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Bard Loses $2 Million Verdict in Vaginal-Mesh Trial

C.R. Bard Inc. was told by a jury to pay $2 million to a woman who alleged the company hid flaws within some of its vaginal-mesh implants in the first federal trial of claims over the devices.

Jurors in Charleston, West Virginia, deliberated about 12 hours over two days before finding Murray Hill, New Jersey-based Bard liable for injuries Donna Cisson blamed on its Avaulta line of devices. The jury awarded $250,000 in compensatory damages for Cisson’s injuries plus $1.75 million in punitive damages.

Bard, based in Murray Hill, New Jersey, still faces more than 8,000 other claims over its Avaulta devices, which Cisson and other women allege can cause organ damage and make sexual intercourse painful when the devices erode. Johnson & Johnson, Endo Health Solutions Inc. and Boston Scientific Corp. face similar claims that their implants, threaded in place through vaginal incisions, shrink over time.

“This jury sent a message that Bard needs to change its ways,” Henry Garrard, one of Cisson’s lawyers, said after the punitive-damages verdict was announced. “The jury is telling them this kind of conduct won’t be tolerated.”

Bard officials said they dispute the jury’s finding that Cisson’s injuries were caused by the vaginal implant and will appeal.

‘Compelling Grounds’

“We disagree with the verdict reached by the jury and believe there are compelling grounds for reversal. We will appeal,” Scott Lowry, a Bard spokesman, said yesterday in an e-mailed statement. “Our Avaulta mesh products are safe and effective medical devices, cleared by the FDA.”

Bard fell 1.7 percent to $133.47 in New York Stock Exchange composite trading. The shares have gained 16 percent this year.

The implant cases against Bard and other manufacturers have been consolidated before U.S. District Judge Joseph Goodwin in Charleston for pretrial information exchanges. Goodwin, who presided over Cisson’s case, also will preside over an Aug. 19 trial. Two other trials are set for next month.

Bard officials pulled the Avaulta implants off the market last year after the U.S. Food and Drug Administration ordered all makers of the devices to study rates of organ damage, infection and pain during sex linked to their products.

A California state court jury last year found Bard liable for a woman’s injuries tied to an Avaulta implant in the first case to go trial in any U.S. court. Jurors ordered the company to pay $5.5 million in damages. Bard is liable for only $3.6 million of that award under state law.

Mesh Removed

Cisson, a public-health nurse from Toccoa, Georgia, got an Avaulta Plus implant in 2009 to buttress organs that were collapsing into her pelvic region, according to evidence in the case. Cisson had several surgeries to remove the mesh after she began suffering pain, bleeding and bladder spasms.

Her lawyers argued during the two-week trial that Bard officials put profits ahead of safety by ignoring warnings about defects in the Avaulta implants.

Bard officials knew the company was making the implants out of plastic which carried a warning that it shouldn’t be permanently implanted in humans, Garrard, an Atlanta-based lawyer, told jurors.

“You have not heard Bard come here and say we accept responsibility and want to make amends,” Garrard told jurors in the punitive-damages phase of the case. He urged them to return an award that would “get the attention” of the company’s executives in New Jersey.

‘No Intent’

Bard’s lawyer countered that company officials properly designed and manufactured the implants and had shown “no intent to harm” Cisson or other women with the mesh.

The company “complied with industry standards” in producing the implants and didn’t deserve to be punished, Lori Cohen, one of Bard’s lawyers, told jurors.

Jurors found that Bard officials defectively designed the Avaulta implants and failed to properly warn doctors and women about the mesh’s flaws. They also found that company officials’ mishandling of the devices amounted to “malice, fraud or wantonness” that deserved punishment, according to the verdict form in the case.

“The economic cost of ignoring patient safety just got a little more expensive,” Paul Farrell Jr., a Huntington, West Virginia-based lawyer representing Cisson, said after the verdict was announced.

Under Georgia law, 75 percent of Cisson’s $1.75 million punitive-damages award will be handed over to the state’s general fund.

Cisson’s first trial, in July, ended in a mistrial after a witness began testifying about the devices’ marketing and removal from the market. Goodwin ruled earlier that plaintiffs couldn’t mention Bard had withdrawn the products.

The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 10-md-02187, and Cisson’s case is Cisson v. C.R. Bard Inc., 11-cv-00195, U.S. District Court, Southern District of West Virginia (Charleston).

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