Decided: January 14, 2016
The Fourth Circuit affirmed the district court on all issues.
This case arose from a lawsuit that Donna Cisson (“Cisson”) filed against C.R. Bard, Inc. (“Bard”), after she received a transvaginal mesh and suffered complications from the surgery. Her suit was added to others that had been filed against Bard, and the jury found for Cisson on the design defect and failure to warn claims and for Bard on the consortium claims. Bard appealed.
The Fourth Circuit begins by first examining Bard’s abuse of discretion claim concerning the district court’s decision to exclude Bard’s evidence that it had complied with the FDA’s 510(k) process. The Court affirmed the ruling based on Federal Rule of Evidence 403. It looked to Georgia’s “risk-utility” test, stating that the “probative value of that evidence must depend on the extent to which the regulatory framework safeguards consumer safety.” The Court then determined that the weight of other courts’ opinions on this issue favored finding that the evidence Bard proffered had little evidentiary value, and concluded that the district court had not abused its discretion by excluding the evidence of the 501(k) clearance, because the district court had found that introducing such evidence would have resulted in “very substantial dangers of misleading the jury and confusing the issues.” The Court next turned to the issue of whether the district court erred when it “overruled Bard’s hearsay objections to the admission of a MSDS pertaining to polypropylene.” Although the Court reversed the district court’s rulings about the hearsay exceptions, it affirmed the decision to admit the evidence as non-hearsay. Cisson argued that the MSDS was used to show that Phillips made the warning statement and that Bard received it. The Court then turned to the issue of whether the district court erred in its instruction to the jury on causation. The Court found that the district court’s instruction met the appropriate standard, that it was “accurate on the law and did not confuse or mislead the jury,” and that there was ample evidence for the jury to base its causation finding. The district court defined the burden of proof for proximate cause as a preponderance of the evidence in accordance with Georgia’s pattern jury instruction, and the Court found that Bard did not submit any evidence that this standard was incorrect. Furthermore, the Court found that Cisson presented ample evidence that supported a jury finding that the design defect in the mesh caused her injuries, including numerous expert and non-expert testimonies. Next, Bard argued that the damages award in this case were constitutionally excessive. The Court looked at the three guideposts that the Supreme had set forth for reviewing the constitutionality of punitive damages awards, and noted that Bard challenged based entirely on the second guidepost, because the punitive award was seven times the compensatory award. The Court, however, found that it was not constitutionally excessive, and declined to adopt a bright-line ratio rule.
Finally, the Court examined Cisson’s cross-appeal that challenged the district court’s ruling that a Georgia split-recovery statute did not violate the Takings Clause of the Fifth Amendment to the United States Constitution. However, the Court found that Cisson failed to provide proper support for her theory that she had a vested property interest in the entire punitive damages award. Therefore, the Fourth Circuit affirmed the district court on all issues raised in the appeal.