Wells v. Ortho Pharmaceutical Corp.

• Decision Date: 06 May 1986
• Docket Number: No. 85-8683,85-8683
• Citation: 788 F.2d 741
• Parties: Prod.Liab.Rep.(CCH)P 10,997 Katie Laurel WELLS, et al., Plaintiffs-Appellees, v. ORTHO PHARMACEUTICAL CORPORATION, Defendant-Appellant.
• Court: U.S. Court of Appeals — Eleventh Circuit

Page 741

788 F.2d 741

Prod.Liab.Rep.(CCH)P 10,997

Katie Laurel WELLS, et al., Plaintiffs-Appellees, v. ORTHO PHARMACEUTICAL CORPORATION, Defendant-Appellant.

No. 85-8683.

United States Court of Appeals Eleventh Circuit.

May 6, 1986.

Robert L. Pennington, Atlanta, Ga., Barry L. Shapiro, Marc S. Klein, Newark, N.J., for defendant-appellant.

James C. Simmons, Jr., Atlanta, Ga., for plaintiffs-appellees.

Appeal from the United States District Court for the Northern District of Georgia.

Before GODBOLD, Chief Judge, VANCE, Circuit Judge, and THOMAS ^*, Senior District Judge.

VANCE, Circuit Judge:

Defendant Ortho Pharmaceutical Corporation ("Ortho") appeals a $5.1 million judgment in favor of plaintiffs Katie Laurel Wells, an infant, Mary Maihafer, her mother, and Gary Wells, her father, under theories of negligent failure to warn and strict liability. The case concerns a spermicide manufactured by Ortho that allegedly caused Katie Wells to be born with birth defects. After reviewing the extensive factual record we affirm with respect to Ortho's liability but modify the amount of damages.

I. Factual Background

Katie Laurel Wells was born on July 1, 1981 with birth defects including deformity of her right hand, the complete lack of a left arm with only partial development of her left clavicle and shoulder, a cleft lip, and nostril deformity. A later diagnosis showed that she also has an optic nerve defect in her right eye. The plaintiffs alleged that these birth defects were caused by a spermicidal jelly used by the mother for approximately four weeks after conception until she discovered that she was pregnant. ¹ 1] The spermicidal jelly used by Mary Maihafer, in conjunction with a diaphragm, was manufactured and marketed without a prescription by Ortho. Called Ortho-Gynol Contraceptive Jelly ("Ortho-Gynol"), this vaginal spermicide has as its active ingredient a non-ionic surfactant known as Octoxynol-9. ² The Ortho-Gynol label and package insert in 1980 contained only this warning--the spermicide might cause irritation to the female or male genitalia, is not 100 percent effective, and should be kept out of the reach of children.

Plaintiffs brought suit against Ortho alleging that Ortho-Gynol caused Katie Wells' birth defects, that Ortho negligently failed to warn that its spermicide could cause serious birth defects, and that Ortho's failure to warn proximately caused the birth defects. Plaintiffs sought damages for Katie Wells' pain and suffering, medical expenses and disability, as well as Mary Maihafer's emotional distress and lost wages. The parties waived a jury, and the district court tried the case from January 1 through January 22, 1985. The district court found that plaintiffs had proven to a reasonable degree of medical certainty that the birth defects of Katie Wells' left arm and shoulder and her right hand were proximately caused by Ortho's product, but found otherwise with respect to her cleft lip, nostril deformity and right optic nerve defect. The district court also found that Ortho knew or should have known that its product might cause birth defects. Damages were awarded exceeding $5.1 million. ³ Ortho later moved to reopen the trial for the consideration of two new scientific studies, but the district court denied this motion.

II. Discussion

In this appeal we must examine the district court's factual findings under the clearly erroneous standard. In our review we are guided by Anderson v. City of Bessemer City, --- U.S. ---, 105 S.Ct. 1504, 84 L.Ed.2d 518 (1985), in which the Supreme Court stated:

"In applying the clearly erroneous standard to the findings of a district court sitting without a jury, appellate courts must constantly have in mind that their function is not to decide factual issues de novo." Zenith Radio Corp. v. Hazeltine Research, Inc., 395 U.S. 100, 123, 89 S.Ct. 1562, 1576, 23 L.Ed.2d 129 (1969). If the district court's account of the evidence is plausible in light of the record viewed in its entirety, the court of appeals may not reverse it even though convinced that had it been sitting as the trier of fact, it would have weighed the evidence differently. Where there are two permissible views of the evidence, the factfinder's choice between them cannot be clearly erroneous.

Anderson, --- U.S. at ---, 105 S.Ct. at 1511-12.

A. Causation

Defendant Ortho argues that plaintiffs failed to prove causation to a reasonable degree of medical certainty. See Robertson v. Emory University Hospital, 611 F.2d 604, 608 n. 13 (5th Cir.1980); Parrott v. Chatham County Hospital Authority, 145 Ga.App. 113, 243 S.E.2d 269, 270 (1978). Ortho asserts that the district court made a clearly erroneous finding of fact concerning causation and that this finding derives from a clearly erroneous fact-finding methodology. Ortho complains that despite the inconclusive nature of the scientific and medical studies introduced, the district court erroneously held that plaintiffs carried their burden of proof regarding causation. Ortho argues that the district court's findings based on the oral testimony of plaintiffs' experts should be set aside because those findings are not based on opinions with scientifically reliable foundations. In Ortho's estimation plaintiffs failed to focus sufficiently on epidemiology--the field of science dealing with the relationships of the various factors which determine the frequencies and distributions of certain conditions and diseases in human populations. ⁴ Ortho asserts that epidemiological studies should be relied on to provide the essential data to formulate an opinion on causation. Ortho also challenges the district court's credibility choices in analyzing both sides' experts.

After reviewing the record we reject Ortho's arguments and conclude that the district court's finding of causation is not clearly erroneous. We note that plaintiffs presented well qualified experts who testified at length concerning causation. ⁵ These experts relied on their particular areas of expertise, their personal examinations of the child (at least by Dr. Buehler and Dr. Sutherland), and medical and scientific studies relative to causation to conclude that Ortho-Gynol caused Katie Wells' birth defects. Plaintiffs presented several epidemiological studies that indicated an association between spermicide use and deleterious effects on the fetus. ⁶ Plaintiffs noted various studies relative to absorption suggesting that absorption of the spermicide by the mother produced vascular disruption in the fetus that led to the birth defects. ⁷ The district court turned to the oral testimony of the various expert witnesses to resolve conflicts in the studies presented by each side. The court stated that it "found the studies to be inconclusive on the ultimate issue of whether the Product caused Katie Wells' birth defects." In facing this "battle of the experts," the district court was thus forced to make credibility determinations to "decide the victor." ⁸ Ferebee v. Chevron Chemical Co., 736 F.2d 1529, 1535 (D.C.Cir.), cert. denied, --- U.S. ---, 105 S.Ct. 545, 83 L.Ed.2d 432 (1984).

We recognize, as did the Ferebee court, that

a cause-effect relationship need not be clearly established by animal or epidemiological studies before a doctor can testify that, in his opinion, such a relationship exists. As long as the basic methodology employed to reach such a conclusion is sound, such as use of tissue samples, standard tests, and patient examination, products liability law does not preclude recovery until a "statistically significant" number of people have been injured or until science has had the time and resources to complete sophisticated laboratory studies of the chemical.

Id. at 1535-36. The district court properly noted that "its ultimate focus was the birth defects suffered by Katie Wells. Plaintiffs' burden of proving that Katie Wells' defects were caused by the Product did not necessarily require them to produce scientific studies showing a statistically significant association between spermicides and congenital malformations in a large population." As the D.C. circuit noted in Ferebee, a distinction exists between legal sufficiency and scientific certainty. Id. at 1536. If the factfinder here is convinced that plaintiffs have proven to a reasonable degree of medical certainty, which is the legal standard employed in this case, that Ortho-Gynol caused Katie Wells' arm, shoulder and hand defects, it does not matter in terms of deciding the case that the medical community might require more research and evidence before conclusively resolving the question. What matters is that this particular factfinder found sufficient evidence of causation in a legal sense in this particular case, and that that finding is not clearly erroneous.

B. Failure to Warn

Ortho next argues that the district court's liability finding based on Ortho's negligent failure to warn is clearly erroneous. Ortho contends that the district court misinterpreted Georgia law on the duty to warn, that the court's finding lacks substantial evidence in the record, and that the court improperly failed to consider two FDA review panels' determinations that no warning is necessary for non-ionic surfactant spermicides. We reject Ortho's arguments and conclude that the district court's finding concerning Ortho's negligent failure to warn is not clearly erroneous.

Georgia law states that a manufacturer has a duty to warn of non-obvious foreseeable dangers from the normal use of its product. Rhodes v. Interstate Battery System, Inc., 722 F.2d 1517, 1519 (11th Cir.1984); Kicklighter v. Nails by Jannee, Inc., 616 F.2d 734, 740 n. 4 (5th Cir.1980). If a manufacturer has actual or constructive knowledge of potential dangers of a product, the manufacturer must warn purchasers at the time of sale and delivery. Id.; Beam v. Omark Industries, Inc., 143 Ga.App. 142, 237 S.E.2d 607, 610 (1977). Properly applying Georgia law, the...