July 25, 2012 — C.R. Bard, the manufacturer of the Avaulta vaginal mesh, has been ordered to pay a woman and her husband $5.5 million in damages for vaginal mesh side effects. The landmark judgement is the first vaginal mesh lawsuit to go to trial. Approximately 650 vaginal mesh lawsuits are currently pending, and women continue to contact vaginal mesh lawyers due to serious injuries caused by the devices.
The plaintiff, Christine Scott, was an avid runner who got the implant in 2008 to treat incontinence. The device began eroding into her colon and tissue has grown through holes in the mesh. She has undergone eight surgeries to correct the complications. Scott said, “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.”
After four years of legal battles, Scott’s case went to trial in Bakersfield, California. The jury found that Bard officials were negligent in testing the products before putting them on the market. Later research would show that the device could erode into tissues, cause severe pelvic pain, and permanent complications.
Elaine Houghton, Scott’s attorney, 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.” According to Gene Lorenz, another lawyer representing Scott, “They advertised it as FDA-approved. It’s not. It’s a crime.”
The jury agreed, and awarded Scott $5 million in damages. They also awarded her husband $500,000 for loss of consortium.
Bard officials said they were disappointed in the jury’s verdict. According to Michael Brown, attorney for C.R. Bard, “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 has vowed to appeal the jury’s decision.
Despite the imminent appeal, Scott says she is happy that her court-ordered silence is over, and now she can raise awareness about the severe side effects of vaginal mesh. She and her husband plan to start a support group and a website for women injured by vaginal mesh side effects.
As word spreads, it is likely that the litigation will continue to grow. The Securities and Exchange Commission (SEC) estimates that 47,000 women have been implanted with the Bard Avaulta device. Hundreds of thousands of women have other vaginal mesh, tape, or slings. There are currently 650 vaginal mesh lawsuits pending.
Earlier this year, the Judicial Panel on Multidistrict Litigation (JPML) consolidated nationwide vaginal mesh lawsuits under U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia. Attorneys are currently gathering evidence against four manufacturers — C.R. Bard, Boston Scientific Corp., American Medical Systems, and Johnson & Johnson. The first trial is set for February 5, 2013.
The U.S. Food and Drug Administration (FDA) has also issued several announcements about vaginal mesh side effects, but has issued no recalls. In August 2011, the devices were re-classified as “high-risk,” and the FDA warned that serious complications are “not rare.” The agency also ordered 31 manufacturers to conduct safety studies regarding the risk of organ damage and long-term complications. It will be another three years before those studies are complete.
Instead of conducting the studies, some manufacturers have decided to stop selling vaginal mesh. Johnson & Johnson recently halted sales of all four of its vaginal mesh devices. Bard stopped selling the Avaulta mesh in 2012, after the FDA demanded more clinical trials. Both companies claim their decisions were not prompted by safety concerns, but declining sales and the expense of clinical trials.
Do I have a Vaginal Mesh Lawsuit?
The Schmidt Firm, PLLC is currently accepting vaginal mesh induced injury cases in all 50 states. If you or somebody you know has been injured by vaginal mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Vaginal Mesh Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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