Bard Executives Hid Vaginal-Mesh Device Flaw, Lawyer SaysJef Feeley
CR Bard Inc. officials knew some of the company’s vaginal-mesh devices were made of a plastic deemed unsuitable for human implantation and hid that flaw from doctors and women who used the products, a lawyer said.
Executives of a Bard unit made implants for shoring up pelvic muscles out of plastic that carried a warning saying it shouldn’t be permanently implanted in people, Henry Garrard, a lawyer for a woman suing over the devices, told a jury in federal court in West Virginia.
The warning by the plastic’s manufacturer “was a red flag to Bard, but they just went on by it and ignored it,” Garrard told jurors in the first federal-court trial of lawsuits over the company’s Avaulta line of vaginal inserts. Doctors and women such as Donna Cisson would have shunned the mesh if they had known about the warning, he said in opening statements in the trial of Cisson’s case.
Bard, based in Murray Hill, New Jersey, faces at least 3,600 claims over its Avaulta Plus vaginal mesh, which Cisson and other women allege can cause organ damage and make sexual intercourse painful when the devices erode. Other implant makers, such as Johnson & Johnson, Endo Health Solutions Inc. and Boston Scientific Corp., face similar claims that their products, threaded in place through vaginal incisions, degrade and shrink over time.
Many of those cases have been consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia, for pretrial information exchanges. Goodwin is presiding over Cisson’s case. A five-woman, three-man jury began hearing evidence in the two-week trial today.
Cisson, a public-health nurse from Toccoa, Georgia, got an Avaulta Plus implant in 2009 to buttress organs that were collapsing into her pelvic region, Garrard said. The 55-year-old Cisson had several surgeries to remove the mesh after she began suffering pelvic and rectal pain, bleeding and bladder spasms.
Bard’s lawyers contend Cisson’s vaginal-mesh device was properly designed to reinforce failing pelvic muscles and produced from the same plastic used in medical devices and procedures for the last 50 years.
The plastic is “a time-tested material” relied upon by manufacturers of products ranging from sutures to heart devices, Lori Cohen, one of Bard’s attorneys, told jurors in her opening argument. Cisson’s suit is a “lawyer-driven attack on a medical device that functioned properly,” she said.
Bard officials decided to pull the Avaulta line of implants off the market last year after the U.S. Food and Drug Administration ordered all makers of the devices to study rates of organ damage, infection and painful sex linked to their products.
Cisson’s lawyers contend Bard officials ignored research showing plastic implanted in the human body creates a higher risk of erosion and infection and improperly relied on animal testing to decide if the mesh would be safe for women.
The company intentionally ignored a warning from a unit of Chevron Phillips Chemical Co., which made the mesh-implant’s plastic, that cautioned the material shouldn’t be used in “medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues,” Garrard told jurors.
To protect their supply of mesh plastic, Bard officials warned each other in e-mails not to allow Chevron Phillips executives to learn they were using the material in human implants, Garrard added
“Bad decisions led to the development of a bad device,” he added.
Cohen countered the warning by Chevron Phillips officials was inserted into safety reports about the plastic solely “to avoid getting sucked into” lawsuits against medical-device makers.
Bard did extensive testing on the Avaulta line of vaginal inserts prior to putting the products on the market and the devices treat medical ailments that can be “life altering,” Cohen said.
The company’s lawyer also said Cisson’s doctors implanted a Bard product designed to treat urinary incontinence that was made out of the same plastic as the vaginal device.
“They’ve said there’s been no problem” with the urinary implant, Cohen added.
The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 2:10-md-02187, and Cisson’s case is Cisson v. C.R. Bard Inc., 2:11-cv-00195, U.S. District Court, Southern District of West Virginia (Charleston).