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February 12, 2013~ On this last day of evidence presented in the Linda Gross v. Ethicon trial in New Jersey Superior Court both sides took the opportunity to make a final impression on the jury. For the defense that meant to cement the testimony of urogynecologist, Dr. Elizabeth Kavaler, who examined Ms. Gross in preparation for her role as a defense witness.
Monday the doctor testified it was her opinion that Linda Gross suffers chronic pelvic pain due to the number of pelvic surgeries she endured after the Prolift was placed in to treat prolapse in July 2006 and not the polypropylene implant itself.
Today she recounted the numerous meetings with doctors Linda Gross sought out to resolve her unrelenting pain following Prolift surgery. Dr. Benson, her surgeon from Watertown, South Dakota, had operated on her for a rectocele, a small cystocele and enterocele, bladder prolapses in three areas that needed correcting.
The rectocele was particularly bad, in the Linda had to manually aid in defecating because of the bulge from her rectum into her vagina. The prolapse began after her hysterectomy in 2001.
Five weeks after surgery she felt better though Ms. Gross said some days were better than others in terms of pain. She was able to defecate, said Dr. Kavaler, indicating the Prolift had corrected the problem it was intended to treat. By September, Dr. Benson reported Linda had pain in her left groin crease as he wrote,”at the site of the superficial wing of the Pro Lift on the left side.”
“Her pain definitely seems different than what it was before,” he says in his report describing it as waxing and waning.
By October the plan was to excise a portion of the mesh from the top of the vagina. Dr. Benson warned Ms. Gross there could be complications. “She wanted to proceed,” says the notes.
At some point, Dr. Benson began consulting with other doctors, Mike Fiegan in Sioux Falls South Dakota, Dennis Miller, Dr. Trabuco at the Mayo Clinic, Dr. James Raders from Florida.
The patient was suffering a foreign body reaction said Dr. Benson. Give it time it will resolve itself.
Dr. Kavaler said the six removal surgeries that followed didn’t help matters. Pain that moves around the pelvis is consistent with a muscular situation, the urogynecologist pointed out, saying that her mesh had been placed under the vagina between it and the rectum and that would not explain abdominal pain.
At one point Dr. Trabuco from the Mayo Clinic found a mesh bundle around the ureter but Dr. Kavaler said bunching of mesh does not always cause symptoms of pain and a mesh extrusion is often just left because it too is asymptomatic except to a sexual partner.
At times Dr. Kavaler seemed to be second guessing the medical care Linda Gross received. Three doctors performed surgery to remove mesh, which the urogynecologist said she wouldn’t have done.
Describing pelvic spasms resulting from trauma of surgeries the doctor said, “They are painful. It takes time, it takes patience for these to resolve and mostly rest and recovery not necessarily lying in bed. The pelvic floor has to have a chance to quiet down. She’s had two surgeries in addition to the original one. The removal of mesh seems to be making it worse. The location of pain is not over the site of the mesh.”
Dr. Kavaler insisted that mesh does not move around within the pelvic area. “It does not have a life of its own,” she said.
Christy Jones, attorney for Ethicon asked: ‘If she didn’t have pain before the Prolift surgery how can you say the Prolift and mesh associated with Prolift didn’t cause her pain?”
Kavaler: “If she had pain from the Prolift, taking it out would help, but her pain got worse.”
Jones closed with her witness: “Based on your training and experience, was Prolift an effective medical treatment for her pelvic organ prolapse? Yes it was, said the doctor.
Jones: “Did Prolift cause the plaintiff’s pain we’ve been talking about this morning?”
Kavaler: “In my opinion it is not the source of her migratory myofascial pain.”
AFTERNOON CROSS EXAM
In the afternoon it was the job of Adam Slater, attorney for Ms. Gross to undo the damage. He established the Dr. Kavaler charged $7,000 for the day of testimony and another $400 an hour to prepare for the case. But there was more.
Slater: “You’ve been an expert witness in 20-25 cases, all but one for the defense?
He then showed the jury a release from a public relations company, Robin Leedy & Associates, showing the doctor’s work heralding the drug Cystex. In the release the firm in promoting its services said Dr. Kavaler was a “key opinion leader” indicating the PR company could hire others to support and sell a product. Dr. Kavaler said she used the drug and would not appear to support it if she didn’t.
Slater recounted her deposition where she said she “was a big mesh user.” That is what got her the attention of Dr. Vincent Lucente, an Ethicon consultant, who introduced her to Ethicon. Dr. Kavaler was driven to the company headquarters and attended a dinner in the Meat Packing District in New York City where she said she wanted to talk to other doctors.
After first being contacted by Ethicon in 2009 she began teaching courses for the company on the use of another mesh, Prosima. She was also hired to proctor a cadaver lab.
Slater made the point – Before the Prolift Linda Gross had no pelvic pain, no dyspareunia, no pudendal nerve damage. Correct said the doctor.
“You would have treated her different than other doctors right?’ he asked. “I have the benefit of hindsight,” she said not wanting to disparage the treatment Ms. Gross had received.
Slater; “Linda is taking the advice and guidance of her doctors right?”
Kavaler: “Yes she is.”
Slater: “They are trying to deal with a very difficult situation.”
Kavaler: “Yes they are.
Slater said and the doctor agreed that there is a lack of any information about mesh extrusions, removals and Ethicon ( Johnson & Johnson) was not informing surgeons then and even today what to expect.
Slater: “In 2006 there was much less information then there is now right?
Slater ran through the past six years of Linda Gross life. Medically her surgeon, Dr. Benson had contacted Dr. Dennis Miller in Milwaukee to get his opinion on the Prolift. Miller suggested he operate and cut the wing arms to try and relieve the pain. After the surgery Linda felt better for awhile.
Dr. Benson performed surgery and removed bunching mesh beyond a mesh extrusion in an area where Linda was feeling pain.
Dr. Feigan said mesh removal was the most appropriate thing to do to relieve her pain. Dr. Kavaler said the extrusion is the only thing that can be called a complication because if mesh is bunched and integrated “it’s not an issue.”
Dr. Trabuco of the Mayo Clinic removed a mass of fibrotic tissue encasing mesh.
In a heated moment Slater and Kavaler disagreed over whether mesh moves. While mesh extruded in Linda’s body the doctor said mesh finds the incision line and extrudes there. often it does not cause problems and she leaves it in the patient.
Slater: “You certainly don’t think it’s a good thing for Linda to have pieces of mesh around her pelvis?”
Kavaler: ” I think its more hurtful to go after them.”
Slater: “He found mass of mesh and scar tissue actually enveloped one of her ureters. He thought it was reasonable. It’s not normal for the mesh to envelope the ureter is it? Is it reasonable that a doctor from the Mayo Clinic remove it? It’s reasonable right?
Kavaler: “That’s not what I would have done.”
Slater: “Is that according to the Ethicon consultant book? Leave it in and hope for the best?”
Currently Linda Gross has urinary retention to the point where she must self-catheterize to urinate. Dr. Kavaler made the point that Ms. Gross was fine for 18 months after her surgery and it’s unknown why she has to catheterize.
In conclusion Slater said Linda Gross now suffers from chronic pelvic pain, debilitating dysparuenia.
She had a catastrophic outcome after her Prolift implant wouldn’t you agree?
Dr. Kavaler: “I’d say she is in an unfortunate and painful place, I agree with that, I don’t agree the cause is the Prolift.”
Taking out the mesh didn’t help, she said.
As Jones came back to conclude the witness for the day she lowered her voice and talked slowly.
“Is the possibility of muscle spasms associated with any type of pelvic surgery? she asked.
Kavaler said, “Yes, that is part of the potential post-operative course; back pain, leg, hip buttock pain, it’s part of pelvic floor surgery.”
Thank you doctor that’s all I have, said Jones.
Suddenly, the case was concluded.
Judge Carol Higbee advised the nine jurors that counsel may motion the court and argue about jury instructions. Jurors were told to check in Wednesday to see if they should report to court Thursday for instructions on the law from the judge then closing arguments.
Otherwise it could be Friday or Tuesday of next week because of the President’s Day holiday Monday, February 18. #