HACKENSACK, N.J. (Legal Newsline) – A jury trial has begun in the lawsuit of a woman suing the manufacturer of a medical pelvic mesh device that was implanted in her transvaginal region to support a sinking bladder but instead allegedly caused her chronic pain.
Plaintiff Mary McGinnis, 62, a resident of North Carolina, alleged in her suit in New Jersey Superior Court in Bergen County that C.R. Bard, a Murray Hill, New Jersey-based manufacturer and marketer of medical implant devices, sold the Avaulta and Align products used in her implant, knowingly ignoring the dangers the devices would cause.
During the trial, which opened on March 19, McGinnis’ attorney Adam Slater of the New Jersey law firm of Mazie, Slater, Katz & Freeman of Roseland, New Jersey, told the jury that patient safety in the case should have come first.
“A medical business is in business to make money, but profit should not come before safety,” Slater told the jury, according to video provided by Courtroom View Network. “They (C.R. Bard) came to a lot of stop lights but went through them.”
The Avaulta device is clear plastic in appearance and looks somewhat like a jelly fish with long, thin arms. It was alleged during the proceeding that chemicals in the polypropylene-made device caused the vaginal tissue to become inflamed, that the device was too large and the body's cells launched protective attacks to try and expel the device, resulting in damaged and scarred tissue.
“The body reacts to it,” Slater said. “Cells attack the foreign invader. Scar tissue forms and the reaction is permanent.”
In addition, Slater alleged that the device constricted, becoming taut after the implant operation on McGinnis in March of 2009, causing chronic vaginal and rectum pain. He stated the device is very difficult to remove. McGinnis had surgeries after the implant to remove it and eventually journeyed to California, Slater said, at her own expense to have needed vaginal reconstruction.
He alleged that officials at C.R Bard were more interested in promoting and selling the implant to patients and doctors than they were in recognizing the dangers and failed to warn patients properly. He added that adequate studies of the device beforehand had not been done.
“C.R. Bard knew in September of 2008 the mesh was dangerous,” Slater said. “They needed to do a clinical study. That’s another reason not to sell this stupid thing.”
On March 22, Dr. William R. Welch, a surgical pathologist who evaluates tissue specimens called as a witness for the plaintiff, described a projected slide photo demonstrating McGinnis’ type of tissue injury as a “severe inflammation” during testimony.
Welch was asked if this is this normal tissue.
“Not at all,” he responded. “It’s very hard and brittle. A certain amount of fibrous tissue is acceptable. But not to this degree.”
Under cross-examination by Cliff Merrell, defense attorney with Greenberg Traurig LLP of Miami representing C.R. Bard, Welch agreed there was usually some sort of complication with implanting any mesh device.
“You’ve never done any academic work concerning mesh?” Merrill asked.
“That’s correct,” Welch responded.
“You’ve never done any surgery concerning mesh correct?”
“That is correct,” Welch said.
Jonathan Conta, former senior products manager at C.R. Bard who left the company in 2008 and whose testimony was projected on a screen in the courtroom, said he was responsible from a marketing standpoint for selling the pelvic products including what was called the Avaulta Classic device.
He stated he was aware of the possibility of side effects, including chronic pain and vaginal erosion, from the product.
Questioned about a lack of clinical data on the product Conta said, “Any product marketer would want as much clinical data as they could get, and I always wanted more.”
Dr. Elizabeth Barbee, a Raleigh, North Carolina, gynecologist who performed the implant on McGinnis, said the training she received from C.R. Bard in April of 2007 and March of 2008 to implant the devices included practice on a human cadaver.
She said she took into account the risks associated with the procedure and believed that C.R. Bard had data that the procedure was a long-lasting solution to McGinnis’ condition.
“Did you think the potential adverse reaction would lead to a catastrophic condition that couldn’t be safely and effectively treated?” Barbee was asked.
“No,” she said.
Barbee testified she advised patients that any company literature advertising a product was bound to have some bias minimizing potential side effects and that it was very important for patients to know the potential side effects and the worst-case scenario.
Under cross-examination from Lori Cohen, also a defense attorney with Greenberg Traurig, Barbee denied the device had improperly rolled or curled into the wrong position during the implant procedure.
“Do you agree there are risks associated with any medical device or surgery?” Cohen asked.
“Yes,” Barbee answered.
Barbee also agreed that such mesh devices were recognized worldwide as treatment for urinary incontinence and were referred to as the "gold standard" for such treatments in 2009.
Additional medical testimony from physicians was taken on March 23.
Streaming video coverage of the trial was provided to Legal Newsline by Courtroom View Network.