Lawsuit Alleges Bard Knew Its Device Was Unsuitable for Use in Humans

Richmond, WVA lawsuit filed against CR Bard Inc, concerning the company’s Avaulta mesh product, alleges that the company knew that the transvaginal Avaulta mesh implant was not fit for use in humans, but sold the product anyhow. The lawsuit, which resulted in a mistrial, is set to go before the court again at the end of July, and alleges patients were harmed by the use of the Bard Avaulta mesh.

Bloomberg (7/26/13) reports that unsealed court documents suggest that Bard’s Davol subsidiary was warned by Chevron Phillips Chemical Co. - maker of the resin-based plastic used in the transvaginal mesh - that the plastic should not be used as a permanent implant in patients. But e-mails sent in 2004 and 2007 suggest executives at Davol encouraged the use of the plastic without telling Chevron Phillips executives that they were doing so.

Lawsuits concerning the Avaulta mesh allege Bard improperly tested its product and did not adequately warn patients about potential risks. They allege patients suffered serious harm, including mesh adhesion to the vaginal walls, requiring multiple surgeries to remove the mesh and repair internal damage. Transvaginal mesh is used to treat stress urinary incontinence and pelvic organ prolapse but can allegedly erode, causing severe pain, internal bleeding and organ damage.

The first federal lawsuit to go to trial involves plaintiff Donna Cisson, with three more bellwether trials scheduled. But Cisson’s lawsuit, which started in June 2013, ended in a mistrial after a judge found that testimony from an expert was improper and unlikely to be disregarded by a jury. The expert, Dr. Lennox Hoyte, reportedly testified that mesh implants are no longer sold or implanted, proof in his opinion that the Avaulta Plus mesh was not a good product. But according to Businessweek (7/10/13), the judge had previously ruled that Bard’s withdrawal of the Avaulta products could not be mentioned during the lawsuit. The new trial will begin on July 29.

Several claims made in Cisson’s lawsuit have been dismissed, according to The Herald-Dispatch (7/15/13), including claims of manufacturer’s defect.

A California lawsuit against Bard involving the Avaulta Plus implant resulted in an award of $3.6 million.

Bard is not the only transvaginal mesh company to face lawsuits alleging transvaginal mesh was defectively designed. Boston Scientific, Johnson & Johnson and other companies also face similar lawsuits.

The Bard lawsuits are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 2:10-md-02187, and Cisson v. C.R. Bard Inc., 2:11-cv-00195, U.S. District Court, Southern District of West Virginia (Charleston).