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C.R. Bard Inc. and a doctor must pay a total of $5.5 million in damages over a vaginal-mesh implant that left a woman incontinent and in chronic pain, a jury ruled in the first case over the devices to go to trial.
Jurors in state court in Bakersfield, California, concluded July 20 that Christine Scott and her husband deserved the damage award because of injuries caused by Bard’s Avaulta Plus vaginal implant, Elaine Houghton, one of the couple’s lawyers, said in a phone interview yesterday.
The panel found Bard officials were negligent in their handling of the devices, used to treat pelvic organs that bulge, or prolapse, or to deal with incontinence, she said.
“They seemed to focus on evidence we produced showing that Bard didn’t properly test the product before putting it on the market,” Houghton said. The lawyer said she asked jurors to consider awarding as much as $11 million in damages to the couple over the implant.
The case is the first to go to trial among hundreds of lawsuits alleging that implants made by Murray Hill, New Jersey- based Bard, Boston Scientific Corp. (BSX) and other companies caused organ damage. The decision comes more than a month after Johnson & Johnson (JNJ)’s Ethicon unit announced it would stop selling four lines of vaginal mesh devices.
In its verdict, the California jury found Bard was 60 percent at fault for Scott’s injuries while Dr. Tillakarasi Kannappan, who surgically implanted the device in 2008, was responsible for the other 40 percent of the liability, according a copy of the verdict sheet filed with the court.
Bard officials said yesterday they were disappointed with the jury’s decision to hold the company liable over the implants and would appeal.
“While we empathize with the complications suffered by the plaintiff, those complications are not the fault of any conduct by the company,” Scott Lowry, a Bard spokesman, said in an e- mailed statement.
“We believe the evidence establishes that our Avaulta mesh products, cleared by the FDA, are safe and effective and provide significant benefits to patients,” Lowry said.
Dennis Thelen, a lawyer representing Kannappan, didn’t immediately return a call seeking comment today on the jury’s verdict in the implant case.
A U.S. Food and Drug Administration report in August 2011 found vaginal-mesh products should be classified as posing high risk to patients based on a review of side-effect reports from January 2008 to December 2010. Women’s groups are demanding that the devices be recalled.
In January, the FDA ordered 31 manufacturers, including Bard and J&J, to study rates of organ damage and complications linked to the vaginal-mesh implants. The companies must conduct three years of safety studies, regulators said. Some women contend the devices eroded and shrank over time, causing pain and injuries.
The following month, the Judicial Panel on Multidistrict Litigation consolidated federal suits against pelvic mesh makers before U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia. The judge is overseeing evidence-gathering efforts in cases against Bard, J&J, Boston Scientific Corp. and the American Medical Systems unit of Endo Pharmaceutical Holdings Inc.
The first trial in those cases is set for Feb 5 and involves a woman’s claim that one of Bard’s Avaulta implants injured her, according to court filings.
“We view this verdict as a promising outcome that underscores the compelling case against the mesh makers and promoters,” Fred Thompson, a lawyer for women whose implant cases are consolidated in federal court in West Virginia, said in an e-mailed statement.
In the California case, Houghton said Scott got the implant in 2008 and then had to have as many as nine surgical procedures to deal with problems the device caused.
“The evidence showed the implant eroded and caused incontinence and pelvic pain,” said Houghton, a former Washington state appeals court judge who tried the case with her husband, Bakersfield attorney Eugene Lorenz.
As part of their verdict, the jurors found Bard officials knew or should have known that surgeons “performing pelvic- floor repair would not realize the potential risks” posed by the implant, according to verdict sheet.
Jurors wound up awarding $5 million to Scott for her medical expenses and pain and suffering along with $500,000 to her husband, Roy, a detective with the Kern County Sheriff’s Department, for loss of consortium with his wife, according to the verdict sheet.
The case is Scott v. Kannappan, S-1500-CV-266034-WDE, Superior Court for Kern County, California (Bakersfield).
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