Court Affirms District Court’s Judgment on All Issues in Transvaginal Mesh Appeal

Court Affirms District Court’s Judgment on All Issues in Transvaginal Mesh Appeal

Case Date: 01/14/2016

IN RE: C.R. BARD

United States Court of Appeals for the Fourth Circuit

In August 2013, a jury awarded Donna Cisson $250,000 in compensatory damages on a design defect and failure to warn claim against C.R.  Bard, Inc. (“Bard), a proprietor of transvaginal mesh medical devices. The jury awarded Cisson an additional $1,750,000 in punitive damages, to be split pursuant to a Georgia statute.

On appeal, Bard challenged the district court on multiple issues: First, the Court addressed whether the district court had abused its discretion by granting Cisson’s motion in limine,asking the court to exclude evidence that Bard had complied with the FDA’s 510(k) process. The Court affirmed the district court’s ruling based on Federal Rule of Evidence 403, for being substantially more prejudicial than probative, called the 510(k) procedure “of little or no evidentiary value,” and noted, Bard’s evidence would have initiated a battle of experts.

Next, the Court addressed whether the district court erred when it overruled Bard’s hearsay objections to the admission of a MSDS pertaining to polypropylene, a material used in the construction of the transvaginal device. The Court affirmed the decision to admit the evidence as non-hearsay, finding that any use of the evidence by Cisson that went beyond the limited purpose for which it was admitted resulted in harmless error and was not prejudicial to Bard’s defense.

Third, the Court addressed whether the district court erred in its instruction to the jury on causation, and affirmed the district court’s ruling. Bard argued Georgia law requires injury causation be proved by “expert testimony stated to a reasonable degree of medical probability or certainty.” The Court found Bard incorrectly stated the standard of proof applicable in the present case, and attempted to insert the standard for medical malpractice cases into a product liability case. The Court noted, under Georgia product liability case law, a plaintiff need only show that “the device did not operate as intended and this was the proximate cause of [the plaintiff’s] injuries.”

Finally, Bard argued the punitive award was constitutionally excessive. The Court found the seven-to-one ratio of punitive v. compensatory damages was not excessive, particularly in light of the reprehensibility of Bard’s misconduct, which resulted in Cisson’s injuries.

In a cross-appeal, Cisson argued the district court committed constitutional error by failing to find the Georgia split-recovery statute violates the Takings Clause. The Court found Cisson failed to articulate a viable theory in support of her contention she had a vested property interest in the entire punitive damages award. Accordingly, the Court affirmed the judgment of the district court.

Submitted By: Neil, Dymott, Frank, McFall, Trexler, McCabe & Hudson APLC


This summary was posted on January 19, 2016 on The Federation of Defense & Corporate Counsel hot cases list.

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