Patricia Jill Mesigian &
Dr. Joye Lowman
Blog: Summary of Pelvic Mesh Trial of
Patricia Jill Mesigian
May 14, 2019
Direct Examination of Defense Expert, Dr. Joye Lowman
Use of mesh for prolapse repairs decreases the re-operation rate compared with native tissue repairs.
With use of mesh for prolapse repair, there is a smaller number or incidence of recurrence of the prolapse.
There are no de novo (new) cases of dyspareunia associated with using mesh for pelvic organ prolapse repairs (aka “POP”).
Regarding the Cochrane Report, native tissue repairs have a high rate of re-occurrence compared with mesh used for pelvic organ prolapse repairs.
The Cochrane Report, a group or society of Gynamesh surgeons, a research group, performed two meta data analysis studies, including a 41,000 woman large cohort study, made possible because New York has a statewide registry system. Also, Canada has a universal healthcare system that enabled the study to keep better track of everyone participating in the study.
There was also a 60,000 woman study, of these women only 2-3% returned to the operating room following having mesh implanted for pelvic organ prolapse repair. Over a ten-year period, only 1 out of 20, or only 5% returned to the operating room.
There was a 2017 study, where clinical pathologists examined tissue under the microscope to determine levels of inflammation, fibrosis (scar tissue formation), and reported complications, nerve injury or trauma.
Dr. Lowman claims this study showed only mild-moderate inflammation, and only to tissue in direct contact with the mesh. It did not affect tissues surrounding the mesh.
She claims polypropylene is very well tolerated, with only normal inflammation, which is expected, and not extreme.
She claims the management of complications has been successful according to the Crosby study done in Michigan in 2014. Said the treatment of erosions has been successful, has a 95% success rate, in correcting the erosion surgically.
Cross-Examination of Dr. Joye Lowman by Plaintiff's counsel.
There was good reason to investigate the potential of using Ultra Pro instead of polypropylene mesh for “POP” repairs, to reduce complications, exposure & retraction. Evidence based medicine and case control studies showed that Prolene Soft or Vipro would do well.
There was feedback from surgeons before Prolift was put on the market, as to what characteristics surgeons desired of the material used in pelvic organ prolapse repairs.
Dr. Jacquatin, inventor of the Prolift, did a study using 100 women patients, found using Vipro would have a 17% erosion rate, and found the material very supple. There was an email in 2014 to Ethicon’s Laura Angelini, stating that erosion rate using soft Prolene was lower than using polypropylene mesh for “POP” repairs.
There was a study, where they were looking at Vipro, a mixed fiber, that was partially absorbable, and this also had a high erosion rate, using this did not reduce inflammation, and had disappointing results in terms of tolerance.
In 2004, before Prolift was put on the market in 2005, it was known there were problems with Vipro, this was never on the market for treating POP. It was known before Prolift was put on the market in 2005 that there problems with the polypropylene mesh in terms of retraction and rigidity.
Gynamesh put Prolift on the market between 2005 and 2012, when it was withdrawn.
A softer mesh was requested, with less contraction and rigidity, they needed a new mesh, and less mesh.
According to the 2013 Cochrane Report, it stated that the data on morbidity was limited.
According to the 2009 Carey Study, before introducing the Prolift on the market, the authors concluded that a larger study was required to assess safety and efficacy. Ethicon had not done a single study using a live woman, did not implant the Prolift into a single live woman, before bringing the Prolift to market.
Science lagged innovation, Ethicon rolled out the Prolift with little evidence to support its safety and efficacy.
Dr. Joye Lowman wrote an article, and the Prolift was not mentioned by name, as she was told not to mention trade names, but she wrote there was little evidence to support safety and efficacy of polypropylene mesh for pelvic organ prolapse repairs.
She stated in her article that there was a need to reduce stiffness and shrinkage of the area after the mesh was incorporated, yet these risks were not mentioned in the product information brochure, the “IFU”, when the Prolift was brought to market.
Once the polypropylene mesh was used, Ethicon was closed to innovation, in its TVT slings.
The Prolift +M was invented when the Prolift was still on the market. Plaintiff, Patricia Jill Mesigian, was implanted with Prolift in 2008, she missed the next frontier, got only what was available at the time.
In 2013, information was limited, earlier years also had limited information compared to where we are today, comparatively speaking.
No mesh is the best mesh, she claims that is opinion evidence.
Dr. Axel Arnaud, Ethicon Medical Director of Europe, said that the risk of anatomic distortion must be put on the label of the Prolift.
Dr. Joye Lowman was paid more than $132,000 in this case alone, and she earned $160,000 in just 18 days. She spent more than 300 hours, doing mock cross-examinations, getting ready for Attorney Kila Baldwin’s cross-examination and questions.
She claims Ethicon did meta analysis and evidenced based practice, she also claimed there was systematic literature review done as to the Prolift +M.
In a 2011 study of 120 patients, it proved that the material was not biologically inert, there were photographs of the degradation process. There was a higher risk of erosion than abdominal mesh surgery (for hernia repairs). This was meta analysis, the highest level of evidence.
There was a meeting in March of 2009, and they only looked at published studies.
A 2015 review, stated that the mesh had an erosion rate of up to 36%.
There was a Pennsylvania Consulting Report stating that no one believed there was a zero complications rate with the mesh.
The complications of the mesh are debilitating: erosion, pain and dyspareunia, and surgical management may not resolve the symptoms.
According to the Crosby Study, patients are referred to a tertiary care center, (the worst complications patients) – 63 out of 90 patients, and the treating doctors found that the mesh was not lying flat, and was not tension free, at the time of mesh removal, there were 5 mesh removal surgeries. The mesh was found to be bunched, rolled, in a tight ball, taut and gathered.
Dr. Joye Lowman kept making speeches, making sure to get certain catch phrases and bullet points said before the jury, even where no question was pending, prompting numerous objections from Kila Baldwin, many of which were sustained by the trial judge, Judge Daniel Anders.
There was a 2017 Study which said that more studies had found that there was no evidence that the benefits outweighed the risks, said between 7-18% of the group required repeat surgery for mesh exposure, that there was a higher rate, 1.3%, of de novo (new) stress incontinence, and a 3.92% bladder injury rate.
Dr. Lowman claimed that the rates of dyspareunia are equal (mesh versus native tissue repairs), and that there is a very low quality of evidence supporting these complications rates for mesh used in POP repairs. Attorney Kila Baldwin told Dr. Lowman to stop talking when no question was pending, and asked Judge Anders to instruct the witness accordingly.
There were 32 randomized control trials which showed there was no evidence to support that the benefits outweighed the risks as to the Prolift being used for pelvic organ prolapse repairs.
The implanter (surgeon implanting the mesh) did not know of the risks despite the surgeon’s monograph, which Plaintiff's counsel stated in his closing statement was like a treatise.
The product information brochure, or the IFU, described the Prolift procedure as “minimally invasive,” when in fact it was a major invasive procedure, in fact it was listed as number 6 on the list of major invasive procedures – the Gynecare Prolift used for pelvic floor repairs.
In 2013, the Schimph Study and the Cochrane Review, and the Debagner Study (not sure of spelling), cited by Dr. Joye Lowman in her 2008 article, mentioned the mesh was cut to fit, before the Prolift kits went to market, this study was translated from the French, and stated complication rates including the Prolift kit, and said there was a lack of serious studies, a lack of standardization, and the surgical procedures were not validated.
There was a lack of information as to patient quality of life, and was unacceptable for functional surgery, given the rate of complications.
The French surgeons gave their ideas and opinions, the expert surgeons that created the product, and their ideas were intended to lead to actions, to make the product safer, the product should have been removed from the market.
There was debilitating chronic pelvic pain, and a lack of long term follow-up studies.
There was a 24% rate of de novo dyspareunia, a high rate based on returned patient questionnaires.
There was a changed study design, and still there was a 17% high rate of dyspareunia.
Dr. Lowman was told there is a 39.3% rate of dyspareunia, which Dr. Lowman claimed was along the same rates as occurred with native tissue repairs.
The Plaintiff testified that it felt as if she was being torn apart when she attempted to have sex with her husband. She was in extreme pain.
Kila Baldwin asked Dr. Lowman how many mock cross-examinations she participated in, Judge Anders sustained the objection of defense attorney, Kat Gallagher, of Beck Redden, that this question was beyond the scope of her examination of Dr. Lowman.
During Ms. Gallagher’s re-direct, Dr. Lowman claimed there was a 40-50% success rate with native tissue repairs according to recent data.
She understood where higher erosion rates come from but claimed the true erosion rate according to the Chabady Study (not sure of spelling) showed only a 2% erosion rate.
Dr. Lowman said the Cochrane Study showed a composite outcome with unfair results because there can be no erosion with native tissue repairs because there is no erosion without mesh, that including erosions in complication rates skewed the results in favor of native tissue repairs.
She called this “stacking the deck” and opined that the Cochrane Study results were, hence, biased.
Dr. Charlotte Owens,
Dr. Charlotte Owens via Video Deposition from 9/12/2012
Chronic pelvic pain and dyspareunia are common risks of all pelvic floor surgeries, with our without mesh.
The mesh is safe and efficacious, the benefits outweigh the risks.
Cross-examination by Adam Slater, Esq., Plaintiff’s Counsel
Dr. Owens is not a uro-gynecologist. She has done native tissue repairs predominantly.
She is not an expert in pelvic floor mesh in the vagina.
She knows of preclinical and animal studies regarding the Prolift system.
When it was first marketed it was never used in human patient bodies.
There was adverse event reporting, cadaver work and animal studies.
The mesh can become contaminated on the way through the trocars and introducers, and this can cause infection. It can be difficult to treat infection.
Infections do not happen often and it is not difficult to treat, in Dr. Owens’ opinion.
The mesh is intended to lay flat in the pelvis and provide intended support.
According to Doug Hale, a surgeon that Gynecare had great respect for, he contacted Kris Hillman at Ethicon, and informed her and Paul Mcrasko, who was in charge of sales, that he has already seen erosion with grafts placed vaginally, and it does not sit well with him, he is not comfortable using it. This was said in an October 28, 2004 email. He said he would like to see what happens with it, he’s conservative. He’s reluctant to use the mesh vaginally.
In an email from Giselle Bonot to Charlotte Owens, dated November 1, 2004, she said that erosion is a concern of Dr. Hale, using the gynamesh material in the Prolift.
Dr. Owens said that patient’s disease contributes to erosion, co-morbidities such as smoking. There was no discussion that this was not the right mesh, even though there was another material available to Ethicon, with a better safety profile.
A January 14, 2005 email from Gene Kammerer, regarding using Ultrapro for pelvic floor repair, was sent to Dr. Zenobia Walji of Ethicon in the USA.
Dr. Owens worked in Somerville, NJ. She was copied on the email.
The email stated it was necessary to reduce scar contraction, reduce recurrence of prolapse, and reduce erosion, reduce and lower density of scar formation.
Gynamesh PS versus Ultrapro. Dyspareunia caused by scar contraction. Foreign body reaction, inflammatory response and formation of scar tissue.
Some patients are a bad risk for surgery, such as women contemplating pregnancy, there are contra indications.
Want to change to the IFU. Include risk of anatomical distortion of the vaginal cavity as a stated risk, which can interfere with sexual intercourse.
There is a risk of complication, an increased risk in the case of a woman who has had a hysterectomy.
Axel Arnaud wanted to have the IFU revised as soon as possible (ASAP), to include risks to sexually active women.
Dr. Owens was asked how much time she spent preparing for her deposition, meeting with lawyers and reviewing documents. She said a week, well over 40 hours.
She signed the Clinical Expert Report dated 9/20/2002, prepared by her and also signed by Martin Weisberg. The Gynamesh clinical report is identical to the clinical report for the Prolift system for Pelvic Floor repair.
She authored it. Scott Ciarrocca authored part of the report. Part of the report was copied from the Gynamesh PS, put the same info in the Prolift report.
It is impossible to forecast the amount of mesh retraction, because it is highly variable.
Contraction of the mesh can cause severe pain and dyspareunia.
Dr. Owens said there is mesh contraction also with hernia repair.
It is hard to remove mesh from a woman’s body, there has never been a study on how to remove mesh.
Mesh is a lifelong implant and can lead to lifelong pain and disability.
The IFU falsely describes a “transient” inflammatory body response, part of healing, and incorporates mesh into tissues, as seen in animal studies.
There is a more severe inflammatory body response in women, which is permanent, which could occur in some women.
Animal studies – the response is not like in live women. The Prolift was used in cadavers, but not in live women. Ethicon never placed the Prolift or Gynamesh in a human body prior to marketing it.
Scarring and implant contraction can lead to chronic pelvic pain, and dyspareunia – which could permanently compromise the quality of life, on a long term basis.
Dr. Owns claims that there are no side effects that were not anticipated as of the date of launch of the Prolift.
Professor Jacquetin – the inventor of the Prolift – he wanted to ensure good sexual activity post-surgery, and told Laura Angelini to improve the materials is the next frontier, a next generation of materials was already being talked about and looked at, because there was a need to improve the mesh materials.
There is a 33.6% post-surgical complications rate, including 77 granulomas, 11.3% exposures, 80 retractions & contractions of the mesh, 36 or a 6.9% prolapse recurrence rate.
Retraction, dyspareunia, pelvic pain and Dyschezia, which is defective reflex for defecation, and painful bowel movements.
Thomas Kline, Esq.
Thursday, May 16, 2019
By Thomas Kline, Esq., on behalf of Plaintiffs
This is an epic tale of corporate misconduct, profits put before patient safety.
Unmet needs versus corporate billions.
This contraption – $7 million spent to market it, only $600,000 spent on clinical testing.
Ethicon has net worth of $59 billion, almost $60 billion.
Strategy: Seize and conquer. Take over the world with the Prolift. Not out to help women.
Want to grab a $300 million pot of gold. Put a large mesh implant in the vagina of women.
Polypropylene slings used for SUI (stress urinary incontinence). Inventors were paid for their inventions. The inventors knew their inventions were not safe, that they caused erosions.
Emails stated: sex like screwing a wire brush, making fun at expense of women.
Takes an electric knife to get the mesh slings out.
The vagina is not the abdomen. They took abdominal mesh (used for hernia repairs) – it was not specifically designed, and is not ideal for placement in the vagina of women.
They had the next better product already.
Micro-porous is pores less tha 1 mm.
Pore size is sensitive.
In 2013 litigation, trying to figure out the pore size, they haven’t figured it out, have not put it in writing.
There was no company witness that still works for Ethicon.
Charlotte Owens is a former Ethicon employee.
The mesh becomes hard as a rock, folds like a potato chip. They knew this, knew the safety problems of Gynemesh.
The inventors were concerned with the shrinkage of the mesh, knew it caused pain and dyspareunia, knew erosion was very common.
They had a 2005 email stating that Gynemesh causes infection, scar contraction, balling of the mesh, inflammation, pain, stiffness, discomfort with sex, the safety profile has a quite worrying erosion rate.
Bernard Jacquetin, the inventor of the Prolift, said he would not like his own wife to undergo this procedure.
Recall the emails where they are snickering at the expense of women.
There was a stop sign held up, telling them to stop.
They never tested the candulis and trocars (insertion devices), the mesh does not lie flat or tension free.
They tested a different device.
Professor Clinga, Plaintiff’s expert, by way of video deposition, testified that the pore collapse increases risk considerably – and he’s their man.
Surgeons are pressing for changes, want new mesh and need it tomorrow (ASAP), both inventors and surgeons.
They knew they had advanced mesh which is better. But they wanted to sell today, and safety advances tomorrow.
Ultrapro was not used in the Prolift, it was not good business. Gynemesh was selling at a premium price.
Prosima has no cannulas to rope through, and can be used to hold up the anterior prolapse.
They knew about Prosima in 2004, and that it does not have the pile of mesh in it, it uses 1/3 of the mesh, yet they chose to sell the Prolift, with mesh the size of a football field.
Prosima was later used for POP 2 – prolapse repairs.
The unmet needs piled up: shrinkage, vaginal distortion.
Why market it? $400 million market by 2008, 46% of the market.
Two problems: exposure and shrinkage. Doctors say it’s a problem.
2008-pieces of excised mesh. Mesh erosion removal specialists, fibrosis, mesh folded over.
POP doctors, top doctors – not good evidence? Need a softer mesh, too much scarring, need less erosion, less shrinkage.
2012: no women implanted since.
Defense experts do not use vaginal mesh in their patients. Women are horribly injured.
Preponderance of evidence – on any issue – Plaintiff wins, tip scale ever so slightly.
Verdict Slip. Patricia – 2 years to file lawsuit from when she knew or should have known that her injuries were caused by conduct of another.
The implanter would use again – 2018 still safe. Good evidence.
December 5, 2008 – erosion. Needed “tweek.” Trim and fix it.
For 3 ½ years, no problem. 2012 – spotting, second erosion, 4 ½ years later.
Plaintiff saw tv commercial, something wrong with the mesh she started thinking.
She had a discussion with her husband George.
2013 – third surgery, second removal surgery.
Definition of defective: fail to meet physician expectations or risks outweigh benefits, not mean broken.
Consumer expectation test – not perform as safely as normal physician would expect it to perform.
33 failure points: Dr. Margolos testified to, from the medical records. All defects, never challenged. He’s not in Ethicon’s hip pocket.
The mesh is not inert, foreign body reaction for the rest of her life.
Told by their own doctors and by the inventors – told by early users and top customers.
Cochran review: risks outweigh benefits, highest level of evidence.
Abdominal Sacrocolpopexy: surgery of choice by their own expert.
Dr. Joye Lowman: She did this for a sexually active patient. Plaintiff had normal sexual function and normal anatomy.
Not ethical – manipulating the literature, they are spinning it.
17-39% dyspareunia rate, 16.7% - her own study.
Risk – Utility Test: risks outweigh benefits, higher rate of repeat surgery – you betcha!
A factual cause of her harm: mesh causes erosion, it’s the only cause of erosion, it mutilated Plaintiff’s vagina. Dr. Lowman’s testimony confirms this. Find for Jill.
Dr. Lowman testified: 2 erosions, did mesh erosion cause her bleeding and dyspareunia? Said yes, was a deer caught in the headlights.
Injury board: from the medical records, unassailable.
Atrophy, smoking, COPD (lung condition), liten schlerosis, constipation – “make up” charges
Additional cause – contributing factor is not a defense, won’t get them across the plate.
Atrophy is their defense.
No mesh is the best mesh – never woke up to it.
Failure to adequately warn of the risks of a Prolift. Warnings are not a get out free card.
Properly and adequately warned is required. Not warn about dyspareunia.
Don’t use the IFU, packaged out of the box. Doctors understand the risks and counter indications. That’s what Dr. Lowman and Dr. Owens testified.
That’s an excuse – no one reads it.
The surgeon’s monograph – like a treatise. Not warn surgeons of the chronicity, frequency and severity.
Axel Arnaud – medical director – not warn of dyspareunia.
Should only be used for grade 3 and 4 Prolapse.
Not say chronic or severe – understated the risks.
Not specifically designed – abdominal mesh, never put in human body before Prolift released on the market.
Bilateral elasticity – false statement.
Minimally invasive – not true, only 5 procedures are listed as more invasive than the Prolift. Plaintiff had 5 operations because of repeated erosions.
Training = marketing. Rope in the doctors.
Dr. James Cosgrow, a Delaware gynecologist – sent a consent form, minimized the procedures, handed off to his partner to do the procedure.
Plaintiff said “I didn’t sign up for this.”
Damages: fully compensate for past and present, through the rest of her life.
That’s your job – a tall order. Solely in your discretion. You’re the bosses (to the jury).
1) disfigurement, 2) pain & suffering, 3) loss of life’s pleasures, and 4) embarrassment & humiliation.
Long term potential for voiding dysfunction and urinary retention.
Cut out mesh piece by piece, recommend removing all mesh I could identify.
Tried sex 6 months ago, felt like being torn apart and vagina being ripped like barbed wire.
Erosions in 2009, 2013, 2016, 2017, 2018.
Recognized by nurses at the hospital – Ethicon’s and Johnson & Johson’s frequent flyer.
Dig mesh from around her bladder, cause her urge urinary incontinence.
Pee runs down her legs at the beach – take walk with her.
Loss of consortium claim by her husband, George, 49 years of marriage.
Punitive damages: their language is money. What makes them work.
Deter them from doing this in the future.
An amount to convince them to do the right thing.
$59 billion, 700 million – almost $60 billion net worth.
Plaintiff Jill Mesigian – she chooses love over pain.
$400 million – enough to motivate them to put Prolift device on the market.
[How much to motivate them to take unsafe products off the market? As of this year, the FDA ordered mesh manufacturers to take mesh off market which is intended to treat pelvic organ prolapse, because no evidence that this application is safe or effective.]
Will they notice if $100 million is gone? It’s the jury’s choice, how much damages to award, but have them notice what their behavior should not be. It’s the jury’s choice, and the right to a jury is inviolate.
Dr. Lowman was a nice lady, Kila Baldwin yelled at her sometimes. [Implication: so what?]
Plaintiff's counsel made stadium analogies, saying each seat in a stadium is worth a certain amount of money, fill enough seats with money so Ethicon knows and feels the amount, a larger amount is needed to get Ethicon to notice, since Ethicon is worth almost $60 billion.
Plaintiff's counsel told the jury that the amount of damages is up to them, repeated this several times during his stadium analogy.
Plaintiff's counsel's Rebuttal Closing, which followed Kat Gallagher's Closing
Defendants are not serious about their challenge based on the statute of limitations, they spent two minutes arguing the statute of limitations in their closing statement.
You cannot seriously conclude that the Plaintiff knew the mesh caused her problems after her second revision surgery in 2009.
You must start the statute only from when the Plaintiff knew her injuries were caused by the conduct of another, there was no way the Plaintiff could have known this back in 2009.
The Prolift – is an example of a company – owned by its shareholders – that lost its way, putting profits ahead of patient safety.
The defense stated in their closing, "the good men and women of Ethicon” – but, in reality, Ethicon is a company owned by its shareholders.
This was an untested product. They spun the data. The product was not tested on 600 women. It was not placed in a single woman’s body before the product was launched on the market.
The emails Ethicon received – how did Ethicon respond? Not by putting additional warnings in the product IFU (instructions for use).
Johnson & Johnson is a company worth almost $60 billion. They got their expert two weeks before the trial, and she billed 22 hours two days in a row – she had only 4 hours sleep in two days?
She was paid $500 to review medical records.
Why was there bad press and why is the company not using the Prolift anymore?
This is courtroom baloney. 16% - 40% dysparuenia rate, 16% erosion rate.
In 2012, while the Prolift was on the market there was an attempt to standardize.
They rolled out kits with little or no evidence to support the safety and efficacy – not little evidence, no evidence.
Dr. Charlotte Owens was a poor manager, she put the brakes on cadaver studies without telling anyone, studies were cancelled.
Jill is not that bad, she had uterine prolapse, her medical records described her prolapse has not being that bad, yet she had a Prolift implanted in her.
The mesh caused a prolapse in another compartment (no medical testimony that makes sense coming to this conclusion).
Dr. Owens earned $600,000 in the past year, twice as much as she could have earned as a medical doctor, for work she did on behalf of Ethicon in lawsuits related to mesh implants.
A $60 billion company, and look who they brought in to testify.
Deformation was stated in Plaintiff’s medical records, same thing as a mutilated vagina.
Don’t blame the product, instead blame the woman’s body. An aging population, atrophy is normal. They designed a product for an aging woman.
Contributing causes do not get them home, the mesh caused and contributed to the Plaintiff’s injuries.
The complications – severity, frequency and permanency – were not known by the doctors.
No one would do this type of implant if the real risks were told.
Plaintiff had three erosions of her mesh.
The $1,400 kit (Prolift) was not tested, and they did not tell the doctors the real risks.
To the jury: Tell them to get their act together, speak truth to them. How bad their product was.
Let them know that you have spoken, from the jury box to the board room.
I am very hopeful, I have watched your faces, thank you very much.
Attorney Kat Gallagher’s
on behalf of Defendants
Plaintiff’s prolapse of her uterus and bladder was a gradual condition, and grew worse over time. The prolapse condition, where her bladder was falling out through her vagina, caused her dyspareunia, and limited her sexual activities.
Plaintiff’s prolapse of her uterus into her vagina was a lot more than annoying to her, she wanted to fix it surgically.
The Prolift was better at fixing prolapses (than native tissue repairs), there was less recurrence of the prolapse, so the Prolift fixed Plaintiff’s prolapse.
There are complications from medical implants, but this does not make the product defective. There is no such thing as a risk free surgical implant.
The risks associated with the Prolift were well known by the surgeons that do pelvic floor surgery, the surgeons also know the risks from medical school, the medical literature and from talks with other physicians.
Chronic pain, dyspareunia, repeat surgeries – these were all known risks at the time of Plaintiff’s procedure.
The Prolift did not pose an unacceptable danger – a relatively low percentage of women get these complications.
Dr. Joye Lowman, a woman with 15 years of education, and having spent 10 years working at Kaiser, Plaintiff’s counsel said she was unemployed when in fact she left Kaiser to set up her own practice. Everyone knows this, she was starting her own business.
So what if Dr. Lowman asked Dr. Vincent Lucente for his assistance in locating work after she left Kaiser. It is no different from Dr. Margolis’ son working at the law firm of Plaintiff, and he’s not a lawyer nor a doctor.
Dr. Margolis learned about the Prolift from watching videos, but he never implanted the Prolift in anyone.
The Prolift has a low complication rate when used to treat pelvic organ prolapse.
The majority of doctors are using polypropylene mesh transvaginally.
The majority of doctors were using the Prolift and believed it was the best option to treat prolapse back in 2008 when it was implanted in the Plaintiff.
Dr. Masaida (not sure of spelling) recommended that Plaintiff have more mesh implanted in her less than two years ago, the Plaintiff said yes, and mesh was implanted in her in 2017 to treat her stress urinary incontinence.
Dr. Margolis has watched doctors implanting mesh in women and he doesn’t say a word.
The Prolift is known for its usefulness and desirability, has a good safety profile and the likeliness and seriousness of injuries suffered is not high.
Native tissue repair – low benefit, higher risk of recurrence of the prolapse.
Abdominal Sacrocolpopexy – skin is tacked onto the bone, there is a high risk of infection. This procedure also can have long term complications.
Every company and business desires to improve their products, there is no such thing as the perfect implant.
Gore-Tex (Teflon) – has a higher erosion rate, and a much higher infection rate.
Vipro has a high erosion rate and high failure rates.
Prosima has the same complications as the Prolift.
There is no evidence that any of these products are any safer than the Prolift.
In 2008, the Prolift was the best available product when Dr. James Cosgrove (Delaware - obstetrician-gynecologist in Wilmington), implanted it in the Plaintiff.
Factual causation is an element of the case. Even if the product has a defect that defective product has to be the cause in fact of the Plaintiff’s injuries.
It is not enough to say Plaintiff had an erosion. This is a known complication of the Prolift. (As if anything other than mesh implants can cause Plaintiff’s erosion.)
There must be a defect in the mesh. Plaintiff’s prolapse, atrophy and COPD (lung condition) caused her erosions, not the mesh (absolutely ridiculous comment).
In September of 2008 Plaintiff had bladder prolapse. Her uterine prolapse was hidden by her bladder prolapse. (Plaintiff's counsel later said during his rebuttal closing that the mesh in one compartment caused a prolapse in another compartment – not sure if there is any basis for this conclusion.)
Uterine prolapse does not happen overnight. In March of 2009 Plaintiff felt her uterus fall half way down her vagina. By September of 2013, Plaintiff’s uterus was 2 cm from the vaginal opening. The uterus at the opening of Plaintiff’s vagina caused her mesh to bunch. (As if the mesh only bunches, rolls and folds when there is a prolapse, the mesh does these things as part of the tissue contracting around the mesh, as part of the foreign body response and scar formation. Retraction and contraction of the mesh causes pelvic pain, even without the existence of a prolapse.)
When she had future erosions in 2013 and 2016, her prolapse contributed to the mesh eroding into Plaintiff’s vagina (a questionable conclusion).
When Plaintiff’s uterus was prolapsing down into her vagina it was recommended that Plaintiff undergo a hysterectomy.
She was diagnosed with vaginal atrophy in 2008, she used Premarin cream off and on for this.
Vaginal atrophy gets worse if left untreated, and gets worse with age. It causes the mesh to be closer to the surface when the tissues get thinner, increasing erosions.
The skin surrounding the mesh was friable, when you touch it, it bleeds.
Plaintiff’s COPD (chronic obstructive pulmonary disease) had a small influence on her erosions (how does a lung condition contribute to erosions?).
COPD restricts the circulation of blood, the tissues need blood circulating properly to keep tissues happy and healthy. (Many people with chronic lung disease have low blood oxygen levels. COPD can cause problems with blood circulation which can cause fluid to pool, particularly in the feet and ankles. Even mild COPD can affect your blood circulation. I have not found anything stating that COPD causes tissues to become weak or thin resulting in a mesh erosion. Creative argument.)
Bleeding, pain, dyspareunia – these were all caused by Plaintiff’s atrophy, which is the number one cause of these complications. Dr. Bowling prescribed Premarin cream, your tissues are not as good as when you are younger.
A hysterectomy can cause permanent scarring, and Plaintiff’s urge incontinence got worse after she had a hysterectomy. She also had bleeding at the vaginal cuff (upper vagina). Her cervix was pulled through her vagina, causing bleeding under her urethra, a place where there was no mesh.
Plaintiff’s liten schlerosis – an uncommon auto immune disease – caused chronic inflammation, and a thinning of the skin, causing Plaintiff pain with sex.
Dr. Bowling did a differential diagnosis, said the most likely cause was that Plaintiff coughed out her mesh (sounds ridiculous).
Plaintiff is facing extensive surgery – claim made by Plaintiff's counsel. Defense attorney claimed that no one suggested that Plaintiff have all of her mesh removed.
A failure to warn claim must relate to dangers not commonly known. The focus is what the doctors knew, and did not warn their patients about.
Surgeons had the IFU and surgeon’s Monograph.
Doctors Rowchinsky and Cosgrow both knew the risks and counseled the Plaintiff.
To win Plaintiff must prove that had her doctors known certain risks it would have changed their behavior. You need not tell doctors what they already know.
Plaintiff’s doctors testified that they still would have recommended the Prolift.
Damages – must be fair and adequate, should not be based on sympathy and emotion, but instead on the evidence. Defense counsel said she does not think the jury will even need to get to the damages issue, but it is her job to mention this.
The medical records do not state anywhere that Plaintiff’s vagina was mutilated by the mesh. This is Dr. Margolis’ term to scare you.
Plaintiff had her implant in 2008, for 5 years thereafter she had no pain nor dyspareunia until 2013. Plaintiff had pain from her erosions.
Ethicon is its employees, that is who is doing the work. The Plaintiff is complaining about what employees at Ethicon did.
There is nothing wrong with making sales projections.
Ethicon only earned $115,000 in Pennsylvania during the 7 year period that the Prolift was marketed there.
In 2009 Plaintiff had revision surgery, as far back as then Plaintiff knew this was due to her mesh, yet she failed to file her lawsuit in 2011.
The Verdict & Concluding Thoughts
The jury started deliberating at around 2:00 p.m. on Thursday, May 16, and rendered its verdict the next day, Friday, May 17, at approximately 4:00 p.m.
The jury was composed of 3 black American men, 8 black American women, and 2 white American women. There were 2 younger women, the rest of the jury was older. One woman wore a muslim headdress, and one man wore a muslim head covering, both of whom were black Americans.
The jury awarded $80.025 million, $30 in compensatory damages, the rest – over $50 million – in punitive damages.
In April of this year, 2019, the Food and Drug Administration (FDA) ordered all manufacturers of transvaginal mesh for pelvic organ prolapse repair to stop selling and distributing their products in the U.S., citing a lack of “reasonable assurance” that the devices were safe or effective.
About 1 in 8 women has surgery to repair pelvic organ prolapse. Reports of mesh erosion resulting in chronic and disabling pain have escalated in recent years. The FDA has previously issued warnings about the devices, resulting in waning sales. As a result, Johnson & Johnson’s Ethicon stopped selling its Prolift mesh kit in 2012.
The Plaintiff had a Prolift mesh implant in September 2008 to treat pelvic organ prolapse, a condition in which the pelvic organs drop down into the vagina. But shortly after being implanted with the mesh, she started bleeding vaginally. When she underwent surgery to treat her symptoms, doctors discovered that a portion of the mesh had cut into her vagina, and removed the portion of mesh.
Four years later, she began bleeding again and sex had become painful. That’s when doctors discovered that the mesh had, once again, eroded into her vagina. She underwent a third surgery to remove more of the mesh. From 2013 to 2017, the Plaintiff had three more surgeries and two treatments to remove scar tissue. She is left with chronic pain.
Plaintiff's counsel stated in his closing statement that the Plaintiff may in the future have a bladder obstruction and difficulty emptying her bladder. Because the mesh is a lifelong implant and rarely can be removed in its entirety, there is a lifelong risk of future erosions and additional surgeries.
The Plaintiff stated that she didn’t sign up for this. Physicians do not know the frequency, severity and permanency of the risk of these mesh implants. If they did, they would not prescribe the Prolift, which has since been discontinued by Ethicon.