On July 8, 2013, the U.S. District Court in Charleston, W.Va., started the first bellwether jury trial in the C.R. Bard, Inc. Multidistrict Litigation (MDL). Bard manufactures transvaginal mesh products. Not long after the beginning of the trial, the trial judge declared a mistrial. After opening statements and the testimony of at least one witness, a physician then testified inadvertently that the manufacturer (Bard) was no longer selling this type of mesh product, which was at issue in the case.
The court declared the mistrial because the testimony violated a pretrial order that prohibited evidence of a subsequent remedial measure. The case was restarted again in mid-August, but this time the jury returned a $2 million verdict for the injuries suffered by Donna Cisson, a public-health nurse from Georgia. She received the Bard Avaulta Plus implant in 2009. Jurors deliberated for 12 hours over two days before reaching their verdict. The vaginal mesh implant is made by Bard. Bard’s attorneys have said on the record that the company intends to appeal the verdict ($250,000 in compensatory damages and $1.75 million in punitive damages), which they say was wrong because Cisson’s injuries were not caused by Bard’s product.
The transvaginal mesh products are used in surgical procedures to repair conditions in women that have pelvic organ prolapse and stress urinary incontinence. Bard has removed its Avaulta Plus implant product off the market in 2012 after the FDA ordered that all makers of these implant products review reports of organ damage, infection and pain during sex.
Pelvic organ prolapse happens when a pelvic organ, like a bladder, drops or prolapses from its normal location in the lower belly and pushes against the walls of a woman’s vagina. This could happen when the muscles that hold the pelvic organs in place become weak or stretched after childbirth. This condition can be painful or uncomfortable. It is not usually a health problem, but it can become worse over time. In some cases, the treatment is conservative with exercise and weight loss. In others, surgery becomes necessary using the transvaginal mesh to support the organs in place.
Additionally, stress urinary incontinence is the involuntary leaking of urine associated with an increase in abdominal pressure that can be caused by straining, physical activity, coughing or sneezing.
In July 2011, the FDA issued a safety update concerning “serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse.”
Most of the reported complications dealt with erosion of the mesh material or contraction of mesh material. Both of these defects in the mesh can lead to severe pelvic pain or painful sexual intercourse. Other complications include organ perforation, bleeding, urinary incontinence and infection, which can lead to additional surgeries.
These cases will continue in the multidistrict litigation process. There were also similar lawsuits pending against Johnson & Johnson, Boston Scientific and Endo Health Solutions, Inc. related to their manufactured implants that have been known to cause severe health issues for women because of the product degrading and shrinking over time. In the Cisson case, her lawyers argued that Bard knew well that the plastic-based implants should not be permanently implanted in the body.
The FDA has reported that the use of the transvaginal placement of surgical mesh has put women at a greater risk for pelvic organ prolapse mesh complications than with other surgical procedures. Complications include mesh erosion, bleeding, urinary problems, vaginal scarring, infection and pain during sex.
In 2012 a California jury found Bard responsible for a woman’s injuries related to an Avaulta implant. The jury’s verdict of $5.5 million was reduced by California state law to $3.6 million. There are other defective vaginal mesh implant cases awaiting trials around the country.
Donna Cisson, et al. v. C.R. Bard, Inc., No. 2:11-195, S.D.W. Va.
Kreisman Law Offices has been handling medical device defect cases, such as vaginal mesh implant defects, for individuals and families who have been harmed, injured or died as a result of the carelessness or negligence of a medical provider for more than 37 years in and around Chicago, Cook County, Illinois and its surrounding areas, including Bensenville, Schaumburg, Rolling Meadows, Evanston, Wilmette, Richton Park, Elmwood Park, Elmhurst, Chicago (Roscoe Village, Bridgeport, Canaryville, East Chatham, Albany Park) and Vernon Hills, Ill.
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