Bard Avaulta Injury Case Ends in Mistrial; Is Rescheduled for Later This MonthJul 11, 2013
Although a C.R. Bard Avaulta transvaginal mesh case just ended in a mistrial, the new jury trial is scheduled for July 29, 2013.
Federal Judge Joseph Goodwin granted Bard's motion to dismiss, court documents indicate, according to MassDevice.com. The mistrial was called on the second day of the trial after a witness referred to the way in which C.R. Bard marketed the Avaulta device. Judge Goodwin previously barred any reference to the device maker’s decision to pull the Avaulta product off of the market in 2012, according to MassDevice.com. "I don’t think it’s a bell that can be unrung," Goodwin said, according to Bloomberg News. "It would be very difficult for the jury to disregard."
This case is one of four bellwether cases selected for a multidistrict litigation (MDL) from the thousands of lawsuits brought against Bard over the Avaulta, according to MassDevice.com.
Bard Inc. has been accused of selling vaginal mesh devices constructed of a plastic that its manufacturer warned was not fit for humans, according to unsealed court records. The resin-based compound is manufactured by a unit of Chevron Phillips Chemical Co. and was used by Davol, a Bard unit, in the manufacture of hernia repair mesh. This, after Chevron Phillips registered a warning that the material should not be used for permanent implantation in humans, Bloomberg News reported, citing emails and documents in a lawsuit involving the Bard devices. Plaintiffs say the plastic mesh was used in some vaginal mesh devices manufactured by Davol. It was Judge Goodwin who unsealed the internal Bard emails, noted MassDevice.com.
"IMPORTANT ... these suppliers will likely not be interested in a medical application due to product liability concerns," Roger Darois, a vice president of research at Bard subsidiary Davol, wrote in a 2004 email, according to MassDevice.com. "We purchase our polypropylene monofilament from an extrusion supplier who purchases the resin directly from the resin manufacturers. Thus, it is likely that they do not know of our implant application. Please do NOT mention Davol's name in any discussions with these manufacturers. In fact, I would advise purchasing the resin through a 3rd party, not the resin supplier to avoid a supply issue once the medical application is discovered."
Darois emails raise "a genuine issue of material fact about whether Bard was aware its conduct was practically certain to cause injuries," Goodwin wrote, according to the documents.
Attorneys representing thousands of women who have brought lawsuits over Bard’s Avaulta implant line say the documents show that Davol officials knew the resin-based mesh was inappropriate for human implantation and attempted to cover up its use of the dangerous material, according to Bloomberg News. The emails are dated from 2004 and 2007. Bloomberg News also reports that Roger Darois, who is now a vice president at Bard was then a Devon executive.
"During the upcoming trial, Bard will provide all the relevant evidence for the jury to consider and render a decision, which will demonstrate that Bard acted appropriately in its acquisition of polypropylene resin," Bard vice president Scott Lowry said in an email last month, according to MassDevice.com. "We believe that the Avaulta polypropylene mesh implant is a safe and effective treatment for pelvic organ prolapse when used in accordance with its instructions."
Transvaginal mesh devices were approved to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP)—conditions most commonly caused by weakened pelvic muscles—by providing additional strength to the pelvic walls. The U.S. Food and Drug Administration (FDA) reports that the most common complications associated with transvaginal mesh surgery may include: Mesh erosion through the vagina (exposure, extrusion, or protrusion), pain, infection, bleeding, dyspareunia (pain during sexual intercourse), and organ perforation. A 2011 FDA safety alert also indicated that complications associated with vaginal mesh implants are “not rare” and use of these mesh devices may be more harmful when compared to other treatment methods.