February 11, 2013 ~ The trial of Linda Gross v. Ethicon started late in the day around noon on Day 21 of the proceedings. Apparently legal arguments were taking place off camera and out of the ear of the jury.
The case has now gone to Ethicon to refute the evidence presented so far. Remember what the goal is as stated by Ethicon attorney Christy Jones:
~ “Plaintiff has the burden of proof that Ethicon failed to warn about the product and the failure to warn caused her injuries. That means they get to go first and they get to go last. In this case it means the plaintiff counsel predicts what I’m going to say before say it. He’s wrong about this. This is not a baseball game, this is a court of law and very serious allegations have been made in this case and allegations the plaintiff has to prove by a preponderance of the evidence and that comes from this witness chair.”
Thanks extended to Courtroom View Network for access to this trial!
LINDA GROSS’ DOCTORS
If one could talk to Linda Gross today it would be interesting to find out how she feels about two doctors, one of whom she sought out for medical help, who today became witnesses for the defense. Ethicon.
The doctor appearing this afternoon did the most damage to Gross’ case so far in the trial.
The first doctor, Dr. James Raders, a urogynecologist from Melbourne, Florida was shown to the jury via videotape around noon.
Here is his profile.
Associated with Dr. Ralph Zipper of Zipper Urogynecology, Dr. Raders saw Linda Gross as a favor to her surgeon Dr. Kevin Benson from South Dakota. Evidence in the case presented so far shows that Drs. Benson and Raders have both worked as consultants to Ethicon, part of their “super user” network the company tried to create around the country.
Raders also spent some time at the Institute for Female Pelvic Medicine and Reconstructive Surgery, which is the same clinic run by Drs. Miles Murphy and Vincent Lucente, two other Ethicon consultants hired to train other doctors in the Prolift procedure.
Dr. Murphy appeared on the stand last week for the defense.
In February 2007, Dr. Raders found Linda Gross was in chronic pain especially on her left side. She described a burning sensation and was unable to fully void, or pass urine.
The doctor said he discouraged her from having further surgery. She had already had a hysterectomy, a Burch and McCalls suspension and a rectocele. She felt the mesh was causing her pain and she wanted it out.
“All mesh products undergo chronic inflammatory reaction, it’s assumed that’s going to be happening. That’s the way in which the body deals with the foreign object,” said Dr. Raders.
Dr. Raders said more than once that he discouraged Ms. Gross from doing more surgery. He relented and on May 22, 2007 he excised a portion of polypropylene mesh from her 5 by 2o mm in size.
He wrote to her doctors back home in South Dakota he was “very happy to report today or the time being she reports significant improvement in symptoms.”
Yet Dr. Raders found Linda Gross was suffering from chronic pain syndrome, “the complication of any pelvic reconstructive surgery. Now the cause of that is less well defined,” he said on videotape.
“She had reconstructive pelvic surgery and developed pain before I saw her,” he added.
Adam Slater, attorney for Linda Gross then handed the doctor page after of page of documented records and read off the date of each one, a dozen at least with different dates.
Slater called them consulting agreements with Ethicon that went back from 2005 to 2011.
“We totaled up the payments and got over $400,000, does that sound right to you?” asked Slater.
“I’d have to go back and do the math,” said Dr. Raders.
Slater: “You would never operate on a patient if you didn’t think the potential benefit of that surgery outweighs the risk correct?
Raders: “I’m not going to even answer that question,” then he said, “If the risks are minimal the potential benefit might be greater than the risk. She wanted it done and that was the benefit to her, she wanted the mass resection. She wanted that out of her rectovaginal space!”
Dr. Raders appeared to be losing his temper on camera.
SEAN O’BRYAN AND DR. CHARLOTTE OWENS
Christy Jones, the attorney for Ethicon played brief clips for the jury which they’ve already seen. O’Bryan was with Regulatory Affairs for Ethicon and he left the company just before the launch of Prolift in 2005.
Dr. Charlotte Owens was Medical Director of Ethicon Women’s Health but has also since left the company.
Slater went through a flow chart with O’Bryan to determine why it was that the product was never brought to the attention of the FDA to undergo some form of approval. The FDA found out years later that the product was being sold and it ordered Ethicon to stop selling Prolift. Eventually the FDA approved it in 2008 along with Prolift+M, the next generation of transvaginal mesh.
Going through a checklist, O’Bryan showed why he didn’t think the new product had to be brought to FDA attention. As the eyes and ears for the FDA within Ethicon he said that if new issues of safety and efficacy were raised by Prolift, it would have had to seek approval. Instead, it was an extension of the Gynemesh PS device, he said.
Slater: “If harms known within your company were not evaluated thoroughly then that would flaw the design-control process right?”
O’Bryan: “Significant risks would be in defiance of good manufacturing practice,” he said.
The videotaped deposition of Dr. Charlotte Owens was once again shown to the jury to reinforce how careful the company was to make sure the Prolift would be safe for women with all different patient profiles. Doctor selection was important too she said.
“We made sure the physicians that we sold the product to were really good experts at pelvic floor repair and at identifying the factors so they would have proper patient selection to minimize risk,” she said adding that Ethicon relied on doctors to engage in a conversation with their patients.
As far as labeling, only women who were pregnant or considering pregnancy were warned against using Prolift in the Instructions for Use.
Slater: “The word dyspareunia doesn’t appear in the IFU, you know that right?
Owens: ” I do know words are in there that are synonymous with dyspareunia to a surgeon.”
Linda Gross attorneys have been trying to establish that not only was the product defective but so were the warnings. Any complications could be addressed by Ethicon’s consultant physicians efforts to create a network of surgeon-consultant trainers who would go into a hospital to train or lecture doctors on the medical device.
Were all possible complications listed in the IFU? Slater asked. “Surgeons are trained to know the complications in the area we operate,” said Owens adding the risks were expected to be low.
Slater asked if there were any adverse events Ethicon did not determine before launch? No, she said.
WITNESS FOR ETHICON – DR. ELIZABETH KAVALER
The last witness of the day was actually sworn in before the jury in the Atlantic City, New Jersey courtroom at the invitation of Ethicon attorney, Christy Jones.
Dr. Kavaler is a urologist with a specialty in women’s health who examined Linda Gross, presumably in an attempt to help her, though that went unsaid.
(*Clarification- addition here*- Dr. Kavaler was hired by the defense to be the defense’s expert. Linda saw her in that capacity. Not willingly or for treatment.*)
She even trained under famed mesh removal doctor Dr. Shlomo Raz at UCLA for one year. Here is her bio.
The New York City-based doctor practices medicine at Lenox Hill Hospital and Cornell Medical School where she also teaches. About 80% of her patients are women who have problems with prolapse, incontinence, infections and pain and she told the jury she has treated all kinds of patients with pelvic floor dysfunction.
With about 10,000 urologists in the country, only about 1,500 are women. Christy Jones asked her why she went into the field.
“I was interested in women’s health and my husband’s career was limited where he could work so I was looking for an underserved community. Women’s health was absolutely an issue. This area of incontinence surgery is not only underserved but there are very few women who enter this field through gynecology or urology so I saw an opportunity,” she said.
The doctor said she trained on all kinds of pelvic procedures including vaginal and abdominal surgery using mesh, native tissue and composite meshes. She and her colleagues used to cut their own hernia mesh for use in the pelvic floor before the Prolift kit was made available. When the kit of precut mesh and placement devices was issued in March 2005, she says she was intrigued, though she says she has no allegiance to any particular type of kit.
Jones asked how Dr. Kavaler received her training. “I was trained by Vince Lucente, who did a lot of training for Ethicon,” she answered.
The list of pelvic surgeries Linda Gross had before being referred to Dr. Kavaler included a hyserectomy in 2001 and sling surgery. She had native tissue repairs to hold up her pelvic organs following the hysterectomy. Five years later she had rectocele surgery.
“In that case, mesh is a very reasonable option,” said Dr. Kavaler. Slater objected and the microphone was turned off as both sides went into a sidebar.
Coming back Jones asked the doctor to continue.
Linda Gross was in pain and it came from spasms from the pelvic floor positioning, instruments and incisions, Dr. Kavaler said.
“That spasm pain is what really has created the issues going forward. Her body didn’t get a chance to heal from those spasms and she had operations and they continued to cause trauma and the spasms were kicked up. The Prolift was not the source! It’s the pelvic floor surgery. If she had time to heal I don’t think she’d be in the position she’s in,” said the doctor, negating the entire defective product case of Linda Gross before the jurors.
Dr. Kavaler added there was no exposed mesh when she did an exam, no evidence of infection or bridging fibrosis, scar tissue that causes mesh to contract and creates chronic pain.
She explained to the jury that pelvic floor dysfunction refers to the musculature of the pelvis. The sheets of muscles are perforated by three structures, the urethra, the vagina and the rectum.
But a muscle spasm is painful and difficult to isolate because it’s so deep inside, she said. Similar to a back spasm, this pelvic floor dysfunction can cause difficulty urinating, defecating and pain with sexual activity. What causes it, asked Jones. Stress could be a factor, so could surgical trauma.
“We see a lot of it after pelvic floor prolapse surgery,” she said.
Jones asked considering all of the procedures Linda Gross endured, would anything be considered to be a contraindication for another pelvic surgery involving Prolift?
“No,” answered Dr. Kavaler. “I think Prolift was a very good option for her.”
“When we present surgical options, we offer safety, efficacy and durability, that means it’s going to last. We don’t want her to come back. The goal is to make this a successful operation and it would involve those three components.A mesh augment is going to give her all three of those.”