Bard Executives Hid Vaginal-Mesh Device Flaw, Lawyer Says
CR Bard Inc. (BCR) 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 (JNJ), Endo Health Solutions Inc. (ENDP) and Boston Scientific Corp. (BSX), 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.
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).
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