Judge is “Frustrated” With Executive in Bard Transvaginal Mesh Personal Injury Trial
On Thursday, August 8th, Laura Bigby, director of research and development for transvaginal mesh manufacturer CR Bard, was cross-examined by the plaintiff’s lead attorney. She spent three hours dodging questions about transvaginal mesh safety and the validity of the tests Bard conducted on their mesh products.
She dodged questions so many times, in fact, that Judge Goodwin had to order her to directly answer the questions multiple times, sometimes in response to the attorney’s objections to her answers, and sometimes out of his own sheer frustration.
The current bellwether case comes from Donna Cisson, who, like many plaintiffs against transvaginal mesh manufacturers, suffered pain, bleeding, and bladder spasms after the implantation of her transvaginal mesh, which required follow-up surgeries. Her trial initially began on July 8th, but ended in mistrial on July 10th when a witness made mention of CR Bard’s marketing tactics, which Judge Goodwin specifically said was not allowed as testimony during the course of the transvaginal mesh trial.
Fortunately, Cisson’s personal injury bellwether case went back before a new jury, with testimony focusing on court documents stating that the transvaginal mesh manufacturer used a type of plastic in their product that is not fit for use in the human body.
The questions Bigby faced on August 8th dealt with product tests she allegedly oversaw for the transvaginal mesh slings. While on the stand, she took exception with nearly every question asked.
However, lead attorney Henry Garrard stayed focused. According to court documents, CR Bard did not properly test their transvaginal mesh on humans before marketing them to surgeons. Allegedly, Bigby and her team tested the product on cadavers, which could not truly replicate how such a device would interact with moving muscle and tissue.
Garrard asked point-blank of Bigby thought the cadaver studies were enough to simulate the stress a living body would put on the transvaginal mesh devices, to which Bigby responded, “It simulates the conditions, yes.”
Garrard continued: “So you had no functional testing of the entire Avaulta Plus model as it would be used in humans?”
“We did not believe it was necessary to do that,” Bigby said.
Bard Expert Witness Denies Degradation of Transvaginal Mesh
In 2004 and 2007, emails filed in a federal court in West Virginia show that an executive from Davol warned colleagues not to tell the plastics manufacturer that the transvaginal mesh company was using the material, despite warnings, in medical devices to be implanted in humans.
“Do not use this Phillips Sumika Polypropylene Co. material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues,” according to the warning. It continued: “Do not use this Phillips Sumika Polypropylene Co. material in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues unless the material has been provided directly from Phillips Sumika Polypropylene Co. under an agreement that expressly acknowledges the contemplated use.”
After Bigby’s testimony, an expert witness on polymer science, Maureen Reitman, was called to the stand. She disclosed that Bard paid her and her company to study the polypropylene mesh and determine if oxidation or degradation of the material could cause the transvaginal mesh side effects described by so many plaintiffs.
Reitman said that the Bard transvaginal mesh devices were usually implanted with a biofilm – in this case, the film was comprised of natural biological substances in Cisson’s body, so the device would be more compatible with her biology.
“Every piece of data I collected showed a biofilm,” she said. “The polypropylene itself is not degrading.”
The Strom Law Firm Fights for Women in Transvaginal Mesh Personal Injury Cases
Transvaginal mesh kits were initially produced to help with pelvic organ prolapse and stress urinary incontinence. Several varieties of mesh kits exist, but transvaginal mesh specifically was supposed to produce less scarring and pain, because the procedure was less invasive. However, vaginal mesh slings can cause a host of problems, including organ perforation, infection, internal scarring, continued organ prolapsed, and bleeding. If you or a loved one has pelvic organ prolapse or stress urinary incontinence, have had a transvaginal mesh device implanted, and have since experienced detrimental complications, you may be entitled to compensation. The experienced lawyers at Strom Law, LLC can help. We offer free consultations, so please contact us today, and we can help get you on the road to recovery. 803.252.4800