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MND, December 3, 2015 ~ It’s not surprising that the defense team in Sherrer v Boston Scientific said that two pelvic meshes on trial in this case – the Boston Scientific Solyx mesh and the C.R Bard Align mesh – are safe and effective and have been cleared by the U.S. Food and Drug Administration (FDA).
That assurance has been said of every other type of polypropylene pelvic mesh that has gone before a jury, no matter which product made by seven pelvic mesh manufacturers facing litigation, even those found to be defectively designed.
What was unique in the first day of this trial in state court in Kansas City, MO is who was blamed for the pelvic injuries to the plaintiff, registered nurse, Eve Sherrer.
Ms. Sherrer, 62, had a Solyx mesh implanted in October 2010 and a Bard Align implanted about five weeks later when the first mesh malfunctioned. After continuing pain – groin, back, pelvic area pain, she decided to have the mesh removed by the world-renowned mesh expert, Dr. Shlomo Raz, a urologist at UCLA. Women come from around the globe to have a removal surgery with Dr. Raz, who comes closer than most any other doctor in the world, to a full mesh excision.
But there was no love lost for Dr. Raz from the defense team – Robert Adams representing Boston Scientific (Shook Hardy) and Lori Cohen representing C.R. Bard (Greenberg Traurig).
Appearing for Boston Scientific, Mr. Adams said Dr. Raz had attempted to remove the pelvic mesh from Ms. Sherrer in April 2014 and that caused more harm than good.
Going one step further, Adams said Dr. Raz, who was a proponent of polypropylene pelvic mesh, made a 180 degree turnabout when he discovered he could make more money by removing it. Adams said when word got out that Dr. Raz could remove a woman’s troubling pelvic mesh, more and more women came to him from around the globe to have him fix their complications. Now, not surprisingly, he’s a big advocate of removing mesh. Please see Dr. Raz debate mesh use at AUA conference here.
Never mind, that Dr. Raz is not in private practice but is on the staff at UCLA where he heads the urology department. Salaried employees are rarely compensated based on the number of surgeries they perform. Never mind that women swear Dr. Raz gave them back their life when they had no hope.
Representing Bard, Lori Cohen presented the jury with the same premise but went one step further. Not only did Dr. Raz go from mesh proponent to opponent, but the plaintiff’s current complaints are partially due to Dr. Raz’s surgical procedures. Ms. Sherrer was not properly evaluated by him before he decided to remove the Align, a TVT, and the Solyx, a TVT-O, and Dr. Raz never investigated the cause of her pain.
It was an unnecessary surgery, Cohen said. The Align was working and there was no reason to remove it. Dr Raz did more harm than good to Ms. Sherrer, she said.
She characterized him as one of the few “outliers” who doesn’t believe in pelvic mesh implants to correct incontinence and prolapse in women
Eve Sherrer is an attractive, blonde woman who looks a decade younger than her 60s’s. She likely will testify in her own behalf in this three-week trial.
To deflect blame for the medical devices, both defense attorneys pointed to the medical condition of Ms. Sherrer prior to her mesh implants. Eight days before the Solyx mesh implant, she had bursitis on right side of the hip diagnosed along with a mild degenerative joint disease of the right hip and muscle spasms in the low back. She had a three-year history of right hip pain.
Today she has severe osteoarthritis on the top of the femur. Since it’s bone-on-bone pain, a hip replacement is recommended. Osteoarthritis, degenerative disc disease, spine issues and multiple other pelvic surgeries account for her hip, leg and groin pain as well as a gait disturbance, a shortened vagina, urge incontinence, pelvic floor spasms and lower back pain.
According to the defense, none of that can be blamed on her polypropylene mesh implants.
Solyx is not risk- free, there are no devices that are risk free, said Adams who added it comes down to balancing risk with benefits of any product. With half of women over the age of 50 who’ve had a vaginal delivery, approximately 300,000 women in the U.S. will need surgery ever year.
Adams did not add that many of those are Burch Procedures or use of a woman’s own fascia to hold up sagging pelvic organs. That’s the same surgery Dr. Raz eventually performed on Ms. Sherrer in 2014, without mesh.
BURDEN OF PROOF
The plaintiffs in this case must prove, by the preponderance of the evidence, that the Solyx and Align are both defective and caused physical damages to Ms. Sherrer. They must also prove that the alleged failure to warn her physicians about the risks, caused her damages. They won’t be able to do that, said Cohen.
Other things to consider jurors were told – that professional medical societies support the use of mesh; and that the treating physicians of Ms. Sherrer all still use mesh. Even Dr. Hill who removed the failed Solyx mesh in October 2010, turned around and put in another mesh, the Bard Align.
Dr Hill is an expert at mesh, added Ms. Cohen. He taught other doctors and was a preceptor for Bard. A preceptor is hired by a company as a consultant and compensated for convincing other doctors to use the medical device. Almost all of the mesh manufacturer who are facing thousands of product liability cases employed the preceptor model to increase sales. Some publications require that relationship be disclosed because of the potential conflict-of-interest.
Cohen then took a swipe at the experts the plaintiffs plan to bring to trial. Dr. Peggy Pence never worked at the FDA and is not a medical doctor, said Cohen; Dr. Michael Margolis disagrees with the medical community regarding mesh; Dr. Bruce Rosenzweig never implanted an Align; Vladimir Iakovlev, a pathologist who will show the jury the degradation of mesh under a microscope, never practiced medicine in the U.S.
Cohen went on to praise the expertise of the experts the defense plans to call during the trial.
PROUD TO REPRESENT BARD AND WOMEN
During his opening, Ms. Cohn said she was proud to be representing Bard and especially honored because it involves women’s issues adding that the polypropylene sling has improved the quality of life for millions of women.
Cohen went on saying the medical device industry is heavy regulated by the FDA and to suggest the Align is not safe is ludicrous. A few minutes in her presentation, the jury may have noticed a power point document that said the FDA Guidance does not require any clinical testing.
To defend this company is really rewarding, she said. #