By Doug Allen
The first federal lawsuit that claims transvaginal mesh harmed patients will begin again today in U.S. District Court for the Southern District of West Virginia, in Charleston. That court is managing nearly 23,000 cases claiming the mesh devices caused serious and painful complications.
The plaintiff, Donna Cisson of Georgia, alleges the mesh device Avaulta Plus, manufactured by C.R. Bard Inc., caused bleeding and internal pain, and required several surgeries to remove. Attorneys for Cisson claim that the company that made the plastic used to manufacture the device warned Bard it was not designed for permanent implantation in humans, but Bard executives ignored the warning.
Court proceedings to hear Cisson’s suit originally began in early July, but stopped when the judge presiding over the case declared a mistrial on the second day of testimony. While Cisson’s trial will focus on the Bard device, a number of other medical device companies face similar lawsuits in the same court, including Boston Scientific, Cook Medical and Johnson & Johnson subsidiary Ethicon.
This lawsuit is one of more than 3,300 federal claims against Bard relating to mesh devices. Cisson’s suit is a bellwether for the cases yet to be heard.
First Trial Ends in Mistrial
U.S. District Judge Joseph R. Goodwin presided over the first trial in mid-July. During testimony, Dr. Lennox Hoyt stated that no doctors implant the devices anymore, and no companies sell them. Defense attorneys immediately called for a mistrial, claiming the statement was prejudicial to the jury.
Goodwin had previously ruled that Bard’s withdrawal of the device from the market could not be referenced during the trial. Attorneys for Cisson argued that a jury instruction to disregard the testimony was sufficient, but Goodwin ultimately disagreed.
“Because I don’t think it’s a bell that can be unrung,” Goodwin said. “And I want to say this in the context of, to my knowledge, never declaring a mistrial in a civil case in nearly 20 years on the bench, I think it would have been very difficult for the jury to disregard it.”
Goodwin said that presenting the jury with complicated Food and Drug Administration (FDA) rules and regulations would only serve to confuse the jury more.
“It is my belief that a so-called curative instruction would simply have made the problem worse and focused the jury’s attention more on the fact that nobody, even though that’s not true, nobody is using mesh products,” he said.
Transvaginal mesh is a net-like device created to fix pelvic organ prolapse (POP) and stress urinary incontinence (SUI). “Transvaginal” refers to the procedure used to implant the device, which is done through the vagina.
POP occurs when a woman’s pelvic muscles weaken and the bladder, rectum and/or uterus drop into the vagina. The mesh was designed to serve as a hammock beneath the organs, holding them in their proper place.
SUI occurs when a woman’s bladder leaks during normal physical activity. The mesh was designed to support the urethra and prevent leakage.
Although designed to help women, transvaginal mesh has been found to cause serious complications. Transvaginal mesh surgery is less invasive than other treatments for pelvic floor disorders, but it has a much higher complication rate.
The mesh can erode or pass through the vaginal wall. After erosion occurs, the mesh can perforate other organs. Other complications can include bleeding, painful sexual intercourse and vaginal scarring.
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Doug Allen is a freelance reporter based in Aspen, Colo. His work has appeared in local and national print and radio outlets, including The Washington Post and Aspen Public Radio. His opinion column, “Culture Shock,” appears every Friday in the Aspen Daily News.