January 10, 2013 ~ Johnson & Johnson was on the defense this afternoon in the trial of a South Dakota woman who claims she is in perpetual pain due to defective transvaginal mesh (TVM).
Linda Gross, 47, from Watertown, South Dakota is represented by New Jersey-based attorney Adam Slater in the first of more than 1,900 cases filed there against Ethicon, a division of Johnson & Johnson (J&J).
Slater told jurors Gross has had 18 operations to try and repair the damage caused by the Gynecare Prolift polypropylene mesh she was implanted with in July 2006. Gross suffered from prolapse of her rectum into her vagina, called a rectocyle.
Courtroom View Network provided a video stream to MDND. Slater made reference to Gross who was standing in the back of the courtroom because she is unable to sit for any period of time. That makes it impossible for her to continue to work as a nurse, he told jurors. Even with early industry studies showing a failure rate of from 12 to 20 percent, that didn’t stop Ethicon from selling the defective mesh, he said.
“Let me tell you what they did after they failed, they acted as if nothing had happened,,, “They knew every single catastrophe before it happened…They knew Linda Gross was going to happen,” Slater told jurors.
Bypassed FDA Clearance
In 2005 Prolift was new on the market as a pre-cut kit complete with implant devices used to place the mesh through cuts in the groin area.
While any medical device is supposed to receive clearance to sell by the Food and Drug Administration (FDA) before it is marketed, Slater told jurors this new mesh was sold with no clearance.
“They went through the guidance documents and they decided was there was no significant difference between the Gynemesh and the Prolift so they didn’t need to do it. You’re going to hear they acted in good faith,” said Slater.
When Ethicon sought clearance for the next generation of transvaginal mesh, the Prolift +M, it cited the Prolift as a “predicate device,” one substantially equivalent. Under the 510(k) clearance procedure within the FDA, one need only cite a similar predicate to gain approval for most medical devices. It was then that the FDA discovered Prolift had been sold with no clearance. The FDA granted the Prolift approval in 2008, three years after it was sold, with no sanctions imposed.
“Would a reasonable doctor use a device that requires FDA clearance that doesn’t have it!? Of course not,” he said adding that the company never studied how to remove a mesh gone wrong.
Linda Gross had a series of pelvic surgeries to shore up her pelvic floor including sutures and her native tissue, so in 2006, when she was told the next generation of mesh would be an answer for her, she researched it. Gross found the Ethicon Prolift brochure online and saw the promises – it was revolutionary with a low rate of complications, it said.
“It’s not that they didn’t warn, they didn’t warn adequately,” about a defective device and the rate of complications. “You will be astounded at what they knew,” Slater promised.
By the afternoon, Ethicon attorney Christy D. Jones of the Butler, Snow law firm of Jackson Mississippi countered,“ The fact is Ethicon warned of potential complications associated with Prolift surgery from day one!”
With a mature voice and slightly southern accent,she assured jurors that at age 41, when she had the implant surgery, Gross already had medical problems. She had given birth to three children and two of which were difficult births; she had suffered stress urinary incontinence from 1990 to 2001, experienced pelvic organ prolapse after her hysterectomy and had problems defecating due to a bulging rectum. A number of surgeries involving native tissue and sutures had failed to resolve her problems. Jones added that any additional repairs using weakened tissues would likely have failed too.
“That’s the condition Ms. Gross was dealing with every time when she went to see her doctor in 2006. That’s the condition for which she got the Prolift.”
Jones told jurors polypropylene had safely been used in the body for over 50 years glossing over the fact that polypropylene was used to treat hernias, not in a woman’s pelvic region. Mesh is associated with a 95 percent success rate, she said, pointing to an “anatomic cure.”
An anatomic cure means the pelvic organs are back in their original place, but many mesh injured women argue that is not a cure if they are in chronic pain.
Even though she told jurors earlier in her opening argument that she had great sympathy for Ms. Gross, Jones went on to say that as a surgical nurse Gross understood the complications that can come from surgery.
“She had worked in a surgical suite and treated a patient who had hernia mesh repair. She was familiar with the potential complications.”
Jones added that even without mesh the medical literature is full of evidence of erosion, pelvic adhesion, dyspareunia, fistula formation and foreign body reaction, all before Prolift was marketed in 2005.
“For our purposes now I want you to simply know the proof will show Prolift never caused anything that wasn’t expressly warned about that Dr. V and Ms Gross were not expressly aware of in 2006.”
Last June, Johnson & Johnson announced it would remove the Prolift and three other vaginal meshes from the market. It continues to sell the Gynecare Gynemesh with a new, redesigned label. One year ago, the FDA ordered 35 mesh manufacturers to study the effects of synthetic mesh on patients. Many of those study plans are overdue, according to the FDA website.