How then did Ortho lose a case in which the trial judge, sitting as the trier of fact, declared that overall the studies failed to show that the spermicide caused any or all of Katie Wells’ birth defects? First, let’s look at the liability case to the extent it depended upon scientific evidence up to the time of actual use of the product by the mother.
State of the Art
The state of the art in 1980 was based in large measure on 30 years of marketing experience.
The plaintiffs’ expert witnesses relied upon a limited number of papers and studies that could have been the basis for a determination that defendant had “knowledge,” actual or constructive, that the product caused birth defects of the type experienced by Katie Wells.
According to the court, the articles cited by some of the plaintiffs’ expert witnesses, in support for a warning on or before November 1980, suggested “the possibility of such a risk” from spermicides. 615 F. Supp. at 294. The studies themselves did not claim that there was a “known” causal relationship between spermicides and any birth defects, let alone the kind of malformations found in Katie Wells. Furthermore, the plaintiffs’ hired expert witnesses did not assert that any of the articles from this time period permitted such a conclusion.
A larger problem loomed in the interpretation of the early studies and papers. Along with non-ionic surfactants, phenylmercuric acetate (PMA) (and also phenylmercuric nitrate) was used in spermicidal preparations. There was some concern over the use of mercury compounds, which had known animal teratogenicity. See FDA OTC Panel on Contraceptive and Other Vaginal Drug Products, Summary minutes of the fourth meeting November 18-19, 1973 (Adopted January 1974). The Panel noted that a report was presented on phenylmercuric acetate (PMA), as a spermicidal agent and active ingredient of some vaginal contraceptive preparations. The report failed to find evidence of adverse effects on women or on human embryos, but it did note that teratogenic effects had been observed in animal experiments.
1. R. Belsky, “Vaginal contraceptives–a time for reappraisal?” Population Reports: Series H – Barrier Methods 37 (Jan. 1975). This appears to be a review article, and none of the witnesses attributed any data or conclusions emanating from the paper. The court described this article, as urged by some of plaintiffs’ hired experts to support a basis for warning on the product sold by Ortho and used by Katie Wells’ mother in 1980. The alleged concern about spermicides is not specified as relating to non-ionic or mercury preparations.
2. Frank W. Oechsli, Studies of the Consequences of Contraceptive Failure (Apr. 8, 1976) (unpublished study). According to the court, this study was the “Final Report for Contract NO1-HD-5-2816” for the Contraceptive Evaluation Branch, Center for Population Research, National Institute of Child Health and Development. The court reports that plaintiffs’ expert witnesses cited this unpublished study as a basis for the defendant’s need to warn.
The elephant on the table for the Oechsli manuscript was why it was never published. The plaintiffs’ expert witnesses sang the praises of NIH investigators, but obviously these investigators never thought that their work was sufficiently important or valid to publish and share with the medical and scientific community. The lead author of this unpublished study, Frank W. Oechsli, has 17 publications listed in PubMed, none of which address potential associations between congenital malformations and spermicide use.
The availability of the Oechsli unpublished study to Ortho, before 1980, was disputed. Plaintiffs and their witnesses argued that Ortho could have obtained it by way of a FOIA request, and that it was cited in the Harlap article, infra, which was published in March 1980. One of plaintiffs’ witnesses colorfully described Ortho as “asleep at the wheel” for not having obtained the unpublished paper. 615 F. Supp. at 277.
The defendant offered undisputed factual testimony that the NIH told the FDA Advisory Committee, considering safety and efficacy of non-ionic spermicides, that the study would not be available during the work of the Committee, which concluded in 1978. 615 F. Supp. at 280. The NIH was aware that the FDA Committee was meeting, but never otherwise offered to share the unpublished Oechsli study. In 1978, the FDA Committee presented its final report to the FDA. The Committee report, which classified non-ionic surfactants as safe, effective, and properly labeled, for use as spermicidal preparations. Id. at 279.
In any event, Dr. Buehler, one of plaintiffs’ hired experts, described the Oechsli study as raising a “question and possible relationship” between spermicides and birth defects. Although the defense had raised the problem of confounding with PMA, which was known to be teratogenic in animals, the court never disambiguated the plaintiffs’ broad brush references to “spermicides,” which could have referred to non-ionic compounds, mercury compounds, or both, in Oechsli’s study, as well as other of the early studies.
3. S. Harlap, P. Shiono, S. Ramcharan, “Spontaneous foetal losses in women using different contraceptives around the time of conception,” 9 Internat’l J. Epidem. 49 (1980). The plaintiffs’ expert witnesses cited the Harlap study only because it referenced the Oechsli study. Harlap, et al., however, reported that their data were contrary to those of the unpublished Oechsli study: “Previous reports [citation to Oechsli] of an excess risk associated with spermicides are not borne out by this study.” Id. at 56.
4. E. S. Smith, C.S. Dafoe, J.R. Miller, P. Banister, “An epidemiological study of congenital reduction deformities of the limbs,” 31 Brit. J. Prev. & Social Med. 39 (1977). This study did evaluate limb deformities, and compared many different maternal exposures among cases and controls, using a chi-squared analysis. With two control groups combined, the chi-square was marginally significant for contraceptive foam or jelly, but no correction was made for the multiple comparisons. The authors noted that this exposure, foam or jelly, involved some products that were known to be teratogenic in animals (mercury compounds).
5. Warburton, Environmental Influences on Rates of Chromosome Anomalies, American Journal of Human Genetics – ABSTRACT (1980). One of the plaintiffs’ witnesses relied upon this abstract, which identified spermicides as a possible factor in spontaneous abortions. Dr. Holbrook suggested that this finding might mean that spermicides were teratogenic as well. The completed paper, however, failed to confirm the suggestion in the Warburton abstract. 615 F. Supp. at 284.
The court found that at the time Katie Wells used Ortho’s product in fall of 1980, Ortho was negligent in failing to warn about an increased risk of birth defects that “might” arise from use of the product. 615 F. Supp. at 294 (emphasis added). Various article and studies suggested “the possibility of such a risk” in this time period. Id. (emphasis added).
The court relied heavily upon plaintiffs’ witnesses’ distorted testimony on this point. For instance, Dr. Dick Gourley, testifying for the plaintiffs, opined 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,” a labeled warning should be provided. Id. at 276. Dr. Gourley thus testified that Ortho should have warned about 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.” Id. Judge Shoob found Gourley “undogmatic,” and thus very credible! Dr. Gourley not only offered opinions that did not conform to the legal standard, he offered opinions based upon his own personal, subjective, ethical and emotive feelings. 615 F. Supp. at 277 n.19. Unlike the treatment of defense experts who possibly strayed outside their fields of expertise, Judge Shoob regarded testimonial frolic and detours, such as Dr. Gourley’s to reflect their emphatic, and confident testimony. Id.
The court similarly appeared to embrace plaintiffs’ expert witness, Dr. Sutherland, who opined that Ortho’s warnings were inadequate on grounds of the Oechsli unpublished paper (1976), and the Smith (1977) study, which together raised a “serious potential” that “spermicides increase the risk of fetal injury.” 615 F. Supp. at 274. Remarkably, Judge Shoob did not require the plaintiffs to address, and to present evidence of, the spermicide at issue, or the specific congenital malformation at issue. The plaintiffs’ witnesses’ testimonies, as summarized by Judge Shoob, refer to possibilities, potentials, and hints of broad, ill-defined fetal harms, but this was held sufficient to satisfy plaintiffs’ burden of showing actual or constructive knowledge. Having conflated hunches with knowledge, the court concluded that:
“This knowledge gave rise to a duty by defendant to warn consumers and certain health professionals of this possible risk.”
Id. at 294.
How did Ortho lose the state of the art issue? Ortho lost when Judge Shoob allowed:
- hints and hunches to substitute for knowledge;
- obscure or unpublished papers to substitute for peer-reviewed, published, data-based, carefully analyzed studies;
- that the evidence no longer had to relate to Ortho’s product, but could include another product, which contained a mercury compound known to cause birth defects in animals;
- any fetal harm to substitute for the relevant congenital malformations; and
- exculpatory opinions, including those of the FDA’s Advisory Committee, to be excluded from consideration.
(to be continued)