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Jury Finds Bard Mesh Defective and Awards Plaintiff $2 Million in First Federal Trial

Defective Medical Devices

The entire trial took just 11 days.

Donna Cisson sued C.R. Bard Co. of New Jersey, maker of the Avaulta Plus transvaginal mesh implanted in her in 2009 to treat pelvic organ prolapse.

Courtesy of WikiCommons and EraSoft24 Last week, the jury awarded the 55-year-old Cisson $250,000 in compensatory damages and $1.75 million in punitive damages due to her pain and ongoing complications that a removal surgery.

This is the third jury trial that alleged defective transvaginal mesh, but the first time the jury has determined that polypropylene mesh is defective. Of the other two trials – one was in California state court naming the Bard Avaulta mesh. The jury there awarded plaintiff Christine Scott. $3.6 million in damages. Last February in New Jersey state court, the jury awarded Linda Gross $11.1 million in damages over an Ethicon transvaginal pelvic organ prolapse mesh implant. That includes a punitive award of $7.76 million.

Both jury awards are on appeal.

The Cisson trial was the first one to be heard in federal court where about 28,000 cases against six mesh manufacturers have been consolidated before Judge Joseph R. Goodwin in Charleston, West Virginia.

In the Cisson case the jury concluded the Avaulta Plus mesh, used to treat pelvic organ prolapse, was defective, not only in its design, but in inadequate instructions to her implanting physician. The jury did not award any damages to Mr. Cisson for loss of consortium or companionship of his wife.

Donna Cisson said at the conclusion of the trial she does not know how many surgeries lie ahead. After a partial removal surgery, she still has 22-inches of plastic mesh remaining in her pelvic region.

Meanwhile she is in constant pain and had difficulty sitting during the trial.

“I’ll spend the rest of my life in pain… my body’s a ticking a time bomb,” the 55-year-old nurse reportedly said to Drugwatch.

Bard’s general counsel, Greg Dadika, issued a statement, “We disagree with the verdict reached by the jury and believe there are compelling grounds for a reversal and will appeal and continue to vigorously defend against all of the lawsuits regarding this product.”

Bard may want to wait. Altogether there are four jury trials lined up back-to-back naming Bard and all alleging defects with its Avaulta line of meshes. If the company continues to face multi-million dollar awards, it may decide that a string of appeals is a waste of its time and could crunch the numbers and decide instead to offer a settlement.

By the way, the company removed the Avaulta mesh from the market last year around the time of its loss in the California case. It’s also be a good coincidence that the Food and Drug Administration in January had ordered Bard and about 32 other mesh manufacturers to conduct three years of post-monitoring on women implanted with their mesh products.

Facing a million dollars worth of research over a questionable product that has lost two trials to date, and the company figured the risk/ benefit analysis was not in its favor. It removed the Avaulta mesh from the market and in doing so removed the FDA requirement to conduct any post-approval monitoring. The FDA essentially let Bard off the hook.

Those women don’t know if they too are implanted with a ticking time bomb and the FDA will not require Bard to find out.

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Posted By: Michael Geoffroy