Pharmaceutical

Bard exec dodges questions about transvaginal mesh testing

vaginal mesh sling Bard exec dodges questions about transvaginal mesh testingA C.R. Bard executive repeatedly dodged questions presented by the lead plaintiffs’ attorney in the first transvaginal mesh case to go to trial, frustrating U.S. District Judge Joseph R. Goodwin, who is overseeing the giant body of litigation in a federal West Virginia court.

Plaintiff Donna Cisson, 55, filed a personal injury lawsuit against C.R. Bard, alleging its Bard Avaulta Plus Posterior BioSynthetic Support System mesh device caused extensive injuries and pain after she had it implanted in May 2009 to correct a form of pelvic organ prolapse. Her case was selected to be tried first out more than 23,000 other cases against transvaginal mesh device manufacturers consolidated into multidistrict litigation (MDL) in West Virginia. More than 4,000 of those cases name C.R. Bard as a defendant.

According to Drugwatch, Judge Goodwin’s temper flared when C.R. Bard executive Laura Bigby took the stand and repeatedly sidestepped questions during cross examination. Many of the questions Ms. Bigby tried to dodge concerned whether C.R. Bard ever tested the Avaulta mesh in living humans before marketing and selling it to women and their physicians nationwide.

“From the stand, Bigby took exception with nearly everything presented by [attorney Henry Garrard], from the results of clinical trials reported in scientific peer-reviewed journals to the phrasing of the questions themselves,” Drugwatch reported. “Garrard repeatedly highlighted the fact that Bard never conducted a clinical trial of Avaulta products in humans before marketing them to surgeons.”

C.R. Bard said that it had tested the device in humans, but rather than in live patients, the company used cadavers. When pressed about the effectiveness of testing the product in a non-functioning human, without the normal stresses of movement and pressure on muscle and tissue, Ms. Bigby became argumentative and continued to evade the questions.

Ms. Bigby’s testimony prompted Judge Goodwin to demand that she answer the questions being asked.

“So you had no functional testing of the entire Avaulta Plus model as it would be used in humans?” Mr. Garrard asked.

“We did not believe it was necessary to do that,” Ms. Bigby replied.

Other manufacturers of transvaginal mesh in the multidistrict litigation include Boston Scientific, Cook Medical Inc., Coloplast Corp, and Ethicon (a unit of Johnson & Johnson).

Source: Drugwatch