January 31, 2013~ On this day 14 of the Linda Gross v. Ethicon trial in an Atlantic City, New Jersey courtroom, plaintiff Linda Gross took the stand.
Gross, 47, had the Prolift transvaginal mesh implant in 2006 and her story is one of a life permanently altered.
Thanks to Courtroom View Network for access to this trial.
By way of background, plaintiff attorney Adam Slater had Linda tell the jury why she chose to work as a hospice nurse. Her late father had been sick and died in hospice. Gross had been made an honorary pallbearer in the funeral of man she knew for a short time while he was in hospice.
Those events led her to helping those who had six months or less to live. For Gross helping the terminally sick instilled a respect for life and was a reminder of the importance of enjoying everyday.
“The person who you see standing here is not who I was,” she told the jury. I was eager, energetic, loved to go to work participate in church and school activities. I took one day at a time and lived for it. God is such a strong person in my life and I hope he continues to get me through this difficult time.”
Slater had Gross recount the number of medications, 20 or so, she is currently taking to cope with chronic pain. Even during her testimony she had to stand, unable to sit longer than 20 minutes.
Slater: “How do you feel?”
Gross: “Exhausted. I have pain all the time inside my pelvic floor. The left side is quivering constantly, doing this all the time (she gestures). The way I try and control it to get it a little relief is if I lay in bed and extend my leg outward it takes the pressure off that pelvic floor bone. I constantly have rectal pain. I guess the only way I can explain if you have had hemorrhoids, multiply that by ten. It feels like something is going to pull through my rectum with sharp pain. We’ve tried various treatments and they can’t break that spasm. ”
As a nurse Linda said she is aware that all of the medication she takes is hard on the kidney and liver.
“I cannot tell you how many days I’ve laid in bed and wondered what’s next for me,” she said to the jury.
Slater established that before her surgery in July 2006, Ms. Gross didn’t have pain, problems with sexual functioning and could sit at work. She didn’t have urinary issues and the surgery with sutures to shore up her pelvic prolapse did not give her pain.
How Linda Gross was Sold on Prolift
Gross told the jury she visited Dr. Benson’s office, the surgeon who eventually implanted the Ethicon Prolift transvaginal mesh, after he diagnosed her with pelvic organ prolapse.
Dr. Benson had been trained by Ethicon on use of the mesh and taught other doctors how to implant the device.
“When I went into his office he did his exam. His options were Prolift. He was very excited about it. He pushed it. He said ‘I have a new revolutionary piece of mesh here we’ve been using with excellent results.’ He was very positive about it.”
But Dr. Benson didn’t have a patient pamphlet, so Gross says she went home and did research on the internet. She understood the mesh would be implanted with trocars, or large needles that would thread the mesh through her pelvic region anchoring into ligaments. Dr. Benson discussed suture repair as an option, though Ms. Gross says he didn’t go into detail. He actually had a piece of mesh in his hand with four wings on it. In less than 10 days you’ll be back to work she was told.
Q: “Did he tell you any of the risks?”
Slater showed her the brochure she used to make her decision.
Reminding Linda Gross of Dr. Anne Weber’s testimony about what was NOT in the Prolift brochure, Slater showed a slide summarizing what critical information was missing.
Slater: “Were you comfortable with the long term results?
Slater: “Soft mesh sounded good?”
Gross: ” Yes it did, he never let me touch it, but he was squeezing it.”
Slater: “Specially designed for placement through the vagina?
Slater: “Used on 1.5 million women, what did that tell you?”
Gross: “It told me it was out there and having positive results.”
Slater: “Is it important when they sell something it’s clinically proven?”
In summary, after Ms. Gross read the brochure combined with her doctor’s enthusiasm she didn’t think she need worry, and Johnson & Johnson was a worldwide company. She trusted what she was reading.
Days earlier, Dr. Anne Weber (right) had told the jury the rest of the story. See Day 6 of coverage here.
Dr. Weber told jurors about the complications associated with mesh that Johnson & Johnson did not include in the patient brochures, complications such as difficulty removing the mesh, its risky use in sexually active women, the potential for pain and mesh erosion.
Slater asked “Would that information have been significant to you?” Yes, Ms. Gross answered.
Life After Mesh
Ms. Gross was asked why she took a risk with mesh?
“I was willing to take that chance if there was a chance I could get better,” referring to the rectocele prolapses he said. In July 2006 she consented to have the Gynecare Prolift mesh, an entirely new transvaginal medical device delivered to doctors in pre-cut kits, implanted in her body.
Gross spent the rest of the morning recounting her life ever since. The mesh had formed a hard band around her abdomen. It was so tight it was causing stretch marks. She had the first of nine mesh removal surgeries at the Mayo Clinic. She then had a pain pump implanted. It began leaking and she developed an abscess and fistula that required an additional surgery.
Jurors were shown images that were not projected in the courtroom.
Then Ms. Gross had a spinal stimulator implanted to see if it would allow her to urinate normally. Medtronic adjusted it but made it too high and she leaked urine. At the Mayo Clinic last October she was injected with a nerve block and awakened part way through the surgery to see if it was hitting the correct nerve.
Remembering the surgery and snippets of the doctor’s voices as she was partially awakened, Ms. Gross began to cry. When she woke up, she said she was in unbelievable pain like labor giving birth. It lasted five days as she lay in a hospital bed waiting for the medication to be absorbed.
“No one should have to go through this, it was just unbelievable,” she said through tears.
“I want to have a normal life, I don’t get to have that choice, it’s not an option anymore. Because I put my faith in people I respected. And I found out it’s a journey others are going through too. But it’s not fair – no one should have to experience it!”
Slater: “What is it like to have a life dominated by doctors?
Gross: “The exams are painful and humiliating.”
Gross said she has repeatedly experienced mesh coming out on its own. Gross has scheduled a visit to the Mayo Clinic’s pain clinic in March to try and learn how to live with the pain.
Slater asked if she can work or if she has tried to work.
After being fired from her job as a hospice nurse in 2010 for exhausting her family leave, Gross went back to work briefly in 2011 because the family needed the money. A friend had an assisted living facility and Linda would work for four hours on then would have to lay down for 2 hours in the facility. It got to be too much to handle.
“I tried and I tried many times to go back. I would do that because I needed to I wanted to and I’m not ready to give up. There is nobody there that can help you. It’s an awful feeling especially when you are doing a minimally invasive procedure.” she cried.
The one time she rallied was for her son, Terry’s wedding in October. The jury was shown pictures of a smiling Linda. She was able to dance one dance and had to excuse herself.
“My friends quit calling me because they don’t know what to say. They cannot believe this is happening. And I put a lot of my trust in healthcare because of what I do.”
Gross says it takes days to recuperate from an outing. She must self-catheterize four times a day to urinate. She discussed using a morphine pump with the doctors at the Mayo Clinic but is concerned about the effect on her body.
“All the time I’m fearful about dying and the effect on my kidney and liver functions and some has to do with the medications I have to take. It’s just beyond words.”
It was Christy Jones turn to cross examine Ms. Gross.
Speaking in carefully measured tones she reviewed Ms. Gross background in nursing. You learned in nursing school there were risks associated with surgeries, she asked. Among those risks might be those associated with anesthesia, potential damage to organs, the risk of scarring and adhesion?
“I’m not understanding your question,” said Ms. Gross on more than one occasion.
Jones: “In fairness that’s one of the things you learned in nursing school, when you implant a foreign body into the body there are also some additional or different potential risks?”
Gross: “Yes, and I did ask a specific question to Dr. Benson regarding my procedure.”
Christy Jones then ran through the litany of ailments affecting Linda Gross from stress urinary incontinence in 2001, bleeding problems, a hysterectomy, which she chose over taking oral contraceptives, spinal headaches, gallbladder surgery. Clearly she was painting a picture of a woman plagued with problems.
Dr. Benson explained he would use trocars and the purpose of the mesh would be to grow into the body, she affirmed. There would be a risk of inflammation and nerve damage. Yes, Gross said.
Jones: “In the course of that, one of the things you understood it might be associated with an exposure of the mesh?
Gross: “When I asked Dr. Benson that question he said you go in and you remove it.”
Gross: “I researched Gynecare and I read it and it sold me. I based that on what I read in the patient brochure. I wasn’t looking for answers I was being told this so I made the decision to go with the Prolift.”
At this point her anger escalated.
“That was my mistake. Why did I need to keep researching? You are trying to blame it on me! It’s not right!!”~Linda Gross
Judge Carol Higbee reminded Ms. Gross not to yell at counsel. At that point they took a break for lunch.
After lunch Adam Slater asked Ms. Gross if doctors continued to perform surgery on her. “Did you force them, stick a gun to their head?” “I did not,” she said.
Slater asked why she wanted the polypropylene (PP) mesh out of her body.
“My body is rejecting the mesh; it is horrific pain and every day every day I pay for it. These doctors at the Mayo Clinic were fearful of making me worse than I already am. I find out mesh wings cannot be removed.”
“My vagina was on fire, we were able to calm it down with medications. Then in November it began to be found piece by piece”
The calm, soft spoken Ms. Gross told the jury about the surprise of physicians who have found mesh.
“Dr. White said ‘What the f*** is going on here!’ he told me that,” she said after another doctor found more eroding mesh particles in her pelvic region.
Judge Higbee warned she needed to be calm.
After a few questions about what the Prolift brochure which promised a “revolutionary” new product, the jury was sent out at 3:10 pm to formulate any questions it might have for the witness.
The jury came back and asked to see the video of witness Dr. Patrick Retterath, a pain doctor who has treated Linda Gross with pain blocks.
He confirmed pudendal nerve damage.
“You don’t have control of employment, enjoyment of their kids, they are overwhelmed in this case I was seeing that,” he said in his taped deposition.
On cross exam he was asked whether he could say whether scar tissue from repeated surgeries and not the mesh may be causing her pain.
A: “Chronically, it seems from the story presented it was isolated to that surgery and it seemed to be related to that mesh.”
Q: “You don’t have any information about irritation to the pudendal nerve prior to Prolift?”
A: “She did not have those complaints to me.”