Bard Avaulta Mesh Implant Device Case Ends in Mistrial

bard_mesh_lawsuit_mistrialA federal judge declared a mistrial yesterday in a personal injury lawsuit against medical device maker C.R. Bard over its Avaulta transvaginal mesh device, according to court documents.

Judge Joseph Goodwin declared a mistrial during the second day of the trial, MassDevice reports. A witness referred to Bard’s marketing of its transvaginal mesh devices, although the judge had barred any reference to Bard’s decision to pull the product off the market last year.

A new trial is scheduled to begin July 29. Bard faces thousands of lawsuits over its transvaginal mesh devices. This case is one of four selected as bellwether cases in multidistrict litigation of the suits. The outcome of bellwether cases is important in indicating trends in litigation and can provide a basis for negotiating a settlement.

Plaintiffs in the suits allege that transvaginal mesh implants caused serious, often permanent, injuries. The mesh implants are intended to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) by providing support to internal organs.

Late last month, Goodwin unsealed Bard emails showing that the company ignored manufacturer’s warnings that the plastic used in its transvaginal mesh devices was unsuitable for implantation in humans, according to MassDevice. Bard executives sought to conceal this use of the plastic from its manufacturer, a division of Chevron Phillips Chemical Co., records show.

In a 2004 email, Roger Darois, vice president of research at Bard subsidiary Davol, wrote that the resin manufacturers likely “do not know of our implant application. Please do NOT mention Davol’s name in any discussions with these manufacturers.”

The U.S. Food and Drug Administration (FDA) estimates that in 2010 some 300,000 women had pelvic organ prolapse surgery and mesh implants were used in about a third of the procedures, according to Bloomberg News. The FDA said about 80 percent of 2010 incontinence surgeries used transvaginal mesh implants. Last year the FDA ordered Bard, J&J, and other mesh device makers to undertake three-year studies of rates of organ damage, infection, and painful intercourse allegedly linked to the mesh implants.




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