HACKENSACK, N.J. (Legal Newsline) – Attorneys for the plaintiff and defendant jousted again over the issue of whether a pelvic mesh implant intended to treat a sagging bladder was the cause of damage to a woman’s body, or whether it was her own arthritic condition that caused her alleged pain.
Streaming video coverage of the trial was provided to Legal Newsline by Courtroom View Network.
Mary McGinnis of North Carolina sued C.R. Bard in New Jersey Superior Court in Bergen County. Her lawsuit faulted the New Jersey company for its Avaulta and Align pelvic mesh implant devices for causing inflammation and resulting scar tissue after the implants contracted and changed shape.
The result, the suit states, was excruciating pain, a loss of mobility, pain with sexual intercourse, and the cost of several surgeries to remove the mesh.
The mesh appears like clear plastic and comes in a box in kit form. It is made of polypropylene. During testimony, doctors said they clip off the "arms" of the mesh as much as possible to reduce the size of the device inside the body. A contention of the prosecution from the start has been that the implant was too big, provoking McGinnis’ body to try and expel it by the formation of stiff scar tissue and resulting in alleged pain.
In addition, McGinnis’ suit said C.R. Bard officials ignored warnings of the potential danger of the implant devices and offered them on the market beginning in 2007 without proper background study.
During the April 4 session, Adam Slater - of Mazie, Slater, Katz & Freeman in Roseland, New Jersey and McGinnis’ attorney - questioned a witness for the defendant, Dr. Sharon Lee Mount, a Vermont-based pathology specialist. He asked if the reaction of McGinnis’ body to the implant caused her pain.
“You expected a foreign body response that included the formation of fibrotic tissue on and across the mesh?” Slater asked.
“That’s correct,” Mount said.
“You’re saying that what happened to Mary McGinnis was a normal, expected reaction, right?” Slater asked.
“That’s correct,” Mount said.
“Bard had to know that when they put this mesh into women’s bodies that what happened to Mary McGinnis was going to happen, right?” Slater asked.
“Could you explain?” Mount asked.
“The bridging of scar tissue between the fibers, the encapsulating of the mesh, and whatever happened to Mary (McGinnis) as a result, that’s what they expected, right?” Slater asked.
“I can’t answer that question,” Mount said.
“The mesh contracts with the remodeling of the scar tissue, right?” Slater asked.
“Correct,” Mount said.
“As it contracts, it contracts the mesh down with it, correct?” Slater asked.
“There is wound (from surgery) contraction,” Mount said.
The attorney for C.R. Bard, Lori Cohen of Greenberg Traurig, questioned Dr. Thomas Bradbury, an orthopedic surgeon from Atlanta, Georgia. A projected opinion display read that McGinnis’ condition was not caused by the mesh implant, but by an osteoarthritic condition that predated the implant and caused groin, hip, pelvic, thigh and lower back pain.
Reviewing film of the woman’s pelvic condition taken in July 2007, Bradbury said it was not normal.
“Impingement in the hip is significant enough to cause the damage we’re seeing from the arthritis,” he said.
Additional films showed disc narrowing. Bradbury agreed such a condition was degenerative in that it gets worse over time.
“I think she has arthritis that can provide the hip and groin pain,” Bradbury said.
Bradbury ventured that in McGinnis’ case, he would not have recommended further surgery but orthopedic nonoperative treatments instead.
“Then if those failed, I would consider surgery,” he said.