July 25, 2012 — A jury has ordered C.R. Bard, the manufacturer of Avaulta vaginal mesh, to pay Christine Scott and her husband $5.5 million in damages because the device caused serious long-term complications. The highly-anticipated verdict is the first Avaulta vaginal mesh lawsuit to go to trial. More than 650 additional lawsuits are currently pending in federal court, and women continue to contact vaginal mesh lawyers seeking compensation and justice for their vaginal mesh injuries.
Scott was an avid runner who suffered from urinary incontinence. She decided to get the Avaulta vaginal mesh back in 2008. Shortly thereafter, the device eroded into her colon, and tissue began growing through the holes in the mesh. This caused serious complications, and Scott was forced to undergo eight surgeries. She says, “I don’t know if I’ll have ten surgeries now. I don’t know if I’ll have one. I don’t know if I’ll have 100. The doctors cannot tell me.”
Scott contact a vaginal mesh attorney and filed a lawsuit. After four years of litigation, her lawsuit went to trial. A jury in Bakersfield, California found that C.R. Bard was negligent in failing to conduct adequate studies or warn about the risk of side effects. After Bard’s Avaulta mesh was implanted in tens of thousands of women, researchers would discover it could cause severe complications — including erosion of the device into nearby tissues or organs, scarring, nerve damage, disfigurement, pelvic pain, and other permanent side effects.
One of Scott’s attorneys, Elaine Houghton, said, “They tested this on 12 rats, 16 rabbits, four sheep and, by their own researcher’s admission, the next living being this product went into was women.” Gene Lorenz, another vaginal mesh lawyer representing Scott, said, “They advertised it as FDA-approved. It’s not. It’s a crime.”
The jury agreed with Scott’s vaginal mesh lawyers. The jury found C.R. Bard responsible for Scott’s injuries, and ordered the company pay her $5 million in damages. The jury also awarded Scott’s husband $500,000 for loss of consortium.
Attorneys for C.R. Bard were disappointed in the verdict. Michael Brown, one of the attorneys representing C.R. Bard, said, “This is a product that has been cleared for use by the FDA and can be safe and effective when used properly and for the right patient.” Bard plans to appeal the jury’s decision.
Although Bard will likely appeal the judgement, it is still good news for Scott. Now that the litigation is over, she is no longer required to remain silent about her case. She has vowed to immediately start a support group and a website to raise awareness about severe vaginal mesh side effects.
It is likely that the number of vaginal mesh lawsuits will continue to grow. The Securities and Exchange Commission (SEC) has estimated that nearly 50,000 women were implanted with the Avaulta vaginal mesh before Bard voluntarily recalled it earlier this year. Hundreds of thousands of women have been implanted with other brands of vaginal mesh, tape, or slings. Approximately 650 vaginal mesh lawsuits have already been filed, but as word spreads about the litigation, the number is likely to grow.
The Judicial Panel on Multidistrict Litigation (JPML) consolidated hundreds of vaginal mesh lawsuits earlier this year, under U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia. Four different vaginal mesh manufacturers are involved in the litigation: C.R. Bard, Johnson & Johnson, American Medical Systems, and Boston Scientific Corp. The first trial has been slated for February 5, 2013.
As the number of vaginal mesh lawsuits continues to climb, the U.S. Food and Drug Administration (FDA) has issued several announcements but has not forced any manufacturers to recall the devices. In August, 2011, the FDA reclassified vaginal mesh as a “high-risk” medical device, ordered 31 manufacturers to conduct a three-year safety study, and warned that serious complications are “not rare.”
Some manufacturers have decided to stop selling vaginal mesh instead of conducting the studies. Johnson & Johnson has stopped production of all four of its vaginal mesh products. C.R. Bard has also stopped production of the Avaulta vaginal mesh. Both companies claim that their decisions had nothing to do with growing safety concerns, but rather declining sales and the expense of clinical trials.
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