Each panel was charged with determining whether certain products were (1) “generally recognized as safe”; (2) “generally recognized as effective”; and (3) “not misbranded.” Transcript at 1056-61. Although much of Mr. Welch’s testimony about the functioning of the panel paralleled Dr. Braun’s account, Mr. Welch did add several pertinent details. He stated that neither the industry representative, Dr. Braun, nor the consumer representative was allowed to vote, but that the voting members of the Committee solicited their views on all issues. Transcript at 1064. Mr. Welch also described the panel’s requests for information, search of the literature, two symposia, and other efforts at obtaining data on vaginal products. According to Mr. Welch, NIH was aware of the panel’s proceedings and requests for information. Transcript at 1067-77. Quoting from the Committee’s report, Mr. Welch testified that this panel had attempted to evaluate the safety of ingredients found in over-the-counter vaginal products, but found that the available literature contained little information about most of the ingredients under review. Transcript at 1077-78. According to Mr. Welch, based on the available data and the lack of “significant adverse reports,” the panel concluded that the non-ionic surfactants used in spermicides were safe for over-the-counter use. Transcript at 1078. In Mr. Welch’s opinion, despite the panel’s concern about the scarcity of available information, the panel members felt they had sufficient information to reach this conclusion. Transcript at 1083. Moreover, Mr. Welch could recall no suggestion by the panel that spermicides containing non-ionic surfactants should carry a warning concerning teratogenicity or pregnancy. Transcript at 1085-86. Mr. Welch added that other products containing non-ionic surfactant spermicides have since undergone the scrutiny and testing of the FDA’s “New Drug Application” procedure. At least two of these products—a vaginal sponge and a lubricated condom using non-ionic surfactants—have been approved by the FDA without any warning concerning teratogenicity or pregnancy. Transcript at 1087-89. On cross-examination, Mr. Welch testified that at one time “there was a rumor of a report” at NIH that might have been relevant to the Committee's inquiry. He was assigned to obtain a copy of this report for the panel. According to Mr. Welch, upon inquiring about the report, he was informed that whatever the report was, it would not be available during the life of the panel. Transcript at 1103-08. Generally, Mr. Welch was an honest but unimpressive witness. His training was not extensive, nor did his testimony as to the panel’s investigation greatly assist the Court in its findings. L. Dr. Richard N. Watkins Dr. Richard N. Watkins next testified for defendant. Dr. Watkins, a physician who is board-certified in emergency medicine, practices in Seattle with Group Health Cooperative of Puget Sound. He testified that he has participated in several epidemiological studies and was a co-author of the 1981 Jick study, “Vaginal Spermicides and Congenital Disorders.” Dr. Watkins’ testimony focused on how this study had been conducted and on his criticisms of the study. He stated that he had helped obtain approval to use the records of Group Health Cooperative as a data source for the proposed study, had assisted in the collection of the data, and had reviewed between four and eight drafts of the study prior to publication. Transcript at 1118-28. Dr. Watkins explained that the study defined persons as “presumed exposed” to spermicide if the mother had received a prescription for spermicide within eleven months before conception. Dr. Watkins then summarized the study’s findings of major congenital anomalies. Of the total population, four infants had limb reduction defects, and three of these were presumed exposed. Two infants with neoplasms were presumed exposed. Three of four infants with chromosomal anomalies were presumed exposed, as were two infants with hypospadias. Dr. Watkins further observed that the study found no cleft lips, amniotic banding, or eye anomalies among those infants presumed exposed. Transcript at 1124-27. On direct examination, Dr. Watkins testified that the first draft of the study had made him “rather ill at ease” because “there were several problems.” Transcript at 1128. The first, he stated, was the question whether mothers in the “presumed exposed” group actually had used spermicide. Second, he testified that the size of the population was too small. Third, he had reservations that “these disparate conditions were lumped together without assigning causality.” Transcript at 1128-29. Dr. Watkins testified that he voiced his objections to Dr. Jick and to members of Group Health’s medical staff; he recalled that the staff reacted negatively to the study after reviewing it. Subsequently, according to Dr. Watkins, Dr. Jick requested that Dr. Watkins have nothing more to do with the study. Transcript at 1129-34. Dr. Watkins went on to testify that sometime after the study was published, at the request of an employee of defendant he reviewed more closely the records of some of the patients in the study. He stated that, in his opinion, some mothers identified in the study as users of spermicide in fact were not using spermicide. Transcript at 1135-36, 1153. Dr. Watkins concluded that he did “not believe that any reasonable conclusion regarding the association of the use of the spermicides with congenital defects can be drawn” from this study. Transcript at 1156. On cross-examination Dr. Watkins acknowledged that, despite his present criticism of the Jick study, he had been a co-author and had signed his name to the Jick study before it was published in the widely-read Journal of the American Medical Association. Transcript at 1161-62. Dr. Watkins admitted that prior to signing as co-author of the study, he had learned of one instance in which a nurse had discovered that one mother identified by the study as a user of spermicide actually had planned her pregnancy; nonetheless, he signed as co-author. Transcript at 1168. He further admitted that, except for that single instance, he had no other information about “presumed users” being “nonusers” until one or two months before trial, when he investigated the data underlying the study at defendant Ortho’s request. Transcript at 1169. Moreover, Dr. Watkins conceded that although he previously had indicated to certain individuals his concerns about the study’s conclusions, in the almost four years since the study was published he had never before stated these concerns publicly. Transcript at 1170. Finally, Dr. Watkins testified that he was not familiar with the studies by Oechsli, Smith, and Buttar that addressed the potentially harmful effects of spermicides on developing fetuses. Transcript at 1170-71. Because'he had participated in the 1981 Jick study, Dr. Watkins might have been an ideal witness to comment on the validity of its conclusions. Dr. Watkins’ testimony on cross-examination, however, severely eroded his credibility. It is perplexing that a physician would risk his professional reputation by signing his name to a study about which he had serious reservations, especially when he knew the article would be published in a widely-read journal. See Transcript at 1128-35,1161. Moreover, the dispute between Doctors Jick and Watkins, when Dr. Jick requested that Dr. Watkins discontinue work on the study, creates some question about Dr. Watkins’ impartiality. Finally, that Dr. Watkins chose this courtroom as the first public forum in which to repudiate a study that he had helped conduct nearly four years earlier creates further doubt about his credibility. For these reasons, the Court found Dr. Watkins’ testimony not credible. M. Mr. Robert M. Kirsch Defendant also presented as a witness Mr. Robert M. Kirsch, who for the past twelve years has worked for Johnson and Johnson or one of its affiliates. For the past five years, Mr. Kirsch has been in the employ of defendant Ortho Pharmaceutical Corporation, where he presently is Manager of Regulatory Affairs, Advanced Care Products Division. Mr. Kirsch stated that he holds a bachelor’s degree in biology and that his only postgraduate training has been in business. Transcript at 1186-87. Mr. Kirsch testified that his duties with defendant include ensuring that his division complies with federal law and managing his division’s preclinical toxicology testing. He noted that defendant has sold millions of tubes of Ortho products containing non-ionic surfactants, including but not limited to Ortho-Gynol Contraceptive Jelly. Mr. Kirsch observed that Ortho-Gynol Contraceptive Jelly was on the market before the institution of the FDA’s “New Drug Application” procedures, which require that drugs be tested in animals and humans for safety and effectiveness. Nonetheless, he stated that other Ortho products containing the same or similar non-ionic surfactants have been approved by the FDA under these procedures. Transcript at 1181-91. Mr. Kirsch’s area of responsibility at Or-tho is animal testing, and he discussed various tests sponsored by Ortho or by other groups investigating the effects of non-ionic surfactants. According to Mr. Kirsch, these tests, which are described more fully in the footnote below, attempted to measure irritation; toxicity, including carcinogenicity and mutagenicity (i.e., effects on genes and chromosomes); and teratogenicity. Although these tests showed that non-ionic surfactants cause mild to moderate irritation in animals, according to Mr. Kirsch they indicated no toxic or teratogenic effects. Transcript at 1194-1206. Mr. Kirsch testified that he knew of no animal testing that has found a non-ionic surfactant to be a teratogen. When asked if he knew of any studies that indicated that non-ionic surfactants are not teratogens, he mentioned that he had seen abstracts of the Buttar study of embryotoxicity and teratogenicity, which found “no discernible skeletal malformations.” Still, Mr. Kirsch conceded that he had “very little information on the study itself,” “was not familiar with its methodology,” and that therefore it was “difficult for me to assess his results.” Transcript at 1206-09. Mr. Kirsch criticized procedures used in the Chvapil study, which indicated that nonoxynol-9 is absorbed through the vagina. He testified that Ortho had conducted a study that could detect no absorption of nonoxynol-9 through the vagina. Transcript at 1212-14. The testimony of Mr. Kirsch also touched on several aspects of the government’s activities in this area. Mr. Kir